donaldson emea supplier quality assurance
DESCRIPTION
Donaldson EMEA Supplier Quality Assurance. PPAP TRAINING January 2013. CORP MAN 006 PPAP WORKBOOK TRAINING – Rev 5 – dd 03/04/2013. What is PPAP?. Production Part Approval Process - PowerPoint PPT PresentationTRANSCRIPT
Donaldson EMEA Supplier Quality Assurance
PPAP TRAINING
January 2013
CORP MAN 006 PPAP WORKBOOK TRAINING – Rev 5– dd 03/04/2013
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
• AIAG’s 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.)
Purpose of PPAP
• Provide evidence that all customer engineering design record and specification requirements are properly understood by the organization
• To demonstrate that the manufacturing process has the potential to produce product that consistently meets all requirements during an actual production run at the quoted production rate
PPAP manages change and ensures product conformance!
When is PPAP Required?New partEngineering change(s)Tooling: transfer, replacement, refurbishment, or additionalCorrection of discrepancyTooling inactive > one year (needs Cpk study)Change to optional construction or materialSub-supplier or material source changeChange in part processingParts produced at a new or additional location
PPAP is required with any significant change to product or
process!
Benefits of PPAP Submissions• Helps to maintain design integrity• Identifies issues early for resolution• Reduces warranty charges and prevents cost of poor quality• Assists with managing supplier changes• Prevents use of unapproved and nonconforming parts• Identifies suppliers that need more development• Improves the overall quality of the product & customer
satisfaction
DBV = online supplier monitoring● After a successful submitted and approved PPAP, part can be
supplied to the Donaldson organization● Each supply get’s monitored and deliveries are measured in ppm
and in % on-time● When defect parts are found, an NCR and 8D is executed● Monthly the DBV committee communicates supplier ranking● Yearly SQA management at headquarter organizes an supplier
PPM improvement event, based on a 6 months supplier base performance.
● Our purchase department has an active role encouraging our suppliers to be the best in class
Production Run
• PPAP data must be submitted from a production run using:
Production equipment and toolingProduction employeesProduction rateProduction process
All data reflects the actual production process to be used at
start-up!
Readiness Review (R-R)• The purpose of a R-R is to verify the supplier’s manufacturing
process is capable of producing components that meet Donaldson’s quality requirements, at quoted tooling capacity, for a specified period of time
• Verification of the R-R will be at the Supplier Quality Engineer’s (SQE) discretion. The supplier will be notified of the need to perform a R-R as early in the process as possible.
• The number of components to be produced during the R-R should be sufficient to demonstrate process capability and will be predetermined by the SQE and the supplier.
Factors such as product complexity, shelf life, storage, cost and single shift vs. multiple shift operations will be taken into consideration
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 Info”To do so, headers of other sheets are filled out automatically.
● Most of the fields are filled out by the Donaldson PPAP team
Submit
Submit
SubmitSubmitSubmit
RequiredSubmitSubmitSubmitSubmit
Submit
SubmitSubmit
Appearance approval Report
Design recordsAuthorized change documentsPart Dimensional approvalList of checking aidsPart Material approvalProcess Flow MapDesign and or Process FMEA
PPAP Level 5 Checklist
Sample partsMaster Sample (If applicable)Customer Engineering Approval Form
Control Plan
Process Capability Study, Cpk Calculation
Measuring System Study, Gage R&R
Please execute and show evidense of capabillity
Supplier PPAPRemarks
If designated appearance part, appearance compliance will be identified via a special purchase order notification.
Country
LEVEL 3Requirements
Part Submission Warrant
PPAP Assigned Quality EngineerSupplier NameSupplier Number
Postcode / Zip code
Phone Number
Street Address City
PPAP Submission
Part Name (DonaldsonPart Number (Donaldson)
Due Date
Revision (Donaldson)Revision date (Donaldson)Supplier Part Number (optional)
Supplier Contact
van den Enden, Ed:SCROLL to find the right level
Official PPAP Requirements1. Design Records2. Authorized Engineering Change Documents3. Customer Engineering Approval, if required4. Design Failure Modes and Effects Analysis (DFMEA) applied in special situations5. Process Flow Diagram6. Process Failure Modes and Effects Analysis (PFMEA)7. Control Plan8. Measurement Systems Analysis (MSA)9. Dimensional Results10. Records of Material / Performance Test Results11. Initial Process Studies12. Qualified Laboratory Documentation13. Appearance Approval Report (AAR)14. Sample Production Parts15. Master Sample16. Checking Aids17. Customer-Specific Requirements18. Part Submission Warrant (PSW)
Have a closer look
Donaldson’s PPAP Requirements
Supplier shall submit 12 items and retain a
copy of 12 + 2 (R) records at
appropriate locations
For PPAP Level 5, SQA will witness at supplier location and will fill out PPAP level 5 work sheet.
