ML20213E512
| ML20213E512 | |
| Person / Time | |
|---|---|
| Site: | 07100614 |
| Issue date: | 10/28/1986 |
| From: | NUS CORP. |
| To: | |
| Shared Package | |
| ML20213E478 | List: |
| References | |
| NUDOCS 8611130198 | |
| Download: ML20213E512 (78) | |
Text
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O ENGINEERING DIVISION QA MANUAL FOR DESIGN, FABRICATION, ASSEMBLY, AND TESTING OF PACKAGING USED IN THE TRANSPORT OF RADIOACnv.ts MATERIAL i
O Prepared by MJS Corporation 910 Clopper Road Gaithersburg, Maryland 20878-1399 October 28,1988 O
8611130198 M O PDR ADOCK PDR D
i SECTioN REVISION EFFECTIVE DATE PAGE i_
[-s gg,_,_g; iATION A
0 10/28/86 1 of 1 ENGINEERING DIVISION TITLE Engineering Division QA Miinual for Design MGINEERING DMSION rabrication, Assembly and Testing or eackaging QUALITY ASSURANCE MANUAL Used in the Transport of Radioactive Material Custody Form 1
The Engineering Division Director of Quality Assurance has authorized assignment of the noted copy (copies) of this manual to the custody of the person named below:
Name Organization bi O
Copy Number Date of Assignment Controlled Uncontrolled APPRoV E D APPROVED p h 9 % L J asda T
/
n, t otals, 2
DIRECTOR OF QUALITY ASSURANCE DATE V/ E P[ESIDENT AND GENER AL MANAGER DhTE' v
SECTION REVISloN EFFECTIVE DATE PAGE I
'l B
0 10/28/86 1 of 2 V
CCFN:ORADON ENGINEERING DIVISION TITLE ENGINEERING DIVISION Engineering Division QA Manual for Design Fabrication, Assembly, and Testing of Packaging QUALITY ASSURANCE MANUAL used in the Transport of Radioactive Material TABLE OF CONTENTS Section Title Revision A
Custody Form 0
B Table of Conteats O
C Policy Statement 0
D Revision and Control of Quality Assurance O
Manual E
Regulatory Compliance 0
F Glossary 0
1.0 Organization 0
2.0 Quality Assurance Program 0
V) 3.0 Package Design Control 0
4.0 Procurement Document Control 0
5.0 Instructions, Procedures, and Drawings 0
6.0 Document Control 0
7.0 Control of Purchased Material, Equipment, 0
and Services 8.0 Identification and Control of Materials, O
Parts, and Components 9.0 Control of Special Processes 0
10.0 Internal Inspection 0
11.0 Test Control 0
12.0 Control of Measuring and Test Equipment 0
13.0 Handling, Storage, and Shipping 0
i 14.0 Insoection. Test. and Ooeratinn Status O
APPROVED APPROVED f
VICE[ RESIDE'NT AND' GENERAL MANAGER ATE' DIRECTOR OF QUALITY ASSURANCE DATE L/
s"t*a
- Design Fabrication, Assem.
Rmen EHutw Date Pege bly, and Testing of Packaging Used in the Transport of Rad-0 10/28/86 2 of 2 loactive Material i
TABLE OF CONTENTS (Continued)
Section Title Revision 15.0 Nonconforming Materials, Parts, O
Components, or Services l
16.0 Corrective Action 0
17.0 Quality Assurance Records 0
18.0 Audits 0
N O
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SECTioN REVISION EFFECTIVE DATE PAGE C
0 10/28/86 1 of 2
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CO+G ATION ENGINEERING DIVISION TITLE ENGINEERING DMSION
.cy Ratemed o
QUALITY ASSURANCE MANUAL It is the policy of NUS Engineering Division (NUSED) to perform its work profes-sionally and consistently to achieve a quality level which meets or exceeds estab-lished requirements. NUSED quality assurance policy insists on compliance with the provisions of this manual, its subtier procedures, and project-specific qual-ity assurance plans. The NUSED Quality Assurance Manual and implementing proce-dures, as supplemented by project-specific quality assurance plans, apply to all quality-affecting activities performed by the Division. Compliance with specific regulatory requirements, codes, and standards for quality-affecting activities shall be as indicated in Section E of this manual.
The NUSED Vice-President and General Manager has the overall responsibility for ensuring that the quality assurance program is maintained and implemented. He has appointed the NUSED Director of Quality Assurance as the individual responsible
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for directing efforts for (1) implementing and revising the provisions of the quality assurance program and (2) regularly assessing the scope, status, implemen-tation, and ef fectiveness of the quality assurance program.
In keeping with this delegation of authority, the NUSED Vice-President and General Manager has granted the NUSED Director of Quality Assurance the authority, access, and organizational freedom to:
e Identify quality problems.
s Initiate actions to resolve those problems.
e Verify the implementation of solutions to those problems.
e Control further processing, use, delivery, or installation of non-conforming conditions or items until proper disposition has been made and corrective action, when determined necessary, has been completed, n
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APPROV E D APPROVED
&lu.-,sc w uksu of olak DIRECTOR OF QUALITY ASSURANCE DATE VICF/f}E'SIDENf AND G'EN ER AL MAN AGER
'OATE t/
SectNm Title Rowseon Effectwo Date Page C
Policy Statement 0
10/28/86 2 of 2 Compliance with the requirements of the NUSED quality assurance program is required of all NUSED employees through the implementation of requirements applicable to their work and through support of the Director of Quality Assurance in complet.ing his assigned responsibilities.
O I, 7(2n..--
J
. Stone Vice-President and General Manager O
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_ _ _ _ _, _ _ _., _ _ _. _ _ _ _ _ _ _ _ _ _ _. -. _ _ _ _ _ - 1
SECTioN REVISION EFFECTIVE DATE PAGE
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10/28/86 1 of 3 CLA A RATION sv ENGINEERING OlVISION TITLE ENGINESING DMS10N Revision and Control of Quality Assurance Manual QUALITY ASSURANCE MANUAL The preparation, control, issuance, and revision of the Quality Assurance Manual are under the direction of the Director of Quality Assurance. The manual and its revisions are approved by the Vice President and General Manager of the Engineer-ing Division. Evidence of these approvals is shown by signatures appearing on the first page of each major subdivision of the Manual and on each advance change notice (ACN) that is issued.
The ACN authorizes an interim change until a revi-sion of the applicable subdivision of the manual can be accomplished.
This manual is identified on the title page by effective date. Approved changes are made subdivisions of the Manual and status is shown and controlled in the Table of Contents.
The revision indicator and issue date for the revision are marked on each page of each subdivision of the manual, and changes are shown by annotating the text margin with the applicable revision number and appropriate
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sidelining. Each copy of the Jianual shall be serialized as issued and as shown on the Custody Form; each shall remain the property of NUS.
The Director of Quality Assurance shall establish an approved distribution for issuance of the manual.
The responsibility for issuance of the manual will be discharged by the document control clerk, who shall utilize a Document Transmittal Record (DTR) (Figure 1) to issue controlled copies as authorized by the approved distribution.
The document control clerk shall transmit ACN's, revisions, and the Record of Revision to holders of controlled copies; the document control clerk may provide revised material upon request from holders of uncontrolled copies.
Holders of controlled copies shall sign and return the acknowledgment copy of the DTR to the document control clerk within 30 days.
The holder shall show on the acknowledgment copy of the DTR that the previous version of the material either has been marked "0BSOLETE" or " SUPERSEDED" or has been destroyed.
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APPROV E D APPROVED Q&!
fi UM. L 7?
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lO E[ESIDENT Ar[o GENERAL MANAGER
' D AT'E DIRECTOR OF QUALITY AS5uRANCE oATE vt
Sectum Title Revie.on Effectwo Date Page D
Revision and Control of 0
10/28/86 2 of 3
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Quality Assurance Manual If the holder's acknowledgment of updating of a controlled copy on external dis-tribution has not been received within 30 days after transmittal, the document control clerk shall inform the Director of Quality Assurance, who will contact the holder to obtain acknowledgment of receipt.
