Transition ISO/TS 16949:2009 To IATF-16949:2016: CQA - Paul de Geyter - September 2016
Transition ISO/TS 16949:2009 To IATF-16949:2016: CQA - Paul de Geyter - September 2016
Transition ISO/TS 16949:2009 To IATF-16949:2016: CQA - Paul de Geyter - September 2016
16949:2016
• The IATF-16949 “Rules for Certification” are not finished yet, but are
announced to be published mid of November 2016.
• The IATF-16949 3rd party auditor qualification process (training and
exams for both, IATF-16949 requirements and rules) is expected to
start in December 2016.
Jan.
…only 16 to 18 month !
.
IATF-16949:2016 general facts
- Rev.
IATF-16949:2016 general facts
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IATF-16949:2016 general facts
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IATF-16949:2016
Expectations regarding Transition Process
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IATF-16949:2016
Expectations regarding Transition Process
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IATF-16949:2016
Expectations regarding Transition Process
• TNCERT expects that there might be a additional short term peak from
June to August 2017 initiated by those clients with “ARD” from October
to December to have an early “TS-3”- Surveillance resp. re-audit
based on “ARD” - 3 month. These clients may face some risk of having
a (too) late IATF-16949 transition acc. to the time requirements in
2018.
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TNCERT expectations regarding IATF-16949
Transition (Outlook to 2017/2018)
expected
Number
of Audits
E
x
p
e
c
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e total
d IATF-16949
Audits IATF-16949
Transition Surv.-Audits
p Audits
e TS-3 IA /
a RA /
k Surv.-Audits
t
i
m IATF -16949
Initial-Audits
e
f
time
o
r
T Note: graph
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scale
n
IATF- 16949 Transition:
TNCERT recommendations for clients
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IATF-16949:2016 vs. ISO/TS-16949:2009
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Main Changes related to IATF-16949:2016
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Section 4
• 4.3.2 Customer-specific requirements
Customer-specific requirements shall be evaluated and included in the scope of
the organization’s quality management system.
• 4.4.1.1 Conformance of products and processes
The organization has the responsibility to ensure conformance of all products
and processes, including service parts and those that are outsourced, to all
customer, statutory, and regulatory requirements
• 4.4.1.1.1 Product safety
The organization shall have a documented process for the management of
product-safety related products and manufacturing-processes which shall
include a number of safety related activities (as lot traceability, specific training
of personnel, lessons learned, special approvals of FMEA and control plans,
…)
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-Section 5
• 5.1.1.1 Corporate responsibility
-The organization shall define and implement an employee code of conduct
policy and ethics escalation policy (“whistle-blower policy”) with the purpose
to ensure business integrity in the social and environmental performance of
the supply chain.
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Section 6
• 6.1.2.1 Risk Analysis
The organization shall include in its continual risk analysis, at a minimum,
potential and actual recalls, field returns and repairs, complaints, scrap, and
any rework.
• 6.1.2.2 Contingency plans
Numerous requirements from a) to g) including e.g.: prepare contingency
plans to ensure continuity of supply in the event of any of the following: key
equipment failures (also see Section 8.5.6.1), interruption from supplier
operations, natural disasters, utility interruptions, labour shortages, or
infrastructure. disruptions; periodically test the contingency plan for
effectiveness, including simulations, as appropriate; annual review of these
plans;…
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Section 6
• 6.2.2.1 Quality objectives and planning to achieve them -
supplement Top management shall ensure quality objectives that are
needed to address customer-specific requirements are defined, established,
and maintained for
relevant functions, processes, and levels throughout the organization
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Section 7
• 7.1.5.2 Measurement traceability
Records of the maintenance activities for all software used for product and
process control shall be retained
• 7.2.1 Training
Identification of training needs shall include awareness
• 7.3.1 Awareness - supplemental
The organization shall assure, that all employees are aware of their impact
on quality etc.,…..The organization shall evaluate the extent to which
personnel is aware of this impact …..
