ML19341B896
| ML19341B896 | |
| Person / Time | |
|---|---|
| Site: | 07100271 |
| Issue date: | 10/09/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Ridihalgh J EGGERS, RIDIHALGH PARTNERS, INC. |
| Shared Package | |
| ML19341B893 | List: |
| References | |
| 18208, NUDOCS 8102280085 | |
| Download: ML19341B896 (27) | |
Text
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OCT 191379 I
FCTC: RHO 71-0271 Ridihalgh, Eggers & Associates ATTrt: fir. John L. Ridihalgh 2112 luka Avenue Columbus, OH 43201 I
,'entlemen:
G t e have evaluated your Quality Assurance Program submitted with your January 29, 1979 letter to satisfy the requirements of 10 CFR 671.51.
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,
[
W Charles E. MacDonald, Chief Transportation Certification Branch I
Division of Fuel Cycle and !!aterial Safety, f04SS
Enclosure:
Request for Additional Information 8102280085
A-1 RIDIHALGH, EGGERS & ASSOCIATES (71-0271)
Request for Ad_ditional Information l
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 implement;d.
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 matrix of these procedures cross-referenced to each criterion of Appendix E to 10 CFR Part 71.
7.
Identify the sa fety-related structures, systems, and components controlled by the QA program.
8.
Provide a statement that an indoctrination and training program is I
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 perfonning quality-affccting 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, comercial (off the shelf) or which have been previously approved for a different application are reviewed for suitability prior to selection.
A-2 I
11.
Identify the positions or groups responsible for design reviews and other design verification 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 statement 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 requirements 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 acccedance 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.
6 16.
Provide a statemr t 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 I
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.
A-3 I
22.
Provide a statement that the QA organization reviews and concurs with inspection plans; test, calibration, and special process procedures; I
drawings and specifications; and changes thereto or acceptable alternatives are described.
23.
Provide a statement that approved changes are included in instructions, I
procedures, drawings, and other documents prior to implementation of the change.
I 24.
Provide a statement that obsoletc 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 number of instructions, procedures, specifications, drawings, and procurement documents.
This list is updated and distributed to predetermined, responsible personnel to I
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.
(.
QA manuals.
e.
Design criteria documents.
f.
Manufacturing, inspection.
! testing instructions.
g.
Test procedures.
h.
Design change requests.
- i. fionconformance 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.
I
k A-4 I
28.
Provide a statement that the evaluation of suppliers is based 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.
A survey of the supplier's facilities and QA program to determine c.
his capability to supply a product which meets the design, manufacturing, l
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, I
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 requirements. 'These procedures provide for:
I Instructions that specify the characteristics or processes to be a.
witnessed, inspected or verified, and accepted; the method of I
surveillance and the ei ent of documentation required; 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:
Documentation that identifies the purchased material or equipment a.
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 been 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 l
QA program and, as a minimum, shall be undertaken by a responsible QA individual.
I I
A-5 32.
Provida a statement that suppliers' certificates of conformance 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. performed to assm e:
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 fonvarding them to a controlled storage area or releasing them for installation or further work.
Provide a statement that the effectiveness of the control of quality by I34.
suppliers is assessed by REA at intervals consistent with the importance, complexity, an'd quantity of the item.
35.
Provide a statement that identification requirements are determined during generation of specifications and design drawings.
I36.
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 l
traced to the appropriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
I38.
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 statenent that correct identification of material, parts, and components is verified and documented prior to release for fabrication, assembling, shipping, and installa tion.
40.
Provide a statement that qualification records of procedures, equipment, and personnel associated with special processes are established, filed, and kept current..
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A-6 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 inspected, b.
Identification of the individuals or groups 2sponsible for performing the inspection operation.
c.
Acceptance and rejection criteria.
d.
A description of the method of inspection.
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 operation.
43.
Provide a statement that inspectors are qualified in accordance with applicable codes, standards, and company training programs; and their I
qualifications and certifications are kept current.
44.
Provide a statement that measuring and test equipment is traceable to the I
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 I
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 "s ta te-of-the-a rt. "
I 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 I
QA organization.
I
A-7 I
Prccide a statement that documentation identifies the nonconforming item; 51.
describes the nonconfnrmance, the disposition of the nonconformance, and the inspection requ rements; and includes signature approval of the disposition.
52.
Identify those individuals or groups delegated the responsibility and authority for the disposition and approval of nonconforming items.
Provide a statement that nonconfonning items are segregated from acceptable 53.
items and identified as discrepant until properly dispositioned.
Provide a statement that acceptability of rework or repair of materials, 54.
parts, components, systems, and structures is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
Provide a statement that nonconfonnance reports dispositioned " accept as is" 55.
or " repair" are made part of the inspection records and forwarded with the hardware to REA for review and assessment.
Provide a statement that nonconformance reports are periodically analyzed 56.
to show quality trends, and the results are reported to management for review and assessment.
