1. PRODUCTION PART APPROVAL PROCESS Based on PPAP Manual 4 edition
Copyright © 2009 Fideltronik

2. PPAP is third part of APQP methodology
APQP (ang. Advanced Product Quality Planning) - this is a defined process for product development. According to the AIAG (Automotive Industry Action Group), the purpose of APQP is "to produce a product quality plan which will support development of a product or service that will satisfy the customer." The process is described in the AIAG manual
The product implementation process is divided into several phases:
Planning
Planowanie
Partia próbna
Sample batch
Produkcja
Production
Prototype
Prototype
Plan and definition of the program
Implementation to production (PPAP)
Mass production
Product design
Particular phases of the APQP specify the appropriate steps to ensure proper quality of the product.
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3. PPAP – Production Part Approval Process created by AIAG (Automotive Industry Action Group)
PPAP is used to establish confidence in suppliers and their processes, by demonstrating that:
Customer design record and specifications and other requirements are properly understood by the supplier.
Process proposed by the supplier has the potential to produce product consistently meeting these requirements with defined production rate.
PPAP is required for:
A new part or product (i.e., a specific part, material, or color not previously supplied to the specific Customer).
Correction of a discrepancy on a previously submitted part.
Product modified by an engineering change to design records, specifications, or
material.
Any situations required by Customer.
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4. PPAP samples must be produced at mass production conditions
There are 5 Submission Levels The items and/or records specified by the level as requested by the customer must be submitted by the supplier: Level 1 – Warrant only (and for designated appearance items, an Appearance Approval Report) submitted to the Customer. Level 2 - Warrant with product samples and limited supporting data submitted to the Customer. Level 3 - Warrant with product samples and complete supporting data submitted to the Customer. Level 4 - Warrant and other requirements as defined by the Customer. Level 5 - Warrant with product samples and complete supporting data available for review at the supplier’s manufacturing location.
Important:
PPAP samples must be produced at mass production conditions
(Significant Production Run – PPAP ptk. 2.1) using chosen for mass production tool, production plant, production line, cavity etc..
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5. For points 5-9, 12 more information at reference manuals
PPAP elements:
Part Submission Warrant (PSW)
Design records
Approved Engineering Change Documentation
Customer Engineering approvals
Design FMEA
Process Flow Diagrams
Process FMEA
Control Plan
Measurement System Analysis Studies (MSA)
Dimensional Results
Material, Performance, Test Results
Initial Process Study
Qualified Laboratory Documentation
Appearance Approval Report (AAR), if applicable
Sample Product
Master Samples
Checking Aids
For points 5-9, 12 more information at reference manuals
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6. Retention Requirement Table / Submission Level
Requirement :
Level 1
Level 2
Level 3
Level 4
Level 5 1.
Part Submission Warrant R AR 2.
Design records - 3.
Approved Engineering Change Documentation 4.
Customer Engineering approvals 5.
Design FMEA 6.
Process Flow Diagrams 7.
Process FMEA 8.
Control Plan 9.
Measurement System Analysis Studies
10.
Dimensional Results
11.
Material, Performance, Test Results
12.
Initial Process Study (Cpk) Capability Studies
13.
Qualified Laboratory Documentation
14.
Appearance Approval Report (AAR), if applicable
15.
Sample Product
16.
Master Sample
17.
Checking Aids
R- Required, AS- As Requested, „-” Not required
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7. Part Submission Warrant (PSW)
Standard form (available in PPAP Manual – page: 22-25)
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8. 2. Design records
Shall contain all important information regarding the product such as - material used, dimensions, technology etc. Not required if Supplier is not project/design owner.
What should be submitted by Supplier?
1. Copy of drawing for product/part, including design records for components; for PCB Gerber
files (GBR)
2. For catalog parts, the design records may consist only of a Functional specification or a reference to a recognized industry standard.
3. Reporting of Part Material Composition
Material/ Substance Composition (100% composition of part). This material report may be entered into the IMDS (International Materials Data Systemhttp:// or other customer-specified method and the results must comply with Customer Specific Requirements (CSR).
4. Marking of Polymeric Parts (PPAP -4e.): „- Plastic parts weighing at least 1OOg (using IS /1043-1) - Elastomeric parts weighing at least 200g (using IS /1629)”
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9. 4. Customer Engineering Approvals
3. Authorized Engineering Change Documents
Ref. PPAP 4 e.:
What should be submitted by Supplier?
PCN – Product/Process Change Notification (for Truck Industry PPAP page:62-64)
ECN – Engineering Change Notification
EQ- Engineering Queries -> confirmed by Customer list of engineering questions
4. Customer Engineering Approvals
Customer Validation Report, or other written form of approval.
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10. 5. Design FMEA – Not required if Supplier is not project/design owner.
7. Process FMEA
FMEA – Failure Mode and Effects Analysis
Standard Form included in FMEA reference manual.
What is it?
A tool used to identify and prioritize risk areas and their mitigation plans.
Objective:
Identifies potential failure modes, causes, and effects. Inputs come from the process flow diagram.
