MSIL Training on VSA Check Sheet

Welcome Vendor System Audit Training Session

- November is observed as Quality Month every year in MSIL. year ’s Theme is ‘DRIVE QUALITY – REVIEW RULES & ENSURE - This year’ ADHERENCE’

Theme Focus : - Drive Drive Quali Quality ty in all aspe aspects cts of of busine business ss by revie reviewin wing g rules, rules, tra traini ining ng 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%

Importance of Quality Systems Serious Quality Problem due to System Non Adherence Possibility of Door opening in half lock Condition

Door Latch found NG

System Failure -

(No inspection of parts after change)

Tier-2 -

Tier-1

Weak 4M Change Management

No 4M change information to Tier-1

- CTQ parameters not communicated to Tier-2

Improper Mould Repair by Tier 2 Vendor

65478 Vehicles repaired

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

O (Circle) ∆ (Traingle)

X (Cross)

+3 0 -3

Criteria System defined & Implemented Minor deficiency either in system definition or implementation 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%

Yellow 63%

Red 18%

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 • Input regarding Best Practices

• Pilot implementation at Supplier

Nov’17 – Dec.’17

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

Clause 1 – Production Preparation S No 1

Sub Clause

S No

Regarding implementat ion rule (procedure) of production preparation

1

Check Point

Requirement

Do you define the procedure  for Product development including the following ? scope of parts, responsibility of each department, control contents / items? 

2

Procedure for product development from receipt of order to SOP at customer end (preferably as per APQP guidelines) to be available and the team should understand it. Defined roles and Responsibilities.

 APQP matrix for deciding Do you define importance 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


Sub Clause

S No

Regarding management / implementatio n by production preparation plan / report (master plan)

1

2

Check Point

Requirement

 Do you implement follow-up to control the schedule and progress  of production preparation items?

Master Timing plan as per APQP matrix Customer events (sample approval, trial dates, SOP at customer end) and vendor's events (sample submission, pilot lot submission, SOP)  Plan Vs Actual updation  Micro timing plan matching with MACRO plan (wrt timing)  Capturing delays in plan v/s actual in timing plans.

Are production preparation plan • and report controlled by a person  in charge of progress (top management) periodically?

Evidence of review by project leader and top management in the timing plan MOM or record of reviews (for evidence)

63% Supplier don’t follow New Part development procedure

Clause 1 – Production Preparation S No

3

Sub Clause

S No

Defect prevention on the stage of process design by using FMEA/Matrix diagram

1

Check Point

Requirement

Do you consider following items  Past defect History . - List of problems reported in past at and implement corrective and preventive action to the processes customer end and in-house (lessons learnt from past experience/kakotora sheet) and standards before regular - List of problems expected production? - List of problems which can't be ‘ -Troubles in the past; captured at customer end (warranty related -Defect items expected; -Defect items unable to capture at problems) - List of problems difficult to repair customer; -Defect items difficult to repair;  Verification of past actions during upcoming new part development.

80% Supplier not able to show implementation of Past learning


Sub Clause

S No

Defect prevention on the stage of process design by using FMEA/Matrix diagram

2

Check Point

Do you review and improve FMEA or Matrix diagrams when any critical issue occurs after SOP?

Requirement

 





Procedure for FMEA with CFT approach Rating of FMEA as per AIAG guidelines and having back up data for rating. Allocation of 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 FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)

What is It? – A tool used to identify and prioritize risk

Item:

Process Responsibility

Model Year(s)/Program(s)

areas and their mitigation plans.

•

Objective or Purpose – Identifies potential failure modes,

APPLICATION

ORGANIZATION

Key Date

Core Team: Process Step / Function

Requirements

Potential Failure Mode

Potential Effect(s) of Failure

n o i t a c i f i s s S l a C y t i r e v e

Potential Causes(s) of Failure

e c n e r r u c c O

Current Process Controls

Current Process Controls

Prevention

Detection

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. • Prior to tooling for production

– When troubleshooting production issues – When planning and closing preventive and corrective actions

IMPORTANT!

The PFMEA is a CFT activity, Never do it alone! Always assign correct rankings as per AIAG guidelines!

n o i t c e t e D

N P R

PFMEA (Severity Ranking)

PFMEA (Occurrence & Detection rankings)


Sub Clause

4

Product/proc ess evaluation at the quality evaluation meeting in each trial

S No 1

Check Point

 Do you prevent defects by quality improving activities of cross-function team to evaluate quality  performance?

Requirement

Complete analysis of problems reported during development. Summary in PDCA sheet , and analysis

Clause 1 – Production Preparation Resp Pers erified B App by

Date : №

Problem Point

After press operation , Bolt 1 Insertion Position shifted by 2 mm.

2

3

4

5

6

Reason

Bolt holes misaligned as the jig position was out.

C/M Deadline

2/23

Resp Deptt

Countermeasure

Prodn 2 locator positions added in the jig. Engg

C/M Impl date

3/15

Follow up results

Initial flow period follow up result

Confirmatio Confirmatio Confirmatio Confirmatio n : Month n : Month n result n result

3/15

OＫ

6/15

NG


4

Sub Clause

S No

Check Point

Requirement

Product/proce ss evaluation at the quality evaluation meeting in each trial

2

For confirming development targets. Do you define condition to start mass production and then (Mass production readiness sheet) check on the product line prior to SOP?

