Welcome

Vendor System Audit

Training Session

1
- November is observed as Quality Month every year in MSIL.

- This year’s Theme is ‘DRIVE QUALITY – REVIEW RULES & ENSURE

ADHERENCE’

Theme Focus :
- Drive Quality in all aspects of business by reviewing rules, training
rules and adhering to defined rules
 Quality System

Development Line PDI Market

3
Importance of Quality Systems

Quality Problems due to

“System Not Adequate / Non Adherence’

Quality Problems

System
Non
Adherence
70%

4
Importance of Quality Systems
Serious Quality Problem due to System Non Adherence

Possibility of Door Door Latch found Improper Mould

opening in half lock NG Repair by Tier 2 Vendor
Condition

System Failure 65478

- Weak 4M Change Management Vehicles
Tier-2 (No inspection of parts after change) repaired

- No 4M change information to Tier-1

Tier-1 - CTQ parameters not communicated to Tier-2

 Reason for Defect ?

Technical Root cause

System failure

Actual Root Cause is not only in ‘Process’

but also in ‘Systems’
 Supplier Responsibility

Adherence to Process :-
- Process Control standard (PCS)
- Maruti Inspection Standard (MIS-P)

Adherence to System:-
- Vendor Quality Assurance Manual (VQM)
 Quality Systems Assessment by MSIL
 MSIL QA-VSA conduct System Audit at Tier 1
Supplier periodically.
 Total Clause in Check Sheet: 14
 No. of Check Points: 79
 Scoring:

Score Criteria
O (Circle) +3 System defined & Implemented
∆ (Traingle) 0 Minor deficiency either in system definition or implementation
X (Cross) -3 Major deficiency either in system definition or implementation

 Vendors are categories as Red / Yellow / Green

Red are vendors with < 50% marks
 Quality Systems Status
Red Yellow Green Supplier Status *

Green
19%

Red
Yellow 18%
63%

18% suppliers are categorized in Red category

 Improvement Methodology

• Kick off meeting with Supplier Top Management 16th Oct’17

• Training of suppliers about system Requirements

- By MSIL 1st ~ 2nd Nov’17

• Guidance thru visits (2 visit / month)

• Adequacy Check Nov’17 – Dec.’17
• Input regarding Best Practices

• Pilot implementation at Supplier Dec’17

• Horizontal deployment & Sustenance by Supplier Jan.’18 - Mar’18

• Confirmation Audit by MSIL QA Apr’18 – May’18

 Clause 1
(Production Preparation)

GOAL : FLAWLESS LAUNCH !

 Clause 1 – Production Preparation

“More efforts during development stage results

in smooth launch of part in production”
 Starting Development of Parts
Tech Review Meeting with MSIL

Specification meeting to discuss & finalize

requirements

Periodic monitoring of ‘Part Development

Activity Chart’

Joint Development review with MSIL

Preparation of Part Development

problem history

14
 Clause 1 – Production Preparation
S Sub Clause S Check Point Requirement
No No

1 Regarding 1 Do you define the procedure  Procedure for product

implementat for Product development development from receipt of
ion rule including the following ? - order to SOP at customer end
(procedure) scope of parts, responsibility (preferably as per APQP
of production of each department, control guidelines) to be available and
preparation contents / items? the team should understand it.

 Defined roles and

Responsibilities.

2 Do you define importance  APQP matrix for deciding

level during production development activities based on
preparation for each product categorization of parts (for new
and clarify control items and modifications)
based on it ?

71% Supplier don’t have adequate New Part development procedure

 Clause 1 – Production Preparation

S Sub Clause S Check Point Requirement

No No

2 Regarding 1 Do you implement follow-up to  Master Timing plan as per APQP matrix
management / control the schedule and progress  Customer events (sample approval, trial
implementatio of production preparation items? dates, SOP at customer end) and
n by production vendor's events (sample submission,
preparation pilot lot submission, SOP)
plan / report  Plan Vs Actual updation
(master plan)  Micro timing plan matching with
MACRO plan (wrt timing)
 Capturing delays in plan v/s actual in
timing plans.

2 Are production preparation plan • Evidence of review by project leader

and report controlled by a person and top management in the timing plan
in charge of progress (top  MOM or record of reviews (for
management) periodically? evidence)

63% Supplier don’t follow New Part development procedure

 Clause 1 – Production Preparation
S Sub Clause S Check Point Requirement
No No

3 Defect 1 Do you consider following items  Past defect History .

prevention on and implement corrective and - List of problems reported in past at
the stage of preventive action to the processes customer end and in-house (lessons learnt
process design and standards before regular from past experience/kakotora sheet)
by using production? - List of problems expected
FMEA/Matrix -Troubles in the past; - List of problems which can't be ‘
diagram -Defect items expected; captured at customer end (warranty related
-Defect items unable to capture at problems)
customer; - List of problems difficult to repair
-Defect items difficult to repair;
 Verification of past actions during
upcoming new part development.

80% Supplier not able to show implementation of Past learning

 Clause 1 – Production Preparation
S Sub Clause S Check Point Requirement
No No

3 Defect 2 Do you review and improve  Procedure for FMEA with CFT
prevention on FMEA or Matrix diagrams when approach
the stage of any critical issue occurs after  Rating of FMEA as per AIAG
process design SOP?
guidelines and having back up
by using
data for rating. Allocation of
FMEA/Matrix
diagram severity, occurrence & detection as
per AIAG manual
 Cut off criteria for taking action as
per latest AIAG manual (actions to
be taken for top 3 RPN processes)
 Review of FMEA as per decided
criteria and at decided frequency

90% Supplier not preparing PFMEA as per AIAG Guideline

 PFMEA
POTENTIAL

• What is It?
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA)

– A tool used to identify and prioritize risk

Item: Process Responsibility ORGANIZATION
Model Year(s)/Program(s) APPLICATION Key Date

areas and their mitigation plans. Core Team:

Process Step

• Objective or Purpose

Classification

Occurrence
Current Current

Detection
/ Function

Severity
Potential Potential Potential

RPN
Process Process
Failure Effect(s) Causes(s)
Mode of Failure of Failure Controls Controls

– Identifies potential failure modes,

Prevention Detection
Requirements

causes, and effects. Inputs come from

the process flow diagram.
– Identifies key inputs which affect quality,
reliability and safety of a product or
process.
• When to Use It
– New product launches
• After completion of the process flow
diagram. IMPORTANT!
• Prior to tooling for production
The PFMEA is a CFT activity,
– When troubleshooting production issues
Never do it alone!
– When planning and closing preventive
and corrective actions Always assign correct rankings
as per AIAG guidelines!
 PFMEA
(Severity Ranking)
 PFMEA
(Occurrence & Detection rankings)
 Clause 1 – Production Preparation
S No Sub Clause S Check Point Requirement
No

4 Product/proc 1 Do you prevent defects by  Complete analysis of problems

ess evaluation quality improving activities of reported during development.
at the quality cross-function team to
evaluation evaluate quality  Summary in PDCA sheet , and
meeting in performance?
analysis
each trial
 Clause 1 – Production Preparation
Resp PersVerified By App by
Model Name：　 　　Quality evaluation meeting
Stage : Primary Trial Problems and follow up results
（This list is for follow up initial flow period the problems encountered in the production during the preparation period Date :
Initial flow period follow
C/M Follow up results
C/M Resp up result
№ Problem Point Reason Deadline Deptt Countermeasure Impl
date Confirmatio Confirmatio Confirmatio Confirmatio
n : Month n result n : Month n result
Date Date
After press operation , Bolt
Bolt holes misaligned as the jig Prodn
1 Insertion Position shifted by 2 2/23 2 locator positions added in the jig. 3/15 3/15 OＫ 6/15 NG
position was out. Engg
mm.