PPAP Submission Levels
Level 1 Production Warrant and Appearance Approval Report (if applicable) submitted to Donaldson
Level 2 Production Warrant, product samples, and dimensional results submitted to Donaldson
Level 3Production Warrant, product samples, and complete supporting data submitted to Donaldson
Level 4 Production Warrant and other requirements as defined by Donaldson
Level 5Production Warrant, product samples and complete supporting data (a review will be conducted at the supplier's manufacturing location)
PPAP Submission Level Table
S = Supplier shall submit to Donaldson & retain a copy of records or documentation items at appropriate locations
R = Supplier shall retain at appropriate locations
and make readily available to Donaldson
upon request
* = Supplier shall retain at appropriate
locations, and submit to Donaldson upon
request. Donaldson will identify what is needed
for submission.
Definition of Risk and PPAP level• High Risk
• Parts associated with multiple critical features, complex design, or high end technology that is not yet established in the general manufacturing environment
• Supplier’s quality system and/or quality performance is not to Donaldson satisfaction
• Medium Risk• Parts that have at least one critical feature
• Low Risk• Parts that have no critical features and can be manufactured by any
manufacturer in the commodity category • Supplier’s quality system and quality performance are acceptable
Submission Level Requirements• New Parts
• Level 2 is required for Low Risk Parts• Level 3 is required for Medium and High Risk Parts
• Part Changes
• Level 3 is required for Parts produced at a new or additional location• Supplier Quality Excellence will define the level required for all other
changes
Donaldson reserves the right to redefine the submission level required
PPAP StatusApproved- The part meets all Donaldson requirements- Supplier is authorized to ship production quantities of the partInterim Approval- Donaldson permits shipment of part on a limited time and quantity clearly in
writing defined.On Hold- SQA needs more infoRejected- 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 Approval
Electronic Submission Requirements• Donaldson requires that all PPAPs be submitted electronically
• Use of paper submission must have prior approval by the SQA
• 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
Donaldson requires all submissions to be electronic
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 DonaldsonReduces the number of files to manageEnables the SQA / PPAP team to quickly see if anything is
missing
Show PPAP book “CORP SQADOC 004”
Part Submission Part Submission Warrant Warrant
Part Submission WarrantWhat 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 PurposeUsed to :
• document part approval• provide key information• declare that the parts meet
specificationWhen to Use It• Prior to shipping production parts
Have a closer look
Part Submission Warrant
Donaldson Part NumberEngineering released finished end item part number
Safety and/or Government Regulation“Yes” if so indicated by the Design Record,otherwise “No”
Engineering Change Level & DateShow the change level and date of the Design Record
Additional Engineering ChangesList all authorized Engineering changes not yet incorporated in the design record but which are incorporated in the part
Shown on Drawing NumberThe design record that specifies the customer part number being submitted
Checking Aid Number, Change Level, & DateEnter if requested by the customer
Purchase Order NumberEnter this number as found on the contract / purchase order
Product weightEnter the product weight
Part Submission Warrant
Donaldson LocationShow the location where parts will be shipped toBuyer / Buyer Code
Enter the buyer’s name and code
Restricted SubstancesEnter “Yes” or “No”
Model Name / NumberEnter the model nameand number
Parts Identified with Appropriate Marking CodesULUL = Underwriters Laboratories safety standardsCECE = Conformite Europeenne (European Conformity) –Certifies that a product has met European consumerSafety, health, or environmental requirementsISO = International Organization for StandardizationEnter “Yes” or “No”
Supplier Manufacturing InformationShow the name and code assigned tothe manufacturing site on the purchase order / contract
Part Submission WarrantReason For SubmissionCheck the appropriate box(es)
Requested Submission LevelIdentify the submission levelrequested by Donaldson
Submission ResultsCheck the appropriate boxes
Mold / Cavity / Production ProcessIf production parts will be produced from more than one mold, cavity, tool, die, pattern, or production process, the supplier shall complete a dimensional evaluation onone part from each. The specific molds,lines, etc. shall then be identified here.
Part Submission Warrant
The approved Production Warrant officially warrants the parts ready for production
DeclarationEnter the number of pieces manufactured during the significant production run and the time (in hours) takenfor the significant production run
Explanation / CommentsProvide any explanatory comments on thesubmission results or any deviationsfrom the Declaration. Attach additionalinformation as appropriate.
Supplier Authorized SignatureA responsible supplier official, after verifying that the results show conformance to all Donaldsonrequirements and that all required documentationis available, shall approve the declaration
For Donaldson Use OnlyTo be completed by appropriateDonaldson Supplier Quality Engineer
DeclarationAffirmation that the samples represented by the warrant are representative and were made by a process that meets Donaldson’s PPAP requirements
PPAP Warrant DispositionApproved, Rejected, OtherDonaldson Signature
Signed by Donaldson Supplier Quality Engineer
Part Submission Warrant
●Reviewers ChecklistMust be completely filled outMust be signed by the supplierPart Number must match the POSubmitted at the correct revision levelSubmitted at the correct submission levelSpecify the reason for submissionReport the approval / Reject to the PPAP team and the
APD team
AUTHORIZED ENGINEERING AUTHORIZED ENGINEERING CHANGE DOCUMENTS CHANGE DOCUMENTS
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 studiesSupplier change requestsSub-assembly drawingsLife or reliability testing requirements
PROCESS FLOW DIAGRAM PROCESS FLOW DIAGRAM
Process Flow DiagramWhat is It?• A visual diagram of the entire
process from receiving through shipping, including outside processes and services
• To help people “see” the real process. Process maps can be used to understand the following characteristics of a process:
• Set-by-step process linkage• Offline activities (measurement,
inspection, handling)• Rework, scrap
Objective or Purpose
When to Use It• To understand how a process is
done• Prior to completing the PFMEA
OperatorGet Traveler andNest from Holding
Shelf(26)
OperatorPrints Cut Tags
(27)
OperatorLoad Machine with
Blanket(28)
OperatorDownload Cutting
Infomation(2s to 2m)
(29)
OperatorProgram
Command"Ready to Cut"
(30)
OperatorObserve Cutting
Operation forErrors(32)
Cutting Error?(33)
OperatorSeparate Cutting
Tags(31)
OperatorCutting Operation
Complete(34)
Large or Small Pliesor Test Coupons?
