Electronics: Printed Boards And Printed Board Assemblies

Electronics: Printed Boardsand Printed Board AssembliesCritical manufacturing processes for theMedical Device Industry

Julia MarkardtPerformance Review Institute (PRI), Staff Engineer40 years of experience in the electronics industryExtensive experience with NASA and US Military projectsEPTAC, IPC Master Instructor (IPC MIT)Harris Corporation, Technical Trainer (IPC CIT)Eastern Florida State College, Adjunct ProfessorSoldering and Advanced SMTSpace Tech ProgramReliable Systems Services, Quality Manager/Configuration ManagerANSI/ASQC Q9003-1994 for DLA1

Michael Brown, StrykerMichael began his career with Celestica at their headquarters in Toronto, Ontario. Rolesincluded PCBA Mechanical Test engineer (Vibration, thermal and shock environments) andAdvanced Process Development Engineer for new processes (fine pitch, lead-free, PCBAstress/strain analysis). He joined Stryker as a Supplier Quality Engineer with StrykerElectronics (in-house PCBA manufacturer) and now is a Staff Audit Supplier QualityEngineer with a focus on PCBA supplier auditing and development. He is based in RedondoBeach, CA.Bachelor of Mechanical Engineering and Management - 2001MBA, Management of Innovation and New Technology - 2003McMaster University, Hamilton, ON Canada2

AgendaCritical Manufacturing ProcessExamples of Product FailureTechnical Standards ComplianceTop Non-ConformancesTypical Initial Root Cause ResponsesCritical Process ElementsPBAPBWhat is the Medical Device industry doing to improve PBA/PB Quality and Supply ChainOversight?3

Critical Manufacturing ProcessBest practices for ensuringQualityConsistencySafetyReliability4

Examples of FDA Product Failure Recalls - PBAsProductClassReasonImpactBio-Console ExtracorporealBlood Pumping ConsoleIIMotor controller printed circuit boards with a capacitorinstalled in reverse can result in a shut down of theproduct pump126 units recalledVentilatorIIAn increased likelihood of failure of the CPU circuitboard. This could result in a blank display or loss ofmechanical ventilation.46 units recalled5

Technical Standards Compliance is CriticalPrinted BoardsIPC-6010 series - Qualification and Performance SpecificationsIPC-A-600 – Acceptability of Printed BoardsPrinted Board AssembliesIPC-A-610 – Acceptability of Electronic AssembliesJ-STD-001 – Requirements for Soldered Electrical and Electronic AssembliesJ-STD-002 - 033IPC-7711/7721 – Rework, Modification and Repair of Electronic AssembliesIPC-TM-650 – Test Methods ManualMedical IndustryQMS Certification such as ISO 13485, ISO 9001, etc.21 CFR part 820.181 Device Master Record21 CFR part 820.184 Device History Record6

Technical Standards Compliance ensures:Product QualitySolder Purity – contaminated solder can cause poor electrical connection, solder joint failureand degradationHand Soldering Technique & Certification – wrong technique can cause solder joint failure anddegradationConsistencyProcess ValidationTime Temperature ProfilesRecipesDetailed Work InstructionsSoldering Iron Tip Temperature7

Technical Standards Compliance ensures:SafetyElectrical TestingReliabilityClass 2 or Class 3?Environmental TestingMaterial Management – Read the technical data sheet!Cleanliness testingHow long will a solder joint last?8

Top Non-conformancesSolder PurityEnvironmental ControlsESD (Electrostatic Discharge)Moisture ControlCleanlinessFOD (Foreign Object Debris/Damage)Flux ResidueShelf Life/Work and Pot LifeGold EmbrittlementRecording ReworkSolderability9

Typical Initial Root Cause ResponsesEngineer did not read or fully understand the technical standardExample: J-STD-033 requirements include:Moisture Barrier Bag shall meet MIL -PRF-81705, Type IDesiccant Material shall meet MIL -D-3464, Type IIHumidity Indicator Card (HIC) shall have 3 color spots of 5%, 10% and 60%Operator did not know how to read HIC cardEngineer wasn’t aware that solder touch-up needed to be recordedExample: J-STD-001 requirements include:13.1 Hardware defects shall (N2D3) be documented before rework. Rework for Class 2 should and forClass 3 shall be documented. The second application of a soldering iron during a hand solderingoperation of a single connection is not considered rework.10