6
Clause 1 – Production Preparation

S No Sub Clause S Check Point Requirement

No

4 Product/proce 2 Do you define condition to For confirming development targets.

ss evaluation start mass production and then (Mass production readiness sheet)
at the quality check on the product line prior
evaluation to SOP?
meeting in
each trial
 Clause 2
(Initial flow Management)
 Clause 2 – Initial Production Control
S Sub Clause S Check Point Requirement
No No

2 Regulation 1 Do you define  Initial Production Control procedure

(procedure) following items having following:
for related to initial - Scope (for new parts and modifications)
Initial production control - Initial production control start date (from
Production by standards ? SOP at vendor's end) and end date (after
Control -controlled parts; completion of period after SOP at customer
-controlled items; end)
-inspection - Initial production control period
method; - Persons responsible for start/end
-initial production - Finish conditions (including following):
control period;
-a person who
announce
start/end of initial
production
control;
-finish condition;
 Clause 2 – Initial Production Control

S
Sub Clause S No Check Point Requirement
No
Regulation ② How do you define items required Special controls (increased
2 for special control during initial inspection, increased sample size etc.
initial production control? Do you set at all stages - incoming, in-process &
production stricter inspection methods than the final)
control ordinal inspection?

③ Do you share the information of IFC announcement, Trend monitoring,

initial production control among the Exit if target achieved.
related department?
 Clause 2 – Initial Production Control
Objective:
 To verify the validity of assurance and mechanism adopted at
NPD stage
 To confirm that quality problem at production preparation stage
is solved
 To promote quality stabilisation at initial mass production stage

Scope:
Initial flow control is applicable for newly developed parts or
parts developed after engineering change or after process
change.

Announcement >> IFC Activity plan >> Target Monitoring >> Countermeasure >> Exit
 Clause 2 – Initial Production Control
Control period:
 For newly developed parts – 3 months or 3000parts (whichever is
later)
 For ECN/PCN parts – 1 month or 1000parts
(whichever is later)
ECN PCN
SOP SOP SOP

IFC
IFC

IFC
Production preparation ECN PCN

IMPORTANT!
Always ensure implementation of
IFC in new part & post-SOP
ECN/PCN cases!
Announcement >> IFC Activity plan >> Target Monitoring >> Countermeasure >> Exit
 Clause 2 – Initial Production Control
Roles & Responsibility:
 Choose responsible information receiver
 Choose responsible person who takes countermeasures for defects
Overall
Responsible

Equipment/
Quality Assurance Manufacturing & Delivery
Tools/Jigs

Receive & share customer

Full quantity check of
information
appearance/ assembly defects
Inspects parts to be shipped
(missing/ wrong parts etc.)
Improve & maintain (appearance, wrong/missing parts/
Understand analyse and improve
equipments – Colour tone)
results of process defects
Manufacturing jigs & Prevent outflow of serious defects
4M changing point control
tools Take countermeasures on quality
Comply with standard operation
defects
Eradicate short stoppages
Check 4M changing point
Ensure consistency of standards

Announcement >> IFC Activity plan >> Target Monitoring >> Countermeasure >> Exit
 Clause 2 – Initial Production Control
Special control during IPC period:
 Increased or tightened inspection across all inspection stages within the process
Incoming, in-process, doubled inspection for FG parts (Addition Firewall/ IPC station)
 Monitoring of Process capability for each product and process

Detail for Special Control:

Normal period IPC period
S. Inspection
Control Item Inspection Inspection Inspection Inspection Judgment
No. Stage
method Frequency method Frequency

OK . NG

OK . NG

OK . NG
IMPORTANT!
OK . NG
It is necessary to deploy stringent
checks at respective inspection OK . NG
stages
OK . NG

Announcement >> IFC Activity plan >> Target Monitoring >> Countermeasure >> Exit
 OK . NG

Clause 2 – Initial Production Control OK . NG

Exit targets and results:

S. Result
Control Item Target Judgment Remarks
No. Month 1 Month 2 Month 3

1 Customer complaints 0 OK . NG

2 Defects @ Firewall/ IPC station 0 OK . NG

3 Inprocess rejection 100ppm OK . NG

4 Cpk 1.67 min OK . NG

Result of c'measure taken against

5 Effective OK . NG
problems during production preparation
Result of c'measure taken aginst
6 Effective OK . NG
problems during initial control period

7 Process Audit results 0 open NC OK . NG

Result of Initial Production Control OK . NG Initial control checks can be terminated YES . NO

If No, IPC period extended by _______ days, reason for extension ____________________________________________________________

___________________________________________________________________________________________________________________
(please use new sheet for extension period)
End of IPC (Termination)
ENGG PROD PUR PE HOD - QA

Distribution to CFT members :

Unit Head, Head Engineering, Head Purchase, Head Production, Head PE

Announcement >> IFC Activity plan >> Target Monitoring >> Countermeasure >> Exit
 Clause 2 – Initial Production Control
Countermeasure:
Checkpoint when any defect occurs

 Defect description. Understand defect phenomenon precisely.

 When was defect reported? When did it occur?
 Where did the information come from? Who received the information?
 Single defect? Or many? When did the first defect occur? What is the production
volume? << Remember, it
is not necessary that the defect caught is the first one >>
 Judge severity
 Effect to other plant
 In-house product or purchased product?
 Role assignment for countermeasure plan

Clarify the content of action and measure (when, who, where,

action contents, To which parts should be checked etc.)

Announcement >> IFC Activity plan >> Target Monitoring >> Countermeasure >> Exit
 Clause 2 – Initial Production Control
Initial control period termination conditions:
Initial production control period can be terminated in case if following targets
are achieved:
 Zero customer complaints
 Zero Firewall/ IPC station defects
 Inhouse rejection ppm (less than annual target)
 Process capability Cpk>1.67 (or Process performance Ppk)
 Effective implementation of countermeasure for production preparation issues
 Effective implementation of countermeasure for issues observed during Initial production
control period

This means that the production can be resumed as per normal controls as specified in control plan.

Announcement >> IFC Activity plan >> Target Monitoring >> Countermeasures >> Exit
 Clause 3
(4M Change Management)
 Clause 3 –Change Management

4M Man , Machine, Material, Method

Change something become different from standard

Management To Manage the situations

Clause 3 –Change Management

It is a systematic approach to dealing

with change.

4 M Change Management is systematic

approach to deal the changes in Man , Material,
Machine and Method
 Clause 3 –Change Management

S S No
Sub Clause Check Point Requirement
No

3.1 Definition and 1 Do you define  List of changes that can occur
implementatio unexpected change in process related to 4M.
n of changing (unusual) and planned  Distribution of changes into
management change clearly? planned and unplanned

Major Observation:-
 4M changes related to man, method and material not
identified clearly.
 No clarity on planned and unplanned.

88% Supplier don’t have adequate 4M Change Management Procedure

 Clause 3 –Change Management
Planned
Changes

4M
Change
Unplanned
Changes

Planned Changes Unplanned Changes

New operator Hiring Sudden change in operator

Man Extended /Extra Shift Man Operator sick/ injured

New Machine Procurement Machine break down

Machine Preventive maintenance Machine Tool breakdown
Pokayoke breakdown
New R/M source
Material New R/M grade or Spec. Material shortage
Material
BOP Parts Bin/Trolley fallen down
New inspection instrument /
Method gauge Packaging/storage method change
Method
Inspection Method Change
 Clause 3 –Change Management

S S No
Sub Clause Check Point Requirement
No

3.1 Definition and 2 Do you define  What actions will be taken if

implementatio procedure(rules applied 4M change occurs.
n of changing from sharing information  How many parts to be
management to result confirmation) at checked.
change occurrence?  What is difference in checking
for planned and unplanned
changes
 Awareness to operator about
chnages

Major Observation:-

 Actions to be taken during 4M unplanned changes are not defined.

 Usually set up part check is considered sufficient.
 Operators are not aware of 4M changes

73% Supplier don’t have adequate action plan in 4M change situations

 Clause 3 –Change Management
What are the
changes in 4 M
category

In-house and
Brainstorming Past Defect
customer end
session History
standards

Training
 4 M CHANGE CONDITIONS & ACTIONS
Process : Injection Molding, Assembly & Ultrasonic welding
Action Plan
Retroactive
Set up approval
S 4M Inspection
Change Change Detail Cut off criteria in case of Abnormal Situations
No Category (checking of
(checking of parts
parts before &
after change)
after change)

1. Opera tor goi ng on l ea ve wi th i nti ma ti on -

Expected
2. Job rota ti on Yes -
(Pl a nned)
3. New Opera tor
1 Ma n
Unexpected 1. Opera tor not a bl e to work due to
Yes Yes -
(Unpl a nned) s i cknes s or a cci dent
Abnorma l 1. Defecti ve PARTS Produced by negl i gency
Yes - Whol e l ot /s hi ft to be checked
Condi ti on of opera tor

Expected 1. Remova l & Addi ti on of Poka Yoke's

Yes - -
(Pl a nned) 2. Preventi ve ma i ntena ce
1. Ma chi ne brea kdown Yes Yes -
Machine Parameter change* Yes -
Unexpected
Change in Mold* Yes - Customer approval required & relevant documents to be
(Unpl a nned)
Machine change* Yes - submitted as per MSIL requirements.