(35)
OperatorTag while Laying
on the CuttingTable(39)
OperatorRemove SmallPlies from theCutting Table
(36)
OperatorMove to Kitting
Table(37)
Small Plies
LargePiies
AndCoupons
OperatorRemove Plies
from the CuttingTable(40)
OperatorTag Small Plies
(38)
OperatorMove Plies toKitting Table
(41)
Yes
Evaluate forCorrective Action
OperatorStamp Traveler
(43)
TravelerComplete?
(42)
Yes
No
No
Project Idea
Fill Out MasterForm
with InitialInformation
Is HardSavings > $???
Does theProject Involve
Only YourGroup?
Does theProject Involve
>3 Depts.outside Eng?
Does theProject Involve>2 Groups in
Eng?
Do youhave BB/GB toAssist/Work the
project?
Prefer to workthis projectwithin your
area?
6 SigmaProject
Departmentor GroupProject
Yes
No
Yes
No
Yes
No
No
No
Yes
Yes
Yes No
Enter RemainingInformation onMaster Form
Master Form WillGenerateContract
Finance Approvaland Signature
Other RequiredSignatures:
Segment CEOChampion
Process OwnerBB or GB
6 Sigma AssignsProject NumberGet WO Assigned
Begin/WorkProject
Follow DMAIC orDFSS process
Monitor Progressthrough PowerSteering and
MonthlyFinancialReviews
Complete Project(Has to be fully
Documented
Finance Approvaland Signature
Other RequiredSignatures:
Champion: Dir T&EProcess OwnerProject Owner
Dept BB or MBB
Enter RemainingInformation onMaster Form
Master Form WillGenerateContract
Finance Approvaland Signature
Other RequiredSignatures:Champion:
Process OwnerProject Owner
Dept GB/BB/MBB
Group AssignsProject Number
Get DLNAssigned
Monitor Progressthrough Bi-
Weekly Updatesand Monthly
Reviews
Begin/WorkProject
Follow DMAIC orDFSS process
Complete Project(Has to be fullyDocumented)
Finance Approvaland Signature
Other RequiredSignatures:
Champion: Dir T&EProcess OwnerProject Owner
Dept BB or MBB
Complete allDocumentation
including a(1) Page Close-
out Sheet
CloseProject
Complete allDocumentation
including a(1) Page Close-
out Sheet
Final ProjectReview
CloseProject
Final ProjectReview
6 Sigma ProjectHigh Level Process Map
Department/Group ProjectHigh Level Process Map
Process Flow Diagrams
Process Flow Diagrams
●Reviewers ChecklistProcess Flow must identify each step in the processShould include abnormal handling processes
ScrapRework
Process Flow must include all phases of the processReceiving of raw materialPart manufacturingOffline inspections and checksAssemblyShipping
PROCESS FMEA PROCESS FMEA
Process FMEA (PFMEA) CORP QEHSDOC 014
When to Use It• After completion of the process
flow diagram.• Prior to tooling for production
Failure Mode and Effects Analysis(Design FMEA) FMEA Number:
Page ofSystem/Component: Prepared by:
FMEA Date (Orig.) (Rev.)Core Team:
ActionsTakenSev
Occur
Detec
R.P.N.
Design Responsibility:
Action ResultsOccur
Current Design Controls
Prevention
Current Design Controls Detection
Detec
R.P.N.
Recomm ended Action(s)
Responsibility & Target Completion
Date
Potential Cause(s)/Mechanism(s) of
Failure
Item / Process
Function
Potential Failure Mode
Potential Effect(s) of Failure
Sev
What is It?• A tool used to identify and prioritize
risk areas and their mitigation plans.
The PFMEA should be completed using a cross-functional team!
IMPORTANT!
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.
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
Process FMEA (PFMEA)
This is included in the PPAP book!
Spray head clogged: - Viscosity too high- Temp too low- Pressure too low
5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads
5 175
Detec
R.P
.N.
Class
Potential Cause(s)/
Mechanism(s) of Failure
Occur
Current Process ControlsProcess Step Potential Failure
Mode
Potential Effect(s) of
Failure
Sev
280Allows integrity breach of inner
door panel
Corroded interior lower door
panels
Deteriorated life of door leading
to: - Unsatisfactory appearance due to rust through paint over time
- Impaired function of
interior door hardware
Insufficient wax coverage over
specified surface
Op 70: Manual application of
wax inside door panel
7 Manually inserted spray
head not inserter far
enough
Variables check for film
thickness; Visual check for coverage
58
PFMEA - Step 1
TIPS• There should be at least one failure mode for each input.
