Microsoft Power Point - AL-PPAP

PLM - PPR PROCESS

PRODUCTION PART APPROVAL PROCESS PRODUCTION PART APPROVAL PROCESS

TRAININGTRAINING

It is designed to provide comprehensive knowledge to

the participants on understanding the requirements of

PPAP Manual & Implementation Guideline.

.

INTRODUCTIONINTRODUCTION

•• PurposePurpose is tois to ensure that all customer Engg. ensure that all customer Engg.

requirements are understood, and to demonstrate requirements are understood, and to demonstrate

the capability of supplier to meet the requirements, the capability of supplier to meet the requirements,

initially & during actual production run at quoted initially & during actual production run at quoted

production rate.production rate.

•• To validate that the products made from production To validate that the products made from production

tools and processes meet the Engg. Requirementstools and processes meet the Engg. Requirements

PURPOSEPURPOSE

APQP INTRODUCTIONAPQP INTRODUCTION

Expansion of APQP is Advanced Product Quality Planning

A structured method of defining and establishing the steps

necessary to ensure that a product satisfies the customer.

Originator of APQP- AIAG

(Automotive Industry Action Group

of Engineers from 3 Giants)

BENEFITS OF APQP

Changes required are identified early

Changes after production launch are avoided

Quality product is provided on-time at the lowest cost


4 PHASES OF APQP

1. Plan and Define the program

2. Product Design and Development

3. Process Design and Development

4. Production Part Approval Process (PPAP)

* There are 19 requirements for PPAP

* PPAP Submission in 5 Levels


5 Levels of PPAP

Level -1 Warrant Only

Level -2 Warrant, Product Samples, Limited Data

Level- 3 Warrant, Product Samples, Complete data submitted

Level -4 Warrant, Other requirements as defined by the Customer. All other PPAP Documents)

Level -5 Warrant, Product samples, Complete Data reviewed at

Supplier End.

PPAP REQUIREMENTS

1. Design Records of Saleable Product

- for proprietary components / details

- for all other components / details

2. Engineering Change Documents, if any

3. Customer Engineering Approval, if required

4. Design FMEA

5. Process Flow Diagrams

6. Process FMEA

7. Control Plan

8. Material / Performance Test Results

9. Dimensional Results

10. Initial Process Study

11. Measurement System Analysis Studies

12. Qualified Laboratory Documentation

13. Part Submission Warrant (PSW)

14. Appearance Approval Report (AAR), if applicable

15. Bulk Material Requirements Checklist (for bulk material

PPAP only)

16. Sample Product

17. Master Sample

18. Checking Aids

19. Records of Compliance with Customer Specific

requirements

R*SRRDesign FMEA4

R*SRRCustomer Engineering Approval, if reqd3

R*SSREngineering Change Documents, if any2

R*SSRfor all other components / details1.2

R*RRRfor proprietary components / details1.1

R*SSRDesign Records of Saleable Product1

54321

Submission LevelRequirementsSl.No

PPAP SUBMISSION LEVELS

R*SSSAppearance Approval Report (AAR), if

applicable

14

RSSSSPart Submission Warrant (PSW)13

R*SRRQualified Laboratory Documentation12

R*SSRMeasurement System Analysis Studies11

R*SRRInitial Process Study10

R*SRRDimensional Results9

R*SSRMaterial, Performance, Test Results8

R*SSRControl Plan7

R*SRRProcess FMEA6

R*SRRProcess Flow Diagrams5

Submission LevelRequirementsSl.No

R*SRRRecords of Compliance with Customer

Specific requirements

19

R*SRRChecking Aids18

R*RRRMaster Sample 17

R*RSRSample Product16

R*RRRBulk Material Requirements Checklist

(for bulk material PPAP only)

15

Submission LevelRequirementsSl.No.