Provide a statement that follow-up reviews are conducted to verify proper 57.
implementation of corrective actions and to close out the corrective action documentation.
Provide a statement that record storage facilities are constructed, located, 58.
and secured to prevent destruction of the records by fire, flooding, thef t, I
and deterioration by environmental conditions such as temperature or humidity.
Provide a statement that audits are regularly schedulcd on the basis of the 59.
I 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.
I Provide a statement that audit data are analyzed and the reports, which indicate 60.
quality trends and the effectiveness of the QA program, are reported to management for review and assessment.
I
i l
I APPENDIX B ANSWERS TO NRC QUESTIONS CONCERNING QUALITY ASSURANCE l
MANUAL SUBMITTED BY RIDIHALGH, EGGERS AND ASSOCIATES I
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A.P_PEi(DI X. B_
ANSWERS T0_ NRC_ QUESTIONS CONCERNING QUALITY ASSURANCE !4ANUAL SUBMITTED BY RIDIHALGH, EGGERS AND ASSOCIATES These answers are in response to a letter from Mr. C. E. MacDonald, NRC to Mr. J. L. Ridihalgh, REA, dated October 19, 1979, File Number FCTC: RHO, 71-0271, requesting additional information on REA Quality Assurance Manual.
The questions corresponding to these answers are contained in Appendix A.
1.
Controls to assure all elements of 10CFR71, Appendix E will be implemented throuah audit and follow-up actions.
(Ridihalqh, Eggers and Associates' (REA) QA Manual,Section I, p. 3 of 4, Par. 3.3.8.).
Paragraphs 3.3.1. through 3.3.7. delineate specific items for which REA QA organization will audit, inspect, or provide services.
REA QA Manual,Section II, p. 15 of 15 oresents a 17 item check list for QA controls cerformed by REA QA organization for operations an<i main-tenance for design and fabrication of a product.
QA'4, Section 02.1.,
p.1 of 5 states that REA QA Manaaer will aporove QA programs of those organizations ' suppliers.
QAM, Section 02.1., p. 3 of 5 indicates that REA QA.' tanager will review each proposal to identify quality require-I ments for which Appendix E will apply. QAM, Section 03.1., p. 2 of 5 states that the aesignated Quality Enqineer will review design conceots, drawings, and test plans and a check list of items evaluated under design control which are cresented on pp. 2 through 5 of Section 03.1.
REA QAM, Section 09.1 states that the QA '4anager will verify that controls on special processes have been established and suqgests four areas for consideration.
REA QAM, Section 04.2. and Section 07.1. implies that REA QA 'ianager will review suppliers and maintain a supplier directory and history as illustrated on forms in Section 04.2., pp. 4 and 5.
The QA Manager will review all purchase requests for products and services.
The following tabulation summarizes the check lists and forms which present detailed procedures on specific areas for quality inspection performed by REA QA Manager or the appropriate delegated authority to control quality of products and services.
I L
B-2 REA QAM Reference Procedure
-Pages 10CFR71, Appendix E Name of Control Procedure Section Reference Section Design Control 03.1 4,5 3
Drawing Release Approval 03.2 2,3 5,6 Procurement Request 04.1 3,4 4
Supplier Directory 04.2 4
4,7 Supplier History 4.2 5
4,7 Control of Purchased Paterial, I
Equipment, and Services 07.1 3,4 7
Identification and Control of Materials, Parts, and Component ;
08.1 2
8 Control of Special Processes 09.1 2
9 Manufacturing Controls 09.1 3,4,5,6 7,9 Control of Subtier Supplier Special Processes 09.1 8,9,10 7,9 Inspection and Test Receiving Inspection 10.1 4,5 10,11 In-Process Inspection 10.1 6,7,8 10,11 Final Inspection 10.1 8-11 10,11 Test Control 11.1 3
11 Control of Measuring and Test Equipment 12.1 4
12 Metrology Control 12.1 5-9 12 Checklist for Evaluation of Contractor's Calibration System 12.1 10-14 12 Guide for Environmental Controls 12.1 15,16 12 Detrimental Effects of Environment 12.1 17 12 Handling, Storage, and Shipping 13.1 3,4,5 13 Marking and Labeling 13.1 3
13 Inspection, Test, and Operating Status 14.1 5
14 Material Control and Identifi-cation 14.1 3,4 14 Nonconforming Material Control 15.1 3,4,5 15 I
Nonconforming Material, Parts, or Components 15.1 6,7 15
REA QAM Reference ProcedLFe~ ~
~ ~Pigis 10CFR71, Appendix E I
flame of Control Procedure Section Reference Section Corrective Action Criteria 16.1 3
16 Corrective Action Evaluation Criteria for Nonconforming Material Control 16.1 2
16 Evaluation Criteria for Records 17.1 3,4 17 QA Records Criteria 17.1 5,6 17 Audits Criteria 18.1 7,8 18 Audit Reporting Format 10.1 5,6 18 I
Quality of Spare Parts 19.1 1,2 7,8,9,10,11 Control of Lifting Devices 19.2 1
7,8,9,10,11 In summary, the REA QA Manual presents minimum, and in some cases, suggested controls for each category of functions delineated in 10CFR App'endix E.