Using the completed Process Flow Diagram, enter the process step.
Failure ModesFor each Process Input, determine the ways in which the input can gowrong.
Spray head clogged: - Viscosity too high- Temp too low- Pressure too low
5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads
5 175
Detec
R.P
.N.
Class
Potential Cause(s)/
Mechanism(s) of Failure
Occur
Current Process ControlsProcess Step Potential Failure
Mode
Potential Effect(s) of
Failure
Sev
280Allows integrity breach of inner
door panel
Corroded interior lower door
panels
Deteriorated life of door leading
to: - Unsatisfactory appearance due to rust through paint over time
- Impaired function of
interior door hardware
Insufficient wax coverage over
specified surface
Op 70: Manual application of
wax inside door panel
7 Manually inserted spray
head not inserter far
enough
Variables check for film
thickness; Visual check for coverage
58
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.
Potential Failure EffectsFor each Failure Mode, determine what effectthe specific failure could have on the process output.
Spray head clogged: - Viscosity too high- Temp too low- Pressure too low
5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads
5 175
280Allows integrity breach of inner
door panel
Corroded interior lower door
panels
Deteriorated life of door leading
to: - Unsatisfactory appearance due to rust through paint over time
- Impaired function of
interior door hardware
Insufficient wax coverage over
specified surface
Op 70: Manual application of
wax inside door panel
7 Manually inserted spray
head not inserted far
enough
Variables check for film
thickness; Visual check for coverage
58
Occur
Current Process ControlsProcess Step Potential Failure
Mode
Potential Effect(s) of
Failure
Sev
Detec
R.P
.N.
Class
Potential Cause(s)/
Mechanism(s) of Failure
PFMEA - Step 3
TIPS• There should be at least one potential cause for each failure mode.
Potential CausesFor each Failure Mode, determine the possible cause of the failure.
Spray head clogged: - Viscosity too high- Temp too low- Pressure too low
5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads
5 175
Detec
R.P
.N.
Class
Potential Cause(s)/
Mechanism(s) of Failure
Occur
Current Process ControlsProcess Step Potential Failure
Mode
Potential Effect(s) of
Failure
Sev
280Allows integrity breach of inner
door panel
Corroded interior lower door
panels
Deteriorated life of door leading
to: - Unsatisfactory appearance due to rust through paint over time
- Impaired function of
interior door hardware
Insufficient wax coverage over
specified surface
Op 70: Manual application of
wax inside door panel
7 Manually inserted spray
head not inserter far
enough
Variables check for film
thickness; Visual check for coverage
58
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.”
Current ControlsFor each potentialcause, list the currentmethod used for preventing or detectingfailure.
PFMEA - Step 4
Spray head clogged: - Viscosity too high- Temp too low- Pressure too low
5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads
5 175
Detec
R.P
.N.
Class
Potential Cause(s)/
Mechanism(s) of Failure
Occur
Current Process ControlsProcess Step Potential Failure
Mode
Potential Effect(s) of
Failure
Sev
280Allows integrity breach of inner
door panel
Corroded interior lower door
panels
Deteriorated life of door leading
to: - Unsatisfactory appearance due to rust through paint over time
- Impaired function of
interior door hardware
Insufficient wax coverage over
specified surface
Op 70: Manual application of
wax inside door panel
7 Manually inserted spray
head not inserter far
enough
Variables check for film
thickness; Visual check for coverage
58
PFMEA - Step 5● Assign Severity, Occurrence, and Detection ratings
Assign Severity(How serious is the effect if it fails?)
Assign Occurrence(How likely is the cause to occur?)
Assign Detection(How easily can the cause or failure mode be detected?)
Severity, Occurrence and Detection rating details on next slide
PFMEA - Definition of Terms
● SeveritySeverity (of Effect)SSeverity of the effect on the Customer and other stakeholders (Higher Value = Higher Severity)
● Occurrence Occurrence (of Cause)Frequency with which a given Cause occurs and creates Failure Mode. ((Higher Value = Higher Probability of Occurrence))
● DetectionDetection (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))
Caution: Notice the scale difference for DetectionDetection!
High 10
Low 1
Rating Severity Occurrence Detection*Hazardous
without warning
Very high and almost
inevitable
Cannot detect or detection with very low
probabilityLoss of primary
functionHigh repeated
failuresRemote or low
chance of detection
Loss of secondary function
Moderate failures
Low detection probability
Minor defect Occasional failures
Moderate detection
probabilityNo effect Failure unlikely Almost certain
detection*If No Controls Exist, Detection = 10
Referring too 4th Edition FMEA Manualand the scales in Donaldson PPAP workbook.
An Example of Rating Definitions
Spray head clogged: - Viscosity too high- Temp too low- Pressure too low
5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads
5 175
Detec
R.P
.N.