• S – The supplier shall submit to designated customer product approval activity and retain a copy of records or documentation items at appropriate locations, including manufacturing

• R – The supplier shall retain at appropriate locations, including manufacturing, and make readily available to the customer representative upon request

• * - The supplier shall retain at appropriate locations, and submit to customer upon request

• Level 3 as default level

• For Bulk materials, Level 1 as default level

• This is carried out as per APQP timing plan

- Any one or more of the following as appropriate shall satisfy the

intent

• Min. Of 1 hr to 1 shift production with specific production

quantity to a total of min.300 consecutive parts

• Quantity specified by customer quality representative

• Produced from production site using tooling, gauging, process ,

material, operators from the production environment

• Parts from unique tools, lines, cavity, mould, pattern are

measured and representative parts tested

SIGNIFICANT PRODUCTION RUNSIGNIFICANT PRODUCTION RUN

• Part drawings, specifications, CAD data or any

documents referenced

• If it is electronic format, hard copy to identify

measurements taken

• for bulk materials

- Raw material identification

- Formulations

- Processing steps & parameters

- Final product specifications & acceptance criteria

1. DESIGN RECORDS

• Authorized change documents provided by customer

incorporated in the part not incorporated in the drawing

3. ENGINEERING APPROVAL

• As required by design record

• For bulk materials, signature of customer on bulk material

approval check list or inclusion of supplier’s name in

customer list of approved materials

2. ANY AUTHORISED ENGG. CHANGE DOCUMENT

Applicable to design responsible suppliers

for bulk materials, Design Matrix & Design FMEA are

prepared as required by bulk material requirements

checklist

for bulk materials, Design FMEA ratings for SEV, OCC,

DET specified in PPAP manual can be used

4. DESIGN FMEA

Purpose of Process Flow Diagram

To understand all the processes involved from the Incoming stage to

the final product despatch.

BENEFITS

1) Can able to see at once all the processes

2) Allows each operation to questioned

3) Exposes source variations

4) Highlights Non Value Added activities involved in the process

5. PROCESS FLOW DIAGRAM

Inputs for Process Flow Diagram

1) Customer Drawings

2) In-process Drawings

3) Plant Layout

4) Design FMEA outputs

5) FMEA for Similar Products

PFD

How to prepare the PFD

1) Operation sequences

2) What is the output of each process/operation

3) What are the Input characters which affect the output of the

process/operation

4) What are the Process characters which affect the output of the

process/operation

5) What is the symbols to be used for Process Flow Diagram

PFD

1st 2nd3rd 4th5th

PFD

OPERATI0N No & DESCRIPTION

Following guide line shall be followed to provide the Operation nos for the processes.

Category Operation Nos.

1 One Machine-One operation OP 10, OP 20,

OP 30…

2

One Machine- Multi Operations in this

Component cannot be checked stage wise by

Manually or automatically till the operation

Completed.

OP 10, OP 20, OP 30..

3

One Machine-Multi Operations in this

Component can be checked stage wise by

Manually or automatically.

OP 10, OP 10A,

OP 10B, OP 10C,…,

OP 20, OP 30,…

PFD

Incoming Source Variations (ISV)

This could be due to

Raw Material:

If it is due to Raw Material Variation Check the Supplier FMEA, Process

Flow, etc.

Any Previous Operation’s out comes:

If it is due to any Previous operations, clearly specify the operation/machine

from where this Variation occurred.

PFD

Product Characteristics/Desired OutcomeThese are the characters which to be obtained from the particular operation.

This Desired outcome shall be one or more of the Below mentioned.

a) Blue Print (BP)a) Dimensions

b) Engineering Specification (ES)

a) Test procedures b) Reliable checks c) Material specification

c) In process Characteristics (IP)

a) Rough turn ID

d) Process Characteristics (PC)

a) Temperature b) Time c) Pressure d) Speed

e) Functional characteristics (FC)

a) Visual b) Operational c) Fit d) Assembly guidelines

f) Regulatory

a) Safety b) Noise c) Environmental d) Emissions

PFD

Process Characteristics

These are also the Characters which affects the Desired outcome

during the particular operation.

These can be from one or more of the below Mentioned

a) Man

b) Machine

c) Method

d) Process Materials

e) Environment

PFD

Process Flow Diagram identifies

a) Where the inspection is carried out

b) Where the Operator involvement is required

c) Where the Delay is occurred during the process

This process flow Diagram (with the symbols) indicates,Where ever the Non Value added

actives are there in the process

Transportation

Operation or

Machine

Operation with self /Auto inspection

Inspection

Storage

Operation with Multiple Product

streams inspection

Delay

Decision

Primary Path

Alternate Path

Operator

Partial operator

--------------

PFD

1.Casting Variation 1) Reference Dimension - BP 1.Tool Wear 2.Material Hardness Variation 2) Seal Bore Diameter - BP 2.Speed & Feed