Additional items may be included in all of the controls as a particular situation seems to warrant.
2.
Solid lines in Figure 1 (REA QAM,Section III, p. 5) indicate lines of authority.
Dotted lines indicate lines of communication between the QA Manaaer and the Project Manager and subcontractors necessary to carry out QA functions.
Corrective actions, however, follow lines of management (solid lines).
3.
The QA Manager must be a graduate of an approved engineering school with the equivalent of a Bachelor of Science in engineering.
For further sc.eening of applicants in case of more than one, qualifications, such as number of years of practice, type and level of experience, Professional Engineer License, and Quality Control Certification, will be considered.
'I 4.
REA QAM, Section 06.1, p. 1 Par. 4.1.1. states that the QA manuals and its revisions will be controlled and verified and Par. 4.1.2.1. covers I
the issuance (distribution) of documents, which includes the QA manuals and revisions thereto.
Distribution lists for QA manuals and its I
revisions will be maintained and Par. 4.1.2.8. of QAM 06.1, p. 2 provides for reviewing these lists.
B-4 5.
Provisions are established for communicating and making contractually binding (legally mandatory) (REA QAM I, p. 2, Par. 3.1.2. and 3.1.3.)
quality assurance requirements on projects under contract.
Within the corporation, the QA Manager (REA QAM,Section II, p.1, Par.
- 3) shall (Meaning mandatory, see Preface, Par. 2) perform the eight listed functions which comunicates compliance (mandatory) requirements of 10CFR71, Appendix E.
6.
A listino of the OA procedures and a matrix of these procedures cross-referenced to each criterion of 10CFR71, Appendix E are presented as a table of contents to the REA QA Manual and imediately follows the
" Preface" Section.
7.
QA programs for the control of safety-related structures, systems, and components will be developed as the need arises, i.e., as REA acquires ownership of equipment. An example of the QA program framework for l
lifting devices is presented in REA QAM,Section 19.2.
For equipment developed and constructed for others under contract, the control of safety-related structures, systems and components will be included in REA QAM Sections 3 through 5, 7 through 11, and 13 through 18.
Examples of safety-related shipping cask components that would be I
controlled are containment vessels, covers, bolts and fasteners, valves, plugs, and any component penetrating the containment boundary.
External I
to this boundary, trunnions, gamma and neutron shielding and their surrounding vessels, impact limiters, and thermal transfer devices would be controlled.
I I
B-5 I
8.
Personnel performing quality-related activities are instructed in the purpose, scope, and implementation of applicable quality-related manuals, instructions, and procedures prior to the start of any activity (REA QAM, Section 02.1).
The effectiveness of the REA QA department is a'ssessed at least annually and specific functional areas will be reviewed quarterly (REA QAM, Section 18.1, p. 2).
The recertification of welders, for example, is controlled by the contractor hiring the welders and the organization responsible for certification.
Welding deficiencies are identified through inspection.
For all personnel, the proficiency of each person is evaluated and each is retrained, reexamined, and/or recertified depending on pro-ficiency, introduction of new methods, and lapse of time since last certification.
I 9.
REA QAM, Section 03.1 provides for documenting of design reviews which will identify crrors and deficiencies of design.
The QA Manager is a member of the design review team (REA QAM, Section 17.1, p. 2, Par. 4.3.1.)
who follows up to ensure that corrective action is taken (REA QAM, Section 17.1, p. 2, Par.
4.3.3.2.).
If deficiencies occur, the appropriate manager prepares a report describing corrective action to be taken and the schedule for correction (REA QAM, Section 18.1, p. 4, Par. 5.5.1.).
l If a deficiency is repeated, a separate written report must be prepared by the applicable manager and sent to REA President, through a Vice President, who recommends actic.n to be taken (REA QAM, Section 18.1,
- p. 4, Par. 5.5.2.).
I I
t
B-6
- 10. Materials, parts, and equipment which are standard, cormerical (off the shelf), or previously approved for a different application shall be reviewed for suitability prior to selection (REA QAM 07.1. Par. 4.1.2.),
I 11.
REA QAM, Section 17.1, p.2, Par. 4.3.1. states that the QA Department will participate in design reviews.
If the QA Manager is not personally competent to review the design, he will designate a Quality Engineer (or engineers as required) (REA QAM, Section 03.1), who will review the design concepts, drawings, and test planning for definition com-pared with preselected requirements, compliance with ccntractual requirements, and consideration of customer support.
The Quality Engineer is an independent person not previously associated with the design that is being reviewed.
