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Quality Assurance Program Description, Revision 11 Effective Date: 12/31 /13 .... QUALITY ASSURANCE PROGRAM DESCRIPTION LBNL/PUB-3111, Rev. 11 EFFECTIVE DATE: December 31, 2013 Ernest Orlando Lawrence Berkeley National Laboratory This work is supported by the U.S. Department of Energy under Contract No. DE-AC02-05CH11231 . LBNL/PUB-3111, Quality Assurance Program Description, Revision 11 Effective Date: 12/31 /13 Review and Approval Approved by: Date: Aundra Richards Manager, Berkeley Site Office Department of E ergy Approved by: Date: enn D. Kubiak ~ l Chief Operating Officer Lawrence Berkeley National Laboratory Approved by: Date: Director, Institutional Assurance ~ wrence Berkeley National Laboratory Preparedby: ~ Date: elanie Gr ois Manager, Assurance & Quality Program Office of Contractor Assurance Lawrence Berkeley National Laboratory This document was prepared as an account of work sponsored by the United States Government. While this document is believed to contain correct information, neither the United States Government nor any agency thereof, nor the Regents of the University of California, nor any of their employees, makes any warranty, express or implied, or assumes any legal responsibility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. Reference herein to any specific commercial product, process, or service by its trade name, trademark, manufacturer, or otherwise, does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government or any agency thereof, or the Regents of the University of California. The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States Government or any agency thereofor the Regents of the University of California. LBNL/PUB-3111, Quality Assurance Program Description, Revision 11 Effective Date: 12/31 /13 Table of Contents RECORD OF REVISION ............................................................................................................ .4 OBJECTIVES AND APPLICABILITY ........................................................................................... 5 1.0 ORGANIZATION AND QUALITY ASSURANCE PROGRAM ............................................. 6 1.1 ORGANIZATION ....................................................................................................... 6 1.2 GRADING ITEMS AND SERVICES AND APPL YING MANAGEMENT CONTROLS .8 1.3 PLANNING ...............................................................................................................8 1.4 STAFF PROFICIENCY ............................................................................................. 8 2.0 QUALITY IMPROVEMENT ............................................................................................... 9 2.1 MANAGEMENT ASSESSMENT .............................................................................. 9 2.2 ASSESSMENT ....................................................................................................... 10 2.3 CONTINUOUS IMPROVEMENT ............................................................................ 11 3.0 DOCUMENT AND RECORDS MANAGEMENT .............................................................. 12 3.1 DOCUMENT CONTROL .......................................................................................... 12 3.2 CONSENSUS STANDARDS ................................................................................... 13 3.3 RECORDS MANAGEMENT ................................................................................... 13 4.0 WORK PROCESSES ...................................................................................................... 13 4.1 DESIGN ................................................................................................................. 13 4.2 PROCUREMENT ................................................................................................... 14 4.3 ACCEPTANCE OF PROCURED ITEMS OR SERVICES ....................................... 14 4.4 INSPECTION ......................................................................................................... 15 4.5 TESTING ............................................................................................................... 15 4.6 MONITORING, MEASURING, TESTING & DATA COLLECTION EQUIPMENT .... 15 4.7 CALIBRATION ....................................................................................................... 16 4.8 SAFETY SOFTWARE QUALITY ASSURANCE ..................................................... 16 ATTACHMENT A- DEFINITIONS ............................................................................................ 18 ATTACHMENT B- GRADED APPROACH RISK METHODOLOGY ........................................ 21 ATTACHMENT C - QUALITY CLAUSES .................................................................................. 24 LBNL/PUB-3111, Quality Assurance Program Description, Revision 11 Effective Date: 12/31 /13 Page 4 of 32 Record of Revision Rev. No. Date Description 3 DRAFT Rewrite of the LBL Institutional Quality Assurance (11/11/92) Program Plan, Rev. 2, dated December 21, 1988, to incorporate requirements of DOE Order 5700.6C. 3 213193 Comments incorporated. Issued to Laboratory for use. 4 6/15/94 Updated in the following areas: -suspect/counterfeit parts program -maintenance management -DOE Order 5480.25, Accelerator Safety -total quality management -general editorial 5 1115/96 Rewrite of OAP, Rev. 4 6 1/15/98 Revise to integrate with ISMS 7 4/18/00 Updated in the following areas: - IO CFR 830.120 and 414.1, Quality Assurance - conduct of operations - maintenance management 8 12/06 Rewrite of the LBNL Operating and Quality Management Plan, dated April 18, 2000, to incorporate requirements of DOE Order 414.1 C and ISO 9001-2000. Also updated to reflect current LBNL organizations and operations. Appendix D demonstrates how QAPD addresses DOE 0 414.1 C requirements. 9 06/08 Clarified section 2.7, Document Control policy. 10 10/08 Clarified and expanded upon section 2.6.5, Software Quality Assurance 11 12/31/13 Changed the title of this document from "Operating and Quality Management Plan" to "Quality Assurance Program Description" (QAPD); rewrote to describe how the Lab implements QA requirements; moved policy to the RPM and removed procedural steps; aligned QAPD with the Contractor Assurance and Integrated Safety Management systems; better aligned QAPD elements with DOE 0 414.1 D and ANSI/ISO/ASQ Q9001-2008; added definitions and quality clauses; and revised the Graded Approach Risk Methodology. LBNL/PUB-3111, Quality Assurance Program Description, Revision 11 Effective Date: 12/31 /13 Table of Contents RECORD OF REVISION ............................................................................................................ .4 OBJECTIVES AND APPLICABILITY ........................................................................................... 5 1.0 ORGANIZATION AND QUALITY ASSURANCE PROGRAM ............................................. 6 1.1 ORGANIZATION .......................................................................................................6 1.2 GRADING ITEMS AND SERVICES AND APPL YING MANAGEMENT CONTROLS .8 1.3 PLANNING ...............................................................................................................8 1.4 STAFF PROFICIENCY ............................................................................................. 8 2.0 QUALITY IMPROVEMENT ............................................................................................... 9 2.1 MANAGEMENT ASSESSMENT .............................................................................. 9 2.2 ASSESSMENT ....................................................................................................... 10 2.3 CONTINUOUS IMPROVEMENT ............................................................................ 11 3.0 DOCUMENT AND RECORDS MANAGEMENT .............................................................. 12 3.1 DOCUMENT CONTROL. ......................................................................................... 12 3.2 CONSENSUS STANDARDS ................................................................................... 13 3.3 RECORDS MANAGEMENT ................................................................................... 13 4.0 WORK PROCESSES ...................................................................................................... 13 4.1 DESIGN ................................................................................................................. 13 4.2 PROCUREMENT ................................................................................................... 14 4.3 ACCEPTANCE OF PROCURED ITEMS OR SERVICES ....................................... 14 4.4 INSPECTION ......................................................................................................... 15 4.5 TESTING ............................................................................................................... 15 4.6 MONITORING, MEASURING, TESTING & DATA COLLECTION EQUIPMENT .... 15 4.7 CALIBRATION ....................................................................................................... 16 4.8 SAFETY SOFTWARE QUALITY ASSURANCE ..................................................... 16 ATTACHMENT A-DEFINITIONS ............................................................................................ 18 ATTACHMENT B - GRADED
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