Section Title Rows on Effectrue Date Page D
Revision and Control of 0
10/28/86 3 of 3 Quality Assurance Manual Figure 1 NUS DOCUMENT TRANSMITTAL RECORD CONTRACT:
TRANSMITTAL NO.:
DATE:
TO:
NAME TITLE COMPANY NAME AND ADDRESS
SUBJECT:
SUBJECT IS:
PLEASE:
ORAWINGS PRE LIMIN ARY COMMENT SPECIPICATIONS ISSUED FOR APPROVAL APPROVE CHANGE NOTICE APPROVED FOR CONSTRUCTION FILE FOR RECORD CE RTIFIE O DESTROY PREVIOUS REVISION k
OESCRIPTION/
ITEM REV OATE REMARKS RETURN TO: NuG CORPORAf TON DISTRisuTION TRANS ATTACH.
910 CLOPPER ROAO GAITNERSsURG.MO. 20075 enn: DOCUMENT CONTROL CLERK RETURN THIS COPY TO SENDE R
- 0.e.
~ te has been renewed en sfus este:
Prevenue asness have been merlied
- De80LETE*, *1UPERSEDED".
er have been destroyed.
SENDER:
Siened:
DCC 014 (609)
SECTioN REVIStoN EFFECTIVE oATE PAGE E
O 10/28/86 1 of 3 T"N V
-FiATON ENGINEERING DIVISION ENGINEERING DMSION hegui e ry Compliance QUALITY ASSURANCE MANUAL
~
1.0 Compliance This NUS Engineering Division (NUSED) QA Program Manual, established for the j
design, fabrication, assembly, and testing of packaging used in the transport of radioactive material complies with the following regulatory requirements and the applicable codes and standards referenced therein.
U.S. NRC Code of Federal Regulations, Title 10, Part 71, (10CFR71) o
" Packaging and Transportation of Radioactive Material," Subpart H,
" Quality Assurance," Paragraphs 71.103 through 71.137.
U.S. NRC Regulatory Guide 7.10, " Establishing Quality Assurance Programs o
for Packaging Used in the Transport of Radioactive Material," Annex 1,
" Quality Assurance Programs Applicable to the Design, Fabrication, Assen-
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bly and Testing of Packaging Used in Transport of Radioactive Material."
U.S. NRC Code of Federal Regulations, Title 10, Part 21 (10 CFR 21) o
" Reporting of Defects and Noncompliance."
ANSI /ASME - NQA-7, " Quality Assurance Program Requirements for Nuclear o
Facilities."
2.0 Other Requirerents In the event that client procurement documents impose the provisions of regulatory or agency documents or society codes and standards for NUSED work other than those identified herein, sudi edditional requirements will be addressed and complied with using the project-specific Quality Assurance Plan which is described in Section 2.0 of this manual.
V APPROVED APPROVED t d A.
dr k k i n a hek..
T / 1/ W sel2g/8, olRECToR OF QUALITY ASSURANCE oATE (Cj PRESIDENT AbD GENERAL MANAGER
'DATE
i SectHm
' Title n,,,seen Effective Date Page E
Regulatory Compliance 0
10/28/86 2 of 3 3.0 Demonstrated Compliance Section 2.0 of this manual describes the overall structure and component parts of this NUSED QA Manual.
10CFR71 Subpart H requirements 71.103 through 71.137 are individually addressed within the QA Manual sections 1.0 through 18.0 and supple-mented by the detailed requirements of the associated EDP provisions.
The attached Matrix, Figure 2, provides an easy reference for identifying NUSED procedures and QA Manual sections as they apply to various regulatory require-ments, and society standards.
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section Title Rev'seOn Effective Date Page E
Regulatory Compliance 0
10/28/86 3 of 3
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SECTioN REVIStoN EFFECTIVE DATE PAGE F
0 10/28/86 1 of 6 CORPORATION ENGINEERING DIV?S!ON ENGINEERING DMS10N classary OUALITY ASSURANCE MANUAL Purpose The purpose of this section is to define certain quality-related terms that are used in this manual and its supporting procedures, and to describe the supporting procedures associated with these terms.
Terms and Definitions Acceptance criteria.
Specified limits placed on characteristics of an item, process, or sr evice defined in ecdes, standards, or other requirement documents.
Approved supplier. A supplier that has been evaluated and found capable of supplying particular items or services.
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Audit.
A planned and documented activity performed to determine, by investiga-tion, examination, or evaluation of objective evidence, the adequacy of a product or service; its compliance with established procedures, instructions, drawings, and other applicable documents; and the effectiveness of its implementation. An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance.
1 Certificate of conformance.
A document signed by an authorized individual certi-fying the degree to which items or services meet specified requirements.
Certification.
The act of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with specified requirements.
Characteristic.
Any property or attribute of an item process or service that is distinct, describable, and measurable.
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APPROVED APPROV E D f/l 1.LLI C4
/6 C $
k, f0 otRECTOR OF QUALITY ASSURANCE DATE VICE[R$SIDENT A'ND GErkERAL MANAGER
'DATE L/
Secturn Title Roweson Effectrve Date Page F
Glossary 0
10/28/86 2 of 6 Condition adverse to quality.
An all-inclusive term used in reference to any of the following:
failures, malfunctions, deficiencies, defective items, and noncon-formances. A significant condition adverse to quality is one which, if uncor-rected, could have a serious effect on safety or operability.
Corrective action.
Measures taken to rectify conditions adverse to quality and to preclude repetition.
Design input.
Those criteria, parameters, bases, or other design requirements upon which detailed, final design is based.
Design process.
Technical and management processes that commence with identifi-cation of design input and lead to and include the issuance of design output documents.
Deviation.
A departure from specified requirements.
O Document.
Any written or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results. A document is not considered to be a quality assurance record until it satisfies the definition of a quality assurance record as defined in this section.
External audit.
An audit of those portions of another organization's quality assurance program not under the direct control or within the organizational struc-ture of the auditing organization.
Final design.
Approved design output documents and approved changes thereto.
Guideline.
A suggested practice that is not mandatory in programs intended to comply with a standard.
The word should denotes a guideline, and the word shall denotes a requirement.
Inspection.
Examination or measurement to verify whethei or not an item or activity conforms to specified requirements.
Section Title Rome.on Effectme Date Page
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Glossary 0
10/28/86 3 of 6 v]
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4 Inspector.
A person who performs inspection activities to verify conformance to l
specific requirements.
Internal audit.
An audit of those portions of an organization's quality assur-ance program retained under its direct control and within its organizational structure.
Item.
An all-inclusive term used in place of any of the following: appurte-nance, assembly, component, equipment, material, module, part, structure, subas-sembly, subsystem, system, or unit.
Heasuring and test equipment (M&TE).
Devices or systems used to calibrate, meas-ure, gauge, test, or inspect in order to control or acquire data to verify con-formance to specified requirements.
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Nonconformance.
A deficiency in characteristic, documentation, or procedure that
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renders the quality of an item or activity unacceptable or indeterminate.
Objective evidence.
Any documented statement of fact, other information, or record, either quantitative or qualitative, pertaining to the quality of an item or service, based on observations, measurements, or tests which can be verified.
Package.
The packaging together with its radioactive contents as presented for transport.
Packaging.
The assembly of components necessary to ensure compliance with the packaging requirements of 10CFR71.
It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks.
l Procedure.
A written requirement that specifies or describes how an activity is to be performed.
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Purchase requisitions, purchase orders, drawings, con-s tracts, specifications, or instructions used to define requirements for purchase.
Section Titse Revieeon Effectrve Date Page Q
F Glossary 0
10/28/86 4 of 6 N/'
Project.
