PANDTREVIEW(2).doc

(T1) Design and Process Technical Concept Review ChecklistProgram Title:Tracking Number:Project Leader:Date:Checklist ItemsTargetActualR/Y/GComments1. Project Technical Objectives Defined/Reviewed Preliminary Product Plan and kit requirements defined Marketing claims identified/concepts defined No Inventions Required Concept Design reviews including safety concerns cpt. E1 Electronics Review Completed/Results PresentedYesYesPresentConfirmYesYes2. Review DFSS Status DFSS Top Level Performance Scorecard Functional Block Diagrams created for each alternate Structure model with CTQs (Ys & Xs) Results from required 3P Lean Events Transfer function and tolerance loop needs Initial Human Factors design results Field Failure root cause to CTQ Analysis Reviewed PresentYesYesPresentPresentYesYes3. Preliminary QFD Step 2 complete (for each alternative)Yes4. Review DFR Status for Warranty and Life Show populated DFR scorecard T1 Estimate Show complete sub-system & component FBDs Preliminary FMEA to connect failure modes with test plan Reliability Evaluation Plan/Acceptance Criteria Cost of quality roll-up including warranty prediction FRACAS reporting InitiatedYesYesPresentPresentPresentYes5. Product technical specification released. Technical Literature Needs/Responsibilities defined All regulatory and safety requirements defined for all countries where the product will be sold. Installation Process and Tools definedYesYesYesYes6. Review competitive tear down analysis/testingYes7. Service Review (S1) complete by country of sale Present 8. Feasibility phase schedule and design approach for each alternate: Preliminary design analysis complete. Long lead tooling and equipment identified. P2eq activities and schedule presented. Impact on shipping and handling presented. Feasibility engineering plan defined/reviewed including design approach, analysis/modeling, & test plan Design/Process Acceptance criteria defined Prelim. Technical Risk Assessment conducted - high probability/high impact risk items defined & reviewed. Compliant with Human Factors SIPresentYesYesYesYesYesYesYes9. Manufacturing and Sourcing Reviews complete MFG1 Review results presented Sourcing 1 Review results presentedPassPass10. EHS sub-system risk assessment process - Checklist 1 cptYes11. Patent risk assessment process initiated for all countries of sale and mfg location, main concept infringement risks assessed & reviewed Joint Development Agreements signed w/ key suppliersYesYes12. Overall assessment Any open concept issues Agreement on options for feasibility definedProceedNoYesKey Issues:Prepared by:_Acknowledged:_Name/Title/DateName/Title (T2) Design & Process Technical Feasibility Review Checklist. (Page 1 of 2)Program Title:Tracking Number:Project Leader:Date:Checklist ItemsTargetActualR/Y/GComments1.Project technical objectives defined/ reviewed.100%2.Review status of all T1 open items.100%3.Product Technical Specification Changes Reviewed Product Plan finalized (models & kits) Marketing Claim identification complete Global and Domestic needs defined. Serviceability targets defined. Installation Process and Tools definedYes YesYesYesYesYes4. Review DFR Status for Warranty and Life Show updated DFR scorecard - T2 estimate. FMEA updated with design and validation actions Reliability test plan, and passing criteria presented Cost of quality roll-up including warranty predictionYesYesYesYes5.Design and technical feasibility results presented: (system and component) FEA, DFA, noise, late point ID, etc. Validation of analysis and test results. Control system hardware and software specs released E2 Electronics Review complete/results presented. Claim feasibility demonstrated Transfer functions correlated to test results. FRACAS reporting initiated Shipping and packaging plan presented. Marketing kit feasibility demonstrated. Compliant with Human Factors SIYesYesYesYesYesYesYesYesYesYes6. Manufacturing and Sourcing Reviews Complete MFG2 Review results presented Sourcing 2 Review results presentedPassPass7.Feasibility Product Safety review complete by country of sale & on file: Toxicity code estimates complete on all parts RoHS SI compliance requirements defined Wiring review Codeboard / agency requirements defined.YesYesYesYesYes8.EHS design sub-system review cpt Checklist 2 cptYes9. Review DFSS status Transfer functions and loops reviewed and effects of deflection, assembly, heat, etc. are included. DFSS Scorecard populated with estimated Z values and msmt frequency (min. acceptable-expert opinion) QFD step 2 complete Critical Subsystem to Component transfer functions cpt Field Failure root cause to CTQ Analysis Reviewed Preliminary control plans for all CTQs completeCompleteYesYesYesYesYesYes10. Service Review (S2) complete Present issuesYes(Continued)(T2) Design & Process Technical Feasibility Review Checklist (Page 2 of 2)Program Title:Tracking Number: Project Leader:Date:Checklist ItemsTargetActualR/Y/GComments11. Review project plan highlighting: Equipment and early