2 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 techniquesInitially developed by AIAG (Auto Industry Action Group) in 1993 with input from the Big 3 - Ford, Chrysler, and GMAIAG’s 4th edition effective June 1, 2006 is the most recent versionPPAP is part of the Donaldson Supplier Business Operating Standard (S.B.O.S.S.)
3 PPAP manages change and ensures product conformance! Purpose of PPAPProvide evidence that all customer engineering design record and specification requirements are properly understood by the organizationTo 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 ratePPAP manages change and ensures product conformance!
4 PPAP is required with any significant change to product or process! 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 locationPPAP is required with any significant change to product or process!
5 Benefits of PPAP Submissions Helps to maintain design integrityIdentifies issues early for resolutionReduces warranty charges and prevents cost of poor qualityAssists with managing supplier changesPrevents use of unapproved and nonconforming partsIdentifies suppliers that need more developmentImproves the overall quality of the product & customer satisfaction
6 DBV = online supplier monitoring After a successful submitted and approved PPAP, part can be supplied to the Donaldson organizationEach supply get’s monitored and deliveries are measured in ppm and in % on-timeWhen defect parts are found, an NCR and 8D is executedMonthly the DBV committee communicates supplier rankingYearly 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
7 Production RunPPAP data must be submitted from a production run using:Production equipment and toolingProduction employeesProduction rateProduction processAll data reflects the actual production process to be used at start-up!
8 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 timeVerification 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
9 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. P 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
10 Official PPAP Requirements Design RecordsAuthorized Engineering Change DocumentsCustomer Engineering Approval, if requiredDesign Failure Modes and Effects Analysis (DFMEA) applied in special situationsProcess Flow DiagramProcess Failure Modes and Effects Analysis (PFMEA)Control PlanMeasurement Systems Analysis (MSA)Dimensional ResultsRecords of Material / Performance Test ResultsInitial Process StudiesQualified Laboratory DocumentationAppearance Approval Report (AAR)Sample Production PartsMaster SampleChecking AidsCustomer-Specific RequirementsPart Submission Warrant (PSW)Have a closer look
11 Donaldson’s PPAP Requirements Supplier shall submit 12 items and retain a copy of (R) records at appropriate locationsFor PPAP Level 5, SQA will witness at supplier location and will fill out PPAP level 5 work sheet.
12 PPAP Submission Levels Production Warrant and Appearance Approval Report (if applicable) submitted to DonaldsonLevel 2Production Warrant, product samples, and dimensional results submitted to DonaldsonLevel 3Production Warrant, product samples, and complete supporting data submitted to DonaldsonLevel 4Production Warrant and other requirements as defined by DonaldsonLevel 5Production Warrant, product samples and complete supporting data (a review will be conducted at the supplier's manufacturing location)
13 PPAP Submission Level Table * = Supplier shall retain at appropriate locations, and submit to Donaldson upon request. Donaldson will identify what is needed for submission.S = Supplier shall submit to Donaldson & retain a copy of records or documentation items at appropriate locationsR = Supplier shall retain at appropriate locations and make readily available to Donaldson upon request
14 Definition of Risk and PPAP level High RiskParts associated with multiple critical features, complex design, or high end technology that is not yet established in the general manufacturing environmentSupplier’s quality system and/or quality performance is not to Donaldson satisfactionMedium RiskParts that have at least one critical featureLow RiskParts that have no critical features and can be manufactured by any manufacturer in the commodity categorySupplier’s quality system and quality performance are acceptable
15 Submission Level Requirements New PartsLevel 2 is required for Low Risk PartsLevel 3 is required for Medium and High Risk PartsPart ChangesLevel 3 is required for Parts produced at a new or additional locationSupplier Quality Excellence will define the level required for all other changesDonaldson reserves the right to redefine the submission level required
16 PPAP Status Production quantities may not be ApprovedThe part meets all Donaldson requirementsSupplier is authorized to ship production quantities of the partInterim ApprovalDonaldson permits shipment of part on a limited time and quantity clearly in writing defined.On HoldSQA needs more infoRejectedThe part does not meet Donaldson requirements, based on the production lot from which it was taken and/or accompanying documentationProduction quantities may not beshipped before Donaldson Approval
17 Electronic Submission Requirements Donaldson requires that all PPAPs be submitted electronically Use of paper submission must have prior approval by the SQASubmission must be received on or prior to the PPAP due dateReview and Approval Process:Donaldson will attempt to review and provide feedback within 3 business daysDonaldson requires all submissions to be electronic