An activity having characteristics which differentiate it from other assignments, such as administration, sales, purchasing, clerical work, and quality assurance activities.
Common characteristics are:
o A specific, unique work assignment is to be performed, usually with a defined cost, scope, and schedule, o A particular client is identified, either external or internal.
o An individual is assigned to overse,e or manage the assignment.
Project QA plan. A document which provides the technical, administrative, and quality requirements and guidance necessary for the successful completion of the project.
p Qualification (personnel).
The characteristics or abilities gained through
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education, training, or experience, as measured against established requirements such as standards or tests, that qualify an individual to perform a required function.
Qualified procedure.
An approved procedure that has been demonstrated to meet the specified requirements for its intended purpose.
Quality-affecting activities or items.
Those features of a structure, system component, or services under the control of the QA program which are necessary to ensure its integrity or its capability to prevent or mitigate the consequences that could result from release of radioactive material.
These include training of personnel, designing, fabricating, purchasing, handling, storing, shipping, cleaning, installing, repairing, modifying, operating, inspecting, and testing.
j Quality assurance (QA).
All those planned and systematic actions necessary to l
l provide adequate confidence that a structure, system, or component will perform satisfactorily in service.
V Quality assurance record.
A completed and approved document that furnishes
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evidence of the quality of items and/or activities affecting quality.
Section Title Reneson Effectwo Date Pege
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F Glossary 0
10/28/86 5 of 6 b;
Repair.
The process of restoring a nonconforming characteristic to a condition such that the capability or an item to function reliably and safely is unimpaired, even though that item still does not conform to the original requirement.
Rework.
The process by which an item is made to conform to original requirements by completion or correction.
Rights of access.
The right of a purchaser or designated representative to enter the premises of a supplier for the purpose of inspection, surveillance, or quality assurance audit.
Service.
The performance of activities such as design, fabrication, inspection, nondestructive examination, training, repair, or installation.
Special process.
A process, the results of which are highly dependent on the g'~g control of the process or the skill of the operators, or both, and in which the v
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specified quality cannot be readily determined by inspection or testing of the p roduct.
Supplier.
Any individual or organization that furnishes items or services in accordance with a procurement document; it is an all-inclusive term used in place of any of the following: vendor, seller, contractor, subcontractor or his supplier, fabricator, or consultant.
Surveillance.
The act of monitoring or observing to verify whether or not an item or activity conforms to specified requirements.
Testing.
An element of verification for the determination of the capability of an item to meet specified requirements by subjecting the item to a set of physi-cal, chemical, environmental, or operating conditions.
T raceability.
The ability to trace the history, application, or location of an i
item and like items or activities by means of recorded identification.
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Use-as-is.
A disposition permitted for a nonconforming item when it can be established that the item is satisfactory for its intended use.
Section Title Revieeon Effectrve Date Page F
Glossary 0
10/28/86 6 of 6
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Verification.
The act of reviewing, inspecting, testing, checking, auditing, or otherwise determining whether or not items, processes, services, or documents j
1 conform to specified requirements.
Waiver.
Documented authorization to depart from specified requirements, j
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SECTioN REVISloN EFFECTIVE DATE PAGE L
pd 1.0 0
10/28/86 1 of 10 CORPORATION ENGINEERING DIVISION ENGINEERING DMS10N Organization QUALITY ASSURANCE MANUAL I
1.1 General Requirements l
1.1.1 The authority and duties of persons and organizations performing activities affecting quality shall be clearly established and deline-ated in writing.
1.1.2 The work of establishing and executing the quality assurance program or any part of the program may be delegated to others, such as con-tractors, agents, or consultants, but NUS Engineering Division (NUSED) shall retain responsibility for the program.
1.1.3 Activities affecting quality include performing the functions associ-ated with attaining quality objectives and the quality assurance func-0) tions.
The quality assurance functions are (1) ensuring that an (v
appropriate quality assurance program is established and effectively executed and (2) verifying, through methods such as checking, auditing, and inspection, that activities affecting quality have been correctly performed.
1.1.4 The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions.
1.1.5 The persons and organizations performing quality assurance functions shall report to a management level which ensures that the required authority and organizational freedom, including sufficient independ-ence from cost and schedule when opposed to safety considerations, are provided.
APPROVED APPROVED Jt_da~
ar TW ss DIRECTOR OF QUALITY ASSURANCE DATE VhPRESIDENT AND GENERAL MANAGER
'oATE v
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section Title Roweson Effectwe Date Pege O) 1.0 Organization 0
10/28/86 2 of 10 tv 1.1.6 Irrespective of the organizational structure, the individuals assigned the responsibility for ensuring effective execution of any portion of the quality assurance program et any location where activities subject to this section are being performed must have direct access to the levels of management necessary to perform this function.
1.2 References 1.2.1 10CFR71, Subpart H, " Packaging and Transportation of Radioactive Material Quality Assurance."
1.2.2 ANSI /ASME NQA-1, " Quality Assurance Program Requirements for Nuclear Facilities."
1.2.3 USNRC Regulatory Guide 7.10, " Establishing QA Programs for Packaging Used in the Transport of Radioactive Materials."
v 1.2.4 10CFR21, " Reporting of Defects and Noncompliance."
1.3 NUS Engineering Division Quality Organization The NUS Engineering Division organization structure and assignment of responsibilities are as follows:
1.3.1 The relationship of the Director of Quality Assurance, Engineering to the NUSED organization and lines of authority are shown in Figure 1.
Figure 2 presents a functional project organization.
Together, Fig-ures 1 and 2 identify the organizational elements of NUSED. All personnel involved function under this NUSED QA Program as it applies to design, fabrication, assembly, and testing of packaging used in the transport of radioactive materials.
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1.3.2 It is NUS policy to perform work in accordance with the requirements v
of the applicable regulatory requirements, codes, and standards speci-fled in contractual documents.
Section Title Remeson Effectrve Date Page (O) 1.0 Organization 0
10/28/86 3 of 10 v
In keeping with this policy, the NUSED Vice President and General Manager has committed to providing top management support and organi-zational freedom to the quality assurance organization.
It is his primary obligation to ensure that the provisions of this QA program are fully implemented and enforced. He ensures that personnel responsible for quality-related activities are independent of those directly responsible for performing the work.
1.3.3 The Director of Quality Assurance, Engineering is responsible for the quality assurance program and for ensuring its correct implementa-tion.
In carrying out his assigned responsibilities, he shall have access to all levels of management and to all work areas or loca-tions.
He shall have sufficient authority and organizational freedom to (1) identify quality problems; (2) initiate, recommend, or provide solutions to quality problems; (3) verify implementation of the solu-73 tions; and (4) prevent further processing, delivery, installation, or use of nonconforming items until proper disposition or corrective action has taken place.
The Director of Quality Assurance, Engineer-ing is further responsible for assigning qualified individuals to perform required quality control and inspection activities.
To be qualified for the position of Director of Quality Assurance, Engineering, an individual's abilities shall be evaluated on a case-by-case basis and approved and documented by the Vice President and General Manager, Engineering.
The positive factors which may be considered in making the evaluation of candidates as a demonstration of their abilities include the following:
o Academic and related technical training.
o High school diploma or GED.
l rw o Four years' experience in the field of quality assurance, or an equivalent number of years' work experience in a supervisory posi-tion, or a combination of the two.
At least one year of this four
section Title floweseon Effectrve Date Page (n) 1.0 Organization 0
10/28/86 4 of 10 v
years' experience shall be nuclear power-related experience in the implementation of a quality assurance program.
Demonstrated ability to communicate clearly (orally and in o
writing).
o Certification of academic ability and knowledge by corporate management.
Successful completion of lead auditor and/or inspection training o
and associated certification.
