ML20057C052
| ML20057C052 | |
| Person / Time | |
|---|---|
| Issue date: | 09/16/1993 |
| From: | Office of Nuclear Reactor Regulation |
| To: | |
| Shared Package | |
| ML20057C049 | List: |
| References | |
| REF-QA-99900105 NUDOCS 9309270011 | |
| Download: ML20057C052 (2) | |
Text
-.
ENCLOSURE 2 NOT]CE OF NONCONFORMANCE Fisher Controls International, incorporated Docket No. 99900105 Marshalltown lowa Report No. 93-01 Based on the results of a U. S. Nuclear Regulatory Commission (NRC) inspection conducted at the Fisher Controls International, Incorporated (Fisher) facilities. between July 12-15, 1993, it appears that certain of your activities were not conducted in accordance with NRC requirements.
A.
Criterion 11, " Quality Assurance Program," of Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," of 10 CFR Part 50 (Appendix B), requires, in part, that a quality assurance (QA) program which complies with the requirements of Appendix B be established.
The QA program shall provide controls over activities affecting the quality of components, to an extent consistent with their importance to safety.
The program shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.
Criterion X, " Inspection," of Appendix B, requires, in part, that a program for inspection of activities affecting quality shall be established and executed.
Such inspection shall be performed by individuals other than those who performed the activity being inspected.
If inspection of processed material or products is impossible or disadvantageous, indirect control by monitoring processing methods, equipment and personnel shall be provided.
Section 3.1., " Quality System," of Fisher's Standard Quality Assurance Manual (SQAM), approved November 5, 1992, stated,-in part:
This manual delineates the responsibilities for the preparation and implementation of a plan of activities which shall assure and control the quality of those items, parts, or components manufactured by FCS [ Fisher Controls System Business Unit]-Marshalltown Division.
The quality program has been designed to comply with the requirements of 10 CFR Part 50, Appendix B, ANSI N45.2, and ISO 9001-1987 and implement the requirements of 10 CFR Part 21.
This manual is supplemented by various Quality Management Procedures (QMP),
Engineering Standards (ES), and Fisher Manufacturing Procedures (FMP) which describe in more detail the activities, responsibilities, and actions required by the Manual.
Contrary to these requirements, Fisher's SQAM did not appear to adequately address or take into account the need for verification of quality by inspection and test by individuals other than those that
_].
9309270011 930916 PDR GA999 ENVFICO 99900105 PDR:
performed the work activity. Additionally, although Fisher's SQAM stated its quality program was designed to comply with the Appendix B requirements, Section 2, "M agement Responsibility," of the SQAM'only required the QA Manager to " implement a quality program in accordance to 150 9001 and QM1 25," and did not address Appendix B requirements.
(93-01-03)
B Criterion VI, " Document Control," of Appendix B requires, in part, that measures be established to control the issuance of documents, such as B
instructions, procedures, and drawings, including changes thereto, which prescribe all activities af f ecting quality.
These measures shall assure that documents, including changes, are reviewed for adequacy and approved for release by authorized personnel and are distributed to and g.
s used at the location where the prescribed activity is performed.
Sect 1on 7. " Document Control." of the Fisher SQAM states, in part, that "the responsibilities for the preparation, review, approval and distribution of documents shall be in accordance with Table 7.1.l A."
Table 7.1.]A. " Persons Responsible for Original Documents and Revisions " requires that engineering documentation be prepared by engineering staff; be reviewed by product / project engineering or engineering management; and be approved by engineering management.
Contrary to the above, Fisher Controls f ailed to maintain the User's Manual f or the SE1SMIC4 Finite Element Analysis Program under formal document change control.
The version of the document in use by Fisher personnel did not contain any indication of the document revision, the effective date, or the approval authority.
(93-01-04)
Please provide a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN:
Document Control Desk, Washington, D.C. 20555, with a copy to the Chief, Vendor inspection Branch, Division of Reactor inspect ion and Licensee Performance, Of fice of Nuclear Reactor Regulation, within 30 days of the date of the letter transmitting this Notice of Noncon-formance.
This reply should be clearly marked as a " Reply to a Notice of Nonconformance," and should include for each nonconformance:
(1) a descrip-tion of steps that have been or will be taken to correct these items; (2) a description of steps that have been or will be taken to prevent recurrence; and (3) the dates your corrective actions and preventative measures were or will be complet ed.
Dated at Rockville. Maryland This 16th day of September 1993.