Delegated Product Release Verification RATIONALE

Transcription

1 AEROSPACE STANDARD Issued 01 October 2015 Draft Standard Technically equivalent writings published in all IAQG sectors. Delegated Product Release Verification RATIONALE The process for Delegated Product Release Verification (DPRV) varies from one organization to another. Implementation of a standard process reduces the risk of escapes in the aviation, space, and defense industry supply chain, when the organization s product release verification has been delegated to a supplier. FOREWORD To assure customer satisfaction, the aviation, space, and defense industry organizations must produce and continually improve safe, reliable products that meet or exceed customer and regulatory authority requirements. The globalization of the industry and the complexity of resulting organizations supply chains have complicated this objective. End-product organizations face the challenge of assuring the quality of, and integrating, product purchased from suppliers throughout the world and at all levels within the supply chain. Furthermore, suppliers and processors, within the industry, face the challenge of delivering product to multiple customers having varying quality expectations and requirements. The aviation, space, and defense industry established the International Aerospace Quality Group (IAQG) for the purpose of achieving significant improvements in quality and safety, and reductions in cost, throughout the value stream. This organization includes representation from aviation, space, and defense companies in the Americas, Asia/Pacific, and Europe. This document defines the minimum requirements for delegation of product release to a supplier within the aviation, space, and defense industry. The establishment of common requirements should result in improved quality, safety, and reduced costs by minimizing customer specific requirements and the resultant variation inherent in these multiple expectations. While primarily developed for the aviation, space, and defense industry, this standard can also be used in other industry sectors where a DPRV process may be of benefit.

2 2 TABLE OF CONTENTS RATIONALE... 1 FOREWORD SCOPE General Application APPLICABLE DOCUMENTS TERMS AND DEFINITIONS REQUIREMENTS System Requirements for Delegating Organization Supplier Responsibilities Qualification / Requalification of Delegated Product Release Verification Personnel Review of Product by Delegated Product Release Verification Personnel Records Retention NOTES... 8 APPENDICES APPENDIX A DELEGATED PRODUCT RELEASE VERIFICATION CHECKLIST (EXAMPLE).9

3 3 1. SCOPE 1.1 General This standard specifies requirements for DPRV to establish common product/service requirements for use at all levels of the supply chain. This standard shall apply when an organization elects to delegate product release verification by contractual flow down to their supplier (reference 9100 and 9110 standards); to perform product acceptance on their behalf. The delegating organization shall use this standard as the baseline for establishing a DPRV process, although they may include additional contract requirements to meet their specific needs. 1.2 Application This standard is intended for use by organizations that produce and/or provide aviation, space, and defense products, including organizations providing maintenance, spare parts, materials, and services. It is emphasized that the requirements specified in this standard are complementary, not alternative, to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable contractual, statutory, or regulatory requirements, the latter shall take precedence. 2. APPLICABLE DOCUMENTS The following documents support the application/use of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. When a conflict in requirements between this standard and the referenced documents exist, the requirements of this document shall take precedence Quality Management Systems Requirements for Aviation, Space and Defense Organizations 9102 Aerospace First Article Inspection Requirement 9107 Direct Delivery Authorization Guidance for Aerospace Companies 9110 Quality Management Systems Requirements for Aviation Maintenance Organizations 9114 Direct Ship Guidance for Aerospace Companies NOTE: Equivalent versions (e.g., AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published internationally in each IAQG sector. ISO 9000 Quality management systems Fundamentals and vocabulary

4 4 3. TERMS AND DEFINITIONS For the purposes of this standard, the following terms and definitions apply: 3.1 Delegated Product Release Verification (DPRV) A process whereby a supplier is delegated the authority to act on behalf of the delegating organization to verify and release products/services. 3.2 Final Inspection The verification of product features and documentation to validate that the completed product conforms to all customer requirements. 3.3 Organization Group of people and facilities with an arrangement of responsibilities, authorities, and relationships (reference ISO 9000). 3.4 Supplier Organization or person that provides a product or service (reference ISO 9000). 4. REQUIREMENTS 4.1 System Requirements for Delegating Organization The delegating organization shall have a documented process defining their delegation requirements, including the organization s responsibilities and authority for selection, qualification, maintenance, removal, suspension, and limitation of the delegation DPRV supplier selection criteria shall include the following: a. The supplier shall be approved on the delegating organization s supplier register. b. The delegating organization shall provide documented authorization of the supplier s participation in their DPRV program. c. During selection of suppliers for DPRV, the delegating organization shall review the supplier s quality performance. Supplier performance criteria shall be defined and documented by the delegating organization. The data reviewed shall include a measure of product/process conformance and responsiveness to corrective action requests. d. The delegating organization shall verify that the supplier is knowledgeable of its requirements and expectations associated to product quality The delegating organization shall define and document the scope and limitations of the delegation. Documentation stating the scope and limitations of delegation shall be provided to and acknowledged by the supplier.