3) Seal Bore Surface Finish - BP 3.Operator Skill 4) Seal Face Depth - BP 4. Machine Repeatability 5) Seal Face Chamfer - BP

6) Seal face Surface Finish - BP

7) Seal Face Perpendicularity wrt Seal Bore -BP

8) Spigot Diameter - BP

9) Spigot Diameter Chamfer - BP

10)Spigot Diameter Surface Finish - BP

11) Spigot Face to MTG Face Depth - BP

12) Spigot Diameter Position - BP

13) Mtg Face Perpendicularity wrt Seal Bore - BP

14) Mtg Face Surface Finish - BP

15) Groove Diameter - BP

16) Groove Diameter Position - BP

17) Groove Diameter Suface Finish - BP

18) Groove Depth - BP

19) Chamfer - BP

20) Radius - BP

1.Seal Bore Variation 1) Bearing Bore - BP

2) Bearing Bore Chamfer - BP 1.Tool Wear

3) Bearing Bore Concentricity wrt Seal Bore - BP 2.Speed & Feed

4) Bearing Bore Surface Finish - BP 3.Operator Skill 5) Total Height - BP 4. Machine Repeatability 6) Bearing Face Surface Finish - BP

Bearing Bore

Process

Characteristics

Incoming Source of

VariationPFD

Product Characteristics /

Desired Outcome

OP 10 Seal Bore

Operation

Number

Operation

Description

OP 20

PFD

WHY FMEA

Tool for 6 Sigma

Catch the cause before the problem occurs

Prevent the failure

Easy understanding of Process

Reducing the cost of poor quality

Customer Satification

Optimize the controls

6. Process Failure Mode Effective Analysis

Process Flow of PFMEA

PFMEA

PFMEA

Example

Process function / description

- Machining of outer diameter

� Specify the description and

Function of the process

Potential

Failure

Mode

RequirementsProcess Step

/ Function

PFMEA

Example

Outer diameter, run-out, free from tool

mark

� List out Outputs of the Process

Potential

Effect(s)

of Failure

Potential

Failure

ModeRequirements

PFMEA

Example

Bent, Diameter oversize, Diameter undersize, Cracked,

Deformed, Open Circuited, Burred

Two Assumptions are

1. Consider all inputs are acceptable

2. Consider the Design is acceptable

� List the failure modes those are possible to occur

against the requirements specified in the previous

column.

� Apart from Engg. Specification, what would a

customer consider objectionable

1) No Function, 2) Partial / Over,

3) Degraded Function (after sometime failure),

4) Intermittent, 5)Un Intended Function.

SevPotential Effect(s)

of FailurePotential Failure Mode

PFMEA

Example

Cannot locate, Cannot face, Does not fit, Does not match Scrap,

re-work, Vehicle / item inoperable, Loss of primary function,

Customer dissatisfaction

� List the effects of failure in

1) Next operation,

2) Subsequent operations / Down Stream,

3) Operator Safety,

4) Machine / Equipment,

5) Customer / End User,

6) Vehicle,

7) Govt Regulation.

� For each failure mode, more than one effect can be listed

ClassSevPotential Effect(s) of Failure

PFMEA

� Assess the seriousness of the effect in a 1-10 scale

� This rating applies to EFFECT only

(i.e. previous column)

� Consider the Design FMEA

� Consult subsequent Mfg./ Assembly plant

� Safety related effects should be rated in Nos.9 or 10

� While giving ranking consider only the required

criteria (i.e. next opn. / vehicle)

Potential Cause(s)

/ Mechanism

(s) of Failure

ClassSeverity

PFMEA

Hazardous without warning

Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning

May endanger operator (machine or assembly) without warning

10

Hazardous

without warning

Very high severity ranking when a potential failure mode

affects safe vehicle operation and/or involves noncompliance with government regulation without warning

May endanger operator (machine or assembly) without warning

9

Very High Vehicle/item inoperable (loss of primary function) 100% of product may have to be scrapped, or vehicle/item

repaired in repair department with a repair time greater than one hour.

8

High Vehicle/ item operable but at a reduced level of performance. Customer very dissatisfied.

product may have to be sorted and a portion (less than

100%) scrapped, or vehicle/item repaired in repair

department with a repair time between a half-hour and an hour.

7

Moderate Vehicle/ item operable but Comfort/Convenience item(s) inoperable.Customer dissatisfied.

