Issue Date: 02/07/07 88111 1

NRC INSPECTION MANUAL NMSS/RII

INSPECTION PROCEDURE 88111

10 CFR, PART 21, INSPECTION-FACILITY CONSTRUCTION

PROGRAM APPLICABILITY: 2630

88111-01 INSPECTION OBJECTIVE

To provide assurance that the applicant, licensee, individual, partnership, corporation,

dedicating entity, or other entity subject to the regulations of 10 Part, CFR 21, has

established procedures and program activities to effectively implement the requirements

of Part 21, "Reporting of Defects and Noncompliance."

88111-02 INSPECTION REQUIREMENTS

Procedure Review and Program Assessment. Determine whether the applicant’s or

licensee’s, individual’s, partnership’s, corporation’s, dedicating entity’s, or other entities

procedures and program activities effectively implement the requirements of 10 CFR,

Part 21, "Reporting of Defects and Noncompliance" (which all the above-mentioned entities

are subject to).

02.01 Verify that the applicant, licensee, individual, partnership, corporation, dedicating

entity, or other entity, subject to the regulations of Part 21, has implemented the posting

requirements of 10 CFR 21.6 by selecting at least one location for inspection.

02.02 Verify that the applicant, licensee, individual, partnership, corporation, dedicating

entity, or other entity, subject to the regulations of Part 21, has implemented the

requirements of 10 CFR 21.31 regarding specifying, in appropriate procurement

documents, the applicability of Part 21, by selecting at least five procurement documents

for examination.

02.03 Verify that the applicant, licensee, individual, partnership, corporation, dedicating

entity, or other entity, subject to the regulations of Part 21, has effectively implemented the

requirements of 10 CFR 21.21(a), regarding evaluating identified deviations by:

a. Determining that procedures and/or controls to evaluate identified deviations have

been established.

b. Determining the effectiveness of established procedures and/or controls to

evaluate identified deviations, by selecting at least three records of an evaluated

deviation that did not result in the identification of a defect, or failure to comply,

verify that:

1. The item was identified for evaluation consistent with established procedures

or by other means.

2. The information and data used in the evaluation appear to be factual and

complete.

3. The finding of the evaluation that a substantial safety hazard or failure to

comply does not exist is a logical conclusion of the evaluation.
88111 Issue Date: 02/07/07 2

4. Determining that the controls and/or procedures identify a specific director

or responsible officer to notify of identified defects or failures to comply.

02.04 Verify that the applicant, licensee, individual, partnership, corporation, dedicating

entity, or other entity, subject to the regulations of Part 21, has implemented the

requirements of 10 CFR 21.21, regarding directors or responsible officers notifying U.S.

Nuclear Regulatory Commission (NRC) of identified defects, or failures to comply, related

to significant safety hazards, by:

a. Determining that the controls or procedures accurately reflect the provisions of 10

CFR 21.21, regarding time frames for reporting identified defects or failures to

comply.

b. Selecting (if available) at least two records of instances in which the identified

director or responsible officer notified the Commission of a defect or failure to

comply and determining that the notification complies with the provisions of 10

CFR 21.21, regarding time frames for reporting identified defects or failures to

comply.

c. Selecting (if available) at least two records of instances in which the identified

director or responsible officer was notified of a defect or failure to comply, but

chose not to notify the Commission, and verifying that this was an acceptable

action.

02.05 Verify the implementation of the requirements of 10 CFR 21.51, regarding

maintenance of records, by determining that the applicant, licensee, individual, partnership,

corporation, dedicating entity, or other entity subject to the regulations of Part 21, has

appropriate controls and/or procedures to assure proper maintenance of records.

88111-03 INSPECTION GUIDANCE

General Guidance. The inspector should refer to the Mixed-Oxide Project Quality

Assurance Plan, for information on commitments to Part 21, during construction activities.

03.01 Specific Guidance. No specific guidance is provided.

88111-04 INSPECTION RESOURCES

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

2 to 8 hours of inspection per facility or vendor visit. Once the construction authorization

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

construction phase, at the construction site, and at each major vendor involved with

construction activities.
Issue Date: 02/07/07 88111 3

88111-05 REFERENCES

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.

U.S. Code of Federal Regulations, Title 10, Part 21, "Reporting of Defects and

Noncompliance.”

END
ATTACHMENT 1

Revision History for IP 88111

CommitmentTrackingNumber

Issue Date Description of Change Training

Needed

TrainingCompletionDate

ComAcce

02/07/07CN 07-006

IP 88111 is a newly issued procedure. Issued for MOX inspection program toimprove effectiveness and efficiency byincorporating and consolidating 10 CFRPart 21 inspection requirements duringfacility construction.

None N/A ML0

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