Ed van den Enden

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Ed van den Enden

• PPAP TRAINING
• Production Part Approval Process 4th Edition

PPAP WORKBOOK TRAINING Rev 6 dd 06/06/2014
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Its the goal of this lecture to

• to show you the basic content and the rules of
  the Production Part Approval Process
• and to explain the purpose and the background
• but this lecture will not save you from learning
  how to practically use this system

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Notes to this lecture

• this lecture was created for training purposes
  only
• it is not an extensive description, but
• a help for getting started
• view of contents, basic idea and goals
• The content of this lecture shall not be used as
  a reference for daily work
• Please make sure that you are working only with
  original latest level documents
• This lecture does not refer to customer specific
  requirements, nor to special PPAP
  rules/requirements for bulk materials, tires, nor
  truck industry!

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What is PPAP?

• Production Part Approval Process
• Standard used to formally reduce risks prior to
  product or service release, in a team oriented
  manner using well established tools and
  techniques
• Initially developed by AIAG (Auto Industry Action
  Group) in 1993 with input from the Big 3 - Ford,
  Chrysler, and GM
• AIAGs 4th edition effective June 1, 2006 is the
  most recent version
• PPAP is part of the Donaldson Supplier Business
  Operating Standard (S.B.O.S.S.)

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Content
1. Introduction 2. Content of the PPAP 1.
General 2. PPAP Process Requirements 3. Customer
Notification and Submission Requirements 4.
Submission to Customer - Levels of Evidence 5.
Part Submission Status 6. Record Retention 3.
Summary of the Process 4. The Documentation and
its Preparation 5. Summary 6. Internet Links
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1 Introduction

• it is the purpose of advanced quality management
  to prevent that unreliable designs or processes
  are used in serial production
• therefore it is necessary to have one extensive,
  strict approval process for new or changed
  designs or processes
• inevitably this process causes some
  administration work
• but its worth while because it reduces the
  production of muda!

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1 Introduction
Saving by taking advantage of the Rule Of The
10 The cost of the remedy of a defect
increases tenfold with every step, the project
advances!
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1 Introduction
Savings by avoiding the 71 muda
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1 Introduction
Savings by avoiding to high stock

• take space
• raise assets employed
• require additional searching
• require additional administration
• require additional transport
• are a risk, because parts might exceed expiration
  date or become unsaleable
• are a risk, because parts might be damaged
• complicate the overview
• are often a consequence of a weak process
• cover weak process

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1 Introduction
Requirements for Lower stock

• ? Controlled and capable processes
• ? Total Productive Maintenance
• since all kind of process problems will cause
  delivery stops, if the stocks are low!

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1 Introduction

• satisfied customers by good quality and avoided
  muda
• no scrap, no rework
• constant flow of material
• low stocks possible

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1 Introduction

• such an extensive and strict process is an
  obligatory requirement
• the name of this process is
• Production Part Approval Process

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2. Content of the PPAP
Customer specific requirements are not discussed
in this presentation for this please lookup
SharePoint chapter Customer Requirements
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Content
1. Introduction 2. Content of the PPAP 1.
General 2. PPAP Process Requirements 3. Customer
Notification and Submission Requirements 4.
Submission to Customer - Levels of Evidence 5.
Part Submission Status 6. Record Retention 3.
Summary of the Process 4. The Documentation and
its Preparation 5. Summary 6. Internet Links
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PPAP is, so to speak, the goal of APD

• APD (APQP) makes sure
• that all requirements are recognized before the
  Product Development is started
• that those special characteristics of the
  product are specified which influence these
  requirements
• that it is verified again and again that the
  planned design can safely meet these
  requirements, if the special characteristics are
  within tolerance
• that only those production processes are
  specified, which are controlled and capable
  according to SPC regarding these characteristics
• A Readiness Review and PPAP are used to validate
  that all processes are under control and capable
• the produced parts fulfil all requirements

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Purpose and Applicability

• It is the purpose of PPAP to
• define generic requirements for production part
  approval
• determine if all customer engineering design
  record and specification requirements are
  properly understood by the organization
• determine that the manufacturing process has the
  potential to produce the product consistently
  meeting these requirements during an actual
  production run at the quoted production rate
• Applicability
• PPAP shall apply to internal and external
  organization sites supplying production
  materials, sub assemblies or customer service
  parts.For bulk material and standard catalogue
  parts, PPAP is not required unless specified by
  the APD project-team or customer. Material
  certificates and dimensional reports are the
  minimum required documents .

