Training On VSA Check Sheet PDF

Welcome
Vendor System Audit

Training Session
1
Quality System
Development Line PDI Market
2
Importance of Quality Systems
Quality Problems due to

“System Not Adequate / Non Adherence’
Quality Problems
System
Non
Adherence
70%
3
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
Categorization of suppliers
Category Criteria
Red Total Score < 50%
Total Score >50%

Yellow Any Key Clause* Score <50%
Total Score >50%

Green All Key Clause Score >50%
Key Clauses
1. 4M change Management
2. Tier 2 Control
3. Quality Abnormality Handling
4. Equipment Maintenance
5. Operator Training and Education
Quality Systems Status
Red Yellow Green Supplier Status
Clause 1
(Production Preparation)
GOAL : FLAWLESS LAUNCH !

Clause 1 – Production Preparation
“More efforts during development stage results

in smooth launch of part in production”
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

for each department during the
development of new product.
 Availability of APQP matrix/

Development cycle to standardize
the list of development activities.
No No
1 Regarding 2 Do you define importance  Identification of Critical activities

implementat level during production in the New product development
ion rule preparation for each product plan
(procedure) and clarify control items
of production based on it ?  Availability of micro plans for the
preparation major/critical activities e.g Tool
development, child part
development etc.
 Availability of system for

monitoring the enquiries/ New
projects/ECN received from
customers.

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)
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, in-house rejections and
process design and standards before regular Child part issues (lessons learnt from past
by using production? experience/kakatora sheet)
FMEA/Matrix -Troubles in the past; - List of problems expected
diagram -Defect items expected; - List of problems which can't be ‘
-Defect items unable to capture at captured at customer end (warranty related
customer; problems)
-Defect items difficult to repair; - List of problems difficult to repair
 Deployment of these past learnings

during New Product development
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 (Based on
Priority level decided by SOD
ratings)
 Review of FMEA as per decided
criteria and at decided frequency
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)
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
 Preparation of Things gone

wrong/ Things gone Right
(TGW/TGR) at the completion of
project
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
S No Sub Clause S Check Point Requirement

No
4 Product/proce 2 Do you define condition to Checksheet should be available, for

ss evaluation start mass production and then verifying the line readiness prior to SOP.
at the quality check on the product line prior Targets need to be defined and monitored
evaluation to SOP? before giving the go ahead for mass
meeting in production.
each trial
Decision Check Sheet for Transition to Mass Production Quality Assurance De p
Part Name/Part No.: Decision Result Approval Che ck In charge
Model : This Process has nonconforming items to 60 items.

Therefore, Transition to mass production at this model is OK / NG.
Plant/Process : 1049/58
If this process has 1 nonconforming item and more.
Confirmation Person
You have to complete those items by planed date of SOP
Time and Date : and receive re-decision of transition to mass production.
Planed date of SOP :
If check item is enough, Judgement is “O” not enough, Judgement is “x” Proje ct In De pt He ad
Judgement Che ck Re sult / Evide nce Corre sponde nce to NG De adline
Class No. Che ck Ite m charge Sign
Have drawings and Cad Data of completed product.
1
Have drawings and Cad Data of completed Welding Fixture, Panel Checker and
2
Receiving Gauge
De sign 3 Have drawings and Cad Data of completed Cell Layout
4 Have PLC programme of cell
5 Have PLC Cercuit drawings of cell
6 All tools ready and handover to production
7 All Jigs ready
8 All Gauges ready
9 All Hand Gauge ready (If applicable)
Mass 10 All Panel Checker ready

Production
Pre paration 11 Cell ready
12 PPVT done along with production team and its closer
13 Fixture and Gauge observation closer
14 All Master Sample available
15 Cell meet the customer required quantity
16 All process operation standard(Press/Weld/Final) are ready.

