Section 1
Overview of the Nuclear Industry
1.Describe the nuclear fuel cycle.
Uranium is mined, enrich to 5% U235. Turn into fuel pellets, fuel rod bundles, use in reactor.
After about 5 years, remove to spent fuel pool, then to dry cask storage.
Reprocess or long term storage/underground.
2.Describe a typical chain reactionthat occurs in a nuclear reactor.
U235 absorbs neutron, splits into smaller elements, loss of mass converted to energy, release of additional neutrons.
3.What forms of energy are present in nuclear power generation?
Core – nuclear / heat / pressure
Steam Generator – heat / pressure
Turbine – pressure / mechanical
Generator – electrical
Section 2
Regulations and Standards
1.What are four of the roles that are present in the nuclear power industry?
Operators
Regulators
Construction
Design/Engineering
2.Name a country’s regulatory requirements.
10 CFR 50
3.What is the purpose of an application and license?
Application gives plan and commitment to how the facility will function
License is formal government approval to operate to the plan
4.Who has the overall responsibility for ensuring the license requirements are met?
Operators
5.What is the purpose of a quality management system?
Systematic method of addressing risks and applying resources
6.How has the approach to quality management changed over history?
QC – testing and inspection
QA – planned and systematic processes
TQM – customer satisfaction
Integrated Management Systems – applying approach to achieving all goals; quality, environment, safety, securing
7.What’s the PDCA management cycle?
Plan – control plans, documentation (procedures, parameters, limits), training, facility
Do
Check – audits, inspection/testing, process monitoring, management reviews
Act – corrective action
8.Discuss the 4-level documentation pyramid.
Level 1 – Quality Assurance Manual - policies
Level 2 – Quality Procedures – details on how policies are met
Level 3 – Work Instructions (SOP’s) – performing work processes
Level 4 – Forms and records – documents activities
Section 4
Quality Audit Program
1.What are typical responsibilities of an audit program manager?
Audit Schedule
Audit Initiation
Auditor Qualification
Supplier Interface
2.How often are suppliers audited?
Triennially
3.How often are internal audits performed?
Annually
4.Describe the “participation” requirements for Lead Auditor?
Five audits within 3 years
One has to be nuclear within year prior to qualification
5.When are supplemental audits performed?
Change in management, ownership, equipment, location, QA program
6.What are some typical examples of process audit that you may encounter?
NDE, welding, heat treat
7.Review requirements for maintaining proficiency as alead auditor.
Annual review – can maintain proficiency by participation in audits, reviewing codes, training
8.Who certifies Lead Auditors?
Employer
9.Why should you develop an audit schedule as early as possible?
Availability of key personnel
Unforeseen events
Slow times
Geographical considerations
Section 5
Preparation
1.When/who would identify safety equipment needed during an audit?
Lead auditor needs to determine if the team needs to bring PPE.
2.What is the purpose of an audit plan and what information should it include?
Documentation of the task to be performed.
Scope (location/products), dates, audit personnel, audit requirements (standards), applicable documents (supplier QA manual), activities to be audited, organizations to be notified
3.What should a Lead Auditor consider when selecting the audit team?
Technical expertise of the audit team in meeting the audit requirements
4.What can be achieved by good preparation for an audit?
Most efficient use of on-site time
Section 6
Performance
1.Describe objective evidence.
Statement or observation of fact that don’t have recourse to the opinion of the originator.
2.Determining compliance during an audit can be accomplished by…
Review the procedure
Observe the process
Examine records
3.Who would you expect to be at the opening audit meeting?
QA Manager
Department Managers
Audit team
General Manager
4.What are “personality issues” might you encounter in an interviewee?
Hostile
Defensive
Nervous / Fear / Shy
5.When should potential audit findings be discussed?
At the time of discover with the supervisor or manager of the area
6.How should proprietary information be handled?
Respect the right to keep private, don’t put on checklist
7.When should team meetings be done?
At least daily
8.Can an auditee fix a finding during the audit?
Yes, but it is still documented in the report and handled through the CA program.
9.What are requirement and performance-based auditing?
Requirement – auditing each of the 18 requirements of NQA-1
Performance – following an order through process reviewing each activity
10.What is an open-ended question used for? Closed-ended? Summarizing?
Open – Establish initial understanding of subject
Closed – short answer to get fact
Summarizing – show an understanding of the subject
Section 7
Reporting and Follow Up
1.What information should you see on an audit report?
Auditee, scope, dates, requirement (standard), audit team, personnel contacted, findings, statement of effectiveness, lead auditor approval
2.What would justify an onsite follow-up for a corrective action?
Cannot verify completion of actions by reviewing documentation
3.What needs to be on a corrective action report? What information should not be reported?
Deficiency/requirement not met, cause, action to eliminate cause and prevent recurrence, date of completion, verify completion/effectiveness, 10 CFR Part 21 Applicability
Do not report names or place blame
4.What is the recommended time for issuance of an audit report?
30 days
Section 8
Nuclear Program Information
1.Describe NUPIC’s organization and objectives.
Nuclear Utilities sharing audits of mutual suppliers to reduce audit costs.
2.Describe the NIAC Organization and objectives.
Suppliers to the nuclear industry provide information on which suppliers have been evaluated
3.What documents need to be posted according to 10 CFR Part 21?
10 CFR Part 21
Energy reorganization act of 1974
Company Procedure for implementing requirements
4.What is the relationship between 10 CFR Part 21 and ASME NQA-1?
None, which is why it must be included as a purchase order requirement
5.Why is failure to meet the requirements of 10 CFR Part 21 more critical than other requirements?
Possibility of nonconforming item being used in a nuclear safety related application
6.Describe how a company can use a commercial calibration laboratory as a supplier.
May use the assessments performed by the accreditation body as the company’s evaluation (CGS).
Section 9
Commercial Grade Dedication
1.What are critical characteristics of an item and who determines them?
Characteristics related to the form, fit, function of the item determined by Engineering
2.What are the four recognized methods of CGD?
Method 1 –Special Test and Inspection
Method 2 –Commercial Grade Survey
Method 3 –Source Verification
Method 4 –Supplier Performance History
3.What are some important differences between a commercial grade survey and an audit?
Commercial grade survey – investigation of controls that are implemented
Audit – verification that all requirements of the standards are met
4.How much inspection / verification activity is enough?
Depends – inspection/verification is used in conjunctions with supplier oversight, history of product performance, criticality of components, etc.
5.What are important factors in choosing a sampling plan in a CGD?
Lot homogeneity
Nuclear Lead Auditor Training Course Section 10-1
Rev: 9/11Page 1 of 10