PRODUCT QUALITY REQUIREMENTS PQR 1020 PAGE 1 OF 10 FEDERAL MANUFACTURING & TECHNOLOGIES (PQR 1020_J.doc) SUPPLIER QUALITY PROGRAM, III (U) CHANGE HISTORY ISSUE D E F G H J DESCRIPTION OF CHANGE CORRECTED CHANGE HISTORY ADD COUNTERFEIT COMPONENT SURVEILLANCE ADD A NOTE TO PURCHASING SECTION PAGE 3 ADDA NOTE TO PURCHASING SECTION PAGE 4 UPDATED TO INCLUDE ISO 9001 MODIFIED SECTION 7A T. D. Monroe R. L. Clewell S. C. Davis R. L. Vanhoose S. R. Mandl S. G. Condron A. C. Toney D.R. BOONE D/450 2C36 D/400 2C46 D/450 MD40 D/400 2C36 D/400 2C36 D/418 FK39 D/KF4 K112 SNL 0423 AUTHOR DATE S. L. HALTER T. D. MONROE 10/18/2000 01/26/2009 T. D. MONROE 07/21/2009 T. D. MONROE 08/11/2009 T. D. MONROE T. D. MONROE 10/23/2009 2/23/2010 D. A. Carey T. D. Chasteen B. A. Keefe B. M. Thompson M. D. Allen P. T. Hoopes G. M. Colletti D/800 2A42 D/600 OC44 D/891 1C41 D/892 2B37 D/620 OC44 NNSA 1D49 D/620 OC44 PQR 1020 ISSUE J PAGE 2 OF 10 TABLE OF CONTENTS 1. PURPOSE ................................................... 3 2. DEFINITIONS AND REFERENCE DOCUMENTS ....................... 3 3. ORDER OF PRECEDENCE ....................................... 3 4. BUYERS QUALITY OVERSIGHT .................................. 4 5. REQUIREMENTS OF THE SUPPLIER’S QUALITY PROGRAM ............ 4 6. ISO 9001 REQUIREMENTS ..................................... 7 7. BUYER SPECIFIC REQUIREMENTS (FOR DISTRIBUTORS ONLY) ....... 8 8. APPENDICES ................................................ 9 PQR 1020 ISSUE J PAGE 3 OF 10 1. PURPOSE This specification defines the minimum requirements of Supplier Quality Program III for Suppliers to the Buyer. Each purchase order specifies the Supplier Quality Program level required for product on that order. (See Appendix A, Definitions, Buyer) This document is owned and used by Honeywell Federal Manufacturing and Technologies (FM&T). This document is also used by Sandia National Laboratories (SNL). 2. DEFINITIONS AND REFERENCE DOCUMENTS The list of definitions of terms relating to this specification is included in Appendix A. The list of documents referred to is included in Appendix B. 3. ORDER OF PRECEDENCE The order of precedence of documents that set out the product requirements imposed upon and agreed to by the Supplier and which are incorporated in the purchase order is listed below. All of these items may or may not be included in any single purchase order. A. Purchase order B. Product drawings and specifications, i.e., those documents that define the requirements for the product to be furnished C. Federal, military, industrial or technical society material/process specifications and standards D. Product data forms E. Equipment manufacturers operating procedures PQR 1020 ISSUE J PAGE 4 OF 10 4. BUYERS QUALITY OVERSIGHT A. AUDITS The Buyer and/or its customer, the National Nuclear Security Administration (NNSA), reserve the right to conduct audits to evaluate the degree of compliance with this specification and the purchase order. This includes access to the Supplier’s facility, instructions, procedures, specifications and records as deemed necessary to conduct such audits. Audit results shall not relieve the Supplier of the responsibility to supply conforming product to the Buyer. Disapproval of the Supplier’s quality program or major portions thereof may be cause for withholding Buyer acceptance of product until cause(s), specific corrective action(s) are reported to the Buyer and approval given for continuation of product submittal. B. PROPRIETARY RIGHTS In cases where the Supplier or the Supplier’s Subcontractor(s) reserve certain proprietary rights of controlled documents, hardware, processes, records, etc., the Supplier shall submit a written list of such items to the Buyer. These items will be exempt from Buyer surveillance as appropriate. 