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Submission of PPAP

• Before any supply to the customer the
  organization shall obtain full approval from the
  customer for
• Anny new serial part or serial product
• Correction of a discrepancy or any change on
  previously submitted parts or part processes.
• Product modified by an engineering change to
• design records
• specifications
• materials
• Any tool or equipment change or update.
• Note If there is any question concerning the
  need for PPAP, contact the authorized customer
  representative.

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Content
1. Introduction 2. Content of the PPAP 1.
General 2. PPAP Process Requirements 3. Customer
Notification and Submission Requirements 4.
Submission to Customer - Levels of Evidence 5.
Part Submission Status 6. Record Retention 3.
Summary of the Process 4. The Documentation and
its Preparation 5. Summary 6. Internet Links
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2. PPAP Process Requirements

• 2.1 Significant Production Run
• Products for PPAP shall be taken from a
  significant production run
• This production run shall be from one hour to
  eight hours of production, and with the specific
  production quantity to total of minimum of 300
  consecutive parts, unless otherwise specified by
  the authorized customer representative.
• This significant production run shall be
  conducted at the production, at the production
  rate, using the production tooling, production
  gaging, production process, production materials,
  and production operators.
• Parts from each unique production process, e.g.
  duplicate assembly line and/or work cell, each
  position of a multiple cavity die, mold, tool or
  pattern, shall be measured and representative
  parts tested

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2. PPAP Process Requirements

• 2.2 PPAP Requirements
• the supplier shall meet all specified
  requirements
• as listed in this handbook
• and all customer-specific requirements
• Production parts shall meet all customer
  engineering design record and specification
  requirements
• including safety and regulatory requirements
• If any part specification cannot be met, the
  organization shall document their problem-solving
  efforts and shall contact the authorized customer
  representative for concurrence in determination
  of appropriate corrective action.

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Content
1. Introduction 2. Content of the PPAP 1.
General 2. PPAP Process Requirements 3.
Submission to Customer - Levels of Evidence 4.
Part Submission Status 5. Record Retention 3.
Summary of the Process 4. The Documentation and
its Preparation 5. Summary 6. Internet Links
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3. Submission to Customer - Levels of
EvidenceThe organization shall submit the items
and/or records as specified
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 reviewed at the
organization's manufacturing location. Level 6
Customizable by Region based on circumstances.
Typically Warrant only unless noted by Donaldson
on the PSW. Used for Catalog and/or commercially
available product that may be of
supplier-propriety design, and also low-volume
limited runs.
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3. Submission to Customer - Levels of Evidence
PPAP Element Description Level 1 Level 2 Level 3 Level 4 Level 5
1. Design records Include a copy of the current approved revision drawing with all dimensions, specifications and notes bubbled (circle with corresponding number) for reference to dimensional report. R S S R
2. Engineering Change Documents A document that shows the detailed description of the change / ECO, if any. R S S R
3. Customer Engineering approval Not used with Donaldson submissions. Where specified by the customer, the organization shall have evidence of customer engineering approval. --- --- --- --- ---
4. Design FMEA A copy of the Design Failure Mode and Effect Analysis, if applicable. R R S R
5. Process Flow Diagrams A copy of the Process Flow, indicating all steps and sequence in the fabrication process, from receiving to shipping, steps must match with PFMEA and Control Plan steps. R R S R
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3. Submission to Customer - Levels of Evidence
PPAP Element Description Level 1 Level 2 Level 3 Level 4 Level 5
6. Process FMEA A copy of the Process Failure Mode and Effect Analysis. The PFMEA follows the Process Flow steps, and indicate "what could go wrong" during the fabrication and assembly of each component. Actions required for a) All RPN above 100 with severity 8, c)For RPN btw 100-150 need to be reviewed and preventive / corrective action taken R S S R
7. Control Plan Control Plan provides details on how the "potential issues" are checked in the incoming material, production process and during inspections of finished products, Control Plan must match the Flow Chart and P-FMEA steps. R R S R
8. Measurement System Analysis Studies Gage RR studies are required for Critical/ Significant Characteristics as defined in the Control Plan and/or Donaldson drawing. R R S R
9. Dimensional Results A list of the measurement results for all the characteristics and specifications noted on the ballooned drawing. R S S R
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3. Submission to Customer - Levels of Evidence
PPAP Element Description Level 1 Level 2 Level 3 Level 4 Level 5
10. Material Performance Test Results Records of material certifications and/or test results for test specified on the design record or Control Plan. R S S R
11. Initial Process Studies Process Capability Studies for the critical characteristics identified on the drawing. R R S R
12. Qualified Laboratory Documentation Copy of certifications of the laboratories that performed the tests and measurements reported. R S S R
13. Appearance Approval Report AAR, If a part is a designated appearance item, appearance compliance requirements will be identified via a special purchase order notification. S S S R
14. Sample Product The organization shall provide sample product as specified by Donaldson (typically 1-3 pieces). R S S R
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3. Submission to Customer - Levels of Evidence
PPAP Element Description Level 1 Level 2 Level 3 Level 4 Level 5
15. Master Sample The suppler shall retain an identified master sample for each position of a multiple cavity die, mold, tool or pattern. R R R R
16. Checking Aids When there are special tools for checking parts, this section shows a picture of the tool, design prints and calibration records, including dimensional report of the tool. R R R R
17. Records of Compliance With Customer Specific Requirements Not used with Donaldson submissions. Records of all applicable customer specific requirements. --- --- --- --- ---
18. PSW Upon completion of all PPAP requirements, the organization shall complete the Part Submission Warrant. S S S S R
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Content
1. Introduction 2. Content of the PPAP 1.
General 2. PPAP Process Requirements 3.
Submission to Customer - Levels of Evidence 4.
Part Submission Status 5. Record Retention 3.
Summary of the Process 4. The Documentation and
its Preparation 5. Summary 6. Internet Links
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4. Part Submission Status