Clause 2 (Initial flow Management)

Clause 2 – Initial Production Control S No

Sub Clause

S No

Check Point

Requirement

2

Regulation (procedure) for Initial Production Control

1

Do you define following items related to initial production control by standards ? -controlled parts; -controlled items; -inspection method; -initial production control period; -a person who announce start/end of initial production control; -finish condition;



Initial Production Control procedure having following: - Scope (for new parts and modifications) - Initial production control start date (from SOP at vendor's end) and end date (after completion of period after SOP at customer end) - Initial production control period - Persons responsible for start/end - Finish conditions (including following):

Clause 2 – Initial Production Control S Sub Clause S No No 2

Regulation for initial production control

Check Point

Requirement

② How do you define items required

Special controls (increased inspection, increased sample size etc. special control during initial at all stages - incoming, in-process & production control? Do you set stricter inspection methods than the final) 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.

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 SOP

SOP

Production preparation

C F I

ECN

C F I

PCN SOP

PCN

C F I

IMPORTANT!

Always ensure implementation of IFC in new part & post-SOP ECN/PCN cases!

Clause 2 – Initial Production Control Roles & Responsibility:  Choose responsible information receiver  Choose responsible person who takes countermeasures for defects Overall Responsible

Equipment/ Tools/Jigs

Quality Assurance

Receive & share customer

Improve & maintain equipments – Manufacturing jigs & tools

information Inspects parts to be shipped (appearance, wrong/missing parts/ Colour tone) Prevent outflow of serious defects Take countermeasures on quality defects Check 4M changing point

Manufacturing & Delivery

Full quantity check of

appearance/ assembly defects (missing/ wrong parts etc.) Understand analyse and improve results of process defects 4M changing point control Comply with standard operation Eradicate short stoppages Ensure consistency of standards

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: S. No.

Control Item

Normal period IPC period Inspection Inspection Inspection Inspection Inspection Judgment Stage method Frequency method Frequency OK . NG OK . NG OK . NG

IMPORTANT!

It is necessary to deploy stringent checks at respective inspection

OK . NG OK . NG

stages OK . NG

Clause 2 – Initial Production Control Exit targets and results: S. No.

Control Item

Target

Month 1

Result Month 2

Month 3

Judgment

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

5

Result of c'measure taken against problems during production preparation

Effective

OK . NG

6

Result of c'measure taken aginst problems during initial control period

Effective

OK . NG

7

Process Audit results

0 open NC

OK . NG

Result of Initial Production Control

OK . NG

Initial control checks can be terminated

Remarks

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 Purchas e, Head Production, Head PE

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.)

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.

Clause 3 (4M Change Management)

Clause 3 – Change Management 4M

Change

Management

Man , Machine, Material, Method

something become different from standard

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 No 3.1

Sub Clause Definition and implementatio n of changing management

S No

1

Check Point Do you define unexpected change (unusual) and planned change clearly?

Requirement  

List of changes that can occur in process related to 4M. Distribution of changes into 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 Man

New operator Hiring Extended /Extra Shift

Machine

New Machine Procurement Preventive maintenance

Material

New R/M source New R/M grade or Spec.

Method

Unplanned Changes Man

Sudden change in operator Operator sick/ injured

Machine

Machine break down Tool breakdown Pokayoke breakdown

Material

Material shortage BOP Parts Bin/Trolley fallen down

New inspection instrument / Packaging/storage method change



S No

2

Check Point Do you define procedure(rules applied from sharing information to result confirmation) at change occurrence?

Requirement 

What actions will be taken if 4M change occurs.  How many parts to be checked.  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 Change Management What are the changes in 4 M category

Brainstorming session

Past Defect History

Training

In-house and customer end standards

4 M CHANGE CONDITIONS & ACTIONS Process Process : Injection Molding, Molding, Ass embly embly & Ultrasonic welding Action Plan S No

4M Category

Set up approval

Retroactive Inspection

(checking of parts after change)

(checking of parts before & after change)

Yes

-

Yes

Yes

Yes

-

Yes

-

-

1 . Ma c h i n e b r ea k do wn

Yes

Yes

-

Machine Parameter change*

Yes

-

Yes

-

Yes

-

Change

Change De t ail

Cut off criteria in case of Abnormal Situations

1 . O p er a to r go i n g o n l ea ve wi th i n ti ma ti on Expected (Planned)

2. Job rotation

-

3. New Operator 1

Ma n Unexpected 1. Operator not abl e to work due to to (Unplanned) sickness or acci dent dent Abnormal Condition

1. Defective PARTS PARTS Produced by negli gency of operator

Expected (Planned)

1. Removal Removal & Addition of Poka Yoke's Yoke's

Ma c h i n e

Checking Fixture Change*

Yes Yes

-

1 0 No s to b e c h ec ked b efo r e b r o ken & a fter r ec ti fi c a ti on

P o ka Yo ke n o t wor ki n g

Yes

-

Al l Pa r ts to b e c h ec ked (P r o d u c ed i n l a s t s hi ft)

Machine is not in good condition (Repeated Break Downs)

Yes

-

5 0 No s to b e c h ec ked b efo r e b r ea k do wn & a fter r ec ti fi c a ti o n

Power supply tripping suddenly or repeated

Yes

-

01 No. (Last Prod uced) to be checked before & after power power cut and in case of repeated power supply, check all parts prodcue in la st 01 Hr.

