Supplier Quality Assurance Requirements
AEP 40-002PAGE 1 OF 24Supplier Quality Assurance RequirementsINFORMATION COPY ONLY:Paper copies are not official unless the revision level is verified against the online AEP document before use.NOTE: AEPs apply to the entire company, and are not intended to be site or value stream specific.Document NumberAEP 40-002Original Release Date9/20/2019Business Process40 - Supply Chain ManagementSub ProcessRevisionNEWRevision Release DateProcurementDeveloped or Revised byMark HeppApproved by Process OwnerJim DavisConcurrenceDorel Agafitei, Julie Mazhukhin, Mark HeppDistributionSupplier Quality & Purchasing BuyersReason for RevisionSupersedes AGIS 40-002CA&E AEROSPACE & ELECTRONICS PROPRIETARY:THE INFORMATION CONTAINED HEREIN ISPROPRIETARY TO CA&E AEROSPACE & ELECTRONICS AND SHALL NOT BE REPRODUCED OR DISCLOSEDIN WHOLE OR IN PART OR USED FOR ANY DESIGN OR MANUFACTURE BY NON-CA&E AEROSPACE &ELECTRONICS EMPLOYEES EXCEPT WHEN SUCH USER POSSESSES DIRECT WRITTEN AUTHORIZATIONFROM CA&E AEROSPACE & ELECTRONICS.Table of Contents1. INTRODUCTION41.1 Purpose . 41.2 Order of Precedence. 41.3 Applicability . 41.4 Policy. 41.5 Abbreviations and Acronyms . 51.6 Related Documents . 61.7 References . 62. INSTRUCTIONS72.1 Quality Management System (QMS) Requirements . 72.2 Quality Manual . 82.3 Compliance to Contractual Requirements . 82.4 Customer Access Rights . 82.5 Franchised Distributors . 92.6 Control of Sub-Tier Suppliers . 92.7 Special Process Suppliers . 92.8 Risk Management . 92.9 Control and Release of CA&E Furnished Documents . 92.10 Electronic Documents . 92.11 Application of Acceptance Authority Media (AAM) . 102.12 Federal Aviation Administration Regulations . 102.12.1 Anti-Drug and Alcohol Misuse Prevention Program . 102.12.2 Duty Time Limitations . 102.13 Business Continuity . 112.14 Personnel Awareness . 119/20/2019
AEP 40-002PAGE 2 OF 242.15 Training and Competency . 113. PRODUCT QUALIFICATION113.1 Design and Development Control of System Integrated Programs (SIP) . 113.2 First Article Inspection Requirements (FAIR) . 113.2.1 Printed Wiring Board (PWB) FAIR . 123.2.2 First Article Inspection (FAI) Software . 123.2.3 Component Testing or Screening FAI . 123.3 Production Part Approval Process (PPAP). 123.4 Manufacturing Process Documentation . 124. PROCESS CONTROL134.1 Test Reports . 134.2 Foreign Object Debris/Damage (FOD) . 134.3 Software Control Requirements . 144.4 Key Characteristics . 144.5 Control of Monitoring and Measuring Devices. 144.6 Preventive Maintenance . 144.7 Source Inspection . 144.7.1 CA&E Source Inspection . 144.7.2 Government Source Inspection (GSI) . 154.8 Limited Shelf Life Materials . 154.9 Sampling Inspection. 154.10 Verification of Raw Materials and Procurement Limitations . 154.11 Electro-Static Discharge Sensitive (ESDS) Materials . 154.12 Control of CA&E Supplied Product . 164.13 Casting and Forging Fabricators . 164.14 Restrictions on Acquisition of Specialty Metals per DFARS 252.225-7008 and Certain ArticlesContaining Specialty Metals per DFARS 252.225-7009 . 164.15 Restrictions on Acquisition of Ball and Roller Bearings per DFARS 252.225-7016. 165. CHANGE CONTROL165.1 Change Control Process . 165.2 Supplier Change Requests . 176. CONTROL OF NONCONFORMING MATERIAL176.1 Submittal of Non-Conforming Material . 176.2 Re-Submittal of Material Rejected by CA&E . 186.3 Supplier Containment . 186.4 Material Review Board (MRB) Authority . 186.5 Notice of Escape (NOE) . 187. PACKAGING, LABELING, DELIVERY & RECORD RETENTION187.1 Preservation . 187.2 Packaging . 197.3 Labeling. 197.4 Drop Shipment of CA&E Product From Supplier to CA&E Customer (CA&E-Verification at SupplierPremises) . 197.5 Certificate of Conformance . 197.6 Record Retention . 218. CONTINUAL IMPROVEMENT218.1 Problem Solving Process . 218.2 Supplier Corrective Action . 218.3 Quality Improvement Plans . 219. SUPPLIER PERFORMANCE229/20/2019
