Issue Date: 02/07/07 88106 1

NRC INSPECTION MANUAL NMSS/RII

INSPECTION PROCEDURE 88106

QUALITY ASSURANCE: PROGRAM DEVELOPMENT AND IMPLEMENTATION

(PRE-LICENSING AND CONSTRUCTION) 

PROGRAM APPLICABILITY: 2630

88106-01 INSPECTION OBJECTIVES

01.01 To determine whether the applicant’s quality assurance (QA) activities are

conducted in accordance with U.S. Nuclear Regulatory Commission (NRC) approved QA

program requirements.

01.02 To determine (at the appropriate time of the construction phase) that a process has

been established to assure that structures, systems, and components (SSCs) have been

characterized and classified in accordance with NRC-approved QA program requirements.

01.03 To determine that a process has been established to assure that the necessary

indoctrination, training, and qualification of personnel performing or managing qualityaffecting activities are identified and provided, and that suitable proficiency is achieved and

maintained.

01.04 To determine that the applicant has established a system of management

assessments to evaluate the effectiveness and implementation of QA program elements

and other management measures for items relied on for safety (IROFS) and to address the

technical adequacy of the items evaluated.

88106-02 INSPECTION REQUIREMENTS

Verify that selected elements associated with the applicant’s functional organization and

QA program structure (as identified in an approved inspection plan) are in accordance with

the applicant’s approved QA Plan. Elements chosen for inspection may include two or

more of the following:

02.01 Organization. Applicant’s organizational structure, functional responsibilities, and

delegation authority;

02.02 Classification of Structures, Systems, and Components (SSCs). Quality Level

categorization of SSCs commensurate with their safety significance;

02.03 QA Training. QA indoctrination, training, and qualification of personnel performing

or managing quality-affecting activities are identified and provided to assure suitable

proficiency is achieved and maintained; and
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02.04 Management Assessments. Applicant management assessments and audits of

QA program elements, to evaluate the effectiveness and implementation of QA program

elements and other management measures for IROFS, and to address the technical

adequacy of the items evaluated.

88106-03 INSPECTION GUIDANCE

03.01 Organization. Review the organizational requirements in the approved QA Plan.

Verify that organizational structure, functional responsibilities, delegations of authority, and

interfaces for those managing, performing, and assessing the work, have been properly

established.

03.02 Classification of SSCs and IROFS.

a. Before the license application and associated Integrated Safety Analysis (ISA)

have been reviewed and approved, the inspector should focus on any changes to

the QL designations that would necessitate reevaluation of any QA grading

applied. Specifically, the inspector should verify that:

1. Changes in QA categorization are performed and documented in accordance

with applicable QA project procedures.

2. QA categorization changes require updating of the applicable design

documents for the particular SSC that was changed and that these changes

necessitated the review of applicable QA requirements for confirming or

changing previously established graded QA controls.

3. The licensee’s QA Plan requirements for QLs assigned to SSCs are

commensurate with their safety significance.

The inspector should inform the NRC licensing function of any changes made to

the QL designations.

b. After NRC’s licensing function has reviewed and approved the license application

and associated ISA, the inspector should review the licensee’s QA program and

pertinent implementing procedures and instructions in the steps below, and verify

that the definitions of the various QLs are consistently applied throughout the

program. Verify that the grading process is clearly described in procedures, and

conducted, reviewed, and approved by the appropriately designated organizational

functions.

1. Review the SSCs identified in the applicant’s safety analyses for the selected

areas. Determine if the applicant has identified each SSC with the proper

safety significance, by verifying that it has been properly categorized in the

various QLs. Focus largely on those SSCs that are listed as less risksignificant, to ensure that the applicant is not underestimating the safety 
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significance. For example, would the failure of a control designated as QL1b or lower, lead to loss of double contingency or cause 10 CFR 70.61

requirements to be exceeded.

2. Verify that the applicant applies a graded approach to the process by

ensuring that the level of analysis, documentation, and actions used to

comply with a requirement are commensurate with: (1) the relative

importance to safety, safeguards, and security; (2) the magnitude of any

hazard involved; (3) the life cycle stage of a facility; (4) the programmatic

mission of a facility; (5) the particular characteristics of a facility; (6) the

relative importance of radiological and non-radiological hazards; and (7) any

other relevant factor.

3. Review changes in QA categorization to verify they have been performed in

accordance with QA procedures, and that applicable design documents were

changed accordingly.