Class
Potential Cause(s)/
Mechanism(s) of Failure
Occur
Current Process ControlsProcess Step Potential Failure
Mode
Potential Effect(s) of
Failure
Sev
280Allows integrity breach of inner
door panel
Corroded interior lower door
panels
Deteriorated life of door leading
to: - Unsatisfactory appearance due to rust through paint over time
- Impaired function of
interior door hardware
Insufficient wax coverage over
specified surface
Op 70: Manual application of
wax inside door panel
7 Manually inserted spray
head not inserter far
enough
Variables check for film
thickness; Visual check for coverage
58
TIPS
• The RPN is used to prioritize the most critical risks identified in the first half of the FMEA.
• High RPNs (150 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.
Calculate the Risk Priority Number RPNRPN = Severity x Occurrence x Detection
PFMEA - Step 6
• 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 scoresOthers
490150 75 9350 70 50 25 30250300 15
3 2 2 2 2 4 4 4 4 6 8 910 5 3 3 3 3 7 7 7 710131517
100 95 92 88 85 82 75 68 62 55 45 32 17
60
50
40
30
20
10
0
100
80
60
40
20
0
Defect
CountPercentCum %
Per
cent
Cou
nt
Pareto Chart for RPN
Pareto Chart
?How many items should be the focus of the next steps?
Sort by RPN to determinethe most significant failure modes
Analyzing the PFMEA
PFMEA – Remediation Guidelines● SeveritySeverity
Can only be improved by a design change to the product or process
● OccurrenceOccurrenceCan 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.
● DetectionDetectionCan be reduced by improving detection. Examples are mistake-proofing, simplification and statistically sound monitoring.
In general, reducing the Occurrence is preferable to improving the Detection
Actions Taken
Sev
Occ
Det
R.P
.N.
Add positive depth stop to sprayer
Mfg. Eng. By 5/10/10
Stop added, sprayer checked on-line
Automate spraying
Mfg. Eng. By 5/25/10
Rejected due to complexity of different doors on the same line
175 Use DOE on viscosity vs. temp vs. pressure
Mfg. Eng. By 5/31/10
Temp and press limits were determined and limit controls have been installed - Control charts show process is in control Cpk = 1.85
7 1 5 35
Action ResultsR.P
.N.
Recommended Actions
Responsibility & Target DateProcess Step Potential Failure
Mode
Potential Effect(s) of
Failure
280Allows integrity breach of inner
door panel
Corroded interior lower door
panels
Deteriorated life of door leading
to: - Unsatisfactory appearance due to rust through paint over time
- Impaired function of
interior door hardware
Insufficient wax coverage over
specified surface
Op 70: Manual application of
wax inside door panel
7 2 5 70
FMEA – Step 7• Determine Actions Recommended to reduce High RPNs
For the high RPN numbers, determine the recommended actions.
Actions TakenS
ev
Occ
Det
R.P
.N.
Add positive depth stop to sprayer
Mfg. Eng. By 5/10/10
Stop added, sprayer checked on-line
Automate spraying
Mfg. Eng. By 5/25/10
Rejected due to complexity of different doors on the same line
175 Use DOE on viscosity vs. temp vs. pressure
Mfg. Eng. By 5/31/10
Temp and press limits were determined and limit controls have been installed - Control charts show process is in control Cpk = 1.85
7 1 5 35
Action ResultsR.P
.N.
Recommended Actions
Responsibility & Target DateProcess Step Potential Failure
Mode
Potential Effect(s) of
Failure
280Allows integrity breach of inner
door panel
Corroded interior lower door
panels
Deteriorated life of door leading
to: - Unsatisfactory appearance due to rust through paint over time
- Impaired function of
interior door hardware
Insufficient wax coverage over
specified surface
Op 70: Manual application of
wax inside door panel
7 2 5 70
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).
Resp (responsibility)Assign a specific person who will be responsible for recommended actions.
Actions TakenAs actions are identified and completed, document in the “Actions Taken” column.
SEV, OCC, DET, RPNAs actions are complete reassess Severity, Occurrence, and Detection and recalculate RPN.
Summary Steps To Complete a FMEA1. 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.
Tips and Lessons Learned
• 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
Process FMEA (PFMEA)
Process FMEA (PFMEA) ●Reviewers ChecklistVerify there is a system for prioritizing risk of failure such as RPN
numbers of 150 or aboveMake sure that high RPN process concerns are carried over into the
control planMake sure that all critical failure modes are addressed
SafetyForm, fit, functionMaterial concerns
CONTROL PLAN CONTROL PLAN
Control Plan
A document that describes how to control the critical inputs to continue to meet customer expectations of the output.
What is It?
Objective or Purpose• Primary reference source for
minimizing process and product variation.
• Description of how teams should react to out-of-control situations.
Since processes are expected to be continuously updated and improved, the control plan
is a living document!
NOTEWhen to Use It
• Implementation of new process• Following a process change
Process Steps
New/Revised Process Steps
Project Idea
Fill Out MasterForm
with InitialInformation
Is HardSavings > $???
Does theProject Involve
Only YourGroup?
Does theProject Involve
>3 Depts.outside Eng?