• 7.5.1.1 Quality management system documentation
The organizations QMS shall include a Quality Manual
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Section 8
• 8.2.1.2 Customer Communication - training
The organization shall ensure that personnel responsible for completing
customer communications – including but not limited to capacity reports,
corrective action reports, logistics information, and customer portals –
complete the associated customer-specific training for such communication
requirements
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Section 8
• 8.3.2.2 Planning for design and development – training
The organization shall have a defined process for determining the training
needs of personnel in contact with the customer during the quotation phase,
project development phase, and production phase. When appropriate,
personnel shall be trained in advanced product quality planning (or equivalent)
and related customer specific requirements (CSRs). Records of such training
shall be available. Training shall include, but not be limited to, the following:
FMEA, manufacturing process control, and control plans.
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Section 8
• 8.3.6.1 Design and development changes - supplemental
The organization shall ensure that for products with embedded software the
actual configuration of software and hardware is documented and
communicated to the customer.
• 8.4.1.2 Supplier selection process
The organization shall have a defined supplier selection process. The
selection process shall:
a) be based on an evaluation of the supplier’s quality management
system,
b) include an assessment of the selected supplier’s risk to product conformity and
uninterrupted supply of the organization’s product to their customers, and
c) include multidisciplinary decision making.
The supplier selection process shall include 13 defined standard criteria
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Section 8
• 8.4.2.3.1 Products with embedded software
The organization shall require their suppliers of automotive products, with
embedded software, to implement and maintain a system for software quality
assurance for their products. A widely accepted protocol, such as
Automotive SPICE, or its equivalent, shall be utilized. The organization shall
require that an Automotive SPICE Supplier Self Report, or its equivalent, is
submitted as evidence of the supplier’s system capabilities.
• 8.4.2.4.1 Second-party audits
The organization shall ensure that supplier monitoring includes a second-party
audit process. The organization shall demonstrate the competence of the
auditors undertaking the second- party audits. When supplier monitoring
requires periodic second-party surveillance audits, the audits shall be
conducted at least annually. Records of the second-party audit reports shall
be retained.
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-Section 8
• 8.4.2.5.1 Supplier quality management system development
- The organization should require compliance to Minimum Automotive
Quality Management System Requirements for Sub-Tier Suppliers
(MAQMSR) as a further step beyond compliance with, or certification to,
ISO 9001.
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Section 8
• 8.5.1.1. Control plan
Family control plans are acceptable for bulk material and similar parts using a
common manufacturing process The organization shall review and update
control plans for any of the following: …….; on a periodic basis not to exceed
one year, in a cross-functional team approach, in conjunction with the PFMEA
update.
• 8.5.1.5 Total productive maintenance
f) documented maintenance objectives including but not limited to
OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between
Failure), and MTTR (Mean Time To Repair), which shall form an input into
management to e) periodic overhaul, where the equipment is periodically
stripped down, inspected, and overhauled at fixed intervals and any parts
found below standard are repaired or replaced
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Section 8
• 8.5.1.7 Production scheduling
Top management shall assign a designated person and a back-up person
to manage all customer inputs concerning production scheduling, including
electronic data interchange (EDI). Training records shall be retained and
made available upon request.
• 8.5.6.1 Change control
Changes, including those made at suppliers, may require a production trial run
for verification of changes
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Section 8
• 8.5.6.1.1 Control of bypassed processes
The organization shall identify and document the manufacturing processes
and error-proofing devices that can be bypassed. Based on FMEA severity,
bypass procedures shall be developed and approved internally and, if
required, approved by the customer(s). Prior to shipment of product that was
manufactured using bypass, if required, the organization shall obtain approval
from the customer(s). The organization shall maintain and periodically review
a list of approved bypass devices.