18 Donaldson PPAP book Show PPAP book “CORP SQADOC 004” 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 missingShow PPAP book “CORP SQADOC 004”
20 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 requirementsObjective or PurposeUsed to :document part approvalprovide key informationdeclare that the parts meet specificationWhen to Use ItPrior to shipping production partsHave a closer look
21 Part Submission Warrant Product weightEnter the product weightDonaldson Part NumberEngineering released finishedend item part numberEngineering Change Level & DateShow the change level and date ofthe Design RecordShown on Drawing NumberThe design record that specifiesthe customer part number beingsubmittedAdditional Engineering ChangesList all authorized Engineeringchanges not yet incorporated inthe design record but which areincorporated in the partSafety and/or Government Regulation“Yes” if so indicated by the Design Record,otherwise “No”Purchase Order NumberEnter this number as found onthe contract / purchase orderChecking Aid Number, Change Level, & DateEnter if requested by the customer
22 Part Submission Warrant Supplier Manufacturing InformationShow the name and code assigned tothe manufacturing site on thepurchase order / contractParts Identified with Appropriate Marking CodesUL = Underwriters Laboratories safety standardsCE = Conformite Europeenne (European Conformity) –Certifies that a product has met European consumerSafety, health, or environmental requirementsISO = International Organization for StandardizationEnter “Yes” or “No”Donaldson LocationShow the location whereparts will be shipped toRestricted SubstancesEnter “Yes” or “No”Buyer / Buyer CodeEnter the buyer’s nameand codeModel Name / NumberEnter the model nameand number
23 Part Submission Warrant Reason For SubmissionCheck the appropriate box(es)Requested Submission LevelIdentify the submission levelrequested by DonaldsonMold / Cavity / Production ProcessIf production parts will be produced frommore than one mold, cavity, tool, die,pattern, or production process, the suppliershall complete a dimensional evaluation onone part from each. The specific molds,lines, etc. shall then be identified here.Submission ResultsCheck the appropriate boxes
24 Part Submission Warrant DeclarationEnter the number of piecesmanufactured during thesignificant production runand the time (in hours) takenfor the significant production runDeclarationAffirmation that the samples representedby the warrant are representative andwere made by a process that meets Donaldson’sPPAP requirementsExplanation / CommentsProvide any explanatory comments on thesubmission results or any deviationsfrom the Declaration. Attach additionalinformation as appropriate.Supplier Authorized SignatureA responsible supplier official, after verifyingthat the results show conformance to all Donaldsonrequirements and that all required documentationis available, shall approve the declarationFor Donaldson Use OnlyTo be completed by appropriateDonaldson Supplier Quality EngineerPPAP Warrant DispositionApproved, Rejected, OtherDonaldson SignatureSigned by Donaldson SupplierQuality EngineerThe approved Production Warrant officially warrants the parts ready for production
25 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
27 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
29 Process Flow Diagram What is It? Objective or Purpose When to Use It A visual diagram of the entire process from receiving through shipping, including outside processes and servicesTo help people “see” the real process. Process maps can be used to understand the following characteristics of a process:Set-by-step process linkageOffline activities (measurement, inspection, handling)Rework, scrapObjective or PurposeWhen to Use ItTo understand how a process is donePrior to completing the PFMEA
30 Process Flow DiagramsThe process flow diagram utilizes these symbols to clearly identify each step in the process
31 Process Flow Diagrams Reviewers Checklist Process Flow must identify each step in the processShould include abnormal handling processesScrapReworkProcess Flow must include all phases of the processReceiving of raw materialPart manufacturingOffline inspections and checksAssemblyShipping
33 Process FMEA (PFMEA) CORP QEHSDOC 014 What is It?A tool used to identify and prioritize risk areas and their mitigation plans.Objective or PurposeIdentifies 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 ItAfter completion of the process flow diagram.Prior to tooling for productionIMPORTANT!The PFMEA should be completedusing a cross-functional team!
34 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
35 This is included in the PPAP book! Process FMEA (PFMEA)This is included in the PPAP book!
36 PFMEA - Step 1Failure ModesFor each Process Input,determine the ways inwhich the input can gowrong.Using the completedProcess Flow Diagram,enter the process step.TIPSThere should be at least one failure mode for each input.
37 PFMEA - Step 2Potential Failure EffectsFor each Failure Mode,determine what effectthe specific failurecould have on theprocess output.TIPSThere should be at least one failure effect for each failure mode.Effects should be specific, clear, and leave no doubt to the uninformed reviewer.