1.3.4 NUSED personnel assigned to perform quality assurance, quality control, inspection, or testing functions shall have experience and training in the performance of required inspections and tests and in f_J the organization, evaluation, and review of results of inspection and tests.
They shall be capable of supervising or maintaining surveil-lance over inspections and tests performed by others, and of cali-brating or establishing the validity of calibration of inspection and measuring equipment.
They shall have demonstrated proficiency in planning and setting up tests and shall be capable of determining the validity of test results.
1.4 QA Organizational Responsibilities The organizational structure and assignnent of functional responsibility within NUSED are based on recognition of quality assurance as an interdis-ciplinary function with quality-affecting activities being performed by many individuals from top-level management down to individual contributors and project personnel.
The functional responsibilities are such that:
1 Attainment of quality objectives is accomplished by individuals assigned o
/
responsibility for performing work to specifications.
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o Verification of conformance to established quality requirements is accom-plished by those who do not have direct responsibility for the work.
Secten Title Reveeson Effectrve Date Page
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(G) 1.0 Organization 0
10/28/86 5 of 10 o Personnel in quality assurance functions have direct access to top-level management.
1.4.1 The President and General Manager:
o Is responsible for the technical and administrative direction of all work being managed by or within the Division.
o Has overall responsibility for work performance and quality.
o Delegates authority to accomplish the work to the various managers within the division.
o Provides management, support, and organizational freedom to the quality assurance organization.
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o Ensures that personnel responsible for quality-related activities are independent of those directly responsible for performing the work.
1.4.2 The Director of Quality Assurance, Engineering:
o Plans, develops, and with the concurrence of the Vice President and General Manager, establishes general policies and procedures for quality assurance, o Issues and maintains this Quality Assurance Manual and the Engi-neering Division Procedures Manual (EDP) and Quality Assurance Procedures (QAPs).
o Reviews and approves, when found acceptable, all procedures to l
ensure that they meet applicable quality requirements.
l Reviews all Project QA Plans to ensure that they contain appropri-o ate provisions for meeting NUSED and client quality requirements.
Section Title Revie.on Effectwo Date Poes (7
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1.0 Organization 0
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o Reviews all technical procurement documents for proper inclusion of quality requirements.
o Provides for vendor surveillance audit and approval as may be appropriate. Maintains a list of approved suppliers.
o Performs audits to evaluate the status, adequacy, and effectiveness of the quality assurance program.
o Ensures that corrective action is taken in areas found to be defi-cient during quality assurance audits.
o Ensures that personnel involved in quality-related activities are properly trained in the applicable quality assurance program requirements.
k
o Coordinates quality control activities to ensure that all specifi-cations and quality requirements are met, o Directs the gathering and filing of quality assurance records.
o Ensures the proper documentation of welding procedure qualification reports.
u Ensures that required nondestructive examination (NDE) personnel records are on file and that NDE procedures meet quality assurance requirements as required by contracts.
o Prepares and controls nonconformance reports and approves the resolution of nonconforming items.
1.4.3 The Quality Assurance Engineer / Analyst:
l b o Conducts audits and surveillances, performs and documents inspec-l tions and examinations, and witnesses tests.
Section Title Reveseon Effecteve oote Pego
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o Performs design document reviews.
o Performs other duties assigned by the Director of Quality Assurance.
1.4.4 Document Control Clerk:
o Responsible for the accountability, storage and maintenance of quality assurance documents.
o Responsible for the distribution and control of Controlled Documents.
1.4.5 NUS Corporate Purchasing:
(
o Responsible for the procurement of Code and safety-related items to support division activities.
o Issues formal inquiries and accepts bids.
o Coordinates the evaluation of bids with project managers and QA.
o Issues purchase orders.
1.4.6 Director of Projects:
o Responsible for overall project management.
o Selects and assigns project managers.
o Ensures that Quality Assurance Plans are prepared, reviewed, and issued.
,O V
o Periodically assesses the performance of project managers.
o Ensures corrective action of identified problem areas.
1
Section Title Reviesen Effective Date Pege 1.0 Organization 0
10/28/86 8 of 10 1.4.7 Department Managers:
Assign qualified lead engineers, engineers, and designers from o
their departments to projects.
Responsible for providing technical approval of department work o
performed for projects.
1.4.8 Project Manager:
Responsible for the preparatio, and implementation of the Quality o
Assurance Plan.
I Establishes basic project policy in accordance with project o
requirements.
1
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o Directs all project work.
I Coordinates technical interfaces among various departments.
o o Responsible for prime interface between NUS and client.
1.4.9 Project Staff:
Report to and assist the project manager in the performance of his o
duties.
1 l
1.4.10 Principal Contractor:
the activities of principal contractors for packaging shall be o
controlled by the NUSED procurement documents and conducted in accordance with an NRC-approved QA program.
Responsible for imposing procurement document quality provisions on o
subtier suppliers.
Section Title Revieeon Effective Date Page O
1.0 Organization 0
10/28/86 9 Of 10 Y
Figure 3 FIGURE 3. NUS CORPORATION ENGINEERING DtVISION ORGANIZATION CHART VICE PRESIDENT AND GENERAL MANAGER ENGINEERING DIVISION I
ASS 88 TANT GENERAL MANAGER DIRECTOR DIRECTOR.
AND DIRECTOR OF QUALITY F ACILITIES OF PROJECTS ASSURANCE ENGINEERING I
PROJECT MANAGE RS p
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l ASSURANCE DOCUMENT PROJECT PROJECT ENG EERS CONTROL STAFF ENGINEERS AUDITORS I
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SECTioN REVISION EFFECTIVE DATE PAGE 2.0 0
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)
L.XJHH AATION
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ENGINEERING OlVISION TITLE ENGINEERING DMS10N Quality Assurance Program OUALITY ASSURANCE MANUAL 2.1 General Requirements 2.1.1 The quality assurance program shall be documented by written policies, procedures, or instructions and shall be carried out throughout the life of the activities to which it applies in accordance with those policies, procedures, or instructions.
2.1.2 Measures shall be established for identifying (1) the components, 1
structures, and systems to be covered by the QA program and (2) the I
approach used for verifying that the applicable components, struc-tures, and systems meet design objectives.
1 2.1.3 The quality assurance program shall provide control over the activi-l
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ties affecting the quality and safety of the identified structures,
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systems, components, and services to the extent necessary to ensure that the itens will perform satisfactorily in service. With specific reference to packaging, the quality assurance program shall provide l
controls as necessary to ensure conformance to the approved design of each individual package used for the shipment of radioactive material.
2.1.4 Activities affecting quality shall be controlled under suitably con-trolled conditions to ensure that, as applicable, appropriate equip-ment is used, environmental i.onditions such as adequate cleanliness are provided for, and that ai cerequisites for the given activity I
l have been satisfied.
2.1.5 The quality assurance 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 testing.
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j APPROVE D APPROVED 0
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b DIRECTOR OF OuALITY ASSuR ANCE DATE VipE/ PRESIDENT AND bENERAL MANAGER DATE v
Section Title Roweson Effectrve oete Pege
/~N 2.0 Quality Assurance Program 0
10/28/86 2 of 9 V) i 2.1.6 The quality assurance program shall provide for indoctrination and training of personnel performing activities affecting quality, as necessary, to ensure that suitable proficiency is achieved and maintained.
2.1.7 The status and adequacy of the quality assurance program shall be regularly reviewed by NUSED management.
2.2 Re ferences 2.2.1 10CFR71, Subpart H, " Packaging and Transportation of Radioactive Material Quality Assurance."
2.2.2 ANSI /ASME NQA-1, " Quality Assurance Program Requirements for Nuclear Facilities."
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2.2.3 USNRC Regulatory Guide 7.10, " Establishing QA Programs for Packaging Used in the Transport of Radioactive Materials."
2.2.4 10CFR21, " Reporting of Defects and Noncompliance."