AEP 40-002PAGE 3 OF 249.1 Performance Measures . 2210. RACI249/20/2019
AEP 40-002PAGE 4 OF 241. Introduction1.1 PurposeThis instruction shall apply to suppliers and their sub-tiers (as applicable) fulfilling Crane Aerospace &Electronics (CA&E) purchase orders. By reference on the purchase order or contract, this documentforms a part of said purchase order or contract.By acceptance of the purchase order, the supplier shall certify that materials and processes suppliedunder the purchase order shall be or have been controlled and inspected in accordance with thepurchase order and that they meet the specified order requirements, application specifications, anddrawings.This instruction provides requirements for a Supplier’s Quality Assurance System where the suppliermanufactures or procures parts and/or services that will be provided to CA&E for the incorporation intoCA&E products.Nothing in this instruction shall be interpreted as a waiver of any other provision(s) of the purchase orderof which this document forms a part.In case of doubt as to the applicability of this instruction or its interpretation, the supplier shall notify CA&ESupplier Quality via the appropriate CA&E buyer prior to actions that may affect hardware or itsdocumentations.Note: The Federal Aviation Administration (FAA) shall be notified of plans to use foreign suppliers for themanufacturer of FAA/PMA products or articles, to allow determination of the FAA’s ability to performsurveillance.1.2 Order of PrecedenceIn the event of conflict between the requirements of this specification and other requirements of theapplicable device specification, the precedence in which requirements shall govern, in descending orderis as follows:a. Applicable CA&E Purchase Orderb. CA&E specification or drawingc. Applicable Statement of Workd. This instructione. Specifications, standards, and other documents referenced herein1.3 ApplicabilityThis document applies to all employees of CA&E. All CA&E sites will be compliant with the requirementsof this procedure. Any deviation to this shall be covered by a specific site procedure.1.4 PolicyIt is the CA&E policy to:Ensure that externally provided processes, products and services conform to requirements. Theorganization shall identify and manage the risks associated with the external provision of processes,products, and services, as well as the selection and use of external providers. The organization shallrequire that external providers apply appropriate controls to their direct and sub-tier external providers, toensure that requirements are met.9/20/2019
AEP 40-002PAGE 5 OF 241.5 Abbreviations and AcronymsAAM: Acceptance Authority MediaAEF: Aerospace and Electronics FormAEP: Aerospace and Electronics ProcedureAGIS: Aerospace Group Instruction SystemAQL: Acceptable Quality LimitAQMS: Aerospace Quality Management SystemCA&E: Crane Aerospace & ElectronicsCB: Certification BodyCFR: Code of Federal RegulationsCMM: Coordinate Measurement MachineCOPQ: Cost of Poor QualityCOTS: Commercial Off The ShelfCPPAP: CA&E Production Part Approval ProcessDCMA: Defense Contract Management AgencyDLA: Defense Logistics AgencyDMAIC: Define, Measure, Analyze, Improve and ControlECM/EDM: Electro-chemical machining / Electro-discharge machiningECO: Engineering Change OrderESDS: Electro-Static Discharge SensitiveFAA: Federal Aviation AdministrationFAA/PMA: Federal Aviation Administration/Parts Manufacturer ApprovalFAI: First Article InspectionFAIR: First Article Inspection RequirementsFMEA: Failure Mode and Effects AnalysisFOD: Foreign Object Debris/DamageFPY: First Pass YieldGSI: Government Source InspectionIAQG: International Aerospace QualityIAQG OASIS: International Aerospace Quality Group Online Aerospace Supplier Information SystemIAQG SCMH: International Aerospace Quality