Quality Management in The Automotive Industry: Process Audit

6
Verband der
Automobilindustrie
Quality Management
in the Automotive Industry
Process Audit Part 3
Product Development Process/Serial Production

Service Development Process/Providing the Service
3rd revised edition, December 2016
Document provided by the

VDA-QMC membership service, 02/01/2017 at 16:13
For use by PLASTIC OMNIUM AUTO only

Process Audit
Product Development Process/Serial Production

Service Development Process/Providing the Service
3rd revised edition, December 2016
Verband der Automobilindustrie e.V. (VDA)


ISSN 0943-9412
Print: December 2016
Copyright 2016 by

Qualitäts Management Center (QMC)
10117 Berlin, Behrenstr. 35
Overall production:
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Printed on chlorine-free bleached paper



Non-binding VDA Standard recommendation
The Association of the German Automotive Industry (VDA) recommends its
members to apply the following standard for the implementation and
maintenance of quality management (QM) systems.
Exclusion of Liability
VDA volumes are recommendations available for general use. Anyone
applying them is responsible for ensuring that they are used correctly in each
case.
This VDA volume takes into account state of the art technology, current at the
time of issue. Implementation of VDA recommendations relieves no one of
responsibility for their own actions. In this respect everyone acts at their own
risk. The VDA and those involved in VDA recommendations shall bear no
liability.
If during the use of VDA recommendations, errors or the possibility of mis-
interpretation are found, it is requested that the VDA be notified immediately
so that any possible errors can be corrected.
Copyright
This publication including all its parts is protected by copyright. Any use
outside the strict limits of copyright law, is not permissible without the consent
of VDA-QMC and is liable to prosecution. This applies in particular to copying,
translation, microfilming and the storing or processing in electronic systems.
Translations
This publication will also be issued in other languages. The current status
must be requested from VDA QMC.
3

4

Preface
Technical progress, customer expectations and new production technologies
lead to increasing demands in the entire chain of customer and supplier pro-
cesses. This continually poses the quality management of companies with
new and challenging tasks. It is necessary to ensure that robust processes
are in place and secure throughout the manufacturing and supply chain.
The process audit following VDA 6.3 is an important and well established
method for the analysis of processes. The process audit exhibits a high effec-
tiveness through the evaluation of the real performance of the processes on
site, by examining the interfaces and the supporting functions in the project
and serial phase.
After a first edition was published in 1998 a complete revision was made in
2010. With the 2016 edition our collective experience has been used to up-
date and optimise the volume.
The process standard VDA 6.3 contains the current questionnaire and evalu-
ation criteria and additionally the requirements for the qualification of process
auditors and the preparation and implementation of process audits.
The process audit following VDA 6.3 is part of the VDA strategy “Quality
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standard for the German automotive industry” (VDA6.x Volumes).
QUALITY STANDARDS OF THE

GERMAN AUTOMOTIVE INDUSTRY (VDA 6)
VDA 6 VDA 6 QM-System Audit VDA 6 QM-System Audit VDA 6 QM-System Audit
Part 1 Serial Production Part 2 Services Part 4 Production
Certification Equipment
Requirements
for
VDA 6.1 VDA 6 Process Audit VDA 6 Process Audit

VDA 6.2 Part 3 Serial Production and Services Part 7 Production
VDA 6.4 Equipment
VDA 6 Product Audit

Part 5
5

There is agreement between automobile manufacturers and suppliers on the
execution of audits in accordance with this publication.
We thank the organisations involved and their employees for their contribu-
tions to the preparation of the revised VDA 6.3 volume.
The following firms have cooperated in drawing up the publication:

Adam Opel AG
Audi AG
Benteler Automobiltechnik GmbH
BMW AG
Borg Warner Ludwigsburg GmbH
Continental AG
Daimler AG
Harman Becker GmbH
Knorr-Bremse Systeme für Nutzfahrzeuge GmbH
Magna International Europe AG
MAN Truck & Bus AG
Otto Fuchs KG
Dr. Ing. h.c. F. Porsche AG
Robert Bosch GmbH
Rollax GmbH & Co. KG
Schaeffler AG
Volkswagen AG
ZF Friedrichshafen AG
Technical and administrative assistance:

TU Berlin, Department of Quality Strategy and Quality Competence
VDA QMC
Our thanks go also to all who have given us suggestions in the preparation
and improvement of this publication.
Berlin, 2016
6

Contents
Preface 5
1 Introduction 11
2 Instructions for use 13

2.1 Definition of a process audit 13
2.2 Area of application for a process audit 13
2.3 Classification process audit – Potential analysis 16
2.4 Identification of process risks (risk analysis) 17
3 Requirements for process auditors 19

3.1 Auditor qualification 19
3.1.1 Internal process auditors 19
3.1.2 Supplier auditor 20
3.1.3 Process auditing as an external service provider 20
3.2 Code of conduct for auditors 22
4 Audit process 23
4.1 Audit programme 23
4.2 Audit request 26
4.3 Audit preparation 29
4.4 Conducting the audit 35
4.5 Evaluation 39
4.6 Presentation of results 42
4.7 Follow up and closure 46
5 Potential analysis (P1) 51

5.1 Definition of potential analysis 51
5.2 Requirements 51
5.3 Preparation 51
5.4 Operational sequence of a potential analysis 52
5.5 Evaluation of a potential analysis 52
5.6 Follow up activities after contract award 55
7

6 Evaluating a process audit for material products 55
6.1 Evaluation of the individual questions 55
6.2 Detailed evaluation and downgrading rules 57
6.3 Overall level of compliance and downgrading rules 59
6.4 Evaluation of product groups 61
6.5 Using the questionnaire (Process elements P2 to P7) 63
7 Questionnaire 65
7.1 Overview questionnaire 65
7.2 Project management (P2) 71
7.3 Planning the product and process development (P3) 75
7.4 Implementation of the product and process development (P4) 80
7.5 Supplier management (P5) 86
7.6 Process analysis production (P6) 92
7.7 Customer care, customer satisfaction, service (P7) 115
8 Process audit services 119

8.1 Overview questionnaire for services 119
8.2 Project management (D2) 124
8.3 Planning of the service development (D3) 130
8.4 Implementation of the service/service development (D4) 133
8.5 Procurement management (D5) 138
8.6 Providing the service (D6) 142
8.7 Customer care, customer satisfaction, service (D7) 161
8.8 Application and evaluation of process audit for services 165
8.8.1 Evaluation of the individual questions 165
8.8.2 Detailed evaluation and downgrading rules 167
8.8.3 Overall level of performance 169
9 Assessment forms 171

9.1 Process audit for material products 171
9.2 Potential analysis (P1) as an extract from the VDA questionnaire 174
8

10 Best practice/lesson learned 178
10.1 Example of a supplier self-assessment 178
10.2 Knowledge database 182
11 Glossary 185
11.1 Terms and definiton 185
11.2 List of abbreviations 194
12 Downloads 197
13 Overview matrix 198
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10

1 Introduction
The well established Audit Standard VDA 6.3 from 2010 has been completely
revised. With the 2016 edition our collective experience has been utilised to
update and optimise the volume.
The interaction of the process audit standard VDA 6.3 with other VDA publi-
cations, especially „Maturity Level Assurance for New Parts (MLA)“ und „Ro-
bust Production Processes (RPP)“, has been strengthened. In this volume the
requirements are given for process specific content. Thus the distinction be-
tween process and system audits is made clearer.
Furthermore the questionnaire has been revised both in content and struc-
ture. The interface between hardware and software in products with embed-
ded software has been included. However, for a detailed evaluation of soft-
ware development other methods are to be used (Automotive SPICE, CMMI).
The content of the process audit for services has also been revised.
The calculation of results has been adjusted. All questions are now weighed
equally. The generic approach has been deleted. The classification system
using A, B and C and the reliable downgrading rules have been retained.
Due to the revision, the current edition does not allow audit results from the
previous VDA 6.3 from 2010 to be directly transferred into calculations from
the edition presented here.
Within this volume, the requirements for the qualification of process auditors
are given in more detail. Different requirements for internal and external pro-
cess auditors are given. The qualification of auditors regarding this audit
standard is set out. Focus is also given to the actual implementation of the
audit.
Assessment questions in the areas of sustainable development, compliance
with social standards, environmental protection and conservation of re-
sources are not contained in the questionnaire. For these areas there are
special monitoring methods as well as legal and normative directives. How-
ever, if the auditor observes obvious points that are contrary to the require-
ments of this process audit standard or have a negative impact on the prod-
uct characteristics, these should be documented and included in the evalua-
tion.
11

The other volumes of the VDA series and the AIAG manuals are given as a
reference in a matrix that relates to the questionnaire.
Current information and the latest status of the VDA publications can be
found on the VDA QMC website.
12

2 Instructions for use
2.1 Definition of a process audit

A process audit is a method for impartial analysis and evaluation of the prod-
uct development and realisation as well as the effectiveness of the defined
product.
The goal of the process audit is to check the conformity of the pro-
cess/process steps with the requirements and specifications. Any deviations
that are detected are documented as audit findings and evaluated based on
the product risk and/or the process risk within the audited organisation or in
the supply chain. The evaluation must consider what the resulting risks would
be if the findings indicate non-compliant products can be expected.
2.2 Area of application for a process audit

Process audits can be used internally as well as externally throughout the en-
tire product life cycle. The questionnaire is constructed in such a way that it
can be used for small and medium-sized companies as well as for large cor-
porations.
Using the VDA 6.3 process audit, the processes in the product development
process (PEP) can be analysed and the maturity level and process risk can
be evaluated before SOP.
After SOP the process audit can be used for example for the regular monitor-
ing of the serial production and event orientated failure analysis and elimina-
tion.
The use of the individual process elements in the project phase can vary in
content and implementation period between internal and/or external applica-
tions.
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Fig. 2.1 shows possible use of the individual process elements within the con-
text of a specific project.
Customer Issue Contract SOP
Preselection
Definition of Customer
of Suppliers; Product / Process Serial
Product & Service
Potential Development Production
Process (After Sales)
Analysis
Supplier Receive Order Issue Contract SOP
Offer Preselection
Product/ Product-/ Customer
Processing of Suppliers; Serial
Process Process- Service
(Contract Potential Production
Definition Development (After Sales)
Review) Analysis
VDA 6.3 Potential Analysis (P1)

X1
P2/P3
X2
P2-P4
X3
P5-P7
X4
P5-P7
X5
VDA-MLA Innovation Phase Ongoing Series
ML0 ML1 ML2 ML3 ML4 ML5 ML6 ML7
Parts from Project completion,

Innovation Requirements
Specifiying the Release of Completion of production tools Product and transfer of
release for management
supply chain and technical production and production process responsibilities to
full product for the contract
placing the order specifications planning facilities are approval production. Start
equipment issued
available requalification
Fig. 2.1: Possible use of the process elements

P1: Potential analysis
P2: Project management
P3: Planning the product and process development
P4: Implementation of the product and process development
P5: Supplier management
P6: Process analysis/production
P7: Customer care, customer satisfaction, service
For the potential analysis (X1) see section 5.
The focus of the use of process elements P2 to P4 is on the early phase of

the product development process (X2 + X3). Both the process element P2 and
the process element P3 are used ideally to analyse the planning activities af-
ter contracting (X2).
14

The process element P4 can be scheduled at a later time to analyse and
evaluate (X3) the implementation of the planning activities in accordance with
process element P3.
The breakdown of the process elements offers the possibility to assess the
planning activities as well as the implementation/realisation. The application
of the process elements P2 to P4 is utilised for early identification of maturity
level and process risks from the contracting stage to SOP and thus supports
the process optimisation from the project phase onwards.
The process elements P5 to P7 (X4) are ideally applied at SOP analo-
gous/according to maturity level ML 6 from VDA-MLA.
As part of the serial production process elements P5 to P7 (X5) can be used
for the regular monitoring of the serial process or to support an event-based
reactive process analysis.
In principle, each user/organisation has the right to align the use of the pro-
cess elements to meet their needs during the product development and pro-
duction.
15

2.3 Classification process audit – Potential analysis
As can be seen from figure 2.2, an analysis of potential (P1) can be carried
out before a contract is awarded. The questionnaire, with a reduced scope,
can be used to assess potential suppliers who may be suitable as serial pro-
duction suppliers. Because these are potential suppliers the audit, when nec-
essary must be based on other processes/products which should be compa-
rable with the product to be supplied.
Client Award of Contract SOP
Preselection
Product/ Customer
of Supplier Product / Process Serial
Process Service
Potential Development Production
Definition (After Sales)
Analysis
Organisation Receive order Issue contract SOP
Order Preselection
Product/ Product/ Customer
Processing of Supplier Serial
Process Process Service
(Contract Potential Production
Definition Development (After Sales)
Review) Analysis
Supplier Recieve Order, Issue Contract, SOP
Sub-Supplier Supplier Organisation Client
Fig 2.2: Scope of application in the supply chain
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2.4 Identification of process risks (risk analysis)
In a process audit, the effect of the individual processes on the product is
decisive and the assessment must therefore be made from the standpoint of
the product risks involved. For this reason, the potential risks within the
process must be determined as early as the preparations for the audit (see
also section 4.3), so that they may be assessed adequately in the process
audit itself.
An example of the turtle model using process element P6 is shown below, but
the model can be used for all process elements.
Material Resources (P6.4) Personal Resources (P6.3)

What resources are used to complete the process? What areas, functions, persons support the process
e.g. machines, installations, equipment, … e.g. capacity, competence, authority, …
Interface Interface
Process
I . PS1 O I - Input O - Output I . PS3 O
step 2
Process Operation (P6.2) Effectiveness, Performance Indicators (P6.5)

How does the process work? How effectively is the process carried out?
e.g. work sequence, methods, techniques, instructions,… e.g. effectiveness, efficiency, waste,…
Fig. 2.3: Turtle Model
Firstly, a description is given of what "input" (see questionnaire sub-element

P6.1) is converted into an "output" (see questionnaire sub-element P6.6) by
the process. This is expanded by considering the following questions:
 How does the process work (work content, workflow, methods, pro-
cess, instructions – see questionnaire sub-element P6.2)?
 What areas, functions and personnel support the process (personnel
resources, resources such as capacities, competencies, authorities,
qualifications – see questionnaire sub-element P6.3)?
17

 What means are employed to carry out the process (material re-
sources such as machines, tools, test equipment, facilities, other
equipment – see questionnaire sub-element P6.4)?
 How effectively is the process carried out (effectiveness, performance
indicators, efficiency, waste avoidance, reduction in process variation
– see process sub-element P6.5)?
In a second stage the potential risks arising from these questions are deter-
mined. These potential risks must then be questioned and evaluated in the
audit. This ensures a reasonable degree of risk minimisation. The auditor as
well as the audit team should make use of their know-how to identify potential
product and process risks that could affect the product quality. This allows
focusing on specific points and/or limiting the scope of the audit. Interfaces
have a substantial influence. At interfaces information can be lost or incorrect
information can be passed on.
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3 Requirements for process auditors
3.1 Auditor qualification

Auditor qualification is an important precondition for achieving the audit objec-
tives. Audit results and comparability are greatly influenced by the qualifica-
tion of the auditors. In addition to the qualification criteria of each organisation,
the following minimum requirements should be taken into account. The or-
ganisation determines and documents the procedure for auditor evaluation
including the approval, maintenance and improvement of auditor qualifica-
tions (e.g. observation during audits/approval and witness audits).
3.1.1 Internal process auditors
Specialised knowledge
 Good knowledge of quality tools and methods (e.g. VDA-MLA, DoE,

FMEA, FTA, PPA, SPC, SWOT, 8D Method)
 Knowledge of the relevant customer specific requirements
 Knowledge of the relevant management system requirements (e.g.
ISO/TS 16949 and respectively IATF 16949, DIN EN ISO 9001, VDA
6.1)
 Specific knowledge regarding the product and process
Evidence of specialised training
 Successful participation in a VDA 6.3 training (pass mark in the

knowledge test/certificate of qualification)
Professional experience
A minimum of 3 years professional experience (after 2 years’ professional

experience in-house apprenticeship periods may be considered additionally),
preferably in manufacturing companies within the automobile industry, includ-
ing at least one year experience in quality management.
19

3.1.2 Supplier auditor
 Excellent knowledge of quality tools and methods (e.g. VDA-MLA,

DoE, FMEA, FTA, PPA, SPC, SWOT, 8D Method)
 Auditor qualifications (negotiation, conflict management, audit proce-
dure)
6.1)
 Specific knowledge regarding the product and process
 Auditor qualification as EN ISO 19011 (e.g. VDA6.3 – basic qualifica-

tion, first/second party auditor for DIN EN ISO 9001, ISO/TS 16949
and respectively IATF 16949, or VDA 6.1)
 Successful participation in a VDA 6.3 training (pass mark in the
knowledge test/certificate of qualification)

ing at least one year experience in quality management.
3.1.3 Process auditing as an external service provider

External auditors are from independent, third party organisations and carry
out audits as a service for the organisation.
 Excellent knowledge of quality tools and methods (e.g. VDA-MLA,

DoE, FMEA, FTA, PPA, SPC, SWOT; 8D Method)
20

 Auditor qualifications (negotiation, conflict management, audit proce-
dure)
6.1)
 Specific knowledge of the product and process
 Qualification as an auditor on the basis of EN ISO 19011 (e.g. VDA-

6.3-Basic auditor qualification, 1st/2nd party auditor for DIN EN ISO
9001, ISO/TS 16949 and respectively IATF 16949, or VDA 6.1)
 Examination pass mark with certificate and auditor card as part of a
VDA 6.3 training course

ing at least two years’ experience in quality management.
21

3.2 Code of conduct for auditors
 Process auditors must use their professional skills and judgement,
while respecting the law and upholding the principles of honesty and
integrity.
 Process auditors must continually develop their expertise. They main-
tain their knowledge and skills with respect to audit procedures, QM
systems, products and processes as well as specialised methods,
procedures and relevant standards. They must be knowledgeable
about the quality requirements for products as well as the specific
process risks and the possible impact on the manufactured products.
 Process auditors must at all times behave in a way that does not en-
danger the image and reputation of their own organization.
 Process auditors must not accept assignments that would cause
them a conflict of interests.
 Process auditors must not accept assignments that they cannot carry
out properly because of lack of knowledge.
 Process auditors are bound to secrecy regarding confidential infor-
mation that they have acquired through their professional activities.
22

4 Audit process
This section describes the procedure for the implementation of internal and
external audits.
Audit programme
Conducting Presentation Follow up

Audit request Preparation Evaluation
the audit of results and closure
Fig. 4.1: Audit process
4.1 Audit programme
Audit programme

Generate the Rolling adjustments

audit programme to the audit programme
from the audit as new requirements
requirements emerge
Input Process step Output
 Audit requirements  Audit programme

 Time frame
 Auditor pool Generate the
audit programme
 Current audit pro- from the audit
gramme requirements
 Experience from pre-
vious years
Objective
Audits are planned in accordance with their priority and the organisations internal require-
ments. Qualified auditors are used to achieve the objective.
23

Responsibility
The person responsible for the audit programme draws up an audit schedule
for a defined period.
Description
The need for audits is determined and prioritised by the person responsible for the audit
programme. From this, this person works with the audit customer (and, where appropri-
ate, the organisation to be audited) to set out the following details regarding the audit:
 Main focus of the audit
 When the audit is to be scheduled (calendar week, month, quarter)
 Audit scope
 Details of the auditors, in particular the technical experts
In addition to technical qualifications and the necessary neutrality, the choice of auditors
should also take language skills and and inter-cultural aspects into account.
A technical expert could be needed to assess process-specific questions beyond the com-
petence of the process auditor. This technical expert need not necessarily be a VDA pro-
cess auditor. In conclusion, the audit programme is approved by the respective manage-
ment.
Method/documentation
Audit programme
 Event-driven audit  Current audit pro-

Rolling adjustments
need to the audit programme gramme
as new requirements  Updated resource
emerge
planning
Objective
As a result of continuous adjustment the audit programme is kept current (e.g. addition of
event-driven audits).
24

Responsibility
The person responsible for the audit programme continually adjusts the audit schedule
and plans resources accordingly.
Description
Current quality problems in production or at the supplier's premises, production down-

times, supply shortfalls, new product launches or changed priorities can create new audit
requirements at any time.
During the whole course of validity of the audit programme, the person responsible for
the audit programme must ensure that these additional audits are included in the audit
schedule. The existing resources must be adapted to meet the new requirements. To
achieve this, the person responsible for the audit programme updates the existing
programme and resource planning before coordinating with the organisations to be
audited and if necessary the audit customer.
Management must be involved in up-dating the audit programme.
Updated audit programme
25

4.2 Audit request
Audit programme

Clarify the initial

Draw up the
situation with the
audit request
customer
 Reason for the audit  Audit request

Clarify the initial
 Audit programme situation with the
customer
Objective
The requirements of the audit customer are set out in a precisely detailed audit request.
Examples of requirements:
 Determine/assess/approve the current status
 Analyse/estimate risks
 Qualify/encourage/improve
 Check the effectiveness of actions from a previous audit
 Escalation
The audit request is coordinated between all parties involved in the audit.
Responsibility
Person responsible for the audit programme with the support of the customer.
---
26

 Initial situation  Audit request

 Reason for audit Draw up the
audit request
Objective
Draw up an audit request with all the information required for a structured implementation
of the audit
Responsibility
The audit customer, with support from the person responsible for the audit programme
27

Description
The following factors are for example to be taken into account in an audit request:
 Reason for the audit e.g. new supplier, complaints, evaluation of status
 Audit objective Assessment; process release; status check; etc.
 Audit type Internal/external audit, potential analysis, special audit
 Audit location internal, external
 Audit team (provisional) Auditor, technical experts
 Audit scope Processes, products, manufacturing locations, inter-
faces, outsourced processes
 Customer Person responsible for the audit programme,
management, person responsible for the product
 Audit date Desired date, audit period, shifts
 Date of the contract
 Comments Background information
 Essential documents Test specifications, contracts, important agreements,
cost stipulations etc.
 History Complaints, rejects, delivery performance,
project status
Audit request form
28

4.3 Audit preparation
Audit programme

Draw up check lists

Specify the Gathering of Limit the processes and audit plan and
audit team information and set audit focus coordinate these with
the organisation
 Audit request  Audit team

 Process documents Specify the
audit team
Objective
Selection of a suitable audit team with appropriate qualifications
Responsibility
The lead auditor specifies the final audit team and organises the audit with the team.
Description
The audit team is appointed on the basis of the audit request, any other relevant infor-
mation and by the schedule in the audit programme.
In addition to the personal suitability of the auditors and any technical experts (see section
3.2: "Code of conduct for auditors") the qualifications for the auditor must be taken into
account, especially technical knowledge. A technical expert should be provided to assess
process-specific questions beyond the competence of the process auditor. This technical
expert need not necessarily be a VDA process auditor.
29

Method/Documentation
Code of conduct, audit request
 Audit request  Documents

 Audit team Gathering of  Gathered information
 Information information
Objective
The audit team obtains all the information required to limit the scope and plan the audit.
Responsibility
Audit team with the support of the customer and the organisation to be audited
Description
The information collected for the audit must be able to describe the process as well as
the interplay and interfaces between processes. The following documents can be taken
into account:
Organisational charts, process flow chart, control plans (internal audit), FMEAs (internal
audit), standards, specifications, customer specific requirements, target requirements (e.g.
PPM), process descriptions, quality control charts, audit results, action plan from last audit,
results of supplier quality assessments (quality performance), complaints, layouts, project
plans etc.
Method/Documentation:
Checklists, notes, correspondence
30

 Audit request  Process limits

 Documents/ Limit the processes  Process steps
Gathered information and set audit focus  Focus points for the
audit
Objective
The process is limited and broken down into process steps which can be audited. The fo-
cus points for the audit are determined.
Responsibility
Audit team
31

Description
The first stage in narrowing down the process is to identify the starting and finishing
points of process. The second step is to break down the process into separate
operations in such a way that they can be assessed as separate entities. It is essential to
specify the responsibilities involved to ensure that the findings at each process/process
step are properly addressed.
The breakdown of the process can be based on existing documentation (e.g., process
flow chart) or it must be carried out by the audit team.
The process risk estimation for the isolated process must be based on the information
which is gathered.
The auditor sets main focus points for the audit in the areas where he/she expects the
greatest potential risk for product and process. One method of detecting potential risks is
the "turtle" model (see figure 2.3).
The following investigations can be carried out, depending on the audit request and the
potential risks which have been identified:
Investigation of the process flow:

An audit is carried out along the value creation chain. Various process inputs are
specified as relevant and the review is restricted to their influence on the process chain
and/or further operations in the process chain.
Investigation of the process interface:

The interface between two processes with different tasks is investigated in regard to
responsibilities, communications, the transfer of goods and information, etc.
The two investigations can also be combined.
To narrow down the manufacturing processes, the range of the audit scope is broken
down into individual process steps and/or product groups (see figure 4.2). A product
group may contain one or several process operations.
32

Start Result
(Input) Process (Output)
Client with specific Client with all
requirements requirements met
I . P O I . P O I . P O I . P O
Interface Interface Interface

Fig. 4.2: Principle of linked processes
Before the audit (and particularly in the case of external audits) it is essen-
tial that the auditors have access to all relevant information. The participa-
tion of other personnel must be agreed upon. Any restrictions should be
clarified in advance.
 Audit request  Audit plan

Draw up check lists
 Process limits and audit plan and  Checklists
 Process steps coordinate these
with the organisation
 Audit focus
Objective
The specific checklists are set based on the coordinated audit request.
Responsibility
Audit team
33

Description
From the information obtained and the organisation’s own knowledge database (see
section 10.2), the audit team extends and completes the minimum requirements
covering assessments set out in the VDA 6.3 audit questionnaire.
If any item cannot logically be assigned to an existing question, further questions can be
added. However, this means that the results will no longer necessarily be comparable. In
such cases the assessment matrix will need to be adapted.
In agreement with the audited organisation, the audit team sets out the audit plan, which
will contain the following as a minimum:
 Participants
 Names of the auditors
 Audited organisation/functional unit
 Duration of the audit  the time required for documenting each audit step must be
taken into account (for example, 10 minutes for documentation for every hour of the
audit)
 Audit locations
 Process steps/product groups
Breaks in production (lunch-breaks, etc.) must be taken into account when drawing up
the audit plan, as well as the use of foreign languages, inter-cultural aspects, changes in
shifts and transfer times. In agreement with the auditor and the audited organisation on
site changes are possible.
The planning of the audit duration and capacity depends on the process element to be au-
dited, the structure of the organisation, the location, the complexity of the products and
process, the risk and the process chain with the associated process step.
A partial audit with limited scope may be considered. In this case, it can be used to distin-
guish the identification of the audit results (as described in the example in section 6.3).
A special audit may be used in particular for weak point analysis, complaints, project flow
problems, repeated defects etc.
The use of this flexible and efficient method ensures the results reflect the assessed pro-
cess elements.
Method/documentation:
Audit plan, checklists, questionnaire
34

