Advanced Product Quality PlanningAPQPISO TS 16949:2002 Lead Auditor Course
2Course Objectives• By the end of the course the participantshould be able to;– Audit APQP both internally and externally– Understand the need for a APQP program– Identify the 5 phases of APQP– Develop and add value to an APQPprogram
3The 5 Phases of APQP1.Plan and Define the Program2.Product Design and Development3.Process Design and Development4.Product and Process Validation5.Feedback, Assessment andCorrective Action
4An APQP overviewConceptConceptInitiation/ApprovalInitiation/ApprovalProgramProgramApprovalApproval PrototypePrototype PilotPilot LaunchLaunchPlanningProduct Design and Dev.Process Design and DevelopmentProduct and Process ValidationProductionPlanningFeedback Assessment and Corrective ActionPlan andPlan andDefineDefineProgramProgramProductProductDesign andDesign andDevelopmentDevelopmentVerificationVerificationProductProductand Processand ProcessValidationValidationProcessProcessDesign andDesign andDevelopmentDevelopmentVerificationVerificationFeedbackFeedbackAssessment andAssessment andCorrective ActionCorrective Action
51.0 Plan and Define ProgramConceptConceptInitiation/ApprovalInitiation/ApprovalProgramProgramApprovalApproval PrototypePrototype PilotPilot LaunchLaunchPlanningFeedback Assessment and Corrective ActionPlan andPlan andDefineDefineProgramProgramProductProductDesign andDesign andDevelopmentDevelopmentVerificationVerificationProductProductand Processand ProcessValidationValidationProcessProcessDesign andDesign andDevelopmentDevelopmentVerificationVerificationFeedbackFeedbackAssessment andAssessment andCorrective ActionCorrective Action
6Phase 1Plan and define the program• Form a cross functional team– The first step in planning the program is to definewho will make up the cross functional team. Crossfunctional team does not mean one(1) persondoing everything!– Typical members of a cross functional team mayinclude:• Engineering, Production, Quality, Sales,Costing,Manufacturing, Marketing, Purchasing etc..
7Plan and define the program• ISO TS requires that personnel within the designactivity should be qualified in the following skillsas appropriate– Geometric Dimensioning and tolerancing (GD&T)– Quality Function Deployment (QFD)– Design for Manufacture/Assembly (DFM/DFA)– Value Engineering (VE)– Design of Experiments (Taguchi & Classical)– Failure Mode and Effects Analysis - Design andProcess
8Plan and define the program– Finite Element Methods (FEM)– Solid Modelling– Simulation techniques– Computer Aided Design/Engineering(CAD/CAE)– Reliability Engineering plans
9Plan and define the program• Determine customer requirementsCustomer requirements are typically determined byany or all of the following;– Market research– Warranty history from similar products– Supplier Quality Reports– Team Experience
10Plan and define the program• Business planThe Business plan is a formal requirementof ISO TS. It is a strategic document whichmay place some constraints on thedevelopment of the proposed product.Examples of Constraints:Project timing, cost of investment intechnology, machinery and human resources,quality requirements, manufacturingcapabilities, government regulations
11Plan and define the program• Benchmark data - Process & ProductAt this stage of the program Benchmark data should beobtained for the process and product as appropriate.Benchmark data may be used to establish the “GAP”between your current product or process and that of the“World Best”.Corrective action plans should be developed to close the“GAP” with the focus on becoming “World Best”.
12Plan and define the program• Product and Process assumptionsList all of the current product and process assumptions.Examples may be:– Material Characteristics and Performance– Reliability assessments– Machine capabilities– Management Structure
13Plan and define the program• Product Reliability studiesThis area relates to identifying the frequency of repair orreplacement of components over periods of time.Examples are:– Service every 30,000 miles– Replacement after 2 years– Service after 1,000,000 cycles
14Plan and define the program• At the completion of this stage thefollowing aspects should be defined;• Design goals• Reliability goals• Quality targets
15Plan and define the program• Preliminary Bill of Material (BOM)• Preliminary process flow chart• Preliminary listing of special characteristics• Any governmental, environmental or safetyregulations
16Example(Typical output at completion of phase 1 - Plan and define the program)Supplier Name: World Class Pty LtdPart Name: Boot Carpet trimPart Number: 1234-1 Drawing date: 19 FEB ‘99Brief description of part:The Boot carpet trim is a carpet that is vacuumformed onto a polypropylene substrate. It is thentrimmed by a water jet cutter into shape, followedby an assembly operation where six (6) spacersare located.