Checking Fixture Change* Yes -

Tool s broken s uddenl y Yes - 10 Nos to be checked before broken & a fter recti fi ca ti on
Poka Yoke not worki ng Yes - Al l Pa rts to be checked (Produced i n l a s t s hi ft)
Ma chi ne i s not i n good condi ti on
Yes - 50 Nos to be checked before brea k down & a fter recti fi ca ti on
2 Ma chi ne (Repea ted Brea k Downs )
01 No. (La s t Produced) to be checked before & a fter power cut
Power s uppl y tri ppi ng s uddenl y or
Yes - a nd i n ca s e of repea ted power s uppl y, check a l l pa rts prodcued
repea ted
i n l a s t 01 Hr.
Abnorma l Al l pa rts produced to be checked up to l a s t defecti ve & a l l
Condi ti on Yes Yes
defecti ve pa rts to be rej ected & s cra pped.

Any da ma ge i n mol d l i fter/i ns erts or hol e After mol d recti fi ca ti on pa rts to be checked for a ppea ra nce &
bl ock i n pa rt a ffected di mens i ons by QA & i f found OK then a l l ow for
Yes Yes producti on.
If any major repair or modification is carried out in mold then
customer approval is required before start of production.
Valve Gate : 5 pa rts . to be checked for pa rt wei ght & vi s ua l l y fo
Ai r pres s ure l ow/hi gh Yes -
a ppea ra nce.
Expected 1. Use of alternate source material from
Yes - Thorough inspection & customer approval is required
(Pl a nned) approved source*

Unexpected 1. Use of alternate source material from Not allowed & Customer approval required. All material to be
Yes Yes
(Unpl a nned) unapproved source* rejected.
3 Ma teri a l
1.) I mmedi a tel y check & get veri fy the s us pected or a ffected l ot
BOP Pa rts Bi n/Trol l ey fa l l en down Yes -
Abnorma l by QA or dema nd for new ok l ot.
Condi ti on
Any cus tomer compl a i nt recei ved or Check & s egrega te the whol e l ot l yi ng a t BAPL for the concerned
Yes Yes
Wa rra nty i s s ue recei ved i s s ue
1. Modification of Jigs/fixtures*
2. Process Change*
Expected Customer approval required & relevant documents to be
3. Proces Sequence Change* Yes -
(Pl a nned) submitted as per MSIL requirements.
4. Sub Supplier Process Change *
5. Despatch Packing Change*
4 Method
Check & s egrega te the whol e l ot l yi ng a t BAPL for the concerned
Abnorma l Any intermittent short shot or molding
Yes Yes i s s ue & i f s hi pped to a s s y l i ne then check & i nform to a s s y & QA
Condi ti on defect
for concerned i s s ue.

Abnorma l
FG Bi n/Trol l ey fa l l en down /da ma ge Yes - Al l Pa rts to be checked whi ch a re l yi ng i n tha t trol l ey/bi n
Condi ti on

Remarks
This is a live sheet, if any employee observe any new abnormal or unplanned change condions then he can request for addition of the check
point in this sheet.
 Clause 3 –Change Management
S S No
Sub Clause Check Point Requirement
No
3.1 Definition and 3 Do you record product  Inspection report of parts after
implementatio quality check results to change occurrence
n of changing ensure traceability?  Records of batch code for
management traceability
4 Do you retroactively  Comparison of parts before
check about product and after breakdown
quality when unexpected
change occurs?

Major Observation:-
 Report contains part checked and found ok.
 Content of inspection is not available.
 Parts produced before breakdown (Retroactive parts) are not
checked.

94% Supplier don’t have evidence for Retroactive actions

 Clause 3 –Change Management

Refer the standard Lot Inspection as

Lot identification
for the actions for per the standard
for 4 M change
the change criteria

Recording of Lot approval as

Identification of
inspection result per inspection
NG part (if any)
in 4M change result
 Clause 3 –Change Management
In case there is any change
in 4 M (as per standard)

Change item to be
recorded in
standard format
Clause 3 –Change Management
Clause 3 –Change Management
Clause 3 –Change Management
Abnormal conditions Criteria

Process Flow

Layout

Graph

Hold Card Summary Sheet One Point Lesson

 Cost of Poor Quality
Child Part Process(Tier Assy at Tier 1 Vehicle Assy at MSIL
1 or Tier 2)

Defect due to 4 M 50
change parts 600 parts 12000 Vehicles

X 1000X

Estimate the cost of poor quality?..........................

Clause 3 –Change Management
 Clause 3 –Change Management
S S No
Sub Clause Check Point Requirement
No
3.2 Definition and 1 Do you define initial part  Procedure for First production
implementatio clearly? parts (FPP)
n of changing
management 2 Do you control initial  Implementation of tags for
parts separately and various types of parts as per
make quality records manual.
about them?

Major Observation:-

 Procedure for FPP is generally not found.

 Inspection & identification tags not defined for trail parts
 IPP system not implemented for Tier-2
Clause 3 –Change Management
Clause 3 –Change Management
Clause 3 –Change Management
 Clause 4
(Standard Management)
 Clause 4 – Standard Management
S No Sub Clause S No Check Point Requirement
4.1 Procedure to 1 Do you make process  Prepare control Plan for all the
make process control standards for all part manufactured by your
control products which is company
standards(QA shipped to SMC / MSIL?
process
charts)
 Clause 4 – Standard Management
S No Sub Clause S No Check Point Requirement

4.1 Procedure to 2 Do you mention defined  Mention both process & product
make process both characteristics of characteristic on control plan?
control quality and production
standards(QA control on the process
process control standards?
charts)

Observation (4.1.2)
Gaps in Standard management
 All process characteristics not mentioned in control plan
 Clause 4 – Standard Management
S No Sub Clause S No Check Point Requirement

4.1 Procedure to 3 Do you mention Mention following on control plan:

make process followings on process i. Quality check frequency &
control control standards method
standards(QA required to each ii. WI reference
process process? iii. Boundary sample reference
charts) -quality confirmation wherever required
method; -regulations; iv Poka Yoke Reference in Control
-standards (operation plan.
instruction/items to be
focused on);
-boundary samples; -
parameter chart; -
Pokayoke

Observation (4.1.3)
Gaps in Standard management
 Poka Yoke, Limit sample reference not available in PCS
 Clause 4 – Standard Management
PART ASSY ( Write part number of the VENDOR Write your company's name
NAME INDL
assembly)
( Write part number of the Process Control Standard Write serial no of Write total no. of pages
assembly) each page
(Write M UL, part number of Write A for and A and F for Functional parts
the assembly) MODEL
PART ASSY at the end of Part Number Write name (s) of mode (s) for
which this part is supplied
Page No.
(Write M UL, part number of
the assembly)
NUMBER INDL
Process Control Standard Control Inspectio Critical Control Sam pling R e c o rding
Process Description R e a m rk s
Machine Param ter Spec. Spec. n Method Characteri Incharge schem e/ Yes/ N o
Sl. No. stics frequency
Write check
Write the name of process/ Write For each For each Control Write A triangle Write Write if the For critical
Write frequency e.g.
operation e.g. incoming inspection, result of parameters
type, process control specificati briefly the should be R 100%. N=5
sequence
number
casting, machinging, plating etc. make w rite parameter on must method of marked if Am c=0. Start up Triangle to
checks are
recorded or
write action to
be taken in
control the W (I.e. check 5
checking
of the
For processes w hich are sub-
capacity
etc. of the parameter
w rite the
engineeri
be tighter
than the e.g. visual process P
pieces at the indicate Critical
not. It will be
better to also
case of
abnormally e.g.
process/ ti me of
mention the seggregation,
operation
contracted and for bought out
parts, w rite "sub-contracted"
machine s of both
products
ng standard w ith Go-
No Go
parameter
is critical
or
I
process
setting and
Process
way of scrap rework
used e.g. specificati specificati recording e.g. etc.
w ithing brackets below the Hydraulic (e.g. dia, on value on e.g. gauge, (See start if none is
defective).
Characteristics
name of report,
register, Z.R.
process name. Press 400 hardness w ith 250 + 7C, measurin legends N=3, c=0/Hr. chart etc.
Ton. etc) as tolerance 1.5 + 0.4 g w ith on bottom (I.e. check 3
For processes related to and w ell as or limits kg/cm2 45 micromete left pieces every
Functional items, w rite or process corner) hour and
e.g. 250, 55 r as per
continue if
respectively at the end of process (e.g. + 10C, 1.5 IS ….. none is
name. funace + 0.5 Etc. defective).
temp. kg/cm2 40- N=10, c=0;
Include sketch of the product pressure LOT (I.e.
60 HRC check 10
at each stage before and after etc.) pieces in each
each process lot and
accept the lot
if none is
defected).

