PLM - PPR PROCESS

PRODUCTION PART APPROVAL PROCESS

TRAINING
 INTRODUCTION

It is designed to provide comprehensive knowledge to

the participants on understanding the requirements of

PPAP Manual & Implementation Guideline.

.
 PURPOSE

• Purpose is to ensure that all customer Engg.

requirements are understood, and to demonstrate
the capability of supplier to meet the requirements,
initially & during actual production run at quoted
production rate.

• To validate that the products made from production

tools and processes meet the Engg. Requirements
 APQP 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
 APQP INTRODUCTION

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
 APQP INTRODUCTION

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
PPAP SUBMISSION LEVELS
Sl.No Requirements Submission Level
1 2 3 4 5
1 Design Records of Saleable Product R S S * R

1.1 for proprietary components / details R R R * R

1.2 for all other components / details R S S * R

2 Engineering Change Documents, if any R S S * R

3 Customer Engineering Approval, if reqd R R S * R

4 Design FMEA R R S * R
Sl.No Requirements Submission Level
5 Process Flow Diagrams R R S * R
6 Process FMEA R R S * R
7 Control Plan R S S * R
8 Material, Performance, Test Results R S S * R
9 Dimensional Results R R S * R
10 Initial Process Study R R S * R
11 Measurement System Analysis Studies R S S * R
12 Qualified Laboratory Documentation R R S * R
13 Part Submission Warrant (PSW) S S S S R
14 Appearance Approval Report (AAR), if S S S * R
applicable
Sl.No. Requirements Submission Level

15 Bulk Material Requirements Checklist R R R * R

(for bulk material PPAP only)

16 Sample Product R S R * R
17 Master Sample R R R * R
18 Checking Aids R R S * R
19 Records of Compliance with Customer R R S * R
Specific requirements

• 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
 SIGNIFICANT PRODUCTION RUN

• 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
 1. DESIGN RECORDS

• 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
 2. ANY AUTHORISED ENGG. CHANGE DOCUMENT

• 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
 4. DESIGN FMEA

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
 5. PROCESS FLOW DIAGRAM

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
 PFD

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 3rd 5th 2nd 4th

 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…
One Machine- Multi Operations in this
Component cannot be checked stage wise by
2
Manually or automatically till the operation OP 10, OP 20, OP 30..
Completed.

One Machine-Multi Operations in this OP 10, OP 10A,

Component can be checked stage wise by OP 10B, OP 10C,…,
3
Manually or automatically. 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 Outcome
These 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

Operation or
Machine Delay

Operation with self /Auto inspection

Decision

Operation with Multiple Product Primary Path

streams inspection
-------------- Alternate Path
Inspection

Operator
Transportation

Partial operator
Storage
 PFD

Operation Operation Incoming Source of Product Characteristics / Process

PFD
Number Description Variation Desired Outcome Characteristics
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
OP 10 Seal Bore
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
OP 20 Bearing Bore
4) Bearing Bore Surface Finish - BP 3.Operator Skill
5) Total Height - BP 4. Machine Repeatability
6) Bearing Face Surface Finish - BP
 6. Process Failure Mode Effective Analysis

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
 PFMEA

Process Flow of PFMEA

PFMEA
 PFMEA

Process Step Requirements Potential

Failure
/ Function Mode

Specify the description and
Function of the process

Example
Process function / description
- Machining of outer diameter
 PFMEA

Potential Potential
Failure Effect(s)
Requirements Mode of Failure

List out Outputs of the Process

Example
Outer diameter, run-out, free from tool
mark
 PFMEA

Potential Failure Mode Potential Effect(s) Sev

of Failure
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.
Example
Bent, Diameter oversize, Diameter undersize, Cracked,
Deformed, Open Circuited, Burred
 PFMEA

Potential Effect(s) of Failure Sev Class

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
Example
Cannot locate, Cannot face, Does not fit, Does not match Scrap,
re-work, Vehicle / item inoperable, Loss of primary function,
Customer dissatisfaction
 PFMEA

Potential Cause(s)
Severity Class / Mechanism
(s) of Failure

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)
 Severity Ranking PFMEA

Effect Severity of Effect on Product Severity of Effect on Process Rank

(Customer Effect) (MFG/ASSY Effect)
Hazardous Very high severity ranking when a potential failure mode May endanger operator (machine or assembly) without 10
without affects safe vehicle operation and/or involves noncompliance warning
warning with government regulation without warning

