SUPPLIER’S QUALITY

ASSURANCE MANUAL

Do c u me nt Re f e re nce N u mb er : SAP L/ Q M / 02

E di ti on N u mb er , Da te : 01 , 0 1. 0 7. 2 01 8

Re v is i o n Nu m be r , Dat e : 01 , 1 4. 0 8. 2 01 8

I s t hi s a C on t ro l l ed C opy ? : CONTROLLED COPY

REVIEWED BY A P P RO V E D B Y I S S U ED BY

M AN A G E M E N T
VICE PRESIDENT CEO
R E P RE S E N T A T I V E

Th is Q ual i t y M a nua l i s t he pr o per ty o f S AP L Aut o Pr i va te Li mit e d.

I ts co nt en ts s ha l l n ot b e re pr o duc e d eit he r i n p ar t or f ul l w i tho ut t he
w ri tt en pe rmi s s i on o f V P/ CE O - SA PL .
 TABLE OF CONTENTS

CHAPTER 1.0 GENERAL

1.1 Introduction
1.2 Scope of Application
1.3 Definition of terms
1.4 R e v i e w o f Q u a l i t y S ys t e m s
CHAPTER 2.0 QUALITY MANAGEM ENT RELATED REQUIREMENTS

2.1 P reparation of Qualit y Mana geme nt Outline

2.2 Advanced Quality Planning
2.3 Manufacturing contr ol
2.4 Initial Sa mples and First Production Part Approval
2.5 Change Control
2.6 Inspection
2.7 Mea suring Instrument and Gauge Contr ol
2.8 Lot Traceabilit y
2.9 Rec or ds and Retenti on of Recor ds
2.10 Stock Contr ol
2.11 Corrective and P reventive Action f or Non- Conf or mit y
2.12 Revalidation
2.13 Internal Audits
2.14 Quality Audits
2.15 Minimum requirement at initial sample submission
CHAPTER 3.0 Explanation of Quality requirements

3.1 P r e p a r a t i o n a n d s u b m i s s i o n o f P r o c e s s Fl o w
3.2 P reparation a nd submis sion of C/P LAN
3.3 P reparation a nd submis sion of c hart of qualit y standards f or
Incoming/In-process/Final (PDIR)
3.4 Statistical Process control
3.5 Corrective action and preventive action , control of critical
parts / sub-assemblies
3.5.6 Request for guarantee on re gulations of substances f or
envir onmental concerns
3.5.7 Impleme ntation of inve stiga tion on s ubstances for
envir onmental concerns at time of volume production and
pr ocess change

CH ANGE DE T A I LS

R e v. No . C ha n ge De ta il Da t e Ap pr o ved By
00 Initial release 01.07.18 Mayank Kulshrestha
Sec 2.5 - 4M c hange dec laration from suppliers
01 a dded, Sec 3.4.3 - s trict er i ns pec tion duri ng i nitia l 14.08.18 Mayank Kulshrestha
flow control added
 SUPPLIER Q UALITY MANAGEMENT SYSTEM

1.1 INTRODUCTION
This manual is a guide lines for qualit y M anagement to be carried out b y the
s u p p l i e r i n o r d e r t o g e n e r a t e S A P L’ s Q u a l i t y A s s u r a n c e r e q u i r e m e n t s w i t h r e g a r d t o
the products and semi finished products (hereinafter referred to as ‘products’)
purchased b y SAP L on the basis of the “Purchase Agreement(s) f or Parts Related
Transactions”. Each supplier is responsible for building on these f undamentals to
p r o d u c e a n e f f e c t i v e q u a l i t y m a n a g e m e n t s ys t e m .

S AP L’s Qualit y polic y of Commitment to achieve c ustomer’s expectation

emphasizes the need for up gradation of supplier thru i mpr ovement & training.
This appr oac h will lead to impr ovements in both qualit y and produc tivit y that will
be of mutual benefits to s upplier and SAP L and ultimate to the final Cust omer s.

SUPPLIERS ARE FULLY RESPO NSIBLE FOR THE QUALITY OF THEIR PRODUCTS

1.2 SCOPE OF APPLICATION

T h i s m a n u a l a p p l i e s t o a l l p r o d u c t s w h i c h t h e s u p p l i e r s u p p l i e s t o S A P L.

