Date: 05/18/05 IP 88107 -1-

NRC INSPECTION MANUAL

INSPECTION PROCEDURE 88107 NMSS/FCSS

QUALITY ASSURANCE: DESIGN AND DOCUMENTATION CONTROL

(PRE-LICENSING AND CONSTRUCTION)

PROGRAM APPLICABILITY: 2630

88107-01 INSPECTION OBJECTIVES

01.01 To determine if the design control program is adequately defined and includes

effective procedures that identify design input controls, processes, analyses, verifications,

change controls, interface controls; translates quality standards into design documents; and

control deviations from standards.

01.02 To determine that applicable design bases and other requirements necessary to

assure adequate quality are included or referenced in the applicant’s procurement

documents for procurement of Quality Level 1 (QL-1) and QL-2 material, equipment and

services.

01.03 To determine that quality assurance records are completed documents that furnish

evidence of the quality of items and/or activities affecting quality. 

88107-02 INSPECTION REQUIREMENTS

Verify selected elements associated with the applicant’s design and document control

systems (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 Design Control. Determine if the QA program and associated QA procedures

implement the committed design control requirements.

02.02 Document Control. Determine if the QA program and associated QA procedures

implement the committed requirements for control and content of safety-affecting

documents.

02.03 Quality Assurance Records. Determine if the QA program records for safety

affecting items or activities are being properly generated and controlled.

88107-03 INSPECTION GUIDANCE
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03.01 Design Control.

a. Review the applicant’s system for control of design inputs (design bases,

conceptual design reports, performance requirements, regulatory requirements,

codes and standards) to determine if documentation, review and approval

commitments are being met. 

b. Review the applicant’s design process for translating design inputs into plant

design, fabrication, construction, testing, inspection, and examination requirements.

Verify that this design process is in accordance with QA plan commitments and

requirements. Determine if the design process is controlled to ensure correct

design; proper classification of structures, systems, and components (SSCs) or

items relied on for safety (IROFS); suitable application of materials, parts,

equipment, and processes; and accurate translation of requirements into

specifications, drawings, procedures, and instructions.

c. Review the applicant’s process for design analysis to verify that design analyses

are documented in accordance with QA plan commitments and requirements.

d. Review the applicant’s program for verifying the adequacy of the design of QL-1

controls. Determine if design verifications, reviews and qualification tests (or

independent verification) were performed in accordance with QA plan commitments

and requirements. 

e. Review the applicant’s design change control program to determine if design

changes were controlled in accordance with QA plan commitments and requirements. Verify that design changes are subject to design control measures

commensurate with those applied to the original design. 

f. Review the applicant’s design interface control program to determine if design

internal and external interfaces were identified, procedurally controlled, and

documented in accordance with QA plan commitments and requirements. 

g. Refer to IP 88112, Software Validation, for inspection requirements pertaining to

the applicant’s computer software control program.

03.02 Document Control.

a. Review a variety of the applicant’s documents that specify quality requirements or

prescribe activities affecting quality associated with QL-1 controls. These

documents would include project procedures, Design Requirements Documents,

Basis of Design documents, Engineering Specification, drawings, calculations, and

procurement documents. Determine if these documents were prepared, reviewed,

approved, and distributed to and used at the location where the prescribed activity

is performed in accordance with QA plan commitments and requirements for

document control. Verify that changes resulting from applicant evaluations or precontract negotiations are incorporated into the procurement documents. 

b. When reviewing the applicant’s QA program implementing documents (QA

procedures, drawings, and specifications), determine if the document contents are

in accordance with QA plan commitments and requirements for instructions,

procedures and drawings.

c. Verify that the requirements of 10 CFR 21, Reporting of Defects and

Noncompliance, are delineated, as applicable, on IROFS procurement documents.
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03.03 Quality Assurance Records.

a. When reviewing QA program implementing documents, determine if they properly

specify the QA records to be generated, supplied and maintained.

b. Review a variety of the applicant’s QA records required by the reviewed

implementing documents. Determine if the records have been produced as

required by the implementing procedure(s) and determine if the records are

received, classified, and processed in accordance with the QA plan commitments

and associated implementing procedures for QA records. If corrections have been

made to any of the records, determine if the corrections are being performed per

the approved QA plan.

c. Observe the applicant’s record repositories for both temporary and permanent

storage to determine if they meet QA plan commitments. Determine if record

retrieval from and retention in each type of repository is in accordance with the

approved QA plan.

88107-04 INSPECTION RESOURCES

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

24-40 hours of inspection per facility visit. Once the construction authorization is issued,

the basics of this inspection procedure should be conducted during the construction phase

on an annual basis. 

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

design control changes occur. Estimated effort is 16 to 24 hours per occurrence.

04.02 Document Control. This section should be inspected once per year or when

significant additions or changes occur. The resource estimate for this section is

4 to 8 hours per occurrence.

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

additions or changes occur. The resource estimate for this section is 4 to 8 hours

per occurrence.

88107-05 REFERENCES

10 CFR Part 70, “Domestic Licensing of Special Nuclear Material.”

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 3, 4,

5, 6, and 17).

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

Authorization Request, latest revision accepted by NRC.

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

Fuel Fabrication Facility, August 2000. 

END