Supplier Selection & Assessment Training.pptx

Supplier Selection & Assessment  CDC Certification Standards Supplier Selection & Assessment Criteria 2014/68/EU, “Pressure Equipment 10 CF...

Supplier Selection & Assessment  CDC Certification Standards Supplier Selection & Assessment Criteria 2014/68/EU, “Pressure Equipment 10 CFR Part BPVC_XIII, “ASME Directive (PED – 50_Appendix B, Boiler and Pressure ISO 9001, “Quality Module D: Quality Assurance Vessel Code Section Management Conformity to the Criteria for Nuclear XIII- Mandatory Systems” Type Based on Power Plants and Fuel Appendix III: Quality Quality Assurance of Reprocessing Plants Control System” the Production Process” AS9100, “Quality ISO/IEC 80079, Management ISO 3834-3, “Explosive Systems - “Standard Quality Atmospheres Part 34: Requirements for Requirements for Application of Quality Aviation, Space and Fusion Welding of Systems for Ex Defense Metallic Materials” Product Manufacture” Organizations” ISO 9001: 2015 Clause 8.4 – Control of Externally Provided Products & Services Evaluation, Selection, and Monitoring of External Providers  The organization must determine and apply criteria for evaluating, selecting, monitoring, and re-evaluating external providers based on their ability to meet requirements.  The organization is responsible for conformity of all externally provided processes, products, and services  The organization must retain documented information of these activities and any necessary actions arising from evaluations. AS9100D Clause 8.4.1.1 define the process, responsibilities, and authority maintain a register of its for the approval status external providers that decision, changes of the includes approval status (e.g., The organization shall: approval status, and approved, conditional, conditions for a controlled use disapproved) and the scope of of external providers the approval (e.g., product depending on their approval type, process family); status; periodically review external define the requirements for define the necessary actions provider performance controlling documented to take when dealing with including process, product information created by and/or external providers that do not and service conformity, and retained by external meet requirements; on-time delivery performance; providers.  Evaluation: External providers must be evaluated to ensure they have the capability to comply with specified requirements. Methods to evaluate external providers include: Assessment of their Ex quality management system by an accredited body (ISO/IEC 80079 -34) EN ISO / Having a quality management system certificate in accordance with the appropriate standard from an IEC 80079- accredited body (ISO/IEC 17021) A documented site assessment to ensure effective 34 controls Re-evaluation & Review: The manufacturer must review the ongoing ability of external providers to provide conforming products, processes, or services at intervals not exceeding one year. External providers not used for over a year must be re- evaluated before placing a contract or purchase order.  10 CFR Part 50-Appendix B: VII. Control of Purchased Material, Equipment, and Services. Measures are established / implemented for the evaluation, selection and assessment of suppliers (including distributors and calibration, NDE, testing lab. etc.) consistent with the importance, complexity and quality of the product or service. Evaluations for selection of suppliers are performed: 1) prior to award of contract, 2) at the specified frequency, 3) to ensure only approved suppliers are used, 4) and documented to provide objective evidence of satisfactory review by one of the following means: By Supplier History providing identical items. Current Quality Records supported by documented qualitative and quantitative information. Direct evaluation of the supplier’s facilities. When subcontracted audits are used as a basis for supplier qualification, the evaluation shall be documented, performed and evaluated by qualified personnel, and evidence of applicable elements adequately addressed. For commercial calibration and testing services that are commercial grade accepted/dedicated providers must hold ISO/IEC 17025:2017 accreditation from an ILAC-MRA within the past 48 months.  10 CFR Part 50- Appendix B: IX Control of Special Processes. ASME BPVC.XIII_2023 DIRECTIVE Measures shall be Appendix III: 2-8 2014/68/EU Module established to assure Non-Destructive D 3.1.3 Non- that special Testing: destructive Tests: processes, including welding, heat For pressure Suppliers treating, and Provisions exist for identifying the equipment, non- destructive tests of nondestructive Providing Non - testing, are appropriate NDE procedures permanent joints shall be carried out controlled and Destructive accomplished by applicable to the scope of Code work. by suitable qualified personnel. qualified personnel Examination using qualified (1) NDE personnel are qualified in procedures in (NDE) Processes accordance with accordance with the applicable Code For pressure equipment in applicable codes, Section requirement; categories III and IV, standards, (2) NDE the personnel shall specifications, examinations are be approved by a criteria, etc. performed in third-party Records on organization accordance with qualifications of recognized by a written procedures special processes, Member State when required; personnel performing pursuant to Article special processes, (3) NDE equipment is 20. and equipment used calibrated. in special processes are current and maintained.  