SUPPLIER QUALITY PROGRAM, IV (U)

Transcription

1 PRODUCT QUALITY REQUIREMENTS PQR 1050 PAGE 1 OF 14 FEDERAL MANUFACTURING & TECHNOLOGIES (PQR 1050_L.doc) SUPPLIER QUALITY PROGRAM, IV (U) CHANGE HISTORY ISSUE DESCRIPTION OF CHANGE AUTHOR DATE D CORRECTED CHANGE HISTORY S. L. HALTER 10/18/2000 E UPDATED FORM CALLOUTS S. L. HALTER 10/21/2002 F DELETED REFS. TO FORM 1609B S. L. HALTER 9/15/2004 G UPDATED TITLE TO PQR-2767 G. D. SWANSON 12/15/2006 H UPDATED WITH ISO 9001 & AS9100 T. D. MONROE 10/23/2009 J UPDATED BUYER REQUIREMENTS T.D. MONROE 6/22/2011 K UPDATED BUYER REQUIREMENTS N. W. BETOW 3/26/2012 L ADD INCORPORATION AND CORRECT ISSUE K RELEASE ISSUE N.W.BETOW 4/27/2012

2 PAGE 2 OF 14 TABLE OF CONTENTS 1. PURPOSE ORDER OF PRECEDENCE DEFINITIONS AND REFERENCE DOCUMENTS BUYERS QUALITY OVERSIGHT REQUIREMENTS OF THE SUPPLIER S QUALITY PROGRAM ISO 9001 REQUIREMENTS BUYER SPECIFIC REQUIREMENTS APPENDICES... 10

3 PAGE 3 OF PURPOSE This specification defines the minimum requirements of Supplier Quality Program IV 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). INCORPORATION GUIDANCE Changes to this document must be incorporated on all new and open Purchase Orders no later than May 31, 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 3. DEFINITIONS AND REFERENCE DOCUMENTS The list of definitions of terms relating to this specification is included in Appendix A. The list of Honeywell/Sandia documents referred to is included in Appendix B. The list of additional Honeywell FM&T documents is included in Appendix C. The list of additional Sandia referenced documents is included in Appendix D.

4 PAGE 4 OF BUYERS QUALITY OVERSIGHT A. AUDITS, SURVEYS AND INSPECTIONS The Buyer and/or its customer, National Nuclear Security Administration (NNSA), reserve the right to perform quality system audits, quality assurance surveys and verification inspections at Supplier locations 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, surveys and inspections. The 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) and preventive corrective action(s) are submitted to and approved by the Buyer. When requested, the Supplier shall arrange permission for the Buyer and/or NNSA to perform any audits, surveys and inspections at its Subcontractors. B. SUPPLIER S PROPRIETARY RIGHTS In cases where the Supplier or the Supplier s Subcontractors 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. C. RESIDENT REPRESENTATIVES The Buyer and/or NNSA may station resident quality representative(s) at the Supplier s facility during the term of the purchase order. The Supplier shall provide all reasonable facilities and assistance for the safety and convenience of the representatives of the Buyer and/or NNSA in the performance of their duties. 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.

5 B. SUPPLIERS NOT REGISTERED WITH ISO 9001 OR AS9100 PQR 1050 PAGE 5 OF SURVEYS FOR SUPPLIERS NOT REGISTERED WITH ISO 9001 OR AS9100 If the Supplier is not registered with an accredited registrar to ISO 9001, International Organization for Standardization Quality Management Systems Requirements, or AS9100, Quality Management Systems Requirements for Aviation, Space and Defense Organizations, an initial survey shall be conducted by authorized Buyer audit personnel to determine the Supplier s quality program compliance with the Buyer s requirements. The survey shall be conducted to ISO 9001, Sections 5.A, 5.B, 6 and 7 of this document and the Buyer s Purchase Order requirements if available. 2. RECERTIFICATION SURVEYS FOR SUPPLIERS NOT REGISTERED WITH ISO 9001 OR AS9100 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 or AS9100. The Buyer reserves the right to conduct periodic surveys to determine compliance with these requirements. C. SUPPLIERS REGISTARED WITH ISO 9001 or AS SURVEYS FOR SUPPLIERS WITH ISO 9001 or AS9100 RESISTRATION Suppliers and/or Product Manufacturers that are registered with an accredited registrar to ISO 9001 or AS9100, 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, shall be subjected to an initial survey conducted by authorized Buyer audit personnel. The auditor will verify the ISO 9001 or AS9100 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. In addition, the auditor will also verify compliance with Section 5.A, 6 and 7 of this document and the Buyer Purchase Order requirements. This survey is valid until the expiration of the Supplier s current ISO 9001 or AS9100 registration. If it is verified through traceability that the ISO 9001 or AS9100 registration is not with an accredited registrar, then the Supplier and/or Product Manufacturer is deemed non ISO 9001 or AS9100 registered, and the requirements of 5.B.1 and 5.B.2 of this document shall become effective.

