质量管理计划

ODM Quality Management PlanProduct Name: Y seriesProduct P/N:Approvals(Name) (Name)Global Quality Engineer Global Quality Manager Lenovo Lenovo(Name)GSC Procurement ManagerLenovo(Name) (Name)Quality Account Manager Quality Manager Supplier ABC Supplier ABC (Name)Executive Sponsor / General ManagerSupplier ABC (site specific)Quality Plan Document Revision HistoryContents1.Purpose Page 92.Key Performance Indicators and Quality Goals Page 102.1.DOA (D+30) Page 102.2.DOA (D+90) Page 102.3.Missing, Wrong, & Damage Page 102.4.Repair Action (Overall) Page 112.5.Supplier Internal Process Goals Page 112.5.1.Incoming Parts Line Reject Rate Page 112.5.2.PCBA-SMT Process Yield Page 122.5.3.Box Assembly Process Yield Page 122.5.4.Out-of-Box (OOB) Page 122.6.Process Capability Index (Cpk) Page 133.General Requirements Page 133.1.System Part Number & Ship Location Page 133.2.Manufacturing Location Page 133.3.Critical Contact Page 133.4.Quality Systems and Process Audit Page 143.5.Critical Component Control Page 143.5.1.Critical Component Listing Page 143.5.2.Critical Component Quality Monitoring Page 143.6.Sub-tier Supplier Management Page 143.7.Quality Organization Page 153.7.1.Quality Organization Page 153.7.2.Quality Executive and Sponsor Page 163.7.3.Quality Training Page 164.Specifications & Change Management Page 164.1.Product Specification, Technical Drawings, Page 16and Service & Repair Manual4.2.Engineering Changes Page 164.3.Process Change Request Page 165.New Product Introduction: SVT, SOVP, and Ship Support Page 175.1.System Verification Test (SVT) Page 185.1.1.Notebook Page 185.1.2.Desktop Page 195.1.3.Workstation Page 195.1.4.Server Page 195.2.Start of Volume Production (SOVP) Page 195.2.1.Notebook Page 205.2.2.Desktop Page 205.2.3.Workstation Page 205.2.4.Server Page 205.3.Ship support (SS) Page 215.4.Corrective Action Plans Page 215.5.Data Collection & Reporting Page 225.6.Post Mortem / Post Build Review Page 225.7.Production Process Flow/Process Page 22Management Plan5.8.Approved Vendor List Page 235.9.Fist Article Inspection Page 236.New Site / Facility and Production Line Qualification Page 247.Quality Plans Page 257.1.Quality Control Page 257.1.1.Incoming Parts Page 257.1.2.In-process Inspection Page 257.2.Quality Assurance Audit Page 257.2.1.Out of Box Audit Page 257.2.1.1.Incoming Items and Criteria Page 257.2.1.2.OOB Sampling Plan Page 257.2.1.3.OOB Reporting Page 257.2.2.XCSA Page 257.3.Quality Alert: Q-hold, Stop Build, & Stop Ship Page 267.4.Failure Mode Effect Analysis Page 277.5.Failure Analysis Page 277.5.1.Factory/Production Rejects Page 277.5.2.Field Returns / Dead-on-Arrival Page 277.6.Closed Loop Corrective Actions Page 277.7.Product Rework / Rescreen Page 288.Statistical Process Control Page 288.1.Gauge Repeatability and Reproducibility Page 288.2.Process Capability (Cp / Cpk) Page 309.Reporting Page 30Glossary & AcronymsAOI: Automated Optical InspectionAIO: All in oneATE: Automated Test EquipmentAVL: Approved Vendor ListCLCA: Closed Loop Corrective Actions DOA: Dead-on-ArrivalFA: Failure AnalysisFAI: First Article InspectionFMEA: Failure Mode Effect AnalysisFPY: First Pass YieldGR&R: Gauge Repeatability and Reproducibility GSC: Global Supply ChainHDD: Hard Disc DriveHMU: Hot Mock UpICT: In-Circuit TestKPI: Key Performance IndexLME: Lenovo Manufacturing Engineering LRR: Line Reject RateMRR: Manufacturing Readiness Review MWD: Missing, Wrong, and DamageNB: NotebookNPI: New Product IntroductionODD: Optical Disc DriveOOB: Out-of-Box AuditORT: On-going Reliability TestPCBA: Printed Circuit Board AssemblyPCR: Process Change RequestPE: Procurement EngineeringPMP: Process Management PlanPPAP: Piece Part Approval ProcessQBR: Quarterly Business ReviewQ-Hold: Quality HoldQPA: Quality Process AuditQSA: Quality System AuditRA: Repair ActionRTY: Rolled Throughput YieldSPC: Statistical Process ControlSMT: Surface Mount TechnologySTD: Standard DesktopSOVP: Start of Volume ProductionSS: Ship SupportSVT: System Verification TestSVR: ServerTPG Edge: BVKE and ThinkPad E series product VLRR: Verified Line Reject RateWS: WorkstationXCSA: External Customer Simulation Assurance1.PurposeThe purpose of this agreement is to document the part number specific product quality requirements from Lenovo that are not covered in the Terms and Conditions outlined in the Master Purchase Agreement and the Quality Agreement/Addendum.Appendix/Attachment in this Quality Management Plan shall be updated as necessary to reflect the most current/accurate operation practices and requirements.2.Key Performance Indicators (KPI) & Quality GoalsThe KPIs and/or Quality Goals are critical to favorably differentiate product quality performance as experienced by Lenovo’s customers. The objective is to deliver products that achieve business goals and meet customers’ qualityexpectations in the markets and environments for which they are designed, produced, and serviced.Quality goals outlined below are intended as initial baseline. Lenovo Quality team will publish/update the Quality goals as appropriate to meet higherstandard of Business Requirements, Process/Technology advancement, and Customer Experience.2.1.DOA (D+30)2.2.DOA (D+ 90)2.3.Missing, Wrong, and Damage (MWD)2.4.Repair Action (Overall)2.5.Supplier Internal Process Goals2.5.1.Incoming Parts Line Reject Rate2.5.2.PCBA-SMT Process Yield2.5.3.Box Assembly Process Yield2.5.4.Out-of-Box (OOB)2.6.Process Capability Index (Cpk)3.General Requirements3.1.System Part Number & Ship Location (Appendix A)The Supplier will complete System Part Number and Ship Location matrix with all the appropriate information.Example,3.2.Manufacturing Location (Appendix B)The supplier will complete the Manufacturing Location matrix and provide manufacturing facility enablement & readiness plans two (2) weeks after project kickoff.The supplier shall provide production line qualification plan to Lenovo Global Qualityengineer and the production lines and/or facility must be approved by LenovoManufacturing Engineering (LME) prior to manufacturing of any Lenovo product.Any changes to the manufacturing matrix will require 90-day prior notification to Lenovo LME organization.3.3.Critical Contact (Appendix C)The supplier will provide Critical Contact information two (2) weeks after project kickoff.The supplier shall maintain and update the Critical Contact matrix to ensure information in the matrix is up to date. Lenovo LME and/or Global Quality Engineering will approve any changes to the Critical Contacts List before the implementation is made.3.4.Quality Systems and Process Audits (Appendix D & E)The supplier shall establish and maintain a Quality Standards/Systems to drive quality excellence.Lenovo Global Quality Engineering will perform one time and/or recurring Quality Systems audit(s) and/or Quality Process audit(s) to supplier’s manufacturing facility. The supplier shall provide necessary support, access, and obtain “Full Approved” audit status. In the event of the supplier receiv ed a “Conditional Approved” audit status, the supplier shall provide an acceptable corrective actions plan to Lenovo Global Quality Engineering within 7 days from Quality System and/or Quality Process audit(s) complete. Lenovo Global Quality Engineering wi ll review the implementation of corrective actions and may issue a “stop-production” notice to the supplier in the event corrective actions implementation fail to meet the quality intent/objectives.3.5.Critical Component Control (Appendix F, G)3.5.1.Critical Component ListingThe supplier will establish and provide a critical component list (Appendix F), including parts from sub-tier suppliers/sub-contractor, prior to mass production release. Any proposed changes to the critical component list will require submission ofengineering/process change request to Lenovo Manufacturing Engineering.3.5.2.Critical Component Quality MonitoringThe supplier shall establish a quality system to track and report quality performance of critical components.3.6.Sub-tier Supplier ManagementThe supplier shall establish and maintain a Lenovo approved Sub-tier Supplier Quality Management Program. The Sub-tier Supplier Quality Management Program shall include following minimum requirements:•Supplier Sub-tier Strategy: Develop a quality strategy plan to highlight objectives and drive quality excellence•Critical Component Identification•Quality Control: Identify and utilize appropriate quality control tools and statistical techniques•Critical Process/Parameters: Define critical component process/parameters for improvement and optimization•Supplier Rating and Raking System: Establish a rating and ranking system to enable sub-tier supplier quality performance benchmarking•On-site Failure Analysis and Support Process: Define sub-tier supplier on-site support requirements and verification approach•Reporting: Reports Sub-tier Supplier performance to Lenovo Quality/PE team.Supplier will also provide Lenovo Quality/PE team a “Focus Sub-tier Supplier List”to drive continuous improvement of incoming materials quality performance.3.7.Quality Organization3.7.1Quality OrganizationThe supplier shall establish