Yes

Yes

Any damage in mold l ifter/inserts or hol e block in part Yes

Yes

All parts pr oduced to be checked up to to la st defective defective & al l defective defective parts to be rejected rejected & s cra pped. After After mold rectifica tion parts to be checked checked for appearanc e & affected affected dimensions by QA & if found OK then then all ow for for production.

If any major repair or modification is carried out in mold then customer approval is required before start of production. checked for part weight & vis vis ual ly fo Valve Gate : 5 pa rts. to be checked appearance.

Ai r p r es s u r e l o w/hi gh

Yes

-

1. Use of alternate source material from approved source*

Yes

-

Unexpected 1. Use of alternate source material from (Unplanned) unapproved source*

Yes

Yes

Not allowed & Customer approval required. All material to be rejected.

BO P P a r ts Bi n/Tr o l l ey fa l l en d o wn

Yes

-

1.) Immedia tely check & get veri fy the sus pected or affected lot by QA or demand for new ok lot.

Any customer customer compla int received or Warranty issue received

Yes

Yes

Check & segregate the whol e lot lyi ng at BAPL for the concerned issue

Expected (Planned)

1. 2. 3. 4. 5.

Yes

-

Abnormal Condition

Any intermittent short shot or molding defect

Yes

Yes

Abnormal Condition

FG Bi n/Tr ol l ey fa l l en d o wn /d a ma ge

Yes

-

Expected (Planned)

Thorough inspection & customer approval is required

Ma ter i a l Abnormal Condition

4

Customer approval approval required & relevant documents to be submitted as per MSIL requirements.

Too l s b r o ken s u d denl y

Abnormal Condition

3

W h o l e l ot /s h i ft to b e c hec ked

2. Pr eventive eventive maintenace

Unexpected Change in Mold* (Unplanned) Machine change*

2

-

Modification of Jigs/fixtures* Process Change* Proces Sequence Change* Sub Supplier Process Change * Despatch Packing Change*

Meth od

Customer approval approval required & relevant documents to be submitted as per MSIL requirements.

Check & segregate the whol e lot lyi ng at BAPL for the concerned issue & if shipped to assy line then check & inform to assy & Q for concerned issue. Al l Pa r ts to b e c h ec ked whi c h a r e l yi n g i n th a t tr o l l ey/b i n

Clause 3 – Change Change Management S No 3.1


S No 3

4

Check Point

Requirement

Do you record record product quality check results to ensure traceability?



Do you retroactively retroactively check about product quality when unexpected change occurs?





Inspection report report of parts after change occurrence Records of batch code for traceability Comparison of parts before and after breakdown

Major Observation:Observation: Report contains part checked and found ok.  Content of inspection is not available.  Parts produced before breakdown (Retroactive (Retroactive parts) are not checked. 94% Supplier don’t have evidence for Retroactive actions


Lot identification for 4 M change

Refer the standard for the actions for the change

Recording of inspection result in 4M change

Identification of NG part (if any)

Lot Inspection as per the standard criteria

Lot approval as per inspection 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 Abnormal conditions

Criteria

Process Flow

Layout Graph

Hold Card Summary Sheet

One Point Lesson

Cost of Poor Quality Child Part Process(Tier 1 or Tier 2)

Defect due to 4 M change

50 parts

X

Assy at Tier 1

Vehicle Assy at MSIL

600 parts

12000 Vehicles

1000X

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




S No

Check Point

Requirement

1

Do you define initial part clearly?



2

Do you control initial parts separately and make quality records about them?



Procedure for First production parts (FPP) Implementation of tags for various types of parts as per manual.

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

4.1

Procedure to make process control standards(QA process charts)

S No 1

Check Point Do you make process control standards for all products which is shipped to SMC / MSIL?

Requirement 

Prepare control Plan for all the part manufactured by your company


Sub Clause

4.1


S No 2

Check Point Do you mention defined both characteristics of quality and production control on the process control standards?

Requirement 

Mention both process & product characteristic on control plan?

Observation (4.1.2) Gaps in Standard management  All process characteristics not mentioned in control plan


Sub Clause

4.1


S No 3

Check Point Do you mention followings on process control standards required to each process? -quality confirmation method; -regulations; -standards (operation instruction/items to be focused on); -boundary samples; parameter chart; Pokayoke

Requirement Mention following on control plan: i. Quality check frequency & method ii. WI reference iii. Boundary sample reference wherever required iv Poka Yoke Reference in Control plan.