All inspection report(app. ,dim. & performance) are ok ( Press/Weld/Final) &
17
available.
18 CTQ parameters are identified.
Quality 19 All PPAP documents prepared & varified as per actual process
20 Poka Yoke check sheet available.
21 All work instructions available.
22 All measuring & testing equipment available.
23 Operator training provided

Human
Re source
24 Man power available as per requirement.
25 All curtain should be work properly
5S Safe ty 26 Curtain should be available on each gate
27 Tower Lamp should be available on each gate

Clause 2
(Initial flow Management)
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
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 - Initial production control start date (from
Production control by SOP at vendor's end) and end date (after
Control standards ? completion of period after SOP at customer
-controlled parts; end)
-controlled items; - Initial production control period
-inspection - Persons responsible for start/end
method; - Finish conditions (including following):
-initial production - Extension criteria
control period;
-a person who
announce
start/end of initial
production
control;
-finish condition;
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? System for identification of IFC
parts/process.
Control period:
 For newly developed parts – 3 months or 5000 parts (whichever is
later)
 For ECN/PCN parts – 1 month or 3000 parts
(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!
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
S
No
1 Do you pick up issues and improve Do you record, analyze and improve
2 Implement them during initial production the issues reported during IFC
ation of control? period.
initial
production
control
② Do you control process capability Do you monitor Process capability,
and defect rate during initial defect rate during IFC period.
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.)
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
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
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

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
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.
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
S S No
No
3.1 Definition and 2 Do you define  What actions will be taken if 4M
implementatio procedure(rules applied change occurs.
n of changing from sharing information  How many parts to be checked.
management to result confirmation) at  What is difference in checking
change occurrence? for planned and unplanned
changes
 Awareness to operator
,supervisors and in-charges
about the rules.
 System for information flow of
each 4M change to all
concerned agencies and in-
charges
 Do you make 4M change matrix
process-wise
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
What are the
changes in 4 M
category
In-house and
Brainstorming Past Defect
customer end
session History
standards
Training
Document No:-
Revision No:-
4M CHANGE MANAGEMENT GUIDELINES Revision Date:-
Set up approval to be done as per OI/Control Plan

Set Up Approval
Retro parts are the parts which are already produced when we come to know of change in process like m/c break down / pokayoke failure etc .
Part Inspection Containment Parts are the parts produced after change ( ex. part produced by lower skill operator , part produce at time of pokayoke bypass
If any NG part observed in Retroactive and Containment Inspection then 100% parts to be checked since last ok check(Setup/Periodic inprocess check)
Set up Retroacti ve Contai nment MSIL /CARV

S.No 4M Category S.No Type of Change Change Detai l Acti on pl an OJT Res pons i bi l i ty Part checki ng Rul e Ref. i nvoi ce no.
approval (A) i ns pecti on(B) Acti on (C) Approval req. or not
1. Opeartor of s ame s ki l l deputed who has been

NO Yes NO NO Supervi s or (A) No No
worki ng on the s tati on frequemtl y.
1. Operator on l eave wi th/wi thout

i nformati on (Duri ng Start of s hi ft) ( A)
Opeartaor of under s ki l l deputed under the
YES Yes NO YES Supervi s or (C-Vi s ual i ns pecti on 100% di m No Yes
s upervi s i on of s upervi s or.
as per s ampl i ng pl an )
Pl anned change
1.1
(Expected Change)
( A) (C-Vi s ual i ns pecti on 100%
2. Job rotati on Part/Product Trai ni ng before pl aci ng on the s tati on YES Yes NO YES Supervi s or No Yes
di m as per s ampl i ng pl an )
Provi de trai ni ng before deputed and obs erved cl os el y ( A) (C-Vi s ual i ns pecti on 100%
4. New Operator YES Yes NO YES Supervi s or No Yes
by s upervi s or di m as per s ampl i ng pl an )
1 Man ( A)
( B) ALL PARTS SINCE LAST QA
Unpl anned Change 5.Operator not abl e to work due to
1.2 Operator of s ame s ki l l deputed NO Yes YES No Supervi s or INSPECTION TO BE CKECK No Yes
(Unexpected Change) s i cknes s or acci dent
VISUALY AND DIM CHECK AS PER
SAMPLING PLAN )
( A)
INSPECTION TO BE CKECK
Unpl anned Change 5.Operator not abl e to work due to
1.3 Operator unders ki l l deputed. YES Yes YES YES Supervi s or VISUALY AND DIM CHECK AS PER No Yes
(Unexpected Change) s i cknes s or acci dent
SAMPLING PLAN )
(C-Vi s ual i ns pecti on 100% di m
6. Operator Worki ng on extended ( A) (C-Vi s ual i ns pecti on 100%