38 PFMEA - Step 3Potential CausesFor each Failure Mode,determine the possible cause of the failure.TIPSThere should be at least one potential cause for each failure mode.
39 PFMEA - Step 4Current ControlsFor each potentialcause, list the currentmethod used forpreventing or detectingfailure.TIPSThis 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.”
40 Severity, Occurrence and Detection rating details on next slide PFMEA - Step 5Assign Severity, Occurrence, and Detection ratingsAssign Severity(How serious is the effect if it fails?)Assign Detection(How easily can the cause or failuremode be detected?)Assign Occurrence (How likely is the cause to occur?)Severity, Occurrence and Detection rating details on next slide
41 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)Caution: Notice the scale difference for Detection!
42 An Example of Rating Definitions SeverityOccurrenceDetection*Hazardous without warningVery high and almost inevitableCannot detect or detection with very low probabilityLoss of primary functionHigh repeated failuresRemote or low chance of detectionLoss of secondary functionModerate failuresLow detection probabilityMinor defectOccasional failuresModerate detection probabilityNo effectFailure unlikelyAlmost certain detectionRatingHigh 10Low 1*If No Controls Exist, Detection = 10Referring too 4th Edition FMEA Manualand the scales in Donaldson PPAP workbook.
43 PFMEA - Step 6Calculate the Risk Priority Number RPN = Severity x Occurrence x DetectionTIPSThe 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.
44 ? Analyzing the PFMEA RPN Thresholds 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 determinethe most significantfailure modes?How many items should bethe focus of the next steps?RPN ThresholdsWhen using an RPN threshold, DO NOT forget to address high Severity scoresPareto Chart
45 PFMEA – Remediation Guidelines Severity Can only be improved by a design change to the product or processOccurrence Can 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.Detection Can be reduced by improving detection. Examples are mistake- proofing, simplification and statistically sound monitoring.In general, reducing the Occurrenceis preferable to improving the Detection
46 FMEA – Step 7 Determine Actions Recommended to reduce High RPNs For the high RPN numbers,determine therecommended actions.
47 FMEA – Steps 8 and 9 Now recalculate your RPNs Resp (responsibility)Assign a specific personwho will be responsible for recommended actions.Actions TakenAs actions are identifiedand completed, documentin the “Actions Taken”column.SEV, OCC, DET, RPNAs actions are completereassess Severity,Occurrence, and Detectionand recalculate RPN.Now recalculate your RPNsbased on mitigation plans.TIPS:Continue updating the actions taken and resulting RPNs until all risks are at an acceptable level (below 100).
48 Summary Steps To Complete a FMEA For each Process Input, determine the ways in which the Process Step can go wrong (these are Failure Modes).For each Failure Mode associated with the inputs, determine Effects on the outputs.Identify potential Causes of each Failure Mode.List the Current Controls for each Cause.Assign Severity, Occurrence and Detection ratings after creating a ratings key appropriate for your project.Calculate RPN.Determine Recommended Actions to reduce High RPNs.Take appropriate Actions and Document.Recalculate RPNs.Revisit steps 7 and 8 until all the significant RPNs have been addressed.
49 Tips and Lessons Learned Process FMEA (PFMEA)Tips and Lessons LearnedCollaborative Effort: Do not try alone, use a groupVery comprehensive: Time consuming process. Take necessary breaks.Action items are required for completionTrain team ahead of time by explaining scoring criteriaProper preparation is needed for meetingsSummarize often: FMEA is a living document
50 Process FMEA (PFMEA) Reviewers Checklist Verify 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 addressedSafetyForm, fit, functionMaterial concerns
52 Control Plan What is It? Objective or Purpose NOTE When to Use It A document that describes how to control the critical inputs to continue to meet customer expectations of the output.What is It?Objective or PurposePrimary reference source for minimizing process and product variation.Description of how teams should react to out-of-control situations.NOTESince processes are expected to be continuouslyupdated and improved, the control planis a living document!When to Use ItImplementation of new processFollowing a process change
53 New/Revised Process Steps Control PlanTool InteractionProcess StepsProcess FlowchartProcess FMEANew/Revised Process StepsRisk PrioritizedProcess StepsProcess StepsControl PlanImprovedControlsNew/RevisedProcess Steps
54 This is included in the PPAP book! Control PlanThis is included in the PPAP book!
55 Control Plan 3 Distinct Phases 3 Distinct Phases Prototype – a description of the dimensional measurements and material and performance tests that will occur during Prototype build.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
56 Administrative Section Control PlanAdministrative SectionAdministrative SectionIdentifies part number and description, supplier, required approval signatures, and dates.