R- Patrol Inspection Write briefly the reson for Date Prepared By Approved By
revision and referevce
AM - Automatic
Measurement Vendor
Legend for W- Operator
control P- Process Approval
Incharge I- Inspector
Write Revision Dates REV NO/DT Description Appd By MUL
 Clause 4 – Standard Management
S No Sub Clause S No Check Point Requirement

4.2 Procedure to 1 Do you define following Procedure for document

control concerned about preparation & retention
standards standards?
-department in charge Define clearly about
・Process of making; -department in charge of making;
control -a person in charge of -a person in charge of making;
standards making; -a person in charge of authorizing;
・Inspection -a person in charge of -making period; -timing to submit
specifications authorizing; to customer;
・Operation -making period; -timing -revision rule; -retention period;
instructions to submit to customer;
-revision rule; -
retention period;

Observation (4.2.1)
Gaps in Standard management
 Retention period is not mentioned in procedure
Clause 4 – Standard Management

 Procedure for Enactment, Revision and Control of

Operation Standards/ WIS

 Indicate A in Standard for A item/ Part

 Review the Standard for Quality feedback, ECN etc.

 Availability of WI at the point of use

Operator must follow the work sequence as defined in WI

62
 Clause 4 – Standard Management
S No Sub Clause S No Check Point Requirement

4.2 Procedure to 2 Do you have Define the same information in all

control consistency to keep the related documents (i.e. same
standards process control information in Control plan, MIS-P,
standard, inspection WI etc.)
・Process specification, operation
control inspection and
standards parameter chart?
・Inspection
specifications
・Operation
instructions

Observation (4.2.2)
Gaps in Standard management
 Different process/ product characteristics in PCS, WI etc.
 Clause 4 (Standard Management)
S No Sub Clause S No Check Point Requirement

4.2 Procedure to 3 Do you make use of lists Do you have the system to control
control to control preparation the revision details of any
standards and revision of document.
standards and share the
・Process updated information?
control
standards
・Inspection
specifications
・Operation
instructions

Observation (4.2.2)
Gaps in Standard management
 Revision history not maintained properly.
 Revision not captured in document.
 Clause 5
(Education & Training)
 Clause 5 – Education & Training
Training Process

 Annual training plan(Including contractual)

 Special focus on Maru A Operators
 Proper training for New Operator
 Check the Effectiveness of Training

Skill Development

 Identify Skill requirement

 Skill Evaluation & Development system
 Multi Skill training Plan based on needs
 Contractual Employees
 Clause 5 – Education & Training
S S No
Sub Clause Check Point Requirement
No

5.1 Education/ 1 Do you clarify the  Procedure for training &

training department in charge of employee skill development.
procedure promoting quality  Training need identification
education, implement system & matching with annual
education based on training calendar.
annual plan?  Status for training plan vs actual.
Are records of education  Training contents covers areas
kept? like technical, behavioral, safety
etc.

Observation:- Gap in new operator training process

 New operator training process not defined.
 On Job Training evaluation not done
 Skill matrix not updated at the time of new operator starts working at station
Gap in existing employee training process
 Training need identification not done.
 TNI not reflected in annual training plan.
 Monitoring of annual training plan not done to capture poor adherence.
 No backup plan to improve annual training plan adherence.
 Clause 5 – Education & Training

Process Requirement Remarks

New Joining
Operator

Induction 1. Training module for classroom training Person can be Level

training 2. Training effectiveness check 1 after completion

On Job 1. Training under expert operator. It can be off line

Training 2. To be recorded as 4M change in ‘Man’ also in Dojo

OJT 1. Objective judgement to be defined.

Person can be Level
Evaluation 2. Should include achieving ‘Zero Defect’ and
‘Tact Time’ as passing criteria.
2 or 3 after OJT

Skill Matrix 1. Update skill matrix as he goes on line for

Update working

Work on
Station
 Clause 5 – Education & Training

ON THE JOB TRAINING EFFECTIVENESS CHECK

New Joinee
Operator Name
Supporter
Work change
Supervisor Name
Return to some
Confirmation Period
Check Item Standard Method to Verify Remarks
30 min 60 min 4 hrs day 1: End day 2 day 3 week 1 week 2 1 month
Operator follows Operator should
Observe
Observe confinuously after the training

standard procedure follow OPS

Operator understands Operator should
Discuss and Observe
critical point understand
Operator adheres to Operator should
rule in case of follow abnormality Observe
abnormality handling procesdure
Operator has no
Operator should not
problem in doing Discuss and Observe
face any problem
operation
The quality of products
Zero Defect in parts Observe
is good

Tact Time of Operation ________ Sec. Observe and count

Judgement
 Clause 5 – Education & Training
S S No
Sub Clause Check Point Requirement
No

5.1 Education/ 2 Do you define and  Skill evaluation criteria for

training implement the skill operators to be objectively defined.
procedure evaluation of operator  Station wise skill matrix.
to determine whether  Method of skill evaluation:
operator can work Supervisor observation or operator
without exam etc.
surveillance?(e.g.  Training plan for taking operator to
acceptable the next skill level or multiskilling.
level/evaluation  Periodic check of the operator skill
frequency/evaluation level. (for e.g., operator observance
method) check sheet as per plan etc)

Observation:- Gap in Operator skill Assessment

 Supervisor judging the skill level as per his own judgement. No guidelines or
checkpoints defined for supervisor regarding skill assessment.
 Minimum time period of working on station not defined before assessing for
multiskilling or next skill level.
 Minimum skill level not defined for each operation.
98% Supplier don’t have proper skill matrix evaluation system
 Clause 5 (Education & Training)
Training schedule for new working associates
Duration Training after joining
1st day Joining formalities in HR
Briefing General Rules and Regulations
a. Explanation of standing orders
2nd day b. Canteen, dispensary and other medical facilities
c. Briefing on safe working in the shop floor
d. Fire & safety training
Week 1

General orientation about the company

a. Briefing on the HR policies
3rd day b. Orientation on suggestion scheme & Quality circle activities
c. Overview of Production Division
d. Training on Quality Consciousness
4th day Shop floor visit
5th day Behaviourial & discipline training
6th day Work culture of Company & the shopfloor
Skill evaluation test based on Questionnaire for 'level 1'
End of week 1 > Certify the trainee as level 1 skilled if test is qualified. If not, then retrain on gap areas & re-
evaluate. Modify the training schedule, if required.
Duration Training plan for skill level 2 certification
1st day Basic concept of 5s
Week 2

