control of critical characteristics, or acceptable industry-wide performance. The use of industry-wide performance should not be employed alone unless the established documented performance record is based on industry-wide performance data that is directly applicable to the item's critical characteristics and the intended safety-related application. Information pertinent to the item’s quality of performance obtained from outside sources (e.g., operational event reports, NRC, vendor equipment technical information program, and Institute of Nuclear Power Operations) and from commercial-grade surveys, source verifications, receipt inspections, previous dedication or qualification, and operational history is factored into the dedication process. This method should be used in combination with one or more of the methods explained above to collect the objective evidence necessary to ensure acceptable historical performance of the supplier. 03.03 Review a representative sample of dedication packages to assess whether procedures for dedication activities have been adequately planned and implemented. Verify that the dedication process identifies those design, material, and performance characteristics relevant to the safety function as described in Section 03.01 of this procedure. Verify that the dedicating entity demonstrated that the critical characteristics are met appropriate acceptance methods as described in Section 03.02 of this procedure. 03.04 Review a representative sample of procurement documents for dedicated by a third party. a. Verify that the procurement documents have adequate controls for the dedicating entity and the proper critical characteristics and acceptance methods were used for the dedication. Verify that receipt inspections performed adequately for the acceptance of the dedicated item. Verify that upon receipt any restrictions to the use of the dedicated item are clearly documented so that the item is only used in an application that is prescribed in the procurement documents. 03.0 Initial Evaluation. eaknesses in the commercialgrade dedication program may when the important design, material, and performance characteristics that are necessary to provide reasonable assurance that the dedicated CGI will perform its intended safety function are not addressed during dedication.
Attachment 1 - Revision History For 43004 Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Description of Training Required and Completion Date Comment Resolution and Closed Feedback Form Accession Number (Pre-Decisional, Information N/A 10/03/07 CN 07 030 Researched commitments for 4 and found none. Initial issuance N/A N/A N/A ML110871957 04/25/11 CN 11-007 Revised Inspection Procedure to refer to the applicable Manual Chapter. Added the applicable Manual Chapters to the references. This revision is in response to OIG audit (OIG-10-A-02 (ML103020267)). N/A N/A N/A ML13280A478 11/29/13 CN 13-027 This revision is a complete re-write. IP 38703 has been integrated into this procedure to have one CGD inspection procedure for the agency. N/A ML13280A479 N/A ML16344A092 01/27/17 CN 17-002 Revised Inspection Procedure to incorporate the QA aspects involved in the use of ILAC accreditation process in lieu of surveys for laboratory calibration and testing services N/A ML16344A090