12.
REA QAM, Section 05.1, p.1 states that national consensus standards, codes, and specifications shall be utilized in product definition, production, and operations in meeting all contractual, regulatory, and statutory requirements.
The aforementioned list includes suitable l
materials, parts, equipment, and processes.
13.
Program Management or designated personnel needing materials for I
projects prepare a procurement request (REA QAM, Section 04.1, p. 1).
The QA Manager or a designated individual and Programs Management (as mentioned previously and in REA QAM, Section 07.1, p. 2, Par. 4.1.2. and Section 04.1, p.1) reviews the document.
The purchasing department issues a purchase order, a copy of which is reviewed and filed by the QA Manager (REA QAM, Section 04.2, p. 3, Par. 5.5.2.).
l The QA Manager prepares and distributes check lists and formatted documents to the appropriate organization as needed.
Documents not
'I I
B-7 nentioned later, such as written correspondence, specifications, and incoming information, are initiated by othc-s.
The QA Manager or an independent designated qualified individual reviews the documents.
The reviewer approves the document for quality; however, other line managers nay also need to approve the document for contractual or I
other reasons.
The QA Manager maintains a file of a copy of the aforementioned reviewed documents and serds the orginial copy to the appropriate organization.
REA QAM, Section 06.1 under " Purpose", establishes a procedure for the control of all documents.
In the " Procedures" section, the QA Manual and supplier quality related functions are examples listed.
Other examples include procurement request document; purchase orders; shipping and packing lists; vendor material receipts; logs (material receipt, laborai.ory notebook, computer printout, print distribution, and tracing); design control procedure document; drawing release approval document; design change document; supplier directory; control of pur-chased material; equipment and services document; manufacturing and process controls document; control of special processes document; inspection and test document; inspection criteria document; test control document; control of measuring and testing equipment; metrology control document; check list for evaluation of contractor's calibration system; handling, storage, and shipping document; marking and labeling document; I
storage, handling, packaging, and shipping document; inspection, test, and operating status document; material control and identification document; nonconforming material control document; supplier records document; and supplier audits documents.
14.
Procurement documents are reviewed and approved by a qualified person familiar with the application but not working on that particular aspect of the project for which the procurement is intended.
The reviewer determines that quality requirements are correctly stated, compared with program requirements and contractual specifications.
The reviewer also determines that important attributes are inspectable and controllable; that codes, if included in the procurement request, are appropriate and I
B-8 applicable; and that omission of reference documents are noted for inclusion.
Moreover, the reviewer ensures that the acceptance and rejection criteria for receiving the procurement, is adequate for the purpose intended of the procurement.
The QA Manager or designated individual reviews the completed procure-ment documents to ensure that they have been prepared, reviewed, and approved with signatures of the appropriate persons according to QA Manual procedures (REA QAM, Section 04.1, p.2, Par. 4.2. ).
15.
The QA Manager or designated individual copies the procurement documents that have been reviewed and approved for purchase and files them for verification.
The QA Manager or designated individual then releases the procurement document to the originating program management for disposition af ter approval (REA ')AM 04.1, Par. 4.1.1.).
16.
The aforementioned program requirements and contractual specifications that the reviewer uses for determining adequacy of the procurement includes drawings, specifications, procedures, inspection and fabrica-tion plans, inspection and test records, personnel and procedure qualifications, chemical and physical test results of materials, and any other documentation necessary to describe or qualify the procurement.
If these documents are included in the procurement document by reference, I
a copy of the reference document shall be prepared and submitted to REA for review and approval.
A copy of the approved reference document will be maintained in REA QA files.
For standard documents already prepared (e.g., ASTM specifications) a copy shall be maintained in REA QA files.
17.
Procurement documents shall identify those records to be retained, controlled, and maintained by the supplier, and thore delivered to REA prior to installation or use of the procurement (REA QAM 04.1, Par. 4.2.).
18.
REA QAM, Section 06.1, p.1 states that changes to quality related documents will receive the same degree of review and approval as the orginial documents.
This includes procurement documents, thus, changes and revisions to procurement documents shall be subject to at least the
B-9 same revicw and approval as the original document.
19.
Instructions and procedures to the QA Manual or documents relevant to quality assurance is prepared by the QA Manager and reviewed by the President of REA or a designated person.
REA President approves the QA instructions and procedures.
The QA Manual contains detailed descriptions for the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, pro-cedures, and drawingo Af ter award of a contract, a QA progiam is planned following the guidelines in the REA QA Manual (REA QA'4 02.1,
- p. l.).
20.
REA QAM, Section 02.1, p. 1 states that the REA QA Program complies with the requirements of 10CFR71, Appendix E.
The REA QA Manual in subsequent secticas presents detailed procedures for complying with each of the itenized criteria in 10CFR71, Appendix E.