Identifies key inputs which positively or negatively affect quality, reliability and safety of a product or process.
Work in group which base on:
Identifying : Process -> mistake in the process -> potential defect -> potential failure effect -> cause -> corrective actions
Calculating: Risk Priority Number (RPN)
Analyzing: RPN = Importance x Occurrence x Detection
Areas with high RPN-I should be included in the Control Plan
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11. What gives us FMEA?
The use of FMEA in the early stages of the implementation of the product, gives us a much better chance of eliminating potential defects at lower cost.
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12. Process FMEA – step 1
Assign Occurrence (How likely is the cause to occur?)
Assign Detection
(How easily can the cause or failure
mode be detected?)
Assign Severity
(How serious is the effect if it fails?)
Potential Causes
For each Failure Mode,
determine the possible cause of the failure.
Failure Modes
For each Process Input, determine the ways in which the input can go wrong.
Current Controls
For each potential cause, list the current method used for preventing or detecting failure.
Potential Failure Effects
For each Failure Mode,
determine what effect
the specific failure could have on the process output.
Process Name
Using the completed
Process Flow Diagram, enter the process step.
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13. Process FMEA – step 2 High 10 Low 1
Calculate the Risk Priority Number RPN = Severity x Occurrence x Detection
High 10
TIPS
The RPN is used to prioritize the most critical risks identified in the first half of the FMEA.
High RPNs (125 or above) are flags to take effort to reduce the calculated risk.
Regardless of RPN, high Severity scores (9 or 10) should be given special attention.
Low 1
IMPORTANT !
Create a rating system that makes sense for the defects you are trying to prevent.
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14. Analyzing the PFMEA
Once the RPN Numbers are determined, they can be used to prioritize the most significant failure modes.
Sort the FMEA by the RPN numbers. Graphical and statistical tools can help the team select a “cut-off” RPN for the next steps.
Sort by RPN to determine
the most significant
failure modes ?
How many items should be
the focus of the next steps?
RPN Thresholds
When using an RPN threshold, DO NOT forget to address high Severity scores
Pareto Chart
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15. 6. Process Flow Diagrams (The guidelines in the reference manual APQP)
Process mapping, also known as a flow diagram or FLOW CHART is one of the basic
techniques of describing the process of product or service implementation. It is also one
of the basic quality tools used for identification of the individual steps of a product
realization and the subsequent analyzing of them.
Process Flow must identify each step in the process
Should include abnormal handling processes
Scrap
Rework
Process Flow must include all phases of the process
Receiving of raw material
Part manufacturing
Offline inspections and checks
Assembly
Shipping
Process mapping allows to:
Document particular steps of processes, better understand processes for customers/third parties, Facilitate communication with the customer/vendor (symbols are known all over the world). This is one of the first stages of product implementation in accordance with ISO-TS Furthermore, it allows to identify a number of weaknesses in the process.
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16. Material / data download
Flow-Chart symbols
The map process contains many symbols that represent individual operations, testing, storage, transportation, etc. E.g.:
Material / data download
Process
Decision
Document
Terminator
Standard (most commonly used)
Material / data download
Control
Operation
Decision, Test
Transport
Used in automotive industry
Based on already withdrawn standard ANSI-Y15.3M
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17. 8. Control Plan Standard Form available in APQP reference manual
What is it?
A document that describes how to control the critical inputs to continue to meet customer expectations of the output.
Objective:
Primary reference source for minimizing process and product variation.
Description of how teams should react to out-of-control situations.
IMPORTANT!
Since processes are expected to be continuously updated and improved, the control plan is a living document!
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18. Control Plan – description
Number of process (from process map)
Process description (from process map)
Description, symbol of machine, device or tool which is used for a particular operation
Number of characteristic (e.g. from drawing)
Product characteristic (special and normal)
Process characteristic (special and normal)
Symbol (type/class) of Special Characteristic
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19. Control Plan – description
Reaction plan in case of nonconformance
Control method – eg. SPC card, first article control or number of procedure which describes the management of particular characteristic
Sampling frequency
Used measurement system (method, measurement tool, measurement jig etc.)
Control sample size
Specification for given product or process characteristic (from product documentation, material specification, norm, production instruction etc.)
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20. Control Plan - Example C Special Characteristic of process
Normal Characteristic of product
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21. 9. Measurement System Analysis Studies (MSA)
More information included in MSA reference manual
The statistical method that specifies how reproducible the measurement result is of given special characteristics and what the influence of the operator, and measurement device are on tested products with the overall result of the measurement
Operator
Measurement result
Measurement device
Product
The MSA element is R&R (Repeatability & Reproducibility) analysis (also called GR&R). Its purpose is to determine what is the influence of the operator and measuring device on the measured size. For calculation, relevant algorithms are used.
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22. MSA
The variability of the process (and the measured product) and its components.