1.3 DEFINITIO N OF TERMS

SAPL ’s qualit y requirements :

1.3.1 All items such as samples, drawings, purchasing s pecifications and other related
d o c u m e n t s s h a l l b e o n l o a n f r o m S AP L t o t h e s u p p l i e r s .

1.3.2 All items specified in drawing and suppl y standards prepared by the supplier shall
b e a p p r o v e d b y S A P L.

1.3.3 An y other items deter mined b y joint negotiations shall be appr oved b y SAPL’ s
P roduct Developme nt department.

1.4 REVIEW OF Q UALITY SYSTEMS

1.4.1 S A P L s h a l l r e v i e w t h e s u p p l i e r ’ s q u a l i t y m a n a g e m e n t s ys t e m s , t h e i r i m p l e m e n t a t i o n
a n d o p e r a t i o n a s p a r t o f a n o v e r a l l s u p p l i e r r a t i n g s ys t e m .

CH APTER 2 QUALITY M ANAGEMENT RELATED REQ UIREMENTS

BASIC REQUIREMENTS
In accor dance with the ‘Purchase Agreement, the supplier is respon sible f or pr oducing and
s u p p l yi n g p r o d u c t s w h i c h m e e t t h e q u a l i t y l e v e l r e q u i r e m e n t s o f S A P L a n d a r e a c c e p t a b l e t o
S AP L . In order to achieve this, the supplier shall carr y out the f ollowings :

• E s t a b l i s h a n d m a i n t a i n a Q u a l i t y M a n a g e m e n t s ys t e m i n d i c a t i n g ‘ c l e a r a r e a s of
r e s p o n s i b i l i t y, a u t h o r i t y a n d a c c o u n t a b i l i t y ’ , i n o r d e r t o m a n u f a c t u r e p r o d u c t s of
c o n s i s t e n t q u a l i t y, a s p e r d r a w i n g s p e c i f i c a t i o n s w i t h m i n i m a l d i s p e r s i o n .

• T h e s ys t e m s h a l l e x e r c i s e s f o r t h e c o n t r o l o f i n c o m i n g q u a l i t y , p r e v e n t i o n o f i n - p r o c e s s
discrepancies, f or time l y and positive corrective & preventive action which required, and
f o r t h e p r e v e n t i o n o f s h i p m e n t o f n o n - c o n f o r m i n g p r o d u c t s t o S A P L.

• Shall maintain records of neces sar y data and inf or mation f or effective application.
Recor ds should be made available to S AP L’s Representative on re quest.
2.1 P R E P A R A T I O N O F Q U A L I T Y M A N A G E M E N T O UT L I N E
• The s upplier s hall es tablis h and manage a con siste nt Qualit y Ma nagement s ystem
covering all pr oduction pr ocesses with regard to pr oducts s upplied to S AP L.
For this purpose, the supplier shall prepare a Qualit y Mana gement Outline in
which all concrete qualit y Ma nagement methods s hall be describe d in detail i.e.
2.1.1 • Organization chart f or Qualit y mana gement s ystem in or ganization
2.1.2 • Lis t of meas uring and testing equipment with its calibration plan.

2.2 • Advance Quality Planning :

2.2.1 SPECIFICATION REVIEW

Specification Revie w should be jointl y carried out between Supplier and SAP L
P urchase, P r oduct Development and Q. A. Department to ensure clear understandin g
o f p r o d u c t r e q u i r e m e n t s i n t e r m s o f P e r f o r m a n c e , Q u a l i t y, S a f e t y a n d C r i t i c a l
Characteristics.

2.2.2 FEASIBILITY REVIEW

Following the Specific ations Review, complete manufacturing Feasibility Review in

terms of Manufacturing P rocess E quipme nt used, Ca pacit y P lanning, Inspection and
Testing aids, adequacy of Infra-structure, Labor etc. must be carried out by the
Supplier to ens ure c onfor mance with respect to all Engineering r equirements at
specifie d volume levels. Achievement of satisfactor y capabilit y mus t be considered
for all characteristics.

2.2.3 QUALITY PLANNING SCH EDULE

Supplier should prepare the Qualit y Planning Schedule and submit to SAP L Purchase
De partment P eriodical audit will be carried out b y SAP L team to ens ure compliance t o
the schedule.