Does theProject Involve>2 Groups in
Eng?
Do youhave BB/GB toAssist/Work the
project?
Prefer to workthis projectwithin your
area?
6 SigmaProject
Departmentor GroupProject
Yes
No
Yes
No
Yes
No
No
No
Yes
Yes
Yes No
Enter RemainingInformation onMaster Form
Master Form WillGenerateContract
Finance Approvaland Signature
Other RequiredSignatures:
Segment CEOChampion
Process OwnerBB or GB
6 Sigma AssignsProject NumberGet WO Assigned
Begin/WorkProject
Follow DMAIC orDFSS process
Monitor Progressthrough PowerSteering and
MonthlyFinancialReviews
Complete Project(Has to be fully
Documented
Finance Approvaland Signature
Other RequiredSignatures:
Champion: Dir T&EProcess OwnerProject Owner
Dept BB or MBB
Enter RemainingInformation onMaster Form
Master Form WillGenerateContract
Finance Approvaland Signature
Other RequiredSignatures:Champion:
Process OwnerProject Owner
Dept GB/BB/MBB
Group AssignsProject Number
Get DLNAssigned
Monitor Progressthrough Bi-
Weekly Updatesand Monthly
Reviews
Begin/WorkProject
Follow DMAIC orDFSS process
Complete Project(Has to be fullyDocumented)
Finance Approvaland Signature
Other RequiredSignatures:
Champion: Dir T&EProcess OwnerProject Owner
Dept BB or MBB
Complete allDocumentation
including a(1) Page Close-
out Sheet
CloseProject
Complete allDocumentation
including a(1) Page Close-
out Sheet
Final ProjectReview
CloseProject
Final ProjectReview
6 Sigma ProjectHigh Level Process Map
Department/Group ProjectHigh Level Process Map
Process FlowchartProcess Flowchart
New/Revised
Process Steps
Process Steps
Process StepKey
Process Input
Potential Failure Mode
Potential Failure Effects
SEV
Potential CausesOCC
Current ControlsDET
RPN
EOC
Actions Recommended Resp. Actions Taken
Receive Payment
Checks Delay internal mail
AR balance does not go down
7
Inadequate staffing in mail room 7
None
10 490
Investigate mail room staffing and associated processes
G. Lee
7 1 10 70
Identify Customer
Wire Transfer reference line
Information not supplied
AR balance is past due
10
Customer or bank did not include name and/or account info on wire transfer
5
Acct identifies problem when trying to apply payment
5 250
Poka-Yoke wire transer process
N. Peart
10 1 3 30
Identify Invoice Checks Incorrect invoice supplied
Invoice shows outstanding (AR balance does go down)
5
Customer error
5
Customer might catch it when reviewing the next statement 10 250
Provide payment stub with statement for each invoice
A. Lifeson
5 1 5 25
Identify Invoice Checks Invoice number not supplied
Invoice shows outstanding (AR balance does go down)
5
Customer error
10
Acct identifies problem when trying to apply payment 5 250
Provide payment stub with statement for each invoice
S. Hagar
5 1 5 25
Process FMEAProcess FMEA
Risk Prio
ritize
d
Process
Steps
Improv
ed
Contro
ls
Control PlanControl Plan
Tool Interaction
Control Plan
Control Plan
This is included in the PPAP book!
Control Plan
3 Distinct Phases1. Prototype – a description of the
dimensional measurements and material and performance tests that will occur during Prototype build.
3 Distinct Phases
3 Distinct Phases2. Pre-Launch – a description of the
dimensional measurements and material and performance tests that will occur after Prototype and before full Production.
3 Distinct Phases3. Production – a comprehensive
documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production
Control Plan
Administrative SectionIdentifies part number and description, supplier, required approval signatures,
and dates.
Administrative Section
Control Plan
Part/ProcessUse this area to define
part/process number and description.
Machine/ToolsList the machine, device, jig, or tools
that will be used in the manufacturing process
CharacteristicsDefine the characteristics of the product or process
Process, Machine/Tools, Characteristics
Control Plan
Specifications/ToleranceUse this area to define upper/lower
spec limits for each control element.
Measurement TechniqueFor each line in the control plan, list the measurement procedure that will be used (may list R&R Gage Plan or Poka-Yoke).
Sample SizeWhat is the size of the
sample you should gather data from?
FrequencyDefine the frequency for which the measurement
will be taken.
Specifications, Measurement, Sample Size & Frequency
Control Plan
Control MethodMethod that will be used
to control the process
Reaction PlanActions to be taken if
controls fail
Control Method, Reaction Plan
Control Plan
• 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 controlsControl 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.
Audit Plans
Control Plan
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 performanceAll product and process characteristics at every step throughout the processAn periodical Audit. (Audit Frequency indicated and data stamp for next Audit given!)
The control method should be based on an effective analysis of the processSuch as SPC, Error Proofing, Inspection, Sampling Plan
Control plans should reference other documentationSpecifications, tooling, etc.
Reviewer’s Checklist
MEASUREMENT SYSTEM MEASUREMENT SYSTEM ANALYSIS (MSA) ANALYSIS (MSA)
Measurement System Analysis (MSA) Gage R&R
An G R&R is a statistical tool used to determine if a measurement system is capable of precise measurement.