2nd day Understanding of OS, WI & abnormal situation handling

3rd day Basic training as per training module
4th - 6th
Practical training (OJT) on line with assistance from the line supervisor and technician
day
Skill evaluation test based on Questionnaire for 'level 2'
End of
week 2 > Certify the trainee as level 2 skilled if test is qualified. If not, then retrain on gap areas & re-
evaluate. Modify the training schedule, if required.
Duration Training plan for skill level 3 certification
Week
Practical training (OJT) on line without assistance from the line supervisor and technician
3, 4
Skill evaluation test based on Questionnaire for 'level 3'
End of
week 4 > Certify the trainee as level 3 skilled if test is qualified. If not, then retrain on gap areas & re-
evaluate. Modify the training schedule, if required.
Periodic Training plan & skill level 4 certification (if reqd)
- Trainings as per annual training calendar (internal & external)
- Daily production meeting for quality & productivity improvement
Week
- Multiskilling on operations & processes, if required
5 onwards
> Periodic review of performance (effectiveness check) based on current skill; Perform evaluation
for skill 'level 4' based on company requirement.
Clause 5 – Education & Training
 Clause 5 – Education & Training
OBSERVANCE OF OPERATION STANDARDS CHECK SHEET
Department Section Prepared by Verified by Approved by

Name of the
Category
Operator
No Instructions
Line No. Process Name
Problem Required

Checked by Designation O X
Classificati Sub Item Plan
Item No. Check Point Remarks
on No. Actual
Coherence between specification mentioned in
1
Operation Operation Standards condition & actual condition.
A
Conditions Whether operator is immediately reading the "display
2
value" and recording them in the check sheet or not?
Operation Is the operation being carried out as per decided
B 1
Sequence operation sequence or not?
are Quality checks being carried out and the finding are
1
Quality recorded in the check sheet or not?
C
Checks Checks in of "Initial Product" and "Proper display" for
2
Initial Production are being carried out or not?
Equipment Checking of Machine and Equipments is being carried
D 1
Checks out and check sheets are duly filled or not?
Working condition checks are being carried out in
regard to device in which Fool proofing are being
1
incorporated, entries are made accordingly in the check
sheets or not?
Equipment Working conditions checks are also being carried out
E 2
Testing for Dies and Jigs or not?
Working condition checks are being carried out in
3 regard to "Inspection Equipments, Measurement
purpose tools, Devices, Gauges etc. or not?
Is the grinding and changeover of the Cutting Tools,
Changeov 1 Grinding Stone, Electrodes etc. being timely carried out
 Clause 5 – Education & Training
S S No
Sub Clause Check Point Requirement
No

5.1 Education/ 3 Prior to SOP, do you  Training record should be evident

training instruct each operator as per the APQP master plan
procedure based on actual
operation
instructions?

Observation:- Gap in pre-SOP trainings

 No training is planned for common operations such as machining. Change point
details and new model information sheet not prepared for operator education.
 Method of teaching to operator: In many cases, teaching method of supervisor
is not correct. Teach operator to understand the steps in WI & work according
to it.
 Training content should also educate that If operator produces NG parts, what
are the consequences for the defects on the customer.
 Clause 5 – Education & Training
S S No
Sub Clause Check Point Requirement
No

5.2 Education for 1 Do you implement  Supervisor require special skills

managers/Ins planned education to like delivering education to
pectors/ supervisors for skill operators, communication skill,
Special improvement ? management skill, crisis
operators management, abnormal situation
handling etc. Training content for
supervisors should be adequately
defined.
 Roles & responsibilities of
supervisors to be clearly defined.

Observation:- Gap in Supervisor training

 Supervisor roles and responsibilities are either not defined or not educated.
 Refresher training should be planned for supervisor periodically.
 Clause 5 – Education & Training
S S No
Sub Clause Check Point Requirement
No

5.2 Education for 2 Do you implement  Special education curriculum, Maru

managers/Ins special education or A process training, & other special
pectors/ technical training to process training required.
Special inspectors and Certificate for special training is
operators operators of particular better.
process (required  Training for critical & special
specialized skills)? processes, is required.
Are training records
kept?

Observation:- Gap in Supervisor training

 Training for critical & special processes is not done. For e.g., for operator on
heat treatment, information on microstructure & for welding operator,
information on types of welding defects to be planned.
 Qualification criteria for training and skill evaluation of special operations not
defined.
 Clause 5 – Education & Training
S S No
Sub Clause Check Point Requirement
No

5.2 Education for 3 Do you periodically  Inspector skill need to be

managers/Ins monitor the skill of periodically monitored. Defect part
pectors/ certificated operators catching should be performed at
Special and follow up to line speed.
operators improve their skill?

Observation:-Gap in operator skill monitoring

 Method of periodic skill assessment not defined. (for eg. For evaluating
inspector skill, supervisor can judge it by mixing some NG in OK parts, then
judge the ability at line speed).
 If special process operator makes mistakes, then what kind of actions does the
supervisor take is not defined.

73% Supplier don’t have periodic review of skill

 Clause 6
(Quality Audits)
Clause 6 – Quality audit and process verification
S S No
Sub Clause Check Point Requirement
No

6.1 Activity to 1 Do you conduct internal  Internal audit procedure, Audit

keep/improv quality auditor plan, Schedule, List of certified
e production periodically? auditors, audit check sheet, NC
quality following are recording & verification system,.
standardized:, -auditor  In case more than one shift are
team; -audit frequency; - running, both shifts are covered
audit timing; -audit during audit of manufacturing
method; -audit check process related functions (line
sheet. production dept., QA dept., etc.).
 Auditor should not be from the
same department.

Observations: Gap in Internal QMS Audit

 Internal auditor qualification criteria not defined.
 Internal audit plan not adhered.
 Timeline for closure of internal audit NCs is not defined.
 Internal audit check sheet or interaction matrix is not defined.
Clause 6 – Quality audit and process verification
S S No
Sub Clause Check Point Requirement
No

6.1 Activity to 2 Do you conduct quality  Evidences for audit conducted,

keep/improv audit to identify issues Non conformities report & their
e production and properly improve closure.
quality them?  Adequate closure of audit NCs
with detailed analysis through
problem solving tools such as
5Why.

Observations: Gap in Internal QMS Audit

 Summary of internal audit NCs is not available.
 Audit NC not raised for checkpoint where marks are deducted.
 Closure of internal audit NCs not adequately done.
 Root cause analysis of audit NCs not evident.
 Standardization of internal audit NC closure not evident.
Clause 6 – Quality audit and process verification
S S No
Sub Clause Check Point Requirement
No

6.2 Content of 1 Do you focus on useful  In case of internal process audits,

process know-how of operation, check for shop floor
review operations with poor improvement evidences like
workability and Know-how of operations, Kaizens,
operation which need a Operator feedback etc.
lot of repair and  Check for the easiness of
standardize them? workability of operator. Check
for evidence for improvements in
PCS revision or other
improvement initiatives.

Observations: Gap in Internal Process Audit

 Process audit checksheet does not have checkpoints for workability of
operators.
 Operator feedback about work related improvement is not captured during
internal process audits.
Clause 6 – Quality audit and process verification
S S No
Sub Clause Check Point Requirement
No

6.2 Content of 2 Do you confirm  Process audit checksheet to

process consistency between confirm that the operator is
review actual operation and following the instructions or
standard? other rules.
 This is cross check of 11-1-4 i.e.
internal auditor should verify that
line leader is doing the operator
observance correctly or not.
Clause 6 – Quality audit and process verification
S S No
Sub Clause Check Point Requirement
No

6.2 Content of 3 Do you confirm if  Check whether the confirmation

process countermeasures are of the actions is periodically
review taken properly to performed. (e.g. Kakotora/
prevent reoccurring of process trouble history sheet).
quality fail?  Check for the implementation of
actions taken against past
troubles observed at customer /
in-house as per Kakotora (Past
trouble database) sheet and
previous internal audit
observations.

Observations: Gap in Internal Process Audit

 Check point for verification of countermeasures taken against previous audits
NCs and customer complaints is not defined.
 In case if the NC are re-occurring, then review of actions for better
effectiveness is not available.
 Clause 7
(Tier 2 Control)
 Sub Vendor (Tier-2) Control Process

Tier -2 Selection , Information of Tier -2 Parts supply by tier -2

Evaluation & Up gradation. selection to MSIL with proper Traceability

Audits & C ’measure

Actions in case of Quality
issues & Info to MSIL

Periodic Audits at Tier-2 location /

Ranking of Tier-2 Tier -2 by Tier-1 4M change info to MSIL

85
 Clause 7 – Tier 2 Control
S S No
Sub Clause Check Point Requirement
No

7.1 Evaluation 1 Do you define criteria to  Procedure for New Supplier

method for certificate new suppliers selection and Check sheet for
new suppliers and implement them? evaluation should be available.