• Approved
• The part meets all Donaldson requirements
• Supplier is authorized to ship production
  quantities of the part
• Interim Approval
• Donaldson permits shipment of part on a limited
  time and quantity clearly in writing defined.
• On Hold
• SQA needs more info
• Rejected
• The part does not meet Donaldson requirements,
  based on the production lot from which it was
  taken and/or accompanying documentation

Production quantities may not be
shipped before Donaldson / Customer
approval
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Content
1. Introduction 2. Content of the PPAP 1.
General 2. PPAP Process Requirements 3.
Submission to Customer - Levels of Evidence 4.
Part Submission Status 5. Record Retention 3.
Summary of the Process 4. The Documentation and
its Preparation 5. Summary 6. Internet Links
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5. Record Retention
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The start of using the PPAP workbook

• Safe the Workbook template as an Excel
  Workbook.File name Donaldson Part number
  followed by Donaldson Part rev number.E.g.
  P566611-rev8-( free suffix)
• Fill out the sheet PPAP Submission InfoTo do
  so, headers of other sheets are filled out
  automatically.
• Most of the fields can be filled out by the
  Donaldson PPAP team

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Electronic Submission Requirements

• Donaldson requires that all PPAPs be submitted
  electronically ? ppap.emea_at_donaldson.com
• Submission must be received on or prior to the
  PPAP due date
• Review and Approval Process
• Donaldson will attempt to review and provide
  feedback within 3 business days

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Donaldson PPAP book

• What is the Donaldson PPAP book?
• An Excel spreadsheet containing templates of the
  documents suppliers are required to submit to
  Donaldson.
• Organization formats are allowed as long these
  documents are providing the same. (Preferred
  language is English)
• Why use the PPAP book?
• Simplifies the process for suppliers by serving
  as a checklist of what needs to be submitted to
  Donaldson
• Reduces the number of files to manage
• Enables the SQA / PPAP team to quickly see if
  anything is missing

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Part Submission Warrant

• What is It?
• Document required for all newly tooled or revised
  products in which the supplier confirms that
  inspections and tests on production parts show
  conformance to Donaldson requirements

• Objective or Purpose
• Used to
• document part approval
• provide key information
• declare that the parts meet specification

