Implementing Procedure. DEDICATION OF COMMERCIAL GRADE ITEMS Approved/Date President & COO /vji!"l~:l

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1 A Trans nuclear AREVA TRANSNUCLEAR INC. Page 1 of 10 Revision Summary: DEDICATION OF COMMERCIAL GRADE ITEMS Approved/Date President & COO /vji!"l~:l Approved/Date Director, Quality Assu;ye P. Triska for R. Grubb 11/9/2011 ~ (7/ 11/9/2011 This revision modifies the direction provided in Appendix B on the use of Acceptance Method 3 and adds direction for the use of Acceptance Method 4; adds responsibility in Section 3 for the Director, Quality Assurance to approve all CGDE/Ps in which Acceptance Method 4 is used. Forms and references were also update. Added NOTE following paragraph j & k for clarity purposes and other editorial changes were made as necessary for clarity purposes. 1.0 Purpose and Scope 1.1 This procedure establishes requirements for the dedication of commercial grade items or services intended for use in important to safety applications or safetyrelated applications. 1.2 This procedure does not apply to items or services subject to the requirements of the QAPDM for ASME Section Ill, Division 1 and 3 applications. 1.3 This procedure does not apply to the dedication of calibration services. See TIP 4.1 for details. 1.4 This procedure does not apply to the dedication of procured commercial off-theshelf software. Dedication of software is performed and controlled by testing as provided for in TIP Terms and Definitions 2.1 See TIP 1.2 and Appendix A for terms, definitions, and acronyms applicable to this procedure. 2.2 When used in this procedure, defined terms are generally identified by capitalizing the first letter of the term. 3.0 Responsibilities Controlled Copy: I-01A UNCONTROLLED IF PRINTED 3.1 The Project Engineer (PE) is responsible for developing Commercial Grade Dedication Evaluations/Plans (CGDE/P) 3.2 The Quality Assurance Specialist (QAS) is responsible for assigning CGD numbers, reviewing sampling plans and acceptance methods identified by the PE in a CGDE/P. 3.3 The Engineering Checker is responsible for checking completed CGDE/P for correctness in detail and in engineering principle. 3.4 The Engineering Manager (EM) is responsible for approving all CGDE/Ps. 3.5 The Director, Quality Assurance is responsible for approving all CGDE/Ps that involve the use of Acceptance Method The Quality Assurance Specialist (QAS) or other appropriately qualified individual is responsible for performing verification activities when required by a

2 Page 2 of 10 CGDE/P and generating the resulting Commercial Grade Dedication Report (CGDR) 3.7 The Quality Assurance Manager (QAM) is responsible for approving CGDRs. 4.0 General Requirements 4.1 Commercial Grade Items and Services intended for use in a Quality Category A (10CFR71/72) or Safety Related (10CFR50) application shall be dedicated in accordance with the requirements of this procedure. For dedication of calibration services, see TIP 4.1. The definition of a Commercial Grade Item (CGI) is dependent upon the regulatory basis of the intended use for Item or Service. See TIP 1.2 for CGI definitions for Items and Services associated with 10CFR71/72 (Important to Safety) and 10CFR50 (Safety Related) 4.2 The controls provided by this procedure may also be utilized for Quality Category B items at the discretion of management. The use of commercial grade dedication controls for Quality Category B items is at management discretion. These controls are not being utilized to satisfy regulatory requirements for dedication. 4.3 The composite record documenting the dedication of an item consists of an Evaluation/Plan (CGDE/P) and Report (CGDR) An evaluation/plan (CGDE/P) may be developed for generic (more than one project) purposes or for project specific purposes A report (CGDR) is generated each time an item (or series of items) is dedicated utilizing the requirements of the associated evaluation/plan (CGDE/P). 4.4 For specific verification required by the CGDE/P, engineering or services staff should be used for the verification of specific critical characteristics in order to have the verification performed by the most knowledgeable individual. 5.0 Procedure 5.1 Logging and Numbering Commercial Grade Dedication Evaluation/Plan (CGDE/P) Form The QAS shall maintain a log of CGDE/Ps that contains the following minimum information: a. A unique number for each document that consists of the four digits of the calendar year that the document was initiated and a two digit sequential number starting with 01 (example: ) b. Identification of the Project Number for which the item is being dedicated or the term Generic if the CGDE/P is for more that one project c. Identification of the initiator of the document d. A brief description of the item