Hazardous Very high severity ranking when a potential failure mode May endanger operator (machine or assembly) without 9
without affects safe vehicle operation and/or involves noncompliance warning
warning with government regulation without warning

Very High Vehicle/item inoperable (loss of primary function) 100% of product may have to be scrapped, or vehicle/item 8
repaired in repair department with a repair time greater than
one hour.
High Vehicle/ item operable but at a reduced level of performance. product may have to be sorted and a portion (less than 7
Customer very dissatisfied. 100%) scrapped, or vehicle/item repaired in repair
department with a repair time between a half-hour and an
hour.
Moderate Vehicle/ item operable but Comfort/Convenience item(s) A portion (less than 100%) of the product may have to 6
inoperable.Customer dissatisfied. scrapped with no sorting, or vehicle/item repaired in repair
department with a repair time less than a half-hour.

Low Vehicle/Item operable but Comfort/Convenience item(s) 100% of product may have to be reworked, or vehicle/item 5
operable at a reduced level of performance. repaired off-line but does not go to repair department.

Very Low Fit and Finish/Squeak and Rattle item does not conform. The product may have to be sorted, with no scrap, and a 4
Defect noticed by most customers (greater than75%) portion (less than 100%) reworked.

Minor Fit and Finish/Squeak and Rattle item does conform. Defect A portion (less than 100%) of the product may have to be 3
noticed by 50% of customers. reworked, with no scrap, on-line but out-of-station.

Very Minor Fit and Finish/Squeak and Rattle item does not conform.. A portion (less than 100%)0f the product may have to be 2
Defect noticed by discriminating customers (less than 25%) reworked, with no scrap, on-line but in-station.

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

 PFMEA

Potential
Current
Cause(s) /
Process
Classification Mechanis
Control
m (s) of
prevention
Failure

Classify special process

characteristics (e.g. critical, key,
major)
 PFMEA

Current Process
Potential Cause(s) / Mechanism (s) of
Control Occur
Failure prevention

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……
 PFMEA

Current Process
Potential Cause(s) / Mechanism (s) of Failure Control Occur
prevention

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
 PFMEA

Current
Process
Current Process Control prevention Occur
Control
Prevention
•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,
 PFMEA

Current
Process
Occurrence Control
Prevention

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
 Occurrence of Cause - Ranking PFMEA

Probability Likely failure Rates Ranking

Very High:Persistent > 100 per thousand pieces 10

Failures >100000 PPM
50 per thousand pieces 9
50000 PPM
High: Frequent Failure 20 per thousand pieces 8
20000 PPM
10 per thousand pieces 7
10000 PPM
Moderate: Occasional Failures 5 per thousand pieces 6

5000 PPM
2 per thousand pieces 5

2000 PPM
1 per thousand pieces 4
1000 PPM
Low: Relatively Few Failures 0.5 per thousand pieces 3

500 PPM
0.1 per thousand pieces 2

100 PPM
Remote: Failure is Unlikely < 0.01 per thousand pieces 1

10 PPM
 PFMEA

Current Process Control Detection Detect RP/N

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
 Detection - Ranking PFMEA

Detection Crieteria Inspection types Suggested Range of Detection Methods Ranking

1 2 3

Almost Absolute certainty of non- Cannot detect or is not checked 10

Impossible detection x

Very Remote Controls will Control is achieved with indirect or random 9

Probably not detect x checks only

Remote Controls have poor chance of Control is achieved with visual inspection 8
detection x only

Very low Control have poor chance of Control is achieved with double visual 7
detection x inspection only

Low Controls may detect x x Control is achieved with charting 6

method,such as SPC (Statistical Process
Control)
Moderate Controls may detect x Control is based on variable gauging after 5
parts have left the station, or Go/No Go
gauging performed on 100% of the parts
after parts have left the station.
Moderately High Controls have a good chance Error detection in subsequent operations, or 4
to detect. x x gauging performed on setup and first-piece
check(for setup cause only)
High Controls have a good chance Error detection in-station,or error detection in 3
to detect. x x subsequent operation by multiple layers of
acceptance: supply, select, install,
verify.Cannot accept discrepant part.
Very High Controls almost certain to Error detection in-station (automatic gauging 2
detect. x x with automatic stop feature). Cannot pass
discrepant part.
Very High Controls certain to detect. Discrepant parts cannot be made because 1
x item has been error proofed by
process/product design.