57 Control Plan Process, Machine/Tools, Characteristics Characteristics Define the characteristics of the product or processPart/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
58 Control Plan Specifications, Measurement, Sample Size & Frequency What is the size of the sample you should gather data from?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).FrequencyDefine the frequency for which the measurement will be taken.
59 Control Plan Control Method, Reaction Plan Control Method Method that will be used to control the processReaction PlanActions to be taken if controls fail
60 Control Plan Effectiveness of controls Audit PlansAudit 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.
61 Control Plan Reviewer’s Checklist Use process flow diagram and PFMEA to build the control plan; keep them alignedControls 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 PlanControl plans should reference other documentationSpecifications, tooling, etc.
63 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 PurposeTo 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 ItOn 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.Who Should be InvolvedEveryone that measures and makes decisions about these measurements should be involved in the MSA.Measurement System Analysis is an analysis of the measurement process, not an analysis of thepeople!!IMPORTANT!
64 Attribute and Variable MSA Attribute Data Examples:Count, Pass/fail, yes/no, red/green/yellow, timekeeping bucketsVariable Data Examples:Physical measurement (length, width, area, …)Physical conditions (temperature, pressure…)Physical properties (strength, load, strain…)Continuous or non-endingUnless approved by an Donaldson SQA, attribute datais not acceptable for PPAP submission
65 Measurement System Analysis (MSA) VariationThe 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. ObservedVariationProcessVariationConducting an MSA reduces the likelihood of passing a bad part or rejecting a good part
66 Measurement System Analysis (MSA) Observed VariationMeasurementSystemVariationObservedVariationThe output of the processmeasured by:Cycle timeDimensional dataNumber of defects and othersProcessVariation
68 Calibration Addresses Accuracy Measurement System Analysis (MSA)Observed VariationResolutionPrecision(Variability)RepeatabilityReproducibilityMeasurementSystemVariationLinearityAccuracy(Central Location)ObservedVariationBiasStabilityProcessVariationCalibration Addresses AccuracyLet’s take a closer look at Precision
69 Measurement System Analysis (MSA) ResolutionError in Resolution The inability to detect small changes.Possible Cause Wrong measurement device selected - divisions on scale not fine enough to detect changes.
70 Measurement System Analysis (MSA) RepeatabilityError in Repeatability The 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
71 Measurement System Analysis (MSA) ReproducibilityError in Reproducibility The 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
72 Variable MSA – Gage R&R Study Gage R&R is the combined estimate of measurement system Repeatability and ReproducibilityTypically, a 3-person study is performedEach person randomly measures 10 marked parts per trialEach person can perform up to 3 trialsThere are 3 key indicatorsEV or Equipment VariationAV or Appraiser VariationOverall % GRR
73 Donaldson’s Gage R&R Form Automatically calculates EV, AV, and % GRR!Included in PPAP Playbook!
74 Variable MSA – Gage R&R Steps Select 10 items that represent the full range of long-term process variation.Identify the appraisers.If appropriate, calibrate the gage or verify that the last calibration date is valid.Open the Gage R&R worksheet in the PPAP book to record data.Have each appraiser assess each part 3 times (trials – first in order, second in reverse order, third random).Input data into the Gage R&R worksheet.Enter the number of operators, trials, samples and specification limitsAnalyze data in the Gage R&R worksheet.Assess MSA trust level.Take actions for improvement if necessary.
75 Steps 1 and 2: Variable MSA - Gage R&R Select 10 items that represent the full range of long-term process variation.Step 1Step 2Identify 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.
76 Steps 3 and 4: Variable MSA – Gage R&R If appropriate, calibrate the gageor verify that the last calibrationdate is valid.Step 3Step 4Open the Gage R&R worksheet in thePPAP book to record the data
77 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 !!
78 Steps 6 and 7: Variable MSA – Gage R&R Input data into the Gage R&R worksheetStep 7Enter the number of operators, trials, samples and specification limits
79 Steps 8 and 9: Variable MSA – Gage R&R Analyze data in the Gage R&R worksheetStep 9Assess MSA Trust Level.Red: > 30% (fail)Yellow: 10-30% (marginal)Green: < 10% (pass)% Tolerance*10%30%
80 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.