The table following the Prefac of the REA QA Manual references each REA QAM section which complies with each of the 18 10CFR71 criteria. After award of a contract, a project-specific QA program is planned using the REA QA Manual which contains all of the QA elements in 10CFR71, Appendix E.
Thus, the new plan also contains all of the elements of I
MCFR71, Appendix E.
l 21.
REA QAM, Section 05.1, p.2, Par. 4.1.3. states that written instructions will be used to check products and services for compliance. Wri tten instructions include procedures, drawings, contracts, regulations, codes, standards, specifications, and any other document that describes the product or service to be supplied.
These written instructions shall describe the product or service in sufficient quantitative and qualitative details that the product or service can be provided with-out verbal communication. These details shall include acceptance criteria for each quantity or quality specified (REA QAM, Section 10.1,
- p. 2).
Thus, for example, drawing dimensions will include tolerances; material type specifications will reference standards (ASTM, other, or special soecifications) which in turn specify tolerances of composition,
0-10 strength, or other qualities, operating and test parameters (i.e.,
pressure, temperature, or input horsepower) will specify limits, ranges of operation, or tolerances; and qualities will be described, such as color or surface roughness, by specifications as completely as possible.
In reference specifications that state to the effect that qualities of workmanship shall conform to " standard or good" practice in the industry, the appropriate supplier must furnish references at which similar products can be viewed, or if no prior experience exists, must furnish samples to demonstrate qualities that can not otherv ise be specified.
One of the responsibilites of the QA Organization is to verify that criteria for determining the acceptability and inspectability have I
been designated (REA QAM, Section 10.1, p. 2, Par. 4.2. l. ).
22.
REA QA Organization reviews inspection plans (REA QAM, Section 10.1,
- p. 2, Par. 4.2.2.), test procedures (REA QAM, Section 11.1, p. 2, Par 4.2. ), calibration procedures (REA QAM, Section 12.1, p. 2, Par 4.2.),
special processes (REA ')AM, Section 09.1, pp. I and 2), drawings and specifications (REA QAM, Section 05.1, p. 2, Par. 4.1.3; Section 09.1,
- p. 1, Par. 4.2.1: and Section 10.1, p.2, Par 4.2.1.), and changes or acceptable alternatives thereto.
Concurrence of the QA Organization to these procedures is provided through signatures on the audit reports (reference aforementioned QA Manual sections and REA QAM, Section 18.1,
- p. 4, Par. 5. 4.2. ).
23.
REA QAM, Section 05.1, p. 2, Par. 4.1.3. states that the QA Organization will review contractually applicable documents (i.e., instructions, procedures, drawings, and other documents) for the proper 9ffectively and/or change requirements.
One of these change requirements is to ensure that changes are approved in writing and made a part of the applicable document prior to implementation of the change.
- 24. A portion of the procedures of the REA QA Organization is fulfilling the requirements of REA QAM, Section 06.1, p.1, Par. 4.1.2. is to audit various organizations to assure that they maintain logs of various documents.
1he logs require the date, document numbers and description, document numbers being superseded (if applicable), distribution and t
B-11 date of receipt of superseded document and their document numbers at the place of origin of the documents.
Therefore, by requesting the return of obsolete or superseded documents, use of them is precluded if they are returned.
25.
Master lists (logs) are maintained of many types of documents (e.g.,
letters, contract revisions, and specifications of drawings; and procurement documents) which identify the current revision number, description of document, date nf issue, document numbers being super-seded, distribution, and date of receipt of superseded documents (if received).
The master lists are distributed to individuals receiving the documents and serve as an additional QA control to preclude use of superseded documents in the event that superseded documents are not returned.
Reasons for not returning documents may include conti-nuity of records for difficult-to-copy documents, e.g., drawinas.
- Thus, an option Qf not returning documents, may be exercised at th.e risk of the document receiver.
26.
Documents controlled under REA QA program include the following:
a.
Design specifications, contracts, contract changes letters b.
Drawings--Design, manufacturing, construction, installation, engineering assembly, layout, preliminary, and conceptual c.
QA manuals e.
Design and testing criteria documents f.
Manufacturing, process, special process, inspection, and testing instructions and specifications g.
Test procedures h.
Measuring and test equipment, metrology control document, and check list for evaluation of contractor's calibration system
- i. Lifting devices and other equipment
- j. Design change requests k.
Supplier directory, supplier records, and supplier audits documents 1.
Purchased materials, material control and idertification, and non-conforming materials m.
Handling, storage, and shipping document
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- 27. Qualified personnel [ Program Manager or designated personnel (REA QAM, Section 04.1, p.1, Par. 4.1)] initiates a procurement by completing a Procurement Request Document.
Item 6 of that document evaluates suppliers and recommends a supplier in the " place order with" line.
The Procurement Request document is completed before the procurement order is awarded and the engineering group (Program Manager) and the QA Organization (REA QAM, Section 04.1, p. 2, Par. 4.2 and Item 5 on Procurement Request) participate in the evaluation of those suppliers providing critical components.