a Quality organization, ensure adequate staffing andappropriate skill set, to meet or exceed its internal Quality Policy, Quality Objectives, Quality operations, and Lenovo’s qua lity requirements/initiatives. The supplier’s Quality organization shall include below minimum functional groups:3.7.2Quality Executive and SponsorThe supplier shall identify an Exe cutive and a Sponsor to support Lenovo’s Qualityrequirements and initiatives.3.7.3Quality TrainingThe supplier shall establish appropriate Quality curriculum and conduct Quality training on a regular basis to ensure high standard of its quality operations.4.Specifications & Change Management4.1.Product Specifications, Technical Drawings, and Service & RepairManualThe supplier shall provide and/or maintain an up-to-date copy (version) of the Product Specifications, Packaging Specifications, Technical Drawings, and Product Service & Repair Manual.The technical drawing shall include (but not limited to) items below:•Mechanical parts•Electrical parts•Cables•Packing box and packing materials•Software / CDs•Pallet / Palletizing requirement•Labels4.2.Engineering ChangesAll engineering changes will be revision controlled and processed via Windchill system (for BOM/components specification related).Changes cannot be made without Lenovo approval and notification.4.3.Process Change Request (Appendix H, I)The supplier will submit to a Process Change Request (PCR) to Lenovo ManufacturingEngineering via e-mail for any production and/or manufacturing changes affecting the product. The supplier will provide Lenovo with 30 days of written notice for any PCR. Forurgent PCR, Lenovo will make good faith efforts to qualify and approve the PCR ifcircumstances allow.All appropriate documentation will be provided to ensure the change is qualified for implementation. Only Lenovo approved changes will be implemented. The supplier will submit a PCN log on a Monthly basis giving visibility to the proposed changes.5.New Product Introduction: SVT, SOVP, and Ship SupportBelow is the typical IOD process:The supplier shall follow the phase gate requirements outlined in the IOD procedures for new product launch.5.1.System Verification Test (SVT)Lenovo GSC NPI/Quality will provide the system configuration test plan to the supplier. The supplier is required to ensure adequate resource and ownership assignment to support a successful SVT. Typical activities and requirements for SVT are as below:5.1.1Notebook5.2.Start of Volume Production (SOVP)Lenovo GSC NPI/Quality will provide the system configuration test plan to the supplier. The supplier is required to ensure adequate resource and ownership assignment to support a successful SOVP. Typical activities and requirements for SOVP are as below:5.2.1Notebook5.3.Ship Support (SS)Lenovo LME will conduct Ship Support meeting to review compliance of Phase Gates requirements. Lenovo GSC Quality will provide Ship Support notification to the supplier via e-mail. The supplier is only allowed to mass production and product shipment after receiving “Ship Support Letter”.5.4.Corrective Action Plans (Appendix J)•Supplier shall establish a system to track and evaluate build results vs established goals for each critical process during SVT, SOVP, and SS. A formal (daily/weekly)review of build results will be conducted with Lenovo GSC Quality. Supplier shallprovide corrective action plans for all issues identified during SVT, SOVP, and SS.•Supplier shall re-conduct SVT, SOVP, SS build process in the event phase gates goals/requirements are not fulfilled.•Supplier will exit phase gates when all phase gates requirements have been fulfilled.•Supplier shall establish a process control plan based on issues, findings, and/or corrective actions from each phase gates. Lenovo GSC Quality will review theprocess control plan and may request additional checkpoints based on phase gatesresults.•T he supplier shall assign “Severity” rating to all issues identified in SVT, SOVP, and SS.Guideline for “Severity” rating criteria as below:•Severity 1 - Critical problem detected and test activities cannot be continued.Issue related to Safety, Regulatory, and/or critical functional issues.Unable to proceed with major portion of test or development and/or defectcauses a major checkpoint to slip day by day.Customer is unable to perform common operations / critical functions.Immediate fix is needed. During test the submitter should call and inform thedeveloper that a severity 1 defect has been written.