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

NAME

INDL

( Write part number of the

PART NUMBER

ASSY INDL

(Write MUL, part number of the assembly)

Sl. No. Write the name of process/ operation e.g. incoming inspection, casting, machinging, plating etc . For processes w hich are subcontracted and for bought out parts, w rite "sub-contracted" w ithing brackets below the process name. For process es related to and Functional items, w rite or respectively at the end of process name. Include sketch of the product at each stage before and after each process

Legend for control Incharge

Write A for and A and F for Functional parts at the end of Part Number

Wri te seri al no of

MODEL

R- Patrol Inspection AM - Automatic Measurement W- Operator P- Process Approval I- Inspector Write Revision Dates

Process Machine

Control Paramter

Standard Spec.

Control Spec.

Inspectio Critical n Method Characteri stics

Write type, make capacity etc. of the machine used e.g. Hydraulic Press 400 Ton.

For each process w rite control parameter s of both products (e.g. dia, hardness etc) as w ell as process (e.g. funace temp. pressure etc.)

For each control parameter w rite the engineeri ng specificati on value w ith tolerance or limits e.g. 250, + 10C, 1.5 + 0.5 kg/cm2 40 60 HRC

Control specificati on must be tighter than the standard specificati on e.g. 250 + 7C, 1.5 + 0.4 kg/cm2 45 55

A triangle Write briefly the should be marked if method of the checking e.g. visual process parameter w ith Gois critical No Go gauge, measurin g with micromete r as per

Write briefly the reson for revision and referevce

Write your company's name

VENDOR

(Write MUL, part number of the assembly)

Process Description

Write sequence number of the process/ operation

Process Control Standard

Control Incharge

Write R Am W P or I (See legends on bottom left corner)

IS …..

Etc.

Date

Wri te total no. of pages

Write name (s) of mode (s) for which this part is s upplied

Sampling scheme/

Recording Ye s/ N o

Write check frequency e.g. 100%. N=5 c=0. Start up (I.e. check 5 pieces at the i me of process setting and start if none is defective). N=3, c=0/Hr. (I.e. check 3 pieces every hour and continue if none is defective). N=10, c=0; LOT (I.e. check 10 pieces in each lot and accept the lot if none is defected).

Write if the result of checks are recorded or not. It will be better to also mention the wayof recording e.g. name of report, register, Z.R. chart etc.

Page No.

Reamrks

For critical parameters write action to be taken in case of abnormally e.g. seggregation, scrap rework etc.

Triangle to indicate Critical Process Characteristics

Prepared By

Approved By Vendor

Clause 4 – Standard Management S No 4.2

Sub Clause Procedure to control standards ・Process control standards ・Inspection specifications ・Operation instructions

S No 1

Check Point Do you define following concerned about standards? -department in charge of making; -a person in charge of making; -a person in charge of authorizing; -making period; -timing to submit to customer; -revision rule; retention period;

Requirement Procedure for document preparation & retention Define clearly about -department in charge of making; -a person in charge of making; -a person in charge of authorizing; -making period; -timing 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 4.2


S No 2

Check Point Do you have consistency to keep process control standard, inspection specification, operation inspection and parameter chart?

Requirement Define the same information in all the related documents (i.e. same information in Control plan, MIS-P, WI etc.)

Observation (4.2.2) Gaps in Standard management  Different process/ product characteristics in PCS, WI etc.

Clause 4 (Standard Management) S No 4.2


S No 3

Check Point Do you make use of lists to control preparation and revision of standards and share the updated information?

Requirement Do you have the system to control the revision details of any document.

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 No 5.1

Sub Clause Education/ training procedure

S No 1

Check Point Do you clarify the department in charge of promoting quality education, implement education based on annual plan? Are records of education kept?

Requirement  

 

Procedure for training & employee skill development. Training need identification system & matching with annual training calendar. Status for training plan vs actual. Training contents covers areas 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.

Clause 5 – Education & Training Process

Requirement

Remarks

New Joining Operator Induction training

1. Training module for classroom training 2. Training effectiveness check

Person can be Level 1 after completion

On Job Training

1. Training under expert operator. 2. To be recorded as 4M change in ‘Man’

It can be off line also in Dojo

OJT Evaluation

1. Objective judgement to be defined. 2. Should include achieving ‘Zero Defect’ and ‘Tact Time’ as passing criteria.

Person can be Level 2 or 3 after OJT

Skill Matrix Update

1. Update skill matrix as he goes on line for working

Work on Station

Clause 5 – Education & Training ON THE JOB TRAINING EFFECTIVENESS CHECK New Joinee Supporter Work change Return to some

Operator Name Supervisor Name Check Item Operator follows standard procedure ar

ni

in

g

Standard Operator should follow OPS

Operator understands Operator should critical point understand r

ht

e

t

Operator adheres to rule in case of abnormality o

u

s

yl

a

tef

Method to Verify Observe Discuss and Observe

Operator should follow abnormality Observe 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 s

e

vr

e

c

o

n

f

ni

u

O

b

Tact Time of Operation ________ Sec.