release needs Verify P2eq approval for all long lead tool P.O.s Master evaluation plan (including Reliability Test requirements & acceptance criteria) Field test requirements Model build and part qualification Part critical analysis completePresent planYesPresent planPresent planPresent planYes12. Technical risk assessment complete No high probability/high impact items (no red 25s)YesYes13. Feasibility Patent Risk Assessment Review complete Infringement Risks by country of sale and mfg location (including appearance, functional, and structural design features) assessed & approved. All Joint Development Agreements signedYesYesYesOverall AssessmentProceedThis change requires sign-off by Product Development Mgr & Chief Engr.Yes/NoIf yes, a risk abatement plan is requiredKey Issues:Prepared by:_Acknowledged:_Name/Title/DateName/Title(T3) Technical Design & Process Confirmation Review ChecklistProgram Title: Tracking Number:Project Leader:Date:Checklist ItemsTargetActualR/Y/GComments1. Project Technical Objectives reviewed100%2. Review closure status of all prior review open items.100%3. Review approved changes to Product Technical Spec Confirm technical data supplied for commercial literature100%Yes4. Review design confirmation results (in-house and supplier): System, subsystem, and component test cpt. System level testing confirms control settings Sensitivity analysis to critical parameters Performance results. (International & Domestic) Marketing Claim transfer functions validated E3 Electronics Review complete/results presented Marketing Kit design confirmed Installation review complete and results reviewedPresent100%100%100%100%YesYesYesYes5. Review Technical Risk Management scorecard & abatement actions. No red items100%6. Design Confirmation Safety Review complete by country. Toxicity reports on materials with code 3 or 4 RoHS SI procedure in process on all partsYesYesYes7. EHS sub-system review cpt - Checklist 3 cpt & signedYes8. Review DFSS Status. DFSS scorecards updated and presented with measured sample and Big Y validation data Databases and drawings updated for release Transfer function and tolerance loop validation presented including thermal expansion, deflection, asm, etc. Field Failure root cause to CTQ Analysis Reviewed Control plans for all CTQs initiatedCompletePresentYesPresentYesYes9. Review DFR Status for Warranty and Life Supplier reliability audit complete Show predicted reliability for critical components. Show updated DFR scorecard T3 Estimate Show reliability test plan, passing criteria and results Show updated Duane & Crow Plots, if applicable FRACAS Summary presentedYesPresentPresentYesPresentPresent10. Review Quality status Cost of quality roll-up including warranty prediction Parts Tracker meetings being heldPresentYes11. Review tooling release schedule (In-house & supplier)Yes12. Sourcing 3 Review results presentedPass13. Pack & product shipping test performed - results reviewed Issues affecting long lead tools?YesNo14. MFG3 Review results presentedPass15. Patent Risk Assessment Review complete by country of sale and mfg locationYesOverall AssessmentProceedKey Issues:Prepared by:_Acknowledged:_Name/Title/DateName/Title(T4) Pre-Pilot Run Technical Readiness Review ChecklistProgram Title: Tracking Number:Project Leader:Date:Checklist ItemsTargetActualR/Y/GComments1.Project Technical Objectives reviewed100%2.Review closure status of all prior review open items.100%3.Review approved changes to Product Technical Spec100%4.Review product evaluation. System, subsystem, and component reliability conformance demonstrated vs. plan Field test units inspected, results documented FRACAS Summary presented Show updated DFR scorecard for Warranty and Life Sensitivity analysis to determine critical design and process parameters completed E4 Electronics Review complete/results presented Verification of readiness for claim validation testing In compliance with ship test requirementsPresent100%100%100%PresentYesYesPresentPresent5.Review technical risk management scorecard and abatement actions. No red items.Present6.Present process product safety, agency approvals, toxicity, & RoHS SI procedure data status for all countries.Yes7.EHS pre-pilot assessment cpt- Checklist 4 cpt & signedYes8.Review DFSS Status (In-house & supplier) DFSS scorecards updated and presented with tooled part & process FPIR data Tolerance loops and transfer functions validated Gage R & R complete Alpha rev assembly drawings complete Field Failure root cause to CTQ Analysis Reviewed Control plans complete for all CTQsCompletePresentPresentYesYesYesYes9.Review Quality status Cost of quality roll-up including warranty prediction Preliminary 1st piece - 100% dimensions checked Supplier reliability audit plans verifiedYesYesYesYes10. Manufacturing and Sourcing Reviews MFG4 Review results presented Sourcing 4 Review results presented Bills of Material ReleasedPassPassYes11. Service Review (S3) complete by country of sale PassOverall AssessmentProceedKey Issues:Prepared