•Severity 2 - Serious Problem, Test activities are severely restricted.Test or development is severely restricted due to a defect encountered for whichthere is no acceptance circumvention.The customer is unable to perform mainline function. A fix is needed to proceedwith test or development.•Severity 3 - Problem, Not severely restricted.Able to proceed with limited function which is not crucial to the test ordevelopment.Either the defect is serious but an acceptable circumvention exists or the defectis not serious and no circumvention exists.The customer is affected, but is able to work around the problem. Fix targetdates are subjected to negotiation.•Severity 4 - Problem, Slight hindranceNo immediate impact to test or development. Fix target are subjected tonegotiation.This is more or nuisance item or recommendation and is not a functional defect.5.5.Data Collection & Reporting (Appendix K)▪The supplier is required to monitor each of the processes identified during each of the builds per the goals established via automated shop floor control system.▪SVT, SOVP, SS data collection/reporting template and action plan register will be used for all builds.▪Supplier will provide a daily summary report after completion of each build. The report shall contain all of the appropriate process yields (goals), issues identified,and corrective action plans.5.6.Post Mortem / Post Build Review (Appendix L)A formal post-mortem (Fu-Pan) will be held (at Lenovo’s discretion) within 60 days after Smart GA where the product and quality issues should be identified and published to Lenovo Manufacturing Engineering (LME) as requested.5.7.Production Process Flow / Process Management Plan (PMP)The supplier will provide Lenovo GSC Quality a detailed product/process flow chart prior to production release. The production process flow chart will identify all process form receiving inspection to final shipping. The production process flow chart should include below minimum information:•Process flow by station•Critical stations/parameters•Operation performed•Materials used•Tools and/or equipment•Inspection checkpoints•Inspection method•Inspection frequency (100% or sampling)•Process control points•Process control limits•Process ownerIf the supplier is using PCBA subcontractors, a process flow chart from each sub-contractor will be provided to the Lenovo LME.5.8.Approved Vendor ListThe supplier shall establish a control system for approved vendor list management. The supplier shall conduct necessary maintenance activities to ensure information accuracy in the approved vendor list system.All approved vendor list changes will be revision controlled and processed via the ECN process. Changes cannot be made without Lenovo LME approval and notification.5.9.First Article InspectionThe supplier and/or the sub-contractors are required to perform a First Article Inspection (FAI) using the latest design specifications to verify and assure compliance of part/product produced in a normal production environment to the design engineeringparameters/specifications.The supplier will provide a test plan for critical components, plastic/mechanical, and product level inspection prior to production release.Below are general guidelines for First Article Inspection:•New Product Introduction•New manufacturing facility/site•Engineering Change Notice / Process Change Notice•As requested by the Lenovo LME•Changes to Critical Components•New Sub-Supplier/Sub-Supplier Site (change to the AVL)•New tool/mold/dies (PPAP)•Major tooling or equipment refurbishment (PPAP)•Relocated tooling or production equipment (PPAP)•Revised or modified process flow or production sequence•Changes in materials or material sources•Product following a stop-ship order due to a quality issueFirst Article Inspection may include verification of mechanical dimensions,chemical/cosmetic finishes, solder workmanship verification, system configuration, and system test. A First Article inspection report shall include the supplier name, manufacturing location, part number, and revision. Included in the First Article Report is a list of inspection characteristics to be verified, either visually or through the use of standard inspection tools. An inspector or quality engineer will perform the First Article Inspection. Final approval of the success of the First Article Inspection will be the responsibility of Lenovo LME. Upon request, the supplier will submit FAI data to Lenovo LME for approval prior to production release.6.New Site/Facility and Production Line Qualification (Appendix I) The supplier will submit New Line Qualification request to Lenovo GSC Quality via e-mail. The