1.4 Abnormal Condi ti on Supervi s or s peci al moni tor on operator . NO YES No Yes Supervi s or No Yes
s hi ft. di m as per s ampl i ng pl an )
Oparator j oi ni ng After l ong gap ( A) (C-Vi s ual i ns pecti on 100%

1.5 pl anned Change Supervi s or s peci al moni tor on operator . yes yes No Yes Supervi s or No Yes
( 3 months ) di m as per s ampl i ng pl an )
1.Machi ne/Di e under preventi ve Producti on s hi fte d to othe r ma chi ne (Sa me

ca pa ci ty)Whe re the pa rt ha s be e n produce d e a rl i e r.
NO Yes No No Supervi s or (A) No No
mai ntenance

Producti on s hi fted to hi gher capaci ty machi ne.* NO Yes No Yes Supervi s or Yes Yes
Pl anned change di m as per s ampl i ng pl an )
2.1
(Expected Change)
Producti on s hi fted to l ower capaci ty machi ne.* NO Yes NO YES Supervi s or Yes Yes
di m as per s ampl i ng pl an )
2.Change i n Mol d Start Producti on after s et up and FPA . NO Yes No No Supervi s or (A) No No
( A)
Producti on s hi fte d to othe r ma chi ne (Sa me
ca pa ci ty)Whe re the pa rt ha s be e n produce d e a rl i e r.
NO YES YES NO Supe rvi s or INSPECTION TO BE CKECK No No
SAMPLING PLAN )
( A)
Producti on s hi fted to hi gher / l ower capaci ty
NO YES YES YES Supe rvi s or VISUALY AND DIM CHECK AS PER No
machi ne.*
SAMPLING PLAN )
3.Machi ne/di e / TOOL /MOULDS
under breakdown
( A)
Unpl anned(Unexpecte
2.2 VISUALY AND DIM CHECK AS PER
d Change)
machi n res tarted after temprary repai r.* NO YES YES YES Supe rvi s or SAMPLING PLAN ) No
as per s ampl i ng pl an ) to be
fol l owed up to parmanent
reapi r.
2 Machi ne/
( A)
4.Machi ne Parameter of out of Stop producti on and res tart producti on after
NO Yes YES NO Supervi s or INSPECTION TO BE CKECK Yes Yes
s pc.* res etti ng the parameters .
SAMPLING PLAN )
( A)
Stop producti on and res tart producti on after
5.Checki ng Fi xture Breackdown* NO Yes YES NO Supervi s or INSPECTION TO BE CKECK Yes Yes
res etti ng the parameters .
SAMPLING PLAN )
( A)
10.Power fel i or Operator i nform to s upervi s or, res tart the machi ne. NO YES YES no Supervi s or INSPECTION TO BE CKECK No Yes
SAMPLING PLAN )
( A)
1)Ins pecti on to be s topped
11.Ins trument out of cal i berati on NO Yes YES no Supervi s or INSPECTION TO BE CKECK No Yes
2) Submi t i n l ab and i s s ue cal i berated verni er
SAMPLING PLAN )
( A)
( B) ALL PARTS to be check SINCE
12.Poka Yoka Not worki ng (l eakage 1)Val i date the poka yoka
NO Yes YES no Supervi s or LAST ok veri fi cati on of pokayoke No Yes
tes t) 2) Rej ected parts s houl d be us ed
for the poi nt checked by
pokayoke of that machi ne )
Stop producti on and res tart producti on after ( A) (B-FOA/MOA ) (C-Vis ua l ins pection
14.Noi s e Level Hi gh NO Yes YES YES Supervi s or
100% & n=5 Dimens iona l )
No Yes
recti fyi ng the noi s e of machi ne.
Stop producti on & res tart producti on after correcti on ( A) (B-FOA/MOA) (C-Vis ua l ins pection
15. Ai r pres s ure l ow/hi gh NO YES YES YES Supervi s or
100% & n=5 Dimens iona l )
No Yes
i n ai r pres s ure.
S S No
No
3.1 Definition and 3 Do you record product  Records of quality of parts
implementatio quality check results to produced (Process and
n of changing ensure traceability? product parameters) during
management 4M change condition
 Parts traceability through
identification(tag)?
4 Do you retroactively  Checking records of parts
check about product produced before 4M change
quality when unexpected condition occurs(as per
change occurs? control plan)
Major Observation:-
 Report contains part checked and found ok.
 Content of inspection is not available.
 Parts produced before breakdown (Retroactive parts) are not
checked.
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
In case there is any change
in 4 M (as per standard)
Change item to be
recorded in
standard format
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?..........................

