QUALITY ASSURANCE CRITERIA APPLICABLE TO THE DESIGN PROCESS SUBJECT: PRESENTATION TO THE NUCLEAR WASTE TECHNICAL REVIEW BOARD
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1 U.S. DEPARTMENT OF ENERGY OFFICE OF CIVILIAN RADIOACTIVE WASTE MANAGEMENT PRESENTATION TO THE NUCLEAR WASTE TECHNICAL REVIEW BOARD SUBJECT: PRESENTER: PRESENTER'S TITLE AND ORGANIZATION: QUALITY ASSURANCE CRITERIA APPLICABLE TO THE DESIGN PROCESS EDGAR H. PETRIE ACTING DIRECTOR, ENGINEERING AND DEVELOPMENT DIVISION YUCCA MOUNTAIN SITE CHARACTERIZATION PROJECT PRESENTER S TELEPHONE NUMBER: (702) MARCH 26-27, 1991
2 QA GRADING PROCESS PROVIDE ACTIVITY IDENTIFICATION AND DEFINITION DETERMINE IF ACTIVITY IS ON QUALITY ACTIVITIES LIST OR PROJECT REQUIREMENTS LIST STATE IMPORTANCE TO PROJECT (i.e. WORKER RADIOLOGICAL SAFETY, OPERATIONAL RELIABILITY) IDENTIFY APPLICABLE QA CRITERIA PROVIDE JUSTIFICATION IF CRITERIA IS NOT APPLICABLE OBTAIN QUALITY REVIEW BOARD ACCEPTANCE NWTR BQAP. 126/
3 THE FOLLOWING CRITERIA WERE IDENTIFIED BY THE AE THROUGH THE QA GRADING PROCESS AND ARE APPLICABLE TO ESF DESIGN ACTIVITIES NWTRBQAP.126/
4 1 ORGANIZATION 2 QA PROGRAM 3 DESIGN CONTROL 4 PROCUREMENT DOCUMENT CONTROL 5 PLANS, PROCEDURES, INSTRUCTIONS AND DRAWINGS 6 DOCUMENT CONTROL 7 CONTROL OF PURCHASED ITEMS AND SERVICES 16 CORRECTIVE ACTION 17 QA RECORDS 18 AUDITS 19 COMPUTER SOFTWARE NWTRBQAP. 126/
5 CRITERION 1 - ORGANIZATION ESTABLISHMENT OF LINES OF AUTHORITY DEFINITION OF FUNCTIONAL RESPONSIBILITIES DEFINITION OF LINES OF COMMUNICATION FOR GUIDANCE, DIRECTION AND CONTROL e FULL DOCUMENTATION OF ORGANIZATIONAL ACTIONS NWTR BQAP, 126/
6 CRITERION 2 - QUALITY ASSURANCE ESTABLISHMENT OF A QA PROGRAM QA ORGANIZATIONAL INDEPENDENCE IDENTIFICATION OF QUALITY AFFECTING ITEMS OR ACTIVITIES IDENTIFICATION OF APPLICABLE QA CRITERIA IDENTIFICATION OF QA CONTROLS DOCUMENTED PERSONNEL QUALIFICATION TRAINING OF PERSONNEL PROGRAM TRAINING RECORDS NWTRBQAP.126/
7 CRITERION 3- DESIGN CONTROL DEFINITION OF DESIGN CONTROL PROCESS CONTROL OF DESIGN INPUTS e DESIGN VERIFICATION ESTABLISHMENT OF CHANGE CONTROL MEASURES e ARCHIVING OF DESIGN DOCUMENTATION NWTRBQAP. 126/
8 CRITERION 4- PROCUREMENT DOCUMENT CONTROL APPLICABLE DESIGN BASES/REQUIREMENTS NECESSARY TO ASSURE QUALITY TO BE INCLUDED OR REFERENCED IN PROCUREMENT DOCUMENTS O PROCUREMENT DOCUMENTS TO SPECIFY THAT SUPPLIERS HAVE AN ADEQUATE QUALITY ASSURANCE PROGRAM NWTRBQAP. 126/
9 CRITERION 5- PLANS, PROCEDURES, INSTRUCTIONS AND DRAWINGS DESIGN ACTIVITIES TO BE CONDUCTED IN ACCORDANCE WITH APPROVED PLANS AND PROCEDURES IDENTIFICATION OF ACCEPTANCE CRITERIA FOR DESIGN PRODUCTS e CONTROLLED CHANGES TO PLANS AND PROCEDURES NWTRBQAP. 126/
10 CRITERION 6 - DOCUMENT CONTROL CONTROL OF DESIGN GENERATED DOCUMENTS e ESTABLISHMENT OF CRITERIA FOR CONTROL OF DESIGN INPUTS STATUS OF DESIGN GENERATED DOCUMENTS TO BE MAINTAINED e DOCUMENTATION OF DESIGN CHANGES NWTR BQAP. 126/
11 CRITERION 7 - CONTROL OF PURCHASED ITEMS AND SERVICES t CONTROL OF PROCUREMENT OF ITEMS AND SERVICES TO ASSURE CONFORMANCE WITH SPECIFIED REQUIREMENTS INCLUDES - SOURCE EVALUATION AND SELECTION - OBJECTIVE EVIDENCE OF QUALITY (BY SUPPLIER) - SOURCE INSPECTIONS/AUDITS - EXAMINATION OF ITEMS/SERVICES UPON DELIVERY NWTR BQAP. 126/
12 CRITERION 16 - CORRECTIVE ACTIONS PROMPT IDENTIFICATION AND CORRECTION OF CONDITIONS ADVERSE TO QUALITY REMEDIAL ACTION IDENTIFICATION OF ROOT CAUSE OF CONDITION INVESTIGATIVE ACTION CORRECTIVE ACTION DOCUMENTATION OF ACTION TAKEN NWTRBQAP. 126/
13 CRITERION 17 - QA RECORDS e DOCUMENTION OF EVIDENCE OF COMPLIANCE TO QA REQUIREMENTS LEGIBLE AND IDENTIFIABLE RECORDS e PROVISIONS FOR SUPPLEMENTING OR AMENDING RECORDS e SUBMITTAL OF RECORDS TO APPROVED RECORDS FACILITY NWTR BQAP. 126/
14 CRITERION 18 - AUDITS t AUDITS AND SURVEILLANCES OF QUALITY AFFECTING OR QUALITY RELATED DESIGN ACTIVITIES NWTRBQAP. 126/
15 CRITERION 19- COMPUTER SOFTWARE REQUIRES" DEVELOPMENT OF A COMPUTER SOFTWARE DEVELOPMENT AND CONTROL PROGRAM DEVELOPMENT OF A COMPUTER SOFTWARE QUALITY ASSURANCE PLAN NWTRBQAP. 126/
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