Observe and count Judgement

30 min

60 min

4 hrs

Confirmation Period day 1: End day 2 day 3

week 1

week 2 1 month

Remarks



S No 2

Check Point Do you define and implement the skill evaluation of operator to determine whether operator can work without surveillance?(e.g. acceptable level/evaluation frequency/evaluation method)

Requirement   

 

Skill evaluation criteria for operators to be objectively defined. Station wise skill matrix. Method of skill evaluation: Supervisor observation or operator exam etc. Training plan for taking operator to the next skill level or multiskilling. Periodic check of the operator skill level. (for e.g., operator observance 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 1st day

2nd day 1 k e e W

3rd day

4t h day 5th day 6th day End of week 1

W

e

e

k

2

Duration 1s t day 2nd day 3rd day 4th - 6th day End of week 2

Duration Week 3, 4 End of week 4

Training after joining Joining formalities in HR Briefing General Rules and Regulations a. Explanation of standing orders b. Canteen, dispensary and other medical facilities c. Briefing on safe working in the shop floor d. Fire & safety training General orientation about the company a. Briefing on the HR policies b. Orientation on suggestion s cheme & Quality circle ac tivities c. Overview of Production Division d. Training on Quality Consciousness S hop floor vis it Behaviourial & discipline training Work culture of Company & the shopfloor Skill evaluation test based on Questionnaire for 'level 1' > Certify the trainee as level 1 skilled if test is qualified. If not, then retrain on gap areas & reevaluate. Modify the training schedule, if required.

Training plan for skill level 2 certification B as ic conc ept of 5s Understanding of OS, WI & abnormal situation handling Basic training as per training module Practical training (OJT) on line with assistance from the line supervisor and technician Skill evaluation test based on Questionnaire for 'level 2' > Certify the trainee as level 2 skilled if test is qualified. If not, then retrain on gap areas & reevaluate. Modify the training schedule, if required.

Training plan for skill level 3 certification Practical training (OJT) on line without assistance from the line supervisor and technician Skill evaluation test based on Questionnaire for 'level 3' > Certify the trainee as level 3 skilled if test is qualified. If not, then retrain on gap areas & reevaluate. Modify the training schedule, if required.

Periodic Training plan & skill l evel 4 certification (if reqd) Week 5 onwards

- Trainings as per annual training calendar (internal & external) - Daily production meeting for quality & productivity improvement - Multis killing on operations & process es, if required

Clause 5 – Education & Training

Clause 5 – Education & Training OBSERVANCE OF OPERATION STANDARDS CHECK SHEET Department

Section

Prepared by

Verified by

Name of the Operator

Category

Line No.

Proces s Name

Checked b y Item No.

A

Classificati on Operation Conditions

B

Operation Sequence

C

Quality Checks

D

E

Equipment Checks

Equipment Testing

Approved by

Designation Sub Item No.

Check Point

Plan

No Problem

Instructions Required

O

X Remarks

Actual

1

Coherence between s pecification mentioned Operation Stand ards co ndition & actual condition.

in

2

Whether operator is immediately reading the "display value" and recording them in the check sh eet or not?

1

Is the operation being carried out as per decided operation s equence or not?

1

are Quality checks b eing carried o ut an d th e finding are recorded in the ch eck sheet or not?

2

Checks in of "InitialProduct" and "Proper display" for Initial Production are b eing carried o ut or no t?

1

Checking of Machine and Equipments is being carried out an d check sh eets are duly filled or not?

1

W orkin g co nd itio n ch ecks are b ein g carried o ut in regard to device in which Fool proofing are being incorporated, entries are made accordingly in the check sheets or not?

2

Working conditions checks are also being carried out for Dies and Jigs o r not?

3

W orkin g co nd itio n ch ecks are b ein g carried o ut in reg ard to " In sp ectio n Eq uip men ts , M eas uremen t pu rpos e too ls, Devices, Gaug es e tc. or not?



S No 3

Check Point Prior to SOP, do you instruct each operator based on actual operation instructions?

Requirement 

Training record should be evident as per the APQP master plan

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.


Sub Clause Education for managers/Ins pectors/ Special operators

S No 1

Check Point Do you implement planned education to supervisors for skill improvement ?

Requirement 



Supervisor require special skills like delivering education to operators, communication skill, management skill, crisis 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.



S No 2

Check Point Do you implement special education or technical training to inspectors and operators of particular process (required specialized skills)? Are training records kept?

Requirement 

Special education curriculum, Maru A process training, & other special process training required. Certificate for special training is better.  Training for critical & special processes, is required.

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 No 3

Check Point Do you periodically monitor the skill of certificated operators and follow up to improve their skill?

Requirement 

Inspector skill need to be periodically monitored. Defect part catching should be performed at line speed.

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 No 6.1

Sub Clause Activity to keep/improv e production quality

S No 1

Check Point Do you conduct internal quality auditor periodically? following are standardized:, -auditor team; -audit frequency; audit timing; -audit method; -audit check sheet.

Requirement 

Internal audit procedure, Audit plan, Schedule, List of certified auditors, audit check sheet, NC recording & verification system,.  In case more than one shift are running, both shifts are covered during audit of manufacturing process related functions (line 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.