A portion (less than 100%) of the product may have to scrapped with no sorting, or vehicle/item repaired in repair department with a repair time less than a half-hour.

6

Low Vehicle/Item operable but Comfort/Convenience item(s) operable at a reduced level of performance.

100% of product may have to be reworked, or vehicle/item repaired off-line but does not go to repair department.

5

Very Low Fit and Finish/Squeak and Rattle item does not conform. Defect noticed by most customers (greater than75%)

The product may have to be sorted, with no scrap, and a portion (less than 100%) reworked.

4

Minor Fit and Finish/Squeak and Rattle item does conform. Defect noticed by 50% of customers.

A portion (less than 100%) of the product may have to be reworked, with no scrap, on-line but out-of-station.

3

Very Minor Fit and Finish/Squeak and Rattle item does not conform.. Defect noticed by discriminating customers (less than 25%)

A portion (less than 100%)0f the product may have to be reworked, with no scrap, on-line but in-station.

2

None No discernible effect. Slight inconvenience to operation or operator, or no effect. 1

Effect Severity of Effect on Product

(Customer Effect)

Severity of Effect on Process

(MFG/ASSY Effect)

Rank

Severity Ranking PFMEA

� Classify special process

characteristics (e.g. critical, key,

major)

Current

Process

Control

prevention

Potential

Cause(s) /

Mechanis

m (s) of

Failure

Classification

PFMEA

� List the first level potential causes such as

man, machine, tool, process parameter, fixture etc.

� List the root causes under the first level causes

using WHY? WHY? analysis

� Describe the causes in such a way that can be

eliminated or controlled

� Don’t use statements such as operator mal-

functioning, fixture problem etc.

� Use the cause and effect diagram, if required

� consider input materials in last iteration of cause

analysis

Continued……

Occur

Current Process

Control

prevention

Potential Cause(s) / Mechanism (s) of

Failure

PFMEA

Example

Under Man

Fails to clean, Fails to assemble, Fails to tight, Mis-

locate

Under machine

inadequate lubrication, excessive vibration, excessive

spindle run-out

Under process

improper time / temperature, inadequate gating / venting

Under design

Symmetric design, Difficult to assemble

Under Raw Material,

Mixed material, New source, Alternate material,

Excessive hardness

Occur

Current Process

Control

preventionPotential Cause(s) / Mechanism (s) of Failure

PFMEA

•List the existing controls, which can detect the causes or failure mode

Type Examples Prevention of causes Mistake proofing,

Check Sheet,

SPC chart,

On-line monitoring

Auto-control of temperature,

Current

Process

Control

Prevention

OccurCurrent Process Control prevention

PFMEA

� Estimate the probability of occurrence on a 1-10 scale

� Rate against each causes

� Use existing or past data as a basis rejection data for ranking

� Document the basis of occurrence ranking

� For a new processes, if there is no previous experience, use team judgement

Don’t consider failure detecting measures while giving ranking (100%

inspection)

GUIDELINES FOR OCCURRENCE NUMBER

1) Occurrence number is to be calculated for causes based upon actual data

2) If data is not there related to cause, calculated the occurrence no. of the failure mode data and same occurance number has to be transferred to the causes using engineering judgement

3) If you don’t have data related failure mode & causes, calculate occurrence number based on the Cpk Value

4) If the above 3 is not available, use the occurrence number from similar product

5) None of these are available, use the “GUT FEEL

Current

Process

Control

Prevention

Occurrence

PFMEA

Occurrence of Cause - Ranking

Probability Likely failure Rates Ranking

Very High:Persistent

Failures

> 100 per thousand pieces

>100000 PPM

10

50 per thousand pieces

50000 PPM

9

High: Frequent Failure 20 per thousand pieces

20000 PPM

8


10000 PPM

7

Moderate: Occasional Failures 5 per thousand pieces

5000 PPM

6


2000 PPM

5


1000 PPM

4

Low: Relatively Few Failures 0.5 per thousand pieces

500 PPM

3

0.1 per thousand pieces

100 PPM

2

Remote: Failure is Unlikely < 0.01 per thousand pieces

10 PPM

1

PFMEA

ϖAssess the probability of controls listed in the

previous column, which will detect the cause or

failure mode

ϖWhile giving ranking, assume the failure is

occurred

ϖDon’t assume ranking is low because the

occurrence is low

ϖRandom controls should not influence detection

ranking

ϖOne detection ranking can be assigned to multiple

controls

ϖWhile listing, specify the frequency of detection

measures

RP/NDetectCurrent Process Control Detection

PFMEA

Detection Crieteria Inspection types Suggested Range of Detection Methods Ranking