• When to Use It
• Prior to shipping production parts

Have a closer look
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Part Submission Warrant
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Part Submission Warrant
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Part Submission Warrant
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Part Submission Warrant
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Part Submission Warrant

• Reviewers Checklist
• Must be completely filled out
• Must be signed by the supplier and customer
• Part Number must match the PO
• Submitted at the correct revision level
• Submitted at the correct submission level
• Specify the reason for submission
• Report the approval / Reject to the PPAP team and
  the APD team
• Upload to the central Supplier or Customer PPAP
  SharePoint Site by sending to ppap.emea_at_donaldson
  .com

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Authorized Engineering Change Documents

• The supplier shall provide authorized change
  documents for those changes not yet recorded in
  the design record, but incorporated in the
  product, part or tooling, such as
• ECNs (must be approved, not pending)
• Specifications (ECO)
• Feasibility studies
• Supplier change requests
• Sub-assembly drawings
• Life or reliability testing requirements

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Process Flow Diagram

• What is It?
• A visual diagram of the entire process from
  receiving through shipping, including outside
  processes and services

• When to Use It
• To understand how a process is done
• Prior to completing the PFMEA

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Process Flow Diagrams
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Process Flow Diagrams

• Reviewers Checklist
• 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

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Process FMEA (PFMEA) CORP QEHSDOC 014

• What is It?
• A tool used to identify and prioritize risk areas
  and their mitigation plans.

• Objective or Purpose
• 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.

• When to Use It
• After completion of the process flow diagram.
• Prior to tooling for production

IMPORTANT!
The PFMEA should be completed using a
cross-functional team!
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FMEA Origin

• Created by NASA following Apollo 1 mission
  failure
• Allows us to take a proactive approach to what
  can go wrong in a process and manage our risks
  better

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Process FMEA (PFMEA)
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PFMEA - Step 1

• TIPS
• There should be at least one failure mode for
  each input.

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PFMEA - Step 2

• TIPS
• There should be at least one failure effect for
  each failure mode.
• Effects should be specific, clear, and leave no
  doubt to the uninformed reviewer.

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PFMEA - Step 3

• TIPS
• There should be at least one potential cause for
  each failure mode.

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PFMEA - Step 4

• TIPS
• This step in the FMEA begins to identify initial
  shortcomings or gaps in the current control plan.
  
• If a procedure exists, enter the document number.
• If no current control exists, list as none.

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PFMEA - Step 5

• Assign Severity, Occurrence, and Detection ratings

Severity, Occurrence and Detection rating details
on next slide
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PFMEA - Definition of Terms

• Severity (of Effect)Severity of the effect on
  the Customer and other stakeholders (Higher Value
  Higher Severity)
• Occurrence (of Cause)Frequency with which a
  given Cause occurs and creates Failure Mode.
  (Higher Value Higher Probability of Occurrence)
• Detection (Capability of Current Controls) -
  ability of current Control scheme to detect the
  cause before creating the failure mode and/or the
  failure mode before suffering the effect (Higher
  Value Lower Ability to Detect)

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An Example of Rating Definitions
Severity Occurrence Detection
Hazardous without warning Very high and almost inevitable Cannot detect or detection with very low probability
Loss of primary function High repeated failures Remote or low chance of detection
Loss of secondary function Moderate failures Low detection probability
Minor defect Occasional failures Moderate detection probability
No effect Failure unlikely Almost certain detection
Rating
High 10
Low 1
If No Controls Exist, Detection 10
Referring too 4th Edition FMEA Manual and the
scales in Donaldson PPAP workbook.
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PFMEA - Step 6

• TIPS
• The RPN is used to prioritize the most critical
  risks identified in the first half of the FMEA.
• High RPNs (100 or above) are flags to take effort
  to reduce the calculated risk.
• Regardless of RPN, high Severity scores (gt8)
  should be given special attention.

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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.

• RPN Thresholds
• When using an RPN threshold, DO NOT forget to
  address high Severity scores

Pareto Chart
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PFMEA Remediation Guidelines

• SeverityCan only be improved by a design change
  to the product or process
• OccurrenceCan only be reduced by a change which
  removes or controls a cause. Examples are
  redundancy, substituting a more reliable
  component or function or mistake-proofing.
• DetectionCan be reduced by improving detection.
  Examples are mistake-proofing, simplification and
  statistically sound monitoring.