What is It?
Objective or Purpose• To determine how much error is in
the measurement due to the measurement process itself.
• Quantifies the variability added by the measurement system.
• Applicable to attribute data and variable data.
When to Use It• On the critical inputs and outputs
prior to collecting data for analysis.• For any new or modified process in
order to ensure the quality of the data.
Measurement System Analysis is an analysis of the measurement process, not an analysis of the people!!
IMPORTANT!Who Should be InvolvedEveryone that measures and makes decisions about these measurements should be involved in the MSA.
– AttributeAttribute Data Examples: Count, Pass/fail, yes/no, red/green/yellow,
timekeeping buckets
– VariableVariable Data Examples: Physical measurement (length, width, area, …) Physical conditions (temperature, pressure…) Physical properties (strength, load, strain…) Continuous or non-ending
Attribute and Variable MSA
Unless approved by an Donaldson SQA, attribute data is not acceptable for PPAP submission
Measurement System Analysis (MSA)
Process Variation
Measurement System Variation
Observed 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.
Conducting an MSA reduces the likelihood of passing a bad part or rejecting a good part
Measurement System Analysis (MSA)
Process Variation
Measurement System Variation
Observed Variation
The output of the process measured by:
• Cycle time• Dimensional data• Number of defects and others
Observed Variation
Observed Variation
Process Variatio
n
Measurement System Variation
Reproducibility
Precision(Variability)
Linearity
Bias
Stability
Resolution
Repeatability
Accuracy(Central Location)
Observed Variation
Calibration addresses accuracy
Measurement System Analysis (MSA)
Observed Variation
Observed Variation
Process Variatio
n
Measurement System Variation
Precision(Variability)
LinearityBias
Stability
Resolution
Repeatability
Reproducibility
Accuracy
(Central Location)
Calibration Addresses AccuracyLet’s take a closer look
at Precision
Measurement System Analysis (MSA)
Measurement System Analysis (MSA)
Error in ResolutionThe inability to detect small changes.
Possible Cause Wrong measurement device selected - divisions on scale not fine enough to detect changes.
Resolution
Measurement System Analysis (MSA)
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.
Repeatability
Equipment Equipment VariationVariation
Measurement System Analysis (MSA)
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.
Reproducibility
Appraiser Appraiser VariationVariation
Variable MSA – Gage R&R Study
• Gage R&R is the combined estimate of measurement system RepeatabilityRepeatability and ReproducibilityReproducibility
• Typically, a 3-person study is performedEach person randomly measures 10 marked parts per
trialEach person can perform up to 3 trials
• There are 3 key indicatorsEVEV or Equipment VariationAVAV or Appraiser VariationOverall % GRR% GRR
Donaldson’s Gage R&R Form
Included in PPAP Playbook!
Automatically calculates EV, AV, and % GRR!
Variable MSA – Gage R&R 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 R&R 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 R&R worksheet.7. Enter the number of operators, trials, samples and specification limits8. Analyze data in the Gage R&R worksheet.9. Assess MSA trust level.10. Take actions for improvement if necessary.
Step 1 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10Step 2
Steps 1 and 2: Variable MSA - Gage R&R
Select 10 items that representthe full range of long-term processvariation.
Step 1
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.
Step 2
Steps 3 and 4: Variable MSA – Gage R&R
If appropriate, calibrate the gageor verify that the last calibrationdate is valid.
Step 3
Open the Gage R&R worksheet in the
PPAP book to record the dataStep 4
Step 5: Variable MSA – Gage R&R
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 !!
Step 5
Steps 6 and 7: Variable MSA – Gage R&R
Input data into the Gage R&R worksheet
Enter the number of operators, trials, samples and specification limits
Step 6
Step 7
Steps 8 and 9: Variable MSA – Gage R&R
Analyze data in the Gage R&R worksheet
Assess MSA Trust Level.
– Red:Red: > 30% (fail)
– Yellow:Yellow: 10-30% (marginal)
– Green:Green: < 10% (pass)
Step 9
Step 8
% Tolerance*
10%30%
Step 10: Variable MSA – Gage R&R
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.
Step 10
MSA Parameters» (3) Operators» (3) Trials» (10) Samples
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.
A Gage R&R was conducted in order to validate the process.
MSA Process
Variable MSA – Gage R&R Example
Selected 10 samples to be measured
Chose 3 operators to be appraisers
Had each appraiser measure each
sample 3 times
Results calculated automatically
Entered the number of operators, trials,
and samples
Entered upper and lower process
specification limits
Variable MSA – Gage R&R Example
Variable MSA – Gage R&R Example
Repeatability = (EV) Equipment VariationReproducibility = (AV)
Appraiser VariationRepeatability & Reproducibility = R&R
% Tolerance*
10%30%
% Tolerance is > 30% MSA fails!
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 processInvolve the supervisionInvolve the suppliers and customers of the process
An MSA primarily addresses precision with limited accuracy information.