- 28. The evaluation of suppliers is based on the following:
The supplier's capability to comply with 10CFR71 (e.g., quality a.
of products or services conform to procurement documents and the supplier's effectiveness in controlling quality) is evaluated (REA QAM, Section 04.2, p. I and p. 2, Par. 5.1. Section 07.1, pp.
1 and 2, and Section 07.i, Control of Purchased Material, Equipment, and Services form) and data are entered in the supplier directory (REA QAM, Section 04.2, Supplier Directory form).
b.
Previous records and the performance of suppliers who have provided similar articles of the type being procured are reviewed (REA QAM, Section 04.2, p. 2) and the supplier history (REA QAM, Section 04.2, Supplier History form) is completed when each procurement is received.
The supplier history is further reviewed by the QA Organization before a procurement is placed with a supplier (REA QAM, Section 04.1, p. 2, Par. 5.2,),
The suppliers facilities may be surveyed to determine his capability c.
to supply a product which meets the design, manufacturing, and quality requirements (REA QAM, Section 04.t pp 1 and 2), and the date, type of survey, and the results are recorded in the supplier directory (REA QAM, Section 04.2, Supplier Directory form).
REA QA Organization reviews and audits supplier;s QA program with assistance of quality assurance system evaluation (QASE) form in REA QAM, Section 07.1, p. 2, Par. 4.1.3, and pp. 3 and 4.
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29.
Supplier evaluations are documented and filed by REA QA Orgainzation.
Documents filed include:
a.
Control of Purchased Material, Equipment, and Services (REA QAM, Section 07.1, pp 3 and 4) b.
Supplier History (REA QAM, Section 04.2, p. 2) c.
Supplier Directory (REA QAM, Section 04.2, p.1) d.
Procurement Request (REA QAM, Section 04.1, p.1) e.
Supplier QASE, Inspection and Test (REA QAM, Sections 10.1.4.3 and 10.1.4.4) f.
Supplier QASE, Metrology Control (REA QA'1, Section 12.1.4.4, pp 5 through 9) 9 Check list for Evaluation of Contractor's Calibration System (REA QAM, Section 12.1.4.5) h.
Supplier QASE, Storage, Handling, Packaging, and Shipping (REA QAM, Section 13.1.4.3)
- i. Supplier QASE, Material Control and Identification (REA QAM, Section 14.1.4.3) j.
Supplier QASE, Nonconforming Material Control (REA QAM, Section 15.1.4.3) k.
Supplier QASE, Nonconformine Materiil Control, Corrective Action (REA QAM, Section 16.1.4.2) 1.
Supplier QASE, Records (REA QAM, Section 17.1.4.4) m.
QASE form, Audits (REA QAM, Section 18.1, Procedure pp 1 and 2, Subsections 1C.1 through 18.3 and 18.0, 8 through F for Suppliers) 30.
REA QA Manual has written procedures for planning and performing surveillance of suppliers during various phases of supply (i.e.,
I fabrication, inspection, testing, and shipment) of materials, equip-ment, and components to assure conformance to the purchase order requirements.
Procedural planning and method of surveillance is presented in check lists which specify characteristics or processes to be witnessed, inspected or verified and documentation required.
These check lists are presented in REA QA Manual for each phase of supply as follows:
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Section Name of Check List Supplier Phase 09.l.4.3 Supplier QASE, Manufacturing and Process Control Fabrication l
10.1.4.3 Supplier, QASE, Inspection and Test Inspection 11.1.4.3 QASE, Tesi. Control Tes ting 13.l.4.3 QASE, Handling, Storage, and Handling Shipping Those responsible for implementing the written procedures are the REA QA Organization (REA QAM, Section 09.1, p. 1, Par. 4.2; Section 10.1,
- p. 2, Par. 4.2; Section 11.1, p. 2, Par. 4.2; and Section 13.1, p. 2, Par.
4.2., which include the QA Manager or a designated, qualified, independent engineer.
I Surveillance is performed on those items where verification of procurement requirements can not be determined upon receipt.
Audits and surviellance are conducted to assure that suppliers comply with requirements of his quality assurance program (REA QAM, Section 09.1, p. 2, Par. 4.2.2. and QASE form, Section 09.1.4.3.l. 9; Section 10.1, p. 2, Par. 4.2.2. and QASE form, Sections 10.1/
4.3.1.2, 4.3.2.3. and 4.3.2.7; Section 11.1, p. 2, Par. 4.2.3. and l
- QASE, Sections 11.1/ 4.3.1.5. and 4.3.2.1. and Section 13.1, p. 2,
- Par. 4.2.3. and QASE form, Section 13.1.4.4.1).
31.
