SUPPLIER QUALITY PROGRAM, V (U)

Transcription

1 FEDERAL MANUFACTURING & TECHNOLOGIES PQR 1060 PAGE 1 OF 17 SUPPLIER QUALITY PROGRAM, V (U) CHANGE HISTORY ISSUE DESCRIPTION OF CHANGE AUTHOR DATE E CORRECTED CHANGE HISTORY S. L. HALTER 10/18/2000 F UPDATED FORM CALLOUTS S. L. HALTER 10/21/2002 G DELETED REFS. TO FORM 1609B S. L. HALTER 9/15/2004 H UPDATED TITLE TO PQR-2767 G. D. SWANSON 12/15/2006 J UPDATED TO INCLUDE AS9100 T. D. MONROE 10/23//2009 K L M UPDATED BUYER REQUIREMENTS UPDATED REQUIREMENTS PER CAR CORRECT ERROR W/ L RELEASE T. D. MONROE N. W. BETOW N.W. BETOW 6/22/2011 5/23/ /01/2012 T. D. Monroe D/450 2C36 D. A. Carey D/800 2A42 R. L. Clewell D/400 2C36 C. C. Mears D/600 OC44 S. C. Davis D/450 MD40 T. A. Davis D/882 FJ42 R. L. Vanhoose D/400 2C36 T. J. TeKolste D/876 2B37 S. R. Mandl D/400 2C36 P. E. Biagioli D/620 OC44 S. G. Condron D/418 FK39 P. T. Hoopes NNSA 1D49 M. N. Perez D/KF4 K109 G. M. Colletti D/620 OC44 E. H. Detlefs SNL 0665 D. R. Boone SNL 0872 R. N. Burton SNL 0665 R. B. Muniz SNL 0872

2 PAGE 2 OF 17 TABLE OF CONTENTS 1. PURPOSE ORDER OF PRECEDENCE DEFINITIONS AND REFERENCE DOCUMENTS BUYERS QUALITY OVERSIGHT REQUIREMENTS OF THE SUPPLIER S QUALITY PROGRAM APPENDICES... 10

3 PAGE 3 OF PURPOSE This specification defines the minimum requirements of Supplier Quality Program V 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 JUNE 29, 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 Reference documents is 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 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. 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 PAGE 5 OF 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 requirements. All work performed under Buyer purchase orders will be performed within the scope of the Supplier s quality program. The Buyer reserves the right to conduct final inspection and/or testing of the Supplier s product to assure conformance with the requirements. The Supplier s quality program will be compliant to AS9100 (Excluding Section 7.3 Design and Development). B. QUALIFICATION FOR THE BUYER S APPROVED SUPPLIER LIST Suppliers shall furnish a copy of their quality manual or equivalent to the Buyer prior to surveys for qualification or requalification. 1. INITIAL SURVEYS An initial survey shall be conducted by authorized Buyer audit personnel to AS9100 (Excluding Section 7.3 Design and Development), Buyer specific requirements of this document, and the Buyer s Purchase Order requirements. Suppliers gain approved status upon completion of the survey and closure of any related findings. 2. REQUALIFICATION Requalification will be at the Buyer s discretion, normally at 3-year intervals. The Buyer will review the Supplier s performance and conduct a survey to AS9100 (excluding Section 7.3 Design and Development), Buyer specific requirements of this document, and Buyer Purchase Order requirements.

6 PAGE 6 OF 17 Suppliers that demonstrate excellent performance and maintain AS9100 registration with an accredited registrar may requalify by submitting a copy of their registration to the Buyer annually on the anniversary of their qualification date. The Buyer may also require supplier requalification as a result of quality problems with a supplier s parts, supplier change of ownership, supplier relocation, and significant changes to the supplier s quality manual. C. 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. 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: 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. A software quality assurance process shall be established. Software configuration management shall ensure: o A software baseline is established.

7 PAGE 7 OF 17 o Changes subsequent to the baseline are traceable to software requirements, approved, documented and added to the baseline so that the baseline defines the most recently approved software configuration. 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 plans(s) submitted by the Product Realization Team. 2. 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.

8 PAGE 8 OF 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. 4. 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.

9 PAGE 9 OF TRAINING Personnel training needs shall be evaluated at intervals not to exceed 3 years. Training shall be documented and records retained for 3 years. 6. D-TEST/ENGINEERING SAMPLES 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.

10 PAGE 10 OF APPENDICES A. DEFINITIONS Administrative Change: Buyer: Buyer Requirements: A change to Supplier production or inspection work instructions, which is not defined as significant. Honeywell Federal Manufacturing and Technologies (FM&T) or Sandia National Laboratories (SNL) The Purchase Order 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.

11 PAGE 11 OF 17 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. Calibration Program Approval (Sandia National Laboratories): Certificate of Conformance: 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. A signed document stating that the supplied product meets specified Buyer requirement.

12 PAGE 12 OF 17 Certification: Certified Processes: 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. 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.

13 PAGE 13 OF 17 Engineering Change Order: Inspection: 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. 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.

14 PAGE 14 OF 17 Laboratory/Test Capability Approval: Qualification: 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. 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.

15 PAGE 15 OF 17 Quality Evidence: Quantitative Data: Qualitative Data: Process Control Data: 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, nondestructive tests or any combination of these. This information includes: 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. 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). 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.

16 PAGE 16 OF 17 Sales Office: Significant Change: Subcontractor: Supplier: Supplier Evaluation: An independent distributor or a company division that handles sales and marketing for the entire Supplier organization. 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). The term used herein to designate an individual or organization supplying material, parts and/or services to the Supplier. The term used herein to designate the individual(s) or organization that has entered into a purchase order with the Buyer to supply materials, parts, components, apparatus or services to Honeywell FM&T or Sandia National Laboratories. 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.

17 PAGE 17 OF 17 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 AS9100 Rev B or later: Quality Management Systems Requirements for Aviation, Space And Defense Organizations PQR 2698: PQR 2700: ANSI/ISO/IEC 17025: ANSI/NCSL Z540: Calibration Control Specification General Requirements for Calibration (CCL) & Testing (CTL) Laboratories General requirements for the competence of testing and Calibration Laboratories 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 FM&T REFERENCED DOCUMENTS PQR 2767: Designated Calibration Source (DCS) Calibration Program Specification D. LIST OF ADDITIONAL SANDIA REFERENCED DOCUMENTS Designated Calibration Source (DCS) Approval Process