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Section 8
• 8.6.1 Release of products and services — supplemental
The organization shall ensure that the planned arrangements to verify that the
product and service requirements have been met encompass the control plan
and are written documented? as specified in the control plan -> Strengthening
the process controls to align with the control plan
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Section 9
• 9.1.1.1. Monitoring and measurement of manufacturing processes
The organization shall perform process studies on all new manufacturing
(including assembly or sequencing) processes…… These documents shall
include objectives for manufacturing, effectiveness, efficiency, process
capability, reliability, maintainability, and availability, as well as
acceptance criteria.
• 9.1.1.3 Knowledge of basic statistical concepts
…. shall be understood and used by employees involved in the collection and
analysis of data. The organization shall train and evaluate personnel whose
responsibilities include statistical data management and the identification of
statistical tools. This includes, but is not limited to, the appropriate use of
statistical analysis,….
• 9.1.2.1 Customer satisfaction - supplemental
The monitoring shall include the review of customer performance data
provided through online customer portals and customer scorecards.
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Section 9
• 9.2.2.1 Internal audit programme
The organization shall have a documented internal audit process. The process
shall include the development of an annual audit programme covering all
internal quality management system audits, manufacturing process audits,
and product audits. The organization shall determine the number of audits and
audit days for each audit type to accomplish an assessment of the entire
quality management system annually.
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Section 9
• 9.2.2.5 Internal auditor qualification
The organization shall have a process to ensure internal auditors can
demonstrate competence to audit the requirements of this Automotive QMS
Standard, manufacturing processes, and products. The organization shall
maintain a list of qualified internal auditors. The organization shall ensure that
training is provided, regardless of subject matter, by a trainer who can
demonstrate competence as stated below. Internal auditors should be
qualified as defined in ISO 19011, Guidelines for Quality Management
Systems application. In addition, internal auditors shall be competent in the
following:
a) understanding and applying the automotive process approach for auditing;
b) core tools including FMEA, MSA, SPC, and other reference manuals;
c) the relevant internal/external customer requirements;
d) knowing the consequences for the customer of any non-conforming product or process;
e) evaluating internal audit results;
f) understanding product and process controls.
Maintenance of internal auditor competence shall be demonstrated through:
minimum # of audits and continuous training.
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Section 9
• 9.3.2.1 Management review inputs –
supplemental Input to management review shall
include:
a) cost of poor quality (failure, appraisal, and
prevention);
b) measures of process effectiveness;
c) measures of process efficiency;
d) product conformance;
e) plant, facility, and equipment planning to ensure manufacturing feasibility (see
Section 7.1.3.1);
f) customer satisfaction (see Section 9.1.2);
g) predictive and preventive maintenance action plans;
h) warranty performance;
i) review of customer scorecards;
j) identification of potential field failures identified through analysis of FMEA;
k) actual field failures and their impact on safety or the environment.
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Section 10
• 10.2.3 Problem solving
The organization shall have a defined process for problem solving (see Annex
D) including:
a) containment, interim actions, and related activities necessary for control of
nonconforming outputs (see Section 8.7);
b) root cause analysis, methodology used, analysis, and results;
c) implementation of systemic corrective actions, including consideration of the
impact on similar processes and products;
d) verification of the effectiveness of implemented corrective actions;
e) review and update of appropriate process documents (e.g., PFMEA, control
plan).
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Section 10
• 10.2.4 Error-proofing
The organization shall have a process to determine the use of appropriate
error-proofing methodologies. Details of the method used and test frequencies
shall be documented in the PFMEA and control plan (see Annex C and D).
The process shall include the testing of error-proofing devices for failure or
simulated failure. Records shall be maintained.
Masters and challenge parts, when used, are identified and calibrated where
applicable. Error-proofing device failures shall have a reaction plan (approved
bypass process, see Section 8.5.6.1.1)
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Section 10
• 10.2.5 Warranty management systems
The organization shall implement a warranty management process using
existing industry standards (see Annex D), unless otherwise specified by
the customer. This process shall also define the procedure for warranty part
analysis, including an NTF (no trouble found) process.
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