Group Supply Chain Management HandbookICOP: Industry Controlled Other PartyKPI: Key Performance IndicatorM&TE: Measuring and Test EquipmentMRB: Material Review BoardNadcap: National Aerospace and Defense Contractors Accreditation ProgramNOE: Notice of EscapePCI: Process Continuous ImprovementPFMEA: Process Failure Mode and Effects AnalysisPPAP: Production Part Approval ProcessPPM: Parts per MillionPWB: Printed Wiring BoardQIP: Quality Improvement PlanQML/QPL: Qualified Manufacturers List / Qualified Products ListQMS: Quality Management SystemR&O: Repair and OverhaulRFQ: Request for QuotationSCAR: Supplier Corrective Action ReportSCD: Source Control DrawingSIP: System Integrated ProgramsSRR: Supplier Rejection Report9/20/2019
AEP 40-002PAGE 6 OF 241.6 Related DocumentsCA&E Specifications: AGIS 40-007: Request for Quotation Process AGIS 40-018: Supplier Request for Change Process AEP 40-011: Counterfeit Electronic Parts Risk Management Plan AEP 40-022: System Integrated Programs and Subcontract Management AGIS 40-028: CA&E Production Part Approval Process AEF 74-102-01: CA&E Corrective Action ReportIndustry Specifications: ISO 9001: Quality Management Systems - Requirements ISO 10012: Measurement Management Systems – Requirements for Measurement Processesand Measuring Equipment ISO/IEC 17025: General Requirements for the Competence of Testing and CalibrationLaboratories AC7004: Quality Management System Requirements for Nadcap Accredidation AS13000: Problem Solving Requirements for Suppliers AS9003: Inspection and Test Quality Systems Requirements for Aviation, Space, and DefenseOrganizations AS9006: Deliverable Aerospace Software Supplement for AS100A Quality ManagementSystems – Aerospace – Requirements for Software AS9100: Quality Management Systems – Requirements for Aviation, Space and Defense AS9102: Aerospace First Article Inspection Requirement AS9103: Quality Management Systems – Variation Management of Key Characteristics AS9115: Quality Management Systems – Requirements for Aviation, Space and DefenseOrganizations – Deliverable Software AS9120: Quality Management Systems – Requirements for Aviation, Space and DefenseDistributors AS9138: Quality Management Systems Statistical Product Acceptance Requirements(supersedes SAE ARP 9013) AS9146: Foreign Object Damage (FOD) Prevention Program – Requirements for Aviation,Space and Defense Organizations ARP 9134: Supply Chain Risk Management Guideline NCSL Z540.1: Calibration Laboratories and Measuring & Test Equipment Requirements1.7 ttps://www.sae.org/?PORTAL CODE ma.mil/POLICIES/9/20/2019
AEP 40-002PAGE 7 OF 242. InstructionsThe following set of general quality requirements applies to all Suppliers.2.1 Quality Management System (QMS) RequirementsSuppliers shall maintain a QMS suitable to the products and services provided to CA&E. The systemshould be certified by an accredited third-party certification body to the latest version of one or more ofthe following items below, as applicable: Distributors/Stockists - shall establish and maintain a QMS that is in compliance withAS9120/EN9120, AS/EN/JISQ 9100 or the latest revision of ISO 9001. Calibration Suppliers - shall establish and maintain a measurement management system that is incompliance with either: ANSI/NCSL Z540.1: Calibration Laboratories and Measuring & Test EquipmentRequirements; or ISO 10012: Requirements for Measurement Processes and Measuring Equipment; or ISO/IEC 17025: General Requirements for the Competence of Testing and CalibrationLaboratories Special Process Suppliers - shall establish and maintain a QMS that is in compliance withAS/EN/JISQ 9100, AS9003 or PRI/NADCAP AC7004. Software Suppliers (Deliverable Software Only) - shall establish and maintain a QMS that is incompliance with RTCA/DO-178, AS9006 and the Software Engineering Institute CapabilityMaturity Model guidelines of