**NRC INSPECTION MANUAL** CQV

INSPECTION PROCEDURE 43003

REACTIVE INSPECTIONS OF NUCLEAR VENDORS

PROGRAM APPLICABILITY: 2507

43003‑01 INSPECTION OBJECTIVES

01.01 In response to reported problems involving vendor-supplied
products or services, verify that vendors supplying basic components
have developed and implemented adequate procedures to evaluate and
correct conditions adverse to quality.

01.02 In response to reported problems involving vendor-supplied
products or services, verify that vendors supplying basic components
have taken adequate corrective actions to preclude recurrence of
conditions adverse to quality.

This procedure is to be used in combination with the following
inspection procedures, when applicable: Inspection Procedure (IP) 36100,
AInspection of 10 CFR Part 21 and 50.55(e) Programs for Reporting
Defects and Nonconformance,@ and IP 43004, AInspection of
Commercial-Grade Dedication Programs.@

43003‑02 INSPECTION REQUIREMENTS

02.01 Review the vendor=s nonconformance and corrective action program
to verify that the vendor has identified and evaluated conditions
adverse to quality that have potentially affected basic components
supplied by the vendor.

02.02 Verify that the root causes of conditions adverse to quality have
been adequately identified, including identification of weaknesses in
the QA program that contributed to the condition adverse to quality.

02.03 Verify that actions taken to correct both the specific conditions
adverse to quality and the causal factors are adequate to preclude
recurrence.

02.04 Review the vendor=s implementation of corrective actions for
outstanding items identified during previous inspections and/or pending
issues, as applicable.

02.05 When applicable, in accordance with IP 36100, verify that the QA
program provides adequate controls for evaluating and reporting defects
and noncompliance.

02.06 When applicable, in accordance with IP 43004, verify that
commercial-grade products or services procured for use in safety-related
applications are dedicated through the implementation of a suitable
dedication program.

02.07 When directed by the Allegations Review Board, follow-up on
potentially safety significant allegations to determine their validity,
and, if valid, evaluate the vendor\'s corrective actions taken to
resolve the matter.

02.08 Assess whether the circumstances and/or behavior of the inspected
party should be subject to evaluation and possible investigatory
measures by the Office of Investigations (OI).

43003‑03 INSPECTION GUIDANCE

[General Guidance]{.underline}. Reactive inspections will be conducted
at vendor facilities in response to unexpected situations that could
affect the quality of the basic components supplied. Problems may be
identified through 10 CFR Part 21 reports, 10 CFR 50.55(e) reports, 10
CFR 50.72 reports (immediate notifications), 10 CFR 50.73 reports
(licensee event reports), allegations, NRC operating experience
community reports, information provided by vendors, applicants, and
licensees, and requests from the regional offices or other branches
within the NRC.

The lead inspector will prepare an inspection plan in accordance with
established guidelines. The inspection plan should provide the scope and
basis for the inspection; describe the proposed evaluation of the
vendor=s activities, including the QA program procedures and its
implementation, and identify the work assignments for each inspector.
Guidance on inspection plans is contained in IMC-0613, A10 CFR Part 52
Licensed Power Reactor Construction and Test Inspection Reports.@

The inspector will evaluate the effectiveness of the vendor\'s QA
program and procedures, as it relates to the reported problem, using a
graded approach with emphasis in the guidance described below.

03.01 Review the vendor\'s nonconformance and corrective action process
and its implementation to verify if the condition adverse to quality was
evaluated and causal factors identified. Examine vendor\'s records to
determine if the condition adverse to quality is repetitive, and, if so,
determine why previous corrective actions were ineffective. In the event
that other vendor products are affected, verify that corrective actions
and notifications have taken place.

03.02 Verify that the vendor has performed a thorough root cause
analysis, including an evaluation of the vendor\'s QA program to
identify potential programmatic deficiencies that may have led or
contributed to the condition adverse to quality. Verify that the
identified root causes and programmatic deficiencies are being or have
been corrected.

03.03 Verify that the vendor=s compensatory measures and corrective
actions are adequately documented and sufficient to prevent recurrence.
Evaluate the adequacy of the corrective actions to preclude recurrence
as well as the timeliness of their implementation.

03.04 Verify that the vendor\'s corrective actions on previously
identified inspection findings have been adequately implemented
consistent with its QA program requirements. Identify and document
issues of a generic nature.

03.05 Refer to IP 36100, AInspection of 10 CFR Part 21 and 50.55(e)
Programs for Reporting Defects and Nonconformance@ for additional
guidance.

03.06 Refer to IP 43004, AInspection of Commercial-Grade Dedication
Programs@ for additional guidance.

03.07 If applicable, through interviews and observations, gather the
information necessary to either substantiate the alleger\'s claims or
provide reasonable assurance that the claims are unfounded. Some of the
information provided by vendor employees, contractors, or other
individuals during the inspection may be considered allegations. This
information needs to be addressed in conformance with NRC Management
Directive (MD) 8.8, \"Management of Allegations.\"

03.08 Evaluate the information obtained during the inspection to
determine if potential wrongdoing has occurred. If potential wrongdoing
has been identified, it must be considered an allegation and should
immediately be reported to the inspector=s management and the Office
Allegation Coordinator, for possible referral to the Office of
Investigations, or other appropriate action.

43003-04 NOTIFICATION TO AFFECTED LICENSEES

The inspector will provide input to the NRC generic communications
process to determine the need for wider distribution of information
obtained during the inspection.

43003-05 RESOURCE ESTIMATE

This inspection procedure is used for reactive inspections of vendors
providing basic components to licensees. The resource estimate for this
inspection procedure is approximately 200 hours of direct inspection
effort.

43003‑06 REFERENCES

Inspection Manual Chapter 2507, AVendor Inspections.@

Inspection Procedure 43002, ARoutine Inspections of Nuclear Vendors.@

Inspection Procedure 43004, AInspection of Commercial-Grade Dedication
Programs.@

Inspection Procedure 36100, AInspection of 10 CFR Part 21 and 50.55(e)
Programs for Reporting Defects and Nonconformance.@

NRC Management Directive 8.8, \"Management of Allegations.\"

END

Attachments:

1\. Revision History

ATTACHMENT 1

[Revision History for IP 43003]{.underline}

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| Comm   | Issue | Description of | Training | Training | Comment      |
| itment | Date  | Change         | Required |          | Resolution   |
| Tr     |       |                |          | Co       | Accession    |
| acking |       |                |          | mpletion | Number       |
| Number |       |                |          | Date     |              |
+--------+-------+----------------+----------+----------+--------------+
| N/A    | 10/   | Researched     | None     | N/A      | N/A          |
|        | 03/07 | commitments    |          |          |              |
|        |       | for 4 years    |          |          |              |
|        | CN    | and found      |          |          |              |
|        | 0     | none.          |          |          |              |
|        | 7-030 |                |          |          |              |
|        |       | Initial        |          |          |              |
|        |       | issuance       |          |          |              |
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