**NRC INSPECTION MANUAL**NMSS/RII

INSPECTION PROCEDURE 88111

10 CFR, PART 21, INSPECTION-FACILITY CONSTRUCTION

PROGRAM APPLICABILITY:  2630

88111‐01INSPECTION 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."

88111‐02INSPECTION 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).

02.01Verify 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.

02.02Verify 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.

02.03Verify 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.

4. Determining that the controls and/or procedures identify a specific director or responsible officer to notify of identified defects or failures to comply.

02.04Verify 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.

02.05Verify 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.

88111‐03INSPECTION 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.

03.01Specific Guidance.  No specific guidance is provided.

88111‐04INSPECTION 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.

88111‐05REFERENCES

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

2

88111Issue Date: 02/07/07

2

Issue Date: 02/07/0788111