S S No
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?  Proper storage system for
Initial parts to avoid mix-up.
 System/Rule for Pre-ECN/PCN
parts disposition.
 System/Rule for customer
information / approval before
implementation of planned
changes.
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 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)
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
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 v Mention the special
focused on); characteristics if applicable
-boundary samples; -
parameter chart; -
Pokayoke
Observation (4.1.3)
 Poka Yoke, Limit sample reference not available in PCS
 Not mention the details of Tier-2 & control characteristics
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
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)
 Retention period is not mentioned in procedure
 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
63
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, checksheet etc.)
・Process specification, operation
control inspection and
standards parameter chart?
・Inspection
specifications
・Operation
instructions
Observation (4.2.2)
 Different process/ product characteristics in PCS, WI etc.
Clause 4 (Standard Management)
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)
 Revision history not maintained properly.
 Revision not captured in document.
 Retrieval of old documents and distribution of new 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
S S No
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?  Training contents covers areas
Are records of education like technical, behavioral, safety
kept? etc.
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.
Training Plan based on TNI
S S No
No
5.1 Education/ 2 Do you define and  Skill evaluation ,Multiskilling

training implement the skill criteria for operators to be
procedure evaluation of operator objectively defined.
to determine whether  Level wise skill evaluation based on
operator can work Theoretical & Practical assessments.
without  Training Methodology (Dojo Room,
surveillance?(e.g. training modules/content,
acceptable authorised trainer etc.)
level/evaluation  Station wise skill matrix with Min
frequency/evaluation skill requirement to be defined.
method)  Training plan for taking operator to
the next skill level or multiskilling.
Observation:- Gap in Operator skill Assessment
 New operator training process not defined. Minimum time period of working
on station not defined before assessing for multiskilling or next skill level.
 Evaluation system not defined for operator skill assessment.
 Common evaluation parameters for all process/ skill levels.
 Training content not available against training provided to operators.
 Minimum skill level not defined for each operation.
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)
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
End of
week 2 > Certify the trainee as level 2 skilled if test is qualified. If not, then retrain on gap areas & re-
Duration Training plan for skill level 3 certification
Week
Practical training (OJT) on line without assistance from the line supervisor and technician
3, 4
End of
week 4 > Certify the trainee as level 3 skilled if test is qualified. If not, then retrain on gap areas & re-
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.
Evalutions test papers – Skill level wise
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
S S No
No
5.1 Education/ 3 Prior to SOP, do you  Training record should be evident

training instruct each operator for New model/ECN/PCN cases.
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.
S S No
No
5.2 Education for 1 Do you implement  Status for training plan vs actual.
managers/Ins planned education to  Training effectiveness check and
pectors/ supervisors for skill re-training criteria.
Special improvement ?  Training content for planned
operators training should be adequately
defined.
 Roles & responsibilities of
supervisors to be clearly defined.
Observation:- Gap in Supervisor training