4.4 Conducting the audit
Audit programme

Initiate immediate
Opening discussion to Carry out audit
action if the audit
communicate the audit according to audit
detects crucial
objectives and schedule plan, using checklists
problems
 Audited organisation  Current audit plan

(on site)  Contact personnel
 Audit plan Opening discussion to
communicate the audit
 Audit team objectives and schedule
 Audit questionnaire
 Specific checklists
Objective
Important points of the audit process are set in the opening discussion.
Responsiblity
Lead auditor
35

Description
The opening discussion takes place with the management of the organisation to be
audited. The objectives of the audit are presented, together with the extent of the audit
and the audit criteria. The audit plan is confirmed and the audit leader explains briefly the
planned audit activities.
The time schedule is checked, any necessary corrections are made and the time for the
closing discussion is determined.
The units/processes to be audited can be presented by those responsible. The auditors
introduce themselves and explain their roles in the audit. The contact personnel between
the audit team and the organisation to be audited are specified.
The process of reporting and the assessment procedure is presented. Reference is
made to the confidentiality of the information and results obtained. The organisation to
be audited confirms the availability of the necessary facilities (rooms, printer, etc.) for the
audit team. In the event that personal protective equipment is necessary, this is clarified
in advance.
---
 Checklists  Audit evidences

 Time schedule  Audit records
 Contact personnel Carry out audit
according to audit
 Documents
plan, using check-
 Audit questionnaire lists
 Information from the
knowledge database
Objective
The quality standard is documented and verified taking account of the audit plan and the
situation on site
Responsibility
Audit team
36

Description
The auditor analyses whether the audited division implements the general specifications of
the organisation, the requirements of standards, the customer requirements and legal and
regulatory obligations. The analysis is carried out by asking questions and making spot
checks based on the chronological sequence of activities within the process, using the ques-
tionnaire and any checklists which have been specifically drawn up. The auditor is required
to ask open questions (see "Audit pyramid" in section 6.5).
Based on concrete cases and evidence the auditor must investigate the suitability and
effectiveness of the processes. Technical facilities (equipment, tools, test equipment,
parts storage etc.) are checked through direct inspection and evaluated if they are
suitable and in good condition. As a general rule, the discussion moves from general
questions to concrete, detailed questioning.
The auditor carries out spot checks on the implementation of instructions and
requirements relating to the products and processes, by examining appropriate
documents and records. Findings relevant for the results are noted.
Employees on-site must be brought into the audit by questioning and their responses
verified by inspection of the QM documentation.
Any audit deviations must be communicated directly on the spot with the relevant
personnel.
The audit team should meet periodically, exchange information, assess the progress of
the audit and (if necessary) reallocate the distribution of tasks within the team.
Information regarding the progress and status of the audit can be given periodically to
the audited organisation or those responsible.
The audit plan must be verified regularly by the audit team regarding the time schedule
and modified if necessary in agreement with the audited organisation.
Audit termination
An audit can be terminated at the discretion of the audit team, for example on the
following grounds:
 Refusal to provide necessary information during the audit
 Clear infringements of the law
 Active hinderance to the auditor
 Refusal to allow access to areas relevant to the audit, despite previous agreement
 Deficient preparations for the audit by the organisation
 Presentation of obviously false information
The termination of an audit must be justified by stating the reasons. Audit findings up to
the point when the audit is broken off must be documented.
The audited organisation decides about the implementation of a new audit.
37

Audit questionnaire, database, checklists
 Audit evidences Initiate immediate

 List of corrective ac-
 Notes action if the audit tions which have been
 Deviation report detects crucial prob- introduced
lems
Objectives
To prevent the further spread of serious failures (customer complaints, vehicle break-
downs, loss of function, safety-critical components, critical characteristics, etc.).
Responsibility
The lead auditor is responsible for demanding immediate measures in the occurrence of
serious failures.
Description
Facts which identify a serious risk must be pointed out to the organisation without delay,
so that appropriate, immediate action can be taken.
If serious failures occur that pose a risk for the product and process quality, the audited
organisation must define immediate actions to be used as a safeguard.
Audit report, audit evidence for starting/justification for immediate action
38

4.5 Evaluation
Audit programme

Evaluation in
Decision about
accordance with the
follow up audit
evaluation scheme
 Findings  Findings
 Audit evidence Evaluation in  Quantitative assess-
 Evaluation scheme accordance with the ment
evaluation scheme
 Individual questions
from the checklists
Objective
The quantitative assessment reflects the quality capability status of the process under
consideration. The comparability of the audit results is ensured and changes in regard to
previous audits are noted in the sense of a continuous improvement process.
Responsibility
Lead auditor, audit team
39

Description
Based on the findings of the audit the audit team evaluates the individual questions as
described in the assessment procedure in section 6.1. The basis for the evaluation is
whether or not the relevant requirements are achieved and the risks involved.
If a question is not answered (n. a.) a reason for this must be stated.
The assessments of the individual questions lead to the overall audit assessment. To
distinguish the scope of the audit the identification given in section 6.3 can be utilised.
This allows the audit results to be compared.
Evaluation - section 6
 Audit evaluation  Decision about the ne-

 Classification Decision about cessity of a follow up
 Deviation report follow up audit audit
Objective
The decision about a follow up audit is taken on the basis of the findings.
Responsibility
Lead auditor
40

Description
Under what circumstances a repeat audit is necessary must be specified. Rules for a
repeat audit can be:
 Not reaching a defined level of compliance
 Risks associated with a critical process
 Not achieving required results (zero points) for one or more questions marked (*)
 Red traffic light at potential analysis
This repeat audit must be carried out within a specified timeframe. Within this timeframe
the audited organisation must introduce actions to eliminate the deviations effectively.
In the case of a repeat audit, this must be carried out to the same extent as the previous
audit. A reduction of the audit scope to just a review of the effectiveness of introduced
measures is not allowed.
Audit report
41

4.6 Presentation of results
Audit programme

Draw up the Hold the final Release of the

preliminary audit report discussion audit report
 Observation notes  Preliminary audit re-

(positive or negative) port
 Notes on documents
Draw up the
which have been preliminary audit report
examined
 Personnel involved in
the audit
Objective
The audit report is an accurate, concise and clear record of the audit.
Responsibility
42

Description
The audit report is drawn up jointly within the auditor team. It consists of:
 Cover sheet
 Audit findings with regard to the documents which have been inspected
 Explanations regarding the assessment scheme
 Process descriptions, if appropriate
The cover sheet contains the following information:
 Audit procedure
 Fundamental internal and external requirements
 Details of the organisation and processes which have been audited, including
products and customer requirements which have been evaluated
 Audit result
 Summary of the findings
 Must be included: main deviation areas and need for action
 Can be included: positive findings and potential for improvement
 Time schedule for the action plan
Audit report form
 Findings  Draw up report with fo-

 Audit evidences cus on the audit re-
 Notes on documents quest
Hold the final
which have been discussion  Results/findings regard-
examined ing quality capability
 Decide on follow up
audit if necessary
43

Objective
In the final discussion the audited organisation and its representatives are presented with
a report. This report focuses on:
 Notification of the audit results and the audit findings, when necessary with explana-
tions.
 Specifying the next steps, such as dates for defining the corrective actions (action
plan), or arranging a repeat audit if necessary.
The audit report must not contain other findings to what were given at the final discussion.
Responsibility
Description
The following are required in preparation for the final discussion:

 Invitations to the participants as set out in the audit plan
 Sufficient space for all participants/availability of presentation facilities
 presentation of results and if necessary the (preliminary) audit results (“overall
estimation of the quality capability”)
The contents of the final discussion are:
 Presentation of the audit results
 Presentation of the status of immediate actions which have been taken (if
necessary) by the audited organisation
 Specification of further procedure
 Specification of the distribution of the audit report
 Agreement on forwarding the data within the organisation
 Closing comments by the management of the audited organisation
Audit report (assessment of quality capability)
44

 Audit report  Released audit report

Release of the
audit report
Objective
By signing the audit report by the lead auditor and the responsible persons of the audited
organization, the audit report is recognized, approved and confirmed.
Responsibility
Lead auditor
Beschreibung
---
Audit report form
45

4.7 Follow up and closure
Audit programme

Audited organisation specifies Audit team checks the

Effectiveness
corrective actions including actions for plausibility
check and
completion dates and and clarifies any
closure
responsibilities inconsistencies
 Released audit report  Action plan with

Audited organisation specifies
corrective actions including causes, time sched-
completion dates and ules and responsibili-
responsibilities
ties
Objective
To a reasonable degree, causes, actions, responsibilities and completion dates are allo-
cated to the findings.
Responsibility
The audited organisation
Description
The action plan must be drawn up within a time frame coordinated with the audit team. It
contains all the activities involved, stating responsibilities and completion dates and is
designed to permanently eliminate the deficiencies in the process.
Form improvement program/action plan
46

 Action plan with caus-  Action plan (checked)

Audit team checks the
es, time schedule and actions for plausibility
responsibilities and clarifies any
inconsistencies
Objective
Plausibility check of action plan
Responsibility
Audit team
Description
The audit team checks the action plan for plausibility and decides if the actions are
appropriate for eliminating the deficiencies (a check on documents). Here the focus
should be on the permanence of the actions taken, so that repeat failures are prevented.
Even when the action plan is considered plausible by the auditor, the audited
organisation remains responsible for the efficiency of the actions taken.
If there is any lack of clarity or disagreement, the auditor will call for improvements to the
plan. If no response is received the auditor can launch an appropriate escalation
procedure.
Note
In particular in the case of supplier audits the usual escalation procedures should be ap-
plied if action plans are not provided, or are withheld or are not plausible. However,
these escalation procedures should have been agreed upon with the supplier as part of
the contract before the audit takes place.
Action plan
47

 Checked action plan  Corrective actions

Effectiveness  Contract for follow up
check and clo- audit (if necessary)
sure
 Improved process
 Defect-free product
Objective
Closure of the control loop covering the implementation of actions with an effectiveness
check
Responsibility
Audited organisation: Implementation of effective measures
Description
The audited organisation is responsible for implementing the corrective actions and the
person responsible for the process must monitor the implementation. Checking the
effectiveness of the actions agreed upon is carried out primarily by the person
responsible for the process.
Confirmation of the effectiveness of the actions which have been taken is documented in
a dated note in the action plan by the person responsible for the process.
This person also informs the auditor, and when necessary, the monitoring organisation
of the effectiveness of the corrective action.
Possible follow on actions if the effectiveness of the actions is not confirmed are:
 Escalation procedure
 Definition of further actions
 Problem analysis
48

Among others, the following methods can be used for verification:

 Sampling
 Product audit
 Process audit
 Capability studies on machinery and process
 Intermediate status/extent of completion
 Examination of the relevant metrics before and after implementing the actions (ppm
statistics; compliance level of the objective; reject patterns)
49

50

5 Potential analysis (P1)
5.1 Definition of potential analysis

A potential analysis is used to evaluate new suppliers (contenders). For exist-
ing suppliers the potential analysis can be used at new locations, with the in-
troduction of new technologies or for new products.
An estimation is made of the potential to meet the requirements for the re-
quested products and corresponding processes.
The analysis takes into account the experience and skills of the supplier in
developing and manufacturing the scope of products requested and their ca-
pability to fulfil customer specific requirements for the product and process
implementation.
The assessment is based on existing processes for products (if necessary,
competitor products).
The result can be used as preparation for a nomination decision. It gives a
prognosis of the quality capability of the considered supplier/location for the
implementation of the product and process in the event the contract is
awarded.
A potential analysis can also be applied independently of a project at times of
a supplier change or relocation.
As part of a current serial production (completed product development phase)
just the questions from the process element P2 to P4 related to the process
development can be used for an assessment.
5.2 Requirements
Because no contractual relationship exists between the customer and the ap-
plicant (possible supplier) during the enquiry and quotation stages, there
should be an agreement made regarding confidentiality and access permission.
5.3 Preparation
Obtaining information in preparation for the potential analysis is of particular
importance. In addition to the customer’s own research, one valuable means
of obtaining information is to ask the prospective supplier to provide a self-
assessment (see section 10.1).
51

5.4 Operational sequence of a potential analysis
The following diagram (figure 5.1) shows the operational sequence of a po-
tential analysis. The evaluation questions in the P1 analysis are selected from
the process elements P2 to P7. An overview of the questions is given in sec-
tion 7.1.
If suppliers are in-house, a process analysis can be carried out using a similar
product and/or component produced for another manufacturer/customer. The
analysis is performed by using the VDA 6.3 potential analysis evaluation
questionnaire and if necessary, with the use of further specialised information.
A separate evaluation is required for the potential analysis because the
objective here is less to arrive at a classification in percentage terms and
more to decide on "suitable" or "not suitable".
Award of contract
Clarify the
Request Clarify
initial Compile
supplier self Specify the Risk ressources
situation and questionnaire On site visit
evaluation audit team evaluation needed for
limit the module
and rate this qualification
contract
Unknown Feedback to Create questions The audit team Process evaluation Prognosis Clarify the provision of
supplier supplier (request using the should be made based on a similar internal resources
Recommendation
any necessary knowledge data- up of experts in process or product (customer)
Unknown base (for product the following (another customer) Veto
additional
facility e.g. taking part in a
information) and process areas:
Report supplier development
Unknown requirements) or • quality programme
technology for development Presentation of
• development
of requirement results
• procurement Clarify the provision of
specifications
external resources
• logistics
(Supplier)
•…
If necessary addition of
necessary resources in the
nomination documents
(e.g. construction of
necessary infrastructure)
End of auditor
responsibility
Figure 5.1: Operational sequence of a potential analysis
5.5 Evaluation of a potential analysis

Each question is evaluated in terms of consistent compliance with the re-
quirement under review and the risk involved.
52

If a question is not answered (shown as n. a.), a reason for this must be stat-
ed. A maximum of 3 questions may be marked n. a. It should be noted that
the comparability of results and the mutual acceptance of audit results from
other parties may no longer apply.
The assessment is marked, using the traffic light system of "red", "yellow" or
"green" (see below).
Assessment of individual questions
The requirement of the question is not met. R
The requirement of the question is partially met. Y
The requirement of the question is met. G
If a question is marked "red" or "yellow" the reasons and the relevant evi-
dences must be documented.
The overall assessment of the potential analysis is calculated from the num-
ber of questions rated red/yellow/green:
Evaluation based on questionnaire

Classification
Yellow Red
Barred supplier R more than 14 one or more
Conditionally approved supplier Y max. 14 none
Fully approved supplier G max. 7 none
Interpretation of results
U
Green = Fully approved potential supplier (applicant)
The supplier has the potential to meet the customer's requirements to the
extent required and may be considered for awarding a contract.
A contract award (nomination) for the project, component or product group by
the customer is possible without restriction.
53

Yellow = Conditionally approved supplier
Only a conditional approval for a contract award can be given. In some cases
the supplier needs support from the customer to implement the requirements
of the project. Under certain conditions a limited approval for a contract may
be given (quantity reduction, smaller series, …)
An award (nomination) is possible, but is linked to defined conditions:
The conditions to minimize the risk may be:
U U
 Restriction to a defined quantity (small-scale production)

 Restriction to a defined product
 Restriction to part-quantities of the overall enquiry
 The (potential) supplier receives a trial order on probation
 The (potential) supplier is included in a supplier development
programme
 Special support from supplier development teams with careful moni-
toring of the progress of the project.
Note: Conditions must be specified between the relevant quality and
procurement departments.
Red = The (potential) supplier is barred

It is not possible to award (nominate the supplier for) the project,
component or product group in question.
A positively evaluated potential analysis (“green”, “yellow”) is not necessarily

coupled to an award of contract. A negatively evaluated potential analysis
(“red”) excludes a contract award.
54

5.6 Follow up activities after contract award
The results of the potential analysis are used as input when planning the se-
lection of methods or method applications (e.g. process audit for release of
location, VDA-MLA).
A validation of the quality capacity in terms of a release for serial production
can only be given though a PPA-process which corresponds to the analysed
customer scope. To achieve this, a process audit can be held at the same
time as a process release.
6 Evaluating a process audit for material products
6.1 Evaluation of the individual questions

Each question is assessed in terms of compliance with the requirements and
the risk involved. The assessment of each question can result in the award of
0, 4, 6, 8 or 10 points, with the number of points awarded being based on
proven compliance with the requirements.
Points Assessment of compliance with the requirements
10 Full compliance with requirements
8 Requirements mainly++ fulfilled; minor deviations
6 Requirements partially fulfilled; significant deviations
4 Requirements inadequately fulfilled; major deviations
0 Requirements not fulfilled

++
) The term "mainly" means that the relevant requirements are met in most instances and
no special risks have been identified.
55

The following table serves as a guideline for the appropriate allocation of
points for the evaluation of the questions:
Points Evaluation of the compliance of the individual requirements
Risk assessment from Risk assessment from the Systematic view;

the perspective of the perspective of the prod- abstract
process/process step; uct; specific
specific
10 Technical requirements No product defects, the Requirements are

and specifications for the product meets the technical completely met
process are fulfilled standards
8 Small deviations in the Some product defects but Requirements are

process which do not no influence on the function, mainly fulfilled;
affect compliance with use or further process steps minor deviations
the customer specifica-
tions or have an effect
on following process
steps
6 The process does not Product non-conformities do Requirements are

always meet the defined not affect the function; how- partially met;
requirements. This has ever the failure has a nega- significant deviations
an impact on the cus- tive impact on the use or on
tomer or following pro- further process steps
cess steps
4 The process does not Product non-conformities Requirements insuffi-

meet the defined re- have an impact on the func- ciently met;
quirements and has a tion, the failure leads to us- major deviations
significant impact on the age restrictions, significant
customer or following impact on the following pro-
process steps cess steps
0 The process is not ca- Product non-conformities, Requirements are

pable of ensuring com- no function, the use of the not met
pliance with the defined product is considerably re-
requirements duced, further process steps
are not possible
56

If there are several findings for the assessment of a single question, the indi-
vidual assessment which is the greatest risk is decisive for the assessment of
the respective question.
The auditor may require immediate actions depending on the risk of the find-
ings.
If a question is not evaluated (n. a.), the reason for this must be stated. At
least 2/3 of the questions for each evaluated process element, sub-element or
process step must be evaluated. To ensure comparability the entire list of
questions from the VDA 6.3 process element should be covered in full.
If non-conformities from previous audits are repeated, the lack of implementa-
tion of corrective actions can also be regarded as a deviation: e.g. “cause
analysis”, “implementation of measures”, “meeting customer requirements”.
Questions involving special product and process risk (*-Question)

In the process elements, questions involving special risks in terms of product
and process are identified by an asterisk (*). The specific risks in the
*-Questions are already taken into account by the classification rules (see
section 6.3). The evaluation is carried out analogously to the remaining ques-
tions, this means, *-Questions are not evaluated more severely than other
questions.
6.2 Detailed evaluation and downgrading rules
Evaluation of the process elements and the sub-elements from P6 and the
individual process steps.
Process element
The compliance EPn of a process element (P2, P3, …, P7) is calculated as:
Total points awarded for the relevant questions
EPn [%] =
Total possible points for the relevant questions
57

Exception: When more than one result is given for a question
In process elements P3, P4 (separate results for product and process devel-
opment) and P6 (results for each process step), several results for one ques-
tion may be given. In this case the arithmetic mean of all results for the ques-
tion must be calculated first. In calculations following this step, the average is
rounded to two decimal places.
These averages are used in place of “total points” when calculating the level
of compliance of a process element.
For each question only 10 points may be awarded for the total possible
points – regardless of the number of results per question.
Sub-elements of P6
In the process element P6 the following sub-elements are evaluated:
EU1 Process input
EU2 Process management
EU3 Personnel resources
EU4 Material resources
EU5 Efficiency
EU6 Process output
EU7 Transport, handling of parts
The calculation of the sub-elements is carried out in the same manner as the
process elements using the exception: more than one result is given for a
question.
Total points awarded for the relevant questions in

sub-elements of P6
EUn [%] =
Total possible points for the relevant questions in
sub-element P6
Individual process steps

The questions from P6 are used for the evaluation of the individual process
steps. All questions from P6 can be answered in each process step. The
compliance level En of each process step can be calculated as follows:
58

Total points awarded for the P6 questions for this process step
En [%] =
Total possible points for the P6 questions for this process step
Application of the downgrading rules

These results (process element, sub-element of P6 or process step) are con-
sidered in the downgrading rules, but not used as intermediate results to cal-
culate the percentage of the overall results.
6.3 Overall level of compliance and downgrading rules
Process elements for material products
Project management (P2) E P2

R
Planning the product and process development (P3) E P3

R
Implementation of the product and process development (P4) E P4

R
Supplier management (P5) E P5

R
Process analysis/production (P6) E P6

R
Customer care, customer satisfaction, service (P7) E P7

R
The overall compliance E G for the process audit is calculated as follows:

R R
Total points from all evaluated questions from

EP2, EP3, EP4 ,EP5 ,EP6 and EP7 R
EG [%] =
Total of all possible points from these questions
For the process elements P3 and P4 separate evaluations for product devel-
opment (EP3 Product) or for process development (EP3 Process) can be made.
For the calculation of the overall result of all process elements (e.g. P2 to P7)
the mean values of the respective questions in section P3 and/or P4 are used.
The downgrading rules are applied to the entire process element P3 and/or
P4 (joint assessment of product and process development).
If during the audit individual process elements from the questionnaire are
used, the result is calculated based only on the evaluated process elements.
Which process elements have been used in the evaluation must be made
clear in the audit report.
59

Example P5/P6/P7
If the process elements P5, P6, P7 are evaluated (e.g. auditing of serial pro-
duction) then the result is calculated as follows:
Total points awarded for all evaluated questions from
P5, P6 and P7 (EP5 ,EP6 and EP7) R
EG(P5P6P7) [%] =
Total possible points from these questions
Example P4
If only process element P4 is evaluated (e.g. audit at the time of handing over
the project to serial production) then the result is calculated as follows:
Total points awarded for all evaluated questions from P4 (EP4)
EG(P4) [%] =
The designation EG(P5P6P7) and EG(P4) are used to easily identify the process ele-
ments evaluated.
Overall level of compliance

The overall result is rounded to the nearest percentage point.
Classification Level of compliance Description of the classification

E G or EG(Pn) [%]
R R
A EG or EG(Pn) ≥ 90 Quality capable
B 80 ≤ EG or EG(Pn) < 90 Conditionally quality capable
C EG or EG(Pn) < 80 Not quality capable
Level of compliance for partial audits

To classify the level of compliance of a partial audit the calculated level of
compliance (e.g. EG(P5P6P7) or EG(P4)) is compared to the benchmarks as given
above (at least 80% for a “B” classification of conditionally quality capable or
at least 90% for “A” quality capable).
60

Rules for downgrading
The following rules for downgrading are to be used and documented in the
audit report:
Reasons for downgrading from A to B even though the level of compli-
U
ance is EG or EG(Pn) ≥ 90%

 At least one process element (P2 to P7) or process step (E1 to En) is
evaluated with a level of compliance EP or En < 80%.
 A level of compliance EU1 to EU7 in one of the sub-elements of P6
is < 80%.
 At least one *-Question is rated with 4 points.
 At least one question from the process audit is rated with 0 points.
Reasons for the downgrading to C even though the level of compliance

U
is EG or EG(Pn) ≥ 80%
RU
 At least one process element (P2 to P7) or process step (E1 bis En) is R
evaluated with a level of compliance EP or En < 70%.