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FMEA Step 7

• Determine Actions Recommended to reduce High RPNs

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FMEA Steps 8 and 9

• Now recalculate your RPNs
• based on mitigation plans.

• TIPS
• Continue updating the actions taken and
  resulting RPNs until all risks are at an
  acceptable level (below 100).

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Summary Steps To Complete a FMEA

1. For each Process Input, determine the ways in
   which the Process Step can go wrong (these are
   Failure Modes).
2. For each Failure Mode associated with the inputs,
   determine Effects on the outputs.
3. Identify potential Causes of each Failure Mode.
4. List the Current Controls for each Cause.
5. Assign Severity, Occurrence and Detection ratings
   after creating a ratings key appropriate for your
   project.
6. Calculate RPN.
7. Determine Recommended Actions to reduce High
   RPNs.
8. Take appropriate Actions and Document.
9. Recalculate RPNs.
10. Revisit steps 7 and 8 until all the significant
    RPNs have been addressed.

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Tips and Lessons Learned
Process FMEA (PFMEA)

• Collaborative Effort Do not try alone, use a
  group
• Very comprehensive Time consuming process. Take
  necessary breaks.
• Action items are required for completion
• Train team ahead of time by explaining scoring
  criteria
• Proper preparation is needed for meetings
• Summarize often FMEA is a living document

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Process FMEA (PFMEA)

• Reviewers Checklist
• Verify there is a system for prioritizing risk of
  failure such as RPN numbers of 150 or above
• Make sure that high RPN process concerns are
  carried over into the control plan
• Make sure that all critical failure modes are
  addressed
• Safety
• Form, fit, function
• Material concerns

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Control Plan
NOTE
Since processes are expected to be continuously
updated and improved, the control plan is a
living document!
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Control Plan
Tool Interaction
Process Steps
New/Revised Process Steps
Risk Prioritized Process Steps
Process Steps
Improved Controls
New/Revised Process Steps
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Control Plan
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Control Plan
3 Distinct Phases
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Control Plan
Administrative Section
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Control Plan
Process, Machine/Tools, Characteristics
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Control Plan
Specifications, Measurement, Sample Size
Frequency
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Control Plan
Control Method, Reaction Plan
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Control Plan
Audit Plans

• Audit plans should be included in the control
  plan as a separate line.
• Auditing is an important tool for control.
• Process auditing should be a key element of the
  quality system of a business.
• Audits generally cover
• Effectiveness of controls
• Control plan (say) vs. what is actually done (do)
• Audits should be objective (done by internal or
  external third parties if possible).
• Audit frequencies should be based on balancing
  level of risk (FMEA) and cost.

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Control Plan
Reviewers Checklist

• Use process flow diagram and PFMEA to build the
  control plan keep them aligned
• Controls must be used to be effective. Keep it
  simple.
• Ensure that the control plan is in the document
  control system of the business.
• Good control plans address
• All testing requirements - dimensional, material,
  and performance
• All product and process characteristics at every
  step throughout the process
• An periodical Audit. (Audit Frequency indicated
  and data stamp for next Audit given!)
• The control method should be based on an
  effective analysis of the process
• Such as SPC, Error Proofing, Inspection, Sampling
  Plan
• Control plans should reference other
  documentation
• Specifications, tooling, etc.

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Measurement System Analysis (MSA) Gage RR
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Attribute and Variable MSA

• Attribute Data Examples
• Count, Pass/fail, yes/no, red/green/yellow,
  timekeeping buckets
• Variable Data Examples
• Physical measurement (length, width, area, )
• Physical conditions (temperature, pressure)
• Physical properties (strength, load, strain)
• Continuous or non-ending

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Measurement System Analysis (MSA)
Measurement System Variation
The observed variation in process output
measurements is not simply the variation in the
process itself it is the variation in the
process plus the variation in measurement that
results from an inadequate measurement system.
    