The variability of the process
The real variability of the process
The variability of measurement
Long-term variability
Short-term variability
Variability within the samples
Influence of the operator
Influence of the measuring device
Repeatability
Precision
Stability
Linearity
Reproducibility
For these aspects we use R&R analysis
It is responsibility of the calibration
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23. MSA What does Reproducibility and Repeatability mean Reproducibility 23 4 5 6 1
Operator A B C
Readout 1
Readout 2
Repeatability
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24. R&R – Inspection Instructions
Complete the top section of the R&R worksheet
Enter the number of operators, trials, and samples
Enter the upper and lower specification limit
Assess MSA Trust Level.
Red: > 30% (fail)
Yellow: 10-30% (marginal)
Green: < 10% (pass)
Interpret results - are improvements required?
% Tolerance*
10%
30%
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25. 10. Dimensional Results
Standard Form, PPAP str. 29
Shall contain all dimensions marked on the drawing, characteristics and specifications for each individual process (with an accuracy of production line, form/mold, cavity etc. see PSW).
Quantity of samples which should be measured and production run size must be agreed with the Customer.
PPAP/2.1: Significant Production Run (1-8h, 300pcs min)
VDA2: Production run size shall be agreed with Customer taking into consideration type of a
product– this standard is practiced by Fideltronik
Customer can choose one of the submitted samples and approved (by signature or stamp) as Master Sample (see pt. 16. Master Sample)
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26. 11. Material, Performance, Test Results
Material Test Results
„The organization shall perform tests for all parts and product materials when chemical, physical, or
metallurgical requirements are specified by the design record or Control Plan. „
Standard Form, PPAP p. 31
E.g. Supplier Manual/ p.15 wires:
„The supplier shall additionally (if the specification does not explicitly quote other quality standards):
take samples of clamped cables and measure the stripping force of the clamp tips at start up, in progress and at the end of the clamping process. The measurements must be made for each type of clamped tips. Minimum stripping force is defined in the standard PN-EN „
Performance Test Results
„The organization shall perform tests for all part(s) or product material(s) when performance or functional requirements are specified by the design record or Control Plan. „
Standard Form, PPAP p. 33
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27. 12. Initial Process Study
The level of initial process capability or performance shall be determined to be acceptable prior to submission for all Special Characteristics designated by the customer or organization.
Where no special characteristics have been identified, the customer reserves the right to require demonstration of initial process capability on other characteristics
Initial process studies are short-term and will not predict the effects of time and variation in people, materials, methods, equipment, measurement systems, and environment.
PPAP, 4 e.:
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28. Index description in accordance to VDA 2:
How big sample size should be used for evaluating initial process study?
PPAP w.4:
For those characteristics that can be studied using X-bar and R charts, a short-term should be based on a minimum of 25 subgroups containing at least 100 readings from consecutive parts of the significant production run (see2.1)
More information in SPC reference manual.
Index description in accordance to VDA 2:
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29. Non-Critical features
Cpk indicator – in accordance to Fideltronik requirements
CPK - Process capability indicator.
An indicator of the extent to which a particular special characteristic meets the requirements in relation to the tolerance limits ( Specification of the Process or Product)
Nominal/ Target value X = 100
After collecting about 50 results, we can estimate how our process looks and we can calculate the indicator of process capability.
In accordance to Customer specification tolerance = 10%
The lower tolerances LSL = 90
Lower Control Limit
LCL
Upper
Control Limit
UCL
Target value X
The upper tolerances USL = 110
Index
Critical features
Non-Critical features
Red (Bad)
<1.33
<1.00
Yellow (Customer approval is needed)
Green (Good)
>1.67
>1.33
Upper tolerance
limit
USL
Lower tolerance
limit
LSL 3σ
100 cm
90 cm
110 cm
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30. 13. Qualified Laboratory Documentation
Material tests specified for the approved parts should be carried out by accredited laboratories. The Supplier shall provide the following:        - A copy of the certificate of accreditation of this laboratory and        - Measurement report which should include: name of the laboratory, the test date          the standard by which the test was made
If tests have not been done in an accredited laboratory supplier must provide the following: - List of competence and training of personnel to perform the test - A list of all test equipment used in the process - List of methods and standards used to calibrate devices
14. Appearance Approval Report (AAR), if applicable
Standard Form, PPAP p
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31. 15. Sample Product/ „reference samples” or „first samples/VDA2”
Delivered on Customer request together with measurement report (see p.10)
Produced under mass production conditions
PPAP/2.1: Significant Production Run (1-8h, 300pcs min)
VDA2: Production run size shell be agreed with Customer taking into consideration
type of a product. – this standard is practiced by Fideltronik
16. Master Sample
produced under mass production conditions, identified and approved by Customer
PPAP/2.2.15/ Master Sample
..”the master sample shall be identified as such, and shall show the customer approval date on the sample. The organization shall retain a master sample for each position of multiple cavity die, mold, tool or pattern, or production process unless otherwise specified by customer.”..
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32. 17. Checking Aids
Checking Aids - Checking aids can include fixtures, variable and attribute gages, models, templates, mylars specific to the product being submitted
The Supplier should:
-provide a list of checking aids and declare that they are compatible with the project requirements
-document all engineering changes implemented to checking aids at the time of submission
-provide a plan of checking aid inspection.
PPAP, 4.e:
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33. THE END
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