supplier will need to conform to requirements specified in “New Site/Facility Line/Process Change Qualification Process”.Lenovo GSC Quality will conduct line qualification prior to mass production.Any deficiencies that are found during the line qualification will require the supplier to develop a corrective action plan with date-to-completion and person responsible. All corrective actions must be closed and approved by Lenovo GSC Quality prior to mass production.7.Quality Plans7.1.Quality Control7.1.1.Incoming parts:The supplier will provide for incoming quality controls for the following•Mechanical parts•Electrical•Storage & Memory•Display•PackagingThe supplier will utilize sound statistical techniques at IQC. The supplier will provide amatrix that indicates the critical components and sampling plan criteria to Lenovo GSC Quality prior to production release. Any changes to the plan will require approval from Lenovo GSC Quality. The supplier shall prepare IQC report that details the (incoming)product performance as compared to the goal on a weekly basis. In instances wherecomponents are beyond the set goal, containment and corrective action will becompleted.7.1.2.In-Process InspectionThe Supplier will provide the Lenovo GSC Quality a listing of critical inspectioncheckpoints. Only sound statistical techniques will be utilized. Statistical ProcessControl (SPC) will be used wherever applicable. The supplier will submit an SPC test plan that includes containment, corrective action if the trend is negative and/or out of goal.Within the listing of checkpoints, the supplier will provide the control limits and setgoals by quarter. The Lenovo GSC Quality must approve the plan prior toimplementation and approve any changes to the in-process controls. In instanceswhere in-process goals are beyond the set goal containment and corrective action willbe completed. The Supplier will be required to provide weekly and monthlyperformance report.7.2.Quality Assurance Audit (Appendix M, N, O, P, Q, & R)7.2.1.Out of Box Audit (OOB)Out of Box Audit sampling plan will be as according to MIL-STD-1235c, CSP1. Thesupplier shall perform OOB sampling as according to requirement specified in Appendix M.The Supplier will provide OOB inspection plan to Lenovo GSC Quality prior to production release. The Lenovo GSC Quality will approve the plan prior to implementation. Anychange to the OOB plan must be communicated to Lenovo GSC Quality via e-mail. The supplier shall only implement the change after receive approval from GSC Quality.7.2.1.1Inspection Items and CriteriaOOB inspection shall include below minimum requirements:•Electrical functions and performance characteristics•Cosmetic and Finishes•Packaging and Labels•Accessories and ContentsA high level OOB inspection guide is in Appendix N, O, P, Q, R.7.2.1.2OOB Sampling PlanThe product will be sampled from finished goods prior to packing box taping station.7.2.1.3OOB ReportingThe Supplier will provide Lenovo GSC Quality a summary report of the OBA data on a weekly basis and monthly basis. In the event where the performance is beyond the set goal, the supplier will implement containment, corrective and preventive action.7.2.2.XCSALenovo XCSA is designed to duplicate the customer’s experience u pon receiving the new computer system. The supplier is required to develop a XCSA inspection plan and submit to Lenovo GSC Quality for approval.A high level OOB inspection guide is in Appendix O, Q, & R.7.3.Quality Alert: Q-hold, Stop Build, & Stop Ship (Appendix S)The supplier shall comply with Quality Alert/Escalation as according to process and requirement stated in “Quality Alert and Problem Management Process”. Quality Alert general guideline/criteria as below:•No recovery plan within 48-72 hrs.•No root cause clue and long term fixed solution within 7 calendar days.•Mfg needs to do extra testing (e.g. higher OOB, extended test) more than 2 weeks.The supplier will provide their Q-hold, Stop Build, and Stop Ship Run Rules to Lenovo Manufacturing Engineering for approval prior to mass production. The supplier shall specify conditions to re-start/resume production after line stop/line down.Supplier is required to submit a daily report (with status update and recovery plan) and a CLCA in the event of Q-hold, Stop build, and/or Stop ship to Lenovo GSC Quality.7.4.Failure Mode Effect Analysis (Appendix T)Process Failure Mode Effect Analysis (FMEA) will be conducted to identify high risk areas. Corrective actions plans must be instituted to ensure high risk are resolved.7.5.Failure