Sub Clause Activity to keep/improv e production quality

S No 2

Check Point Do you conduct quality audit to identify issues and properly improve them?

Requirement 

Evidences for audit conducted, Non conformities report & their closure.  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.


Sub Clause Content of process review

S No 1

Check Point Do you focus on useful know-how of operation, operations with poor workability and operation which need a lot of repair and standardize them?

Requirement 

In case of internal process audits, check for shop floor improvement evidences like Know-how of operations, Kaizens, Operator feedback etc.  Check for the easiness of 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.



S No 2

Check Point Do you confirm consistency between actual operation and standard?

Requirement 



Process audit checksheet to confirm that the operator is following the instructions or 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.



S No 3

Check Point Do you confirm if countermeasures are taken properly to prevent reoccurring of quality fail?

Requirement 



Check whether the confirmation of the actions is periodically performed. (e.g. Kakotora/ process trouble history sheet). 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 , Evaluation & Up gradation.

Information of Tier -2 selection to MSIL

Parts supply by tier -2 with proper Traceability

Audits & C ’measure Actions in case of Quality issues & Info to MSIL

Ranking of Tier-2

Periodic Audits at Tier -2 by Tier-1

Tier-2 location / 4M change info to MSIL

Clause 7 – Tier 2 Control S No 7.1

Sub Clause Evaluation method for new suppliers

S No 1

Check Point Do you define criteria to certificate new suppliers and implement them?

Requirement 

Procedure for New Supplier selection and Check sheet for 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


Sub Clause Management, quality evaluation and instruction for suppliers

S No 1

Check Point Do you collect supplier failure information, determine supplier grade according to quality level and conduct audit and instruction periodically?


 



Procedure for Supplier ranking. Adherence of supplier ranking 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

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



S No 2

Check Point For outsourcing any production, do you instruct them clearly about function and important control items of products at the meeting ?

Requirement 



Explanation of Part functions and important control items clearly during development & implement them. Preparation of inspection standard with supplier for every part

Observation (7.2.2) Gaps in Development  Inspection Standard not decided with Sub Supplier.  Explanation of Part criticality not evident



S No 3

Check Point For outsourced process, do you control the progress of production preparation and confirmed issues ?

Requirement  



Procedure for Supplier Part development Monitoring of Part development schedule ,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 No

Sub Clause

7.2

Management, quality evaluation and instruction for suppliers

S No 4

Check Point Do you make suppliers to conduct initial production control and decide department in charge of conduct?

Requirement 

Procedure to instruct suppliers about Initial flow control and its monitoring.



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.


Sub Clause

7.2


S No 5

Check Point Regarding the parts which are shipped directly to the customers from outsourced suppliers, do you have method to assure product quality performance?

Observation (7.2.4) Gaps in Outsourced process  No Gaps .

Requirement 

Procedure to control the outsourced process where Delivery is done directly by Supplier to customer?  Adherence of Product Quality checks as per procedure


Sub Clause

7.2


S No 6

Check Point Do you make outsourced suppliers to conduct initial parts and 4M changing management and is it possible to trace?

Requirement 



Procedure for Change approval request from suppliers & after getting change information how do you manage the activities at 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 No 8.1

Sub Clause Handling when abnormal situation occurs

S No

1

Check Point Do you define clearly what is abnormal situation and make operators know the definition?

Requirement 

 

List of Quality related abnormal Situations i.e Defect album, NG samples, etc. Rule for handling defect 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.  In most of Cases, operators are not aware of Abnormal conditions and actions to be done during abnormal situation.



S No 2

Check Point Do you clarify and standardize the handling rules/routes for customer claims, in process failure and supplier failure?

Requirement 

Procedure for handing customer complaint, internal rejection & incoming rejection.

Major Observation: Procedure is made but does not cover about standardization of

documents, horizontal deployment and timeline for closure and analysis.



S No 3

Check Point Do you have criteria to estimate the scope of suspected lot for abnormal situation? When abnormal situation occurs, do you trace suspected lot based upon the criteria?

Requirement  

System for suspected part check. Incase product is prepared by multiple dies/molds etc how you narrow down suspected range

Major Observation: Generally parts from all mold / dies are not covered.  Rule for previous part check not available.


Sub Clause

Prevention of recurrence ・Customer claims ・In process failure ・Suppliers failure

S N o 1

Check Point

Do you prevent recurrence of issues by analyzing cause of occurring defect based on process investigation result such as 5-why analysis?

Requirement

 

Quality of 5 why Format used for 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


Sub Clause


S N o 2

Check Point

Do you reflect corrective action to improvement of process control and review of standards?

Requirement



Once the c/m is established it needs to be standardized by modifying control plan, FMEA, WIP etc.

Major Observation: C/m are not updated in control plan etc.  Pokayoke etc are added but FMEA, CP are not revised.


Sub Clause


S N o 3

Check Point

After corrective action are taken, do you conduct onsite checkup and evaluate the effectiveness?

Requirement



System for checking the effectiveness of c/ms.

Major Observation: Most of vendors monitors that whether defect is repeating or

not.  Onsite verification of c/ms is not done.