Observed Variation
Process Variation
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Measurement System Analysis (MSA)
Observed Variation
Measurement System Variation
Observed Variation
Process Variation
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Observed Variation
Measurement System Analysis (MSA)
Resolution
Precision (Variability)
Repeatability
Reproducibility
Measurement System Variation
Linearity
Accuracy (Central Location)
Observed Variation
Bias
Stability
Process Variation

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Observed Variation
Measurement System Analysis (MSA)
Resolution
Precision (Variability)
Repeatability
Reproducibility
Measurement System Variation
Linearity
Accuracy (Central Location)
Observed Variation
Bias
Stability
Calibration Addresses Accuracy
Process Variation

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Measurement System Analysis (MSA)
Resolution
Error in ResolutionThe inability to detect
small changes. Possible Cause Wrong measurement
device selected - divisions on scale not fine
enough to detect changes.
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Measurement System Analysis (MSA)
Repeatability
Error in RepeatabilityThe inability to get the
same answer from repeated measurements made of
the same item under absolutely identical
conditions. Possible Cause Lack of standard
operating procedures (SOP), lack of training,
measuring system variability.
Equipment Variation
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Measurement System Analysis (MSA)
Reproducibility
Error in ReproducibilityThe inability to get
the same answer from repeated measurements made
under various conditions from different
inspectors. Possible Cause Lack of SOP, lack of
training.
Appraiser Variation
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Variable MSA Gage RR Study

• Gage RR is the combined estimate of measurement
  system Repeatability and Reproducibility
• Typically, a 3-person study is performed
• Each person randomly measures 10 marked parts per
  trial
• Each person can perform up to 3 trials
• There are 3 key indicators
• EV or Equipment Variation
• AV or Appraiser Variation
• Overall GRR

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Donaldsons Gage RR Form
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Variable MSA Gage RR Steps

1. Select 10 items that represent the full range of
   long-term process variation.
2. Identify the appraisers.
3. If appropriate, calibrate the gage or verify that
   the last calibration date is valid.
4. Open the Gage RR worksheet in the PPAP book to
   record data.
5. Have each appraiser assess each part 3 times
   (trials first in order, second in reverse
   order, third random).
6. Input data into the Gage RR worksheet.
7. Enter the number of operators, trials, samples
   and specification limits
8. Analyze data in the Gage RR worksheet.
9. Assess MSA trust level.
10. Take actions for improvement if necessary.

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Steps 1 and 2 Variable MSA - Gage RR

• Select 10 items that represent
• the full range of long-term process
• variation.

• Identify the appraisers.
• Should use individuals that actually do the
  process being tested.
• Can also include other appraisers (supervisors,
  etc.).
• Should have a minimum of 3 appraisers.

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Steps 3 and 4 Variable MSA Gage RR

• If appropriate, calibrate the gage
• or verify that the last calibration
• date is valid.

Open the Gage RR worksheet in the PPAP book to
record the data
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Step 5 Variable MSA Gage RR

• Have each appraiser assess each item 3 times.
• Each appraiser has to work independently.
• Items should be evaluated in random order.
• After each appraiser completes the first
  evaluation of all items repeat the process at
  least 2 more times.
• Do not let the appraisers see any of the data
  during the test !!

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Steps 6 and 7 Variable MSA Gage RR

• Input data into the Gage RR worksheet

Enter the number of operators, trials, samples
and specification limits
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Steps 8 and 9 Variable MSA Gage RR

• Analyze data in the Gage RR worksheet

• Assess MSA Trust Level.
• Red gt 30 (fail)
• Yellow 10-30 (marginal)
• Green lt 10 (pass)

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Step 10 Variable MSA Gage RR

• If the Measurement System needs improvement
• Brainstorm with the team for improvement
  solutions.
• Determine best practical solution (may require
  some experimentation).
• Pilot the best solution (PDSA)
• Implement best solution train employees.
• Re-run the study to verify the improvement.

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Variable MSA Gage RR Example
Problem Statement

• The sulfuric acid concentration in process tank 8
  is measured at least once per day
• Additions/deletions of chemicals and decisions to
  shut down the process are dependent on these
  results.
• Based on current data, we need to do an MSA.

MSA Process
A Gage RR was conducted in order to validate
the process.