2.2.4 PREPARATION O F PRO CESS FLOW CHART, CO NTROL PLAN, PRO CESS
CO NTROL AND INSPECTIO N STANDARDS
The supplier shall prepare P r ocess Flow Charts, Contr ol Plan, Inspection Sta ndards
and other Work Instructions and will have updated versions read y for submis sion at
all times. These shall be c onsidered live doc uments in the or ganization.
This document s hould be ava ilable on S AP L d e m a n d a n d a r e t o b e s u b m i t t e d t o
S AP L Q A a n d P r o d u c t D e v e l o p m e n t D e p a r t m e n t B e f o r e s u b m i s s i o n o f i n i t i a l s a m p l e s
or at the time of initial samples submis sion to use.

2.2.5 PRESERVATIO N AND PACK AGING

The choice of preser vation (cleaning, rust prevention etc.) and packaging can have a
s i g n i f i c a n t e f f e c t o n p r o d u c t q u a l i t y. An a ppropriate preservation and packagin g
s ys t e m s h o u l d b e u s e d t o e n s u r e t h a t p r o d u c t r e a c h e s a t S A P L ’ s p l a c e w i t h o u t a n y
d a m a g e . S A P L p r e f e r s f l e x i b l e / r e c yc l a b l e p a c k a g i n g f o r t h e i r p r o d u c t s .

2.3 MANUFACTURING CONTROL

• In or der to stabilize the manufacturing processes, the supplier shall carr you t
manufacturing contr ol in accorda nce with the Contr ol P lan and other wor k
instruction.
 • F u r t h e r , t h e s u p p l i e r s h a l l e x e r c i s e p r o c e s s c a p a b i l i t y, o n e a c h s p e c i f i e d c r i t i c a l
operation in order to achie ve minimum dispersion on dimensions.

• Process capacit y is a measure of the variation of the pr oce ss and its abilit y to
consistentl y produce components within s pecif ication.

• Process capa bilit y of each operation will be docume nted in SP C f or mat.

• Process Capa bilit y can be defined onl y whe n a pr ocess is in statistica l contr ol, i. e.
when it is being influenced by onl y common causes and special causes ha ve been
eliminated. P rocess ca pabilit y is meas ured b y the pr ocess capabilit y index Cpk.

2.4 INITIAL CO NTRO L

• In accordance with initial contr ol specified b y S AP L, the supplier must give
priorit y to standardization and improvements during the designated period, and
thus strive toward the s tabilization of pr oduction at an earl y sta ge.

• The supplier shall implement Initial control when pr ocess change (method of par t
processing) occurs or when the pr oduct de sign/s pecifications cha nge. During this
initial Contr ol P eriod, supplier must carr y out strict P r oduct c ontrol and revise
necessary Standards i.e. control plan, Work Instructions etc..
In case of pr oces s changes, the supplier s hall als o submit an initial Contr ol plan
to SAP L `s Purcha se & QA Deptt in principle prior to the star t of pr oces s
change.
• Prior to the suppl y of first pr oducts, the supplier shall complete the
requirements, which shall be submitted to SAP L’s Purchase & QA Dep’t.

2.4.1 CO NTROL OF CRITICAL PARTS AND OR SUBASSEMBLIES, SAFETY

PRODUCTS
T h e s u p p l i e r s h a l l c a r r y o u t c o n t r o l a c t i v i t i e s a s i n s t r u c t e d b y S AP L ( i n d o c u m e n t
such as drawings, purchasing specifications, notes), and shall maintain the pr oper
le vels of contr ol.

2.4.2 P L A N N E D P R E VE N T I V E M A I N T E N A N C E
S u p p l i e r s s h o u l d m a i n t a i n a f o r m a l a n d w e l l d o c u m e n t e d s ys t e m f o r t h e r o u t i n e
maintenance of pr oduction pr ocesses and equipme nt. The frequenc y of s uch
maintenance should be lar gel y base d on Breakdown detail, manufacturer’s
recommendations and an y historical reliabilit y or tool wear s ituations that are know n
to exist.

2.4.3 INCOMING (CUSTOMER APPROVED SO URCES) PRODUCTS

2.4.3.1 I n c a s e o f a p p r o v e d m a t e r i a l s / p a r t s ( S A P L) d e f i n e f o r s u p p l i e r , t h e s e m u s t b e p r o c u r e d
from approved sources. This doe s not relieve the supplier or the responsibilit y to
ensure that the pr oduct received fr om s ub- supplier confirm full y to S AP L
specification and requirements.