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

 PFMEA

Responsibility &
Recommended Target
RPN Action Completion
Date

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
 PFMEA

Responsibilit
y
Action
& Target
Results
Completion
Recommended Action Date

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
 PFMEA

D
Responsibility & Target Actions
Sev
Oc e
RPN
Taken c
Completion Date t

Specify the responsibility and target

completion date for every actions identified

During APQP, the FMEA completion dates
should be prior to production run
 PFMEA

Action Results

Actions Taken Sev Occ Det RPN

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
 PFMEA

Current Current
Operation Potential Sev. Occur. Dectection Recommended
Opn No. Potential Effect Class Potential Cause Process Proces RPN S O D RPN
Description Failure mode No No. No. Actions
Control Prev. Control Det.

Bearing 8 SC 3 Inprocess 4 96
OP 20 Bearing Bore Bore Dia u/s Inspection
Next Process
Hardness out of Receiving
3 4 96
Nil spec. Inspection
Assy
Work
Tight Fit 5 un skilled operator 3 instruction 96
Customer
Bearing Failure 7 M/c not repeatable 2 P.M 64
Field
Operator
Engine Failure 8 Insert wear 2 self 64
Inspection

Bearing 8 SC 3 Inprocess 4 96
Bore Dia o/s Inspection

Work
un skilled operator 3
Next Process 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
 7. Control Plan

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.
Control Plan

1 Header information
2 Part/Process Number
Process Name/
3
Operation Description
Machine, Device, Jig,
4 For each operation that is described, name the processing equipment as appropriate.
Tools for Manufacturing
5 Number
6 Product
7 Process
CONTROL PLAN COLUMN DESCRIPTIONS
Control Plan
Enter the header information as required.
This 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.
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.
Enter 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.
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
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 COLUMN DESCRIPTIONS Control Plan
Use the appropriate classification to designate the type of special characteristic or this field can be left blank
Special Characteristic
8 for other undesignated characteristics. Please refer to the Danaher Motion Quality Manual to see the
Classification
descriptive terms and symbols.
Product/ Process/
9 Specification/tolerance may be obtained from the engineering documents.
Specification/ Tolerance

This columns identifies the measurement system being used. This could include gages, fixtures, tools, and/or
Evaluation/
10 test equipment required to measure the part/process/manufacturing equipment. An analysis of the
Measurement Technique
reproducibility, repeatability and accuracy of the

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

This column contains a brief description of how the operation will be controlled, including procedure numbers
12 Control Method where applicable. The control method utilized should be based on effective analysis of the process. The
control method is determined by the type

The reaction plan specifies the corrective actions necessary to avoid producing nonconforming products or
13 Reaction Plan 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 COLUMN DESCRIPTIONS Control Plan
CONTROL PLAN COLUMN DESCRIPTIONS Control Plan
 8. MATERIAL / PERFORMANCE TEST RESULTS

• 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)
 9. DIMENSIONAL 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
 10. INITIAL PROCESS STUDIES

• 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.
 10.1 QUALITY INDICES
• 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.,
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.
 11. MEASUREMENT SYSTEMS ANALYSIS STUDIES

Why MSA ?

Part Variation Measurement system Variation

 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.
 12. QUALIFIED LABORATORY
DOCUMENTATION

• 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
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)

Sl.
Requirements
No

1 A new part or product

2 Correction of a discrepancy on a previously submitted part

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

For bulk materials, Process technology new to the supplier, not previously
4
used for this product
• SITUATIONS WHERE NOTIFICATION & SUBMISSION TO
CUSTOMER IS REQUIRED

Sl. Requirements
No.

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

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

3 Production following refurbishment or rearrangement of existing tooling or

equipment

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

from an additional plant location
Sl. Requirements
No

5 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.

6 Product produced after the tooling has been inactive for volume production
for twelve months or more

7 Product and process changes related to components of the production

manufactured internally or manufactured by s/c

8 Change in test / inspection method – new technique

Sl. Requirements
No

9 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
5.2 SITUATIONS WHERE CUSTOMER NOTIFICATION IS NOT
REQUIRED (Track changes & Update any PPAP documents)

Sl. Requirements
No

1 Changes to component level drawings

2 Tool / Equipment movement within the same plant

3 Changes in equipment

4 Identical gage replacement

Sl. Requirements
No
5 Rebalance of operator job content with no change in process flow

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

flow)

7 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