2.2.5 EDP 20.0, " Personnel Training."
2.3 Program Description NUSED has established a quality assurance program which provides controls over the activities of NUSED employees, each of whom has specific responsi-bilities for meeting the required quality objectives.
The program consists of several component parts which collectively provide for conducting activities affecting quality.
2.3.1 Program Structure / Component Parts The progran has been structured to address the common requirements of several regulatory requirements and regulatory endorsed industry codes and standards as they may be applicable to specific NUSED activities
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Q 2.0 Quality Assurance Program 0
10/28/86 3 of 9 V
performed during the design, fabrication, assembly and testing of packaging used in the transport of radioactive material.
A.
NUSED QA Manual The NUSED QA Manual identifies the overall quality assurance requirements for the conduct of the activities performed during the design, fabrication, assembly and testing of packaging used in the transport of radioactive materials.
The manual is divided into eighteen sections, each of which identifies the detailed requirements to be observed for specific quality-affecting activi-ties.
In addition, each manual section identifies the required Engineering Division Procedures (EDP) Quality Assurance Procedures (QAPs) to be observed for the proper implementation of the detailed requirements. A breakdown of overall quality assurance requirements addressed in the manual is as follows:
G Section 1.0, Organization: Provides an overview of the NUSED organization as it relates to quality-affecting activities.
Duties, responsibilities, and reporting lines of organizations performing QA activities are defined.
Section 2.0, Quality Assurance Program: Provides a description of the program established to ensure that quality-affecting activi-ties are. controlled.
Section 3.0 t'ackage Design Control:
Identifies the measures established to ensure that regulatory requirements, design bases, and licensed package designs are correctly translated into speci-fications, drawings, procedures, and instructions.
Section 4.0, Procurement Document Control Identifies the meas-p ures established to ensure that adequate quality is required in b
NUSED procurement documents and in those of its suppliers and subtier suppliers.
1
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Section 5.0, Instructions, Procedures, and Drawings:
Identifies the measures established to ensure that all quality-affecting activities are documented by written requirements of a type appropriate to the circumstances.
Section 6.0, Document Control:
Identifies the measures estab-lished for the control, issuance, and revision of quality-affecting documents.
Section 7.0, Control of Purchased Material, Equipment, and Services:
Identifies the measures established to ensure that purchased items and services conform to procurement document requirements.
Section 8.0, Identification and Control of Materials, Parts, and p
Components:
Identifies the measures established to ensure that V
materials, parts, and components are identified and traceable and that incorrect or deficient items are not inadvertently used.
Section 9.0, Control of Special Processes:
Identifies the measures established to ensure that special processes are con-trolled and accomplished using qualified personnel and procedures meeting specified requirements.
Section 10.0, Internal Inspection:
Identifies the measures established to ensure that structures, systems, and components, including packaging and packaging corrponents, are properly inspected or examined in accordance with the applicable design documents and/or packaged approvals to verify conformance to requirements.
Section 11.0, Test Control Identifies the measures established to ensure that structures, systems, and components, including O
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packaging and packaging components are properly tested in accord-ance with the applicable design documents and/or package approvals
SectMHi Title Reviseen Effectrve Date Page O
2.0 Quality Assurance Program 0
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to demonstrate that the structure, system, component, or package will perform satisfactorily in service.
Section 12.0, Control of Measuring and Test Equipment:
Identifies the measures established to ensure that measuring and test devices used for quality-affecting activities are properly controlled, calibrated, and adjusted.
Section 13.0, Handling, Storage, and Shipping Control Identifies the measures established to ensure that materials and equipment used for quality-affecting activities are properly handled, stored, shipped, cleaned, and preserved.
Section 14.0, Inspection, Test, and Operating Status:
Identifies the measures established to ensure the pecper identification of pg items with regard to the satisfactory completion of inspections
\\d and testing and their operational status.
Section 15.0, Nonconforming Haterials, Parts, or Components:
Identifies the measures established to ensure that nonconforming materials, parts, or components are not inadvertently used or installed.
Section 16.0, Corrective Action:
Identifies the measures estab-lished to ensure that conditions adverse to quality are promptly identified and corrected.
Section 17.0, Quality Assurance Records:
Identifies the measures established to ensure that written records sufficient to furnish evidence of activities affecting quality are properly completed, identified, and retained in a manner consistent with the appli-cable regulatory requirements.
bi V
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Section 18.0, Audits:
Identifies the methods, procedures, and systems established to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program.
B.
Engineering Division Procedures (EDP)
The Vice President and General Manager is responsible for the preparation approval and control of Engineering Division Proce-dures EDP that implement the engineering requiremento of this manual.
The Engineering Division Procedure Manual establishes requirements for the revision, distribution and control of EDP's and the record of revision status of these procedures.
C.
Quality Assurance Procedures b
V Quality Assurance Procedures (QAP's) required to implement the quality assurance requirements of this manual have been developed and approved by the Director of Quality Assurance, Engineering.
These procedures are distributed and controlled to assure that copies are maintained current.
D.
Quality Assurance Plan For each project, the project manager shall, at the earliest practicable time consistent with the schedule for accomplishing Code and safety related activities, prepare and issue a quality assurance plan for the life of the project.
The plan shall be approved by the Director of Engineering, the Director of Projects, the Director of Quality Assurance, and, as appropriate, by the client.
g The plan chall provide or reference as appropriate:
h a.
NUS' contractual relationship for the procurement, i.e.,
independent contractor or " Owner's Agent" or designee.
Secteon Title Reveeson Effectrve Date Page (O
2.0 Quality Assurance Program 0
10/28/86 7 of 9 t
1 V'
b.
Scope of work to be accomplished by NUS.
c.
Identification of the major structures, systems and components to be covered by the quality assurance program.
d.
An organization chart defining key project personnel and reflecting interfaces between the participating NUS design and client organizations, e.
Applicability of this manual, the Engineering Division Proce-dures and quality assurance procedures to the project and inclusion of any client specified supplemental criteria, including types of records, their retention time, and iden-tification requirements.
f.
Method of specifying quality assurance system requirements in V
specifications where item or service is not to be procured by NUS.
g.
Special procedures (if any) for the control of field change requests.
h.
Provisions for the imposition of standards, special processes, procedures, and controls which may be necessary during the design, fabrication, and procurement of equipment to assure defined quality levels. For projects involving the imposition of Code requirements, the Plan shall establish the effective Code Edition, Addenda, and Code Cases to be used for construc-tion which shall be included in the Design Specification.
i.
Any delegations of responsibility defined by this manual.
- 2. 3. 2 Personnel Training and Qualification Engineering Division Procedure Q
EDP 20.0, " Personnel Training" provides measuren for ensuring that
l Section Title Revieson Effectrve Date Page 2.0 Quality Assurance Program 0
10/28/86 8 of 9 d
personnel performing quality-affecting activities receive indoctrina-tion and training commens2 rate with the skill levels required to per-form assigned tasks.
Key project and technical personnel who participate in work on safety related projects shall be trained in " project specific" items, e.g.,
Project Quality Assurance Plan at the time of project commencement.
All Quality Assurance and Project Training shall be documented on forms established in EDP 20.0.
The documentation of training shall be sent to DCC for filling.
Verification of personnel (technical and educational) qualification for their job classification shall be based on the following criteria:
(
o Academic degree (s)
D]
o Years of experience in the field i
o Prior work experience o Professional registration, and o Personal interview (s).
A record af personnel qualification shall be established and filed.
2.3.3 Disputes Disputes involving quality that arise from a difference of opinion between QA/QC personnel and personnel from other organizations shall be resolved through arbitration between the parties involved and the NUSED Vice President and General Manager, O
Section Title Reveeson Effecteve Date Page O) 2.0 Quality Assurance Program 0
10/28/86 9 of 9 2.3.4 Controlled Conditions Measures established by NUSED to ensure that quality-affecting activities are accomplished under controlled conditions include the following:
o The provisions of each section of this Quality Assurance Manual.
o The NUSED administrative, technical, and quality assurance implementing procedures, o The Project QA Plan written for each project, including a list of items important to safety.