1 2 3

Almost

Impossible

Absolute certainty of non-

detection x

Cannot detect or is not checked 10

Very Remote Controls will

Probably not detect x

Control is achieved with indirect or random

checks only

9

Remote Controls have poor chance of

detection x

Control is achieved with visual inspection

only

8

Very low Control have poor chance of

detection x

Control is achieved with double visual

inspection only

7

Low Controls may detect x x Control is achieved with charting

method,such as SPC (Statistical Process Control)

6

Moderate Controls may detect x Control is based on variable gauging after

parts have left the station, or Go/No Go

gauging performed on 100% of the parts after parts have left the station.

5

Moderately High Controls have a good chance to detect. x x

Error detection in subsequent operations, or gauging performed on setup and first-piece

check(for setup cause only)

4

High Controls have a good chance

to detect. x x

Error detection in-station,or error detection in

subsequent operation by multiple layers of

acceptance: supply, select, install, verify.Cannot accept discrepant part.

3

Very High Controls almost certain to detect. x x

Error detection in-station (automatic gauging with automatic stop feature). Cannot pass

discrepant part.

2

Very High Controls certain to detect.

x

Discrepant parts cannot be made because

item has been error proofed by process/product design.

1

Detection - Ranking

Inspection Types: 1-Error-proof, 2-Gauging, 3-Manual Inspection

PFMEA

� Risk Priority Number is the

multiplication of S O D

severity x occurrence x Detection.

� While calculating RPN,

First consider only highest severity

rating of each failure mode

Alternatively (Different Scenarios)

S O - severity x occurrence

S D - severity x Detection

Responsibility &

Target

Completion

Date

Recommended

ActionRPN

PFMEA

�Policy for RPN to take action

-define a target RPN and anything above that can be

considered for action. Ex. It can be 50. Considering 95%

of the failures are attended

-consider only high priority no. for take action and

review periodically

�As a first priority, take action on causes to reduce

occurrence ranking

�The next priority is to consider action on controls to

reduce detection ranking

�severity ranking can be reduced by

-elimination of failure mode by change in processes or

design

Action

Results

Responsibilit

y

& Target

Completion

DateRecommended Action

PFMEA

�Specify the responsibility and target

completion date for every actions identified

�During APQP, the FMEA completion dates

should be prior to production run

RPN

D

e

t

Oc

cSev

Actions

Taken

Responsibility & Target

Completion Date

PFMEA

�Describe the verification results

�Where effectiveness measure is required,

specify the target date accordingly

�After the assessment of the actions taken, re-

assess the values of severity, occurrence,

detection and RPN

RPNDetOccSevActions Taken

Action Results

PFMEA

Opn No.Operation

Description

Potential

Failure modePotential Effect

Sev.

NoClass Potential Cause

Occur.

No.

Current

Process

Control Prev.

Current

Proces

Control Det.

Dectection

No.RPN

Recommended

ActionsS O D RPN

OP 20 Bearing BoreBearing

Bore Dia u/s

8 SC 3 Inprocess

Inspection

4 96

Next Process

NilHardness out of

spec.3

Receiving

Inspection4 96

Assy

Tight Fit 5 un skilled operator 3Work

instruction 96

Customer

Bearing Failure 7 M/c not repeatable 2 P.M 64

Field

Engine Failure 8 Insert wear 2

Operator

self 64

Inspection

Bearing

Bore Dia o/s

8 SC 3 Inprocess

Inspection

4 96

Next Processun skilled operator 3

Work

instruction 96

Nil 6

Assy M/c not repeatable 2 P.M 64

Loose fit

Customer 7

Bearing play

Field 7 Improper feed & 2 C.P 64

Pump poor

performance 7

PFMEA

Follow up actions The Process - responsible engineer is responsible for ensuring that all actions

recommended have been implemented or adequately addressed .

FMEA is a living document and should always reflect the latest design level as

well as the latest relevant actions.