2.4.3.2 Control of sub-supplier Products/Services: Each supplier is responsible for ensuring

that all pr oducts and services it receives fr om sub-contractors f or use in pr oducts for
S AP L c onfor m to S AP L specifications and requirements. Each s upplier is responsible
to ensure contr ol at receipt inspection or at the place of sub- s upplier f or qualit y
require ment to be met as per S AP L `s specification and pr oper records to be
maintained.

The s upplier is responsible for ens uring that all relevant SAP L drawings and
specifications are communicated to the sub-supplier. In case of an y change/non
 c omplia nce supplier must initiate corrective action with sub-supplier on non-
c onforming pr oducts, and maintain detailed r ecords of the se concerns together with
such c orrective actions. Changes in sub-s upplier subsequent to initial sample appr oval
shall be c onsidered as a process change and require initial sample re-submis si on to
SAP L Purchase dept.

2.4 INITIAL SAM PLE & FIRST PRODUCTION SHIPM ENT APPROVALS
2.4.1 INITIAL SAM PLE
An initial sample is a small quantit y of produc ts which is checked f or conf or mance to
e ver y pr oduct and test requirement a s per S AP L part drawing and related
specification. SAP L required that initial samples be taken from a significant
pr oduction run (300 Nos.) Using pr oduction tooling and pr ocesses.
Initial sampling has to be s ubmitted f or appr oval in case f or ;
• New product.
• Whenever there is a change in pr oduct/ process cha nge.
• In case of location change/change of new tooling or equipment
• Ens ure that required gauges and test equipment are available at the time of
inspection and testing of the initial sample at supplier’s end.
• F o r S A FE T Y a n d C R I T I C A L r e l a t e d c h a r a c t e r i s t i c s c a p a b i l i t y i n d i c e s m u s t b e
calculated and recor ded.

When capa bilit y is not proven, the n steps must be take n to impr ove to pr oces s. If
capabilit y can not be achieved, the n the supplier must submit, f or IQA appr oval, a
revised Control plan incor porating 100% ins pection. Appr oval of revised Contr ol
plan will allow initial sample approval. However, the 100% inspection must be
perf ormed as part of the pr oces s itself.
Since 100% inspection is not sufficient f or long ter m, the supplier has to submit plan
for process impr ovement. For safet y and critical item/parameters if required SAP L
Qualit y Dep’t. Require on site approval f or initial sample.

2.4.2 FIRST PRODUCTION SHIPM ENT APPROVAL

A first pr oduction shipment is the first quantit y shipment from the supplier,
manufactured in actual production conditions following SAP L product approval.

For all pr oducts a first pr oduction shipment check will be made b y the supplier to
verify or demonstrate capability on critical and safet y characteristics.
A first Pr oduction Shipment quantit y will be appr oved onl y if capabilit y is pr oven in
terms of a ll dimensions are conf orming to specification. Supplier s hould also ensure
that pac kaging is als o as per agree d.

2.4.2.1 IDENTIFICATIO N

First Production shipment must be clearl y identified thr ough appropriate Tagging,
Labeling.

2.5 CH ANGE CONTRO L

The s upplier has to infor m all ECN/ P CN thr ough ECR request to S AP L QA at least 15
d a ys b e f o r e i m p l e m e n t a t i o n a n d i m p l e m e n t a t i o n a c t i v i t y t o b e s t a r t e d a f t e r S A P L Q A
authorization and SOP to be started after SAPL QA Approval followed by IFC
a c t i v i t y. T h e s u p p l i e r a l s o m o n i t o r s a l l t h e p l a n n e d / u n p l a n n e d c h a n g e s a n d q u a l i t y
c onfirmation recor d to be retained. S upplier has to submit monthl y 4M change
declaration thr ough 4'M Change Control Ma nagement Matrix – S AP L/F/MR/168 to
S AP L on and bef ore 7th of ever y month
2.6 INSPECTION
The supplier s hall conduct inspection f or inc oming, in-pr ocess and final pr oduct and
ensure that OK/Rej/U/Dev/Rewor k/Scra p identification are maintained at each level of
pr oduct ma nufacturing to avoi d mix- up.