2.3.5 Program Review O
The Director of Quality Assurance, Engineering, in conjunction with the Vice President, General Manager, and the key personnel, shall review the status and adequacy of the overall quality assurance pro-gram annually.
Program revisions will be accomplished, as necessary, in accordance with the QA Manual, Section D.
Alternately, the requirements for annual review of the QA program may be satisfied by the NUS corporate QA audits which are performed on an annual basis and which include reviews for program adequacy and pro-gram implementation.
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SECTION REVISloN EFFECTIVE DATE PAGE
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N ENGINEERING DIVISION TITLE ENGINEERING DMSION Package Design Control QUALITY ASSURANCE MANUAL 3.1 General Requirement Measures shall be established and implemented to ensure that applicable regu-latory requirements and the package design, as specified in the license for those materials and components to which 10CFR71 applies, are correctly trans-lated into specifications, drawings, procedures, or instructions.
3.2 References 3.2.1 EDP 1.0, " Design Input Requirements."
3.2.2 EDP 3.0, " Engineering Drawings."
3.2.3 EDP 5.0, "Non ASME Section III Analyses and Verification."
3.2.4 EDP 8.0, " Test Specification and Test."
3.2.5 EDP 9.0, " Document Review."
3.2.6 EDP 11.0, " Documentation of Design."
3.2.7 EDP 18.0, " Preparation of Equipment Specifications."
3.3 Specific Requirements The following specific requirements have been established to implement the general requirement stated above.
3.3.1 Appropriate quality standards shall be identified, documented, reviewed, and approved in accordance with the above referenced documents as applicable.
3.3.2 Changes or deviations from identified quality standards, including the reason or justification for tha changes, shall be identified, approved, documented, and controlled in accordance with EDP 5.0, EDP 9.0, and EDP 11.0 as applicable.
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APPROVED APPROVED k
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DIRECTOR OF QUALITY ASSLJRANCE
' DATE VICf[ESIDENT ANo GENERAL MANAGER DATd L/
Secteen Titse Revessen Effectrue Date Paes O
3.0 Package Design Control 0
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3.3.5 Materials, parts, components, systems, or processes shall be selected
]
and reviewed for the suitability of their intended application in accordance with EDP 1.0, EDP 3.0, and EDP 18.0.
3.3.4 Interfaces between participating design organizations shall be iden-tified, coordinated, and controlled in accordance with EDP 5.0, EDP 9.0, and EDP 11.0 as applicable.
3.3.5 Procedures or instructions shall be established among participating design organizations for the review, approval, release, distribution, and revision of design documents involving design interfaces.
3.3.6 The design documents shall be verified or checked to ensure the adequacy of design by design review, alternate or simplified calcula-tional methods in accordance with EDP 1.0, EDP 3.0, EDP 5.0, EDP 9.0, EDP 11.0, and EDP 18.0 or a suitable test program developed in t
accordance with EDP 8.0 as applicable.
3.3.7 The design shall be verified or checked by someone other than those who performed the original design.
l 3.3.8 The immediate supervisor of the individual who originated the design l
document may perform the verification of design, provided thatt The supervisor is the only one technically capable of performing o
the verification.
I o The need is documented and approved in advance.
QA oudits are performed to prevent abuse of this practice.
o O
l l
Section T6tle Reveeson Effectwo Date Page
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3.0 Package Design Control 0
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l 3.3.9 When a test program is used to verify or check the adequacy of a specific design feature in lieu of other verifying or checking processes, it shall include suitable qualification testing of a l
prototype or semple under the most adverse conditions in accordance 1
with EDP 8.0.
3.3.10 Design parameters, such as criticality physics, radiation shielding, l
stress, cooling, thermal, hydraulic, decontamination, maintenance, repair, inservice inspection, handling, storage, shipping, cleaning, accident analyses, and delineation of acceptance criteria for inspec-tions and tests, as applicable, shall be properly considered, reviewed, and approved by the responsible design organization.
3.3.11 Design changes, including field changes, shall be subject to the same controls applied to the original design in accordance with EDP 9.0.
(N Changes in design that could result in conditions differing from
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those identified on the packaging Certificate of Compliance shall be approved by the NRC prior to implementation.
3.3.12 For design activities performed by others, procurement documents shall require that the design be accomplished under the control of an NRC-approved QA program or the NUSED QA program which is approved by the NRC.
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SECTioN REVISloN EFFECTIVE DATE PAGE l /)
E 4.0 0
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CORPORATON ENGINEERING DlVisl0N ENGINEmlNG DMS10N Procurement Document Control QUALITY ASSURANCE MANUAL 4.1 General Requirement I
Measures shall be established and implemented to ensure that applicable regu-i latory requirements, design bases, and other requirements which are necessary I
to ensure adequate quality are included or referenced in procurement docu-ments for materials, equipment, or services, whether purchased by NUSED, its subcontractors or subtier suppliers.
4.2 References l
4.2.1 QAP 8.0, " Procurement Control."
4.2.2 EDP 18.0, " Preparation of Equipment Specifications."
4.2.3 EDP 21.0, " Procedure for Implementation of the Requirements of l
O' 10CFR21."
\\s 4.3 Specific Requirements l
The following specific requirements have been established to implement the I
general requirement stated above.
l l
4.3.1 The preparation, review, concurrence, approval, and issuance of pro-curement documents shall be in accordance with QAP 8.0.
4.3.2 Procurement documents, including those for spare and replacement parts, and any changes thereto shall be reviewed and documented prior to release by quality assurance and technical disciplines to ensure that appropriate technical and quality assurance requirements are included, and that approved supplier item procurements are placed with previously qualified suppliers in accordance with QAP 8.0.
O APPROVED APPROVED bl.exi/Y A b u I as k s/51 0,,, &
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DIRECTOR OF QUALITY ASSURANCE DATE Vijtk [FISIDENT AND GENERAL MANAGER DATE V
section Title Revieson Effecteve Date Pege 4.0 Procurement Document 0
10/28/86 2 of 3 Control 4.3.3 Procurement documents issued at all tiers of procurement shall contain the following, as applicable, in accordance with QAP 8.0 and/or EDP 18.0.
o Scope of work / item description.
o Technical and regulatory requirements, o Quality assurance program requirements for suppliers and subtier suppliers, Rights of access for inspection and/or audit to supplier and o
subtier suppliers.
o Documentation requirements.
OG o Records to be retained, controlled, and maintained by the supplier and those to be turned over to NUSED prior to installation or use.
o Requirements for reporting and approving disposition of nonconformances.
o Space and replacement parts required.
o Material and component identification requirements.
l 0 Testing and inspection requirements.
o Special process instructions or requirements.
o Handling, storage and shipping requirements.
1 O
Secten Title Reneson Effe6tive Date Page 4.0 Procurement Document 0
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Control o 10CFR21 requirements. Note: The provisions of 10CFR21 are implemented through EDP 21.0.
o Certificates of compliance attesting that the package has been manufactured under the control of an NRC-approved QA program or the NUSED program which has been approved by the NRC.
O O
SECTION REVIStoN EFFECTIVE DATE PAGE o
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5.0 0
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ENGINEERING DIVISION TITLE ENGINEERING DMS10N Instructions, erocedures, and Drawings QUALITY ASSURANCE MANUAL 5.1 General Requirement Measures shall be established and implemented to ensure that all quality-affecting activities are performed in accordance with appropriate documented instructions, procedures, or drawings.
5.2 References 5.2.1 EDP 3.0, " Engineering Drawings."
5.2.2 EDP 8.0, " Test Specifications and Test Procedures."
5.2.3 QAP 6.0, " Procedure Preparation and Control."
5.3 Specific Requirements O
The following specific requirements have been established to implement the general requirement stated above.