Similarly, when applying the downgrading rules (process element, sub-
element or process step), the individually calculated results EPn, EUn and En
are rounded to the nearest percentage point.
6.4 Evaluation of product groups

If required, the overall assessment of quality capability can be broken down
into product groups and individual process steps. This procedure is used by
the automotive manufacturers principally for classifying the quality capability
of suppliers. In this way suppliers are evaluated for their quality capability re-
stricted to product groups. This forms part of the preconditions for future con-
tract awards.
61

Product group Possible process steps
Pressed and Stamping, Galvanic plating Painting

stamped parts drawing,
forming
Plastic injection Plastic moulding Painting

mouldings
Control devices Fitting Soldering Assembling Functional check

components
Note: To evaluate process steps, additional process requirements are generated from
the organisation internal knowledge database (see section 10.2).
In the evaluation matrix (see section 9.1: Assessment forms: Process audit
for material products) the relevant process steps are allocated to the product
group being evaluated.
The overall level of compliance for each product group EG(PGn) is calculated as R
follows:
Total of the points awarded++ from the questions

for the evaluated process elements Pn (for each question in P6
the average value per question for each PG of the process step
is calculated)
E G(PGn) [%] =
Total of all possible points++ obtained from the P6 questions
R
for the process steps of the product group PGn
++
Explanations of "points obtained" and "possible points" see section 6.2: Exception.
When evaluating product groups, the downgrading rules are applied specifi-
cally to the product group concerned.
62

6.5 Using the questionnaire
(Process elements P2 to P7)
The questionnaire is one of the main tools for the auditor. Depending on the
phase of the product life-cycle (see section 2.1) the auditor selects the rele-
vant process elements for the audit. Additional specific requirements can be
added to the questions depending on the product/process risks identified.
The questions can be used for processes, both for material products and for
consumable materials.
Structure of the questionnaire

The questions to the process elements are structured as follows:
 Questions
 Minimum requirements relevant for assessment
 Possible examples for implementation
The relevant examples should be selected on a product/process specific ba-
sis and expanded when necessary, analysed and evaluated.
The evaluation is carried out based on the questions in the “Minimum re-
quirements/Relevant for the evaluation” list and not on the “Examples for im-
plementation” list.
For the auditor the audit consists of two mutually independent activities:
1. The auditor asks open questions to evaluate compliance with the re-
quirements. The risks identified in the preparations for and during the
audit are taken into account.
2. The auditor uses closed questions to evaluate the performance
based on the audit findings.
63

Assessment questions
Closed question Assessed by
answered? the Auditor
Yes / No
Open question 4
Open question 3
Open question 1
Open question 2
Audit questions
On site
Open questions
Fig. 6.1: Audit pyramid
The process elements P3 and P4 can be audited either together or separately

when evaluating the product planning/implementation and process plan-
ning/process implementation. This depends on the audited organisation.
If process element P6 “serial production” requires a breakdown into process
steps, each step must be specified and evaluated separately.
Additionally to the VDA 6.3 questions listed in this book, it is recommended
that a knowledge database be created to store information about the risk as-
sociated with individual products and processes. The experience stored in the
database can be used additionally to the requirements listed for the evalua-
tion.
Based on the risk analysis described in section 2.4, risks and their objective
evidence must be matched with the questionnaire and integrated into the ap-
plicable question. If any item cannot logically be assigned to an existing
question, further questions can be added. However, this means that the re-
sults will no longer necessarily be comparable. In such cases the assessment
matrix will need to be adapted. A note must also be made on the cover sheet
of the audit report, pointing out this fact.
64

7 Questionnaire
7.1 Overview questionnaire
Potential Transport
Analysis** Handling
of Parts
P2 Project management
2.1 Is a project management established with a project or-

X
ganisation?
2.2 Are all resources required for the project implementa-

X
tion planned and available and are changes reported?
2.3 Is there a project plan and has this been agreed with
X
the customer?
2.4 Is the advanced product quality planning implemented

X
within the project and monitored for compliance?
2.5* Are the procurement activities of the project imple-

X
mented and monitored for compliance?
2.6* Is change management within the project ensured by

X
the project organisation?
2.7 Is there an escalation process established and is this

X
effectively implemented?
P3 Planning the product and process development
3.1 Are the specific product and process requirements

X
available?
3.2* Is the feasibility comprehensively evaluated according

X
to the product and process requirements?
3.3 Are the activities for the product and process develop-
ment planned in detail?
3.4 Are the activities planned for customer care/customer

satisfaction/customer service and field failure analysis?
3.5 Have the necessary resources been taken into account

for the product and process development?
65

Potential Transport
Analysis** Handling
of Parts
P4 Implementation of the product and process

development
4.1* Are the actions from the product and process develop-
X
ment plans implemented?
4.2 Are personnel resources available and are they quali-

fied to ensure the start of serial production?
4.3 Are the material resources available and suitable to

X
ensure the start of serial production?
4.4* Are the required approvals and releases for the product
X
and process development available?
4.5 Are the manufacturing and inspection specifications

derived from the product and process development and
are they implemented?
4.6 Is a performance test carried out under series condi-

tions for the series release?
4.7 Are the processes established for securing customer

care/customer satisfaction/customer service as well as
the field failure analysis?
4.8* Is there a controlled method for the product handover

from development to serial production?
P5 Supplier management
5.1 Are only approved and quality-capable suppliers used? X
5.2 Are customer requirements taken into account in the

X
supply chain?
5.3 Have target agreements for supplier performance been

agreed upon and implemented?
5.4* Are the necessary releases available for purchased

X
products and services?
5.5* Is the agreed upon quality of purchased products and

X
services ensured?
66

Potential Transport
Analysis** Handling
of Parts
5.6 Are incoming goods delivered and stored appropriate-

X
ly?
5.7 Are personnel qualified for their respective tasks and

are responsibilities defined?
P6 Process analysis/production
6.1 What goes into the process?

Process input
6.1.1 Has the project been transferred from development to

X
serial production and is a reliable start guaranteed?
6.1.2 Are the necessary quantities/production batch sizes of

incoming materials available at the agreed upon time X
and at the correct storage location/work-station?
6.1.3 Are incoming materials stored appropriately and are the

means of transport/packing facilities suitable for the X
special characteristics of the incoming materials?
6.1.4 Are the necessary identifications/records/releases

available and allocated appropriately to the incoming X
materials?
6.1.5* Are changes to the product or process made during the

serial production tracked and documented?
67

Potential Transport
Analysis** Handling
of Parts
6.2 Are all production processes controlled?

Process management
6.2.1 Are the specifications of the control plan complete and

X
have they been effectively implemented?
6.2.2 Does a repeat release for the restart of production take

X
place?
6.2.3* Are special characteristics managed in the production? X
6.2.4* Are non-released and/or defective parts managed? X X
6.2.5 Is the flow of materials and parts secured against mix-

X
ing/wrong items?
6.3 What functions support the process?

Personnel resources
6.3.1* Are the employees able to fulfil their given tasks? X
6.3.2 Do the employees know their responsibilities and au-

thority in the monitoring of the quality of product and
process quality?
6.3.3 Are the necessary personnel resources available? X
6.4 What means are used to implement the process?

Material resources
6.4.1* Can the product-specific requirements from the cus-

X
tomer be met with the manufacturing equipment?
6.4.2 Is the maintenance of the manufacturing equipment

X
and tools controlled?
6.4.3* Can the quality requirements be effectively monitored

X
with the measurement and test facilities in use?
6.4.4 Are the work and inspection stations appropriate for the
X
needs?
68

Potential Transport
Analysis** Handling
of Parts
6.4.5 Are tools, equipment and test equipment stored proper-

ly?
6.5 How effective is the process being carried out?

Effectiveness, efficiency, waste avoidance
6.5.1 Are there targets set for the manufacturing process?
6.5.2 Is quality and process data collected in a way that al-

lows analysis?
6.5.3* In the case of deviations from product and process re-

quirements, are the causes analysed and the corrective X
actions checked for effectiveness?
6.5.4 Are processes and products audited regularly? X
6.6 What should the process produce?

Process result (output)
6.6.1 Do the quantities/production batch sizes meet the

needs and are they systematically directed to the next X
process step?
6.6.2 Are products/components stored in an appropriate

manner and are transport facilities/packing arrange-
X X
ments suitable for the special characteristics of the
products/components?
6.6.3 Are the necessary records/releases retained? X
6.6.4* Are customer requirements met at the delivery of the

X
final product?
69

Potential Transport
Analysis** Handling
of Parts
P7 Customer care, customer satisfaction, service
7.1 Are all requirements related to QM-System, product

X
and process fulfilled?
7.2 Is customer service guaranteed? X
7.3* Is the supply of parts guaranteed? X
7.4* If there are deviations from quality requirements or

complaints, are failure analyses carried out and correc- X
tive actions implemented effectively?
7.5 Are personnel qualified for their respective tasks and

are responsibilities defined?
Explanatory notes: Highlighted marking indicates: *-Questions
** Questions from the Questionnaire that must be audited at a min-

imum within the framework of the potential analysis
70

7.2 Project management (P2)
Process Element P2: Project management
P2.1 Is a project management established with a project organisation?
Minimum requirements relevant for assessment Examples for implementation
A process for project management exists.  Defined roles, tasks, compe-

An interdisciplinary project organisation is specified tence and responsibilities of
and contacts are defined. the project leader/technical
expert
The responsibilities and authority of the project lead-
er and team members are defined.  Project interface in multi-site
projects
The team members of the project are qualified to car-
ry out their tasks.  Project organisational chart
The project organisation meets the customer re-  Composition of the project
quirements. team
Suppliers are involved in project management.  Evidence of qualifications

 Special customer require-
ments for project management
P2.2 Are all resources required for the project implementation planned and
available and are changes shown?
Resource planning takes the customer requirements  Evidence of resource planning

into account and is based on the contract covering (taking other projects into ac-
the project. count)
Resource planning for project members is estab-  Resource planning for equip-
lished and implemented. The staff workload has to ment (e.g. development test
be considered. stand)
Review and where necessary adjustment of resource
planning is carried out when changes occur (dates,
scope of development performance etc.). This ap-
plies to changes that are triggered by the customer
as well as internal changes or supplier changes.
The critical path is given special consideration within
the resource planning.
The necessary project budget for personnel and
equipment (e.g. test and laboratory equipment) is
planned and released.
71

P2.2 Are all resources required for the project implementation planned and
available and are changes shown?
Changes in the project organisation (interface with

customer) are reported.
P2.3 Is there a project plan and has this been agreed with the customer?
The project plan meets the specific customer re-  Project plan with milestones
quirements.
 Specific customer require-
All internal and customer defined milestones are fully ments regarding technologies
incorporated in the project plan. and/or product groups
A review is carried out at the milestones defined in  Customer's project plan
the project plan to check that all planned activities
 Customer's deadlines
are carried out and that the level of maturity required
is achieved.  Customer's milestones
If a statutory authorisation procedure for a product is  Customer's targets (meas-
specifically required, the duration of this procedure is urements within the individual
included in the project planning. milestones)
In-house communication is ensured when changes  Milestone assessments (re-
are made to the project plan. Changes made to the views)
project plan which affect the customer are coordinat-
 Quality Plan (e.g. from VDA
ed with the customer.
MLA or APQP)
The critical path is generated from the project plan
 Country specific certification
and takes account of critical delivery items.
requirements (ECE, SAE,
Detailed quality-related project activities must be part DOT, CCC, …)
of the project plan. This may be in a separate docu-
ment (QM-Plan) that is referred to from the project  Legal and regulatory approv-
plan. The plans must take prototypes and pre-launch als process of critical systems
parts into account. (electroplating, paint, ...)
The project plan must include the detailed activities

concerning procurement. Detail plans may be in a
separate document referred to in the project plan.
72

P2.4 Is the advanced product quality planning implemented within the project
and monitored for compliance?
Advanced product quality planning activities must  Project plan

meet the specific customer requirements.
 Customer milestones
Both product and process assurance measures are
 Customer requirements in re-
part of the advanced product quality planning.
gard to quality plans
Verification and validation of the customer require-
 Customer specifications
ments are contained within the planning.
The planning also addresses critical components and
scope of supply (internal and external suppliers).
The planning is regularly monitored for compliance
and for target achievement.
P2.5* Are the procurement activities of the project implemented and monitored
for compliance?
The activities have to ensure that only approved and  Make or buy decisions
quality-capable suppliers are used in production.
 Supplier selection criteria
The level of activity depends on the risk classification
 Supplier development plan
of procured scope of supplies.
 List of suppliers for the pro-
These include the supplier selection and award crite-
ject
ria, award amount and delivery target date.
The transfer of customer requirements in the supply  List of approved suppliers
chain is ensured.  Risk appraisal of each sup-
The activities also include customer required suppli- plier
ers (directed suppliers) as stated within the agree-  Quality agreement for di-
ment. rected suppliers
The suppliers for facilities, machinery, tools, test and  Component classification
measurement systems as well as services are inte-
 Suppliers for services such
grated.
as development, laboratories
The appointment of suppliers must be traceable and maintenance etc.
through appropriate documentation.
Dates for the assignment, supplier milestones and
release have been laid down in the plan and coordi-
nated with the overall schedule and the progress is
monitored.
73

P2.6* Is change management within the project ensured by the project
organisation?
Change management within the project meets the  Time schedules

customer's specific requirements.
 Process description
Changes (initiated by the supplier, internally or by the
 Change management
customer) must be evaluated and if necessary the
project plan must be adapted. This evaluation must  Change forms
include the risk assessment for the product quality as
 Change history for the product
well as the deadlines.
and the process
Suppliers (critical supplies) are actively involved in
 Evaluation of change
change management.
 Approvals of changes
Changes are reported in a timely manner and are
agreed upon with the customer.
Adherence to defined design freeze steps must be
ensured. Exceptions must be agreed upon and doc-
umented between the customer and the supplier.
All changes must be documented.
The persons responsible for change management
are defined for the customer, internally and to suppli-
ers.
P2.7 Is there an escalation process established and is this effectively

implemented?
The escalation process in the project meets the spe-  Time periods for escalation
cific customer requirements. depending on the risk have
An escalation model (risk management) must be been agreed upon
available for deviations in the project affecting the  Contact personnel/decision
overall schedule. Project risks are identified, as- makers in the escalation pro-
sessed and reduced through appropriate measures. cess are defined
The criteria for escalation are defined, responsibilities  Escalation criteria and paths
and authorities are regulated and measures derived of communication are defined
when deviations occur.
 Protocols of milestone reviews
If risks have been identified in technologies, suppliers including measures
or supplied countries, these risks have to be consid-
ered within the escalation management.
74

7.3 Planning the product and process
development (P3)
Process Element P3: Planning the product and process development
P3.1 Are the specific product and process requirements available?
All requirements regarding the product to be devel- Product/process development

U
oped are known.

 Inquiry documents
For products with embedded software, the require-
 Contract documents
ments at interfaces between hardware and software
are defined. Requirements management is imple-  Requirement specifications
mented for this. (product, process)
The organisation must determine the logistical re-  Customer requirements
quirements and the statutory and regulatory require-
 Legal requirements
ments relevant for the product that are necessary to
meet specific customer requirements.  Purchasing conditions
The organisation must take into account and use re-  QM specific requirements
quirements on the product and the process known  Quality agreements
from previous experience.
 Requirements for documenta-
Special characteristics must be identified on the ba- tion
sis of their own requirements, customer require-
ments, legal requirements, manufacturing technology  Logistics requirements (JIT,
and characteristics that arise from the purpose/use of JIS, on consignment)
the product.  Schedules, technical delivery
The quality requirements from the customer for the conditions
product and the process must be available.  Access to portals/information
Inquiry and contract documents are checked for platform in the internet
completeness.  Definition of responsibilities
If customer requirements cannot be fulfilled the cus- for suppliers (e.g. qualifica-
tomer must be notified or deviations “allowed”/ap- tion, sample submissions,
proved by the customer (if the contract has been approval, testing…).
awarded).  Test regulations
Customer requirements regarding the selection of
 Catalogue of characteris-
suppliers or purchased materials must be document-
tics/boundary samples for
ed.
decorative surfaces
Quality agreements with directed suppliers are avail-
 Experience with previous pro-
able.
jects
75

Process Element P3: Planning the product and process development
P3.1 Are the specific product and process requirements available?
 Product/process characteris-
tics
 Order documents with item
lists and schedules
 Legislation/regulations
 Environmental aspects, recy-
cling requirements
 Proof of capability
Product development
U
 Specifications, technical
drawings, special characteris-
tics
Process development
U
 Suitability of facilities, tools

and test and inspection
equipment
 Layout of work and test facili-
ties
 Handling, packaging, storage
and identification
P3.2* Is the feasibility comprehensively evaluated according to the product and

process requirements?
An interdisciplinary procedure for evaluating the fea- Product/process development

sibility must be used.
 Customer specifications and
All determined product and process specific require- standards
ments (technology, function, quality, logistics, soft-
 Schedules, timeframes
ware, ...) must be checked for feasibility.
 Regulations, standards, legis-
Material and personnel resources must be consid-
lation, environmental impact
ered in the feasibility study.
 Requirements from product
The results of the feasibility study must be available
liability
before tendering.
76

P3.2* Is the feasibility comprehensively evaluated according to the product and
The feasibility of critical purchased parts must be  Buildings, premises

ensured.
 CAM, CAQ
If customer requirements cannot be fulfilled the cus-
 Product/process innovation
tomer must be notified or deviations “allowed”/ap-
proved by the customer (if the contract has been  Interdisciplinary feasibility
awarded). analysis (for example, sales,
development, purchasing,
production planning, produc-
tion, QM planning, logistics)
Product development
 Laboratory/test equipment
Process development
 Capacity monitoring
 Availability of incoming mate-
rials
 Manufacturing possibilities,
manufacturing sites
 Equipment, tools, produc-
tion/test equipment, auxiliary
materials, laboratory facilities,
transport, container, storage
P3.3 Are the activities for the product and process development planned in
detail?
When planning the product and process develop- Product/process development

ment the level of detail is dependent on the compo-
 Overall project plan including
nent, software and complexity of the process.
all deadlines
In the development phase, suitable methods must be
 Customer requirements
used to secure the product and process development
so that when the product goes into serial production  Inspection planning for the
it fulfils the operational conditions (function, reliability, layout inspection
safety). This must be considered in the planning.  Customer schedule
Risk analysis (Product FMEA and process FMEA or
 Lead times
similar methods) are part of the planning.
 Deadlines for the procure-
At the planning stage, the development of new prod-
ment release, supplier ap-
ucts and processes should take into account the re-
77

P3.3 Are the activities for the product and process development planned in
detail?
quirements of the product operational conditions. proval and change stop

The time schedules contain all information for prod-
 Methods used to minimize
uct and process development (including deadlines
risk (QFD, FMEA, statistical
and length of time, milestones within the overall pro-
test plan e.g. DoE, Shainin,
ject plan, performance testing, PPA-date, Software
Taguchi)
standards…).
 Detailed plans for proto-
Methods for development release meet customer
types/pre-launch planning
requirements and must be clarified with the customer
if deviations occur.  Regular status checks on the
progress of the development
Activities related to the procurement scope are
(reviews)
planned and are consistent with the overall schedule.
 Project plans for investment
Outsourced processes and services are part of the
items (facilities and equip-
project planning.
ment)
 Logistics planning for all
phases of the of product and
process development includ-
ing packaging
 Concept for spare parts
Product development
 Detailed planning for reliabil-
ity testing, functional testing,
trial plan
 Deadline for development
phase samples
Process development
U
 Deadlines for the perfor-

mance test, tool timing plans
(off tool parts)
 Detailed planning for inspec-
tion plans, test equipment
plans and maintenance plans
including spare parts man-
agement
78

P3.4 Are the activities planned for customer care/customer
satisfaction/customer service and field failure analysis?
The customer requirements for the supply of parts Product/process development

across the product life cycle are taken into account in
 Training plan
the planning.
 Qualification matrix
Concepts to continually ensure series supply includ-
ing a contingency plan are provided in the planning  Investment planning
phase. Process development
A fallback concept is provided for product and pro-  Inspection planning for
cess innovation. standard and stress testing
The analysis process for 0-km and field complaints is
 Triggering criteria are defined
planned for delivery. The customer requirements are
taken into account for field failure analysis.  NTF process
When introducing new technologies and products,  Concept for the supply of
employee training and the creation of the necessary spare parts
infrastructure are provided also in customer service.  Contingency plans
P3.5 Have the necessary resources been taken into account for the product
and process development?
The process for determination of resources is imple- Product/process development

mented.
 CAx equipment
Determination of resources refers to the availability of
 Availability of qualified per-
qualified personnel, budget, infrastructure such as
sonnel for respective tasks
building, test and inspection equipment (hardware
and software), laboratory facilities, machinery and  Capacity planning for all re-
equipment, ... sources
Capacity for the implementation of prototypes and Product development
U
prototype construction, pitot-run, performance test  Test/inspection/laboratory

and serial production must be planned and consid- equipment (internal and ex-
ered. ternal)
The resource planning is regularly adapted to Process development
changes in the project and potential bottlenecks are
to be considered.  Production sites, tools, pro-
duction and test equipment
79

7.4 Implementation of the product and process development
(P4)
Process Element P4: Implementation of the product and process development
P4.1* Are the actions from the product and process development plans
implemented?
Methods for the product and process development Product/process development

defined in the development planning are applied and
 Methods to minimize risk
implemented in such a way as to ensure fulfilment of
(QFD, FMEA)
requirements (function, reliability, safety).
 Design of experiments (e.g.
In the development phase a risk analysis (such as
Shainin, Taguchi…)
FMEA) must be used to ensure that the product and
process comply with the requirements of the custom-  Poka-Yoke principles
er in terms of function, reliability etc. When carrying Product development
out a risk analysis (for example a product FMEA) the
proposed manufacturing site for the production shall  Test planning
be involved.  Assembly test and system
Special characteristics are defined and identified in test
the relevant documents (FMEAs etc.) and necessary  A, B, C samples
action is taken to ensure conformity.
 Automotive SPICE
In the overall plan, a test plan must be included for
the components, assemblies, subassemblies, com-  Endurance tests
ponents, software and materials. The overall plan  Environmental simulation test
must also include manufacturing processes from pro- (e.g. salt spray test)
totype and pre-launch phase.
Process development
U
All purchased products and services are taken into

 Control plan/inspection plan
account. The implementation of product and process
development is ensured in the supply chain.
The documentation of lessons learned from the pro-
totype phase and the pre-launch phase are available
for reference in the series phase.
The requirements for test equipment are defined and
implemented.
80

P4.2 Are personnel resources available and are they qualified to ensure the start
of serial production?
A staff schedule must be available. Product/process development

Personnel must be qualified for their respective  Customer requirements
tasks. This also applies to the staff of external ser-
 Requirements profile for the
vice providers. Appropriate evidence must be availa-
relevant positions
ble.
 Determination of the need for
Needs assessments will be carried out regularly dur-
training
ing product and process development with regard to
possible emerging bottlenecks and additional re-  Evidence of training
quirements.
 Knowledge of methods and
Qualified workforce resources are available for proto- foreign languages
type building and sample building. Workforce re-
sources for pre-launch, production start-up and serial
production are planned and personnel are qualified
in accordance with the project plan.
Processes that have been outsourced must be con-
sidered.
P4.3 Are the material resources available and suitable to ensure the start of
serial production?
A process to determine resources has been imple- Product/process development

mented.
Resource determination refers to the availability of
 Technical interface to cus-
test equipment, laboratory equipment, machinery,
tomer and suppliers
equipment, and the utilization of machinery and
equipment. Supporting processes must be consid- Product development
U
ered.  Test planning

Within the resource determination the necessary in- Process development
U
frastructure is taken into account.

 Facility planning
Regular needs assessment must be carried out dur-
ing product and process development with regard to  Facility layout
possible emerging bottlenecks and additional needs.  Machinery and equipment
Material resources for the realization of prototypes planning
and sample building are available. Material resources  Quantities and throughput
for pre-production, series start and serial production times
is planned and provided in accordance with the pro-
ject plan.  Transport routes
 Transport, containers, storage
81

P4.3 Are the material resources available and suitable to ensure the start of
serial production?
Outsourced processes must be considered.  Capacity before series start

The resources must be available with a suitable lead (initial stock)
time before the start of customer’s serial production.  Supporting processes for ex-
ample from logistics und IT
P4.4* Are the required approvals and releases for the product and process
development available?
The releases and verification of suitability is demon- Product/process development

strated for all the items, assemblies, software ver-
 Test reports, protocols
sions and purchased products and services in ac-
cordance with development schedules.  Evidence related to pur-
chased parts/suppliers
The material data is confirmed and released.
 Sampling results
The actions from the risk analysis (for example
FMEA) have been implemented and confirmed in Product development
U
their effectiveness.  Specifications, technical

The production process and product approval (PPA) drawings, requirement speci-
must be available on the agreed date. For products fications
with embedded software an additional software test
 FMEA
report is available.
 IMDS, REACH, RoHS
Reference parts from sampling must be kept for at
least the time laid down in the customer require-  Product test (e.g. assembly
ments. test, function test, endurance
test, environmental simula-
The verification and validation of the product and
tion)
process are ensured before the customer SOP.
 Prototypes
 Confirmation of conformity
with legal requirements
 Development releases from
customers
Process development
U
 Logistics concept (e.g. suita-

bility of packaging through
sample shipping)
 Proof of capability of special
characteristics
82

P4.4* Are the required approvals and releases for the product and process
 Capacity studies
 Tool approvals
P4.5 Are the manufacturing and inspection specifications derived from the
product and process development and are they implemented?
The manufacturing and inspection characteristics Product development

U
contain all characteristics from the product and pro-

 Risk analysis (FMEA, FTA
cess development (including special characteristics).
etc.)
These must take into account all the components,
assemblies, subassemblies, parts, software and ma-  Control plan (prototypes pre-
terials including the processes for manufacturing of launch)
the products. Process development
Results of the risk analysis are considered.  Risk analysis
The specifications include information for product (FMEA, FTA etc.)
control, manufacturing process control, methods and  Control plan (pre-series, se-
reaction plans and corrective actions. ries)
Product audits and layout inspection are defined.
 Product audit plan
The specifications must be available for all phases:
 Inspection instruction
prototype phase (if required by the customer), pre-
launch and series phase.  Reaction plan
 Layout inspection planning
 Series release (first and last
piece)
 In-line inspections
P4.6 Is a performance test carried out under series conditions for the series
release?
A performance test must be carried out in time to Process development

assess all production factors and influences and if
necessary corrections must be made.
 Determination of minimum
The performance test has provided evidence that the
quantities (intended produc-
quality capability of the entire production process is
tion rate and flexibility as
given under serial production conditions (tools,
agreed upon)
equipment, cycle time, personnel, manufacturing and
inspection specifications, measuring and test and
83

P4.6 Is a performance test carried out under series conditions for the series
release?
inspection equipment ...).  Process capability study

Note: Depending on the time of the audit some parts  Measurement capability
of the relevant production test could still be at the
 Capability of measurement
planning stage!
processes
The question is not relevant for the product develop-
 Equipment and infrastructure
ment!
are ready for start of serial
production (measurement re-
ports)
 Staff concept for serial pro-
duction
 Work/inspection instructions
 Packaging requirements
 Process validation
P4.7 Are the processes established for securing customer care/customer

satisfaction/customer service as well as the field failure analysis?
The customer requirements for the supply of parts Process Development

during the product lifecycle are established in the
 Evidence of training
processes.
The planned processes for the continuous series
supply including safety margins for emergencies are  Existence of infrastructure
available. and test equipment
The analysis process for 0-km and field complaints is  Service agreements with ex-
established for the scope of delivery. The customer ternal analysis sites
requirements for field failure analysis are taken into
 Equipment for standard and
account.
stress tests
The requirements for the analysis capability at the
 Triggering criteria are defined
site have been agreed with the customer.
 NTF process
If external sites are used for analysis, the interfaces
are defined and evidence of the presence of the re-  Concept to ensure supply of
quired equipment and capacity is available. spare parts
New technologies and products are also taken into  Contingency plans
account in customer support.
The employees designated for these processes are
qualified. The infrastructure is available.
84

P4.8* Is there a controlled method for the product handover from development
to serial production?
A process exists for transferring work results from the Product/process development
project to the production.
For products with embedded software, the results of
 Handover protocols/
the development (including the intermediate results
checklists with handover cri-
and their documentation) are documented.
teria
Prerequisite for project delivery is a successful inter-
 Acceptance reports
nal PPA process. Prerequisite for a series delivery
release is the successful customer approval. Result-  Control plan
ing actions from internal and external releases are
 Inspection instructions
implemented on time.
 Part history
Proof of capability can be shown for all special char-
acteristics.  A method has been deter-
mined to carry out failure
The personnel resources are available in accordance
analysis and to introduce cor-
with the planning and are qualified.
rective actions
The material resources include buildings, test facili-
 Production metrics such as
ties, laboratory facilities, equipment, facilities, etc.
OEE, rejects,…
These are available and have been released.
 Experience from the ongoing
Releases for procurement volumes are available. project
Measures to secure the start-up of production are  Measurement capability
specified and introduced when necessary.
 Capability of Measurement
Processes
85