2.7 MEASURING INSTRUMENTS AND G AUGE CONTROL

The s upplier must pr ovide and maintain adequate gauges and other meas uring and
testing devices for adequate pr ocess con tr ol and suitable f or the pr oduction
e valuations. The s upplier mus t devel op and implement a writte n plan to verif y &
calibrate the acc urac y and repeatabilit y of the se device s at sufficientl y frequent
i n t e r v a l s t o e n s u r e c o n t i n u e d a c c u r a c y.

2.8 LOT TRACIBILITY

The s upplier s hall maintain the traceabilit y of produc t as per agreed contr ol plan.

2.9 RECO RDS AND RETENTION O F RECORDS

The supplier shall contr ol qualit y recor ds with regard to pr oducts supplied, such as
recor ds f or manufacturing c ontrol, inspection and test results, lot traceabilit y,
measuring instr uments and gauge contr ol, ins pection activities with re gard to sub
s u p p l i e r s , a n d c o r r e c t i v e m e a s u r e s f o r n o n - c o n f o r m i t y. T h e s u p p l i e r s h a l l u s e t h e s e
r e c o r d s t o i m p r o v e c o n t i n u a l l y a n d i m p r o v e t h e q u a l i t y m a n a g e m e n t s ys t e m a n d
m a n u f a c t u r i n g q u a l i t y.

T h e r e t e n t i o n p e r i o d f o r t h e s e r e c o r d s s h a l l b e t h r e e ye a r s o r a s p e r S A P L c u s t o m e r
specific requirement which communicates b y SAP L during specification meeting.

2.10 STO CK CONTRO L

The supplier s hall strictl y f ollow the “first in first out” ( FIFO) s ystem in or der t o
accomplish proper suppl y to S AP L, make an ef fort to decrease the stock of unfinished
pr oducts ( just in time) and carr y out consistent stock contr ol. .

2.11 CO RRECTIVE & PREVENTIVE ACTIO N FOR NO N- CONFO RMITY

If SAP L inf orme d the supplier for non-conf ormit y in supplied pr oducts, the supplier
should immediatel y take corrective & preve ntive action and inform SAP L QA of the
a c t i o n t a k e n . I . e . C o n t a i n m e n t A c t i o n - w i t h i n 2 4 h r s . & C o r r e c t i v e a c t i o n - 7 Da ys . I f
non-conf or mit y is discovere d at the supplier’s premises, and it is though pos sible that
product pre viousl y supplied to SAP L ma y have similar defects, then the supplier shall
immediatel y inf or m S A P L P urchase/ Q. A. dept. and take appr opriate a ction.

2.12 RE-VALIDATIO N
T h i s h a s t o b e c a r r i e d o u t b y t h e s u p p l i e r , a t a m i n i m u m f r e q u e n c y o f o n c e a ye a r , f o r
each product. The reports should be made available to S APL Qualit y Dept.
Represe ntative upon request.

2.13 INTERNAL AUDITS

The supplier s hould establish and maintain periodic internal audits (P rocess, pr oduct
a n d s ys t e m ) f o l l o w i n g l o t a c c e p t a n c e , 1 0 0 % i n s p e c t i o n o r S t a t i s t i c a l P r o c e s s C o n t r o l ,
t o v e r i f y t h e e f f e c t i v e n e s s o f t h e o n g o i n g p r o d u c t c o n t r o l s ys t e m .

2.14 SECO ND PARTY AUDIT

S AP L shall, peri odically or fr om time to time, conduct qualit y audit to verif y that the
supplier implements qualit y assurance in acc ordance with this manual.

2.15 MINIM UM REQ UIREMENTS AT INITIAL SAMPLE SUBMISSIO N

The s upplier who has been selecte d f or development has to s ubmit f ollowing
 documents at the time of sa mple submission to S AP L for their appr oval:

1. Minimum number of samples ~ as mutuall y agreed.

2. Ins pection standard / la yout inspection report for each pr oduct / par ameter
3. Control plan
4. Process flow chart
5. Process capa bilit y data sheet f or internal pr ocess/parameter
6. Material test report
7. Lis t of instrument & gauges

CHAPTER 3 : EXPLANATIO N OF Q UALITY REQUIREMENTS

3.1 PREPARATIO N AND SUBMISSIO N OF PROCESS FLOW CHART

P rocess Flow Chart is an outline of the seque nce of activities that are carried out
to manufacture a part, sub assembl y or assembl y starting fr om receipt of
incoming products/raw material through various stages of processing to final
inspection, packaging a nd des patch.
.
3.1.1 Stage of Submission
T h e s u p p l i e r s h a l l s u b m i t t h e P r o c e s s Fl o w C h a r t t o S A P L Q A d e p a r t m e n t a t t h e
time of P ilot lot submission.

