**NRC INSPECTION MANUAL** CQV/EQV

INSPECTION PROCEDURE 36100

INSPECTION OF 10 CFR PART 21 AND 10 CFR 50.55(e) PROGRAMS

FOR REPORTING DEFECTS AND NONCOMPLIANCE

PROGRAM APPLICABILITY: 2501, 2502, 2504, 2507, 2508, 2700, and 2515
(Part 21 only)

36100-01 INSPECTION OBJECTIVE

To verify that applicants and holders of a certified design, an early
site permit (ESP), applicants and holders of a combined license (COL),
holders of construction permits and operating licenses under 10 CFR Part
50, and suppliers of basic components (hereafter referred to
collectively as: Aentity@) have established a program and procedures to
effectively implement 10 CFR Part 21 and 10 CFR 50.55(e) requirements
for reporting defects and failures to comply associated with a
substantial safety hazard (SSH).

36100-02 INSPECTION REQUIREMENTS

02.01 Verify that the entity has effectively implemented the
requirements of 10 CFR 21.21(a)(1) and 10 CFR 50.55(e)(1) for evaluating
deviations and failures to comply.

02.02 Verify that the entity has implemented the requirements of 10 CFR
21.21(d) and 10 CFR 50.55(e)(1) regarding directors or responsible
officers notifying NRC or informing affected customers (when applicable)
of identified defects or failures to comply associated with SSHs.

02.03 Verify that the entity has implemented the requirements of 10 CFR
21.31 regarding specifying the applicability of 10 CFR Part 21 in
procurement documents for basic components.

02.04 Verify that the entity has implemented the requirements of 10 CFR
21.51 and 10 CFR 50.55(e)(9) regarding maintenance of records.

02.05 Verify that the entity has implemented the posting requirements of
10 CFR 21.6.

36100-03 INSPECTION GUIDANCE

03.01 Verify the controls for the evaluation of deviations and failures
to comply as required in 10 CFR 21.21(a) and 10 CFR 50.55(e)(1) by
performing the following:

a.  Verify that the entity has adopted procedures to evaluate deviations
    and failures to comply. Procedures should describe the following:

```{=html}
<!-- -->
```
1.  Measures for the analysis of a deviation or failure to comply.

2.  If the evaluation cannot be completed within 60 days from discovery,
    measures are in place to ensure that an interim report is prepared
    and submitted to the Commission within 60 days of discovery of the
    deviation or failure to comply. The interim report should describe
    the deviation or failure to comply being evaluated and should state
    when the evaluation will be completed.

3.  Measures to determine whether the evaluated deviation or failure to
    comply could create a SSH if it were to remain uncorrected.

```{=html}
<!-- -->
```
b.  Verify that the QA processes to control nonconformance and
    corrective actions provide a direct connection to the Part 21
    program and/or procedures.

c.  Select a sample of evaluated deviations that did [not]{.underline}
    result in the identification of a defect or failure to comply and
    verify that:

```{=html}
<!-- -->
```
1.  The item was identified for evaluation consistent with established
    procedures.

2.  The information and data used in the evaluation is clearly
    documented and complete.

3.  The finding of the evaluation that a SSH does not exist is a logical
    conclusion of the evaluation.

> NOTES: As stated in 10 CFR 50.55(e)(5), for construction permit
> holders, the evaluation of potential defects and failures to comply
> and reporting of defects and failures to comply under \' 50.55(e)
> satisfies each person\'s evaluation, notification, and reporting
> obligation to report defects and failures to comply under 10 CFR
> 50.55(e) and the responsibility of individual directors and
> responsible officers of such licensees to report defects under section
> 206 of the Energy Reorganization Act of 1974.
>
> As stated in 10 CFR 21.3(c), for 10 CFR Part 50 licensees, the
> evaluation of potential defects and appropriate reporting of defects
> under \' 50.72, \' 50.73, or \' 73.71 satisfies each person\'s
> evaluation, notification, and reporting obligation to report defects
> under 10 CFR Part 21 and the responsibility of individual directors
> and responsible officers of such licensees to report defects under
> section 206 of the Energy Reorganization Act of 1974.