4. Review the applicant’s procedure for classifying SSCs and IROFS according

to their importance to safety. Verify that the process described in the

procedure is consistent with the requirements in 10 CFR Part 70, the Mixed

Oxide Project Quality Assurance Plan (MPQAP), and the Construction

Authorization Request (CAR). Verify that the current listing of Principle

Structures, Systems and Components and Items Relied on for Safety

(PSSCs) and IROFS important to safety is documented on a (Q-List).

Select a number of PSSCs/IROFS not on the Q-list and verify that the

engineering basis for not including them is adequately documented.

5. Select several Q-list items and verify that adequate analysis was performed

to demonstrate that the SSCs and IROFS meet the design basis established

in the CAR, license, engineering documents, system descriptions, applicable

regulatory requirements, or other design basis documents.

6. Verify that requirements for the Q-list items are adequately translated into

specifications, drawings, procedures, and instructions.

7. Verify that design work for the Q-list items selected is completed and

documented on a timely basis and to the level of detail to support the overall

design process, fabrication, construction, and operation. Verify that the

design documents have sufficient detail, regarding purpose, method,

assumptions, design input, references, and units to enable a person

technically qualified in the subject to understand the documents and verify

their adequacy without recourse to the originator. Verify that documentation

of design analysis includes: (1) the definition of the objectives of the

analysis; (2) definition of design inputs and their sources; (3) results of

literature searches; (4) identification of assumptions; (5 )identification of

computer calculations; and (6) identification of the originator, reviewer, and

approver for the Q-list items selected. Verify that the design analysis
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documents are legible and in forms suitable for reproduction, filing, and

retrieval.

8. Verify that procedures are established that require documented verification

of dimensional accuracy and completeness of design drawings and

specifications. Verify that procedures are established requiring design

drawings and specifications to be reviewed by the QA organization, to assure

that the documents are; (a) prepared, reviewed, and approved in accordance

with documented procedures; and (b) contain the necessary QA

requirements such as inspection and test requirements, acceptance

requirements, and the extent to which inspections and test results are

required to be documented.

9. Verify that design procedures are prepared, reviewed, and approved in

accordance with the document control program.

10. Select several calculations completed to support the design of SSCs and

IROFS on the Q-list. Verify that the calculations are identified by subject

(including the SSC and IROFS to which the calculations apply), originator,

reviewer, and date – or by other designators, – such that the calculations are

traceable.

03.03 QA Training.

a. Review the QA indoctrination of personnel performing quality-affecting activities,

to verify that it includes the elements specified in the approved QA Plan and

implementing procedures. Verify that all personnel performing quality-affecting

activities have received QA indoctrination.

b. Review the procedures for qualification and certification of Nondestructive

Examination personnel, inspection and test personnel, and/or Audit and Lead Audit

personnel, to verify that these qualification and certification programs meet the

requirements in the approved QA Plan. Verify that periodic reevaluation of job

performance and record-keeping of qualifications and certifications are in

accordance with the QA Plan. Verify that personnel have completed the

qualification/certification program(s) before performing these examinations,

inspections, and tests.

03.04 Management Assessments. Management assessments should include the

following levels of activities to evaluate the effectiveness of the QA program:

Audits - independent planned and documented evaluations performed by the QA

organization. Audits evaluate the scope, status, adequacy, programmatic compliance, and

implementation effectiveness of quality-affecting activities.

Assessments - management-directed evaluations of the scope, status, adequacy,

programmatic compliance, and implementation effectiveness of QA and other management

measures in its area of responsibility.
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a. Verify that written procedures for conducting management assessments and audits

have been established and approved per the QA Plan.

b. Verify that management assessments and audits are being scheduled, performed,

and reported in accordance with these approved procedures.

c. Verify that management assessments and audits are conducted in accordance with

written procedures that include the following elements:

1. Identification of training and qualification requirements for assessment and

audit personnel;

2. Authorization for the assessment team to investigate any aspect of the items

under evaluation, with access to relevant information;

3. Provision for immediate corrective actions with appropriate documentation;

4. Review of assessment results by management having responsibility for the

area evaluated;

5. Documentation and distribution of assessment findings and

recommendations to appropriate management for review and response; and

6. Interface to the corrective action program to ensure timely and effective

corrective action.

d. Review the applicant’s audit program and verify that the following program

elements have been implemented in accordance with the applicant’s approved QA

plan:

1. Internal Audit Schedules: Internal audits should be scheduled in a manner

to provide coverage, consistency, and coordination with ongoing work, and

at a frequency commensurate with the status and importance of the work,

and performance history.