Suppliers are required to furnish records to REA that the identified purchased material or equipment meets the specific procurement require-ments (e.g., codes, standards, and specifications ( (REA QAM, Section 07.1, QASE form, Sections 07.1/4.2.1., 4.2.2.5., 4.2.2.6., and 4.2.2.8.).
Identification and disposition of nonconforming procurements are I
documented by the supplier and presented to REA, which actions are described in REA QAM, Section 15.1, p.1 and p. 2, Par. 4.1.2. which I
B-15 references 10CFR21, including Article 21.21a, which requires notifica-tion of the purchaser (REA). Also, REA QAM, Section 16.1, QASE form, Item 4.2.1.4. requires the identification and disposition of nonconform-ing materials.
Actions to be considered by REA QA Organization include completion of unfinished work, scrap of entire product, rework to specifications, or pass action to a Material Review Board (REA QAM, Section 15.1, p. 2, Par. 4.1.3.).
The Material Review Board, as a minimum, consists of an REA QA representative and an REA engineering department representative (REA QAM, Section 15.1, QASE form, p.
4, Item 4.3.2.4.).
Other members may be I
qualified consultants and customer or supplier representatives.
- 32. Suppliers' r.ertificates of conformance are periodically evaluated by audits (REA QAM, Section 18.1, p. 2, Par.
4.2., Section 07.1, p. 4, Par. 4.2.?.8. of QASE and Section 10.1, QASE, p. 4, Item 4.3.1.3.) by REA QA Organization at least annually (REA QAM, Section 18.1, p. 2, Par 5.1 of Procedures) and more often if quality levels are degraded.
33.
Receiving inspection of the supplier-furnished material, equipment, and services is performed to assure:
a.
The material, component, or equipment is properly identified and corresponds with the identification on receiving documentation (REA QAM, Section 10.1, QASE, p. 4, Item 4.3.1.6. ).
b.
Material, components, equipment, and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use of the product (REA QAM, Section 10.1, QASE, p. 9, Item 4.3.3.16. ).
c.
Inspection records, certificates of conformance, or performance test I
records attesting to the acceptance or conformance of material, components, and equipment (e.g., shipping cask) are available at the nuclear power plant (i.e., the licensee) prior to installation or use as provided in 10CFR71, Par. 71.54 and REA QAM, Section 10.1, QASE, p. 93 Item 4.3.3.14.
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d.
Items accepted or 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 (REA QAM, Section 10.1, QASE form, Items 4.3.1.14. and 4.3.2.5., and Section 07.1,
- p. 1, " General", last sentence of paragraph).
- 34. The effectiveness of the control of quality by suppliers is assessed by REA at intervals consistent with the importance, complexity, and quantity of the item (REA QAM, Section 07.1, p. 2, Par. 4.1.3.).
- 35. Materials, parts, and components identification requirements are determined during generation of specifications and design drawings (REA QAM, Section 03.1.4.2.1.8; Sections 08.1.4.1.1 and 08.1.4.2.1 ).
36.
Identification and control procedures assure that identification is maintained either on the item or on records adjacent to or traceable to the item to preclude use of incorrect of defective items.
(REA QAM, Sections 08.1.4.2.4 and 08.1.4.2.5 and Section 14.1.4.2.1.3 (QUASE)).
37.
Identification of materials and parts important to the function of I
safety-related structures, systems, and components can be traced to the appropriate documentation, such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports (REA QAM, Section 17.1, p. 1).
These and other documents mentioned in the QA Manual in Section 17.1 shall be placed in a project file and be identifiable and retrievable.
- 38. The location and the method of identification do not affect the fit, function, or quality of the item being identified (REA QAM, Section 08.1, p. 1, Par. 4.1. and p. 2, Par. 4.2.1. ).
I 39.
Correct identification of material, parts, and components is verified and documented prior to release for fabrication, assembling, shipping, and installation (REA QAM, Section 08.1,' Par. 4.2.1.).
B-17 I
40.
Qualification records of procedures, equipment, and personnel associated with special processes are established, filed, and kept current (REA QAM, Section, 09.1, p. 2, Par. 4. 2.1. 3. and QASE, p. 3, Pa r. 4.4.2. 4. ).
41.
Inspections are performeo by the QA Organization (REA QAM, Section 10.1, p.1, and p. 2, Par. 4.2.2.), hence the inspection personnel are independent from the individuals performing the activity being inspected as described in REA QAM,Section II, 2, pp 2 and 3 and Section III, Figure 1.
42.
Inspection procedures, instructions, and check lists provide for the following (REA QAM, Section 10.1, p. 2, Par. 4.2.2.):
a.
Identification of characteristics and activities to be inspected (REA QAM, Section 10.1, QASE, pp 3 through 8) b.
Identification of individuals or groups responsible for performing the inspection operation (REA QAM, Section 10.1, QASE, p. 5, Par.
- 4. 3. 3.14. ).
c.
