10 CFR 50 Appendix B Criterion II, Quality Assurance Program

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v t e 10 CFR 50 Appendix B
Quality Assurance Program
Criterion 2	The applicant shall establish at the earliest practicable time, consistent with the schedule for accomplishing the activities, a quality assurance program which complies with the requirements of this appendix. This program shall be documented by written policies, procedures, or instructions and shall be carried out throughout plant life in accordance with those policies, procedures, or instructions. The applicant shall identify the structures, systems, and components to be covered by the quality assurance program and the major organizations participating in the program, together with the designated functions of these organizations. The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety. Activities affecting quality shall be accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanness; and assurance that all prerequisites for the given activity have been satisfied. The program shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test. The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained. The applicant shall regularly review the status and adequacy of the quality assurance program. Management of other organizations participating in the quality assurance program shall regularly review the status and adequacy of that part of the quality assurance program which they are executing.
10 CFR 50 Appendix B Criterion I, Organization 10 CFR 50 Appendix B Criterion II, Quality Assurance Program 10 CFR 50 Appendix B Criterion III, Design Control 10 CFR 50 Appendix B Criterion IV, Procurement Document Control 10 CFR 50 Appendix B Criterion V, Instructions, Procedures, and Drawings 10 CFR 50 Appendix B Criterion VI, Document Control 10 CFR 50 Appendix B Criterion VII, Control of Purchased Material, Equipment, and Services 10 CFR 50 Appendix B Criterion VIII, Identification and Control of Materials, Parts, and Components 10 CFR 50 Appendix B Criterion IX, Control of Special Processes 10 CFR 50 Appendix B Criterion X, Inspection 10 CFR 50 Appendix B Criterion XI, Test Control 10 CFR 50 Appendix B Criterion XII, Control of Measuring and Test Equipment 10 CFR 50 Appendix B Criterion XIII, Handling, Storage and Shipping 10 CFR 50 Appendix B Criterion XIV, Inspection, Test, and Operating Status 10 CFR 50 Appendix B Criterion XV, Nonconforming Materials, Parts, or Components 10 CFR 50 Appendix B Criterion XVI, Corrective Action 10 CFR 50 Appendix B Criterion XVII, Control of Purchased Material, Equipment, and Services 10 CFR 50 Appendix B Criterion XVIII, Audits

Type of violation

	Site	Company⠉	Quarter	Title	Significance	Inspection procedure	Topic
05000461/FIN-2018002-04	Clinton	Constellation	2018Q2	Minor Violation	Severity level Minor	IP 71152, Problem Identification and Resolution (PI&R)
05000461/FIN-2017004-03	Clinton	Constellation	2017Q4	Failure to Identify the Extent of Condition for an Inadequate 10 CFR 50.59 Evaluation	Green	IP 92723
05000461/FIN-2017002-07	Clinton	Constellation	2017Q2	Root Cause Evaluation Failed to Identify Corrective Action to Preclude Repetition	Green	IP 71152, Problem Identification and Resolution (PI&R)
05000331/FIN-2016003-02	Duane Arnold	NextEra Energy	2016Q3	Failure to Identify and Evaluate a Condition Adverse to Quality	Green	IP 71111.15, Operability Determinations and Functionality Assessments	Condition Adverse to Quality Significance Determination Process
05000254/FIN-2016001-02	Quad Cities	Constellation	2016Q1	Failure to Identify Structures, Systems, and Components as Safety-Related	Green	IP 71153, Event Followup	Significance Determination Process
05000461/FIN-2016001-06	Clinton		2016Q1	Inadequate Extent of Condition Associated with an ACE	Green		Significance Determination Process
05000461/FIN-2015007-01	Clinton		2015Q4	Failure to Generate Issue Reports for Conditions Adverse to Quality	Green	IP 71152, Problem Identification and Resolution (PI&R)	Maintenance Rule Program
05000255/FIN-2015004-02	Palisades	Entergy	2015Q4	Failure to Identify Components Required to be Covered by the Quality Assurance Program	Green	IP 71111.21	Operability Assessment
05000255/FIN-2015004-03	Palisades	Entergy	2015Q4	Failure to Provide Bases to Determine Changes Did Not Involve Unreviewed Safety Questions	Green	IP 71111.21	Operability Assessment
05000397/FIN-2014002-01	Columbia	Energy Northwest	2014Q1	Failure to Subject Diesel Generator Intake Air Pre-Filters to the Controls of the Quality Assurance Program	Green	IP 71111.01	Significance Determination Process
05000373/FIN-2013005-06	LaSalle	Constellation	2013Q4	Improper Classification of Secondary Containment Doors as Nonsafety-Related	Green	IP 71153, Event Followup	Significance Determination Process

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