7.5 Supplier management (P5)
Process Element P5: Supplier management
P5.1 Are only approved and quality-capable suppliers used?
In serial production it must be ensured that only ap-  Defined and documented cri-
proved suppliers are used. An evaluation of suppliers teria are used for supplier se-
using defined criteria for the qualification capability lection
must be available.
 Evidence of a qualification
An analysis of the quality performance of existing programme for suppliers who
suppliers has to be considered. did not meet the selection cri-
Risks in the supply chain have been identified, eval- teria
uated and reduced using suitable measures (contin-  Evaluation of the quality ca-
gency strategy). pability (QM-System, Pro-
cess) for example self-
assessment, audit results,
supplier certificates
 Results of the potential anal-
ysis
Can also be used for:
 Research and development
suppliers/prototype suppliers
 Suppliers of intangible prod-
ucts such as software
 Suppliers of equipment, ma-
chinery, tools
 Service providers (e.g. sort-
ing companies)
 External test labs
 Suppliers in outsourced pro-
cesses
86

P5.2 Are customer requirements taken into account in the supply chain?
The communication of customer requirements must  Transmission of require-

be regulated and traceable. ments, tolerances, time
Customer requirements also include requirements schedule, process releases,
from technical drawings, components, software or releases, complaints etc. with
component specifications, from QM agreements and ensuring change manage-
other valid standards. ment
Change management must also be considered dur-  Quality agreement

ing serial production.  QAA (quality assurance
Interfaces are identified and secured. agreements)
 Legal and regulatory re-
quirements
P5.3 Have target agreements for supplier performance been agreed upon and
implemented?
Target agreements have been made with all suppli-  Measurable targets for quali-
ers throughout the supply chain for products and ty, delivery quantity (batch-
processes. These agreements have been agreed es), punctuality, for example
upon and implemented. to: reduce the ppm rates with-
Supplier output must be checked and evaluated within the 0-failure strategy
in defined periods.  QM agreements including es-
If deviations occur actions must be agreed upon and calation mechanisms
their implementation including deadlines is to be  Avoidance of extra tours
monitored.
 Reduction of rejects
 Reduction of the work in pro-
gress
87

P5.4* Are the necessary releases/approvals available for purchased products
and services?
A release must be available for all purchased prod-  Specifications/standards/test

ucts and services before serial production of instructions
new/changed products/processes.
 PPA-Reports when neces-
Unless otherwise specified, the supplier for the sup- sary with software test reports
ply of modules has the full quality control responsibil-
 Proof of capability for special
ity for all individual components.
characteristics
 Legal/country specific re-
quirements (e.g. CCC, Inmet-
ro, IMDS, REACH)
 Qualification tests/reports
 Model releases
 Change management in the
supply chain
 Approval agreements for the
scope of small batches and
individual requirements
88

P5.5* Is the agreed upon quality of the purchased products and services
ensured?
To monitor the quality of purchased products and  Coordination of

services, regular checks are carried out, documented test/inspection procedures,
and evaluated. processes and frequencies
Deviations from the supplier quality are processed  Reference parts
through a standard complaint process.
 Sample size (e.g. Skip Lot)
Layout inspections are carried out according to cus-
 Evaluation of main failures
tomer requirements.
Test and measuring equipment must be sufficiently  ppm evaluations, 8D reports
available to check purchased products. The equip-  Agreement and tracking of
ment must be stored in an orderly manner and asso- improvement programmes
ciated work-stations must be laid out appropriately
 Test possibilities (internal and
(e.g. climate control, lighting conditions, cleanliness,
external laboratories and test
and protection against damage and contamination).
facilities, testing in accord-
ance with ISO/IEC 17025) for
raw materials (material certif-
icates) and finished parts
 Gauges/fixtures
 Technical draw-
ings/specifications
 Ordering and packaging
specifications
 Layout inspections/reports
 Test certificates
89

P5.6 Are incoming goods delivered and stored appropriately?
Incoming materials and loading equipment must be  Packing

stored in accordance with their release status so that
 Inventory control
they cannot be damaged or mixed.
 Labelling (traceability/test sta-
For materials that could be damaged by temperature,
tus/work sequence/use sta-
humidity, vibration, etc. and affect the quality of the
tus)
final product, the transport and storage conditions
must be defined and evidence shown.  Quarantine stores; quarantine
areas
Terms of transport should be determined for critical
incoming materials.  FIFO
“Suspect”/quarantined products must be stored se-  Batch-related use
curely to prevent unauthorised access to them.
 Shelf life requirements
FIFO and batch traceability are to be ensured when
 Climatic conditions
the materials and goods are further processed.
 Protection against dam-
Material stock figures in the inventory control agree
age/contamination/corrosion
with the quantities actually in stock.
Storage conditions conform to the product require-  Order and cleanliness
ments.  Precautions to prevent mix-
ing/mistakes
 Remaining quantities from
production
90

P5.7 Are personnel qualified for their respective tasks and are responsibilities
defined?
A description must be given of what responsibili-  Product/specifications/customer

ties, tasks and authority the employees have in requirements
their relevant work areas (e.g. for incoming in-
 Knowledge about product fea-
spection, complaint processing, supplier man-
tures and production process for
agement, supplier audit).
the individual parts of modules
Qualification requirements must be determined
 Standards/legislation
for each employee in relation to their tasks and
qualifications carried out accordingly.  Packaging requirements
Knowledge of previous complaints is available  Assessment methods (e.g. au-
when appropriate for purchased products and dits, statistics)
services.
 Quality procedures (e.g. 8D-
method, cause/effect diagram)
 Complaints and corrective action
 Job/function descriptions
 Foreign languages
 Qualification of supplier auditors
91

7.6 Process analysis production (P6)
Process element P6: Process analysis production
P6.1 What goes into the process?

Process input
P6.1.1 Has the project been transferred from development to serial production and
is a reliable start guaranteed?
The project transfer to serial production has been  Project status reports
carried out. If necessary, unresolved issues are fol-
 Transfer reports
lowed up on and implemented on schedule. The re-
sponsibilities for the entire handover process are  Milestone reports
regulated and acknowledged.  Defined actions with imple-
A complete production process and product release mentation schedule
(PPA) including the documentation required must
 Process FMEA and actions
take place before the first production shipment.
 Product FMEA and actions
Measures are taken to secure the launch of produc-
tion.  Production release report
The updating and further development of the risk  Machine and process capa-
analysis (e.g. process FMEA/product FMEA) is en- bility examination
sured.  Measurement capability
Tools, test and measuring equipment are available in
the necessary quantities.
process
 Production test/performance
test and evidence
 Transport planning process
 PPA documents including
customer release and refer-
ence sample
 Non-conformity permission
when necessary
 Released software standard
92

P6.1.2 Are the necessary quantities/production batch sizes of incoming materials
available at the agreed upon time and at the correct storage location/
work-station?
The correct product (incoming material, part, compo-  Sufficient and appropriate
nent etc.) must be provided to the agreed quality, in transport facilities
the correct quantity and the correct packing, with the
 Defined storage points
correct documentation, at the agreed time and at the
agreed place. Parts/components must be available at  KANBAN
defined storage areas/work-stations.  Just in time/just in sequence
At the workplace, parts and materials are provided as
 Inventory control
needed, taking into account the order quantity/lot
size (for example, KANBAN, Just in time, FIFO). Up-  Change status
stream processes are taken into account.  Exchange of information to
After order completion, the return of unneeded parts the return of unnecessary
(surplus) including their quantity is regulated. components/surplus
 Inventory
 Production levels tailored to
the customer’s requirements
 Special requirements for
components and containers
(ESD-protection for electronic
components, residue etc.)
93

P6.1.3 Are incoming materials stored appropriately and are the means of transport
means/packing facilities suitable for the special characteristics of the
incoming materials?
Packaging requirements must be consistently taken  Stock quantities

into account/implemented (also in the production
 Storage conditions
stages).
 Released special and stand-
During manufacture and internal transport and also
ard transport containers
when being transported to and from service compa-
nies, suitable transport units must be used to protect  Packaging requirements
the products from damage and contamination.
 In-house transport containers
Store areas/work-stations/containers must be appro-
 Protection against damage
priate for the tidiness and cleanliness required for
the parts/products. Cleaning cycles are defined and  Positioning of parts in the
monitored. workplace
The supply of parts/materials at the work-station/on  Cleanliness, order
the assembly line must allow for safe handling.  Over-filling (bins and contain-
Specified storage times and use-by dates for special ers)
materials/parts must be monitored by appropriate
 Monitoring of storage times
methods (maximum and minimum storage times,
specified interim storage times).
Critical operating and consumable materials for plant
and machinery with a direct effect on the prod-
uct/product quality must be monitored accordingly.
Parts/incoming materials/critical operating and con-
sumable materials must be protected against envi-
ronmental and climatic influences.
94

P6.1.4 Are the necessary identifications/records/releases available and allocated
appropriately to the incoming materials?
Released incoming materials must be clearly identi-  Customer specifications

fied and recognizable. The release status must be
 Customer requirements for
identifiable and the release identification on bun-
labelling and tracing
dles/batches/load containers/parts must be defined.
 Legal requirements, product
It must be ensured that only released materials/parts
liability legislation
are forwarded to production/the next process stage
and used.  Identification of replacement
parts
The traceability of the units produced must be en-
sured within a reasonable framework (e.g., documen-  Process for the release of
tation, batch installation). parts/materials
Depending on the product risk, traceability must be  Identification of released
guaranteed across the entire process chain, from parts/materials (stickers, la-
sub-supplier to the customer. bels, issue slips, …)
Customer identification and traceability requirements  Records of approvals
must be taken into account.
 Traceability system/concept
Legal and regulatory requirements are taken into ac-
 Documentation of conces-
count.
sions (number, duration, type
Test results of characteristics with special require- of identification, …)
ments for documentation and archiving are recorded
accordingly.
95

P6.1.5* Are changes to the product or process in the course of serial production
tracked and documented?
Change management, meaning from the change re-  Trigger matrix in accordance
quest to the implementation, must be clearly docu- with VDA Volume 2
mented. Responsibilities must be regulated.  Change release by the organ-
According to customer requirements changes to the isation and the customer
product and process are to be agreed upon, ap- (feasibility, interface to com-
proved and released by the customer (including ponents, effect on costs and
software changes). If necessary a new PPA must be schedules etc.)
carried out. Documentation of change status must be
 Information about changes is
fully traceable.
passed onto process devel-
It must be ensured that, at all times, the correct de- opment, production areas,
sign level of the incoming materials or software is stores or to sub-suppliers
used and the correct design level of the finished
 The level of implementation
product is manufactured and shipped to the custom-
of the change is tracked
er.
(overview with status)
 Documented change record
(part life history)
 Update of documentation in-
volved (technical drawings,
instructions)
 Updates of the FMEA (Prod-
uct and Process)
 Verification and validation of
changes including documen-
tation
 Controlled introduction of
changes and modified prod-
ucts/parts
 Layout production before ma-
jor changes or relocations
which require a production
stop. Lead times from changes
(customer requirements etc.)
 Change levels of
test/inspection equipment,
gauges, tools and technical
drawings
 Parameter changes
 Software
96

P6.2 Are all production processes controlled?

Process management
P6.2.1 Are the requirements of the control plan complete and have they been
The production and test documents are complete  Evidence of machine and
and available and based on the control plan. Inspec- process capability
tion characteristics, facilities, methods, test frequen-
 Process parameters and tol-
cies, test cycles and layout inspections must be de-
erances (pressure, tempera-
fined.
tures, times, speeds ect.)
Access to these documents must be available at all
 Inspection specifications
times.
(special characteristics, at-
Process parameters influencing product characteris- tributive characteristics,
tics/quality must be fully stated. Tolerances must be measurement equipment,
given for process parameters and inspection charac- methods, test frequency)
teristics.
 Data regarding ma-
The control limits in process control charts are de- chines/tools/auxiliary aids
fined, identifiable and plausible. (identification numbers)
Deviations and actions taken regarding process re-  Guidelines regarding meas-
quirements and inspection characteristics are to be urement fixtures/reference
documented. points
Required measures (response plan) for process dis-  Work instructions including
turbances are known and initiated and documented reworking
by the responsible employees.
 Inspection instructions
For products with specific requirements on the manu-
facturing process the appropriate data about ma-  Specific requirements on the
chinery/tools/resources must be noted in the control manufacturing technology,
plan and/or the manufacturing and inspection docu- e.g. sampling relevant as-
ments. signment of machines and
plants
Conditions governing rework are specified and se-
cured within the process (parts identification; re-
checking/inspection etc.).
97

P6.2.2 Does a repeat release for the restart of production take place?
The production repeat release is the order-related  Release of a batch

approval for production start-up.
 Release of reworked parts
Criteria for triggering a production repeat release
 First piece release/first part
must be defined e.g. after an interruption of produc-
release
tion.
 Tooling diagrams/reference
A repeat release is necessary for product and pro-
parts/installation parts (e.g.
cess and must be carried out and documented by
defect identification)
authorised employees using acceptance criteria. De-
viations and measures taken are to be documented.  Possible triggering criteria for
A repeat release inspection must be carried out using a repeat release:
clear inspection instructions (quantity and method). ○ Production interruption
If production is continued after collection of samples, (e.g. night time in two
parts should be isolated until the samples are ap- shift operations, tool
proved. changes, materi-
al/batch/product change)
At the time of release the necessary reference and
tolerance samples must be available. ○ Repair, tool change
○ Setting data
P6.2.3* Are special characteristics managed in the production?
Special product characteristics and process parame-  Product FMEA/process

ters that affect the special characteristics are marked FMEA
in the control plan and systematically monitored.
 Control plan
Records are maintained of non-compliances and cor-
 Quality records
rective actions. Deviations affecting the characteris-
tics of the product must be approved by the custom-  Statistical evaluations
er.
 SPC evaluations
Quality records are specified for significant character-
 Quality control charts
istics (duration and type of archiving) and are coordi-
nated with the customer.  Proof of capability Cpk, Cmk,
machine capability checks
etc.
processes analyses
 Inspection results
 Technical drawings
 Special characteristics
98

P6.2.4* Are non-approved and/or defective parts managed?
Non-approved parts and/or parts with defective char-  Labelling of scrap, rework,
acteristics (scrap and rework parts) must be separat- reference and setting parts
ed and recorded or when necessary safely removed
 Labelling of containers for
from the production process.
scrap, rework and setting
These parts are to be either directly marked or parts
marked on their container.
 Defined scrap/rework-
Reworking criteria including testing are defined, stations in production
known and implemented.
 Storage areas for blocked
Storage areas for blocked stock and restricted areas stock and restricted areas
must be clearly labelled. Accidental use of restricted
parts must be excluded.  Records of rework and scrap
Setting masters, setup and reference parts must be

labelled and protected against accidental use.
99

P6.2.5 Is the flow of materials and parts secured against mixing/wrong items?
A mix of materials or the use of wrong materials,  Material and parts flow
software or components must be ruled out.
 Product/process FMEA
Appropriate measures and checks must be taken to
 Poka Yoke actions
ensure the early detection and ejection of incorrectly
installed items. Associated topics and actions must  Checks and tests in produc-
be included and examined in the risk analysis (pro- tion facilities
cess FMEA and, if appropriate, in the product
 Parts identification
FMEA).
 Identification of work, inspec-
The process and/or inspection status of parts must
tion and usage status
be clearly visible.
 Batch identification, traceabil-
The reuse of residual quantities, separated parts,
ity of the installation of batch-
reworked parts, reusable parts from product audits,
es or the production of batch-
inspected items etc. must be clearly defined (includ-
es
ing regulations for traceability).
 Removal of invalid labelling
Regulations for reintroducing parts of outsourced
processes (e.g. sorting service) must be available.  Working papers with master
data for parts/production
 Design status
 Material flow analysis
 Value stream
 Regulations for reworking
100

P6.3 What functions support the process?

Personnel resources
P6.3.1* Are the employees able to fulfil their given tasks?
A description of tasks with an appropriate job profile  Training/qualification evi-

must be available for employees. A qualification pro- dence
gramme (if necessary) is derived from this profile.
Who is qualified for each task and activity must be
 Initial training plan with evi-
documented.
dence
Trainings, instruction, briefings/proof of qualifications
 Knowledge about the product
that have been performed must be documented.
and failures that have oc-
Employees must be instructed in the handling and curred
treatment of products with special characteristics.
 Handling of measuring
Suitable evidence of qualification for each activity equipment
must be present (e.g. forklift driving license, welding
certificate, soldering certificate, vision test, hearing  Training in work safe-
test). ty/environmental aspects
Employees responsible for measuring and testing  Training in special character-

must be trained in the correct use of measuring istics
equipment.  Suitable evidence of qualifi-
Trainings/instructions are given at changes to the cation (e.g. welding certifi-
product/process and these are documented. cate, vision test results, driv-
ing license for forklift trucks)
The requirements apply to both internal and external
temporary employees.  Product training
P6.3.2 Do the employees know their responsibilities and authority in the

monitoring of the product and process quality?
Responsibilities, duties and authority of the employ-  Work/inspection instructions

ees in their task areas are described and implement-
 Qualifications matrix
ed (e.g. process release, first piece inspection, em-
ployee self-inspections, stopping the process).  Job descriptions
The employees know the consequences of faulty  Employee self-inspections
workmanship (which tasks/functions the product has
 Process release (setup re-
and what happens when they are no longer guaran-
lease, first piece inspection,
teed due to faulty installation etc.).
last piece inspection)
101

P6.3.2 Do the employees know their responsibilities and authority in the
monitoring of the product and process quality?
Employees receive regular information on the current  Process control (interpreta-

standard of quality reached, both internally and with tion of control charts)
the customer (complaints).
 Authority to stop and start the
The requirements apply to both internal and external process
temporary employees.
 Order and cleanliness
 Repair and maintenance is
carried out or when neces-
sary, arranged for
 Parts supply/storage
 Provision and adjustment of
test/measuring equipment is
carried out or when neces-
sary, arranged for
 Training about the product
 Quality information (tar-
get/actual values)
 Product safety/product liabil-
ity trainings
P6.3.3 Are the necessary personnel resources available?
The required number of qualified employees is avail-  Shift plan

able for all shifts. Employee qualifications need to be
 Evidence of qualifications
considered when scheduling staff (e.g. qualification
(qualification matrix)
matrix).
 Documented absence man-
Rules exist for supporting areas that are not continu-
agement rules
ally in use (e.g. laboratory, measurement room).
 Workforce scheduling
Fluctuations in customer orders and workforce ab-
sences (e.g. illness, holidays, training) are taken into
account in the workforce schedule.
The requirements also apply to internal and external
102

P 6.4 What means are used to implement the process?

Material resources
P6.4.1* Can the product-specific requirements from the customer be met with the
manufacturing equipment?
Evidence must be shown that the processes are im-  Evidence of machine/process
plemented in accordance with the customer re- capability for special charac-
quirements using the existing production facilities teristics or process-
and that the resulting products meet the customer determining parameters (e.g.
specifications. pressure, time, temperature)
The production facilities, machinery and equipment  Output/production capacities
must be able to comply with the specified tolerances
 Warning at deviations from
for the respective product and process characteris-
limit specifica-
tics.
tions/parameters (e.g. an
Process capability must be determined for selected alarm, lamp, automatic shut-
product and process characteristics and their per- down, unloading)
formance verified.
 Feed and removal systems
The process capability must meet the customer re-
quirements. For long term process capability the  Capability of replacement
minimum requirement of C pk ≥ 1,33 must be met. In
R R
tools
the case of significant characteristics where no ca-  Reproducibility of gauges, fix-
pability level can be proven, 100% inspection is re- tures etc.
quired.
 Cleanliness requirements
Layout and condition of the equipment, tools, fixtures
and handling facilities meet the requirements under
real production conditions.
103

P6.4.2 Is the maintenance of the manufacturing equipment and tools controlled?
Maintenance activities (maintenance, inspection and  Availability/use of the appro-

repair) are determined and implemented for all instal- priate technical documents
lations, equipment, machines and tools.
 Maintenance plan and
Maintenance activities that have been carried out maintenance tasks
(scheduled and unplanned) are documented and an-
 Weak-point analysis
alysed for improvement measures.
 Preventative tool exchange
A process for the analysis and optimization of down-
programme for units subject
time, machine utilization and tool life is implemented
to increased wear and tear
effectively.
The key processes and bottleneck machines are  Storage and retrieval ma-
identified and appropriate maintenance activities chines/equipment for
(preventative or predictive) are carried out and doc- transport and storage etc.
umented in terms of a risk-based maintenance pro-  Availability of spare parts at
gramme. production facilities producing
The availability of replacement parts must be en- key products
sured.  Adherence to the prescribed
Resources needed to carry out necessary mainte- maintenance intervals
nance measures are available.  Documentation of mainte-
Tools undergo a tool management which includes nance activities
the following:  Regular plausibility check of
 Status indication (e.g. OK, NOK) the scheduled maintenance
intervals
 Tool life cycle including all changes made to the
tool  Hiring of external service
companies to carry out
 Tool life maintenance
 Tool ownership (e.g. customer ownership)
104

P6.4.3* Can the quality requirements be effectively monitored with the measurement
and test facilities in use?
Test and measuring equipment/facilities used are  Control plan

suitable for the planned purpose and handling in
 Capability of test equipment
production. They are included in the control plan.
 Capability of measuring
Capability studies are carried out on the test and
equipment
measuring equipment/facilities employed. There is an
identification system for test and measuring equip-  Capability of measurement
ment. Administration of this equipment is based on process
the identification.
 Data collection and interpret-
A process for the periodic monitoring of measure- ability
ment and inspection equipment is installed and im-
 Evidence of the calibration of
plemented (responsibility for collection and return is
inspection equipment
defined). This process also takes into account the
calibration of process-integrated measurement tech-  Comparison of inspection
nology with an influence on the product characteris- equipment/measurement
tics. processes with the customer
(e.g. inter-laboratory compar-
Auxiliary equipment for measuring and test equip-
isons)
ment that have an influence the measurement result
are monitored in the same way.  Inspection stickers or certifi-
cates
 Reference component/setup
parts (e.g. error test pieces)
P6.4.4 Are the work and inspection stations appropriate for the needs?
Conditions for the workplaces and their surroundings  Lighting

are appropriate for the products and the work carried
 Cleanliness and tidiness
out, in order to prevent or eliminate contamination,
damage, mixing-up of parts and misinterpretations.  Climate control
This also applies to permanent and temporary estab-  Noise pollution
lished rework, sorting and inspection stations.
 Clean rooms
In addition, the workplace layout is adapted ergo-
 Workplace lay-out
nomically to the work to be carried out.
 Surroundings/handling parts
at the workplace
 Work safety
105

P6.4.5 Are tools, equipment and test equipment stored properly?
Tools, equipment and test equipment (including  Stored protected against

gauges) must be stored and managed properly. This damage
also applies for tools, equipment and test equipment
not in use or not yet released.
 Defined storage location
All tools, equipment and test equipment are identified
with their current status and all changes are docu-  Environmental influences
mented (change history).
 Status identification
Storage is provided where the equipment is protect-
 Identification showing cus-
ed against damage and environmental effects.
tomer's property, prod-
Cleanliness and tidiness are ensured.
ucts/tools/devices provided
The issue and use of this equipment is controlled on loan
and documented.
 Defined release status and
change level
 Storage and retrieval ma-
chines/equipment for
transport and storage etc.
 Reference component/setup
parts (e.g. error test pieces)
106

P6.5 How effective is the process being carried out?

P6.5.1 Are there targets set for the manufacturing process?
Process-specific targets are defined, monitored and  Availability of installations

communicated (e.g. quantities produced; quality met- and machines
rics/failure rates, audit results, throughput times, de-
 Number of parts produced
fect costs and process effectiveness figures/Cpk).
per unit of time
Target requirements are agreed upon and achieva-
 Rework, scrap
ble; they are guaranteed to be up to date.
 Production runs with no re-
Customer requirements are taken into account when
working, first passes, first
setting targets.
time through quality, first
A regular comparison is made between specified and pass yield
actual results.
 Quality metrics (e.g., failure
rates, audit results)
 Process metrics (process ca-
pability)
 Reduction of waste (e.g.,
scrap and rework, energy and
process materials)
107

P6.5.2 Is quality and process data collected in a way that allows analysis?
To demonstrate compliance with the requirements  Defect collection charts

and objectives which are needed for the evidence of
 Control charts
product conformity, it is necessary to define and doc-
ument quality and process parameters (target val-  Special characteristics
ues) and record the actual data.  Process parameters (temper-
It must be ensured that data can be evaluated. ature, time, pressure etc.)
Special incidents are documented (shift/equipment  Factory data collection
book).
 Fault signals (e.g. plant
The recorded data can be related to a product and standstill, power failure, pro-
process, the data is available, legible, accessible and gramme error message)
archived as specified. Requirements for traceability
are respected.
 Error type/error frequencies
The collected data is analysed and appropriate ac-
tion for improvement is initiated.  Error costs (non-conformity)
The potential for improvement must be continuously  Rejects/reworking
determined from findings on quality, costs, and ser-
 Blocking message/sorting ac-
vices.
tions
Events that result in a change to the process or to
 Cycle times, through-put
the product must be documented in the appropriate
times
risk analysis (e.g. FMEA) and the respective
measures taken are recorded.  SPC
 Pareto analyses
 Cause and effect diagrams
 Risk analysis (FMEA, FTA
etc.)
 Traceability concept
108

P6.5.3* In the case of deviations from product and process requirements, are the
causes analysed and the corrective actions checked for effectiveness?
If deviations from product and process requirements  8 D method

occur, immediate containment actions must be taken
 Cause and effects diagram
to comply with the requirements, until the causes of
failure are eliminated and evidence has been provid-  Taguchi, Shainin
ed of the effectiveness of the corrective actions.  5 Why method
These actions are known by the employees.
 FMEA/error analysis
Suitable methods for root cause analysis are in use.
 Process capability analysis
Corrective actions are derived, their implementation
is monitored and the effectiveness verified.  Quality control circles/quality
circle
Control plan and risk analysis (e.g. FMEA) are up-
dated as needed.  Analytical assessment meth-
ods
Non-conformities that affect the properties of the de-
livered product are communicated to the customer.  Information flow to the cus-
tomer
 Product FMEA and process
FMEA
 Waivers/concessions
 Additional dimensional mate-
rial, functional and endurance
checks and tests
109

P6.5.4 Are processes and products audited regularly?
The audit programmes for process and product au- Product and process audit
U U
dits are available and implemented. Customer re-

 Specifications
quirements are taken into account.
The process and product audits carried out are suit-
able to identify specific risks and weak points and  Audit programme for product
implement corrective action. and process audits including
scheduled and event-based
A root cause analysis is carried out when deviations
audits
occur. Corrective actions are derived, their imple-
mentation is monitored and the effectiveness is veri-  Frequency of audits
fied.
 Audit requirements
Product audits are periodically carried out and docu-
 Audit results, audit reports
mented. Scope of the audit is the end product and
where necessary intermediate products. In the prod-  Auditor qualification
uct audit specified characteristics are examined and Process audit
U
tested according to defined specifications.