Acceptance and rejection criteria (REA QAM, Section 10.1, QASE, p. 6, Item 4.3.2.1.).
d.
A description of the methods of inspection (REA QAM, Section 10.1, QASE, p. 4, Par. 4.3,1.2 3 p, 8, Par, 4.3. 3.1. ; and p, 8, par. 4.3.3.5,).
e.
Recording evidence of completing and verifying a manufacturing, I
insoection, or test operation (REA QA'i, Section 10.1, QASE, p. 5, Par.
4.3.1.11. ; p. 5, Par. 4.3.1.16. ; p, 5, Par. 4.3.1.17. ; p. 7, Par. 4.3.2.5. ;
- p. 7, Par. 4.3.2.7. ; p. 7, Par. 4.3.2.8;. ; and p. 8, Par. 4.3.3.8 through 4.3.3.11.).
f.
Recording inspector or data recorder and the results of the inspection operation (REA QAM, Section 10.1, QASE, p. 8, Par. 4.3.3.9. and p. 9, Par. 4.3.3.14.).
43.
Inspectors are qualified in accordance with applicable codes, standards, and company training programs; and their qualifications and certifica-tions are kept current. (REA QAM, Section 10.1, p.1, " General").
- 44. Measuring and test equipment is traceable to the calibration te:t data (REA QAM, Section 12.1, p. 2, Par. 4.2.l.l. ).
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f B-18 I
- 45. Measuring and test equipment is labeled or tagged to indicate date of next calibration (REA QAM, Section 12.1, p. 2, Par. 4.2.1.1.).
- 46. 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 (REA QAM, Section 12.1, p.1, Par. 4.1.1. and p. 2, Pa r. 4. 2.1. 3. ).
- 47. The maximum uncertainty (error) of calibrating standards will be 1/4 of the tolerance of the equipment being calibrated, unless limited by the state-of-the-art (REA QAM, Section 12.1, p.1, Par. 4.1.1. and I
QASE, Par. 4.3.1.2. ).
- 48. The complete status of all items under the calibration system is recorded and maintained (REA QAM, Section 12.1, p. 1, Par. 4.1.1.).
49.
Reference and transfer standards are traceable to nationally recognized standards (NBS); or where national standards do not exist, provisions are established to document the basis for calibration (REA QAM, Section 12.1, p. 1, Pa r. 4.1.1. ).
50.
By-passing of required inspections, tests, and other critical operations I
shall be procedurally controlled under the cognizance of the QA Organization (REA QAM 12.1, Par. 4.2.1.1.).
51.
Documentation will identify the nonconforming item; describe the non-confonnance, the disposition of the nonconfromance, and the inspection requirements; and include signature approval of the disposition (REA QAM, Section 15.1, p. 2, Par. '4.1.2. ).
- 52. The Material Review Board is responsible and has the authority for the
'I disposition and approval of nonconforming items (REA QAM, Section 15.1,
- p. 2, Par. 4.1. 3.4. ). The Material Review Board is composed of at least one member from Quality Control and one from Engineering (REA QAM, Section 15.!, QASE, p. 4, Par. 4.3.2.4. ).
L
B-19 I
53.
flonconforming items shall be segregated from acceptable items and identified as discrepant until properly disposed.
54.
The acceptance of the reworked or repaired materials, parts, components, I
systems, and structures shall be verified by reinspection and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method (REA QAM, Section 15.1, p. 2, Par. 4.1. 3.3. ).
55.
flanconformance reports with disposition recommendations of " accept as is" or " repair" are made part of the inspection records and forwarded with the hardware to REA for review and assessment (REA QAM, Section 15.1, p. 2, Par. 4.1. 3. 4. ).
56.
fionconformance reports are periodically analyzed by the REA QA Organiza-tion to show quality trends, and the results are reported to management (REA President and/or Management Quality Assurance Committee) for review and assessment (REA QAM, Section 15.1, p. 2, Par. 4.2. and QASE,
- p. ?, Par. 4. 3.1.1. 8. and p. 4, Pa r. 4. 3.1. 5. ).
57.
Follow-up reviews shall be conducted to verify proper implementation of corrective actions and to close out the corrective action documenta-I tion (REA QAM, Section 16.1, p.1, Par. 4.l.).
58.
Records shail be stored in a facility constructed, located, and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature and humidity (REA QAM, Section 17.1, p.1).
- 59. Audits will be regularly scheduled on the basis of the status and safety importance of the activities being performed, and they will be initiated sufficiently early to assure effective quality assurance during the design, procurement, and contracting activities (REA QAM, Section 18.1,
- p. 2, Procedure Par. 5.1.).
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I B-20 I
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i
- 60. Audit data shall be analyzed and reports, which indicate quality trends and the effectiveness of the QA program, shall be reported to REA President and/or Management QA Review Co=.ittee for review and assessment (REA QAM, Section 18.1, p. 1).
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