5. REQUIREMENTS OF THE SUPPLIER’S QUALITY PROGRAM A. GENERAL The Supplier’s quality program shall demonstrate recognition of the Buyer’s requirements in order to assure conformance of product requirements. In the event the Supplier operates as a sales office, the product manufacturer shall also meet the requirements of this specification and the purchase order. The Buyer reserves the right to conduct final inspection and/or testing of the Supplier’s product to assure conformance with the requirements. Requirements of ISO 9001 Section 4 also apply. PQR 1020 ISSUE J PAGE 5 OF 10 B. NON-ISO 9001 REGISTERED SUPPLIERS 1. SURVEYS FOR NON ISO 9001 REGISTERED SUPPLIERS For Suppliers that are not registered with an accredited registrar to ISO 9001, International Organization for Standardization Quality Management Systems Requirements, an initial survey shall be conducted by authorized Buyer audit personnel to ISO 9001, 5.A, 5.B, 6 and 7 of this document and the Buyer’s Purchase Order requirements if available. 2. RECERTIFICATION SURVEYS FOR NON-ISO 9001 REGISTERED SUPPLIERS Section 5.B.1 is to be repeated every 3 years for Suppliers and/or Product Manufacturers that are not registered with an accredited registrar to ISO 9001. The Buyer reserves the right to conduct periodic surveys to determine compliance with these requirements. C. ISO 9001 REGISTERED SUPPLIERS 1. SURVEYS FOR ISO 9001 SUPPLIERS Suppliers and/or Product Manufacturers that are registered with an accredited registrar to ISO 9001, and have had the Supplier’s material received by the Buyer within the last 24 months or forecasted (determined through the Buyer’s Purchase Order Management System) to have a Purchase Order with the Buyer within the next 12 months, will be subjected to an initial survey. In addition, the Buyer’s responsible personnel shall verify ISO 9001 registration with an accredited registrar by reviewing the current Certificate of Registration and verifying traceability of the Certificate of Registration back to the accredited registrar. The auditor will also verify compliance with Sections 5.A, 6 and 7 of this document and the Buyer’s Purchase Order requirements. This survey is valid until the expiration of the Supplier’s ISO 9001 registration. If it is verified through traceability that the ISO 9001 registration is not with an accredited registrar, then the Supplier and/or Product Manufacturer is deemed non ISO 9001 registered, and the requirements of 5.B.1 and 5.B.2 of this document shall become effective. PQR 1020 ISSUE J PAGE 6 OF 10 If ISO 9001 registration with an accredited registrar is suspended or lapsed, the Supplier shall immediately notify the Buyer’s contracting representative as to the suspension or lapse of registration. Upon the suspension or lapse of the ISO 9001 registration, the Supplier and/or Product Manufacturer is deemed non-ISO 9001 registered, and the requirements of 5.B.1 and 5.B.2 of this document shall become effective. In lieu of ISO 9001, the Supplier may be registered with an accredited registrar to AS9100, Quality Management Systems – Requirements for Aviation, Space and Defense Organizations. All other requirements of this document and the Buyer’s Purchase Order shall apply.. 2. RECERTIFICATION SURVEYS FOR ISO 9001 REGISTERED SUPPLIERS Suppliers and/or Product Manufacturers that have maintained registration with an accredited registrar to ISO 9001 shall provide on an annual verification of current registration with an accredited registrar to ISO 9001. This shall be accomplished by the Supplier/Product Manufacturer providing a copy of the current Certificate of Registration to the Buyer’s responsible personnel. Traceability of the Certificate of Registration back to the accredited registrar shall be verified by the Buyer’s responsible personnel. The Supplier and/or Product Manufacturer shall have had the Supplier’s material received by the Buyer within the last 24 months or forecasted (determined through the Buyer’s Purchase Order Management System) to have a Purchase Order with the Buyer within the next 12 months. This shall be verified by the Buyer’s responsible personnel. For Suppliers and/or Product Manufacturers that do not maintain the provisions of this paragraph, the requirements of 5.B.1 and 5.B.2 of this document shall become effective. The recertification process is the same for Supplier registered to AS9100 in lieu of ISO 9001. PQR 1020 ISSUE J PAGE 7 OF 10 The Buyer reserves the right to conduct periodic surveys to determine compliance with these requirements. Reasons for conducting new Buyer surveys include quality problems with a supplier’s parts, supplier change of ownership, supplier relocation, and significant changes to the supplier’s quality manual. 