 No backup plan to improve annual training plan adherence.
 Effectiveness check post training not done.
Training Plan and Monitering - Example
Training effectivenss Evaluation Scoring criteria
Re- training criteria

S S No
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.
S S No
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?  Process Operator skill need to be
periodically monitored – Operator
Observance should be performed
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).
 Poison test / Operator Observance not planned for all inspectors/operators.
 If special inspector / operator makes mistakes, then what kind of actions does
the supervisor take is not defined.
 All possible defect are not covered in the poison test .
Poison test Plan Defect Matrix
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
er of or not? Are the records retained or not?
Clause 6
(Quality Audits)
Clause 6 – Quality audit and process verification
S S No
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, all shifts should be
audit timing; -audit covered during audit of
method; -audit check manufacturing process related
sheet. functions (line production dept.,
Process QC dept., etc.).
 Internal QMS Auditor should not
be from the same function.
Observations: Gap in Internal Audit

 Internal auditor qualification criteria not defined or followed.
 Internal audit plan not adhered.
 Timeline for closure of internal audit NCs is not defined or followed.
 Internal audit check sheet or process interaction matrix is not defined.
S S No
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 Audit

 Summary of internal audit NCs is not available.
 Audit NC not raised for checkpoint where marks are deducted in audit check
sheets.
 Closure of internal audit NCs not adequately done.
 Root cause analysis of audit NCs not followed.
 Verification of implemented actions by auditor not evident.
S S No
No
6.2 Content of 1 Do you focus on useful  During process audits, it is

process know-how of operation, required for auditor to focus on
review operations with poor shop floor improvement
workability and approach like operators working
operation which need a conditions, lux level, part
lot of repair and identification & handling and
standardize them? other areas.
 In order to identify further scope
of improvement in process,
improvement approach such as
Kaizens, process improvement
initiatives, Operator feedback,
etc. should be verified during
audit.
Observations: Gap in Internal Process Audit

 Process audit check sheet does not have checkpoints focusing on
improvement of process.
S S No
No
6.2 Content of 2 Do you confirm  During process audit, it is

process consistency between important to verify process &
review actual operation and product parameters as per
standard? control plan. Working of operator
as per work instruction should
also be verified.
 During product audit, it is
required to validate all product
parameters as per MIS-P.
Observations: Gap in Process & Product audits

 Process parameters as per control plan not verified during process audit.
 Product parameters as per MIS-P/ drawing not verified during product audit.
S S No
No
6.2 Content of 3 Do you confirm if  During internal audits, it is

process countermeasures are required to verify previous audit
review taken properly to action plan.
prevent reoccurring of  During process audit, it is also
quality fail? important to verify effectiveness
of previous defect
countermeasures in respective
areas.
Observations: Gap in Internal Audits

 Check point for verification of countermeasures taken against previous audits
observations is not defined.
 Verification of effectiveness of countermeasures taken against past defects in
respective process is not ensured.
 In case of repeated audit observations, detailed analysis is not ensured.
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
90
Clause 7 – Tier 2 Control
S S No
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
S
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  Approved supplier list
audit and instruction availability and conducting the
periodically? supplier ranking as per
procedure.
 Action plan and its
implementation for
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
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
 No re-plan available for the audits not conducted.
 Observations are not captured in Supplier selection check sheet
 No Action plan/ Follow up for open observations
S
No
7.2 Management, 2 For outsourcing any  Procedure to instruct suppliers
quality production, do you about Initial flow control at
evaluation and instruct them clearly supplier end.
instruction for about function and  Implementation of Initial
suppliers important control items Supply control at supplier end
of products at the as per Procedure for
meeting ? new/ECN/PCN parts.
Observation (7.2.2)
Gaps in Development
 Inspection Standard not decided with Sub Supplier.
 Explanation of Part criticality not evident
S
No
7.2 Management, 3 For outsourced process,  Part development schedule
quality do you control the monitoring and capturing the
evaluation and progress of production delay reasons and making
instruction for preparation and action plan to meet the
suppliers confirmed issues ? timeline.
 Monitoring the trial results at
supplier and prepare the
action plan based on CFT
approach.
 Conducting PPAP at Suppliers.
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
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.
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 .
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, control of initial
instruction for changing management parts & how have you
suppliers and is it possible to communicated your suppliers
trace? your requirements.
 Does your supplier recording
the change situations
(summarized form) & ensuring
parts traceability and
submitting you at regular
interval.
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
No
8.1 Handling 1 Do you define clearly  List of abnormal Situations