3.2 PREPARATIO N AND SUBMISSIO N OF CO NTROL PLANS

An important phase of the pr ocess f or qualit y planning is the development of

CONTROL PLAN. A C / P L A N i s a w r i t t e n d e s c r i p t i o n o f t h e s ys t e m f o r
contr olling parts and processes. A single C/P LAN ma y appl y to a gr oup or famil y
of products that are produced b y the sa me process at the same sour ce. Sketches,
a s n e c e s s a r y, m a y b e a t t a c h e d t o t h e C / P L A N f o r i l l u s t r a t i o n p u r p o s e s . In
support of a C/P LAN, pr ocess monitoring instructions should be defined and used
c o n t i n u a l l y.
The supplier shall prepare and submit the Con trol Plan to SAPL QA department at
the ti me of submiss ion of pilot l ot f or appr oval.

3.3 PREPARATIO N AND SUBMISSION OF INSPECTION STANDARDS

(INCOMING /INPRO CESS/FINAL)

The supplier s hall prepare and submit inspection standar ds f or the pr oducts to be
s u p p l i e d t o S A P L w h i c h s h a l l b e u s e d t o g u a r a n t e e S A P L’ s q u a l i t y r e q u i r e m e n t s
for appr oval.
1. Incoming standard
2. In-process Standard
3. Final Quality Standard
4. P re Dispatch S tandard in line with SAP L Inc oming standard
3.4 STATISTICAL PRO CESS CONTRO L

To judge the consistent perf or ma nce of manufacturing process es/ assembl y

pr ocesses f or critical /safet y parameter, the supplier has to exercis e contr ol to
achie ve pr ocess consistenc y in line SP C requirements.
The supplier has to validate process at the time of sample s ubmis sion (initial
contr ol) and all the preliminar y pr oces s studies has to pr oduce as an evide nce to
S AP L Q A d e p ’ t . A s & w h e n r e q u i r e d / d e m a n d e d .
 PRO CESS CAPABILITY AND STATISTICAL CO NTRO L

P rocess capabilit y is a measure of the variation of a process a nd its abilit y to

consistentl y pr oduce components within s pecification. P r oces s capabilit y can be
defined onl y when a pr oce ss is in sta tistic al c ontr ol, i. e. whe n it is being
influence d by onl y common causes and special causes have been eliminate d.
P rocess capabilit y is measured b y the process capabilit y index (Cpk).

• Special Cause is a sou rce of variation that is inter mittent or unpredictable –

sometimes called an assignable cause. It is signalled b y a point beyond the
contr ol limits or a r un or other non-random pattern of points within the
contr ol limits. Special causes can usuall y be corrected at the proces s b y the
operator or supervis or , e. g. br oken tool, change in machine setting, and
change in raw material batch or source.
• Common Cau se is a s ource of variation that is alwa ys present – part of the
random variation inherent in the process itself. Its origin can usually be
traced to an element of the s ystem which only management can corr ect, e. g.
poor lighting, poor work station la y out, badl y maintained machines, fragile
tooling and fixturing.
• Process Capability Index (Cpk) is an index which measure s the variabilit y
and setti ng of the pr ocess relative to the s pecification
• When Cpk is less than 1.33, 100% inspection must be implemented and
actions taken to increase Cpk value to a minimum of 1.33.

Measured Data (Variables) are those characteristics of a product whic h can be

qualitatively measured. Examples are length, diameter, surface roughness,
c o n c e n t r i c i t y, s q u a r e n e s s , t o r q u e e t c .

3.4.1 Machi ne Capa bilit y Studies (Cmk) assess the short term influences on product
specifications emanating from the machine/operation/pr oces s alone when the
s t u d y i s p e r f o r m e d , i . e . s p e c i a l c a u s e s a r e n o t i d e n t i f i e d . T yp i c a l l y , a m i n i m u m
of 50 consecutive compone nts are meas ured and t he results are analyzed using a
suitable chart. It is then possible to calculate the machine capa bilit y index
(cmk).