Analysis7.5.1.Factory/Production RejectsThe supplier shall ensure adequate equipment and resource planning to performproduct/parts failure analysis. The supplier shall establish a process for the sub-tier supplier Failure Analysis Engineers to visit its factory to perform parts failure analysis.The supplier shall provide root-cause failure analysis and corrective action for all rejects from manufacturing operations and Quality Audits (OOB and XCSA). The supplier will submit a failure report to the Lenovo GSC Quality on a Weekly and Monthly basis.7.5.2.Field Returns / Dead-on-ArrivalThe supplier shall ensure that Failure Analysis Engineers are present in all major service centers to perform product filed return failure analysis (or Dead-on-arrival failures). The supplier shall establish a process for Field Return / Dead-on-arrival (DOA) failure analysis including a process for second level failure analysis.The supplier shall provide field returns validation report, root-cause failure analysis and corrective action for all the field failures/returns. The supplier will submit a failurereport to the Lenovo GSC Quality on a Weekly and Monthly basis.7.6.Closed Loop Corrective Actions (Appendix J)The supplier will use the CLCA approach to resolve all problems/issues for production excursions and OOB/XCSA failures. All CLCAs will be documented in the CLCA log and provided to Lenovo Sustaining Engineer on a weekly basis.Production/process excursion timeline:•Problem identification within 2hrs of problem notification•Containment plan within 2hrs of problem identification•Corrective actions/Recovery plan within 4 hrs of root cause identification•Problem closure verification within 4 hrs of corrective actionsCLCA Process:1Issue description2Containment3Root cause4Corrective actions5Preventive actions6Verification7Effectiveness review7.7.Product Rework/RescreenThe supplier will notify Lenovo GSC Quality/PE of any rework/screening operations required on Lenovo product prior the release of the product to Lenovo. The Lenovo GSC Quality/PE must approve the rework/screening operations prior to use. Rework and screeningprocedures will be documented and validated to ensure product form, fit and function are maintained. The supplier will submit any rework and screening process/procedures along with validation documentation to Lenovo GSC Quality/PE for approval beforeimplementation.8.Statistical Process Control (Appendix U)8.1.Gauge Repeatability and ReproducibilitySupplier will submit a listing of all gauges that will be controlled through the GR&R process prior to production release. Gauge R&R for manufacturing-measuring equipment will be performed prior to the follow occurrences. Raw data and summary results will besubmitted to Lenovo LME prior to implementation.•New product introduction•Major changes to line configuration or equipment•New line introductions•Statistical capability beyond control limitsThe gauge will be removed from the process if the results of the Gauge R&R are greater than 30%. The GR&R worksheets and results will be reported to Lenovo LME prior toproduction release (product release).GR&R studies should be used to assist in determining the precision, major problems, amount of variation, and acceptability of all gauging systems used throughout the manufacturing process. It will also furnish a comparison of the accuracy of one measuring device against another. Every piece of measuring equipment is subject to a certain amount of variation. It is then in our best interest to conduct a study of the measuring equipment to determine if it is both "correct" and "repeatable". The variation factors that are present in all variable gauges are:•Accuracy,•Stability,•Repeatability,•Reproducibility.Gauge System Error - Is the combination of accuracy, repeatability, reproducibility and stability.Percent Repeatability and Reproducibility (% R&R) - Is the percentage of the specification tolerance that is lost to gauging error.8.2. Process Capability (Cp/Cpk)Statistical Process Control (SPC) and Process Capability Analysis (Cp/Cpk) will be used wherever applicable.Equipment and processes will be qualified using sound statistical techniques. Processes that are below <1.0 Cpk will be rejected for use in the manufacturing product for Lenovo unless special approval is received from Lenovo LME and a corrective action plan is required to ensure process meet the stated goal and quality level. For those processes that meet the 1.0-1.32 Cpk minimum requirement, an improvement action plan is required to enable the process to meet the stated goal.。