Course Curriculum

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