Tips and Lessons Learned
MSA – Gage R&R
If the gage/inspection affects quality, then conduct a Gage R&RMake sure the study is recent - less than 1 yearCompare the control plan gages against the Gage R&RsIf you question that gage, then
−Question the technique and part sampling−Ask for additional studies
Reviewer’s Checklist
DIMENSIONAL RESULTS DIMENSIONAL RESULTS
Dimensional Results
Evidence that dimensional verifications have been completed and results indicate compliance with specified requirements.
What is It?
Objective or Purpose• To show conformance to the
customer part print on dimensions and all other noted requirements.
When to Use It• For each unique manufacturing
process (e.g., cells or production lines and all molds, patters, or dies
Donaldson Dimensional Report (Critical)
Requires 35 data pointsRequires 35 data points
CpkCpk must be greater than or equal to 1.671.67
This is included in the PPAP book!
AutomaticallyCalculates Cpk!
Acceptance Criteria
Critical Non-Critical DecisionRed (Bad) <1.33 <1.00Yellow (OK) 1.33-1.67 1.00-1.33
Green (Good) >1.67 >1.33
Acceptance criteria for critical vs. non-critical characteristics
CpkCpk must be greater than or equal to 1.67 for 1.67 for criticalcritical
processesprocessesCpkCpk must be greater than or equal to 1.33 for 1.33 for non-criticalnon-critical
processesprocesses
Donaldson Dimensional Report Example
Nominal ValueTolerance Sample Data Cp & Cpk CalculationsPass / Fail
CpkCpk > 1.33 for all 1.33 for all non-criticalnon-critical dimensions = Pass!dimensions = Pass!
Dimensional Results
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 sampleFive parts from a production run must be shipped to Donaldson for verification of
form, fit, and functionThe same 5 parts will be used to verify both critical and non-critical dimensionsSupplier must clearly identify which of the 35 parts are being shippedSupplier should make every effort to ship 3 parts that represent both the low and
high ends of the specifications for non-critical dimensionsCapability must be greater than 1.67 for critical dimensions and greater than 1.33
for non-critical dimensions
Reviewer’s Checklist
RECORDS OF MATERIAL / RECORDS OF MATERIAL / PERFORMANCE TEST PERFORMANCE TEST
RESULTS RESULTS
Records of Material/Performance Test Results
Material Test ResultsMaterial Test ResultsThe 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 ResultsPerformance Test ResultsThe supplier shall perform tests for all parts or product
materials when performance or functional requirements are specified by the design record or Control Plan
Material Results
Module Test Results
QUALIFIED LABORATORY QUALIFIED LABORATORY DOCUMENTATIONDOCUMENTATION
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.
APPEARANCE APPROVALAPPEARANCE APPROVALREPORTREPORT
Appearance Approval Report
When to Use It• Prior to tooling for production
What is It?• A report completed by the supplier
containing appearance and color criteria
Typically only applies for parts with color, grain,or surface appearance requirements
IMPORTANT!
Objective or Purpose• To demonstrate that the part has met
the appearance requirements on the design record
Appearance Approval ReportAdministrative Section
Supplier Sourcing & Texture InformationList all first surface tools, grainingSource(s), grain type(s), and grain and Gloss masters used to check part
Pre-Texture EvaluationTo be completed by SQE
Appearance Approval Report
Color Suffix
Master Number
Master Date
Material Type
Material Source
Color Shipping
Suffix
Part Disposition
DL* Da* Db* DE CMC Red Yel Grn Blu Light Dark Gray CleanHigh Low High Low
Color Evaluation
Comments:
Supplier Signature Phone No. Date Customer Representative Signature Date
Chroma Metallic BrillianceGlossTristimulus Data Hue Value
Color SuffixAlphanumeric or numeric color identification
Tristimulus DataList numerical (colorimeter) data of submission part as compared to the customer-authorized master
Master NumberEnter alphanumeric master identification
Master DateEnter the date on which the master was approved
Material TypeIdentify first surface finish and substrate (e.g. paint / ABS)
Material SourceIdentify first surface and substrate suppliers
Hue, Value, Chroma, Gloss, and Metallic BrillianceVisual assessment by Donaldson
Color Shipping SuffixColor part number suffix or color number
Part DispositionTo be determined by Donaldson (approved or rejected)
Tristimulus data
SAMPLE PRODUCTION SAMPLE PRODUCTION PARTSPARTS
Sample Production Parts
Actual samples that reflect the parts documented in the PPAP.
What is It?
Objective or Purpose• Confirm cosmetic or functional part
approval.
When to Use It• Sample parts should be delivered
WITH the PPAP submission
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
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
See Donaldson part label examples on the next
slide
Part Label Example
0Yes NoYes No
NameNumber
Shipping quantityCountry of origin
PPAP sample submission To: Donaldson Italia S.r.l., Via Dell’Industria 17, I-46035 Ostiglia (Mantova), Italy
Sample with PPAP?Sample Parts separate submittedShipping CarrierTracking Number
00
0
Supplier NamePart NamePart NumberPart revision level
Shipping date
PPAP Workbook includes these PPAP samples submission labels.Where applicable, fields get filled out automatically by filling out the PPAP submission sheet.
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!
PPAP to prevent loosing an opportunity for saving costs