ML19256E306
| ML19256E306 | |
| Person / Time | |
|---|---|
| Site: | 07100271 |
| Issue date: | 10/19/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Ridihalgh J EGGERS, RIDIHALGH PARTNERS, INC. |
| References | |
| FCTC:RHO, NUDOCS 7911020074 | |
| Download: ML19256E306 (8) | |
Text
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UNITED STATES y;
g NUCLEAR REGULATORY COMMISSION y
WASHINGTON, D. C. 20555 0CT 151979 FCTC: RHO 71-0271 Ridihalgh, Eggers & Associates ATTN: Mr. John L. Ridihalgh 2112 Iuka Avenue Columbus, OH 43201 Gentlemen:
We have evaluated your Quality Assurance Program submitted with your January 29, 1979 letter to satisfy the requirements of 10 CFR 971.51.
Our review indicates that additional information is required to satisfy the applicable requirements of Appendix E to 10 CFR Part 71. Please address the enclosed request for additional information and submit seven copies of the revised program within 60 days following receipt of this letter.
If you have any questions regarding this request, please feel free to contact Mr. Jim Conway at (301) 492-7741.
Sincerely, b
Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Request for Additional Information 1253 173 C
RIDIHALGH, EGGERS & ASSOCIATES (71-0271)
Request for Additional Information 1.
Describe the QA/QC functions performed by REA's QA organization or delegated to other organizations providing controls to assure all elements of Appendix E will be implemented.
2.
Clarify 'the meaning of the dotted lines in Figure 1 on page 14.
3.
Describe the qualification requirements for the position of Manager -
Quality Assurance.
4.
Provide a statement that provisions are established to control the distribution of the QA manuals and revisions thereto.
5.
Provide a statement that provisions are established for comunicating to all responsible organizations and individuals that quality policies, QA manuals, and procedures are mandatory requirements.
6.
Provide a listing of the QA procedures plus a matr.ix of these procedures cross-referenced to each criterion of Appendix E to 10 CFR Part 71.
7.
Identify the safety-related structures, systems, and components controlled by the QA program.
8.
Provide a statement that an indoctrination and training program is established such that:
a.
Personnel responsible for performing quality-affecting activities are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.
b.
Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.
9.
Provide a statement that errors and deficiencies in the design, including the design process, that could adversely affect safety-related structures, systems, and components are documented; and corrective action is taken to preclude repetition.
10.
Provide a statement that materials, parts, and equipment which are standard, commercial (off the shelf) or which have been previously approved for a different application are reviewed for suitability prior to selection.
1258 174 11.
Identify +he positions or groups responsible for design reviews and other design varification activities.
12.
Provide a statement that measures are established for the selection of suitable materials, parts, equipment, and processes for safety-related structures, systems, and components which include the use of valid industry standards and specifications.
13.
Provide a stakment that procedures are established that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of procurement documents.
14.
Provide a statement that a review and concurrence of the adequacy of quality require,ments stated in procurement documents is performed by qualified personnel. This review should determine that quality require-ments are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with QA program requirements.
15.
Provide a statement that the review and approval of procurement documents are documented prior to release and available for verification.
16.
Provide a statement that procurement documents identify the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemical and physical test results of material' to be prepared, maintained, and submitted to REA for review and approval.
17.
Provide a statement that procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to REA prior to use or installation of the hardware.
18.
Provide a statement that changes and revisions to procurement documents are subject to at least the same review and approval as the original document.
19.
Provide a statement that provisions are established which clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, procedures, and drawings.
20.
Provide a statement that methods for complying with each of the 18 criteria of 10 CFR Part 71, Appendix E, are specified in instructions, procedures, and drawings.
21.
Provide a statement that instructions, procedures, and drawings include quantitative (such as dimensions, tolerances, and operating limits) and qualitative (such as workmanship samples) acceptance criteria to verify that important activities have been satisfactorily accomplished.
[258 175 22.
Provide a statement that the QA organization reviews and concurs with inspection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto or acceptabie alternativas are described.
23.
Provide a statement that approved changes are included in instructions, procedures, drawings, and other documents prior to implementation of the change.
24.
Provide a statement that obsolete or superseded documents are controlled to prevent inadvertent use.
25.
Provide a statement that a master list or equivalent is established to identify the current revision numb:
af instructions, procedures, specifications, drawings, and proc
.ent documents. This list is updated and distributed to predetermined, responsible personnel to preclude use of superseded documents.
26.
Identify the documents that are controlled under the QA program. As a minimum, this should include:
a.
Design specifications.
b.
Design, manufacturing, construction, and installation drawings.
c.
d.
QA manuals.
e.
Design criteria documents.
f.
Manufacturing, inspection, and testing instructions.
g.
Test procedures.
h.
Design change requests.
- i. Nonconformance reports.
27.
Provide a statement that qualified personnel evaluate the supplier's capability to provide acceptable quality services and products before the award of the procurement order or contract. The QA and engineering groups participate in the evaluation of those suppliers providing critical components.
1258 176 28.
Provide a statement that the evaluation of suppliers is cased on one or more of the following:
a.
The supplier's capability to comply with the elements of 10 CFR Part 71, Appendix E, that are applicable to the type of material, equipment, or service being procured.
b.
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
c.
A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manufacturing, and quality requirements.