 Adherence of New Supplier

selection procedure.

Observation:-
Gaps in Selection check sheet

 Mandatory points not defined in check sheet.

 In most of Cases, Selection is done on Overall Score, No separate
weightage given to each area.
 Observations are not captured in Supplier selection check sheet
 Clause 7 – Tier 2 Control

S
Sub Clause S No Check Point Requirement
No

7.2 Management, 1 Do you collect supplier  Procedure for Supplier

quality failure information, ranking.
evaluation and determine supplier  Adherence of supplier ranking
instruction for grade according to procedure
suppliers quality level and conduct  Action plan and its
audit and instruction implementation for
periodically? improvement of worst
Suppliers.
 Procedure for Supplier Audit
and check sheet.
 Conduct the audit as per
procedure and guidance
systematically.
 Follow-up against the
improvement points
 Clause 7 – Tier 2 Control

Observation (7.2.1)

Gaps in Vendor Ranking

 Mismatch of data in Supplier defect and Defect taken in Vendor
ranking.
 Monthly Vendor ranking process is not available/ Adhered.

Gaps in Audits
 Audit not planned/ Conducted for all supplier
 Observations are not captured in Supplier selection check sheet
 No Action plan/ Follow up for open observations

92% Supplier don’t conduct Supplier audit effectively

 Clause 7 – Tier 2 Control
S
Sub Clause S No Check Point Requirement
No
7.2 Management, 2 For outsourcing any  Explanation of Part functions
quality production, do you and important control items
evaluation and instruct them clearly clearly during development &
instruction for about function and implement them.
suppliers important control items  Preparation of inspection
of products at the standard with supplier for
meeting ? every part

Observation (7.2.2)
Gaps in Development
 Inspection Standard not decided with Sub Supplier.
 Explanation of Part criticality not evident
 Clause 7 – Tier 2 Control
S
Sub Clause S No Check Point Requirement
No
7.2 Management, 3 For outsourced process,  Procedure for Supplier Part
quality do you control the development
evaluation and progress of production  Monitoring of Part
instruction for preparation and development schedule
suppliers confirmed issues ? ,Capture the delay reasons
and make action plan to meet
the timeline
 Monitor the Trial results at
supplier and prepare the
action plan based on CFT
approach.

Observation (7.2.3)
Gaps in Development
 APQP Time plan Vs Actual not evident for Sub Supplier parts. Only
inspection reports available.
 PPAP Approval not done / delayed
 Clause 7 – Tier 2 Control
S Sub Clause S No Check Point Requirement
No
7.2 Management, 4 Do you make suppliers to  Procedure to instruct suppliers
quality conduct initial about Initial flow control and
evaluation and production control and its monitoring.
instruction for decide department in
suppliers charge of conduct?  Implement Initial Supply
control at supplier end as per
Procedure for new parts/
Change parts/ PCN cases.

Observation (7.2.4)
Gaps in Tier Initial flow control
 IFC procedure not evident for Tier 2 Suppliers
 Supplier Audit check sheet doesn’t contain related to IFC.
 Clause 7 – Tier 2 Control
S Sub Clause S No Check Point Requirement
No
7.2 Management, 5 Regarding the parts  Procedure to control the
quality which are shipped outsourced process where
evaluation and directly to the customers Delivery is done directly by
instruction for from outsourced Supplier to customer?
suppliers suppliers, do you have  Adherence of Product Quality
method to assure checks as per procedure
product quality
performance?

Observation (7.2.4)
Gaps in Outsourced process
 No Gaps .
 Clause 7 – Tier 2 Control
S Sub Clause S No Check Point Requirement
No
7.2 Management, 6 Do you make outsourced  Procedure for Change
quality suppliers to conduct approval request from
evaluation and initial parts and 4M suppliers & after getting
instruction for changing management change information how do
suppliers and is it possible to you manage the activities at
trace? suppliers end?
 Check whether Suppliers is
recording the change
situations & ensuring parts
traceability.

Observation (7.2.4)
Gaps in Change management
 Guidelines for changes is not prepared for Sub Suppliers.
 Procedure for Change approval request from Sub Suppliers not
available.
 Clause 8
(Handling abnormality in
quality)
Clause 8 – Handling abnormality in quality

S S No
Sub Clause Check Point Requirement
No

8.1 Handling 1 Do you define clearly  List of Quality related

when what is abnormal abnormal Situations i.e Defect
abnormal situation and make album, NG samples, etc.
situation operators know the  Rule for handling defect part,
occurs definition? hold part, dropped parts etc.
 System for making operators
aware of abnormal situations.

Major Observation:-

 Abnormal situations are defined related to Organization but not

related to Quality.
 In most of Cases, operators are not aware of Abnormal
conditions and actions to be done during abnormal situation.
Clause 8 – Handling abnormality in quality
S S No
Sub Clause Check Point Requirement
No
8.1 Handling 2 Do you clarify and  Procedure for handing
when standardize the handling customer complaint, internal
abnormal rules/routes for customer rejection & incoming rejection.
situation claims, in process failure
occurs and supplier failure?

Major Observation:-

 Procedure is made but does not cover about standardization of

documents, horizontal deployment and timeline for closure and
analysis.
Clause 8 – Handling abnormality in quality
S S No
Sub Clause Check Point Requirement
No
8.1 Handling 3 Do you have criteria to  System for suspected part
when estimate the scope of check.
abnormal suspected lot for abnormal  Incase product is prepared by
situation situation? When abnormal multiple dies/molds etc how
occurs situation occurs, do you you narrow down suspected
trace suspected lot based range
upon the criteria?

Major Observation:-

 Generally parts from all mold / dies are not covered.

 Rule for previous part check not available.
Clause 8 – Handling abnormality in quality
S
S N
Sub Clause Check Point Requirement
No o

8.2 Prevention of 1 Do you prevent recurrence  Quality of 5 why

recurrence of issues by analyzing  Format used for 5 why
cause of occurring defect analysis
・Customer claims based on process
・In process failure investigation result such as
・Suppliers failure 5-why analysis?

Major Observation:-

 5 why Quality is not good. Actual root cause is not established.

 Most of 5 why does not talk about actual root cause.

73% Supplier don’t do why why analysis in detailed

Clause 8 – Handling abnormality in quality
S
S N
Sub Clause Check Point Requirement
No o

8.2 Prevention of 2 Do you reflect corrective  Once the c/m is established

recurrence action to improvement of it needs to be standardized
process control and review by modifying control plan,
・Customer claims of standards? FMEA, WIP etc.
・In process failure
・Suppliers failure

Major Observation:-

 C/m are not updated in control plan etc.

 Pokayoke etc are added but FMEA, CP are not revised.
Clause 8 – Handling abnormality in quality
S
S N
Sub Clause Check Point Requirement
No o

8.2 Prevention of 3 After corrective action are  System for checking the
recurrence taken, do you conduct on- effectiveness of c/ms.
site checkup and evaluate
・Customer claims the effectiveness?
・In process failure
・Suppliers failure

Major Observation:-

 Most of vendors monitors that whether defect is repeating or

not.
 Onsite verification of c/ms is not done.
Clause 8 – Handling abnormality in quality
S
S N
Sub Clause Check Point Requirement
No o

8.2 Prevention of 4 Do you cascade  C/m established on one

recurrence information of corrective process to be horizontally
action to similar parts and implemented to other
・Customer claims processes? processes & other
・In process failure plants(incase mutliple
・Suppliers failure plants)

Major Observation:-

 Horizontal deployment of countermeasure is not done from one

line to another. Incase of mutliple plants information is not
passed on to other plants.
 Clause 9
(5S management)
 Clause 9 – 5S Management
S No Sub Clause S No Check Point Requirement

5.1 Location of 1 Do you keep store  Check storage condition of raw

production material, work-in- material & child parts, work-in-
site process, finished process, finished goods. It
products, inventory and should be properly prevented
container at appropriate from dust, rust, rainwater etc.
storage prevented from
dust, rust, scratch,
deformation and
rainwater?

Observation (5.1.1)
Gaps in 5S

 Child part / Raw Material storage condition inappropriate.