3.4.2 P rocess Capa bilit y studies (Cpk) provide as ses sment of the abi lit y of the process
to produce products that meet SAPL specific ation. The y are c onducted using a
sample of at least 50 units taken from a significant production run. The data is
g a t h e r e d i n s u b - g r o u p s t h r o u g h o u t t h e p r o d u c t i o n r u n a n d i s a n a l yz e d u s i n g
contr ol charts. When the chart shows neither an y points outside the contr ol
limits nor an y evidence of trends, pr ocess ca pabilit y ma y be deter mi ned in the
same wa y as f or machine capabilit y studies.

The pr ocess s hould be operating under actual pr oduction conditions until all
factors likel y to contribute to pr oces s variation (e. g. raw material, personnel,
envir onment, tool wear) are reflected in the pr ocess output. The process
capabilit y can be deter mined if the pr ocess has been in stat istical contr ol f or at
l e a s t 3 0 d a ys p r o d u c t i o n .

P rocess is the combination of people, machine and equipment, materials, methods

and e nvironment that pr oduces a given pr oduct or ser vice. Efforts to increase
Cpk should continue at all time to pursue continuous improveme nt f or conduction
pr ocess capabilit y studies.
3.4.3 Initial flow control
A lot of suc h parts, Whic h are manufactur ed first time after sample appr oval
using actual mass prod uction pr ocess and c onditions or which are produced first
time just after implementation of one or more changes.

The supplier shall designate initial contr ol in the f ollowing cases :

1) New Part, Engineering Change and P rocess c hange
o A new part ma nufactur ed
o Modification in parts
o Change of machiner y
o Change in Method
o Change of Material
o An y other f or m above change whic h the pers on responsible f or
i n i t i a l c o n t r o l c o n s i d e r s t o h a v e a s t r o n g e f f e c t o n q u a l i t y.
The initia l flow period should be 3 mont hs for new parts and 1 month f or
ECN/P CN parts. Howe ver, it should be decided in the specification re view
meeting.
S u p p l i e r h a s t o p e r f o r m s t r i c t e r ( i n c r e a s e d f r e q u e n c y) i n s p e c t i o n d u r i n g i n i t i a l
flow contr ol period at incoming, in- pr ocess and Final inspection stages.

Ta ble 1 – Criteria f or the Ter mination of Initial Contr ol

Control Item Target
SAPL Complaints 0

Defects@ Firewall/IFC station 0

In process rejection -

Process Capability (Cpk) ≥1.33

Results of countermeasure taken against problem during product development Effective

Results of countermeasure taken against problem during initial control period. Effective

Process Audit 0 Open NC

If, an y of the criteria listed above are not met, Initial flow contr ol period shall be
extended till time all criteria met.

S AP L - Q A S e c t i o n m a y r e q u e s t t h e s u p p l i e r t o s u b m i t t h e f o l l o w i n g d a t a , i n
or der to evaluate if initial control can be ter minated.

i) P roces s capabilit y rese arch data (for important items)

ii) Control Chart (updated and checked)
iii) Recor ds and descriptions of corrective measur es take n f or defects.
iv) Others

3.5 CONTROL OF CRITICAL PARTS AND OR SUBASSEMBLIES, SAFETY

PRO DUCTS

This section outlines the contr ol of critical parts and s ubas semblies and safet y
products to be carried out by the supplier.

3.5.1 DEFINIT IO N

i. Safet y parts and subassemblies Safet y parts and subassemblies are

P roducts which, if damage or brea kdown occurs, could cause loss of

function of assembled units.
 ii. Critical characteristics

iii. The pr oducts with characteristics which demand special contr ol are called
‘critical characteristic s products’. M ore over, the characteristics of these
parts are of importance , from functional & perfor mance point of view f or
the product.