5.3.1 Quality-affecting activities shall be performed in accordance with documented instructions, procedures, or drawings prepared and controlled in accordance with EDP 3.0, EDP 8.0, QAP 6.0, and the Project QA Plan.
5.3.2 The specific methods for complying with each of the 18 criteria of 10CFR71, Subpart H shall be specified in the Project QA Plan.
5.3.3 Instructions, procedures, and drawings shall include appropriate quantitative and qualitative acceptance criteria to verify that the activity has been satisfactorily accomplished, g.q kj APPROVE D APPROVED b'-
k MlCV/'d L 1$
mLj on DIRECTOR oF QUALITY ASSURANCE DATE VICp$SIDENT AND GENERAL MANAGER
' OAT $
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sectm Title mene.on Effectrve Date Page O
5.0 Instructions, Procedures 0
10/28/86 2 of 2 and Drawings 5.3.4 Quality assurance shall review and concur with inspection plans, test-ing, calibration, and special processes, operating procedures, instructions, specifications, project plans, and any changes thereto.
Plans for inspection, including maintenance and repair, shall be coordinated with quality assurance personnel to ensure that appropri-ate inspection and hold points are included, as necessary, to verify that the activities have been satisfactorily completed.
O
SECTioN REVIStoN EFFECTIVE DATE PAGE a
i-6.0 0
10/28/86 1 of 2 Cth-e O iATION ENGINEERING DIVISION ENGINEERING DNISION Document Control OU ALITY ASSURANCE MANUAL 6.1 General Requirement Measures shall be established and implemented to control the issuance and revision of quality-affecting documents.
6.2 References 6.2.1 QAP 3.0, " Quality Assurance Records."
6.2.2 QAP 4.0, " Internal Quality Assurance Implementation Audit and Periodic Inspections."
6.2.3 QAP 5.0, " External Quality Assurance Audit."
6.2.4 QAP 6.0, " Procedure Preparation and Control."
6.2.5 QAP 7.0, "Nonconformance and Corrective Action."
(3 6.2.6 QAP 8.0, " Procurement Control."
g 6.2.7 EDP 1.0, " Design Input Requirements."
6.2.8 EDP 3.0, " Engineering Drawings."
6.2.9 EDP 5.0, "Non-ASME Section III Analyses and Verification."
6.2.10 EDP 11.0, " Documentation of Design."
6.2.11 EDP 18.0, " Preparation of Equipment Specifications."
6.2.12 EDP 21.0, " Procedure for the Implementation of the Requirements of 10CFR21."
6.3 Specific Requirements The following specific requirements have been established to implement the general requirement stated above.
6.3.1 Documents which prescribe or affect quality shall be controlled.
The control system shall ensure that all documents are properly identified filed, and retained traceable for the appropriate time specified in qj APPROVED APPROVED k
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10/28/86 2 of 2 J
the contract, purchase order, project plan, or other governing docu-ment; are adequately reviewed and approved prior to issuance; and that current documents are available at the location where the activity is being performed. Document changes other than typographical errors shall be reviewed and approved in the same manner as the original document.
6.3.2 Procedures shall be controlled in accordance with QAP 6.0.
6.3.3 Administrative instructions shall be controlled in accordance with QAP 6.0.
6.3.4 Drawings shall be controlled in accordance with EDP 3.0.
6.3.5 Procurement documents (purchase orders) shall be controlled in accord-('
ance with QAP 8.0.
6.3.6 Design documentation shall be controlled in accordance with EDP 1.0, EDP 5.0, EDP 11.0, and EDP 18.0 as applicable.
6.3.7 This QA Manual shall be controlled in accordance with Section D of this QA Manual.
6.3.8 Nonconformances and corrective action reports shall be controlled in accordance with QAP 4.0, QAP 5.0, QAP 7.0, and EDP 21.0 as applicable.
6.3.9 All quality-affecting documents generated by suppliers shall be controlled in accordance with QAP 8.0 and EDP 18.0 as applicable.
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SECTION REVIStoN EFFECTIVE DATE PAGE b(%
0 10/28/86 1 of 3 CORPORATON ENGINEERING OlVISION ENGINEERING DIVISION control or Purchased Material, Equipment, and QUALITY ASSURANCE MANUAL Services 7.1 General Requirement Measures shall be established ano implemented to ensure that material, equipment, and services purchased either directly or through contractors and' subcontractors conform to the procurement documents.
7.2 References 7.2.1 QAP 3.0, " Quality Assurance Records."
7.2.2 QAP 7.0, "Nonconformance and Corrective Action."
7.2.3 QAP 8.0, " Procurement Control."
wJ 7.2.4 EDP 13.0, " Vendor Print Review."
7.2.5 EDP 18.0, " Preparation of Equipment Specifications."
7.2.6 EDP 21.0, " Procedure for the Implementation of the Requirements of 10CFR21."
7.3 Specific Requirements The following specific requirements have been established to implement the general requirement stated above.
7.3.1 Procurement planning methods shall be described in the Project Quality Assurance Plan. Planning shall determine what is to be accomplished, who is to accomplish it, how it is to be accomplished, and when it is to be accomplished.
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Control of Purchased 7.0 Material, Equipment, 0
10/28/86 2 of 3 and Services v
7.3.2 Selection of procurement sources shall be in accordance with QAP 8.0.
Provisions which shall be considered are:
o The supplier's capability to comply with 10CFR71, Subpart H, or other quality-specifying codes or standards.
o Results of the survey of the supplier's facility and QA program.
o Review of the supplier's previous records and performance.
7.3.3 Bid evaluation and award shall be performed in accordance with QAP 8.0 and contractual requirements. Bid evaluation is performed to determine the extent of conformance to procurement documents.
m 7.3.4 Supplier performance control methods shall be established in accord-ance with QAP 8.0 and, as applicable, EDP 18.0.
7.3.5 The extent of quality assurance and engineering verification activi-ties to be performed during fabrication, inspection, testing, ship-ment, and receipt, including methods of acceptance, shall be estab-lished in accordance with QAP 8.0.
7.3.6 The methods of controlling nonconformances written against the pro-curement shall be established in accordance with QAP 7.0 and EDP 21.0.
7.3.7 Records required in order to identify the items and codes, standards, specifications, drawings, regulations, or other documented require-ments met by the items, including nonconformances, shall be maintained in accordance with QAP 3.0 and EDP 18.0.
Vendor documentation shall be reviewed in accordance with EDP 13.0.
Packaging shall be accom-panied by appropriate documentation as identified in the purchase order prior to use.
These documents shall be referenced in the Certificate of Compliance, shall relate to the use and maintenance of
secten Title Reneen Effective Date Pese Control of Purchased O
7.0 Material, Equipment, 0
10/28/86 3 of 3 and Services the package, and shall identify necessary actions to be taken prior to delivery of the licensed material to a carrier for transport.
7.3.8 Measures, such as source surveillance cnd audits, shall be taken to ensure that the design and fabrication of packaging are performed under the control of an NRC-approved quality assurance program.
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SECTloN REVISloN E F F ECTIVI: DATE PAGE 1-(]
COF-o-GFMTON 8.0 0
10/28/86 1 of 2 ENGINEERING OlVISION TITLE ENGINEBilNG DMS10N rdentirication and Control or Materials, QUALITY ASSURANCE MANUAL Parts, and Components 8.1 General Requirement Measures shall be established to ensure that only correct and accepted items are used or installed.
These measures shall provide for the identification and control of materials, parts, and components.
8.2 References 8.2.1 QAP 8.0, " Procurement Control" 8.2.2 EDP 18.0, " Preparation of Equipment Specifications" 8.3 Specific Requirements V
The following specific requirements have been established to implement the general requirement stated above and shall be imposed on NUS Subcontractors in accordance with QAP 8.0 and/or EDP 18.0.