6 PAGE 6 OF 14 If ISO 9001 or AS9100 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 or AS9100 registration, the Supplier and/or Product Manufacturer is deemed non ISO 9001 or AS9100 registered, and the requirements of 5.B.1 and 5.B.2 of this document shall become effective. 2. RECERTIFICATION SURVEYS FOR SUPPLIERS WITH ISO 9001 AS9100 REGISTRATION Suppliers and/or Product Manufacturers that have maintained registration since the initial survey per Section 5.C.1 of this document with an accredited registrar to ISO 9001 or AS9100 shall provide, on an annual basis from the date of the initial survey, verification of current registration with an accredited registrar to ISO 9001 or AS9100. 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 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 When surveys are conducted, the following ISO 9001 standard paragraphs shall be used. In addition, this document and the Buyer Purchase order requirements shall also be used during the surveys to determine the Supplier s compliance with the Buyers requirements. The surveys shall be conducted by authorized Buyer audit personnel to determine the Supplier s conformance.

7 PAGE 7 OF 14 A. QUALITY MANAGEMENT SYSTEM 4.1 General Requirements General Quality Manual Control of Documents Control of Records B. MANAGEMENT RESPONSIBILITY 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy Responsibility and Authority Management Representative C. RESOURCE MANAGEMENT General (Human Resources) Competence, Training and Awareness D. PRODUCT REALIZATION 7.1 Planning of Product Realization Determination of Requirements Related to the Product Review of Requirements Related to the Product a) product information (Customer Communication) b), enquiries, contracts or order handling, including amendments (Customer Communication) Purchasing Process Purchasing Information Verification of Purchased Product Control of Production and Service Provision Validation of Processes for Production and Service Provision Identification and Traceability E. MEASUREMENT, ANALYSIS AND IMPROVEMENT Monitoring and Measurement of Product 8.3 Control of Nonconforming Product Continual Improvement Corrective Action Preventive Action 7. BUYER SPECIFIC REQUIREMENTS 1. CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT The Supplier and/or Product Manufacturer shall comply with the Buyer s PQR 2698, Calibration Control Specification and maintain a calibration program that is compliant with the requirements of ISO 9001 Paragraph 7.6.

8 Any subcontractor that calibrates the Supplier s and/or Product Manufacturer s equipment shall maintain a calibration program that is consistent with one of the following requirements: PQR 1050 PAGE 8 OF 14 o The Buyer s PQR 2700, General Requirements for Calibration (CCL) & Testing (CTL) Laboratories o ANSI/ISO/IEC17025, General Requirements for the Competence of Testing and Calibration Laboratories o ISO Measurement Management Systems -- Requirements for Measurement Processes and Measurement Equipment o ANSI/NCSL Z540, Requirements for the Calibration of Measuring and Test Equipment When measurement standards or M&TE are either removed from service, removed from periodic calibration, or placed in storage, and they have been used since their last calibration, a final calibration or cross-check must be performed. Justification for not performing this function must be formally documented. HONEYWELL FM&T ONLY The Buyer s Purchase Order may require a technical evaluation of the Supplier s and/or Product Manufacturer s calibration program per the Buyer s PQR 2767, Designated Calibration Source (DCS) Calibration Program Specification. When a technical measurement evaluation is required per PQR 2767, calibration program approval by the Buyer is required. SANDIA NATIONAL LABORATORIES ONLY The Supplier and/or Product Manufacturer shall have a Designated Calibration Source (DCS) Approval from the SNL Primary Standards Lab for each component or group of like components, if required, per the measurement assurance plan(s) submitted by the Product Realization Team. 2. BUYER-CERTIFIED PROCESSES For Buyer Certified Processes, the Supplier shall provide adequate methods and facilities to assure conformance with all requirements of the Buyer s certified process specifications. Each certified process shall be performed in accordance with instructions specified in the Buyer requirements which include or reference procedure, personnel and equipment qualification requirements. After written Buyer approval has been granted, the Supplier shall make no changes to certified processes without written Buyer approval. When a Subcontractor is used and approved by the Buyer, the Supplier will not change to another Subcontractor without written Buyer approval.