81 Variable MSA – Gage R&R Example Problem StatementThe sulfuric acid concentration in process tank 8 is measured at least once per dayAdditions/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 ProcessA Gage R&R was conducted in order to validate the process.MSA Parameters(3) Operators(3) Trials(10) Samples
82 Variable MSA – Gage R&R Example Entered upper and lower process specification limitsEntered the number of operators, trials, and samplesChose 3 operators to be appraisersHad each appraiser measure each sample 3 timesResults calculated automaticallySelected 10 samples to be measured
84 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 processInvolve the supervisionInvolve the suppliers and customers of the processAn MSA primarily addresses precision with limited accuracy information.
85 MSA – Gage R&R Reviewer’s Checklist 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, thenQuestion the technique and part samplingAsk for additional studies
87 Dimensional Results What is It? Objective or Purpose When to Use It Evidence that dimensional verifications have been completed and results indicate compliance with specified requirements.What is It?Objective or PurposeTo show conformance to the customer part print on dimensions and all other noted requirements.When to Use ItFor each unique manufacturing process (e.g., cells or production lines and all molds, patters, or dies
88 Donaldson Dimensional Report (Critical) AutomaticallyCalculates Cpk!Requires 35 data pointsCpk must be greater than or equal to 1.67This is included in the PPAP book!
89 Acceptance criteria for critical vs. non-critical characteristics DecisionRed (Bad)<1.33<1.00Yellow (OK)Green (Good)>1.67>1.33Cpk must be greater than or equal to 1.67 for critical processesCpk must be greater than or equal to 1.33 for non-critical processes
90 Donaldson Dimensional Report Example Nominal ValueToleranceSample DataCp & Cpk CalculationsPass / FailCpk > 1.33 for all non-critical dimensions = Pass!
91 Dimensional Results Reviewer’s Checklist Thirty-five critical data points & 5 non-critical data points are required for part qualificationCritical 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
93 Records of Material/Performance Test Results Material 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 PlanFor 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 listPerformance 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
94 Material ResultsMaterial Results shall include:The name of the laboratory that conducted the testThe type of test that was conductedThe number, date, and specification to which the part was testedThe actual test results
95 Module Test Results Module Test Results shall include: The name of the laboratory that conducted the testThe type of test that was conductedA description of the testThe parameters testedThe actual test results
97 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 conductedWhen an external laboratory is used, the supplier shall submit the test results on the laboratory letterhead or the normal laboratory report formatThe 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.
99 Appearance Approval Report What is It?A report completed by the supplier containing appearance and color criteriaObjective or PurposeTo demonstrate that the part has met the appearance requirements on the design recordWhen to Use ItPrior to tooling for productionIMPORTANT!Typically only applies for parts with color, grain,or surface appearance requirements
100 Appearance Approval Report Administrative SectionSupplier Sourcing & Texture InformationList all first surface tools, grainingSource(s), grain type(s), and grain andGloss masters used to check partPre-Texture EvaluationTo be completed by SQE
101 Appearance Approval Report Master NumberEnter alphanumeric master identificationMaster DateEnter the date on which the master was approvedMaterial TypeIdentify first surface finish and substrate (e.g. paint / ABS)Material SourceIdentify first surface and substrate suppliersColor Shipping SuffixColor part number suffix or color numberColor SuffixAlphanumeric or numeric color identificationTristimulus DataList numerical (colorimeter) data of submission part as compared to the customer-authorized masterPart DispositionTo be determined by Donaldson (approved or rejected)Hue, Value, Chroma, Gloss, and Metallic BrillianceVisual assessment by DonaldsonTristimulus data
103 Sample Production Parts Actual samples that reflect the parts documented in the PPAP.What is It?Objective or PurposeConfirm cosmetic or functional part approval.When to Use ItSample parts should be delivered WITH the PPAP submission
104 Sample Production Parts The sample parts provided should be the same parts measured for the dimensional resultsDefault quantity for all submissions is 3 parts unless otherwise requested
105 Sample Production Parts Sample production parts MUST be properly identifiedInclude the following information on the part label:Shipping dateDonaldson part numberQuantity submittedSupplier part number (optional)Donaldson Part nameCarrier nameCountry of originTracking numberApproval markings (UL, CE, etc.) where applicableSee Donaldson part label examples on the next slide
106 Part Label ExamplePPAP Workbook includes these PPAP samples submission labels.Where applicable, fields get filled out automatically by filling out the PPAP submission sheet.
107 PPAP SummaryThe Production Part Approval Process is an extensive approval process for new or changed designs or processesIt is very formalized, so it inevitably causes some administrative workLater changes to the product or process can be expensive and time-consuming!
108 PPAP to prevent loosing an opportunity for saving costs