Sub Clause


S N o 4

Check Point

Do you cascade information of corrective action to similar parts and processes?

Requirement



C/m established on one process to be horizontally implemented to other processes & other plants(incase mutliple 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 5.1

Sub Clause Location of production site

S No 1

Check Point Do you keep store material, work-inprocess, finished products, inventory and container at appropriate storage prevented from dust, rust, scratch, deformation and rainwater?

Requirement 

Check storage condition of raw material & child parts, work-inprocess, finished goods. It should be properly prevented from dust, rust, rainwater etc.

Observation (5.1.1) Gaps in 5S  Child part / Raw Material storage condition inappropriate.  Parts kept on floor, open environment etc.



S No 2

Check Point Do you control material, work-in-process and finished product by designated location, volume and standard using visual control?

Requirement 

Material storage locations defined with identification.  Area identified for storing new model parts.  Storage instructions (for ex. 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.



S No 3

Check Point Do you forbid operators to put temporary storage on work place?

Requirement 

Operator should not keep temporary storage at workplace. 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 • Appearance Not good • Part damage chances are high

• Bin Stacking Ok • Appearance Good • Part damage chances are low


• Part Stacking NG • Appearance Not good • Part damage chances during trolley movement are high

• Part Stacking Ok • Appearance Good • Part damage chances during trolley movement are low


• Less part during stacking • More no. of trollies required

• More part during stacking • Less no. of trollies required



S No 4

Check Point Do you implement inspection or critical operation under the properly controlled environment luminance /temperature/humidity/ vibration/noise/work table, etc.)?

Requirement 



Work station for inspection and other critical operations should be well illuminated and in well maintained condition. Lux level monitoring should be available.

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 5S Management S No 5.2

Sub Clause Production equipment's management

S No 1

Check Point Do you keep condition conditi on of production equipment's, jigs and tools properly?

Observation (5.2.1) Gaps in 5S  Unclean machine, Air  Oil leakage from machine.

Requirement 

Check condition of production equipment's equipment' s on shop floor fl oor.. There should be no equipment's damaged, clamps loose, oil leakage from machine etc.  Check that production equipment should not be fixed fi xed with temporary non-standard non-standard methods like packing with scrap, tied with cloth etc.

Clause 9 – 5S 5S Management S No 5.2

Sub Clause Production equipment's management

S No 2

Check Point Do you keep condition conditi on of inspection equipment's properly to ensure accuracy?

Requirement 

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

Check condition of inspection equipment's equipment' s on shop floor fl oor.. There should be no equipment's damaged, checking fixture clamps loose, datum pins missing etc.

Clause 10 (Equipment/ (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.

Maintenance of Production Equipment (Machine /die /tools /molds /jigs /fixtures)  Preventive maintenance  Predictive maintenance

Daily/Periodic check 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 during production

Inadequate Repair method adopted

M/C improper 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 S No

Sub Clause

10.1

Maintenance of equipment's , jigs and tools

S No 1

Check Point Do you conduct daily/regularly check of production equipment's, dies and jigs? Are records of maintenance kept?

Requirement 

Check the Machine, Dies and Jigs on daily / Periodically as per defined check sheet.



Record the observations and 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.


Sub Clause

10.1


S No 2

Check Point Do you confirm regularly the function of Pokayoke, automated stop and alarm? Are records of maintenance kept??

Requirement 

Define the frequency for checking the functions of all Pokayoke by using master samples?  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


Sub Clause

10.1


S No 3

Check Point Do you standardize frequency of polishing and replacement for consumable tools(blade/electrode/ru b stone, etc.)?

Observation (10.1.1) Gaps in replacement  Monitoring of tool life is not done.

Requirement 

Define the replacement / Preventive Maintenance frequency for Tools, Equipment's and Jigs (Electrode, Machine Tools, 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.

Clause 10 (Maintenance) S No

Sub Clause

10.2

Maintenance of inspection equipment's

S No 1

Check Point Do you calibrate regularly inspection equipment's and put the expire date on them?

Requirement 

Define the calibration frequency for all inspection equipment's / instruments.



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


Sub Clause

10.2

Maintenance of inspection equipment's

S No 2

Check Point Do you control deterioration (expire date) of boundary samples for objective judgments such as appearance inspection?

Observation (10.1.1) Gaps in boundary Samples  Boundary sample not stored adequately.

Requirement 

Define the validation period and check points for Limit samples related to appearance inspection ?  Validate and put confirmation sticker as per defined period?

Clause 11 (Implementation of Standards)

Clause 11 – Implementation of Standards S No

Sub Clause

11.1

Production equipment's management

S No 1

Check Point Do you use easy expression (visualizer, onomatopoeia ,etc.) for operation instructions? So that operator can easily understand process and critical points.

Requirement  All process & station should

have operation standard / work instructions available.  All work instructions should be well defined with pictorial display of instructions and check 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.


Sub Clause

11.1


S No 2

Check Point Do you keep operation instructions on the accessible place and post important quality points and critical operation points on the place where operators can see it easily?