9 PAGE 9 OF HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY The Supplier and/or Product Manufacturer shall have a documented 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. 4. BUYER REQUIRED REPORTS The Supplier shall prepare technical data reports of production and sampling tests and inspection as required by the Buyer. Such reports shall include the Buyer s part name, part number and suffix, drawing number and issue, the Buyer s purchase order number, lot description and quantity. When the Supplier is not the manufacturer of the product, the report shall also include the manufacturer s name. In the case of serially numbered units or products, such data shall be related to the serial number of the unit or product. Records must be legible, reliable, identifiable and retrievable. The Supplier shall prepare technical data reports of chemical and physical properties of materials and plating as required by the Buyer. Such reports shall contain the Buyer s part number and suffix, drawing number and issue, the Buyer s purchase order number, product designation when applicable, lot description including the name of the manufacturer, date of the test and the laboratory/testing facility name if other than the Supplier. When quantitative data are required, such reports shall contain the actual test values. All required reports shall be forwarded to the Buyer as directed by the Buyer. 5. BUYER RECORD RETENTION AND VERIFICATION REQUIREMENTS If the Supplier and/or Product Manufacturer employs a subcontractor to supply material, the Supplier shall verify every 3 years that the subcontractor is in compliance with certifications, test and inspection data and labels. Records that provide evidence that received material and product have been inspected and appropriately dispositioned shall be maintained by the Supplier for 3 years after receipt or as agreed in the Buyer Purchase order. Personnel training needs shall be evaluated at intervals not to exceed 3 years. Training shall be documented and records retained for 3 years. 6. CONTROLLED CONDITIONS Equipment used for process monitoring and data collection shall be calibrated and maintained as appropriate. 7. IDENTIFICATION AND TRACEABILITY The Identification and Traceability process will be documented.

10 8. LIMITED LIFE ITEMS PQR 1050 PAGE 10 OF 14 Material and components having limited calendar, operating or cycle life shall be identified and controlled to preclude use of expired items. Means for efficient recall of expired material will be established. 9. D-TEST/ENGINEERING SAMPLES 8. APPENDICES Controls shall be established for materials or items designated for destructive testing or special evaluation to ensure specified requirements are met and to prevent inadvertent use or shipment. A. DEFINITIONS Administrative Change: A change to Supplier production or inspection work instructions, which is not defined as significant. Buyer: Honeywell Federal Manufacturing and Technologies (FM&T) or Sandia National Laboratories (SNL) Buyer Requirements: The Purchase Product Definition specifies the drawings which set forth the product requirements imposed upon and agreed to by the Supplier. This product definition is amended jointly by mutual agreement by the Buyer and Supplier upon drawing changes (ACO or FCO). Refer to Section II for the itemization and order of precedence of these documents. Calibration Program Approval (Honeywell FM&T): Approval granted to the Supplier that its calibration program meets the requirement of the Buyer s PQR 2767 Designated Calibration Source (DCS) Calibration Program Specification and of the Buyer s PQR 2698 Calibration Control Specification. Calibration program approval requirements are listed in the purchase order.