when what is abnormal with reaction plan and
abnormal situation and make escalation matrix.( process
situation operators know the wise). Rule for handling defect
occurs definition? part, 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 and processes.
 In most of Cases, operators are not aware of Abnormal
conditions and actions to be done during abnormal situation.
S S No
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?  NC parts analysis criteria for
inhouse rejections, Incoming
and Supplier.
Major Observation:-
 Procedure is made but does not cover about standardization of

documents, horizontal deployment and timeline for closure and
analysis.
S S No
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  Traceability system to be
situation situation? When abnormal checked- Traceability system
occurs situation occurs, do you for checking the suspected
trace suspected lot based parts(batch-wise/lot-
upon the criteria? wise/day-wise) for the
abnormal situations
Major Observation:-
 Generally all suspected parts are not covered.

 Rule for previous part check not available.
S
S N
No o
8.2 Prevention of 1 Do you prevent recurrence  Quality of 5 why and to be

recurrence of issues by analyzing followed for all types if
cause of occurring defect issues- Supplier, inhouse
・Customer claims based on process and customer
・In process failure investigation result such as  Control register for Inhouse,
・Suppliers failure 5-why analysis? Supplier and Customer
claims
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.
S
S N
No o
8.2 Prevention of 2 Do you reflect corrective  Review of PFMEA, Control

recurrence action to improvement of plan, Work instructions etc.
process control and review based on the c/ms of
・Customer claims of standards? customer, supplier problem
・In process failure as well as in-house
・Suppliers failure problems to be checked
Major Observation:-
 C/m are not updated in control plan etc.

 Pokayoke etc are added but FMEA, CP are not revised.
S
S N
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 for
site checkup and evaluate customer, inhouse and
・Customer claims the effectiveness? supplier issue
・In process failure
・Suppliers failure
Major Observation:-
 Onsite verification of c/ms is not done.

 Effectiveness monitoring system not followed for inhouse issues
S
S N
No o
8.2 Prevention of 4 Do you cascade  Check & record the horizontal

recurrence information of deployment of c/ms for
corrective action to customer complaints, supplier
・Customer claims similar parts and problem as well as in-house
・In process failure processes? problem
・Suppliers failure  C/m established on one
process to be horizontally
implemented to other
processes & other
plants(incase multiple plants)
Major Observation:-
 Horizontal deployment of countermeasure is not done from one

line to another. Incase of multiple plants information is not
passed on to other plants.
Clause 9
(5S management)
Clause 9 – 5S Management
9.1 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 (9.1.1)
Gaps in 5S
 Child part / Raw Material storage condition inappropriate.

 Parts kept on floor, open environment etc.
9.1 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. Hold parts
and set up parts at work station
to be identified properly.
 Shelf life monitoring is required.
Observation (9.1.2)
Gaps in 5S
 Identification tag not available. Similar parts kept together
 Parts kept on floor, open environment etc.
 Procedure for defining shelf life control, List of items with shelf life
and current status of monitoring not available.
9.1 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 (9.1.3)
Gaps in 5S
 Unidentified material at inspection table, Near machine etc.
• Bin Stacking NG • Bin Stacking Ok

• Appearance Not good • Appearance Good
• Part damage chances are • Part damage chances are
high low
• 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
• Less part during stacking • More part during stacking