3 Page 3 of 10 e. Date that a number was issued for a CGDE/P Commercial Grade Dedication Report (CGDR) Form a. A unique number for each document that consists of the associated CDGE/P. When there is more than one report, a sequential number for each report is assigned (example: , 2, 3, etc.) 5.2 Commercial Grade Dedication Evaluation/Plan (CGDE/P) The PE shall provide the necessary information to and obtain a CGDE/P number from the QAS The PE shall perform the evaluation and define the plan using Form to document the results. Specifically, the PE shall determine and identify: a. Is the Item or Service requiring dedication unique to a project or is it generic (used for multiple projects) b. Technical detail such as drawings, specification, system information necessary for identification and safety function determination c. The regulatory basis of the items intended use: 10CFR71/72 for storage and transportation or 10CFR50 for power reactor applications d. Quality Classification of the Item or Service e. If the item meets the definition of a Commercial Grade Item and as such may be dedicated (Reference TIP 1.2) If the item or service does not meet the definition of a Commercial Grade Item, then the evaluation process/planning shall be stopped and the CGDE/P cancelled as the Item or Service must be procured from a supplier qualified to provide a Basic Component. If the Quality Classification is B, then determination of meeting the definition of a Commercial Grade Item is not applicable f. Identification of the safety function or functions of the item or service in its intended application g. Identification of critical characteristics that must be verified in order to provide reasonable assurance that the Item or Service will perform its intended safety function. The types of critical characteristics that should be considered include Product Identification as well as Physical (Design/Material) and Performance characteristics Appendix A provides a more detailed listing of typical critical characteristics. h. Identification of the engineering / licensing basis utilized in the selection of the critical characteristics to be verified or the establishment of acceptance criteria shall be documented in the Engineering Basis section of the form. For example, if tensile strength is not listed as a selected critical characteristic because hardness is being verified and it has a direct

4 Page 4 of 10 correlation to tensile strength for non-austenitic steels, that logic should be documented. i. Identification of the acceptance criteria for each selected critical characteristic j. Identification of the Acceptance Method(s) for each selected critical characteristic. Consult Appendix B for information regarding the different acceptance methods and limitations of use. k. Identification of the acceptability of using sampling in the dedication process for each critical characteristic and the basis for the selected sampling plan if sampling can be used Section 13.0 identifies several documents that contain information on sampling plans. l. Identification of any additional instruction necessary for performing the verification activities specified When complete, the PE shall sign/date the CGDE/P and obtain QAS review of the CGDE/P. The purpose of the QAS review is to ensure the acceptability of the specified Acceptance Methods and the use of sampling when identified The QAS shall sign/date the CGDE/P once satisfied with the CGDE/P The PE shall provide the CGDE/P to another engineer for checking. The Checker shall review the CGDE/P for adequacy of the identified safety function, critical characteristics, associated acceptance criteria and the engineering basis for the dedication. The Checker shall sign/date the CGDE/P once satisfied On QAS and checker agreement with the PE, the CGDE/P shall be provided to the EM for approval On EM approval, the PE shall provide the CGDE/P to the DCA for records retention purposes. 5.3 Commercial Grade Dedication Report (CGDR) The QAS shall develop the CGDR (Form 7.3-2) to document the results of verification activities required by the CGDE/P. The report shall reference any supporting documentation such as Supplier Commercial Grade Surveys (TIP 7.6), Supplier Surveillance Reports (TIP 7.5), laboratory test reports, and inspection records as applicable. These supporting documents shall be attached to Form unless the documents are available as a standalone record in the records management system (TIP 17.1) Results shall be compared against the acceptance criteria and acceptability documented. Should the results not meet the stated acceptance criteria, a Nonconformance Report shall be generated in accordance with TIP If the disposition results in acceptance of the