11 Calibration Program Approval (Sandia National Laboratories): PQR 1050 PAGE 11 OF 14 Approval granted to the Supplier that its calibration program meets the requirement of the Buyer s PQR 2698 Calibration Control Specification and requirements for Designated Calibration source approval for each component or family of components, if required by the Buyer s measurement assurance plan. Certificate of Conformance: A signed document stating that the supplied product meets specified requirements. Certification: The process of approving the adequacy of an operation or set of operations, a piece of equipment or an individual to produce material that conforms to specified requirements or perform services that are within specified limits. Certification shall be documented and signed by a competent authority and shall be based on an evaluation conducted according to a defined and documented plan that is designed to assure that requirements are met or exceeded. Approval requirements for Buyer required certified processes are defined in the purchase order. Certified Processes: Special manufacturing, inspection and testing methods specified in the purchase order that require the Buyer s review and approval prior to use by the Supplier or the Supplier s Subcontractor. Examples of these processes are dye penetrant inspection, radiography, magnetic particle inspection, fusion welding and ultrasonic testing. Certified process approval requirements are listed directly in the purchase order. Engineering Change Order: A document prepared by the Buyer s technical personnel to modify Buyer drawings and specifications. An engineering change may be issued as an Advance Change Order (ACO) or as a Final Change Order (FCO) concurrently with the drawing change. Incorporation of engineering change orders shall be in accordance with the provisions of the purchase order.

12 PAGE 12 OF 14 Inspection: To critically examine the features of an object, or to exercise it to determine its operating characteristics in order to certify conformance to product drawing requirements. This includes visual inspection and performance testing. Laboratory/Testing Facility: A facility performing physical, chemical, pressure, electrical, plating, environmental or other tests to determine conformance of materials or products to Buyer requirements. Laboratory/Test Capability Approval: Approval granted to the Supplier or Supplier s Subcontractor by the Buyer based upon an evaluation of the ability to perform tests designated by the purchase order. These tests are not independently verified by the Buyer on Buyer controlled equipment. Laboratory/test capability approval requirements are listed directly in the purchase order. Qualification: The approval of a design and associated manufacturing and acceptance processes that confirms the capability of the product or service to meet or exceed customer requirements. QE and EE (Qualification Evaluation and Engineering Evaluation): An evaluation by the Buyer of processes used in manufacture and inspection of the product specified in the Buyer s requirements. Formal written approval from the Buyer is required prior to production beyond the evaluation lot. Quality Evidence: Recorded information, which indicates the extent of conformance of items or characteristics to specified requirements within an identified measurement uncertainty. This information may be based on physical inspections, process controls, physical and chemical tests, non-destructive tests or any combination of these. This information includes:

13 PAGE 13 OF 14 Quantitative Data: Values (variables data) that result from determining the magnitude of a characteristic with respect to a standard scale (such as values obtained by dimensional measurement, chemical analysis, tensile testing or electrical testing). This is the preferred form of data for all Buyer required Supplier tests. Qualitative Data: Determined status of a characteristic (attributes data) with respect to only two possible conditions (such as present or absent, go or no-go, and pass or fail). Process Control Data: Values and resultant statistics accumulated by continuous evaluation of characteristics of a process, and the items it produces, to demonstrate the degree of uniformity or variability among items. Sales Office: An independent distributor or a company division that handles sales and marketing for the entire Supplier organization. Significant Change: A change from an existing specific production location, environmental condition, process, production material, sequence of operations, method or process for producing a product to a new location, environment, material, method, sequence or process for products which require Qualification Evaluation (QE) or Engineering Evaluation (EE). Subcontractor: The term used herein to designate an individual or organization supplying material, parts and/or services to the Supplier. Supplier: The term used herein to designate the individual(s) or organization that has entered into a purchase order with the Buyer.

14 PAGE 14 OF 14 Supplier Evaluation: An examination of the Supplier s documents and/or a survey of the Supplier s facility to determine the capability of the Supplier to meet the requirements of this Quality Program Specification. Testing: To perform a critical evaluation or examination of raw or commercial materials to determine their physical properties, such as chemistry, grain size, tensile strength, hardness, etc. 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 PQR 2698: Calibration Control Specification PQR 2700: General Requirements for Calibration (CCL) & Testing (CTL) Laboratories ANSI/ISO/IEC 17025: General requirements for the competence of testing and Calibration Laboratories ANSI/NCSL Z540: Requirements for the Calibration of Measuring and Test Equipment ISO 10012: Measurement Management Systems Requirements for Measurement Processes and Measurement Equipment C. LIST OF ADDITIONAL HONEYWELL REFERENCED DOCUMENTS PQR 2767: Designated Calibration Source (DCS) Calibration Program Specification D. LIST OF ADDITIONAL SANDIA REFERENCED DOCUMENTS Designated Calibration Source (DCS) Approval Process