 Parts kept on floor, open environment etc.
 Clause 9 – 5S Management
S No Sub Clause S No Check Point Requirement
5.1 Location of 2 Do you control material,  Material storage locations
production work-in-process and defined with identification.
site finished product by  Area identified for storing new
designated location, model parts.
volume and standard  Storage instructions (for ex.
using visual control? maximum height) should be
defined.
 Bin / Raw material bags storage
should be uniform. It Hold parts
and set up parts at work station
to be identified properly.

Observation (5.1.2)
Gaps in 5S
 Identification tag not available.
 Similar parts kept together
 Parts kept on floor, open environment etc.
 Clause 9 – 5S Management
S No Sub Clause S No Check Point Requirement

5.1 Location of 3 Do you forbid operators  Operator should not keep

production to put temporary temporary storage at workplace.
site storage on work place? One piece flow should be
observed wherever possible to
avoid part mix-up..

Observation (5.1.3)
Gaps in 5S
 Unidentified material at inspection table, Near machine etc.
 Clause 9 – 5S Management

• Bin Stacking NG • Bin Stacking Ok

• Appearance Not good • Appearance Good
• Part damage chances are • Part damage chances are
high low
 Clause 9 – 5S Management

• Part Stacking NG • Part Stacking Ok

• Appearance Not good • Appearance Good
• Part damage chances • Part damage chances
during trolley movement during trolley movement
are high are low
 Clause 9 – 5S Management

• Less part during stacking • More part during stacking

• More no. of trollies • Less no. of trollies required
required
 Clause 9 – 5S Management
S No Sub Clause S No Check Point Requirement
5.1 Location of 4 Do you implement  Work station for inspection and
production inspection or critical other critical operations should
site operation under the be well illuminated and in well
properly controlled maintained condition.
environment luminance  Lux level monitoring should be
/temperature/humidity/ available.
vibration/noise/work
table, etc.)?

Observation (5.1.4)
Gaps in 5S
 Lux level not defined as per IS: 6665
 Lux level not monitored in B, C shift
 No defined frequency & records for Lux monitoring.
 Clause 9 – 5S Management
S No Sub Clause S No Check Point Requirement
5.2 Production 1 Do you keep condition  Check condition of production
equipment's of production equipment's on shop floor. There
management equipment's, jigs and should be no equipment's
tools properly? damaged, clamps loose, oil
leakage from machine etc.
 Check that production
equipment should not be fixed
with temporary non-standard
methods like packing with
scrap, tied with cloth etc.

Observation (5.2.1)
Gaps in 5S
 Unclean machine, Air
 Oil leakage from machine.
 Clause 9 – 5S Management
S No Sub Clause S No Check Point Requirement
5.2 Production 2 Do you keep condition  Check condition of inspection
equipment's of inspection equipment's on shop floor. There
management equipment's properly to should be no equipment's
ensure accuracy? damaged, checking fixture
clamps loose, datum pins
missing etc.

Observation (5.2.2)
Gaps in 5S
 Pin missing/ Damage on inspection fixture
 Validation of fixture not done as per time
 No defined frequency for Pin replacement
 Clause 10
(Equipment/ Inspection
equipment's
management )
Maintenance of Inspection Equipment

 Annual Calibration plan

 Maintenance plan

 Inspection Standards & check sheet

 Carry out inspection as per Plan

 Keep all records

 Maintain History card including

Calibration, Repair etc.

113
 Maintenance of Production Equipment
(Machine /die /tools /molds /jigs /fixtures)

 Preventive maintenance Daily/Periodic check

 Predictive maintenance sheets

 Carry out periodic check & Maintenance as per

plan

 In case of Breakdown, Carry out breakdown analysis

 Carry out 1st Piece inspection as per Drawing after

every maintenance/ Breakdown

 Maintain History card including Maintenance,

Repair etc.
 Calibration check points

• Ensure usage of Proper ‘Set’ gauges

• Proper identification of gauges – Stickers / Color coding

• Calibration of gauges / instruments / fixtures as per

“Calibration Plan”

• Availability of calibration records

• Awareness of operator / inspector regarding “Error” &

“Least Count “in gauges / instruments
Case Study - Improper Repair after machine
breakdown

Machine breakdown Inadequate Repair M/C improper

during production method adopted adjustment after repair

Part Validation incomplete

before Production start

 1st piece inspection as per drawing after every maintenance activity

 Adequate critical machine spares to be kept
 Review System/Procedure for breakdown repair.
VQM Ref :- 17.2.2
 Clause 10 – Maintenance
S No Sub Clause S No Check Point Requirement

10.1 Maintenance 1 Do you conduct  Check the Machine, Dies and

of daily/regularly check of Jigs on daily / Periodically as
equipment's , production equipment's, per defined check sheet.
jigs and tools dies and jigs? Are
records of maintenance  Record the observations and
kept? take necessary actions based
on the same.

Observation (10.1.1)
Gaps in Daily check sheet
 Availability of Daily/ Periodic check sheet for all machines, dies,
tools
 Objective values are not captured in Daily check sheet.
 Actual verification not done just putting √ on check sheet.
 Clause 10 – Maintenance
S No Sub Clause S No Check Point Requirement

10.1 Maintenance 2 Do you confirm regularly  Define the frequency for

of the function of Pokayoke, checking the functions of all
equipment's , automated stop and Pokayoke by using master
jigs and tools alarm? Are records of samples?
maintenance kept??  Verify, record the results and
take appropriate actions based
on results of confirmation?
 Define procedure for
Breakdown analysis?
 Conduct breakdown analysis
as per procedure and
standardized (Horizontal
deployment, Standard
updation etc.) based on the
learning.
 Clause 10 – Maintenance

Observation (7.2.1)

Gaps in PM check sheet /Pokeyoke check list

 Before and after condition of maintenance is not captured
 No change in PM frequency based on data.
 How to check poke yoke not evident in check sheet
 Poke Yoke by pass/ Not working

Gaps in Breakdown analysis

 Procedure for B/D analysis unclear & not adhered
 Min. Spare inventory not maintained at stores
 Why why analysis not done properly for B/D
 Updation of check sheet based on analysis is not evident
 Clause 10 – Maintenance
S No Sub Clause S No Check Point Requirement

10.1 Maintenance 3 Do you standardize  Define the replacement /

of frequency of polishing Preventive Maintenance
equipment's , and replacement for frequency for Tools,
jigs and tools consumable Equipment's and Jigs
tools(blade/electrode/ru (Electrode, Machine Tools,
b stone, etc.)? Grinding wheels, Die ,Tools
etc.)
 Verify, record the conditions of
Tools, Equipment's and Jigs as
per plan and take necessary
actions based on the condition.

Observation (10.1.1)
Gaps in replacement

 Monitoring of tool life is not done.

 Clause 10 (Maintenance)
S No Sub Clause S No Check Point Requirement

10.2 Maintenance 1 Do you calibrate  Define the calibration

of inspection regularly inspection frequency for all inspection
equipment's equipment's and put the equipment's / instruments.
expire date on them?
 Calibrate the inspection
equipment's / instruments as
per plan and put the
calibration sticker on all.

Observation (10.1.1)
Gaps in Calibration
 Calibration plan vs Actual not adhered
 No judgement is taken based on calibration reports
 Clause 10 – Maintenance
S No Sub Clause S No Check Point Requirement

10.2 Maintenance 2 Do you control  Define the validation period

of inspection deterioration (expire and check points for Limit
equipment's date) of boundary samples related to appearance
samples for objective inspection ?
judgments such as  Validate and put confirmation
appearance inspection? sticker as per defined period?

Observation (10.1.1)
Gaps in boundary Samples
 Boundary sample not stored adequately.
 Clause 11
(Implementation of
Standards)
 Clause 11 – Implementation of Standards
S No Sub Clause S No Check Point Requirement
11.1 Production 1 Do you use easy  All process & station should
equipment's expression (visualizer, have operation standard / work
management onomatopoeia ,etc.) for instructions available.
operation instructions?  All work instructions should be
So that operator can well defined with pictorial
easily understand display of instructions and
process and critical check points.
points.  It is preferrable to have work
instruction in local language so
that operators can easily
understand the content.