by:_Acknowledged:_Name/Title/DateName/Title(T5) Pilot Run Technical Readiness Review ChecklistProgram Title:Tracking Number:Project Leader:Date:Checklist ItemsTargetActualR/Y/GComments1.Project technical objectives reviewed.100%2.Review closure of all prior review open items.100%3. Review evaluation test results & status System Installation review issues resolved Sub System Component (inc. kits) Life/reliability results Field test (present new issues) Ship test Marketing Claims verified E5 Electronics Review complete & results presented FRACAS Summary presented; FMEAs Updated Show updated DFR scorecard for warranty and life Show updated Duane & Crow Plots, if applicable Energy data submitted to agencies100% Cpt.4. Review conformance section of Product Technical Specification and approved changes since T4.100%+5.Closure of Product Safety Review items on file.100%6.EHS pilot run review - Checklist 5 cpt & signedComplete+7.Confirm product safety, agency approvals, toxicity, & RoHS SI complete for all countries& on file. 100% Cpt8.Review DFSS Status *First piece disposition Confirm formal deviations for required items. Update Z values; Zlt greater than 4.5 All CTQs loaded in Quality Information Systems Verify UPC label first pieced and trial run complete Rev 0 assembly drawings released with CTQs Human Factors items complete Field Failure root cause to CTQ Analysis Reviewed100%100%100%100%YesYesYesYes9.Review pre-pilot results. New P&A items Internal Quality measures Cost of quality roll-up including warranty predictionZeroPresentPresent10.MFG5 Review results presentedPass11. Sourcing Review 5 results presentedPass12. Service Review (S4) complete by country of sale Present Issues13. Confirm kit availability Yes14. Verify Countries Approved for Sale in SPP/PC-poleYes15. Confirm closure of all technical risk abatement itemsYes16. Patent Infringement search repeated for post-T2 filings Docket status complete, with filing planLegal Sign-offYes17. DRB update ownership established.YesOverall AssessmentProceed*Formal deviation required for all non-conforming items. +Formal product sale “hold” required for all incomplete items (Red pending P3 review)Key Issues:Prepared by:_Acknowledged:_Name/Title/DateName/TitleIf Product Development Manager and Chief Engineer were required to approve T2, then sign-off is required for implementation._Product Development Manager/DateChief Engineer/Date(T6) Program Closure Review ChecklistProgram Title:Tracking Number:Project Leader:Date:Checklist ItemsTargetActualR/Y/GComments1.Review closure of all prior review open items100%2. 2. Review closure of evaluation test results and FRACASComplete3.Product Technical Specification revised to include all RSCs, exceptions, and final conformance data. RevisionReleased4.EHS checklist 6 complete & signedComplete5.Review DFSS Status (In-house & supplier) Confirm first piece disposition complete Confirm deviation process used since T5 Confirm QMS System in operation with alarms DFSS Scorecard ownership returned to Systems Field Failure root cause to CTQ Analysis ReviewedComplete100%YesYesYes6.Review pilot/production results New P&A items Internal Quality measures meet goals Pilot safety review complete & on fileZeroYesYes7. Manufacturing and Sourcing Reviews MFG6 Review results presented Sourcing 6 Review results presentedPassPass8. Review Reliability Audit plan and tracking requirementsShow updated DFR scorecard for Warranty and LifeYesPresent9. Confirm service readiness Service Review (S5) complete Present issuesYes10. DRB Update completeYesOverall AssessmentProceedKey Issues:Prepared by:_Acknowledged:_Name/Title/DateName/Title(P1) Program Scope Study & Business Strategy Review ChecklistProgram Title:Tracking Number:Project Leader:Date:Checklist ItemsReqmtActualR/Y/GComments1. Market Requirements Finalize consumer “Big Ys” with metrics Product Feature & Appearance concept research cpt. Styling, feature, form & function IDO models finalized Potential marketing claims identified Comparison to competitive benchmarks complete M-1 Marketing Review complete present issuesPresentCptPresentPresentPresentPresentPresent 2. Product definition and preliminary Product Plan Final feature & appearance requirements by brand Update preliminary volume estimates by country Kit needs identified Product Technical Specification ReleasedCptCptCptYes3. Preliminary schedule reviewed Key milestone schedule established Critical path identifiedPresentCpt4. Resources/ Benefits/Product Cost Overview/Metrics Summary by country of sale Risk Assessment Crystal Ball Program Cost (I&E) 4 BlockPresentPresentAppendix5. Preliminary program risk assessment complete Present red issues and abatement plansPresent6. Technical objectives reviewed (verify T1 passed) Design and Process concept issues identifiedPresentIssues7. DFSS top level scorecard presented Preliminary QFD step 2 completePresentCpt8. Review DFR goals for Warranty and Life Show updated DFR scorecard for Warranty and Life Cost of Quality reduction opportunities define