Observation (11.1.2) Gaps in Implementation of Standards

Requirement 

Work instructions should be kept at accessible place. For Important information in work instructions, highlighting is recommended. .


Sub Clause

11.1


S No 3

Check Point Do operators and supervisors operate according to the operation standards?

Requirement 

Check that operators are following the process as defined in work instructions / OPS.  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) Standards) S No

Sub Clause

11.1


S No 4

Check Point Do you regularly monitored that each operator operates according to the operation instructions ？

Requirement 

 

Observation (11.1.4) Gaps in Implementation of Standards Operator Operator not working as per PCS, WI .

Check that the operator observance process chcksheet and frequency is defined. Check that the operator observance process records. Check if the response action for operator operator observance (in case of operator is found not following f ollowing the rule) is defined on not.

Clause 11 (Implementation of Standards) Standards) S No

Sub Clause

11.1


S No 5

Check Point Is it possible to judge OK/NG specifically by each check sheet (of daily equipment check, quality control report, etc.) you use?

Requirement 

Check sheets (for ex. preventive maintenance, set up verification and in-process check) should be clearly defined. Method of checking and standard values 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 attr ibute parameters checking.  Reaction plan should be clearly clearly mentioned in check sheet.  Recorded check sheets should be signed by the designated person for checking and verification.

Clause 11 – Implementation 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

Sub Clause

12.1

Management of parts flow

S No 1

Check Point Do you keep first-in firstout of finished products and work-in-process (material, reserve parts ） by using identification tag or lot indication?

Requirement 1. Adherence of FIFO in BOP/ RM stores area 2. FIFO for WIP and finished products  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


Sub Clause

12.1


S No 2

Check Point Do you control follows production history by product lot numbers? -production date; production volume; shipping date

Major Observations:- In cases where traceability is not available on the product, lot traceability/ batch traceability should be properly maintained.

Requirement  

System defined for recording of production data. Product traceability though part identification/lot identification/ batch identification etc.


Sub Clause

12.1


S No 3

Check Point Do you control identification of similar parts separately?

Requirement 



Major Observations:- Left and right side parts made on same line and similar looking child parts for both sides kept without proper tags/identification.

Control of similar looking child parts which are running on same/adjacent lines or stations. Control of Left/right side part mix up


Sub Clause

11.2

Nonconfirming parts managemen t

S No 1

Check Point Do you control identification of nonconfirming parts and parts on hold. Do you store them separately?

Red Bin – NG parts of running production


Identification and storage of NC parts in the incoming area. On the line, separate storage areas for NC parts Rule to be followed while discarding NC parts

Yellow – Parts on hold

Orange Bin – NG parts

Blue Bin – Fallen parts/

of NPD/trial production

setup rejection


Sub Clause

11.2


S No 2

Check Point Do you define procedure to handling (following items) non-confirming parts and parts on hold? -root cause analysis; person responsible for final judgment -timing; -feedback procedure.

Requirement 

Root cause analysis of NC parts  Authority for taking the decision of OK/NG for the suspected parts must be defined. Also the judgement criteria(rework matrix) for doing rework need to be defined.


Sub Clause

11.2


S No 3

Check Point Regarding repaired nonconfirming parts and parts on hold to re-use, do you define responsibility to implement? Are repair record kept?

Requirement 

Repair records of reworked parts should be maintained.

Clause 13 (Handling Management)

Clause 13 – Handling Management S No

Sub Clause

13.1

Bins/ Trolley Management

S No 1

Check Point Do you make arrangements with customers about the packing style & transportation system to prevent damage during handling of finished products & perform accordingly.

Requirement 

Packing standard for child parts, WIP & final part should be available & adhered

Observation (13.1.1) Gaps in Handling Management  Approved packaging standard not available for child parts.

Clause 13 – Handling Management S No

Sub Clause

13.1


S No 2

Check Point Are the packaging style & storage environment controlled with consideration to contamination

Observation (13.1.2) Gaps in Handling Management  Broken bins  Overloaded bins/ trolleys  Bins directly on shop floor

Requirement 

Check the bin / trolley and storage condition of work-inprocess, child parts and FG parts. It should be able to control damage and contamination to the parts.

Clause 13 (Handling Management) S No

Sub Clause

13.1


S No 3

Check Point Do you have system to maintain Bins /Trolleys in Good Condition.

Requirement 



System defined at supplier for identification and periodic 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

13.1


S No 4

Check Point Does the Packaging method prevent Transportation damage

Requirement 

Check for the proper packing condition of parts to avoid 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 maintenance system

• Bin trolley maintenance system introduces

Clause 14 (Critical parts Management )

Clause 14 – Critical Parts Management S No

Sub Clause

S No

Check Point

14.1


1&2

1. Do you have Special checks/Inspection for Maru A parameters of Maru A part are available . 2. Do you have Identification of Maru A Process/Operator on Shop Floor.

Requirement 



Identification of Maru A checkpoints should be available in work instruction and inprocess / final inspection standard. Maru A stations / Operator trained and authorised to carry out Maru A operations should 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.

MSIL Training on VSA Check Sheet

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