03.02 Verify that the entity has implemented the requirements of 10 CFR
21.21 and 10 CFR 50.55(e) regarding directors or responsible officers
notifying NRC of identified defects or failures to comply associated
with SSHs by performing the following:

a.  Verify that the entity=s program and/or procedures accurately
    reflect the time frames of 10 CFR 21.21(d) and 10 CFR 50.55(e)(6)
    for reporting identified defects or failures to comply that could
    create a SSH as follows:

```{=html}
<!-- -->
```
1.  A director or responsible officer is informed, as soon as
    practicable, and in all cases, within 5 working days after
    completion of the evaluation.

2.  An initial notification is prepared and submitted via fax to the
    Commission within 2 days of notifying the director or responsible
    officer of the identification of a defect or failure to comply
    associated with a SSH. Verification that the facsimile has been
    received should be made by calling the NRC Operations Center.

3.  A written notification is prepared and submitted to the Commission
    within 30 days of notifying the director or responsible officer of
    the identification of a defect or failure to comply associated with
    a SSH. For holders of a construction permit under 10 CFR Part 50 or
    COL holders under 10 CFR Part 52, the written notification must
    include a copy to the appropriate Regional Administrator and a copy
    to the appropriate Resident Inspector. Confirm that the report has
    been received by the NRC Operations Center by checking the section
    AReports Associated with Events,@ on the NRC website.

> NOTE: For those Part 52 processes which do not authorize continuing
> activities required to be licensed under the Atomic Energy Act, but
> are intended solely to provide early identification and resolution of
> issues in subsequent licensing or regulatory approvals, the reporting
> of defects or failures to comply associated with SSHs may be delayed
> until the time that the Part 52 process is first referenced.

b.  Verify that the entity=s procedures accurately provide for the
    information that shall be included in the written notification as
    required by 10 CFR Part 21.21(d)(4) and 10 CFR 50.55(e)(8).

```{=html}
<!-- -->
```
1.  Name and address of entity informing the Commission.

2.  Identification of basic component that contains the defect or
    failure to comply.

3.  Identification of the firm supplying the basic component.

4.  Nature of the defect or failure to comply and the SSH that could be
    or was created by the defect.

5.  The date that the information of the defect or failure to comply was
    obtained.

6.  The number and location of all such basic components in use at the
    facilities subject to this regulation.

7.  The corrective action taken.

8.  Name of individual responsible for the action.

9.  Length of time taken to complete the action.

> NOTE: For holders of a construction permit under 10 CFR Part 50 or COL
> holders under 10 CFR Part 52, the written notification must clearly
> indicate that the written notification is being submitted under
> \'50.55(e).

c.  Select, if available, a sample of records in which the director or
    responsible officer notified the Commission of a defect or failure
    to comply and verify the timeliness and completeness of such
    notification consistent with the guidance in 03.02(a) and 03.02(b),
    respectively.

d.  For holders of a construction permit under 10 CFR Part 50 or COL
    holders under 10 CFR Part 52, verify that the entity=s procedures
    include the requirements of 10 CFR 50.55(e)(4) for the notification
    of any significant breakdown in any portion of the Appendix B to 10
    CFR Part 50, quality assurance program that could have produced a
    defect in a basic component. Such breakdowns are reportable whether
    or not the breakdown actually resulted in a defect.

e.  For suppliers of basic components, verify that measures are in place
    to inform purchasers or affected licenses in accordance with 10 CFR
    21.21(b). Specifically, verify that:

```{=html}
<!-- -->
```
1.  The entity has established directions to inform all affected (or
    potentially affected) licensees or purchasers within 5 days of the
    determination that the entity does not have the capability to
    perform the 10 CFR 21.21(a)(1) evaluation.

2.  Select, if available, a sample of identified deviations for which
    the entity was not capable of performing a 10 CFR 21.21(a)(1)
    evaluation and verify that:

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

    b.  The entity identified and informed all affected (or potentially
        affected) purchasers or licensees within 5 days from the
        determination.

03.03 Verify the implementation of procurement document controls as
required in 10 CFR 21.31 by performing the following:

a.  Select a sample of procurement documents for basic components and
    verify that each procurement document specifies the applicability of
    10 CFR Part 21.

NOTE: There are no procurement document requirements for 10 CFR
50.55(e).

03.04 Verify the implementation of record controls as required in 10 CFR
Part 21.51 and 10 CFR 50.55(e) by performing the following:

a.  Verify that the entity has procedures and/or controls that
    accurately reflect the time frames of 10 CFR Part 21.51 and 10 CFR
    50.55(e)(9) for maintenance of records. Specifically, verify that:

    1.  Evaluations of all deviations and failures to comply are
        retained for a minimum of five years after the date of the
        evaluation.

