Date: 05/18/05 IP 88110 -1-

NRC INSPECTION MANUAL

INSPECTION PROCEDURE 88110 FCSS/NMSS

QUALITY ASSURANCE: PROBLEM IDENTIFICATION, RESOLUTION and 

CORRECTIVE ACTION (PIRCA)

(CONSTRUCTION, PRE-OPERATION AND OPERATION)

PROGRAM APPLICABILITY: 2630

88110-01 INSPECTION OBJECTIVES

01.01 To determine that the corrective action program is in accordance with requirements

of the NRC-approved QA program and is adequately defined by effective procedures that

identify and correct conditions adverse to quality and preclude recurrence of significant

conditions adverse to quality.

01.02 To verify that the licensee reports to management the results of reviews conducted

on audit reports, internal surveillance reports, corrective action reports, and management

assessments and initiates corrective actions as necessary.

01.03 To determine that significant conditions adverse to quality are evaluated for

reportability and, if warranted, reported in accordance with 10 CFR 21, Reporting of Defects

and Noncompliance.”

88110-02 INSPECTION REQUIREMENTS

Verify selected elements associated with the applicant’s program for PIRCA (as identified

in an approved inspection plan) are in accordance with the applicant’s approved QA Plan.

Elements chosen for inspection may include three or more of the following:

02.01 Procedures. Determine if procedures pertaining to the corrective action program

are approved and adequately implemented. Determine if procedures contain provisions

for identifying, reporting and documenting conditions adverse to quality. Determine if

procedures exist that describe the follow-up, closure and trending processes and ensure

implementation in a timely manner. 

02.02 Identification and Classification of Conditions Adverse to Quality. Determine if

measures are established to assure that conditions adverse to quality, such as failures,

malfunctions, deficiencies, deviations, defective material and equipment, and

nonconformances and significant conditions adverse to quality are promptly identified.

Verify that conditions adverse to quality are appropriately classified according to their

significance and corrective actions are taken accordingly. 
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02.03 Documentation and Reporting of Conditions Adverse to Quality. Determine if a

process and instructions exist for documenting and reporting conditions adverse to quality

to appropriate levels of management responsible for the conditions, and to the organization

responsible for tracking. Verify that the licensee reports to management the results of

reviews conducted on audit reports, internal surveillance reports, corrective action reports,

or management assessments and initiates corrective actions as necessary.

02.04 Follow-up, Closure and Trending. Determine if proper implementation and closure

of corrective action are completed in a timely manner. Determine if criteria are established

for quality trending. Determine if trending information is distributed to affected organization

management and used to identify significant conditions adverse to quality.

88110-03 INSPECTION GUIDANCE

This inspection procedure applies to the implementation of the applicant’s Quality

Assurance Plan and to the structures, systems, and components (SSCs) important to

safety; and the design, fabrication, construction, testing and operation of the SSCs and

barriers of the plant.

Selection of areas for evaluation during inspections shall be based on the risk significance

of the SSCs, related activities, and past performance. The scope of inspections should also

consider the cumulative effect of failures related to low-risk-significant SSCs, regarding their

potential effects on overall system performance and reliability.

03.01 Procedures. Verify that procedures are established that describe the corrective

action program. Verify that the procedures have been reviewed and approved by the

affected organizations. Verify that procedures describe a process for follow-up and closure

of issues, including requirements for documenting closure.

Verify that a process and instructions exist for documenting and reporting conditions

adverse to quality to appropriate levels of management responsible for the conditions and

to the responsible organization for tracking.

Verify that criteria are established and a process described for identifying and tracking

adverse quality trends.

03.02 Identification and Classification of Conditions Adverse to Quality. Verify that criteria

for determining a significant condition adverse to quality are appropriately established.

