ML20010G632
| ML20010G632 | |
| Person / Time | |
|---|---|
| Issue date: | 08/28/1981 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20010G628 | List: |
| References | |
| REF-QA-99900401 NUDOCS 8109220333 | |
| Download: ML20010G632 (2) | |
Text
r Combustion Engineering, Inc.
Power Systems Group Docket No. 99900401/81-02 NOTICE OF NONCONFORMANCE Based on the resuits of an NRC inspection conducted on August 3-6, 1981, it appears that certain of your activities were not conducted in accordance with NRC requirements.
A.
Topical Report CENPD-210-A, Revision 3, dated November 1977, commits to compliance with the requirements of ANSI N45.2.11 - 1974 with noted exceptions.
Section 2.2 (Program Procedure) of ANSI N45.2.11 - 1974 states in part, " Procedures shall be employed to assure that design activities are carried out.
Progra,r. procedures shall cover the following as applicable:..
13.
Taking corrective action (See Section 9)."
Section 9 states in part, "In addition to correcting a deficiency (or error), corrective action also includes, for sfgnifi-cant or recurring deficien::les (or errors), determining the cause and instituting appropriate changes in the design process and the quality assurance program to prewnt similar types of deficiencies (or errors) from recurring....
Where a significant design change is necessary because of an incorrect design, the design process and verification procedure shall be reviewed and modified as r.ecessary."
Contrary to the above, Quality Assurance of Design Procedure 5.7 (Design Change, Field Change, Corrective Action) Revision 2, datad October 1, 1980, which implements Section 9 of ANSI N45.2.11 - 1974, does not require that the design process and verification procedure be reviewed and modified as necessary where a significant design change is necessary because of an incorrect design.
B.
Section 17.18 of Combustion Engineering Topical Report CENPD-210-A Revision 3, dated November 1977, commits to v.he requirements of ANSI N45.2.12 Draft 3, Revision 4.
Group Quality' Assurance is responsible for the independent assessment of the effectiveness of the Power Systems Group quality assurance program.
Combustion Engineering Quality Assurance Procedure QAP 18.1, Revision B dated March.'!1,1981, implements certain of these requirements and states in paragraph (.5.5, "When a nonconformance is identified and is considered significant with regard to impact on quality, further investigation shall be requested of the audited organiza-tion in an effort to identify the cause and effect of the nonconformance and to determine the extent of the corrective action required."
Contrary to the above, a Combustion Engineering (CE) internal quality audit disclosed a nonconformance, but the audited organization did not identify the cause and effect of the nonconformance or determine the extent of corrective action required.
8109220333 810828 PDR GA999 EMVC--E 99900401 PDR
F Combustion Engineeri ~, Inc.
2 Specifically, tha nonconformance identified by the CE internal audit concerned Quai.ty Class 1 orifice plates being procured from Fluidic Techniques without CE having performed a survey to evaluate the vendor's j
capability to comply with the quality requirements of the procurement document. The audited organization's response to this finding was limited to a survey.of the specific vendor, which disclosed numerous proolems with their QA program.
Not incluced in the response to the internal audit finding were:
1.
Identification of the cause; i.e., why the procurement was made witnout a survey; and i
2.
Identification of the effect; i.e., have other vendors been used without a survey and are products shipped by Fluidic Techniques prior to the survey of acceptable quality.
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