5 Page 5 of 10 critical characteristic(s), then a copy of the nonconformance report shall be attached to the CGDR as part of the record Acceptable results for each critical characteristic shall be signed off by the verifier. The QAS signature and date on Form shall represent acceptance of all results unless otherwise noted on the form The completed CGDR (Form 7.3-2) shall be reviewed and approved by the QAM The approved CGDR shall be provided to the DCA for records retention purposes. 5.4 Point of Dedication On satisfactory verification of all specified critical characteristics and approval of the CGDR by the QAM, the Item, or Service is considered dedicated and the reporting responsibilities of 10CFR21 become applicable for dedicated Item or Service The QAS shall tag the dedicated Items and ensure proper storage and control in accordance with TIP 8.1 until ready for use, if applicable. For items being released directly to subcontractors the identification and control shall be in accordance with contract requirements and the subcontractor s approved QA program. 5.5 Revisions to CGDE/Ps and CGDRs Revisions to CGDE/Ps and CGDR s shall receive the same level of review and approval as originally required. 6.0 Supplemental Requirements for ASME Activities This procedure is not applicable to ASME activities 7.0 Supplemental Requirements for Transportation Activities This procedure is not applicable to Transportation activities 8.0 Supplemental Requirements for Safety, Health, and Environmental Activities This procedure is not applicable to EH&S activities 9.0 Supplemental Requirements for Services Activities None 10.0 Forms 10.1 Form 7.3-1, Commercial Grade Dedication Evaluation/Plan 10.2 Form 7.3-2, Commercial Grade Dedication Report 11.0 Records Commercial Grade Dedication Evaluations/Plans, Commercial Grade Dedication Reports, and supporting documentation shall be maintained as records in accordance with TIP Appendices

6 Page 6 of 10 Appendix A, General Listing of Typical Critical Characteristics Appendix B, Acceptance Methods for Commercial Grade Item Dedication 13.0 References 13.1 EPRI NP-5652, Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications 13.2 EPRI TR R1, Guideline for Sampling in the Commercial-Grade Item Acceptance Process 13.3 ANSI/ASQC Z1.4, Sampling Procedures and Tables for Inspection by Attribute 13.4 NRC Information Notice 96-40, Deficiencies in Material Dedication and Procurement Practices and in Audits of Vendors 13.5 NRC Generic Letter 91-05, Licensee Commercial-Grade Procurement and Dedication Programs 13.6 NRC Generic Letter 89-02, Actions to Improve the Dedication of Counterfeit and Fraudulently Marketed Products 13.7 TIP 1.2, Terms, Definitions & Acronyms 13.8 TIP 3.3, Computer Software Test Control 13.9 TIP 4.1, Procurement Document Control TIP 7.5, Supplier/Vendor Oversight TIP 7.6, Commercial Grade Surveys TIP 8.1, Identification and Control of Materials, Parts and Components TIP 15.2, Control of Nonconforming Items TIP 16.1, Corrective Action TIP 17.1, Control of Quality Assurance Records ASME NQA /2009a

7 Page 7 of 10 TRANSNUCLEAR INC. No.: Commercial Grade Dedication Evaluation/Plan (CGDE/P) Rev.: Form Page x of x Project Specific / Project No. Generic Item or Service : TN Drawing No.: TN Specification: System Designation: Regulatory Basis: Important to Safety (10CFR71/71) Safety Related (10CFR50) Quality Category: Quality Category A Quality Category B DEDICATION EVALUATION Does the Item meet the definition of CGI? YES NO NA (Ref. TIP 1.2) If NO Item/Service Cannot Be Dedicated / NA For Quality Class B Identify Item or Service Safety Function: Identify Critical Characteristic(s) Based on Safety Function of Item or Service: Identify Engineering Basis For Each Critical Characteristic: Critical Characteristic: Acceptance Method(s): Acceptance Criteria: Sampling Plan: (Y/N) Sampling Plan Basis: Comments / Additional Instruction: DEDICATION PLAN (Complete for each Critical Characteristic) APPROVALS Prepared By: (PE) Date: Reviewed By: (QAS) Date: Reviewed By: (Engineering Checker) Date: Approved By: (EM) Date: Approved By: (Method 4 Acceptance Only) (DQA) Date:

8 Page 8 of 10 TRANSNUCLEAR INC. No.: Commercial Grade Dedication Report (CGDR) Rev.: PROCUREMENT INFORMATION Form Page x of x PO Number: Supplier: Item/Service No: Item/Service Description: CGDE/P No: Project No: Regulatory Basis: Important to Safety (10CFR71/72) Safety Related (10CFR50) Quality Category: Quality Category A Quality Category B Critical Characteristic: Acceptance Method: VERIFICATION OF CRITICAL CHARTACTERISTICS (Complete for each Critical Characteristic) 1 Sampling Plan: Acceptance Criteria: Verification Results: Satisfactory Unsatisfactory Comments: Verified By: Date: Critical Characteristic: Acceptance Method: 2 Sampling Plan: Acceptance Criteria: Verification Results: Satisfactory Unsatisfactory Comments: Verified By: Date: APPROVALS Prepared By: (QAS) Date: Approved By: (QAM) Date:

9 Page 9 of 10 Appendix A General Listing of Typical Critical Characteristics Product Identification Color Coding Industry Standard Markings Display Type (scale, graduations) Nameplate Data Enclosure Type Part Number/Unique Identifier Physical Characteristics Balance Ductility Plating Capacitance Durometer Hardness Polarity Cloud Point Elasticity Pour Point Coating Fatigue Resistance Purity Color Flammability Resilience Composite Material Hardness Flash Point Resistance Concentration General Configuration/Shape Solubility Conductivity Homogeneity Spring Constant Continuity Inductance Surface Finish Density/Specific Gravity Leachable Halogen Content Surface Hardness Dielectric Strength Luminescence Tensile Strength Dimensions Material of Construction Torque Oil/water Separation Viscosity Drop Point Permeability Weight Performance Characteristics Accuracy Interrupt Rating Power Rating Burn-in Endurance Interrupting Current Pressure Rating Chatter Leakage Repeatability Current Rating Load Rating Ride Out Cycle time Open/Closure Time Rotational Direction Deadband Width Operability (Fail Open/Close, Stroke) Set point Stability Flow Rate Operating Range (No Drift) Speed Gain Performance During/Under Voltage Conditions Horsepower Time/Current/Response Voltage Rating Input/Output Voltage Pick-up/Drop-out Voltage

10 Page 10 of 10 Appendix B Acceptance Methods for Commercial Grade Item Dedication The following acceptance methods shall be used for determining acceptability of the each identified critical characteristic subject to any identified limitations. Special Tests and Inspections (Method 1) These special tests and inspections may be performed by qualified personnel or by designated outside contractors. These contractors shall be either TN Approved Suppliers or their services must be accepted by audit (nuclear suppliers) or by Acceptance Methods 2 or 3 below. Commercial Grade Survey (Method 2) A commercial grade survey is used to verify that the supplier of the item or service to be dedicated has a documented commercial quality program to control the critical characteristics of the item or service. Commercial Grade Surveys are performed in accordance with TIP 7.6. The relevant quality program or procedures must be invoked in s procurement document. Acceptance Method 2 Commercial Grade Survey of the Supplier, shall not be employed as the only basis for accepting items from suppliers with commercial quality control programs that do not effectively implement all necessary program controls or required controls are not fully documented. Likewise, Method 2 shall not be employed as the basis for accepting items from distributors unless the survey includes the item/material supplier and the survey confirms adequate controls by both the distributor and the item/material supplier. Source Verification (Method 3) Source verification involves the verification of critical characteristics for the item or service by witnessing quality activities at the supplier s facility. This method only verifies that appropriate controls are being applied to the specific item or service being supplied. Acceptable Supplier Item or Services Performance Record (Method 4) An acceptable supplier performance record (Method 4) may be used only in conjunction with a periodic Source Verification (Method 3). Acceptance Method 4 shall not be used by itself for the purposes of dedication. If Method 4 is used, then the basis for the determination that the Supplier has an acceptable performance record shall be documented in the CGDE/P. Periodicity requirements (including the basis) and the acceptance criteria to be applied for determining continued acceptable Supplier Performance during the periodic Source Verification shall also be documented in the CGDE/P. Determinations of unacceptable supplier performance and the impact shall be evaluated in accordance with TIP 16.1 and appropriate corrective actions taken.