240: Pressure Equipment Directive (PED) Compliance Audit Non- Conformance #1 - ISO 9001:2015 Section 8.4 Control of externally provided processes, products and services (Approved Suppliers) 247: Receiving Inspection Process Audit Non-Conformance #1 - ISO 9001:2015 Section 8.5.1 Control of Production and Service Provision (China Manufacturing Supplier Requirements) Supplier 248: Receiving Inspection Process Audit Non-Conformance #2 - ISO 9001:2015 Section 8.6 Release of Products and Services (Receiving Related Inspection Plan - Special Processing) 249: Receiving Inspection Process Audit Non-Conformance #3 - ISO Nonconforman 9001:2015 Section 8.6 Release of Products and Services (NDE Supplier Requirements) ces 250: Receiving Inspection Process Audit Non-Conformance #4 - ISO 9001:2015 Section 8.4 Control of externally provided processes, products and services (Approved Suppliers) 254: Supply Chain Process Audit Non-Conformance # 1 - ISO 9001:2015 Section 8.4 External Products & Services & AS9100D Section 8.4.1.1 (Approved Supplier List) 255: Supply Chain Process Audit Non-Conformance # 2 - ISO 9001:2015 Section 7.2 Competence (Training)  QMS is based on existing proven work routines and described in an approved document. Maintain a receiving, in-process, and final CDC inspection system. Compliance: Maintain a control system for identification and traceability of metal Supplier materials or components. Criteria Maintain a calibration control system for precision measuring devices. Provide quality records to the purchaser as requested.  Certified QMS Assessed and certified by a signatory accredidation organization or independent body that conforms ISO/IEC 17021, Certified to the current standard and be within the scope of requested services listed on the purchase order, CDC Issued to the supplier location maintained in CDC’s supplier ERP file. Verified QMS Compliance: QMS Questionnaire (QCF-1014-1) QMS Audit Supplier Evaluation Special Processes Require certifications specific to the services they provide Suppliers performing NDE services (liquid penetrant, magnetic particle, radiographic, and ultrasonic inspection) must submit qualification and training records for all inspectors performing the NDE specified on the purchase order for review and approval by Quality Assurance Purchase orders must be reviewed and approved by Quality Assurance prior to release. Special Process Requirements Required for laboratories performing commercial grade dedication, calibration, dimensional measurement, ILAC-MRA mechanical and chemical testing, and non-destructive examinations (NDE). International Laboratory Accreditation Accredidation Cooperation (ILAC) – Mutual Recognition Agreement (MRA) accredidation includes ISO/IEC 17025 with adherence to specific industry-related standards and will be marked on the supplier’s certificate. ILAC-MRA Required for laboratories performing NDE services on CDC part numbers or customer orders that state “Nuclear Accredidation w/ Safety Related”. The QMS audit shall occur at the supplier’s certified location and be completed within the twelve QMS Audit months prior to the release of the purchase order. Pressure Equipment Required for material manufacturers of raw materials and welding consumables used in the fabrication of the “main pressure bearing” components of rupture disc devices requiring a CE marking. POs do not require approval Directive / EN ISO from Quality Assurance unless specified by the customer order. 9001 Certification NADCAP Required for suppliers of special processes (weld, heat treat, chemical processing, passivation, NDE, and testing services) specified on a CDC order stating “AS9100 Applies”. Certificate must include the services certified by Accreditation National Aerospace and Defense Contractors Accreditation Program (Nadcap). Procedure Qualification Record (PQR) for all weld processes and standards. Welding Services Welder Performance Qualification (WPQ) for each welder performing work and for all weld processes and (Additional standards. Documents) Weld Procedure Specification (WPS) for all weld processes and standards. Evidence of welder qualification prolongation review.  Approved Suppliers that meet approval criteria and commercial Suppliers requirements will be listed on CDC’s Approved Supplier List at any time criterion are met. Qualifying documentation will be stored electronically in the supplier's profile. One-time emergency purchases may be made from suppliers that have not fully completed the supplier approval process as the business needs dictate when approved by the QA Management. Customer CDC Suppliers designated on a customer purchase order shall be Specific provided "Approved Supplier" status for use in conjunction with that specific customer. The need for additional Suppliers qualification shall be determined based upon the product or Compliance: service being supplied and any code or regulatory requirements applicable to the product or service. Supplier Commerci al Distributors or retailers who supply commercial or brand name product to be incorporated into a CDC product are not required to maintain a documented quality system and meet Approval Product pre-qualification requirements. Commercial product shall be Suppliers inspected at receipt for conformance to purchase order and delivery requirements ITAR/EAR Supplier's qualification (DDTC Registration with expiration Restricte date) and contact information for authorized individuals within the organization to receive ITAR restricted information d shall be stored electronically in the current ERP system within Suppliers the supplier's profile and noted on the Approved Supplier's List.  Supplier Metrics On-time delivery (90%) Product acceptance (95%) CDC Purchasing activity (12 months) Approved Quality Management System (QMS) Reported Monthly on Rolling 12 Month Average Compliance: Low-Performing Suppliers Evaluated for the risk to CDC and the appropriate action required Supplier to mitigate this risk Mitigation efforts may include the issuance of corrective action requalification, or revocation of "Approved Supplier" status Performance Dormant Suppliers Have not been issued a PO from CDC within 12-months Evaluated by QA prior to the issuance of a new purchase order Suppliers designated with dormant status for a 24-month period will have their approval status revoked  "Approved Supplier" status may be revoked when CDC's needs are not met, a secrecy agreement is violated, or supplier requirements are not met. CDC QMS certifications are monitored for expiration and supplier’s have 45 days to provide a valid Compliance: certificate before their "Approved Supplier" status is revoked. Supplier QA notifies affected departments, updates the supplier profile in the current ERP system, and Revocation distributes an updated Approved Supplier List after revocation. Suppliers seeking reinstatement as an “Approved Supplier” must go through a new approval process and submit evidence of compliance with CDC's requirements.