5 4.1.4 The delegating organization shall define change notification requirements to the supplier. These requirements shall include the type of changes requiring notification and process for communicating these changes The delegating organization s maintenance process for DPRV shall, at a minimum, include the following: a. A periodic review of the supplier s quality performance. b. A periodic inspection and/or validation of product. c. A periodic review of the supplier s DPRV process. d. Actions to address poor supplier performance. e. Criteria to remove, suspend, and limit the delegation to the supplier and/or DPRV personnel. 4.2 Supplier Responsibilities The supplier shall maintain their QMS approval The supplier s QMS shall have a documented process detailing the requirements for the DPRV, including the establishment of process controls and monitoring for process effectiveness The supplier shall keep a list of authorized DPRV personnel, including the associated scope of approval The supplier is responsible for assuring that the authorized DPRV personnel have prerequisites, including but not limited to those listed below, sufficient to be able to perform their duties. a. Access to product-related documentation. b. Access to necessary facilities and equipment to be able to perform DPRV activities. c. Sufficient time allotted to adequately perform the associated product verification activities. d. The authority to suspend the release of products, until all open issues associated with the product being released are addressed. e. Documented and demonstrable proficiency and training, including appropriate product knowledge The supplier shall provide the delegating organization notification of changes affecting the DPRV process (see section 4.1.4) Suppliers shall obtain documented approval from the delegating organization, if they intend to use a sub-tier supplier to verify and release the 5

6 6 final product, in accordance with the delegating organization s process requirements The supplier shall monitor DPRV personnel performance and have defined criteria to disqualify/suspend the DPRV personnel, including notification to the delegating organization. 4.3 Qualification / Requalification of Delegated Product Release Verification Personnel DPRV personnel shall be qualified by the supplier The selection of DPRV personnel shall be based on their background, experience, and product knowledge. Specific training and/or testing shall be established by the supplier. The supplier shall ensure training and qualification is appropriate for the product being released The DPRV personnel shall have a periodic vision assessment to a recognized standard, unless waived by the delegating organization DPRV personnel shall be subject to periodic requalification and training by the supplier The supplier shall meet additional requirements for DPRV personnel contractually imposed by the delegating organization (e.g., delegating organization approval of DPRV personnel). 4.4 Review of Product by Delegated Product Release Verification Personnel The DPRV shall be performed on each release of product. DPRV shall be performed after final inspection, as close to shipment as practical; conducted as an independent process by someone other than the person who performed the final inspection, unless waived by the delegating organization The DPRV shall consist of but, not limited to: a. Contract / purchase order review. b. Supplier documentation review. Verification that all required product realization operations and inspections are complete. When applicable, verification that product nonconformance has been properly documented and processed, in accordance with the delegating organization s contractual requirements. Verification that the delegating organization s requirements for first article inspection (reference 9102 standard) have been satisfied. c. Physical product verification, including verification of product marking/identification and visual examination. DPRV shall validate special

7 7 requirements, critical items, and key characteristics when contractually required by the delegating organization. d. Shipping / release documentation DPRV personnel shall validate and record the completion of the verification activity. NOTE: An example of a template for recording the DPRV activity can be found in Appendix A (Delegated Product Release Verification Checklist). This template can be adapted to satisfy the delegating organization s and/or supplier s DPRV process criteria Specific stamps, signatures, identification numbers, etc. shall be used for product release when contractually required by the delegating organization Sampling plans for product verification may be used with approval from the delegating organization Product and/or documentation nonconformances detected, during the DPRV process, shall be processed in accordance with the supplier s nonconformance and corrective action procedures, and the delegating organization s contractual requirements. 4.5 Records Retention The delegating organization shall retain the following records in accordance with their defined procedures. a. List of delegated suppliers. b. Scope of delegation approval. c. Delegation limitations, if applicable. d. Delegation acknowledgements from suppliers. e. List of authorized DPRV personnel, if the delegating organization authorizes the personnel. f. Records from periodic DPRV process reviews (see section 4.1.5). g. Revision records of changes to the items identified in this listing. NOTE: Additional records can be maintained at the delegating organization s discretion The supplier granted delegation authority shall retain the following records from DPRV activity, in accordance with the delegating organization s contractual requirements: a. Records that DPRV activity has been performed [e.g., Delegated Product Release Verification Checklist (see Appendix A)].

8 8 NOTE: Further guidance on the use/application of the DPRV checklist can be found within the Supply Chain Management Handbook (SCMH). b. Initial and recurrent qualification records for DPRV personnel. c. List of approved DPRV personnel. d. Vision assessment record for DPRV personnel. e. Records of product and/or documentation nonconformances identified during the DPRV process. f. Approval for sub-tier delegation from the delegating organization (reference section 4.2.6). g. Additional documents, as specified, by the delegating organization. NOTE: Additional records can be maintained at the supplier s discretion. 5. NOTES A change bar ( l ) located in the left margin is for the convenience of the user in locating areas where technical revisions, not editorial changes, have been made to the previous issue of this document. An (R) symbol to the left of the document title indicates a complete revision of the document, including technical revisions. Change bars and (R) symbol are not used in original publication, nor in documents that contain editorial changes only. PREPARED BY THE INTERNATIONAL AEROSPACE QUALITY GROUP (IAQG)

9 9 APPENDIX A DELEGATED PRODUCT RELEASE VERIFICATION CHECKLIST (EXAMPLE)