Select a sample of documented problems and verify the following:

 a. The problems are adequately described and labeled with unique identifiers.

 b. The problems are classified by significance and identify, as a minimum:

1. Conditions adverse to quality, such as:

a. failures;

b. malfunctions;

c. deficiencies;

d. deviations;

e. defective material and equipment; and

f. state of noncompliance with quality assurance program requirements

2. Significant conditions adverse to quality, such as:
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a. Deficiencies that would seriously impact an item from performing its

intended function of assuring public health and safety;

b. Deficiencies in design that have been approved for fabrication or

construction where the design deviates extensively from design criteria

and bases;

c. Deficiencies in the fabrication or construction of, or significant damage

to, structures, systems or components that require extensive evaluation,

re-design or repair in order to establish the adequacy of the structure,

system or component to perform its intended function of assuring public

health and safety;

d. Deviations from performance specifications that require extensive

evaluation, re-design, or repair to establish the adequacy of the

structure, system or component to perform its intended function;

e. A significant error in a computer program used to support activities

affecting quality after it has been released for use;

f. Loss of essential data required for activities or items subject to the

applicant’s QA Program;

g. Repetitive problems indicating programmatic failures or precursor of

significant technical deficiencies; 

h. A condition that, if left uncorrected, has the potential to have a serious

negative impact on activities or items subject to the applicant’s QA

Program.

03.03 Documentation and Reporting of Conditions Adverse to Quality. Select a sample

of completed conditions adverse to quality, and;

a. Verify that for conditions adverse to quality that management has determined the

extent of the adverse condition, completed remedial action as soon as practical,

and documented the results. 

b. Verify that significant conditions adverse to quality are documented and reported

to management responsible for the condition, their upper management, and to the

QA organization for tracking. Verify that the QA organization concurred with the

proposed corrective action, including remedial action. For significant conditions

adverse to quality, verify that corrective actions for root causes have been taken

and are effective. Ensure that the QA requirements described in the licensee’s

corrective action procedures are being implemented.

c. Select several problems that have been resolved and verify that proper

implementation of corrective actions and closures were completed in a timely

manner.

d. Verify that the cause of the significant conditions adverse to quality are determined

by qualified personnel using approved methods and corrective action taken is

adequate to preclude recurrence.
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e. Verify that significant conditions adverse to quality were evaluated for a stop work

condition by the QA organization to determine if stopping work was warranted.

Verify that appropriate action was taken by QA management to issue stop work

orders to the responsible management in a timely manner after a stop work

condition was identified. Verify that appropriate action was taken to lift and close

(in part or total) the stop work issued by the QA organization based on the

resolution of the related significant condition adverse to quality.

03.04 Follow-up, Closure, and Trending. Verify that reports are generated to identify

conditions adverse to quality and significant conditions adverse to quality, and to provide

management with a tool for identifying root causes. Verify that nonconformance

documentation including reports are periodically analyzed by the QA organization to identify

quality trends. Verify that trend evaluations are performed in a manner and at a frequency

that provides for prompt identification of adverse quality trends. Verify that trend evaluations

are distributed to affected organization management. Verify that identified adverse trends

are reported to the management of the organization responsible for corrective action. Verify

that the documentation for closure of the adverse condition has been generated and is

complete, signed off, and properly filed and logged into a system to allow for retrieval.

88110-04 INSPECTION RESOURCES

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

8-16 hours of inspection per facility visit. It is anticipated that the resources need to

complete the initial inspection would be approximately 16 hours. Once the construction

authorization is issued, the basics of this inspection procedure should be conducted during

the construction phase on an annual basis. 

88110-05 REFERENCES 

U.S. Code of Federal Regulations, 10 CFR Part 70, “Domestic Licensing of Special Nuclear

Material.”

NUREG-1718, Standard Review Plan for the Review of an Application for a Mixed Oxide

Fuel Fabrication Facility, August 2000.

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 (Section 16).

Duke, Cogema, Stone and Webster, Mixed Oxide Fuel Fabrication Facility Construction

Authorization Request, latest revision accepted by NRC.

END