• MSA Parameters
• (3) Operators
• (3) Trials
• (10) Samples

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Variable MSA Gage RR Example
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Variable MSA Gage RR Example
Repeatability (EV) Equipment Variation
Reproducibility (AV) Appraiser Variation
Repeatability Reproducibility RR
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Tips and Lessons Learned

• Important An MSA is an analysis of the process,
  not an analysis of the people. If an MSA fails,
  the process failed.
• A Variable MSA provides more analysis capability
  than an Attribute MSA. For this and other
  reasons, always use variable data if possible.
• The involvement of people is the key to success.
• Involve the people that actually work the process
• Involve the supervision
• Involve the suppliers and customers of the
  process
• An MSA primarily addresses precision with limited
  accuracy information.

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MSA Gage RR
Reviewers Checklist

• If the gage/inspection affects quality, then
  conduct a Gage RR
• Make sure the study is recent - less than 1 year
• Compare the control plan gages against the Gage
  RRs
• If you question that gage, then
• Question the technique and part sampling
• Ask for additional studies

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Dimensional Results
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Donaldson Dimensional Report (Critical)
Automatically Calculates Cpk!
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Acceptance Criteria
Acceptance criteria for critical vs. non-critical
characteristics
Critical Non-Critical Decision
Red (Bad) lt1.33 lt1.00
Yellow (OK) 1.33-1.67 1.00-1.33
Green (Good) gt1.67 gt1.33
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Donaldson Dimensional Report Example
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Dimensional Results
Reviewers Checklist

• Thirty-five critical data points 5 non-critical
  data points are required for part qualification
• Critical and non-critical data points must be
  taken from the same 35-piece sample
• Five parts from a production run must be shipped
  to Donaldson for verification of form, fit, and
  function
• The same 5 parts will be used to verify both
  critical and non-critical dimensions
• Supplier must clearly identify which of the 35
  parts are being shipped
• Supplier should make every effort to ship 3 parts
  that represent both the low and high ends of the
  specifications for non-critical dimensions
• Capability must be greater than 1.67 for critical
  dimensions and greater than 1.33 for non-critical
  dimensions

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Records of Material/Performance Test Results

• Material Test Results
• The supplier shall perform tests for all parts
  and product materials when chemical, physical, or
  metallurgical requirements are specified by the
  design record or Control Plan
• For products with Donaldson-developed material
  specifications and/or an Donaldson-approved
  supplier list, the supplier shall procure
  materials and/or services from suppliers on that
  list
• Performance Test Results
• The supplier shall perform tests for all parts or
  product materials when performance or functional
  requirements are specified by the design record
  or Control Plan

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Material Results
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Module Test Results
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Qualified Laboratory Documentation

• Inspection and testing for PPAP shall be
  performed by a qualified laboratory as defined by
  Donaldson requirements (e.g., an accredited
  laboratory).
• The qualified laboratory (internal or external to
  the supplier) shall have a laboratory scope and
  documentation showing that the laboratory is
  qualified for the type of measurements or tests
  conducted
• When an external laboratory is used, the supplier
  shall submit the test results on the laboratory
  letterhead or the normal laboratory report format
• The name of the laboratory that performed the
  tests, the date(s) of the tests, and the
  standards used to run the tests shall be
  identified.

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Appearance Approval Report

• What is It?
• A report completed by the supplier containing
  appearance and color criteria

• When to Use It
• Prior to tooling for production

IMPORTANT!
Typically only applies for parts with color,
grain, or surface appearance requirements
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Appearance Approval Report
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Appearance Approval Report
Tristimulus data
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Sample Production Parts
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Sample Production Parts

• The sample parts provided should be the same
  parts measured for the dimensional results
• Default quantity for all submissions is 3 parts
  unless otherwise requested

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Sample Production Parts

• Sample production parts MUST be properly
  identified
• Include the following information on the part
  label
• Shipping date
• Donaldson part number
• Quantity submitted
• Supplier part number (optional)
• Donaldson Part name
• Carrier name
• Country of origin
• Tracking number
• Approval markings (UL, CE, etc.) where applicable

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Part Label Example
PPAP Workbook includes these PPAP samples
submission labels. Where applicable, fields get
filled out automatically by filling out the PPAP
submission sheet.
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PPAP Summary

• The Production Part Approval Process is an
  extensive approval process for new or changed
  designs or processes
• It is very formalized, so it inevitably causes
  some administrative work
• Later changes to the product or process can be
  expensive and time-consuming!

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PPAP to prevent loosing an opportunity for saving
costs