 Process parameter/capability
Non-conformities that affect the properties of the de-
livered product are communicated to the customer. Product audit
U
 Labelling, packaging
 Capacity of the test equip-
ment
 Software version
110

P6.6 What should the process produce?

P6.6.1 Do the quantities/production batch sizes match needs and are they
systematically directed to the next process step?
Parts/components must be forwarded to defined  Adequate, appropriate means

storage/holding points using suitable means of of transport
transport.
Attention must be given to the order quantity/batch
 KANBAN
size so that only the required quantity of
parts/materials is moved to the stipulated work-  FIFO
station.
 Just in time/just in sequence
The current state of the component (OK parts, re-
 Stores management
worked parts, scrap etc.) must be evident from the
labelling (component, container).  Change status
Varying change statuses of the component must be  Stock
taken into account.  Production quantities tailored
It is ensured that a further processing/forwarding of to the customer’s needs
NOK parts is not possible.
 Special requirements for
components and containers
(ESD-protection for electronic
components, residual dirt
etc.)
111

P6.6.2 Are products/components stored in an appropriate manner and are
transport facilities/packing arrangements suitable for the special
characteristics of the products/components?
The products/components must be protected from  Protection from damage

damage by suitable storage and packing.
 Positioning of parts
Internal and customer-specific packing instructions
 Cleanliness, tidiness, over-
are known and implemented.
filling (storage points & con-
Storage points/containers must meet requirements tainers)
for cleanliness.
 Monitoring of storage peri-
Specified storage times must be monitored (speci- ods/quantities stored
fied maximum, minimum and interim storage times).
 Environmental and climatic
Parts must be protected against environmental and influences
climatic influences during storage and processing.
 Internal and customer-
These requirements are valid for the handling within specific packing instructions
the production process as well as the delivery.
 Customer specific packaging
instructions (incl. packing
supplied by the customer)
 Information on available stock
levels
 Substitute packaging
 Requirements for cleaning
packaging
 Sufficient amount of package
materials
112

P6.6.3 Are the necessary records/releases retained?
The labelling of the release status on contain-  Customer specifications

ers/batches/carriers/components must be specified.
Released products/components must be clearly
 Customer's identification re-
marked and the release status must be visible.
quirements
Concessions/deviation approvals must be traceable
 Customer’s requirements for
by appropriate identification and documentation. The
archiving time limits
documentation must cover the period and/or quantity
of parts involved. These details are documented in-  Archiving require-
cluding the identification on the component/carrier. ments/regulations (EDP, pa-
Internal specifications and customer requirements for per, fire protection, legibility
the labelling of reworked parts must be implemented ect.)
and documented (e.g. amount/quantity/labelling/part  Last piece inspection
history/use).
 Part history
The traceability of units produced must be ensured.
 Identification of concessions
For archiving requirements and duration, the cus-
tomer requirements are taken into account.
Test results of characteristics with special require-
ments for documentation and archiving are recorded
accordingly.
113

P6.6.4* Are the customer requirements met at the delivery of the final product?
The customer specific requirements of the final prod-  Quality agreements with the
uct (delivery reliability, quality goals, quality perfor- customer
mance etc.) are known and monitored.
 Customer specific require-
If deviations occur, corrective actions are defined and ments
implemented.
Final products are shipped in accordance with the the identification of special
customer requirements. characteristics
The handling of supplied products is regulated and  Shipping audit
implemented.
 Storage/recall pro-
Customers should be informed of delivery stops cessing/parts supply/shipping
which affect them and further procedure should be
coordinated with them.  Target agreements
114

7.7 Customer care, customer satisfaction, service (P7)
Process Element P7: Customer care, customer satisfaction, service
P7.1 Are all requirements related to QM System, product and process fulfilled?
The internal and customer specific requirements on  Quality agreements with the
the quality management system are fulfilled. customer
Layout inspection and a functional verification  Layout inspection concept
checks are carried out according to the customer e.g. carried out product au-
requirements. dits, function tests, endurance
The customer requirements for the supply of spare tests
parts during and after the production phase must be  Inclusion of suppliers for the
implemented. supply of spare parts
Customer requirements for the return of parts and  Supply guarantee after serial
their recycling must be implemented. production
 Certification of the QM sys-
tem
P7.2 Is customer service guaranteed?
It must be ensured that competent contact personnel  Knowledge of the product

are available for the various areas in the customer's application
organisation. Communication is ensured in accord-
 Knowledge of problems with
ance with the customer specifications.
the product and complaints
The monitoring of the product in the field is ensured. regarding the product or
Access to customer portals in accordance with the transport
customer specific agreement is ensured.  Implementation of new re-
quirements
 Notification of improvement
actions
 World-wide customer service
 Customer information in the
case of non-compliance with
the requirements
115

P7.3* Is the supply of parts guaranteed?
Contingency concepts and concepts to ensure sup-  Contingency plans (e.g. for
plies are available and up to date. Not only internal alternative production, sup-
processes but also the processes of suppliers are to pliers, transport)
be considered.
 Capacity and reaction time
Procedures must be in place which guarantees that for sorting actions
the organisation informs the customer immediately
 Use of external capacity
when supply shortages are detected. The information
must include the expected duration and extent of the  Communication regarding
shortages, the reason and the actions which have supply shortages
been taken.
 Regulations covering authori-
ty to make deci-
sions/escalation paths when
introducing special actions
 Blocking of parts
116

P7.4* If there are deviations from quality requirements or complaints, are failure
analyses carried out and corrective actions implemented effectively?
A complaint process that meets the customer re-  Process for processing com-
quirements (e.g. 8D) is used for 0-km and field complaints
plaints.
 8D process
Procedures for failure analysis are defined. The nec-
 Internal/external analysis fa-
essary personnel and material resources are availa-
cilities (laboratories, test and
ble to ensure punctual processing. The customer has
inspection facilities, person-
to be informed when deviations to the agreed upon
nel)
time limits occur.
 Use of problem solving meth-
In the case of field complaints a failure analysis is to
ods
be carried out according to customer requirements
(e.g. VDA Volume Field Failure Analysis).  Performance tests
 Flow of information to the
customer in the case of devi-
ations
 Knowledge store, lessons
learned
 Quality control loop
 FMEA
 Access to the necessary re-
lease documents (PPA etc.)
 Test concept for defective
parts in the field (standard
test/stress test/NTF test)
 NTF guidelines
 Performance indicators for
processing of complaints
117

P7.5 Are personnel qualified for their respective tasks and are responsibilities
defined?
It must be determined which responsibilities, duties  Organisational chart

and authorisations each employee has in their re-
 Evidence of knowledge of the
spective area of responsibility.
product/specifications/
Training needs must be determined individually and customer requirements
implemented for each person, depending on their
 Standards/legislation (product
tasks.
liability)
The employees know the product and the conse-
 Processing/use
quences of faulty workmanship for the supply of parts
and the quality of the final product.  Failure analysis
 Evaluation methods (e.g. au-
dits, statistics)
 Quality techniques (e.g. Pare-
to, 8D Method, cause and ef-
fect diagram, Ishikawa)
 Foreign language skills
118

8 Process audit services
8.1 Overview questionnaire for services
D2 Project management
2.1 Is a project management established with a project organisation?
2.2 Are all resources required to carry out the project planned and available and are
changes reported?
2.3 Is there a project plan and has this been coordinated with the customer?
2.4 Are all relevant advanced quality planning activities of the project implemented
and monitored regularly for compliance?
2.5* Are the procurement activities of the project implemented and monitored regular-
ly for compliance?
2.6* Is change management within the project ensured by the project organisation?
2.7 Is there an escalation process established and is this effectively implemented?
D3 Planning service development
3.1 Are the requirements for the development of the service available?
3.2* Is the feasibility comprehensively evaluated according to the service require-

ments?
3.3 Are the activities for the development of the service/service process planned in
detail and coordinated with the customer?
3.4 Are the resources necessary to provide the service available?
119

D4 Implementation of the service/service development
4.1* Are the actions which were defined in the development plan for the service im-
plemented?
4.2* Are personnel resources available and qualified to ensure customer require-
ments?
4.3 Are material resources available and suitable to ensure customer requirements?
4.4* Are the required approvals and releases for the service/service development
available?*
4.5 Are the service specifications derived from the product and process development
and are they implemented?
4.6 Is a performance test for the developed service defined and performed to ensure
the service will perform under the required conditions?
4.7* Is there a controlled method for the project handover from development to provi-
sion of service?
D5 Procurement management
5.1* Are only approved and quality-capable suppliers/external service provider used?
5.2 Are customer requirements taken into account in the supply/service chain?
5.3* Are supplier target agreements/external service provider target agreements im-
plemented with regard to the scope of supply/services?
5.4* Are the necessary releases available for purchased services?
5.5* Is the agreed upon quality of purchased products and services ensured?
5.6 Are personnel qualified for their respective tasks and are responsibilities de-
fined?
120

D6 Providing the service
6.1 What goes into the process?

Process Input
6.1.1* Has the project been transferred from development to the provision of service
and is a reliable start of service provision guaranteed?
6.1.2* Are the necessary materials for providing the service available at the agreed up-
on time, in the right quantity and at the right location?
6.1.3* Are incoming materials necessary to provide the service stored appropriately and
are the means of transport/packing facilities suitable for the special properties of
the incoming materials?
6.1.4 Are changes to the service made during the provision of the service tracked and
documented?
6.2 Are all processes necessary to provide the service determined?
6.2.1* Are the specifications of the service control plan complete and has it been effec-
tively implemented?
6.2.2 Are specific requirements (special characteristics) controlled during the provision
of service?
6.2.3* Are non-conforming services identified and are appropriate measures taken
(immediate measures and corrective actions)?
6.3 What functions support the provision of the service?

Personnel resources
6.3.1* Are the employees able to fulfil their given tasks to provide the service?
6.3.2 Do the employees know their responsibilities and authority in carrying out and
monitoring of the service quality?
6.3.3 Are the necessary personnel resources available?
121

6.4 What means are used to provide the service?
Material resources
6.4.1* Can the specific requirements from the customer for the provision of the service
be met with the equipment used?
6.4.2 Is the maintenance of equipment for the provision of service controlled?
6.4.3* Can the quality requirements of the service be effectively monitored with the
measurement and test facilities in use?
6.4.4* Are the work-stations for the provision of the service appropriate for the needs?
6.4.5 Are tools, equipment and test equipment stored properly?
6.5 How effective is the process for the provision of the service being
carried out?
6.5.1* Are targets set for the provision of the service?
6.5.2 Is quality and process data about the service collected in a way that allows analy-
sis?
6.5.3* In the case of deviations from the service requirements and provision of the ser-
vice, are the causes analysed and the corrective actions checked for effective-
ness?
6.5.4 Are service requirements and provision of the service audited regularly?
6.6 What should the process deliver?

6.6.1* Are the necessary records concerning the service provided retained?
6.6.2 Are customer requirements met at the delivery of the service?
122

D7 Customer care, customer satisfaction, service
7.1 Are all requirements related to QM-System, service and service process fulfilled?
7.2* Is customer support guaranteed?
7.3 Is the provision of service guaranteed?
7.4* If there are deviations/complaints, are failure analyses carried out and corrective
actions implemented effectively?
7.5 Are personnel qualified for the various tasks and are responsibilities defined?
123

8.2 Project management (D2)
Process element D2: Project management
D2.1 Is a project management established with a project organisation?
A process for project management exists.  Defined rolls, tasks, compe-

The project organisation is specified and contacts are tence and responsibilities of
defined. the project leader/technical
expert
The responsibilities and authority of the project lead-
er and team members are defined.  Project interface in multi-site
projects
The team members of the project are qualified to car-
ry out their tasks.  Project organisational chart
The project organisation meets the customer re-  Composition of the project
quirements. team
Suppliers and external service providers are involved  Verification of qualifications

in project management.  Special customer require-
ments for project manage-
ment
124

D2.2 Are all resources required to carry out the project planned and available
and are changes reported?
Resource planning takes account of the customer's  Evidence of resource plan-

requirements, based on the contract covering the ning (taking other projects in-
project. to account)
Resource planning for project members is estab-  Resource planning for
lished and implemented. The staff workload has to equipment (e.g. development
be considered. tests)
Review and where necessary adjustment of resource
planning is carried out when changes occur (dates,
scope of services provided…). This applies to
changes that are triggered by the customer as well
as internal changes or supplier changes.
The critical path is given special consideration within
the resource planning.
The necessary project budget for personnel and
equipment is planned and released.
Changes in the project organisation (interface with
customer) are reported.
125

D2.3 Is there a project plan and has this been coordinated with the customer?
The project plan meets the specific customer re-  Project plan with milestones
quirements.
 Specific customer require-
All internal and customer defined milestones are fully ments regarding provision of
incorporated in the project plan and are monitored services
and updated as necessary.
 Customer's project plan
In-house communication is ensured when changes
 Customer's deadlines
are made to the project plan. Changes made to the
project plan which affect the customer are coordinat-  Customer's milestones
ed with the customer.
 Customer's targets (meas-
The critical path is generated from the project plan urements within the individual
and takes account of required procurement items. milestones)
The project plan must include detailed activities to  QM Plan
ensure the quality of the service provided. Detailed
plans may be in a separate document (QM-Plan) re-
ferred to in the project plan.
The project plan must include the detailed activities
concerning procurement. Detailed plans may be in a
separate document referred to in the project plan.
126

D2.4 Are all relevant advanced quality planning activities of the project
implemented and monitored regularly for compliance?
Do the relevant advanced quality planning activities  Project plan

of the project meet the specific customer require-
 Customer milestones
ments.
 Milestone evaluation (review)
Is a review of the milestones identified within the pro-
ject plan carried out? Are all planned activities im-  Customer requirements in re-
plemented and is the required maturity level reached. gard to quality plans
Verification and validation of the service require-  Customer specifications
ments are contained within the plan.
 Requirements specification
The planning also addresses critical service provision manual
(internal and external services).
The plan is regularly monitored for compliance and
for target achievement.
127

D2.5* Are the procurement activities of the project implemented and monitored
regularly for compliance?
The activities have to ensure that only approved and  Make or buy decisions
quality-capable suppliers/external service provider
 External service provider se-
are used in the serial production phase.
lection criteria
The level of activity depends on the risk classification
 External service provider de-
of procured supplies.
velopment plan
These include the supplier/external service provider
 List of external service pro-
selection and award scope, award amount and target
vider for the project
date for the award.
The transfer of customer requirements in the supply  List of approved external ser-
chain/service chain is ensured. vice provider
The activities also include customer directed suppli-  Risk classification of each ex-
ers/external service providers as stated within the ternal service provider
agreement.
The suppliers for facilities, machinery, tools, test and
measurement systems and services are integrated.
The appointment of suppliers/external service pro-
viders must be appropriately documented and trace-
able.
Dates for the assignment, milestones (supplier and
external service provider) and release have been laid
down in the plan and coordinated with the overall
schedule.
The progress of the activities is monitored.
128

D2.6* Is change management within the project ensured by the project
organisation?
Change management within the project meets the  Time schedules

customer's specific requirements.
 Process description
Changes (initiated by the supplier, external service
 Change management
provider, in-house or by the customer) must be eval-
uated and if necessary the project plan must be  Change forms
adapted. This evaluation must include the risk as-
 Change history
sessment for the service provided as well as the
deadlines.  Evaluation of change
Suppliers/external service providers are actively in-  Approvals of changes

volved in change management (critical scope).
Changes are reported in a timely manner and are
agreed upon with the customer.
Compliance with defined change stops (design
freeze) must be ensured. Exceptions are to be
agreed and documented between the customer and
the supplier.
All changes must be documented.
The persons responsible for change management
are defined for the customer, internally within the or-
ganisation and to suppliers/external service provider.
D2.7 Is there an escalation process established and is this effectively

implemented?
The escalation process in the project meets the spe-  Time periods for escalation
cific customer requirements. depending on the risk have
An escalation model (risk management) must be been agreed upon
available for deviations in the project affecting the  Contact personnel/decision
overall schedule. makers in the escalation pro-
The criteria for escalation are defined, responsibilities cess are defined
and authorities are regulated and measures are tak-  Escalation criteria and paths
en when deviations occur. of communication are defined
If specific risks have been identified in technologies,  Protocols of milestone re-
suppliers/external service provider and supplied views including measures
countries, these risks should be considered within
the escalation management.
129

8.3 Planning of the service development (D3)
Process element D3: Planning of the service development
D3.1 Are the requirements for the development of the service available?
A process for identifying all requirements for the pro-  Inquiry documents
vision of service including responsibilities is regulat-
 Contract documents
ed.
 Requirement specifications
All customer requirements, statutory and regulatory
requirements and other requirements of interested  Service level agreement
parties have been identified and documented.
The organisation must use previous experience and
 Legal and regulatory re-
take into account known requirements for the provi-
quirements
sion of service.
 Purchasing conditions
Special characteristics are identified and taken into
account.  QM specific requirements
There is an agreement with the customer regarding  Quality agreements
the approval procedure for the approval of the devel-
 Requirements for documenta-
oped service.
tion
If customer requirements cannot be fulfilled coordina-
 Logistics requirements (JIT,
tion takes place with the customer. The results de-
JIS, on consignment)
termined are documented.
 Schedules, technical delivery
The conditions needed to fulfil the customer require-
conditions
ments have been determined and allowed for.
 Access to portals (custom-
Identified needs are clear, understandable and verifi-
er/supplier) information plat-
able.
form in the internet
The effect that changes in the requirements have on
 Definition of responsibilities
the service provided is checked (risk management).
for supplier/external service
The procedure for dealing with non-conforming ser- provider together with the
vices is coordinated with the customer. customer (e.g. qualification,
approval, testing…) as part of
the quality agreement
 Experience from previous
projects
 Environmental aspects, recy-
cling requirements
130

D3.2* Is the feasibility comprehensively evaluated according to the service
requirements?
The procedure for an interdisciplinary evaluation of  List of requirements

feasibility is regulated.
 Dates, timeframes
The feasibility assessment is based on the require-
 Buildings, premises
ments that have been determined and documented.
These take into account the technical, scheduling  Contractual terms and condi-
and capacity requirements as well as the administra- tions,
tive specifications (e.g. conditions of purchase).
 Requirement specifications
The results of the assessment are documented.
 Service level agreement
If customer requirements cannot be fulfilled the cus-
 CAM, CAQ
tomer must be notified or deviations “allowed”/
approved by the customer.  Process innovation
The feasibility must be confirmed before an offer is  Means of transport, contain-
submitted. er, storage
D3.3 Are the activities for the development of the service/service process
planned in detail and coordinated with the customer?
All activities from the contract award to the provision  Overall schedule and process
of service are planned, documented (project plan, development plan
milestone plan) and agreed upon with the customer.
The progress of the activities is monitored regularly.
 Customer schedule
Action is taken when necessary.
 Lead times
The identified requirements are checked regularly for
completion/feasibility.  Regular status checks on the
The development of the service process includes a progress of the development
risk analysis and the resulting measures. (reviews)
The steps necessary for release meet the customer  Project plans for investment
requirements or internal specifications. Deadlines items (facilities and equip-
have been set for all release criteria. The results of ment)
the respective release are documented.
Services provided from external service providers are
part of the project planning.
131

D3.4 Are the resources necessary to provide the service available?
The process for determination of resource is imple-  Training plan

mented.
Determination of resources refers to the availability of
 Investment planning
qualified personnel, budget, infrastructure and facili-
ties.  Contingency plans
The resource planning must ensure that all require-
ments specified in the contract with the customer can
be met.
A needs review is carried out regularly during the
development phase to ensure that potential bottle-
necks are prevented.
Processes that have been outsourced have been
considered.
132

8.4 Implementation of the service/service development (D4)
Process element D4: Implementation of the service/service development
D4.1* Are the actions which were defined in the development plan for the service
implemented?
In the development phase a risk analysis (e.g.  Methods to minimize risk

FMEA) must be used to ensure that the service will (QFD, FMEA)
comply with the customer requirements. When carry-
 Statistical design of expire-
ing out the Risk analysis for the provision of service,
ments (e.g.: DoE, Shainin,
the proposed location is included.
Taguci)
Special characteristics are identified, noted in the
 Poka-Yoke principles
relevant documents (e.g. FMEA) and secured
through implemented measures.  Control plan/inspection plan
The procured products and services are taken into  Service control plan
account. The implementation of the service devel-
 Automotive SPICE
opment is ensured in the supply chain/service chain.
The documentation of the findings from the develop-
ment of the service is available for reference in the
provision of service phase.
The requirements for planned test equipment are
defined and implemented.
133

D4.2* Are personnel resources available and qualified to ensure customer
requirements?
A general staff plan must be available.  Customer requirements

Personnel must be qualified for the relevant tasks.  Requirements profile for the
This also applies to the staff of external service pro- relevant positions
viders. Appropriate certification must be available.
 Determination of the need for
Needs assessments will be carried out regularly dur- training
ing service development with regard to possible
 Evidence of training
emerging bottlenecks and additional requirements.
Personnel resources are planned and personnel are  Knowledge of methods and
qualified in accordance with the project plan. foreign languages
Service processes that have been outsourced have  Appropriate behaviour for the
also been considered. quality of service
D4.3 Are material resources available and suitable to ensure customer

requirements?
A process to determine resources has been estab-  Customer requirements

lished.
 Technical interface to cus-
Resource determination refers to the availability of tomer and suppliers
the production facility, warehouses, storage areas,
Product development
U
test equipment, laboratory equipment, equipment etc.

and their utilization. Supporting processes must be  Test planning
considered. Process Development
U
Within the resource determination the necessary in-  Facility planning

frastructure is taken into account.
 Facility layout
Regular needs assessment must be carried out dur-
ing the service development with regard to possible  Transport routes
emerging bottlenecks and additional requirements.  Transport, containers, stor-
Material resources are planned and provided in ac- age
cordance with the project plan.  Supporting processes for ex-
Outsourced service processes must be considered. ample from logistics and IT
should be considered
The resources must be available and approved in
good time before the service is provided.
134

D4.4* Are the required approvals and releases for the service/service
The releases and verification of suitability is con-  Test reports, protocols

firmed for all services and procurement volumes in
 Evidence for purchased
accordance with development schedules.
parts/suppliers
The actions from the risk analysis (e. g. FMEA) have
 Sampling results
implemented and their effectiveness has been con-
firmed.  Specifications, requirement
specifications
An approval procedure is coordinated with the cus-
tomer.  FMEA IMDS, REACH, RoHS
The approval of the service must be available at the  Confirmation of conformity
time agreed upon with the customer. with legal requirements
The verification and validation of the service are en-  Development releases from
sured on the date agreed upon with the customer. customers
 Logistics concept (e.g. suita-
bility of packaging through
sample shipping)
 Proof of capability of special
characteristics
 Capacity studies
D4.5 Are the service specifications derived from the product and process
development and are they implemented?
The service and inspection specifications contain all Product development

inspection characteristics from the service develop-
 Risk analysis
ment (including special characteristics).
(FMEA, FTA, …)
Results of the risk analysis are considered.
 Service control plan
The specifications include information for control of
 Process/service audit plan
the service, methods and response plans and correc-
tive actions.  Inspection plan
Process/service audits are defined.  Response plan
The specifications must be available for all phases.
135

D4.6 Is a performance test for the developed service defined and performed to
ensure the service will perform under the required conditions
A performance test of the service must be carried out  Packaging requirements

in order to assess all factors and influences at the
appropriate time and make any necessary correc-
tions.  Determination of minimum
quantities (intended produc-
A performance test has provided evidence that the
tion rate and flexibility as
quality capability of the entire provision of service is
agreed upon)
given under the agreed upon conditions.
 Process capability study
 Measurement capability
 Suitability of the equipment
and infrastructure (test re-
ports)
 Personnel concept for serial
production
 Work/inspection instructions
 Service tests according to
customer schedule
136

D4.7* Is there a controlled method for the project handover from development
to provision of service?
A process is regulated for transferring work results  Customer requirements

from the project to the service delivery.
 Handover protocols/
Prerequisite for project handover is a successful in- checklists with handover cri-
ternal approval and a successful customer approval. teria
Releases for procurement volumes are available.  Acceptance reports
Resulting actions from the releases are implemented  Service control plan
on time.
 Inspection plans
The provision of service takes place under controlled
conditions.  Part history
The personnel resources required to provide the ser-  A method has been deter-
vice are available in accordance with the planning mined to carry out failure
and are qualified. analysis and to introduce cor-
rective actions
The material resources include buildings, test facili-
ties, laboratory facilities, equipment, facilities, etc.  Metrics such as OEE, re-
These are available and have been released. jects,…
Measures to safeguard the initial provision of service  Experience from the ongoing
are specified and introduced when necessary. project
 Measurement capability
characteristics
137

8.5 Procurement management (D5)
Process element D5: Procurement management
D5.1* Are only approved and quality-capable suppliers/external service

provider used?
Minimum requirements relevant for Assessment Examples for implementation
It must be ensured that only approved suppli-  Defined and documented cri-
ers/external service providers are used. teria are used for selection of
An evaluation of the qualification capability of the suppliers/external service
supplier/external service provider using specified cri- providers.
teria must be available.  Evidence of a qualification
An analysis of the quality performance of existing programme for suppli-
suppliers/external service providers has to be con- ers/external service providers
sidered. who did not meet the selec-
tion criteria
Risks in the supply chain/service chain have been
identified and assessed and appropriate measures  Evaluation of the quality ca-
for their reduction have been implemented (e.g. con- pability (QM-System, Pro-
tingency strategy). cess) for example self-
assessment, audit results,
supplier/external service pro-
vider certificates
138