• More no. of trollies • Less no. of trollies required
required
9.1 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 (9.1.4)
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.
9.2 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 (9.2.1)
Gaps in 5S
 Unclean machine, Air
 Oil leakage from machine.
9.2 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 (9.2.2)
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 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.
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.
119
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.
Clause 10 – Maintenance
10.1 Maintenance 1 Do you conduct  Define Procedure of

of daily/regularly check of Preventive/ Predictive
equipment's , production equipment's, Maintenance of machines/
jigs and tools dies and jigs? Are Jigs/ Fixtures/ Dies/ Molds on
records of maintenance various factors.
kept?  Tool/Die/ Mold maintenance
based upon number of strokes
or after the fixed time and
maintain records of same
 Preparation of Annual
maintenance plan and carry
out maintenance accordingly.
 Before/ After PM situation
capturing.
 Judgment Criteria and
Checking method should be
defined in PM Check sheet..
Observation (10.1.1)
Gaps in Daily check sheet
 Availability of Daily/ Periodic check sheet for all machines, dies,
tools/ Molds
 Objective values are not captured in Daily check sheet.
 Actual verification not done just putting √ on check sheet.
 Checking Methods and Judgment criteria are not defined.
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.
 Modify the PM check sheets
and other relevant documents,
based upon the
countermeasures taken after
analysis.
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
10.1 Maintenance of 3 Do you standardize  Define the replacement /

equipment's , frequency of polishing and Preventive Maintenance
jigs and tools replacement for frequency for Tools, Equipment's
consumable and Jigs (Electrode, Machine
tools(blade/electrode/rub Tools, Grinding wheels, Die
stone, etc.)? ,Tools etc.)
 Verify and record the conditions
of Tools, Equipment's and Jigs as
per plan and take necessary
actions based on the condition.
 prepare list of critical spares for
machines and define minimum,
maximum quantity & reorder
level and periodically check the
actual stock in stores with spare
part monitoring sheet.
Gaps in replacement
 Monitoring of tool life is not done.

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
Clause 10 (Maintenance)
10.2 Maintenance 1 Do you calibrate  Define the Master list with

of inspection regularly inspection calibration frequency for all
equipment's equipment's and put the inspection equipment's /
expire date on them? instruments.
 Calibrate the inspection
equipment's / instruments as
per plan and put the
calibration sticker on all.
 Check the calibrated
instrument / gauge as per
defined acceptance criteria of
each
Gaps in Calibration
 Calibration plan vs Actual not adhered
 No judgement is taken based on calibration reports
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?
Gaps in boundary Samples
 Boundary sample not stored adequately.
Clause 11
(Implementation of
Standards)
Clause 11 – Implementation of Standards
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 preferable to have work
instruction in local language so
that operators can easily
understand the content.
Gaps in Implementation of Standards
 Work instructions not available in English as well as regional
language.
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?
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.
 Check that inspectors are
following the process as defined
in work instructions / OPS.
Records mismatch wrt frequency defined in PCS.

Clause 11 (Implementation of Standards)
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.in all
according to the shifts
operation instructions？  Check that the operator
observance process records.in
all shift
 Check if the response action for
operator observance (in case of
operator is found not following
the rule) is defined or not.
Operator not working as per PCS, WI .

Clause 11 (Implementation of Standards)
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.
 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 3. FIFO for material which is
tag or lot indication? issued from store but left
unused at production shop in
partial quantity
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
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.
- In cases where traceability is not

available on the product, lot
traceability/ batch traceability
should be properly maintained.
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
- Left and right side parts made on

same line and similar looking child
parts for both sides kept without
proper tags/identification.
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
 Procedure for handling the
parts which are already
produced If setup part is
coming NG (where it takes
time and production starts)
 System to retain setup parts
and inspection samples
Red Bin – NG parts
of running production Yellow – Parts on hold
Orange Bin – NG parts Blue Bin – Fallen parts/