17Example(Typical output at completion of phase 1 - Plan and define the program)• Design Goals– Zero Carpet folds– Acceptable color match between carpet and matingcomponents– No peeling of carpet from polypropylene substrate• Reliability Goals– Zero customer returns for carpet wearNote: reliability goals are typically set for mechanicaland/or electrical components.
18Example(Typical output at completion of phase 1 - Plan and define the program)• Quality Targets– PpK of all special characteristics >1.67– Cpk of all special characteristics >1.33– Reject rate < 0.5% for 1st 12 months< 0.35% for 2nd 12 months– Color tolerance for carpet Delta E <0.5 units
19Example(Typical output at completion of phase 1 - Plan and define the program)• Preliminary Bill Of Material (BOM)Name Location Name LocationVacuum Former #4 Production Fixture 1234-1 Store F23Steel frame 1800x1200 mm Store E24 Packaging 50/crate Store F10Poly propylene 1850x1250 Store B16 Spacers 6/unit Store A17Carpet 1850x1250 Store B21 Mounting Fixture 1234-2 Store F24Water Jet cutter #1 Production Labels 1/unit Store F22
20Example(Typical output at completion of phase 1 - Plan and define the program)• PreliminaryProcessFlow ChartReceive materialand locate in store1Vacuum formingoperation2Trim carpet tocorrect shape usingwater jet cutter3Assemble 6spacers to eachunit4Pack instillage5
21Example(Typical output at completion of phase 1 - Plan and define the program)• Preliminary Listing of Special characteristicsie KPC– Color of carpet - Delta E < 0.5 units– Hole locations +/- 1.0 mm– Hole Dimensions +/- 0.5mm• Government, Safety or Environmentalregulations– Substrate of Polypropylene to be identified for recyclingpurposes
22Plan & Define the programDocument a once sentence summary
24Phase 2Product Design and DevelopmentThe Product Design and Development phasebegins with the generation of a Design FMEA• Design Failure Mode and Effects Analysis
25Product Design and Development• ISO TS requires that design output shall be theresult of a process that includes the following;– Efforts to simplify, optimise, innovate and reduce wastewith methods such as;• Quality Function Deployment (QFD)• Design for Manufacture/Assembly(DFM/DFA)• Value Engineering (VE)• Design of Experiment• Tolerance studies (GD&T)• Response surface methodology
26Product Design and Development• Analysis of costs/performance/risks tradeoffs• Use of feedback from testing, productionand the field• Use of Design FMEA’s
27Product Design and Development• Design verification at appropriate stages of designThe purpose of the design verification is to ensure that thedesign output is meeting the planned design input asdefined in phase 1, Plan and Define the program.Example:Phase 1: Design Input - Hole locations +/- 1.0 mmPhase 2: Design Output - Engineering Drawings stipulatingthe Hole locations at the tolerance of +/- 1.0 mm
28Product Design and Development• Design reviews (formal documented review)Design reviews are conducted to monitor theprogress of the project relative to customerrequirements. The reviews are conducted by across functional team and the results of eachreview must be documented.Typically, the Design reviews might cover; DesignFMEA’s, Design verification progress, reliabilitytests and studies, computer simulation results,benchmark data and overall progress relative totime constraints
29Product Design and Development• Prototype build control planA prototype build control plan should be developed for aproduct when required by the customer. This control planwill detail the results from a dimensional analysis, materialand functional tests, engineering and reliability tests.
30Product Design and Development• Finalisation of;– Engineering drawings including CAD data– Engineering specifications– Material specificationsAt this stage the cross functional team should havereviewed and approved all drawings, engineeringspecifications and material specifications.
31Product Design and Development• New equipment, tooling and facilitiesDuring the design review the cross functionalteam may determine that new equipment, toolingand facilities will be required. These details mustbe addressed and included in the overall timingplan. Emphasis must be placed on ensuring thatnew equipment, tooling and facilities arecompleted on time.