The Process responsible engineer has several means of ensuring that concerns

are identified and that recommended actions are implemented . they includes but

not limited to followings :

1) Ensuring design requirements are achieved

2) Reviewing engineering drawings & specifications

3) Conforming incorporation in assembly / manufacturing documentation &

4) Reviewing process FMEA & Control plans

PFMEA

What is Control Plan

Is a written summary of the system for controlling the variation

of all product and process characteristics, important quality and

engineering requirements

Is a contract between the supplier and the customer

Is used as the basis for development of process work instruction

Identifies all customer and supplier specified special

characteristics.

7. Control Plan

Control Plan

CONTROL PLAN COLUMN DESCRIPTIONS

1 Header information Enter the header information as required.

2 Part/Process NumberThis item number is usually referenced from the Process Flow Chart. If multiple part numbers exist

(assembly), list the individual part numbers and their processes accordingly.

3Process Name/

Operation Description

All steps in the manufacturing of a component are described in a process flow diagram. Identify the

process/operation name from the flow diagram that best describes the activity being addressed.

4Machine, Device, Jig,

Tools for ManufacturingFor each operation that is described, name the processing equipment as appropriate.

5 NumberEnter a cross reference number from all applicable documents such as, but not limited to, process flow

diagram, numbered blue print, FMEAs, and sketches (computer generated or otherwise), if required.

6 Product

Product Characteristics are the features or properties of a part, component or assembly that are described on

drawings or other primary engineering information. The Core Team should identify the Special Product

Characteristics that are a compilation of im

7 Process

Process Characteristics are the process variable (input variables) that have a cause and effect relationship

with the identified Product Characteristic. A Process Characteristic can only be measured at the time it

occurs. The Core Team should identify Pro

Control Plan

CONTROL PLAN COLUMN DESCRIPTIONS

8Special Characteristic

Classification

Use the appropriate classification to designate the type of special characteristic or this field can be left blank

for other undesignated characteristics. Please refer to the Danaher Motion Quality Manual to see the

descriptive terms and symbols.

9Product/ Process/

Specification/ ToleranceSpecification/tolerance may be obtained from the engineering documents.

10Evaluation/

Measurement Technique

This columns identifies the measurement system being used. This could include gages, fixtures, tools, and/or

test equipment required to measure the part/process/manufacturing equipment. An analysis of the

reproducibility, repeatability and accuracy of the

11 Sample Size/Frequency When sampling is required list the corresponding sample size and frequency.

12 Control Method

This column contains a brief description of how the operation will be controlled, including procedure numbers

where applicable. The control method utilized should be based on effective analysis of the process. The

control method is determined by the type

13 Reaction Plan

The reaction plan specifies the corrective actions necessary to avoid producing nonconforming products or

operating out of control. The actions should normally be the responsibility of the people closest to the

process, the operator, jobsetter, or supervi

Control Plan

CONTROL PLAN COLUMN DESCRIPTIONS Control Plan

CONTROL PLAN COLUMN DESCRIPTIONS Control Plan

• Compliance to design record / control plan

• Record of qty. tested on each tests

• Engg. Change level or authorized engg. Change

• Date of testing

• Material sub contractor’s name and their code (from

customer approved List)

8. MATERIAL / PERFORMANCE TEST RESULTS

• Compliance to control plan & Design Record and all

characteristics (except ref. Dimensions)

• Dimensional results for each production lines, each

cavities, molds, patterns, dies

• Indicate design record, change level, authorized engg.

Change document ref. On all reports

• Identify master sample which is measured

• Tracing is required when optical comparator is required

• Appendix C can be used

9. DIMENSIONAL RESULTS

• Prior to submission, acceptable level of initial process

capability or performance shall be determined with

customer

• MSA prior to initial process studies

• For special Characteristics of variable data

• Cpk or Ppk can be as per customer agreement

• Control charts are preferred, if X bar – R charts used, Min.

25 sub groups, min 100 nos. from significant production

run.

10. INITIAL PROCESS STUDIES

• Use Cpk or Ppk

• Where historical Cpk data is available for similar parts of same

process, Cpk can be captured

• For chronically unstable processes (within specification) use

Ppk

• For bulk material, customer agreement on usage of

techniques

• Index value > 1.67, Else CA plan is reqd.

• For Unstable processes, notify customer & submit CA plan

• One sided specification or non normal data

• E.g. F/O, R/O, concentricity, twist, effort, surface finish,

uniformity, etc.,

10.1 QUALITY INDICES

�Alternate method of calculation & acceptance criteria with

customer agreement

�For bulk materials, if Ppk/Cpk is not achieved 100%

inspection of a sample (s) from a continuous process or

homogeneous batch, which represents online production run.

