The Regulations and Standards
10CFR50 Appendix B, ASME NQA-1, ANSI N45.2, and 10CFR21
Background and ownership of standards
Application of standards -
where/when does each of the standards apply?
Roles of the Government, nuclear utilities, and vendors
The seven “daughter standards” of ANSI N45.2
The Audit Process and Auditor Responsibilities
Planning and organizing aspects of an audit
Checklist Development
Conducting the Audit
Interview Techniques
Approaches to process flow auditing
Explanation of how to properly complete the NQA-1 checklist and practice in completing a checklist
Completing NCR's and closing out an audit
Explanation of NQA-1 approval requirements
Nuclear Industry Vendor Approvals
NUPIC – Nuclear Utilities Procurement Issues Committee
NIAC – Nuclear Industry Assessment Committee
Calibration Program Accreditations through A2LA and NVLAP
Interpretations of the StandardsComparison of ISO 9001 to ASME NQA-1
A detailed review of the 18 Criteria of 10CFR50 Appendix B and NQA-1
Interpretation of each criterion
Objective evidence that would normally be reviewed
Commercial Products and the Dedication Process for the Nuclear Industry
Critical Characteristics and the Commercial Grade Dedication and Inspection Process (CGDI)
Application of EPRI 5652
Commercial Grade Survey of Vendors
Determining Acceptability and Inspection
Reporting of Noncompliances per 10 CFR Part 21
General, Administrative and Basic Auditing Topics
Course format, attendee requirements and how attendee will be evaluated
Auditors’ personal qualifications and conduct
Roles and responsibilities of audit team members and others associated with the audit
Overview of the types of audits, their purpose and importance
Determining an audit schedule
Degree of importance based on the type of business and applicationFocus of an audit on the organization’s entire documented/defined business systems
Post audit follow-up on nonconformities and closing out of corrective actions
General Topics and Topics Related to Standards
Description of the purpose of a quality management system and its role in helping an organization operate with increased effectiveness, consistency and customer satisfaction
Description of Quality Management Principles and explanation of how they relate to safety
Detailed discussion and explanation of the intent and the requirement of each clause of ASME NQA-1
Discussion and explanation of the documentation required and the interrelationships between the quality manual, procedures, quality planning, policy and objectives
Explanation of the audit evidence needed to demonstrate conformity to NQA-1 requirements
Explanation and practice in evaluating the differing requirements for QMS documentation in a variety of situations
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