3.5.2 DESIG NATIO N

T h e r e l e v a n t p r o d u c t s o r c o m p o n e n t s a n d t h e i r c h a r a c t e r i s t i c s , s h a l l a l w a ys b e
clearly indicate d on dra wings and purchase specifications in the following
manner :

3.5.3 CONTROL O F CRITICAL PARTS AND SUBASSEMBLIES, SAFETY

PRO DUCTS

ix. Indicating / Marking

• Indicating wor k pr oces ses
Wor k Pr ocesses which include safet y and critical c haracteristics s hall be
clearl y indicated by signboards reading (S) for SAFETY PROCESS and [C]
for CRITICAL P ROCE SS.
• Marking of related documents
Stamp ‘S AFETY P ARTS’ (S AFE TY) or ‘CRITICAL PARTS AND
S UBASSEMBLIES’ (CRITICAL) on related document suc h as the
inspection sta ndards, general products.
x. De signation of worker
When wor k pr ocesses include safet y or critical characteristics, onl y
wor kers who have been specificall y designated ma y be as signed.

xi. Verification of process capabilit y

Safet y and critical characteristics must be ins pected and verified dur ing the
initial control period. Also review the work manual, c ontrol chart,
inspection standards and dra wings. Revise and improve the se to secure a
process capabilit y index of Cpk >=1. 33

iv. Inspection of P rocess Contr ol Status

Res ponsible persons of QA Section and the M anufacturing
Department must periodicall y verif y that ma nufacturing pr ocess contr ol is
carried out in accordance with the control chart and other standards.
Corrective action must be ta ken if pr oblems arise.

v. Quality Evaluation
In addition to regular inspection, the responsible department must verify the
qualit y of safet y and critical characteristics b y periodicall y carr ying out
qualit y eval uation of the dimens ions, precision, f unctions and perf ormance.
Moreover, related departments must be informed of non-conf ormit y and
corrective action mus t be purs ued.

vi. Assignment of inspection personnel

All pers onnel assigned to the inspec tion of safet y and critical characteristics
must in principle have at least 6 months experience in wor k unrelated to
such characteris tics. During this s ix month t he pers on in charge of contr ol
must pr ovide instructions f or the f ollowing :
• The importance of safet y and critical characteristics
• Knowledge and tec hnical s kill neces sar y to perfor m pr oper ins pection.
• How to repor t on corre ctive action a gainst, and the nature of defects.
 • Course of action if abnor malit y occ urs.

vii. Retention of recor ds

Recor ds of ins pection and tests, corrective measures f or fault y processes,
investigation and corre ctive measures f or qualit y related complaints and lots
when related to critical parts and subassemblies and safet y products, must in
p r i n c i p l e b e r e t a i n e d f o r 0 3 ye a r s . M o r e o v e r , i f r e c o r d s n e e d t o b e r e t a i n e d
f o r l o n g e r t h a n 0 3 y e a r s , S A P L s h a l l i n f o r m t h e s u p p l i e r a c c o r d i n g l y.

viii. Sec ondar y subc ontracting of safet y a nd critica l pr oces ses

In principle, secondary subcontracting of safety and critical processes is
prohibited. If the supplier must perf or m complete lot trace abilit y in or der
to identif y the lot which contained such defective pr oducts.

ix. Complete lot control

Should defects of safety and critical parts a nd s ubassemblies be disc overed
after shipment, the s upplier must perf or m complete lot traceabilit y in order
to identif y the lot which contained such defective pr oducts?

3.5.4 OUTLINE OF APPROPRIATE CO RRECTIVE ACTIO N IN CASE O F NON-

CO NFO RMITY

The ba sic response to non-conf or mit y is to obtain clear understanding of the

circumstances under which the non-conf ormity was generated, to take immediate
appropriate corrective action and to avoid reoccurrence. The supplier has to submit
corrective and pre ventive action report.

3.5.5 Request for gu arantee on regulation s of substances for environ me ntal concern s

Suppliers shall guarantee to compl y with the regulations regar ding the substances
for envir onmental c on cern, which SAP L specifies in the tec hnical standar ds,
“Restrictions on the us e of substances for environmental concer n are as below.

Substance Maximum concentration limits

Lead and its compounds 0.1% by weight of homogeneous material (1g/kg – 1000 ppm)

Mercury and its compounds 0.1% by weight of homogeneous material (1g/kg – 1000 ppm)

Cadmium and its compounds 0.01% by weight of homogeneous material (100mg/kg – 100 ppm)

Chromium VI and its compounds 0.1% by weight of homogeneous material (1g/kg – 1000 ppm)

3.5.6 I mple mentation of investigation on sub stances f or environment al concerns at

time of volu me production and proces s chan ge.

At the times of starting volume produc tion, making pr oce ss change, or upon request
b y S AP L, suppliers shall inves tigate if the substances for envir onmental concerns
are contained in those parts to be delivered and in the auxiliar y materials used f or
manufacturing.