D5.2 Are customer requirements taken into account in the supply/service chain?
The communication of customer requirements for  Transmission of require-

suppliers/external service providers (see D3.1) must ments, time schedule, ap-
be regulated and traceable. provals, complaints etc. with
Likewise, change management has to be consid- ensuring change manage-
ered. ment
Interfaces are identified, defined and secured. This  Quality agreement

concerns the tasks, competencies and responsibili-  QAA (quality assurance
ties. agreements)
 Legal, regulatory require-
ments
D5.3* Are supplier target agreements/external service provider target

agreements implemented with regard to the scope of supply/services?
Target agreements have been made with all suppli-  Measurable targets for quality,
ers/external service providers throughout the supply delivery quantity, punctuality
chain/service chain for products and processes.
 QM agreements including es-
These agreements have been verified and imple-
calation mechanisms
mented.
Supplier/external service provider performance must
be checked and evaluated within a defined period.
If deviations occur actions must be agreed upon and
their implementation including deadlines is to be
monitored.
To ensure meeting their target agreements, suppli-
ers/external service providers must consider events
such as a disruption in the supply of energy, labour
shortages etc. within their risk analysis and develop
contingency plans to cover these theoretical events.
139

D5.4* Are the necessary releases available for purchased services?
A release must be given for the service provided be-  Specifications/standards/test

fore new or changed services are used. instructions
The supplier has the full responsibility for quality con-  PPA-Reports
trol when services are purchased from an external
service provider.
characteristics
 Qualification tests/reports
 Change management in the
supply chain
D5.5* Is the agreed upon quality of purchased products and services ensured?
To monitor the quality of the out-sourced products  Coordination of test proce-

and services, regular checks are carried out, docu- dures
mented and evaluated.
 Test processes and frequen-
Deviations from the supplier quality are processed cies
through a standard complaint process. The com-
 Evaluation of main failures
plaints process includes a risk assessment with re-
spect to the differences in the scope of procured ser-  ppm evaluations, 8D reports
vices.
 Agreement and tracking of
Supplier/external service provider audits are to be improvement programmes
planned and carried out based on the risk given by a
 Test possibilities (internal and
deviation in the quality of procured services.
external laboratories and test
Test and measuring equipment for the procured ser- facilities
vice are available in the required number, they are
 Gauges/fixtures
stored in an orderly manner and associated work-
stations are laid out appropriately (e.g. damage, con-  Technical drawings/ordering
tamination, climate control, lighting, order, and clean- and packaging require-
liness). ments/specifications
 Test certificates
 Process or service audits
140

D5.6 Are personnel qualified for their respective tasks and are responsibilities
defined?
A description must be given of what responsibilities,  Product/specifications/

tasks and authority the employees have in their rele- customer requirements
vant task areas (e.g. for complaint processing, pro-
 Knowledge about service fea-
cess monitoring of suppliers/external service provid-
tures
ers).
 Standards/legislation
Qualification requirements must be determined for
each employee in relation to their tasks and qualifica-  Assessment methods (audits,
tions carried out accordingly. statistics)
Knowledge of previous complaints is available when  Quality procedures (e.g. 8D-
appropriate for purchased products and services. method, cause and effect di-
agram
 Complaints and corrective ac-
tion
 Job/function descriptions
 Foreign languages
 Qualification of supplier
auditors
141

8.6 Providing the service (D6)
Process element D6: Providing the service
D6.1 What goes into the process?

Process input
D6.1.1* Has the project been transferred from development to the provision of
service and is a reliable start of service provision guaranteed?
The project transfer to the provision of service has  Transfer reports

been carried out. If necessary unresolved issues are
 Defined actions with imple-
followed up on and implemented on schedule. The
mentation schedule
responsibilities for the entire handover process are
regulated and acknowledged.  Service FMEA and actions
Before the first provision of service an approval is  Service release report
available which includes all documents relevant and
 Verification/validation of the
necessary for the service provided.
service and evidences
The scope of service matches the requirements and
 Transport planning process
the process chain. Interfaces with adjacent internal
and external processes are taken into account.  Customer release (service re-
Communication structures are defined. lease)
Based on the risk assessment, measures for the safe  Service level agreement
provision of the service are planned and implement-  Released software standard
ed.
 QM plan
A process for the further development of the FMEA is
defined and regulated.
In order to monitor the effectiveness of the service
process, control mechanisms/systems must be intro-
duced.
Where necessary, tools, test and measuring equip-
ment are available in the necessary quantities.
142

D6.1.2* Are the necessary materials for providing the service available at the
agreed upon time, in the right quantity and at the right location?
The correct material must be provided to the agreed  Sufficient and appropriate
quality, in the correct quantity and with the correct storage facilities
documentation, at the agreed time and at the agreed
location where the service will be provided.
 KANBAN
The stock inventory in the system is the same as the
actual stock level.  Just in time
Defined storage areas for materials necessary for the  Inventory control
provision of service must be provided and infor-
 Change status
mation regarding the release status of these materi-
als is available.  Exchange of information re-
garding the return of unnec-
At the location where the service is provided, parts
essary components/surplus
and materials are provided as needed, taking into
account the order quantity/lot size (for example,  Inventory
KANBAN, Just in time, FIFO). Upstream processes  Production levels tailored to
in the provision of the service are taken into account. the customer’s requirements
After the provision of service, the return of unneeded
 Special requirements for con-
materials including their quantity is regulated.
tainers
Statutory and regulatory requirements are taken into
account.
143

D6.1.3* Are incoming materials necessary to provide the service stored
appropriately and are the means of transport/packing facilities suitable for
the special properties of the incoming materials?
In-house and customer specific packaging require-  Stock quantities

ments must be consistently taken into ac-
 Storage conditions
count/implemented.
 Released special and stand-
Suitable transport units must be used to protect ma-
ard transport containers
terials from damage and contamination during
transport as well as transportation to the location of  Packaging requirements
the service being provided.
 In-house transport containers
Store areas/work-stations/containers must be appro-
 Protection against damage
priate for the tidiness and cleanliness required for the
provision of service. Cleaning cycles are defined and  Positioning of parts in the
monitored. workplace
The supply of parts/materials at the location of the  Order, cleanliness
provision of service must allow for safe handling.  Over-filling (bin areas and
Specified storage times and use-by dates for special containers)
materials/parts must be monitored by appropriate
 Monitoring of storage times
methods (maximum and minimum storage times,
specified interim storage times).
Critical operating and consumable materials for ma-
chinery and facilities with a direct effect on the ser-
vice quality must be monitored accordingly.
Materials operating and auxiliary materials must be
protected against environmental and climatic influ-
ences and regulatory requirements are taken into
account.
144

D6.1.4 Are changes to the service made during the provision of the service
tracked and documented?
Change management from the change request to  Change release by the ser-
implementation must be clearly documented and re- vice provider and the cus-
sponsibilities must be regulated. tomer (feasibility, interfaces,
Changes that impact on customer requirements and effect on costs and schedules
expectations must be coordinated, approved and etc.)
approved by the customer. If necessary a new ser-  Information about changes is
vice agreement must be made. This includes both passed onto service devel-
the actual service as well as the process for the pro- opment, the location where
vision of service. the service is carried out and
Documentation of change status must be fully trace- all sub-suppliers involved with
able. providing the service
 The level of implementation
of the change is tracked
(overview with status)
 Documented change record
including updated service
agreement
 Updates of the FMEA (Ser-
vice and process for provision
of service)
 Verification and validation of
changes including documen-
tation
 Controlled introduction of
changes or changes to ser-
vices
 Change history
 Lead times for service
changes (customer specifica-
tions etc.)
 Change status of test equip-
ment, tools and materials that
are needed to provide the
service
 Changes to software
145

D6.2 Are all processes necessary to provide the service determined?
D6.2.1* Are the specifications of the service control plan complete and has it been
The documentation for the provision of the service is  Parameters, indicators and if
complete and available and is based on the service necessary tolerances
control plan.
 Special characteristics of the
Access to the documents must be possible at all service
times.
 Data regarding ma-
Characteristics of the service, materials and methods chines/tools/materials neces-
used to provide the service must be defined. sary to provide the service
Compliance with the internal/external requirements  Instructions on providing the
must be ensured. service
The service/service product must be clearly identifia-  Parameters for measuring the
ble or marked. quality of the service
Any mixing or confusion of information/data, soft-  Specific requirements regard-
ware, materials and components must be excluded. ing the behaviour of service
Indicators or parameters that influence the quality of providers
the service must be fully documented.  Work instructions
When possible, tolerances in relation to indicators or
 Process descriptions
parameters for controlling the provision of services
are specified.
Deviations to the service control plan and corrective
actions taken must be documented.
Required measures (action plan) for disturbances in
the provision of service are specified.
Services with specific requirements (special charac-
teristics) for the performance of the service provider
must be taken into account in the service control
plan.
146

D6.2.2 Are specific requirements (special characteristics) controlled during the
provision of service?
Special characteristics that significantly affect the  Service FMEA

provision of the service are noted and systematically
 Process FMEA
monitored.
In the case of deviation in regard to special charac-
teristics immediate action is taken and this is docu-  Special characteristics of the
mented. service
If it is not possible to meet the requirements of the  Special characteristics relat-
special characteristics the customer must be notified ed to the performance of the
and changes agreed upon. service provider
When special characteristics are related to the per-
formance of the service being provided, direct feed-
back discussions between the service provider, the
service provider management and when necessary
the customer, are to be carried out to ensure neces-
sary measures are agreed upon and initiated.
D6.2.3* Are non-conforming services identified and are appropriate measures tak-
en (immediate measures and corrective actions)?
Non-conforming services/service products must be  Records of non-conforming

registered, identified and documented. It must be service performance are
ensured that faulty services/service products are not available
used. Whenever possible the customer should be
heard and this information captured and document-
ed.
Action plans (immediate action and corrective action)
covering non-conforming services are documented
and initiated.
147

D6.3 What functions support the provision of the service?

Personnel resources
D6.3.1* Are the employees able to fulfil their given tasks to provide the service?
A description of tasks with an appropriate job profile  Training/qualification evi-

must be available for employees. If necessary, a dence
qualification programme is derived from this profile.
Who is qualified for each task and activity must be
 Orientation training plan with
documented.
evidence
Trainings, instruction, briefings/evidence of qualifica-
 Knowledge about the service
tions that have been performed must be document-
and failures that have oc-
ed.
curred
Employees must be instructed in the handling and
treatment of products with special characteristics.  Handling of measuring and
test equipment
Suitable evidence of qualification for each service
activity must be present (e.g. forklift driving license,  Training in work safe-
vision test, behaviour of the service provider). ty/environmental aspects
Employees responsible for measuring and testing  Training in special character-

must be trained in the correct use of measuring and istics
test equipment.  Suitable evidence of qualifi-
Trainings/instructions are given at changes to the cation (e.g. vision test, driving
service/service process and these are documented. license for forklifts)
The requirements also apply to external temporary  Training about the service be-
employees. ing provided
 Employee behaviour training
for the provision of a service
 Knowledge of the employee
satisfaction
148

D6.3.2 Do the employees know their responsibilities and authority in carrying out
and monitoring of the service quality?
Responsibilities, duties and authority of the employ-  Service level agreement

ees in their task areas are described and implement-
 Job descriptions
ed (e.g. service release, stopping the provision of
services, immediate action, corrective action etc.).  Employee self-inspections
and self-reflection
The employees know the consequences of faulty
services (what reason and the aim of the service and  Approval for the service
what happens when the service is incorrectly carried
 Control of the service being
out or is not guaranteed).
provided
Employees receive regular information on the current
 Stopping the service
standard of quality reached, both internally and with
the customer (complaints).  Order and cleanliness
The requirements also apply to internal and external  Repair and maintenance is
temporary employees. carried out/arranged for if
necessary
 Provision and adjustment of
test/measuring equipment is
carried out/arranged for if
necessary
 Training about the service
 Service quality information
(target/actual values)
 Trainings relevant for appli-
cable legal require-
ments/regulatory require-
ments
149

D6.3.3 Are the necessary personnel resources available?
The required number of qualified employees is avail-  Shift plan

able during the agreed upon time of service provi-
 Evidence of qualifications
sion. Employee qualifications need to be considered
(qualification matrix)
when scheduling staff (e.g. qualification matrix).
 Documented absence man-
Fluctuations in the assignment of the provision of
agement rules
services and through staff absences (e.g. illness,
holidays, training) are taken into account in the  Workforce scheduling
schedule.
The requirements apply to internal, external and
150

D6.4 What means are used to provide the service?

Material resources
D6.4.1* Can the specific requirements from the customer for the provision of the
service be met with the equipment used?
It must be shown that the service processes are im-  Proof of machine/process ca-
plemented in accordance with the customer require- pability for special require-
ments using the existing production facilities. Further ments
it must be shown that the resulting services meet the
 Cleanliness requirements
customer specifications.
The infrastructure/equipment (and when applicable
measuring equipment, facilities etc.) must be able to
comply with the specified requirements for the specif-
ic features of the service.
Design and condition of the equipment/devices (e.g.
tools, fixtures and handling facilities) meet the specif-
ic requirements under real conditions for the provi-
sion of the service.
151

D6.4.2 Is the maintenance of equipment for the provision of service controlled?
Maintenance activities (maintenance, inspection and  Availability/use of the appro-

repair) are determined and implemented for all instal- priate technical documents
lations, equipment and machines.
 Maintenance plan and
Maintenance activities that have been carried out maintenance tasks
(scheduled and unplanned) are documented and an-
 Weak-point analysis
alysed for improvement measures.
 Preventative tool exchange
A process for the analysis and optimization of down-
programme for units subject
time, machine utilization is implemented effectively.
to increased wear and tear
The key processes and critical machines are identi-
fied and appropriate maintenance activities (preven-  Storage and retrieval ma-
tative or prospective maintenance) are carried out in chines/equipment for
terms of a risk-based maintenance programme. The transport and storage etc.
availability of replacement parts must be ensured.  Availability of spare parts at
Resources needed to carry out necessary mainte- production facilities producing
nance measures are available. key products
Tools undergo a tool management which includes  Adherence to the prescribed

the following: maintenance intervals
 Status indication (OK/NOK/in repair)  Documentation of mainte-

nance activities
 Tool identity card including all changes made to
the tool  Regular plausibility check of
the scheduled maintenance
 Tool life (e.g. operating hours) intervals
 Protection from damage  Hiring of external service
 Tool ownership companies to carry out
maintenance
152

D6.4.3* Can the quality requirements of the service be effectively monitored with
the measurement and test facilities in use?
Test and measuring equipment used are suitable for  Service level agreement
the planned purpose and handling of service provi-
 Accuracy of inspection
sion. They are included in the service level agree-
equipment/capability of test
ment.
equipment
Capability studies confirm the suitability of the test
 Proof of the capability of in-
and measuring equipment employed.
spection processes
There is an identification system for the periodic con-
 Data collection and its inter-
trol of measuring and test equipment. Administration
pretability
of this equipment is based on the identification.
A process for the periodic monitoring of test and  Evidence of the calibration of
measuring equipment is installed and implemented inspection equipment
(responsibility for collection and return is defined).  Comparison of test equip-
This process also takes into account the calibration ment/measurement process-
of process-integrated measurement technology with es with the customer (e.g. in-
an influence on the product characteristics. ter-laboratory comparisons)
Auxiliary equipment for measuring and test equip-  Inspection plate
ment that have an influence the measurement result
 Test procedures for behav-
are monitored in the same way.
iour-based services (sales
Testing of behaviour related requirements for ser- test, service test)
vices is carried out using appropriate testing methods
(e.g. sales test, service test etc.).
D6.4.4* Are workplaces for the provision of the service appropriate for the needs?
Conditions for workplaces/inspection stands and their  Lighting

surroundings are appropriate for the work carried out
and the service performed, in order to pre-
vent/eliminate contamination, damage etc.  Climate control
In addition, the workplace layout is adapted ergonomi-  Noise pollution
cally to the work to be carried out.
 Clean rooms
This is applicable for permanent and temporary work-
 Organisation at the location
places.
of the provision of services
 Work safety
153

D6.4.5 Are tools, equipment and test equipment stored properly?
Tools, equipment, test equipment (including gauges)  Storage free from damage
must be stored and managed properly. This also ap-
plies for tools, equipment and test equipment not in
use or not yet released.  Defined storage location
All tools, equipment and test equipment are identified  Environmental influences
with their current status and all changes are docu-
 Status identification
mented (change history).
 Identification showing cus-
Storage is provided where the equipment is protected
tomer's property, prod-
against damage and environmental effects. Cleanli-
ucts/tools/devices provided
ness and tidiness are ensured.
on loan
The issue and use of this equipment is controlled and
 Defined release status and
documented.
change level
 Storage and retrieval ma-
chines/equipment for
transport and storage etc.
154

D6.5 How effective is the process for the provision of the service being
carried out?
D6.5.1* Are targets set for the provision of the service?
Process-specific targets are defined for the provision  Availability of facilities and
of the service. The targets are defined, monitored equipment
and results are communicated.
 Process indicators
Target requirements are coordinated and achievable;
○ Services provided
they are guaranteed to be up to date.
○ Services per unit of time
Customer requirements are taken into account when
setting targets. ○ Quality of service
A regular comparison is made between specified and ○ Number of defective ser-

actual results and measures are initiated if deviations vices
to the targets occur. ○ Audit results
○ Throughput times
○ Costs of defective ser-
vices etc.
 Reduction of waste by the
provision of the service (e.g.
routes, unnecessary trips)
155

D6.5.2 Is quality and process data about the service collected in a way that
allows analysis?
To demonstrate compliance with the requirements  Defect collection charts

and targets the necessary quality and process pa-
rameters (target values) of the service must be de-
fined and documented as well as the actual data (ac-  Service parameters (cycle
tual value). times etc.)
The interpretability must be ensured.  Data collection
Special incidents are documented (breakdown of  Malfunctions (e.g. failure or
facilities/equipment, customer complaints during the non-performance of services)
provision of the service).
The data collected can be attributed to the relevant
 Error type/error frequencies
services and service process. The data is available,
legible, accessible and when necessary archived as  Error costs (non-conformity)
specified.  Rejects/reworking
If requirements for traceability exist, they are taken
 Stopping of services
into account.
 Cycle times; through-put
The collected data is analysed and appropriate ac-
times
tion for improvement is initiated. A risk-based ap-
proach is used here.  Pareto analyses
The potential for improvement of the service must be  Cause and effect diagrams
continuously determined from recent findings about  Risk analysis (FMEA etc.)
quality and costs.
 Traceability concept
Events that result in a change to the service process
or to the service must be documented in the appro-
priate Risk analysis (e.g. FMEA) and the respective
measures taken are recorded.
156

D6.5.3* In the case of deviations from the service requirements and
provision of the service, are the causes analysed and the corrective actions
checked for effectiveness?
If deviations to the service/service process require-  8D method

ments occur, immediate containment actions must be
 Cause and effects diagram
taken to comply with the requirements, until the
causes of failure are eliminated and evidence has  Taguchi, Shainin
been provided of the effectiveness of the corrective  5 Why method
actions. These actions are known by the employees.
 FMEA/error analysis
Suitable methods for root cause analysis are in use.
 Process capability analysis
Corrective actions are derived, their implementation
is monitored and the effectiveness verified.  Quality control loops/quality
circles
The service control plan and the risk analysis (e.g.
FMEA) are updated as needed.  Analytical assessment meth-
ods
Non-conformities that affect the properties of the ser-
vice provided are communicated to the customer.  Information flow to the cus-
tomer
 Service FMEA
 Process FMEA
157

D6.5.4 Are service requirements and provision of the service audited regularly?
Audit programmes for service processes and service Service and service process
audits are available and implemented. Customer re- audit U
quirements are taken into account.

 Specifications
Testing of behaviour related requirements for ser-
vices is carried out (e.g. sales test, service test etc.)
and verified.  Audit programme for services
and service process audits
The service process and service audits carried out
including scheduled and
are suitable to identify specific risks and weak points
event-based audits
and implement corrective actions.
 Audit frequency
When deviations occur a root cause analysis is car-
ried out. Corrective actions are derived, their imple-  Audit requirements
mentation is monitored and the effectiveness is veri-
 Audit results, audit reports
fied.
 Auditor qualification
Service audits are periodically carried out (if possible
after the provision of service) and documented. In the Service process audit
service audit specified characteristics are examined  Process parameter for ser-
and tested according to previously defined specifica- vices
tions.
Service audit
Non-conformities that affect the properties of the ser-
vice are communicated to the customer.  Labelling, packaging
 Capacity of the test equip-
ment
 Software version
 Sales and service testing
158

D6.6 What should the process deliver?

D6.6.1* Are the necessary records concerning the service provided retained?
The scope of the records that are used to document  Customer specifications
the provision of service are specified.
Traceability (agreed with the customer) must be en-
 Specifications for archiv-
sured.
ing/customer requirements
The acceptance of the service by the customer or for archiving (e.g. EDP, pa-
subsequent services must be determined. per, fire protection, legibility)
If the terms of the service level agreement cannot be  Parts history
fully met the required reduction of services must be
coordinated with the customer.  Documentation in the case of
reduced services
Appropriate documented information has to be avail-
able. The documentation includes the relevant time  Compliance
period and/or the number of affected services.
For archiving requirements and duration, regulatory,
internal and customer requirements are taken into
account.
159

D6.6.2 Are customer requirements met at the delivery of the service?
The customer specific requirements in relation to the  Service level agreement with
service provided are known and monitored. If devia- the customer
tions occur, corrective actions are defined and im-
 Customer specific require-
plemented.
ments
Services are delivered according to customer re-
quirements to the customer (service to the customer
special characteristics of the
etc.).
service
If services are stopped the customer must be in-
 Delivery reliability
formed immediately and further procedure is to be
coordinated.  Quality targets of the service
 Quality of the provision of
service
 Planning of the shipping audit
 Storage/recall pro-
cessing/parts supply/shipping
 Target agreements
160

8.7 Customer care, customer satisfaction, service (D7)
Process element D7: Customer care, customer satisfaction, service
D7.1 Are all requirements related to QM-System, service and service process
fulfilled?
The internal and customer specific requirements on  Quality agreements with the
the quality system are fulfilled. customer
The customer requirements must be implemented in  Inclusion of supplier/external
the service development phase and during the provi- service providers
sion of service.
 Certification of the QM sys-
Customer satisfaction is determined by regular anal- tem
ysis, measures are derived and implemented.
D7.2* Is customer support guaranteed?
It must be ensured that competent contact personnel  Knowledge about problems

are available for the various areas in the customer's with the service, complaints
organisation. Communication is ensured in accord- and customer complaints
ance with the customer specifications.
 Implementation of new re-
When required, access to customer portals in ac- quirements
cordance with the customer specific agreement is
 Notification of improvement
ensured.
actions
 World-wide customer service
 Information from the custom-
er in the case of non-
compliance with the require-
ments
161

D7.3 Is the provision of service guaranteed?
Concepts including securing service are available  Contingency plans (e.g., for
and up to date. These concepts also cover emergen- alternative services, external
cy situations. service providers, packaging,
Not only internal processes but also processes of transport)
suppliers/external service providers must be consid-  Use of external capacity
ered.
 Communication regarding
Procedures must be in place which guarantees that supply shortages
the organisation informs the customer immediately
 Regulations covering authori-
when shortages in the provision of services are de-
ty to make deci-
tected.
sions/escalation paths when
The information must include the expected duration introducing special actions
and extent of the shortages in the provision of ser-
vices, the reasons and the actions which have been
taken.
162

D7.4* If there are deviations/complaints are failure analyses carried out and
corrective actions implemented effectively?
An analytic process for defective services must be  Process for processing com-
defined. plaints
The necessary personnel and material resources are  8D process
available to ensure punctual processing.
 Internal/external analysis fa-
The time limits agreed with the customer must be cilities (laboratories, compre-
adhered to, deviations must be communicated. hensive test facilities, per-
Focus points are drawn from customer problems and sonnel)
improvement programs are derived and implement-  Use of problem solving meth-
ed. ods
 Effectiveness tests
 Flow of information to the
customer in the case of devi-
ations
 Knowledge store, lessons
learned
 Quality control loop
 FMEA
 Access to the necessary re-
lease documents (PPA etc.)
 Performance indicators for
processing of complaints
 Take-back agreements
163

D7.5 Are personnel qualified for the various tasks and are responsibilities
defined?
It must be determined which responsibilities, duties  Organisational chart

and authorisations each employee has in their re-
 Evidence of knowledge of the
spective area of responsibility.
product/specifications/
Training needs must be determined individually and customer requirements
implemented for each person, depending on their
 Standards/legislation (product
tasks.
liability)
The employees have knowledge of the service and
 Processing/use
understand the consequences of a defective service
to the customer.  Failure analysis
 Evaluation methods (e.g. au-
dits, statistics)
 Quality techniques (e.g. Pare-
to, 8D Method, cause and ef-
fect diagram, Ishikawa)
 Foreign language skills
164

8.8 Application and evaluation of process audit for services
The use of the questionnaire for a process audt for services is carried out in
accordance with section 6.1 of the questionnare for material products.
8.8.1 Evaluation of the individual questions

Each question is assessed in terms of compliance with the requirements and
the risk involved. The assessment of each question can result in the award of
0, 4, 6, 8 or 10 points, with the number of points awarded being based on
proven compliance with the requirements.
Points Assessment of compliance with the requirements
10 Full compliance with requirements
8 Requirements mainly fulfilled++; minor deviations
6 Requirements partially fulfilled; significant deviations
4 Requirements inadequately fulfilled; major deviations
0 Requirements not fulfilled

++
The term "mainly" means that the relevant requirements are met in most instances and
no special risks have been identified.
165

The following table illustrates the appropriate allocation of points for the eval-
uation of the questions for services:
Points Evaluation of the performance of the individual requirements
Risk assessment from Risk assessment from Systematic view;

the perspective of the the perspective of the abstract
process/process step; service
specific
10 Technical requirements The service meets the Requirements are com-

and specifications for the specified require- pletely met
process are fulfilled ments/standards
8 Small deviations in the The service mostly Requirements are main-

process which do not meets the specified re- ly fulfilled, minor devia-
affect compliance with quirements and produc- tions
the customer specifica- es no serious service
tions or have an effect defects or incidents for
on following process the customer
steps
6 The process does not The service is faulty or Requirements are par-
always meet the defined disturbs the customer tially met; significant de-
requirements. This has processes. This can be viations
an impact on the cus- corrected with additional
tomer or following pro- work
cess steps
4 The process does not The service is not con- Requirements insuffi-
meet the defined re- form or disturbs the cus- ciently met: major devia-
quirements and has a tomer processes. This tions
significant impact on the cannot be completely
customer or following corrected with additional
process steps work/expense
0 The process is not ca- Full failure of the service Requirements are not
pable of ensuring com- provider. The require- fulfilled
pliance with the defined ments of the service are
requirements not met
If there are several findings for the assessment of a single question, the indi-
vidual assessment which is the greatest risk is decisive for the assessment of
the respective question.
The auditor may require immediate actions depending on the risk of the find-
ings.
166