Level 3, prior to CA&E approval. Commercial Off The Shelf Suppliers (COTS) - Suppliers that provide commercial products shallestablish a QMS in compliance with the latest revision of ISO 9001, or equivalent. All Other Suppliers - shall establish and maintain QMS that is in compliance with AS/EN/JISQ9100, and a measurement management system which meets the requirements of eitherANSI/NCSL Z540.1 or ISO 10012.Suppliers registered in accordance with AS9104 shall be listed in the International Aerospace QualityGroup (IAQG) Online Aerospace Supplier Information System (OASIS) database.In the absence of an accredited third-party certification the CA&E Buyer and Quality representative mayauthorize the supplier’s QMS is suitable to the products and services provided to CA&E. Evidence forauthorization may include second-party (CA&E) audit or first-party (self) assessment to the applicablecriteria above, or to a set of alternative basic quality requirements.CA&E reserves the right to: Make final determination regarding compliance to CA&E requirements. Change C
FAI: First Article Inspection FAIR: First Article Inspection Requirements FMEA: Failure Mode and Effects Analysis FOD: Foreign Object Debris/Damage FPY: First Pass Yield GSI: Government Source Inspection IAQG: International Aerospace Quality IAQG OASIS: International Aerospace Quality Group Online Aerospace Supplier Information System
Single Supplier Scorecard (SSS) What is Single Supplier Scorecard (SSS) Single Supplier Scorecard reports the performance of the supplier. Internal user can select one of the Supplier Name for Single Supplier Scorecard. External user, the Supplier is pre-assigned to the dedicated Supplier. Supplier
Expectations for supplier performance Action plans for supplier development These plans are also used by Supplier Quality Engineers as: A baseline to measure supplier growth The basis for Supplier Quality Engineer and Audit Group scheduling for supplier visits A platform for supplier assessments
critical issues the University has established a Quality Assurance Directorate, which is mandated to develop a Quality Assurance Framework and a Quality Assurance Policy. The Quality Assurance Framework would clearly spell out the Principles, Guidelines and Procedures for implementing institutional quality assurance processes.
a contract with the sub-supplier, the supplier must impose an obligation on the sub-supplier regarding performance of this audit. The performance of such inspections shall not lessen the contractual responsibility of the supplier for the PRODUCT. 3. Product development and qualification 3.1 Quality requirements / Quality requirements specification
–3:10 –3:25 Supplier Quality/Mission Assurance Requirements Activity 3:25 –3:30 Supplier Quality Execution –3:30 –3:45 Supplier Oversight –3:45 –3:50 Supplier Ratings - Scorecard –3:50 –4:05 Actions for Non-conformance - Root Cause Corrective Action
This quality assurance manual specifies the methods to prepare and submit Quality Assurance Process Design Diagram for products and parts to be supplied to NSK by suppliers. 2. Purpose Each supplier should prepare quality assurance process design diagram clearly showing the quality assurance methods used in each products and parts production .
2 Supplier Directory Services 3 Supplier User Management 4 Assessments 5 Managing Supplier Registration and Qualification 6 Managing Supplier Profiles 7 Managing Supplier Performance 8 Notifications 9 Managing Supplier Classifications 10 Managing Supplier Hierarchy. x
Quality Assurance and Improvement Framework Guidance 2 Contents Section 1: Quality Assurance and Improvement Framework 1.1 Overview 1.1.1 Quality Assurance (QA) 1.1.2 Quality Improvement (QI) 1.1.3 Access 1.2 Funding Section 2: Quality Assurance 2.1 General information on indicators 2.1.1 Disease registers 2.1.2 Verification