of NPD/trial production setup rejection
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.
11.2 Non- 3 Regarding repaired non-  Rework procedure (re-work

confirming confirming parts and matrix)
parts parts on hold to re-use,  Repair records of reworked
managemen do you define parts should be maintained.
t responsibility to  Traceability of repaired parts
implement? Are repair till dispatch.
record kept?  Separate/identified rework
area for rework
Clause 13
(Handling Management)
Clause 13 – Handling Management
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.
Gaps in Handling Management
 Approved packaging standard not available for child parts.
 WIS not prepared for packaging std for FG parts.
 Packing for FG was not done as per WIS.
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.
 Broken bins
 Overloaded bins/ trolleys
 Bins directly on shop floor
 Bins found dirty/dusty.
Clause 13 (Handling Management)
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 bins / trolleys
or BOP/WIP/FG.
 Check if bins / trolleys are
cleaned at regular frequency
for BOP/WIP/FG.
 Maintenance plan for Bins/ Trolleys
 WIS not prepared for Bin/Trolley maintenance.
 Bins replacement time needs to be standardized.
 Bins cleaning to be ensured before keeping FG parts inside the
bins.
Clause 13 (Handling Management)
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.

 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..
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
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 authorized 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 deployed on Maru A part processing.
 Maru A items not identified in Work instructions.
 Maru A operator not identified on shop floor.
Clause 14 – Critical Parts Management
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.
Gaps in Critical parts management
 Summary of Maru A parts Rework not captured e.g. Rework
record, Re-inspection, Batch code, Dispatch details of Rework part
etc.
Thanks

Training On VSA Check Sheet PDF

Transféré par

Informations du document

Titre original

Copyright

Formats disponibles

Partager ce document

Partager ou intégrer le document

Options de partage

Avez-vous trouvé ce document utile ?

Ce contenu est-il inapproprié ?

Droits d'auteur :

Formats disponibles

Training On VSA Check Sheet PDF

Transféré par

Droits d'auteur :

Formats disponibles

Welcome

Vendor System Audit

Development Line PDI Market

Quality Problems due to

Technical Root cause

Actual Root Cause is not only in ‘Process’

 Vendors are categories as Red / Yellow / Green

Red Total Score < 50%

Total Score >50%

Total Score >50%

GOAL : FLAWLESS LAUNCH !

“More efforts during development stage results

S Sub Clause S Check Point Requirement

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

 Defined roles and Responsibilities

 Availability of APQP matrix/

1 Regarding 2 Do you define importance  Identification of Critical activities

 Availability of system for

S Sub Clause S Check Point Requirement

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

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

 Deployment of these past learnings

– A tool used to identify and prioritize risk

areas and their mitigation plans. Core Team:

– Identifies potential failure modes,

causes, and effects. Inputs come from

S No Sub Clause S Check Point Requirement

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

 Preparation of Things gone

S No Sub Clause S Check Point Requirement

4 Product/proce 2 Do you define condition to Checksheet should be available, for

Part Name/Part No.: Decision Result Approval Che ck In charge

Model : This Process has nonconforming items to 60 items.

4 Have PLC programme of cell

5 Have PLC Cercuit drawings of cell

6 All tools ready and handover to production

7 All Jigs ready

8 All Gauges ready

9 All Hand Gauge ready (If applicable)

Mass 10 All Panel Checker ready

12 PPVT done along with production team and its closer

13 Fixture and Gauge observation closer

14 All Master Sample available

15 Cell meet the customer required quantity

16 All process operation standard(Press/Weld/Final) are ready.

20 Poka Yoke check sheet available.

21 All work instructions available.

22 All measuring & testing equipment available.

23 Operator training provided

25 All curtain should be work properly

5S Safe ty 26 Curtain should be available on each gate

27 Tower Lamp should be available on each gate

2 Regulation 1 Do you define  Initial Production Control procedure

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

Detail for Special Control:

 Defect description. Understand defect phenomenon precisely.

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

Clause 2 – Initial Production Control OK . NG

Exit targets and results:

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