If a question is not evaluated (n. a.), a reason for this must be stated. At least
2/3 of the questions for each evaluated process element, sub-element or pro-
cess step must be evaluated. To ensure comparability the entire list of ques-
tions from the VDA 6.3 process element should be covered in full.
If non-conformities from previous audits are repeated, the lack of implementa-
tion of corrective action can also be regarded as a deviation: e.g. “cause
analysis”, “implementation of measures”, “meeting customer requirements”.
Questions involving special provision of service and process risk

U
(*-Question)
In the process elements, questions involving special risks in terms of product

and process are identified by an asterisk (*). The specific risks in the
*-Questions are already taken into account by the classification rules (see
section 8.8.3). The evaluation is carried out analogously to the remaining
questions, this means, *-Questions are not evaluated more severely than
other questions.
8.8.2 Detailed evaluation and downgrading rules
Process element
The level of compliance EDn of a process element (D2, D3, …, D7) is calcu-
lated as:
Total points awarded for the relevant questions
EDn [%] =
Total possible points for the relevant questions
Exception: When more than one result is given for a question
In process element D6 several process steps for each question may produce
multiple results. In this case the arithmetic mean of all results for the question
must be calculated. In calculations following this step, the average is rounded
to two decimal places.
These averages are used in place of “total points” when calculating the level
of compliance of a process element.
For each question only 10 points may be awarded for the total possible
points – regardless of the number of results per question.
167

Sub-elements of D6
In the process element D6 the following sub-elements are evaluated:

EU1 Process input
EU2 Process management
EU3 Personnel resources
EU4 Material resources
EU5 Efficiency
EU6 Process output
The assessment of the sub-elements is analogous to the evaluation of a sin-
gle process element and the special case: consideration of several results per
question.
Total points awarded for the relevant questions in the sub-elements

EUn [%] =
Total possible points for the relevant questions in the sub-elements
Individual process steps
The questions from D6 are used for the evaluation of the individual process
steps. All questions from D6 can be answered in each process step. The per-
formance level En of each process step can be calculated as follows:
Total points awarded for the D6 questions for this process step
En [%] =
Total possible points for the D6 questions for this process step
Application of the downgrading rules
These results (process element, sub-element of D6, or process step) are

considered in the downgrading rules, but not used as intermediate results to
calculate the percentage of the overall results.
168

8.8.3 Overall level of performance
Process elements for services
Project management (D2) ED2
Planning the service development (D3) ED3
Implementation of the service (D4) ED4
Procurement management (D5) ED5
Providing the service (D6) ED6
Customer care, customer satisfaction, service (D7) ED7
The overall performance EG for the process audit is calculated as follows:

Total points from all evaluated questions from
ED2, ED3, ED4 ,ED5 ,ED6 and ED7
EG [%] =
If during the audit individual process elements from the questionnaire are
used, the result is calculated based only on the evaluated process elements.
Which process elements have been used in the evaluation must be made
clear in the audit report.
Overall level of compliance
Classification Level of compliance E G or EG(Dn) [%]

R R Description of the classification
A EG or EG(Dn) ≥ 90 Quality capable
B 80 ≤ EG or EG(Dn) < 90 Conditionally quality capable
C EG or EG(Dn) < 80 Not quality capable
169

Level of compliance for partial audits
To classify the level of compliance of a partial audit the calculated level of

compliance (e.g. EG(D5D6D7) and EG(D4)) is compared to the benchmarks as given
above (at least 80% for a “B” classification of conditionally quality capable or
at least 90% for a “A” classification of quality capable).
Rules for downgrading
The following rules for downgrading are to be used and documented in the
audit report:
Reasons for downgrading from A to B even though the level of compli-

U
ance is EG or EG(Dn) ≥ 90%
 At least one process element (D2 to D7) or process step (E1 to En) is
evaluated with a level of compliance EG or EG(Dn) or En from < 80%.
 A level of compliance in one of the sub-elements of D6 is < 80%.
 At least one question from the Process audit is rated with 0 points.
Reasons for the downgrading to C even though the level of compliance

U
is E G or EG(Dn) ≥ 80%
UR RU
 At least one process element (D2 to D7) or process step (E1 bis En) is R
evaluated with a level of compliance EG or EG(Dn) or En from < 70%.

The overall result is rounded to the nearest percentage point.
Similarly, when applying the downgrading rules (process element, sub-
element or process step), the individually calculated results EDn and EUn are
rounded to the nearest percentage point.
170

Audit report VDA 6.3 Evaluation of quality capability 9
9.1
Supplier:
Suppl.-No.: D-U-N-S No.: Date:
Audit request: Department: Order No.:

Location:
Audit Reason:
Audit result Statements / Requirements

Evaluation Index EG [%] Rating
Evaluated process element Summary of the audit carried out
P2, P3, P4, P5, P6, P7 EG( P 2 P 3 P 4 P 5 P 6 P 7 ) n.a. n.a.
Evaluated product group Missing!
-- EPN -- --
-- EPN -- --
-- EPN -- --
Assessment forms
-- EPN -- -- During the audit the following significant findings were identified:
Classification scale: A = 90 - 100% quality capable; B>=80 - <90% conditionally quality capable; C = 0 -
< 80% not quality capable
Last Audit Results / Certificate
Certificate / Audit No: Issue Date Conducted by Result / Certificate No. Conclusion

Further action

Participants: Management:
Process audit for material products
Audit team: Audit Organization:

Senior
Management:

Plant Management: Schedule of action plan
Q-Management: Confirmation of measures --- Effectiveness check ---
Corrective Actions see 'Individual Results' in 'Immediate Actions'
Auditor: Manager of audited organisation: Signed by (organisation):
171
Order No.:
VDA Process Audit VDA 6.3 evaluation matrix including total score for product groups
A Development
172
P2 Project management Level of compliance [%]
2.1 2.2 2.3 2.4 2.5* 2.6* 2.7 n.a.Current Target
level Maximum
level Current
level level
-- -- -- -- -- -- -- 7 0 5 -- -- EP2 n.a.

Product Process
3.1 3.2* 3.3 3.4 3.5 n.a.Current Target
level Maximum
level Current
level level 3.1 3.2* 3.3 3.4 3.5 n.a.Current Target
level Maximum
level Current
level level 3.1 3.2* 3.3 3.4 3.5 n.a.Current Target
level Maximum
level Current
level level
-- -- -- -- -- 5 0 4 -- -- -- -- -- -- -- 5 0 4 -- -- -- -- -- -- -- 5 0 4 -- -- EP3 n.a.
EPdP n.a. EPzP n.a.
P4 Implementation of the product and process development

Produktentwicklung Prozessentwicklung
4.1* 4.2 4.3 4.4* 4.5 4.6 4.7 4.8* n.a.Current Target
level Maximum
level Current
level level4.1* 4.2 4.3 4.4* 4.5 4.6 4.7 4.8* n.a.Current Target
level Maximum
level Current
level level4.1* 4.2 4.3 4.4* 4.5 4.6 4.7 4.8* n.a.Current Target
level Maximum
level Current
level level
-- -- -- -- -- n.a. n.a. -- 8 0 4 -- -- -- -- -- -- -- -- -- -- 8 0 5 -- -- -- -- -- -- -- / / -- 8 0 4 -- -- EP4 n.a.
EPdR n.a. EPzR n.a.
B Series production
5.1 5.2 5.3 5.4* 5.5* 5.6 5.7

n.a.Current Target
level Maximum
level Current
level level
P5 Supplier Management -- -- -- -- -- -- -- 7 0 5 -- -- EP5 n.a.
P6 Process analysis /production

5. Effectiveness of the Level of compliance
1. Process input 2. Process Management 3. Process support 4. Material resources 6. Process result / Output 7. Transport and handling of parts
process process step
6.1.1 6.1.2 6.1.3 6.1.4 6.1.5* 6.2.1 6.2.2 6.2.3* 6.2.4* 6.2.5 6.3.1* 6.3.2 6.3.3 6.4.1* 6.4.2 6.4.3* 6.4.4 6.4.5 6.5.1 6.5.2 6.5.3* 6.5.4 6.6.1 6.6.2 6.6.3 6.6.4* 6.1.2 6.1.3 6.1.4 6.2.4 6.2.5 6.6.1 6.6.2 6.6.3
X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 2: two E2
X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 3: three E3
X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 4: four E4
X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 5: five E5
X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 6: six E6
X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 7: seven E7

X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 8: eight E8
X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 9: nine E9
X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
Prozessschritt 10: ten E10

X -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- -- 26 0 17 -- -- n.a. -- -- -- -- -- -- -- --
10
Results of the sub elements for process analysis (Average Levels 1 - n)
6.1.1 6.1.2 6.1.3 6.1.4 6.1.5* 6.2.1 6.2.2 6.2.3* 6.2.4* 6.2.5 6.3.1* 6.3.2 6.3.3 6.4.1* 6.4.2 6.4.3* 6.4.4 6.4.5 6.5.1 6.5.2 6.5.3* 6.5.4 6.6.1 6.6.2 6.6.3 6.6.4* n.a.Current Target
level Maximum
level Current
level level 6.1.2 6.1.3 6.1.4 6.2.4 6.2.5 6.6.1 6.6.2 6.6.3

n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. 260 0 17 0 0 EP5 n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a.
Current Target
level Maximum
level Current
level level Current Target
level Maximum
level Current
level Current
level Target
level Maximum
level Current
level Maximum
level Current
level Maximum
level Current
level Maximum
level Current
level level
0 34 -- -- 0 34 -- -- 0 20 -- -- 0 34 -- -- 0 27 -- -- 0 27 -- -- n.a.
CurrentTarget
level Maximum
level Current
level level
Eu1 n.a. Eu2 n.a. Eu3 n.a. Eu4 n.a. Eu5 n.a. Eu6 n.a. 8 0 54 -- -- Eu7 n.a.
7.1 7.2 7.3* 7.4* 7.5 n.a.Current Target

level Maximum
level Current
level level
P7 Customer care / customer satisfaction / service -- -- -- -- -- 5 0 4 -- -- EP6 n.a.
Responsible for downgrading Overall compliance E G (PGN) [% ] for each product group Overall compliance E G:
n.a. Calculated EG, C<80, B<90
n.a. Asterisk questions for EG, minimum 1 question with 4 ratings = "B", minimum 1 question with 0 = "C" Process Step
Product Group(s): EG(PGN)[%] Rating
n.a. No question rated 0, otherwise "B" No.: EG [%] Rating
Total points awarded for the relevant questions 0
n.a. Eu1…Eu7, <80% rated "B" 0 0 n.a. n.a.
n.a. E1…E10, <80% rated "B", <70% rated "C" 0 0 n.a. n.a. EG [% ] n.a. n.a.
n.a. Sub ratings Ep2, Ep3, Ep4, Ep5, Ep6, Ep7 <80% rate "B", <70% rate "C" 0 0 n.a. n.a.
Total possible number of points for the relevant questions 0
n.a. Overall compliance EG: 0 0 n.a. n.a.
At least 2/3 of questions must be answered for each evaluated process element and sub element Down grading rules must be applied to the classification results (A, B. C). This must be checked by the auditor!
Action plan with defined immediate action
Supplier: Order No.:
Location: Copy sheet to new file (only Date: 28.11.16
Show all rows
for suppliers)
Filled in by the auditor in the questionnaire Filled in by the audited area
Questi Refere Immediate Respon- Effec-

Audit results Reason(s) Measure(s) Deadline
on No. nce action (x) sibility tivity
Points
P2 Project management
2.1
2.2
2.3
2.4
2.5
2.6
2.7
3.1
3.1
3.2
3.2
3.3
3.3
3.4
3.4

3.5
3.5
P4 Implementation of the product and process

development
4.1
4.1

4.2
4.2
4.3
4.3
4.4
4.4
4.5
4.5
4.6
4.7
4.8
4.8
P5 Supplier Management
5.1
5.2
173
Audit Report VDA 6.3 Potential Analysis 9.2
174
Supplier:
D-U-N-S No.: Date:
Location: Order-requestor: Order:
Audit Reason:
Country:
Audit Result Findings/requirements

Project, Product, Process RED YELLOW GREEN n.a. Rating Process description:
Projekt X 0 0 0 36
Projekt Y 0 0 0 36
questionnaire
Projekt Z 0 0 0 36
Remarks Risk assessment
RED Barred supplier: Nomination is not possible:
YELLOW Conditionally approved: Nomination is conditionally possible:
GREEN Fully approved supplier: Nomination is possible: Potential assessment
The findings (conform, nonconform) identified in this report are to be used at own responsibility with cause analysis,
action definition, action implementation and evaluation of effectiveness. This report will be used as the basis for
further/future analysis.
History/Certificates

Audit basis: Date: Conducted by Result: Further course of action:

Participants
Auditteam: Function: Supplier: Function:
Auditor QM
HR
Manufacturing
Development
Sales
Logistic
Purchasing Confirmation of actions Effectiveness review*
Potential analysis (P1) as an extract from the VDA
* After notice of contract award
Lead auditor Audit manager: Senior Management: Q-Management:

Audit Report VDA 6.3 Potential Analysis Overview ratings
Order:
Supplier:
Suppl.-No.:
Location:
Date:
Assessment
Overview ratings
Overall rating ALL
Yellow questions Red questions "GREEN" 0 0 0
Barred supplier
 more than 14 from 0 0
0
0
0
0
0
Controlled supplier
 max. 14 none ALL "n.a." 36 36 36
Approved supplier
 max. 7 none >> n.a. rated >> n.a. rated >> n.a. rated
Question according VDA 6.3 questionnaire PX PY PZ
P2 Project Management
P2.1 Is a project management established with a project organisation? n.a. n.a. n.a.
Are all resources required for the project implementation planned and
P2.2 n.a. n.a. n.a.
available and are changes reported?
P2.3 Is there a project plan and has this been agreed with the customer? n.a. n.a. n.a.
Is the advanced product quality planning implemented within the project
P2.4 n.a. n.a. n.a.
and monitored for compliance?
Are the procurement activities of the project implemented and monitored
P2.5 n.a. n.a. n.a.
for compliance?
Is change management within the project ensured by the project
P2.6 n.a. n.a. n.a.
organisation?
Is there an escalation process established and is this effectively
P2.7 n.a. n.a. n.a.
implemented?
P3.1 Are the specific product and process requirements available? n.a. n.a. n.a.
Is the feasibility comprehensively evaluated according to the product and
P3.2 n.a. n.a. n.a.
Are the actions which were defined in the product and process
P4.1 n.a. n.a. n.a.
development phases implemented?
Are the material resources available and suitable to ensure the start of
P4.3 n.a. n.a. n.a.
serial production?
Are the required approvals and releases for the product and process
P4.4 n.a. n.a. n.a.
development available?*
P5.1 Are only approved/released and quality capable suppliers used? n.a. n.a. n.a.
P5.2 Are the customer's requirements taken into account in the supply chain? n.a. n.a. n.a.
Are the necessary releases available for purchased products and
P5.4 n.a. n.a. n.a.
services?
P5.5 Is the agreed upon quality of purchased products and services ensured? n.a. n.a. n.a.
P5.6 Are incoming goods delivered and stored appropriately ? n.a. n.a. n.a.
P6 Process analysis/production
P6.1 What goes into the process? (Process input)

Has the project been transferred from development to serial production
P6.1.1 n.a. n.a. n.a.
and is a reliable start guaranteed?
P6.2 Are all Production Processes controlled? Process management
Are the specification of the control plan complete and have they been
P6.2.1 n.a. n.a. n.a.
P6.2.2 Does a repeat release for the restart of production take place? n.a. n.a. n.a.
P6.2.3 Are special characteristics managed in the production? n.a. n.a. n.a.
P6.2.4 Are non-released and/or defective parts managed? n.a. n.a. n.a.
P6.3 What functions support the process? (Personnel resources)
P6.3.1 Are the employees able to fulfil their given tasks? n.a. n.a. n.a.
P6.3.3 Are the necessary personnel resources available? n.a. n.a. n.a.
175

P6.4 What means are used to implement the process? (Material resources)
Can the product-specific requirements from the customer be met with the
P6.4.1 n.a. n.a. n.a.
manufacturing equipment?
P6.4.2 Is the maintenance of the manufacturing equipment and tools controlled? n.a. n.a. n.a.
Can the quality requirements be effectively monitored with the
P6.4.3 n.a. n.a. n.a.
measurement and testing facilities in use?
P6.4.4 Are the work and inspection stations appropriate for the needs? n.a. n.a. n.a.
P6.5 How effective is the process being carried out? Effectiveness, efficiency, waste avoidance
In the case of deviations from product and process requirements, are the
P6.5.3 n.a. n.a. n.a.
causes analysed and the corrective actions checked for effectiveness?
P6.5.4 Are processes and products audited regularly? n.a. n.a. n.a.
P6.6 What should the process produce? (Process result/output)

Are products/components stored in an appropriate manner and are
P6.6.2 transport facilities/packing arrangements suitable for the special n.a. n.a. n.a.
characteristics of the products/components?
P6.6.4 Are customer requirements met at the delivery of the final product? n.a. n.a. n.a.
P7 Customer care/customer satisfaction/service
P7.1 Are all requirements related to QM-System, product and process fulfilled? n.a. n.a. n.a.
P7.2 Is customer service guaranteed? n.a. n.a. n.a.
P7.3 Is the supply of parts guaranteed? n.a. n.a. n.a.

If there are deviations from quality requirements, are failure analyses
P7.4 n.a. n.a. n.a.
carried out and corrective actions implemented effectively?
176

Action plan
Supplier: Order:
Location: Date: 28.11.16
Show all rows Copy sheet to new file
Filled in by the auditor in the questionnaire filled in by the audited area

Questi Project Respon-
Findings Validation Reason(s) Measure(s) Date Effectivity
on ID sibility
P2.1 PX PX21
P2.1 PY PY21
P2.1 PZ PZ21
P2.2 PX PX22
P2.2 PY PY22
P2.2 PZ PZ22
P2.3 PX PX23
P2.3 PY Effectivity
P2.3 PZ Effectivity
P2.4 PX PX24
P2.4 PY PY24
P2.4 PZ PZ24
P2.5 PX PX25
P2.5 PY PY25
P2.5 PZ PZ25
P2.6 PX PX26
P2.6 PY PY26

P2.6 PZ PZ26
P2.7 PX PX27
P2.7 PY PY27

P2.7 PZ PZ27
P3.1 PX PX31

P3.1 PY PY31
P3.1 PZ PZ31
P3.2 PX PX32
P3.2 PY PY32
P3.2 PZ PZ32
P4.1 PX PX41
P4.1 PY PY41
P4.1 PZ PZ41
P4.3 PX PX43
P4.3 PY PY43
P4.3 PZ PZ43
P4.4 PX PX44
P4.4 PY PY44
P4.4 PZ PZ44
177
10 Best practice/lesson learned
10.1 Example of a supplier self-assessment

Supplier Self Assessment (SSA)
For procurement enquiry : Date:
Sourcing No.: Part-No.: Part Name:
The return of the supplier self assessment is an obligation (and where appropriate with attachments). The details are exclusively
related to the actual manufacturing site! Please return the completed form immediately! - please insert additional lines if
necessary
1. General Data Supplier

Company name: Responsible: Sales Research&Development Quality
Name:
Tel. No.:
Mobile Phone:
If relevant please provide former name of Email:
the company:
Languages: German German German
English English English
Spanish Spanish Spanish
French French French
Internet-Hompage:
Address of Manufacturing site: Address of Development Centre:
Supplier No. (internal)

D-U-N-S No.: D-U-N-S No.:
Turnover p.A (€): Number of Employees: Number of Employees Development: Number of Employees Quality:
1.1 General Information for the actual Supplier Programme :

Series deliveries of quoted products/product groups from the manufacturing site:
Parts/Products Customers/Plant(s), Vehicle Types Annual Volume Since
1.2 Assessment of Quality

(Cert. DIN/ISO 9000/EN 29000 - Volume/VDA Bd.6/QS 9000/IATF 16949
(Please send the cover page of the last audit)
Parts/Product Groups Company/Auditor Cert. To % Grade Date
178

1.3 External Suppliers
Is it planned that important features e.g. functional and quality relevant components for the currently requested Yes No
project will be purchased from external suppliers? Will external service suppliers be used for the actual quoted
project (e.g. machining, assembly, painting)?
Parts/Product Groups Supplier/Company Cert. To % Grade Date
1.4 Tool Maker Yes No

Is there a tool making facility at the supplier site?
Name and address of the tool maker: Contact/Tel. No.:
2. Development
2.1 Joint Venture Partner / Know-how cooperation
Company/Contact: JV-Share (in %) Cooperation Partners Financial Contribution of Partners
Tel. No.: Fax No.:

Which components involve a joint venture or know-how cooperation? Partner:
2.2 Core Competencies

Core Competencies:
2.3 Research and Development Departments

Yes No
Is the supplier capable to handle all aspects of research and development:
If not, which development work requires to be done elsewhere:
Operation Partner/Organisation License/Joint Venture
2.4 Project Management, Methods of Product Development Yes No

Does the supplier have the project management/development at the OEM site? (e.g. local engineering office)
If yes, contact person and contact details:
Which Development- and Quality Methods are used by the supplier?

a) QFD Methods:
b) FMEA (Design FMEA, Process FMEA):
c) DOE Methods:
d) Others:
179

2.5 CAD Engineering Systems? Yes No
Does the supplier have CAD Systems?
If yes, what systems are they:
1.
2.
Is there a CAD-Data link?
If yes, what sort of link is in use?
Does the supplier use simulation methods?
If yes, what are the systems?
1.
2.
3.
2.6 Innovation Yes No

Does the supplier hold patents?
If yes, for which products or processes: locally Intern.
2.7 Laboratory Equipment: Yes No

Which equipment is available at the suppliers site? available at site ?
Which laboratory equipment is used externally? Partner/Organisation
2.8 Test Equipment Yes No

Which functional test rigs does the supplier maintain at the site? available at site?
Which test rigs are used externally? Partner/Organisation
Which endurance test rigs are maintained at the site? available at site?
Which endurance test rigs are used externally? Partner/Organisation
Which measurement and analysis equipment does the supplier maintain? available at site?
Which measurement and analysis equipment is used externally? Partner/Organisation
180

2.9 Test Facility/Prototyping Yes No
Does the supplier maintain a test facility or prototyping on site?
Which prototyping facilities are used internally?
Which prototyping facilties are used externally? Partner/Organisation
3. Other Information
3.1 Export
Which components are exported and for which customers? How much is the share for the net value of such products?
Components: Customers: Product Net Value:
3.2 Comments/Attachments
www.vda-qmc.de
181

10.2 Knowledge database
Audit results are greatly influenced by the knowledge of the auditor regarding
the product and process being evaluated. Asking relevant questions and
evaluating the answers depends on this knowledge. There are different ways
to build up this knowledge and use it in an audit. This is done for example by:
 The inclusion of product and technical experts in the audit team
 Preparation by the auditor including literature research, online forums
and industry standards
 Discussion with internal experts
It is recommended to systematically record, develop and store this “expert”
information in the knowledge database and make this available for auditors.
Sources of this knowledge are, for example, typical errors and lessons
learned. The confidentiality of this information (from customers, suppliers or
in-house) must be ensured.
It should be noted that questions resulting from this database must not pre-
sent additional requirements that go beyond the requirements agreed upon in
the contract.
This knowledge database can be made available e.g. in the form of wikis or
process-related lists.
Knowledge database for process auditors

(Listing and level of detail are examples)
Knowledge database for process auditors – Plastic injection moulded parts
Input materials Rate storage conditions of granules (temperature, humidity,

batch separation).
Examine pre-drying and conditioning.

 For plastic Type 123 pre-drying and conditioning is always
required in the delivery requirements. Details …
Note the maximum allowed amount of recycled material.

 Recycled material is not permitted in the following plastics: …
182

Knowledge database for process auditors - Plastic injection moulded parts
Production process Evaluate parameter monitoring (temperature, pressure, cycles,

retention time).
 Injection moulding processes often fluctuate. The constancy
of the parameters is to be considered
Evaluate prototypes and tool releases.

 If prototypes were taken from the development process the
machines used in the serial production should be checked for
comparable working parameters (holding pressure, tempera-
ture control etc.).
The temperature distribution in the machine is known to the sup-

plier.
Inspections Sample parts

 Observe the production start of the injection moulding ma-
chine before the first piece inspection.
 How the sample is taken, test sequence and sample type
may affect the parts (e.g. on the shrinkage characteristics).
Surface quality
 If visual tests are being carried out rate the workplace (light-
ing etc.).
 Evaluate the reference samples (approval status, storage
etc.).
Dimensional accuracy
 Evaluate gauges or when appropriate fixture from measure-
ment machines (position point, voltage-free etc.).
Version: Issued: Released:
183

Knowledge database for process auditors – Stamped and punched parts
Input materials Rate storage conditions of input materials.