2. Audit Plans: An audit plan should be developed for each scheduled audit.

3. Audit Teams: Auditors shall be independent of any direct responsibility for

performing the work being audited. Audit personnel should have sufficient

authority and organizational freedom to ensure the audit process is effective.

4. Audit Performance: Elements that have been selected for the audit should

be evaluated against specified requirements; audits should be performed in

accordance with written procedures or checklists; audit results should be

documented by auditing personnel, and reported to, and reviewed by,

management having responsibility for the area audited. Conditions requiring

prompt corrective action should be reported immediately to management of
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the audited organization; conditions adverse to quality should be

documented according to the requirements of the applicant’s approved QA

plan; minor audit findings, if corrected during the audit, shall be documented

and verified by the audit process.

5. Reporting Audit Results: The audit report should be issued to the

management of the audited organization and participating organizations. If

applicable, the audit report should include a response due date for

conditions adverse to quality and minor adverse conditions.

6. Responding to Audits: The management of the audited organization should

respond to conditions adverse to quality according to the requirements of the

applicant’s approved QA plan.

7. Evaluating Audit Responses: The adequacy of corrective actions for

conditions adverse to quality should be evaluated in accordance with the

requirements of the applicant’s approved QA Plan.

8. Closing an Audit: Follow-up action should be taken to verify that corrective

actions are accomplished in accordance with the requirements of the

applicant’s approved QA Plan.

9. Audit Team Qualification Requirements: Auditors should have appropriate

orientation, current applicable training, and demonstrated competency. The

lead auditor should be certified in accordance with the applicant’s approved

QA Plan, as being qualified to lead audits.

88106-04 RESOURCE ESTIMATE

Inspection resources necessary to complete this inspection procedure are estimated to be

32 to 40 hours of inspection per facility visit. Once the construction authorization is issued,

the basics of this inspection procedure should be conducted annually during the

construction phase.

04.01 Organization. This section should be inspected once per year or when significant

organizational or management changes occur. Estimated effort is 4 to 8 hours per

occurrence.

04.02 Classification of SSCs. This section should be inspected once per year or when

significant additions or changes to SSCs occur. Before ISA approval, the resource

estimate for this section is 4 to 8 hours per occurrence. After ISA approval, the resource

estimate for this section is 12 to 16 hours per occurrence.

04.03 QA Training. This section should be inspected once per year or when significant

additions or changes to personnel or qualification requirements occur. The resource

estimate for this section is 8 to 12 hours per occurrence.
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04.04 Management Assessments. This section should be inspected once per year or

when significant QA program deficiencies are identified. The resource estimate for this

section is 4 to 8 hours per occurrence.

88106-05 REFERENCES

1. U.S. Code of Federal Regulations, Title 10, Part 50, Appendix B, “Quality Assurance

Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.”

2. U.S. Code of Federal regulations, Title 10, Part 70, “Domestic Licensing of Special

Nuclear Material.”

3. U.S. Nuclear Regulatory Commission, “Standard Review Plan for the Review of an

Application for a Mixed-Oxide Fuel Fabrication Facility,” NUREG-1718, August 2000.

4. Duke, Cogema, Stone, and Webster, “Mixed-Oxide Fuel Fabrication Facility, MOX

Project Quality Assurance Plan (MPQAP),” Docket Number 070-03098, under US

Department of Energy Contract DE-AC02-99-CH10888, latest revision accepted by NRC

(Sections 1, 2, and 18).

5. Duke, Cogema, Stone, and Webster, “Mixed-Oxide Fuel Fabrication Facility Construction

Authorization Request,” latest revision accepted by NRC.

6. The American Society of Mechanical Engineers, NQA-1-1994 Edition with NQA-1a-1995

Addenda.

7. U.S. Nuclear Regulatory Commission, "Quality Assurance Program Requirements

(Design and Construction)," (Rev. 3), Regulatory Guide 1.28.

END
Issue Date: 02/07/07 A-1-1 

ATTACHMENT 1

Revision History for IP 88106

CommitmentTrackingNumber

Issue

Date

Description of Change Training

Needed

TrainingCompletionDate

ComAcce

02/07/0707-006 06-NMSS

IP 88106 is a newly issued procedure. Issued for MOX inspection program toimprove effectiveness and efficiency byincorporating and consolidating qualityassurance program development inspection requirements during prelicensing and construction.

None N/A ML0