29.
Provide a statement that the results of supplier evaluations are documented and filed.
30.
Provide a statement that surveillance of suppliers during fabrication, inspection, testing, and shipment of materials, equipment, and components is planned and performed in accordance with written procedures to assure conformance to the purchase order requirement. These procedures pro;ide for:
a.
Instructions that spe:ify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of surveillance and the extent of documentation req.uired; and those responsible for implementing these instructions.
b.
Audits and surveillance which assure that the supplier complies with the quality requirements. Surveillance is performed on those items where verification of procurement requirements cannot be determined upon receipt.
31.
Provide a statement that the supplier furnishes the following records, as a minimum, to REA:
a.
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards and specifications) met by the items, b.
Documentation that identifies any procurement requirements which have not oeen met together with a description of those nonconformances dispositioned " accept as is" or " repair."
The review and acceptance of these documents shall be described in REA's QA program and, as a minimum, shall be undertaken by a responsible QA individual.
1253 177 32.
Provide a statement that suppliers' certificates of confomance are periodically evaluated by audits, independent inspections, or tests to assure they are valid.
33.
Provide a statement that receiving inspection of the supplier-furnished material, equipment, and services is perfomed to assure:
a.
The material, component, or equipment is properly identified and corresponds with the identification on receiving documentation.
b.
Material, components, equipment, and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use.
c.
Inspection records or certificates of conformance attesting to the acceptance of material, components, and equipment are available at the nuclear power plant prior to installation or use.
d.
Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for installation or further work.
34.
Provide a statement that the effectiveness of the control of quality by suppliers is assessed by REA at intervals consistentiwith the importance, complexity, and quantity of the item.
35.
Provide a statement that identification requirements are determined during generation of specifications and design drawings.
36.
Provide a statement that the identification and control procedures assure that identification is maintained either on the item or on records traceable to the item to preclude use of incorrect or defective items.
37.
Provide a statement that identification of materials and parts important to the function of safety-related structures, systems, and components can be traced to the appropriate documentation such as drawings, specifications, purchase orders, manufact.uring and inspection documents, deviation reports, and physical and chemical mill test reports.
30.
Provide a statement that the location and the method of identification do not affect the fit, function, or quality of the item being identified.
39.
Provide a statement that correct identification of material, parts, and components is verified and documented prior to release for fabrication, assembling, shipping, and installation.
40.
Provide a statement that qualification records of procedures, equipment, and personnel associated with special processes are established, filed, and kept current.
1258 178
. 41.
Provide a statement that inspection personnel are independent from the individuals performing the activity being inspected.
42.
Provide a statement that inspection procedures, instructions, and check-lists provide for the following:
a.
Identification of characteristics and activities to be insrected.
b.
Identification of the individuals or groups responsible for performing the inspection operation.
c.
Acceptance and rejection criteria.
d.
A description of the method of insoection, e.
Recording evidence of completing and verifying a manufacturing, inspection, or test operation.
f.
Recording inspector or data recorder and the results of the inspection cperation.
43.
Provide a statement that inspectors are qualified in accordance with applicable codes, standards, _nd company training programs; and their qualifications and certifications are kept current. i 44.
Provide a statement that measuring and test equipment is traceable to the calibration test data.
45.
Provide a statement that measuring and test equipment is labeled or tagged to indicate date of the next calibration.
46.
Provide a statement that measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
47.
Provide a statement that calibrating standards have an uncertainty (error) requirement of no more than 1/4th of the tolerance of the equipment being calibrated. A greater uncertainty may be acceptable when limited by the
' state-of-the-art."
48.
Provide a statement that the complete status of all items under the calibration system is recorded and maintained.
49.
Provide a statement that reference and transfer standards are traceable to nationally recognized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
50.
Provide a statement that bypassing of required inspections, tests, and other critical operations is procedurally controlled under the cognizance of the QA organization.
~
,3rn 1'l 0
.- 51.
Provide a statement that documentation identifies the nonconforming item; describes the nonconformance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.
52.
Identify those individuals or groups delegated the responsibility and authority for the disposition and apprcval of nonconforming items.
53.
Provide a statement that nonconforming items are segregated from acceptable items and identified as discrepant until properly dispositioned.
54.
Provide a statement that acceptability of rework or repair of materials, parts, components, systems, and structures is verified by reinspecting and retesting the item as originally inspected and tested or bj a method which is at least equal to the original inspection and testing method.
55.
Provide a stateme'nt that nonconformance reports dispositioned " accept as is" or " repair" are made part of the inspection records and forwarded with the hardware to REA for review and assessment.
56.
Provide a statement that nonconformance reports are periodically analyzed to show quality trends, and the results are reported to management for review and assessment.
57.
Provide a statement that follow-up reviews are conducted to ve:rify proper implementation of corrective actions and to cicse out the corrective action documentation.
58.
Provide a statement that record storage facilities are constructed, located, and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature or humidity.
59.
Provide a statement that audits are regularly scheduled on the basis of the status and safety importance of the activities being performed and are initiated early enough to assure effective quality assurance during the design, procurement, and contracting activities.
60.
Provide a statement that audit data are analyzed and the reports, which indicate quality trends and the effectiveness of the QA program, are reported ;o mananement for review and assessment.
1258 180