32• Finalisation of special characteristicsAt this stage the majority of technical information is knownand as a consequence the special characteristics shouldbe agreed upon by the cross functional team and finalised.The Control Plan should denote the finalised specialcharacteristics.Product Design and Development
33• Any new inspection, measuring and testequipment deviceBased on all the information generated, inparticular, the characteristics which need to bemeasured the cross functional team shoulddetermine whether any new inspection, measuringand test equipment is required.If the equipment is required, this should berecorded into the overall timing plan and progresstowards the acquisition be monitored.Product Design and Development
34• Team Feasibility statement (This is a compulsoryrequirement of ISO TS 16949:2002At this time the cross functional team must be satisfiedthat the proposed design can be manufactured to thecustomer’s requirements.Once satisfied, the cross functional team members mustsign off the Team Feasibility Statement.Product Design and Development
35Product Design & DevelopmentDocument a once sentence summary
363.0 Process Design & DevelopmentConceptConceptInitiation/ApprovalInitiation/ApprovalProgramProgramApprovalApproval PrototypePrototype PilotPilot LaunchLaunchPlanningProduct Design and Dev.Process Design and DevelopmentFeedback Assessment and Corrective ActionPlan andPlan andDefineDefineProgramProgramProductProductDesign andDesign andDevelopmentDevelopmentVerificationVerificationProductProductand Processand ProcessValidationValidationProcessProcessDesign andDesign andDevelopmentDevelopmentVerificationVerificationFeedbackFeedbackAssessment andAssessment andCorrective ActionCorrective Action
37Phase 3Process Design and DevelopmentThe Process Design and Development phase requires thefollowing aspects to be defined and/or documented;• Customer packaging and labelling standardsGenerally, the customer will provide documented packagingand labelling guidelines. These documents should befollowed. When no guidelines are available, the crossfunctional team is responsible for developing guidelines toensure integrity of the packaged product.
38Process Design and Development• Review of the current QualityManagement System to ensure itssuitability for the prospective productand associated processesThe cross functional team should review themanufacturing sites Quality Manual to ensure thecurrent Quality Management System addressesall of the requirements to design andmanufacture the product under consideration.Any additional controls and/or proceduralchanges should be used to improve the QualityManagement System in operation
39Process Design and Development• Finalisation of the process flow chartThe finalized process flow chart is a schematicrepresentation of the process flow. This chart is usedto detect any potential bottlenecks, such as, materialflow problems and manpower.This chart also serves as a starting point whenconducting the Process Failure Mode and EffectsAnalysis.
40Process Design and Development• Floor plan layout with an emphasis on minimisingmaterial travelThe floor plan should be developed to determine theacceptability of inspection points, control chartlocations, visual aid locations, rework area(s) andstorage areas.When developing the process and subsequent floorplan an emphasis must be placed on utilising floorspace for value added activities.
41Process Design and Development• Completion of the Process Failure Mode andEffects Analysis (FMEA)The Process FMEA should be conducted prior toproduction commencing.The process FMEA is a structured and detailedstudy performed by a cross functional team on aprocess to determine how potential external andinternal factors could impact a process. Oncepotential problems are established, preventiveactions are developed to control all suchproblems.
42Process Design and Development• Completion of the Pre-launch Control PlanThe Pre-Launch control plan provides a descriptionof the dimensional measurements and functionaltest that occur after prototype and prior to fullproduction. The pre-launch control plan typicallyincludes additional product/process controls untilthe production process is validated.
43Process Design and Development• Measurement systems analysis plan toencompass all of the inspection measuring andtest equipment designated on the control planAll inspection, measuring and test equipment utilisedto measure product or process characteristics asdefined in the Control plan must under go aMeasurement Systems Analysis. The analysisshould not be just restricted to Gauge Repeatabilityand Reproducibility but should also include studieson, linearity, and accuracy, as appropriate.
44Process Design and Development• Process Monitoring and OperatorInstructions - these shall typically include orreference as follows;– Operation Name and number keyed to process flowchart– Part Name and Number– Current Engineering level/date– Required tools, gages and other equipment– Material identification and disposition instructions– Customer and supplier designated specialcharacteristics– SPC requirements– Relevant Engineering and manufacturing standards
45Process Design and Development– Inspection and test instructions– Corrective action instructions– Revision date and approvals– Visual aids– Tool change intervals and set up instructions
46Process Design and Development• Preventative maintenanceThe cross functional should identify key processequipment and develop an preventative maintenancesystem. At a minimum the system must include;– A procedure that describes planned maintenanceactivities– Scheduled maintenance activities– Predictive maintenance methods• Review of Manufacturers recommendations• Tool wear• Fluid Analysis• Vibration Analysis– Availability of replacement parts for keymanufacturing equipment
47Process Design and Development• Preliminary process capability requirementsIf no requirements have been specified a Ppk valuegreater than or equal to 1.67 should be achieved forpreliminary results (less than 30 production days)• If process is unstable refer to customer
48Process Design & DevelopmentDocument a once sentence summary
494.0 Product & Process ValidationConceptConceptInitiation/ApprovalInitiation/ApprovalProgramProgramApprovalApproval PrototypePrototype PilotPilot LaunchLaunchPlanningProduct Design and Dev.Process Design and DevelopmentProduct and Process ValidationFeedback Assessment and Corrective ActionPlan andPlan andDefineDefineProgramProgramProductProductDesign andDesign andDevelopmentDevelopmentVerificationVerificationProductProductand Processand ProcessValidationValidationProcessProcessDesign andDesign andDevelopmentDevelopmentVerificationVerificationFeedbackFeedbackAssessment andAssessment andCorrective ActionCorrective Action
50Product and Process ValidationThe Product and Process validation phase requires thefollowing aspects to be defined and/or documented;• Production trial run as stipulated in the Control Plan -typically the results from this trial production run areused for;• Preliminary process capability studies• Measurement systems analysis (Gauge R&R)• Process review• Product validation testing (Functional fit)
51Product and Process Validation• Production Part Approval• Packing evaluation• Quality Planning signoff• Finalisation of Production Control Plan
52Product and Process Validation• Measurement Systems EvaluationValidating that all measuring devices used forproduct and process validation have beenevaluated for Measurement error, typically GaugeRepeatability and Reproducibility studies.