 Corrosion protection
 Damage-free surface
Material certificate
 Evaluate material batches and material certificates.
Production process Damage-free parts and tools

 Ensure there is no systematic damage.
Tool maintenance intervals

 Tool life monitoring, quantity monitoring
 Evaluate wear and tear in preventive maintenance
Tool design
 Hardened surfaces
Inspections Visual examination (e.g. damage-free surface)

 workplace evaluation (lighting)
 Boundary samples for surface quality (approval status, stor-
age etc.)
Dimensional accuracy
 Evaluate measuring equipment for series inspections at the
workplace and in the measurement laboratory
 Check data collection and analysis (cp, cpk levels)
Version: Issued: Released:
184

11 Glossary
11.1 Terms and definiton
Term Definition Notes/

References
5 Whys Method used to determine the root cause of

"Five times why" a problem by repeating the question why.
Each question forms the basis for the next
question. With 5 Whys the questions go to
the fifth level to get to the root of the prob-
lem.
8D In the case of a complaint, the 8D method VDA Volume “Definition of

Eight Disciplines Problem Solv- is the standardised method to be used from Failure Cause Categories
ing VDA Volume 4. The error response be- for 8D Reporting V1.0”
tween the supplier and the customer is
guided by 8D. 8D stands for the eight disci-
plines (process steps), to be carried out
during the processing of a complaint to
recognize the underlying problem and to
avoiding repetition.
A, B, C Samples Prototypes during development of a prod-

uct. They show the maturity levels of the
component within the development cycle.
APQP APQP is a process developed by the AIAG AIAG

Advanced product quality plan- (Automotive Industry Action Group) for
VDA Volume 2;
ning product and process development and a
VDA Volume “Maturity Level
procedure for production process and
Assurance for New Parts”
product release (the method is described in
VDA Volume 2 Production Process and
product approval (PPA) or VDA Volume
Maturity Level Assurance for new Parts).
CAM CAM refers to the IT support for control and Committee for Efficient
Computer aided manufacturing monitoring of production equipment and Production (AWF)
processes.
Capability of Measurement The capability of measurement processes VDA Volume 5

Processes documents evidence that the measurement
process used (device/apparatus, operator,
environment etc.) is suitable for a specific
application (see also MSA).
CAQ CAQ System is the generic term for IT sys- VDA Volume “Standardized
Computer aided Quality Assur- tems that are specifically developed to sup- Process for Handling Cus-
ance port quality management processes. tomers´ Complaints”
185

References
CCC A valid certification system in the People’s

China Compulsory Certificate Republic of China. Chinese safety certifica-
tion system required for specified parts or
system parts when they are imported or
used within the Chinese market.
Change Management Change management describes the func- VDA ECM (Engineering
tions and processes that are established in Change Management), ISO
an organisation to ensure changes to a 9001 e.g. chapters 8.3.6,
product are controlled and documented. 8.5.6
Cmk The machine capability shows how a ma- EN ISO 21747:2004-09

Machine Capability Index chine is performing in relation to the toler-
ance limits for variance (capability correct-
ed for position). This is calculated using
mathematical and statistical methods and
only the short time variance (scattering) is
considered with the exclusion of the factors
which influence the process but are inde-
pendent of the machine.
Conflict Management Conflict management is the containment

and prevention of escalation due to con-
flicts of interest. It is about the systematic,
deliberate and targeted approach to con-
flicts in audit situations.
Conformity Confirmation Confirmation of compliance with the re-

quirements; Unlike certification only the
actual status is evaluated. An ongoing mon-
itoring programme does not take place.
Consignment Storage for products which remain in the

ownership of the supplier until removal by
the customer but are however, already
owned by the customer.
Control Chart With the help of control charts the perfor- DIN ISO 10004
mance of processes is monitored and sta-
tistically significant non-random deviations
can be detected. Control charts help to
focus on the stability of a process (see con-
trol cycle).
Control Cycle System which continuously compares its VDA Volume “Robust Pro-
actual value with the desired value and can duction Process”
react to implement corrective changes.
186

References
Cpk Statistical estimation of the result of a char- EN ISO 21747: 2004-09

Capability process index acteristic of a process that has been
demonstrated to be controlled. A process is
capable when the statistical parameters for
variance and position in relationship to the
setpoint and tolerance values meet the
given criteria.
Deviation The difference between a characteristic DIN 55350 – 12:1989- 03.;

value or the value associated with the VDA Volume “Standardized
characteristic and the reference value. In a Process for Handling Cus-
qualitative characteristic: characteristic tomers´ Complaints”
value or the allocated characteristic value
minus reference value.
Deviation/Deviation approval Risk assessment of parts that do not meet VDA Volume 2
the specification. It is assessed whether the
parts can still be used.
The deviation approval/authorisation allows
the use of components that do not reach all
the prescribed release steps and release
specifications.
The deviation approval/authorisation must
include the customer and can only be
granted by authorised person. The devia-
tion approval must be attached together
with the action plan for shortcomings with
the PPF documentation. See also: PPA,
deviation permit/authorisation.
Deviation Permit Risk assessment of parts that do not meet VDA Volume 2
the specifications. It is assessed whether
the parts can still be used. The permit al-
lows the use of components that do not
meet all the required steps and release
specifications.
A deviation permit/authorization can be
granted only by authorized personnel and
only in coordination with the customer. The
deviation permit must be attached together
with the action plan for the execution of the
shortcomings of the PPA documentation.
See PPA and deviation permit/ authorisa-
tion.
Directed Supplier When an organisation manufactures mod- VDA Volume 2

ules and must use parts from a supplier
stipulated by the customer, then this sup-
plier is a directed supplier.
187

References
DoE The objective of this method is to vary fac- VDA Volume 4;

Design of Experiments tors that influence the process or the sys- VDA Volume 11
tem experimentally to find an optimum (e.g.
optimal combination of injector, mixture etc.
to achieve the most fuel-efficient combus-
tion possible). The basis of the method is
an experimental design using statistical
methods to maximize the use of information
from the experiments carried out.
DOT Department of Transportation in the USA.

Department of The DOT defines specific requirements for
Transportation components and their labelling.
ECE Economic Commission for Europe within

Economic Commission for Eu- the United Nations. Sets standards re-
rope quirements for components and related
component labelling.
Embedded Software Embedded software is a part of a technical IEEE (Glossary of software

system and fulfils functions of the system. engineering terminology)
Error test pieces Monitoring the identification of defective

parts using a part with known deviations
from the specification (e.g. red rabbit,
dummy).
External service provider Organisation-external provider of a service. ISO 9000
Feasibility Study A feasibility study assesses at an early VDA Volume 4

stage whether a requested product (part,
component, modules, system, process) can
be produced under series conditions to the
plans and specifications given.
FIFO FIFO refers to the method of using the old-

First in first out est parts in stock before newer parts are
used.
First Pass Yield Percentage of results that are correct in the VDA Volume “Robust Pro-
first process run and do not require rework- duction Process”
ing (corresponds to first-time-through quali-
ty, straight running).
First time through quality Percentage of results that are correct in the VDA Volume “Robust Pro-
ing (corresponds to first pass yield, straight
running).
188

References
FMEA The objective of an FMEA is the early iden- VDA Volume 4

Failure Mode and Effects tification of potential sources of er-
Analysis ror/weaknesses and mistakes. The conse-
quences are evaluated in a methodical risk
analysis that initiates prevention measures.
The FMEA method prioritizes potential er-
rors according to the criteria "importance for
the customer"/"occurrence probabil-
ity"/"detection probability".
FTA The fault tree analysis is a method for risk VDA Volume 4
Fault Tree Analysis analysis for equipment and systems.
IMDS The IMDS is the material data system of IMDS International Material
International Material Data Sys- the automotive industry. All materials used Data System
tem in the manufacturing of vehicles are col-
lected, maintained, analysed and archived
within the IMDS. Through the use of the
IMDS it is possible to fulfil the requirements
of national and international standards,
legislation and regulations that are required
by automotive manufactures and their sup-
pliers.
JIS Provision of parts with a large number of

Just in sequence variants in the planned production se-
quence.
JIT The provision of parts or materials to the VDA Recommendation

Just in time location they are needed in the production 5010
at the time they are required.
KANBAN Method for reducing material stock in the

production by using demand control ac-
cording to the pull principal.
Layout Inspection and Func- A layout inspection and a functional verifi- ISO TS 16949 or IATF
tional Inspection cation to applicable customer engineering 16949
material and performance standards shall
be performed for each product as specified
in the control plans, taking into account the
applicable customer requirements for mate-
rial, function and frequency. Results shall
be available for customer review.
189

References
MSA Evaluates the test process suitability (ca- AIAG; VDA Volume 5
Measurement System pability of measuring instruments and
Analysis measuring systems) based on the product
specifications. MSA is described in a publi-
cation published by the AIAG, in addition
there are organisation specific require-
ments for measurement system analysis.
NTF NTF refers to the fact that a rejected part is VDA Volume “Field Failure
No trouble found analysed (standard test and load test) and Analysis”
no deviations from the specifications are
found. The part is considered OK according
to the findings and the complaint could not
be validated. The cause of the error could
not be identified.
OEE The OEE (Overall Equipment Effective-

Overall equipment ness) is a measure of the effectiveness of a
effectivness production system based on its availability
factor, efficiency factor and quality factor.
Pareto Analysis Using the Pareto analysis priorities can be VDA Volume 4
identified and visualised. In a Pareto analy-
sis the characteristics (e.g. error, defective
components, etc.) are sorted by frequency
or importance.
Parts History All changes that have been made to a VDA Volume 2
numbered part and the associated manu-
facturing process are documented in the
part history.
Performance test The performance test proves that the quali-

ty capability of the complete production
process is given under agreed series condi-
tions.
Poka-Yoke principle System method for preventing mistakes. VDA Volume “Robust Pro-
duction Process”
Positioning parts Parts that are produced during the setup

process or that are required for setting up
the system (e.g. master-parts). These parts
are not suitable to be used by the custom-
er.
PPA Release Procedure for serial production VDA Volume 2

Production Process and Prod- (sampling), described in VDA Volume 2.
uct Approval
190

References
PPAP The purpose of the PPAP is to determine AIAG; VDA Volume 2;

Production Part Approval Pro- whether the product complies with the de- VDA Volume “Maturity
cess sign documents and specification require- Level Assurance for New
ments. Also see: APQP; PPA. Parts”
Ppm Representation of the error component

Parts per million based on the number of 1 million produced
or supplied parts.
Pre-launch Production of a component prior to serial

production.
Process risk All risks associated with the manufacturing

process that could have an effect on the
product quality. Deviations arising from the
process and how they impact on the prop-
erties of the product.
Process Step Defined production step or production pro-

cess as part of the overall process for the
production of a product (e.g. machining,
painting, plastic injection moulding).
Product group Similar products with a comparable manu-

facturing process.
Product risk Risk that a product deviates from the speci-

fications and the possible resulting effects
e.g. to function, safety, installation.
Production peak The production peak is the number of units

produced at maximal planned capacity.
Prototype Sample for functional tests and reliability DIN 55350

tests.
QFD QFD is a quality tool developed in Japan in VDA Volume 4;

Quality Function Deployment the seventies. It is used to determine cus- VDA Volume 11
tomer requirements and their direct imple-
mentation within the technical specifica-
tions. The methodological approach is
based on a separation of the customer
requirements (what) of the technical prod-
uct features and functionality (how).
191

References
Quality assurance agreement A written quality assurance agreement

providing all quality assurance measures
for future deliveries between customers and
suppliers. In this way the rights and obliga-
tions regarding the quality of supply are
regulated. Quality assurance agreements
constitute a contractual agreement between
customers and suppliers.
Risk Risks must be anticipated and estimated ISO 9001

(from their probability and extent of dam-
age, often expressed in possible cost). Also
to consider are the technical, economic,
political and socio-cultural risks.
Shainin Test-based method (named after Shainin) Quentin: Statistical test

used to identify relevant factors through the methods according to
use of different measurement methods and Shainin
experiments.
Skip Lot The method of sampling inspection in which ISO 2859-3

some lots will be accepted within a group
without examination if the results of the
sampling tests at a specified number of
immediately preceding lots, meet defined
criteria.
SOP Start of the serial production. VDA Volume 2

Start of Production
SPC Statistical process control improves the VDA Volume 4

Statistical process control quality of production and service processes
with the help of statistical methods.
Special characteristics Special characteristics are characteristics VDA Volume “Special

which require greater care. characteristics (SC)”
Start of Production The primary goal of the start of production Milling (2008).
phase is to convert a new product from the Start of Production in the
laboratory like conditions to a stable prod- Automotive Industry: Tech-
uct series. This phase begins as soon as nical changes as a cause
the integration of all product components in or symptom of initial diffi-
prototype is successful and ends with the culties?
ability to produce the desired quality and
quantity (see also SOP).
Straight run Percentage of results that are correct in the VDA Volume “Robust Pro-
ing (corresponds to first pass yield, first
time through quality).
192

References
Sustainability Sustainability in the business context in-

cludes the safeguard of requirements re-
garding environmental protection, occupa-
tional safety and social standards as well
as long-term profit orientation.
Taguchi Test-based method (named after Taguchi) Wu:Taguchi's Quality En-

that helps design robust systems, products gineering Handbook
and processes.
Validation Validation is the uses of objective evidence ISO 9000

to confirm that the requirements which de-
fine an intended use or application have
been met.
VDA Maturity Level Assur- Continuous tracking of the maturity level of VDA Volume “Maturity
ance for New Parts new parts in conjunction with an objective Level Assurance for New
assessment of the product and production Parts”
process maturity at agreed times during the
product implementation process.
Verification Verification is the use of objective evidence ISO 9000

to confirm that specified requirements have
been met.
193

11.2 List of abbreviations
Abbreviation
AIAG Automotive Industry Action Group
A-SPICE Automotive SPICE (Software Process Improvement and Capability Determination)
CAx Computer-aided x
CMMI Capability Maturity Model Integration
D2 Project Management
D3 Planning the Service Development
D4 Implementation of the Service
D5 Supplier Management
D6 Providing the Service
D7 Customer Care, Customer Satisfaction, Service
DIN German Institute for Standardisation (Deutsches Institut für Normung e. V.)
EDn Compliance level of the service process element (D2, D3, …, D7)
EDP Electronic data processing
EG Overall compliance for the Process Audit
EG(PGn) Overall compliance for each product group
En Compliance level of each process step
EPn Compliance level of the process element (P2, P3, …, P7)
EU1 Sub-element 1 of P6: Process Input
EU2 Sub-element 2 of P6: Process Management
EU3 Sub-element 3 of P6: Personnel Resources
EU4 Sub-element 4 of P6: Material Resources
EU5 Sub-element 5 of P6: Efficiency
EU6 Sub-element 6 of P6: Process Output
EU7 Sub-element 7 of P6: Transport, Handling of Parts
ESD Electrostatic discharge
IEC International Electrotechnical Commission
Inmetro National Institute of Metrology, Standardization and Industrial Quality
194

Abbreviation
ISO International Organization for Standardization
IT Information Technology
n. a. Not applicable
P1 Potential Analysis
P3 Planning the Product and Process Development
P4 Implementation of the Product and Process Development
P6 Process analysis/Production
P7 Customer care, Customer Satisfaction, Service
REACH Registration, Evaluation, Authorisation and Restriction of Chemicals
RoHS Restriction of Hazardous Substances
SAE Society of Automotive Engineers
VDA German Association of the Automotive Industry
195

Some abbreviations are based on terms from the German Volume. These have not been
translated because of their use in the calculations and assessment forms where one
standard abbreviation is necessary. A summary of these abbreviations is given below.
Abbreviation
D Service or provision of service (D from Dienstleistung in German)
P Process Element (P from Prozesselement in German)
E Compliance level (E from Erfüllungsgrad in German)
EDn Compliance level (E) of the service (D) process element (n)
EG Overall compliance (G from Gesamterfüllungsgrad)
EG(Dn) Overall compliance (G) of the service process element (Dn)
EG(PGn) Overall compliance (G) of the product group n
En Compliance level (E) of each process step n
EPn Compliance level (E) of the process element n
EU Compliance level (E) of the sub-element u (u from Unterelement)
EUn Compliance level (E) of the specific sub-element n
196

12 Downloads
Because the presentation of the tables and figures shown in the print form is
limited we have provided you with pdf downloads under the following link:
www.vda-qmc.de/downloads
The downloads are available free of charge.
Login information:
User name: prozessaudit

Password: vda_6.3
197

13 Overview Matrix
Overview matrix of the references pertaining to the individual questions
of the process elements.
For the process elements P2.1 - P2.7
P2.1 P2.2 P2.3 P2.4 P2.5 P2.6 P2.7
VDA Volume 1 - Documentation and Archiving of

quality requirements and quality records
VDA Volume 2 - Quality Assurance for Supplies

x
Production process an product approval PPA
VDA Volume 3.2/3.3 (Part 1) - Reliability Assurance

of Car Manufacturers and Suppliers
VDA Volume 4 - Quality Assurance in the Process

x x
Landscape
VDA Volume 5 - Capability of Measurement Processes
VDA Volume 6.x - Quality Audit Standards x
VDA Volume 7 - Exchanging Quality Data QDX
VDA Volume 16 - Decorative surfaces of external

fittings and functional parts in the internal and exter-
nals of Automobiles
VDA Volume 19.x - Technical Cleanliness
VDA Volume “Maturity Level Assurance for New Parts” x x x x x x x
VDA Volume “Standardized Process for Handling

Customers´ Complaints”
VDA Volume “Field Failure Analysis”
VDA Volume “Customer-Specific QM Systems Re-

quirements”
VDA Volume “Robust Production Process” x
VDA Volume “Special Characteristics”
VDA Volume “Minimising Risk in the Supply Chain” x
VDA Volume “Automotive SPICE”
AIAG APQP x x x x x x x
AIAG/VDA FMEA x x
AIAG PPAP x
AIAG MSA
198

P3.1 P3.2 P3.3 P3.4 P3.5
VDA Volume 1 - Documentation and Archiving of quality require-

ments and quality records

VDA Volume 3.2/3.3 (Part 1) - Reliability Assurance

x
of Car Manufacturers and Suppliers
VDA Volume 4 - Quality Assurance in the Process Landscape x x x
VDA Volume 6.x - Quality Audit Standards
VDA Volume 16 - Decorative surfaces of external fittings and func-

x x
tional parts in the internal and externals of Automobiles
VDA Volume 19.x - Technical Cleanliness x x
VDA Volume “Maturity Level Assurance for New Parts” x x x x x
VDA Volume “Standardized Process for Handling Customers´ Com-

x x
plaints”
VDA Volume “Field Failure Analysis” x x x
VDA Volume “Customer-Specific QM Systems Requirements”
VDA Volume “Robust Production Process” x x
VDA Volume “Special Characteristics” x x
VDA Volume “Minimising Risk in the Supply Chain” x
VDA Volume “Automotive SPICE”
AIAG APQP x x x x x
AIAG/VDA FMEA x x x
AIAG PPAP
AIAG MSA
199

P4.1 P4.2 P4.3 P4.4 P4.5 P4.6 P4.7 P4.8
VDA Volume 1 - Documentation and Archiv-

ing of quality requirements and quality records
VDA Volume 2 - Quality Assurance for Sup-

plies Production process an product approval x x x
PPA
VDA Volume 3.2/3.3 (Part 1) - Reliability As-

x
surance of Car Manufacturers and Suppliers
VDA Volume 4 - Quality Assurance in the

x x x
Process Landscape
VDA Volume 5 - Capability of Measurement

x x
Processes
VDA Volume 16 - Decorative surfaces of

external fittings and functional parts in the
internal and externals of Automobiles
VDA Volume “Maturity Level Assurance for

x x x x x x x x
New Parts”
VDA Volume “Standardized Process for Han-

x x x
dling Customers´ Complaints”
VDA Volume “Field Failure Analysis” x x x
VDA Volume “Customer-Specific QM Systems

Requirements”
VDA Volume “Robust Production Process” x x x x x x
VDA Volume “Special Characteristics” x
VDA Volume “Minimising Risk in the Supply

x
Chain”
VDA Volume “Automotive SPICE” x x x x x x x
AIAG APQP x x x
AIAG/VDA FMEA x x x
AIAG PPAP x x
AIAG MSA x
200

P5.1 P5.2 P5.3 P5.4 P5.5 P5.6 P5.7
VDA Volume 1 - Documentation and Archiving of

x
quality requirements and quality records

plies Production process an product approval x x
PPA
VDA Volume 4 - Quality Assurance in the Pro-

x x x
cess Landscape
VDA Volume 16 - Decorative surfaces of external

fittings and functional parts in the internal and x
externals of Automobiles
VDA Volume 19.x - Technical Cleanliness x
VDA Volume “Maturity Level Assurance for New

x x x
Parts”
VDA Volume “Standardized Process for Handling

x x
Customers´ Complaints”
VDA Volume “Robust Production Process” x
VDA Volume “Minimising Risk in the Supply

x
Chain”
AIAG APQP x x
AIAG/VDA FMEA x x x
AIAG PPAP x x
For the process elements P6.1.1 - P6.1.5
P6.1.1 P6.1.2 P6.1.3 P6.1.4 P6.1.5
VDA Volume 1 - Documentation and Archiving of quality

x x
requirements and quality records

x x
plies Production process an product approval PPA
VDA Volume 4 - Quality Assurance in the Process Land-

x x
scape
201

P6.1.1 P6.1.2 P6.1.3 P6.1.4 P6.1.5
VDA Volume 16 - Decorative surfaces of external fittings

and functional parts in the internal and externals of Auto-
mobiles
VDA Volume “Standardized Process for Handling Custom-

ers´ Complaints”
VDA Volume “Robust Production Process” x x x x x
AIAG/VDAFMEA x x
AIAG PPAP x x
AIAG MSA
P6.2.1 P6.2.2 P6.2.3 P6.2.4 P6.2.5
VDA Volume 1 - Documentation and Archiving - Code of

practice for the documentation and archiving of quality re- x x
quirements and quality records
VDA Volume 2 - Quality Assurance for Supplies Production

process an product approval PPA
VDA Volume 4 - Quality Assurance in the Process Landscape x
VDA Volume 16 - Decorative surfaces of external fittings and

x
functional parts in the internal and externals of Automobiles
VDA Volume “Standardized Process for Handling Customers´

Complaints”
VDA Volume “Robust Production Process” x x x x x
VDA Volume “Special Characteristics” x x
AIAG/VDAFMEA x
AIAG PPAP
AIAG MSA
202

P6.3.1 P6.3.2 P6.3.3 P6.4.1 P6.4.2 P6.4.3 P6.4.4 P6.4.5
VDA Volume 1 - Documentation and

Archiving of quality requirements and
quality records
VDA Volume 2 - Quality Assurance

for Supplies Production process an
product approval PPA
VDA Volume 4 - Quality Assurance in

x
the Process Landscape
VDA Volume 5 - Capability of Meas-

x
urement Processes
VDA Volume 6.x - Quality Audit

x
Standards
VDA Volume 16 - Decorative surfac-

es of external fittings and functional
x x
parts in the internal and externals of
Automobiles
VDA Volume 19.x - Technical Clean-

x x
liness
VDA Volume “Standardized Process

for Handling Customers´ Complaints”
VDA Volume “Robust Production

x x x x x
Process”
AIAG/VDA FMEA x
AIAG PPAP
AIAG MSA x
P6.5.1 P6.5.2 P6.5.3 P6.5.4 P6.6.1 P6.6.2 P6.6.3 P6.6.4
VDA Volume 1 - Documentation and

Archiving of quality requirements and x x x
quality records

for Supplies Production process an x x
product approval PPA

x x x
in the Process Landscape
203

P6.5.1 P6.5.2 P6.5.3 P6.5.4 P6.6.1 P6.6.2 P6.6.3 P6.6.4
VDA Volume 5 - Capability of Meas-

urement Processes
VDA Volume 6.x - Quality Audit

x x
Standards
VDA Volume 16 - Decorative surfac-

es of external fittings and functional
x x
parts in the internal and externals of
Automobiles
VDA Volume 19.x - Technical Clean-

x x
liness
VDA Volume “Standardized Process

x
for Handling Customers´ Complaints”
VDA Volume “Robust Production

x x x x x x x x
Process”
AIAG/VDAFMEA x x x
AIAG PPAP x x
AIAG MSA
AIAG SPC x
P7.1 P7.2 P7.3 P7.4 P7.5
VDA Volume 1 - Documentation and Archiving of quality require-

x
ments and quality records

x x
VDA Volume 4 - Quality Assurance in the Process Landscape x x
VDA Volume “Field Failure Analysis” x
VDA Volume “Standardized Process for Handling Customers´

x x
Complaints”
AIAG PPAP x x
AIAG/VDA FMEA x
204

Quality Management in the Automotive Industry
The current issues of VDA publications covering quality management in the

automotive industry can be viewed on the internet under the following link
http://www.vda-qmc.de.
Orders for publications can also be made on this website.
Available from:

Qualitäts Management Center (QMC)
Behrenstraße 35
10117 Berlin
Germany
Telephone: +49 (0) 30 89 78 42-235

Telefax: +49 (0) 30 89 78 42-605
E-Mail: info@vda-qmc.de
13T 13T
Internet: www.vda-qmc.de
13T 13T
Forms available from:
Henrich Druck + Medien GmbH

Schwanheimer Straße 110
60528 Frankfurt am Main
Germany
Telephone: +49 (0) 69 96 777- 0

Telefax: +49 (0) 69 96 777-111
E-Mai l: info@henrich.de
13T 13T
Internet: www.henrich.de
13T 13T
205

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6

Product Development Process/Serial Production

3rd revised edition, December 2016

Document provided by the

For use by PLASTIC OMNIUM AUTO only

Product Development Process/Serial Production

3rd revised edition, December 2016

Verband der Automobilindustrie e.V. (VDA)

Document provided by the

For use by PLASTIC OMNIUM AUTO only

Verband der Automobilindustrie e.V. (VDA)

Printed on chlorine-free bleached paper

Document provided by the

For use by PLASTIC OMNIUM AUTO only

For use by PLASTIC OMNIUM AUTO only

For use by PLASTIC OMNIUM AUTO only

For use by PLASTIC OMNIUM AUTO only

standard for the German automotive industry” (VDA6.x Volumes).

QUALITY STANDARDS OF THE

VDA 6.1 VDA 6 Process Audit VDA 6 Process Audit

VDA 6 Product Audit

For use by PLASTIC OMNIUM AUTO only

The following firms have cooperated in drawing up the publication:

Technical and administrative assistance:

Verband der Automobilindustrie e.V. (VDA)

For use by PLASTIC OMNIUM AUTO only

2 Instructions for use 13

3 Requirements for process auditors 19

5 Potential analysis (P1) 51

For use by PLASTIC OMNIUM AUTO only

8 Process audit services 119

9 Assessment forms 171

For use by PLASTIC OMNIUM AUTO only

13 Overview matrix 198

For use by PLASTIC OMNIUM AUTO only

For use by PLASTIC OMNIUM AUTO only

For use by PLASTIC OMNIUM AUTO only

For use by PLASTIC OMNIUM AUTO only

2.1 Definition of a process audit

2.2 Area of application for a process audit

For use by PLASTIC OMNIUM AUTO only

Customer Issue Contract SOP

Supplier Receive Order Issue Contract SOP

VDA 6.3 Potential Analysis (P1)

VDA-MLA Innovation Phase Ongoing Series

ML0 ML1 ML2 ML3 ML4 ML5 ML6 ML7

Parts from Project completion,

Fig. 2.1: Possible use of the process elements

For the potential analysis (X1) see section 5.

The focus of the use of process elements P2 to P4 is on the early phase of

For use by PLASTIC OMNIUM AUTO only

For use by PLASTIC OMNIUM AUTO only

Client Award of Contract SOP

Organisation Receive order Issue contract SOP

Supplier Recieve Order, Issue Contract, SOP

Sub-Supplier Supplier Organisation Client

Fig 2.2: Scope of application in the supply chain

For use by PLASTIC OMNIUM AUTO only

Material Resources (P6.4) Personal Resources (P6.3)