Observation (11.1.1)
Gaps in Implementation of Standards
 Work instructions not available in English as well as regional
language.
 Clause 11 – Implementation of Standards
S No Sub Clause S No Check Point Requirement
11.1 Production 2 Do you keep operation  Work instructions should be
equipment's instructions on the kept at accessible place. For
management accessible place and Important information in work
post important quality instructions, highlighting is
points and critical recommended. .
operation points on the
place where operators
can see it easily?

Observation (11.1.2)
Gaps in Implementation of Standards
 Clause 11 – Implementation of Standards
S No Sub Clause S No Check Point Requirement
11.1 Production 3 Do operators and  Check that operators are
equipment's supervisors operate following the process as defined
management according to the in work instructions / OPS.
operation standards?  Check that supervisor is
performing job as per his daily
work management sheet /
defined job responsibilities.

Observation (11.1.3)
Gaps in Implementation of Standards

Records mismatch wrt frequency defined in PCS.

Clause 11 (Implementation of Standards)
S No Sub Clause S No Check Point Requirement
11.1 Production 4 Do you regularly  Check that the operator
equipment's monitored that each observance process chcksheet
management operator operates and frequency is defined.
according to the  Check that the operator
operation instructions？ observance process records.
 Check if the response action for
operator observance (in case of
operator is found not following
the rule) is defined on not.

Observation (11.1.4)
Gaps in Implementation of Standards

Operator not working as per PCS, WI .

Clause 11 (Implementation of Standards)
S No Sub Clause S No Check Point Requirement
11.1 Production 5 Is it possible to judge  Check sheets (for ex. preventive
equipment's OK/NG specifically by maintenance, set up verification
management each check sheet (of and in-process check) should
daily equipment check, be clearly defined. Method of
quality control report, checking and standard values
etc.) you use? against each checkpoint should
be mentioned.
 Operator should record the
actual value in case of variable
parameters checkpoints (such
as pressure, current etc.) and
OK / NG status can be recorded
in case of attribute parameters
checking.
 Reaction plan should be clearly
mentioned in check sheet.
 Recorded check sheets should
be signed by the designated
person for checking and
verification.
Clause 11 – Implementation of Standards

Observation (11.1.5)
Gaps in Implementation of Standards

 Objective value not captured in check sheet i.e. Air pressure,

Hydraulic pressure etc.
 How to check the check point not mentioned in check sheet.
 In case NG then recheck results not captured in check sheet
 Check sheet in advance .
 Clause 12
(Products
Management)
 Clause 12 – Products Management
S No
S No Sub Clause Check Point Requirement

12.1 Management 1 Do you keep first-in first- 1. Adherence of FIFO in BOP/

of parts flow out of finished products RM stores area
and work-in-process 2. FIFO for WIP and finished
(material, reserve parts） products
by using identification
tag or lot indication?  Adherence of New Supplier
selection procedure.

Major Observations:-

FIFO not maintained due to different reasons :

- FIFO board not available/updated regularly
- Part flow (Receipt – Under Inspection – Stores) not clearly
defined/followed
- WIP area not adequate as per volume
 Clause 12 – Products Management
S No Sub Clause S No Check Point Requirement
12.1 Management 2 Do you control follows  System defined for recording
of parts flow production history by of production data.
product lot numbers?  Product traceability though
-production date; - part identification/lot
production volume; - identification/ batch
shipping date identification etc.

Major Observations:-

- In cases where traceability is not

available on the product, lot
traceability/ batch traceability
should be properly maintained.
 Clause 12 – Products Management
S No Sub Clause S No Check Point Requirement
12.1 Management 3 Do you control  Control of similar looking
of parts flow identification of similar child parts which are running
parts separately? on same/adjacent lines or
stations.
 Control of Left/right side part
mix up

Major Observations:-

- Left and right side parts made on

same line and similar looking child
parts for both sides kept without
proper tags/identification.
Clause 12 – Products Management
S No Sub Clause S No Check Point Requirement

11.2 Non- 1 Do you control  Identification and storage of

confirming identification of non- NC parts in the incoming area.
parts confirming parts and  On the line, separate storage
managemen parts on hold. Do you areas for NC parts
t store them separately?  Rule to be followed while
discarding NC parts

Red Bin – NG parts Yellow – Parts on hold

of running production

Orange Bin – NG parts Blue Bin – Fallen parts/

of NPD/trial production setup rejection
Clause 12 – Products Management
S No Sub Clause S No Check Point Requirement

11.2 Non- 2 Do you define procedure  Root cause analysis of NC

confirming to handling (following parts
parts items) non-confirming  Authority for taking the
managemen parts and parts on hold? decision of OK/NG for the
t -root cause analysis; - suspected parts must be
person responsible for defined. Also the judgement
final judgment criteria(rework matrix) for
-timing; -feedback doing rework need to be
procedure. defined.
Clause 12 – Products Management
S No Sub Clause S No Check Point Requirement

11.2 Non- 3 Regarding repaired non-  Repair records of reworked

confirming confirming parts and parts should be maintained.
parts parts on hold to re-use,
managemen do you define
t responsibility to
implement? Are repair
record kept?
 Clause 13
(Handling Management)
 Clause 13 – Handling Management
S No Sub Clause S No Check Point Requirement

13.1 Bins/ Trolley 1 Do you make  Packing standard for child

Management arrangements with parts, WIP & final part should
customers about the be available & adhered
packing style &
transportation system to
prevent damage during
handling of finished
products & perform
accordingly.

Observation (13.1.1)
Gaps in Handling Management
 Approved packaging standard not available for child parts.
 Clause 13 – Handling Management
S No Sub Clause S No Check Point Requirement

13.1 Bins/ Trolley 2 Are the packaging style  Check the bin / trolley and
Management & storage environment storage condition of work-in-
controlled with process, child parts and FG
consideration to parts. It should be able to
contamination control damage and
contamination to the parts.

Observation (13.1.2)
Gaps in Handling Management
 Broken bins
 Overloaded bins/ trolleys
 Bins directly on shop floor
 Clause 13 (Handling Management)
S No Sub Clause S No Check Point Requirement

13.1 Bins/ Trolley 3 Do you have system to  System defined at supplier for
Management maintain Bins /Trolleys in identification and periodic
Good Condition. maintenance of damaged bins
/ trolleys.
 Check if bins / trolleys are
cleaned before keeping FG
parts for despatch to customer.

Observation (13.1.3)
Gaps in Handling Management
 Maintenance plan for Bins/ Trolleys
 Adequate amount of bins as per production
 Bins replacement time needs to be standardized.
 Clause 13 (Handling Management)

S No Sub Clause S No Check Point Requirement

13.1 Bins/ Trolley 4 Does the Packaging  Check for the proper packing
Management method prevent condition of parts to avoid
Transportation damage damage during internal
movement and also during
dispatch to customer.

Observation (13.1.4)

Gaps in Handling Management

 Parts should not be stacked above bin height, should not protruding
out of side grill of bins and bin flaps should not be tattered etc..
 Clause 13 – Handling Management

Inadequate system for

maintenance of bins /
trolley

• No proper bin trolley • Bin trolley maintenance

maintenance system system introduces
 Clause 14
(Critical parts Management )
 Clause 14 – Critical Parts Management
S No Sub Clause S No Check Point Requirement
14.1 Production 1&2 1. Do you have Special  Identification of Maru A
equipment's checks/Inspection for checkpoints should be available
management Maru A parameters of in work instruction and in-
Maru A part are process / final inspection
available . standard.
2. Do you have  Maru A stations / Operator
Identification of Maru A trained and authorised to carry
Process/Operator on out Maru A operations should
Shop Floor. be identified at shop floor.

Observation (14.1.1 & 2)

Gaps in Critical parts management
 New Manpower on Maru A part processing
 Min. Skill not defined for Maru A operations
 Maru A operator not identified on shop floor.
 Clause 14 – Critical Parts Management
S No Sub Clause S No Check Point Requirement
14.1 Production 3 Do you keep the repair  Rework records of Maru A parts
equipment's history when repairing should be available.
management & using Maru A items  Traceability of person doing
rework and person approving
the part after rework should be
available in the rework records.
 Person skilled and trained for
doing rework should be
authorized and displayed at
station.

Observation (14.1.3)
Gaps in Critical parts management
 Details of Maru A parts Rework not captured