    2.  Suppliers of basic components retain any notifications sent to
        purchasers and affected licensees for a minimum of five years
        after the date of notification.

    3.  Suppliers of basic components retain a record of the purchasers
        of basic components for ten years after delivery of the basic
        component or service associated with a basic component.

    4.  Holders of a construction permit under 10 CFR Part 50 or COL
        holders under 10 CFR Part 52 comply with item 1. above and also
        retain procurement documents, which define the requirements that
        facilities or basic components must meet in order to be
        considered acceptable, for the lifetime of the basic component.

03.05 Verify posting requirements of 10 CFR 21.6 by performing the
following:

a.  Select at least one posting location for inspection and verify the
    following.

NOTE: There are no posting requirements for 10 CFR 50.55(e).

1.  Verify that posting is conspicuously located where activities
    subject to 10 CFR Part 21 are conducted and includes the following
    information as required in 10 CFR 21.6(a)(1):

    a.  Section 206 of the Energy Reorganization Act of 1974,

    b.  The current version of 10 CFR Part 21, and

    c.  The entity=s procedures that implement this regulation.

        2.  If the entity determined that posting in accordance with 10
            CFR 21.6(a)(1) was not practicable, verify that the entity
            implemented the requirements of 10 CFR 21.6(b). This
            subsection requires posting of the following information in
            a conspicuous location where activities subject to Part 21
            are conducted:

```{=html}
<!-- -->
```
(a) Section 206 of the Energy Reorganization Act of 1974,

(b) A notice containing the following:

    1.  A description of Part 21 and the procedures that implement the
        regulation,

    2.  The name of the individual to whom 10 CFR Part 21 reports may be
        made, and

    3.  The location where the 10 CFR Part 21 regulation and
        implementing procedures may be examined.

36100-04 RESOURCE ESTIMATE

Inspection resources necessary to complete this inspection procedure are
estimated to be 40 hours of direct inspection effort.

36100-05 REFERENCES

U.S. Code of Federal Regulations. 10 CFR Part 21, AReporting of Defects
and Noncompliance.@

U.S. Code of Federal Regulations. 10 CFR Part 50.55, AConditions of
Construction Permits.@

U.S. Code of Federal Regulations. 10 CFR Part 50, Appendix B, AQuality
Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing
Plants.@

NUREG-0302, Rev. 1 \"Remarks Presented (Questions/Answers Discussed) at
Public

Regional Meetings to Discuss Regulations (10 CFR Part 21) for Reporting
of Defects and Noncompliance.\" (ADAMS Accession No. ML062080399)

LIC-403, AProcedures for Handling Deficiency Reports (10 CFR Part 21,10
CFR 50.55(e)),@ Revision 1.

END

Revision History Sheet

IP 36100

+--------+-------+-----------------+------+--------+------------------+
| Comm   | Issue | Description of  | Trai | Tr     | Comment          |
| itment | Date  | Change          | ning | aining | Resolution       |
| Tr     |       |                 | Ne   | Com­p   | Ascension \#     |
| acking |       |                 | eded | letion |                  |
| Number |       |                 |      | Date   |                  |
+--------+-------+-----------------+------+--------+------------------+
| N/A    | 10/   | 1\. Initial     | N/A  | N/A    | ML063030096      |
|        | 03/07 | issue to        |      |        |                  |
|        |       | support         |      |        |                  |
|        | CN    | inspections of  |      |        |                  |
|        | 0     | operational     |      |        |                  |
|        | 7-030 | programs        |      |        |                  |
|        |       | described in    |      |        |                  |
|        |       | IMC 2504,       |      |        |                  |
|        |       | NON-ITAAC       |      |        |                  |
|        |       | INSPECTIONS     |      |        |                  |
|        |       |                 |      |        |                  |
|        |       | 2\.             |      |        |                  |
|        |       | Incorporates    |      |        |                  |
|        |       | SRP 17.5        |      |        |                  |
|        |       | guidance        |      |        |                  |
|        |       |                 |      |        |                  |
|        |       | 3\. A review    |      |        |                  |
|        |       | for             |      |        |                  |
|        |       | incorporation   |      |        |                  |
|        |       | of generic      |      |        |                  |
|        |       | requirements    |      |        |                  |
|        |       | has been        |      |        |                  |
|        |       | conducted. None |      |        |                  |
|        |       | found.          |      |        |                  |
+--------+-------+-----------------+------+--------+------------------+