53Product and Process Validation• Preliminary Process Capability studyEnsuring that preliminary process capability studies havebeen conducted on all characteristics identified on theControl Plan
54Product and Process Validation• Production Part ApprovalProduction Part Approval is required to validate that theproduct manufactured meets all customer requirements.
55Product and Process Validation• Production Validation TestingProduction Validation testing refers to Engineeringtests that validate the production process asmeeting all of the customer requirements,particularly, Engineering requirements.
56Product and Process Validation• Packaging EvaluationValidating the packaging to ensure product isprotected to the point of delivery is an integralphase of Product and Process Validation.In addition the cross functional teamrepresentatives should ensure that the type ofpackaging will allow the end user to handle theproduct in a safe and efficient manner.
57Product and Process Validation• Production Control PlanThe production control plan describes the systemsfor controlling the entire process. The productioncontrol plan is a living document that must reflect thecurrent flow of production. Any addition or deletionsof process, inspection activities etc.. must bereflected in the control plan.
58Product and Process Validation• Quality Planning Sign-offThe Quality planning sign off is typically is typicallyconducted by the cross functional team once thecontrol plan accurately reflects the entire process,process instructions are satisfactory, FMEA’s arecomplete and Measurement System Studies havebeen completed.The form which is typically used for sign off isreferred to as the Product Quality PlanningSummary and Sign Off Report.
59Product & Process ValidationDocument a once sentence summary
605.0 Feedback, Assessment & Corrective ActionConceptConceptInitiation/ApprovalInitiation/ApprovalProgramProgramApprovalApproval PrototypePrototype PilotPilot LaunchLaunchPlanningProduct Design and Dev.Process Design and DevelopmentProduct and Process ValidationProductionPlanningFeedback Assessment and Corrective ActionPlan andPlan andDefineDefineProgramProgramProductProductDesign andDesign andDevelopmentDevelopmentVerificationVerificationProductProductand Processand ProcessValidationValidationProcessProcessDesign andDesign andDevelopmentDevelopmentVerificationVerificationFeedbackFeedbackAssessment andAssessment andCorrective ActionCorrective Action
61Feedback, Assessment and Corrective Action• Based on the output of phase 4, more specificallythe;– Production trial run– Measurement Systems Analysis– Preliminary process capability study– Production part approval– Production validation testing– Packaging Evaluation– Customer concerns
62the results(feedback) are assessed and correctiveaction is instigated with a focus on;CONTINUOUS IMPROVEMENTQS 9000Feedback, Assessment and Corrective Action
63Feedback, Assessment & CorrectiveActionDocument a once sentence summary
64Auditing APQP1. How does the organisation select a cross functionalteam?2. Are cross functional teams used for APQP?3. How does the organisation determine customerrequirements and integrate them into Phase 1 – Planand define the program4. Are key dates extracted from the customer and how arethese communicated to the organisations crossfunctional team5. Does the organisation have a defined APQP programand is it followed6. How is this APQP process measured
65Auditing APQP7. What actions are taken when milestones are notachieved?8. How does the organisation monitor supplier APQP9. Examine the mechanism that the organisations has inplace to communicate information to the supplier, andchanges to these requirements10. Does the organisation sign off the team feasibility andcommitment form?11. Is it signed off by a cross functional team?12. Do the team members who sign off this documentunderstand why the are signing the document?13. How does the organisation transition into productionfrom APQP?