PBA Manufacturing - Critical Process ElementsProcess ValidationMedical Record KeepingFODESDCalibrationPreventative MaintenanceFacility Environmental ManagementPurchasing & Authentic Component AssuranceProcess ControlCAD/CAM DataReceipt, Inspection & Control of IncomingMaterialStorage & Handling of Received MaterialsComponent Programming11Electronic Component PreparationStencil PrintingComponent PlacementIn-Process Placement Verification/InspectionAssembly Soldering ProcessesSecondary AssemblyPCBA Cleaning Process and ControlCoating and EncapsulationAdhesive BondingAssembly TestingFinal Acceptance InspectionReworkStorage, Handling & Packaging of Finished Goods

PBA Manufacturing - Critical Process ElementsProcess ValidationMedical Record KeepingFODESDCalibrationPreventative MaintenanceFacility Environmental Managementv Purchasing & Authentic Component AssuranceProcess ControlCAD/CAM DataReceipt, Inspection & Control of IncomingMaterialStorage & Handling of Received MaterialsComponent Programming12Electronic Component PreparationStencil PrintingComponent PlacementIn-Process Placement Verification/InspectionAssembly Soldering ProcessesSecondary AssemblyPCBA Cleaning Process and ControlCoating and EncapsulationAdhesive BondingAssembly TestingFinal Acceptance InspectionReworkStorage, Handling & Packaging of Finished Goods

PBA Manufacturing - Critical Process ElementsPurchasing & Authentic Component AssuranceReceipt, Inspection & Control of Incoming Material13

PB Manufacturing - Critical Process ElementsProcess ValidationMedical Record KeepingProcess ControlEngineering Source File ProcessingMaterial ch-Strip (DES) and Strip-Etch-Strip(SES)Developing Photoimageable ResistCopper Etching of Inner Layers and Outer LayersStripping of Resist Film and Etch-Resist Plating14Etched Image Inspection (Manual or AOI)Permanent Solder MaskSolder Mask ApplicationSolder Mask ExposingSolder Mask Develop and CureOxide Coating / Oxide Replacement CoatingMaterial Lay-Up and LaminationDrillingMechanical DrillingLaser Drilling – In HouseLaser Drilling – Out SourcedPost-Drill Cleaning and EtchbackCopper Plating

PB Manufacturing - Critical Process Elements cont.Electroless Copper/Direct MetallizationElectroplated CopperFinal FinishesHot Air Solder Leveling (HASL)Fused Tin-LeadElectroless (Chemical)/Immersion Plating FinalFinishElectroplated Final FinishOrganic Solder Preservative (OSP)Wire Bondable PlatingLegend and MarkingRouting and Machining15Electrical Test - FunctionalX-Ray Fluorescence (XRF)Microsection Sample Selection Preparation andInspectionStructural IntegrityMaterials LabChemistry LabMonthly Quality Conformance TestingFinal ValidationPackaging

What is the Medical Device industry doing to improve PBA/PB Qualityand Supply Chain Oversight?Electronics PBA / PB Task GroupPhilips, Stryker, J&J, GE Healthcare, Flex, Kimball, Sanmina, EltekOpen to subject matter experts from OEMs, CMs and SuppliersDevelop Audit CriteriaApprove SME auditorsGrant Supplier accreditationsMedAccred Accreditation is used by OEMs/CMs as a criteria toaward new business and oversee their critical process supplychain quality.Suppliers use MedAccred Accreditation to ensure final productquality and improved manufacturing operations.16

Questions?Julia MarkardtMedAccredStaff Engineerjmarkardt@p-r-i.org724-772-864917Justin McCabeMedAccredSr. Specialist, Business Developmentjmccabe@p-r-i.org724-772-8639

Printed Boards IPC-6010 series - Qualification and Performance Specifications IPC-A-600 – Acceptability of Printed Boards Printed Board Assemblies IPC-A-610 – Acceptability of Electronic Assemblies J-STD-001 – Requirements for Soldered Electrical and Electronic Assemblies J-STD-002 - 033