6. ISO 9001 REQUIREMENTS The following current ISO 9001 standard paragraphs shall be used to determine the non-registered ISO 9001 Supplier’s compliance with the Buyer’s requirements. In addition, this document and the Buyer purchase order requirements shall also be. The surveys shall be conducted by authorized Buyer audit. A. Management Responsibility ISO 9001 Paragraphs 5.1, 5.3, 5.5.1, 5.5.2 B. Quality System ISO 9001 Paragraphs 4.1, 4.2.1, 4.2.2, 4.2.3, 4.2.4, 7.1 C. Contract Review ISO 9001 Paragraphs 5.2, 7.2.1, 7.2.2, 7.2.3j and k D. Document and Data Control ISO 9001 Paragraphs 4.2.3, 4.2.4 E. Purchasing (Not for Distributors) ISO 9001 Paragraphs 4.2.4, 7.4.1, 7.4.2, 7.4.3 F. Product Identification and Traceability ISO 9001 Paragraphs 4.2.3(e), 4.2.4, 7.5.3 G. Inspection and Testing (Manufacturer’s and Value-Added Distributors only) ISO Paragraphs 5.2, 7.1(c), 7.2.1(a) (d) H. Control of Inspection, Measuring and Test Equipment (Manufacturer’s and Value-Added Distributors only) ISO 9001 Paragraphs 4.2.4 and 7.6 I. Control of Non-Conforming Product ISO 9001 Paragraph 8.3 PQR 1020 ISSUE J PAGE 8 OF 10 J. Corrective and Preventive Action ISO 9001 Paragraphs 8.5, 8.5.1, 8.5.2, 8.5.3 7. BUYER SPECIFIC REQUIREMENTS (FOR DISTRIBUTORS ONLY) A. Counterfeit Component Surveillance The Supplier shall provide a system for the evaluation of material for possible counterfeit components. This system shall handle authorized (see Definitions) and nonauthorized material and include the following: Authorized material: 1. Physical inspection of material to verify that components have original markings. 2. Verification of origin certification documentation. Non-authorized material: 1. Physical inspection of each component to verify that each component has original marking and has not been salvaged. 2. Supplier shall have a system to notify the buyer when material is non-authorized prior to order placement. 3. Verification method that the Supplier of component is an active member of IDEA or ERAI (see Definitions) with an intern counterfeit detection and prevention procedure(s). 4. Supplier shall have a documented process to handle static sensitive products in order to minimize the chance of static damage and minimize exposure to moisture. B. HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY The Supplier and/or Product Manufacturer shall have an established system to handle, store, package and ship product in a manner that prevents damage, loss or substitution. The Supplier shall have a documented procedure for preparing and submitting a signed certificate of conformance and test data as required by the purchase order with each shipment of product to the Buyer. Product certification shall be supported by quality evidence. PQR 1020 ISSUE J PAGE 9 OF 10 8. APPENDICES A. DEFINITIONS Authorized and Non-authorized Material: Material that can be verified using documentation from the original component manufacturer (OCM). The supplier of the material must be on the OCM’s authorized supplier list. All other material is considered nonauthorized. Authorized Distributor: A supplier that is approved by the original component manufacturer. Broker: A company that provides surplus or hard to find parts. Buyer: Federal Manufacturing and Technologies (FM&T) or Sandia National Laboratories (SNL) Unauthorized Distributor: A supplier that is not identified as approved by the original component manufacturer. Value Added Distributor: A company that provides additional processing to a component per specification or product quality requirements. Supplier: A source of material such as an Authorized Distributor or Broker. IDEA: Independent Distributors of Electronics Association, an association for establishing and communicating standards the sale of electronic components. PQR 1020 ISSUE J PAGE 10 OF 10 ERAI: Electronic Resellers Association International, an association of resellers establishing and communicating standards and data bases for the resale of electronic components. B. LIST OF HONEYWELL/SANDIA REFERENCED DOCUMENTS ISO 9001, 2000 or later: International Organization for Standardization Quality Management System Requirements AS9100, Rev B or later: Quality Management Systems – Requirements for Aviation, Space and Defense Organizations