Part Variation Measurement system Variation

Why MSA ?Why MSA ?

11. MEASUREMENT SYSTEMS ANALYSIS STUDIES

Measurement system analysis (MSA) is an experimental

and mathematical method of determining how much

variation within the measurement process

contributes to overall process variability.

11. MEASUREMENT SYSTEMS ANALYSIS STUDIES

• if in house laboratory is only used for testing / calibration

- Add laboratory scope

• If outside laboratory is used for testing / calibration

• Add NABL certificate or equivalent of that laboratory

• Add scope of accreditation of that lab

12. QUALIFIED LABORATORY

DOCUMENTATION

13. PART SUBMISSION WARRANT

� Separate PSW for each part no.

� Identify Mould / cavity / line no. in PSW

� Part weight shall be rounded off to four decimals derived out

of 10 randomly selected parts

� 10 parts represent all moulds, cavities, lines as appropriate

14. APPEARANCE APPROVAL REPORT

• As required in Design Record

15 . BULK MATERIAL REQUIREMENT

CHECKLIST (Appendix F)

• Jointly agreed by customer during early stage of APQP

• Completion of all agreed activities

16. SAMPLE PRODUCTION PARTS

• As per customer request

17. MASTER SAMPLE

• Retain till new master sample is produced or as per design record

requirement for inspection criteria

• For each position of a multiple cavity, die, tool, mould or pattern, line.

• Retention period can be waived or modified by customer

18. CHECKING AIDS

• Inspection Fixtures, gages, models, templates, etc. specific to the part

• If more than one , prepare & refer the list in PSW including its change

level

• Submit if required by customer

• Certification of checking aid w.r.t part dimensions

• Demonstration of engg. Change in gauge change

• Appropriate MSA studies

19. CUSTOMER SPECIFIC REQUIREMENTS

• compliance records to all specific requirements of customer (Sec. II)

SITUATIONS WHEN PPAP VALIDAITON

& SUBMISSION REQUIRED

• SITUATIONS WHERE SUBMISSION TO CUSTOMER IS

REQUIRED ( Unless waived by customer)

For bulk materials, Process technology new to the supplier, not previously

used for this product4

Engg. Change to design records, specifications, or materials 3

Correction of a discrepancy on a previously submitted part2

A new part or product1

RequirementsSl.

No

• SITUATIONS WHERE NOTIFICATION & SUBMISSION TO

CUSTOMER IS REQUIRED

Production from tooling and equipment transferred to a different plant location or

from an additional plant location

4

Production following refurbishment or rearrangement of existing tooling or

equipment

3

Production from new ort modified tools (Except perishable tools)2

Use of other construction or material than was used in the previously approved part

or product

1

RequirementsSl.

No.

Change in test / inspection method – new technique 8

Product and process changes related to components of the production

manufactured internally or manufactured by s/c

7

Product produced after the tooling has been inactive for volume production

for twelve months or more

6

Change of subcontractor for parts, non-equivalent materials, or services (e.g.

Heat – treating, plating) that affects customer fit, form, function,

durability or performance requirements.

5

RequirementsSl.

No

For bulk materials,

- new source of raw material with spl. Characteristics from new or

existing s/c

- change in production appearance attributes where there is no

appearance specifications

- Revised parameters in the same process

- Change outside of DFMEA of the approved product

9

RequirementsSl.

No

5.2 SITUATIONS WHERE CUSTOMER NOTIFICATION IS NOT

REQUIRED (Track changes & Update any PPAP documents)

Identical gage replacement4

Changes in equipment3

Tool / Equipment movement within the same plant2

Changes to component level drawings1

RequirementsSl.

No

For bulk materials,

- changes within the DFMEA of the approved product

- Changes within PFMEA

- Changes which do not affect the spl. Characteristics

- Changes in approved commodity ingredients

- Change in s/c producing location of a R/M that has no spl. char.

- New sources of R/M that has no spl. Char.

- Tightening of customer/sales acceptance tol. Limits

7

Changes resulting in reduced RPN or PFMEA (with no changes in process

flow)

6

Rebalance of operator job content with no change in process flow5

RequirementsSl.

No