8.3.1 Physical identification shall be used to the maximum extent possible.
Where physical identification is impossible or impractical, physical separation or procedural control or other appropriate measures shall be established.
8.3.2 Markings, when used, shall be applied using materials and methods which provide a clear and legible identification and do not detri-mentally affect the function or use of the item. Markings shall be transferred to each part of an identified item when subdivided or when the required inspections or tests have not been completed and shall not be obliterated or hidden by surface treatment, processing, or coatings unless other means are substituted, m
APPROVED APPROVED L.
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'DATE DIRECTOR OF QUALITY ASSbRANCE DATE
Section Title Reneson Ettocteve Date Page Identification and Con-3 8.0 trol of Materials, 0
10/28/86 2 of 2
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Parts, and Components 8.3.3 The requirement for identification and traceability of items, such as traceability of an item to a particular specification and grade of material, or to heat, batch, lot, part or serial number, specified tests, inspections, or other activities shall be addecssed in procure-ment documents.
8.3.4 Maintenance of identification on stored items shall be in accordance with the specific handling, storage, or shipping procedures. These measures shall include provisions for replacement, protection, or updating as necessary.
8.3.5 Limited-life items shall be marked to prevent their inadvertent use in accordance with the specific handling, storage, or shipping procedure.
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SECTioN REVIStoN EFFECTIVE DATE PAGE (h
9.0 0
10/28/86 1 of 2 It h F-A TIO N ENGINEERING OlVISION TITLE ENGINEERING DMSION control of Special procesees QUALITY ASSURANCE MANUAL 9.1 General Requirement Measures shall be established and implemented to ensure that quality-affecting special processes, including welding, heat treating, and non-destructive testing, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other specified requirements.
9.2 Re ferences 9.2.1 QAP 8.0, " Procurement Control" 9.2.2 EDP 18.0, " Preparation of Equipment Specifications" m
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9.3 Specific Requirements w/
The following specific requirements have been established to implement the general requirement stated above and shall be imposed on NUS Subcontractors in accordance with EDP 8.0 and/or EDP 18.0.
9.3.1 Special processes, such as welding, heat treating, and nondestructive testing, shall be qualified and performed in accordance with the applicable codes, standards, and specifications.
9.3.2 Welding procedures, personnel, and equipment shall be qualified in accordance with the applicable codes, standards, and specifications.
9.3.3 Special processes shall be performed and verified by qualified per-sonnel with recorded evidence of verification.
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'DATE DIRECTOR OF QUALITY ASSURANCE DATE V
Section Title Reveseon Effectrwe Date Page 9.0 Control of Special Processeo 0
10/28/86 2 of 2 9.3.4 The acceptance criteria of the applicable codes, standards, and speci-fications shall be included in or referenced in the procedures or instructions for special processes, along with any other conditions necessary to perform the processes, e.g., equipment requirements, calibration requirements, or environmental conditions.
9.3.5 Records of qualification for personnel, procedures, and equipment shall be established, filed, and kept current.
9.3.6 Nondestructive testing procedures and personnel shall be qualified in accordance with the applicable codes, standards, and specifications.
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SECTioN REVISION EFFECTIVE DATE PAGE 10.0 0
10/28/86 1 of 3
[d' CORPORATION ENGINEERING DIVISION TITLE ENGINMlNG DNISION Internal Inspection QUALITY ASSURANCE MANUAL 10.1 General Requirement Measures shall be established and implemented to ensure that inspection of activities affecting quality by or for the organization performing the activity verifies conformance with the documented instructions, procedures, and drawings or with other requirements for accomplishing the activity.
10.2 References 10.2.1 Q AP 2. 0,
" Qualification of Inspection and Test Personnel."
10.2.2 QAP 8.0,
" Procurement Control."
10.2.3 EDP 18.0, " Preparation of Equipment Specifications."
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10.3 Specific Requirements
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The following specific requirements have been established to implement the general requirement stated above and shall be imposed on NUS Subcontractors, as applicable, in accordance with QAP 8.0 and EDP 18.0.
10.3.1 Inspection planning shall be accomplished to ensure that inspection procedures, instructions, or checklists identify the characteristics and activities to be inspected; acceptance and rejection criteria; J
responsible organization for performing inspection; and recording of 1
1 objective evidence of inspection results. Planning also includes identification of hold or witness points; approval of data by super-visor to ensure tha" all inspection prerequisites and requirements have been satisfied, including operator and equipment qualifica-tions, and establishment of sampling methods, if applicable, in accordance with QAP 8.0, EDP 18.0, and the Project Quality Assurance P lan.
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Section Title Revie.on Effecteve Date Pego 10.0 Internal Inspection 0
10/28/86 2 of 3 qO 10.3.2 Inspections, including receipt, in-process, and final, shall be con-ducted in accordance with QAP 8.0, EDP 18.0, and any requirements imposed by the Project Quality Assurance Plan.
10.3.3 Inspections shall be performed by qualified inspection personnel who have current certifications or qualifications and who are independ-ent from the activity being inspected. NUS inspection personnel shall be qualified and certified to QAP 2.0.
10.3.4 Final inspection shall include a records review of the results of inspection and resolution of nonconformances identified in previous inspections in accordance with QAP 0.0.
Checklists established for packaging prerelease inspection prior to use shall verify that the following inspection requirements have been complied with:
m o Package is properly assembled.
o Moderators / neutron absorbers are present.
o Valves are protected against tampering and are set to specifications.
o Shipping papers are properly completed.
o Packages are durably marked as required by the 00T.
o A designated individual of users of packages signs shipping tags or indicators prior to authorization of shipment.
10.3.5 Quality records generated in support of an inspection shall be reviewed for adequacy and completeness if not previously so examined prior to acceptance.
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Section Title newee.on Effecteve Date Page 10.0 Internal Inspection 0
10/28/86 3 of 3 b(~"N 10.3.6 Inspection records shall contain, at a minimum, the item inspected, date of inspection, inspector, type of observation, results or acceptability, and reference to information on action taken in con-nection with nonconformances.
10.3.7 Project Quality Assurance Plans, equipment specifications or proce-dures shall establish an inspection program for packaging to ensure adequate maintenance of packaging.
The program shall identify the items to be monitored, the criteria for replacement or accepta-bility, and the frequencies of inspection assigned to each item.
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i SECTioN REVISloN EFFECTIVE DATE PAGE
/
COFFORATION 11.0 0
10/28/86 1 of 3 ENGINEERING DIVISION
' ENGINEERING DMSION 1est contro1 QUALITY ASSURANCE MANUAL 11.1 General Requirement Measures shall be established and implemented to ensure that all te:&ing required to demonstrate that structures, systems, components, and packaging will perform satisfactorily in service is identified and performed in accordance with written test procedures which incorporate the requirements and acceptance limits contained in the applicable design documents, govern-ing regulations, certificates of compliance or other specifying documents.
The testing shall include, as appropriate, proof test, preoperational tests, maintenance, repair, modification, replacement, and operational and develop-mental tests.
11.2 References
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11.2.1 QAP 2.0, " Qualification of Inspection and Test Personnel."
11.2.2 QAP 8.0, " Procurement Control."
11.2.3 EDP 8.0, " Test Specifications and Test Procedures."
11.2.4 EDP 18.0, " Preparation of Equipment Specifications."
11.3 Specific Requirements The following specific requirements have been established to implement the general requirement stated above.
11.3.1 Required testing of specific components, parts, structures, or packaging shall be described in the Project Quality Assurance Plans or generic procedures.
The following items should be included in typical testing performed prior to delivery of packaging for trans-port to a carrier: structural integrity; leak-tightness; component performance of valves, gaskets, and fluid transport devices;
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11.3.2 Tests shall be conducted in accordance with written test procedures prepared in accordance with EDP 8.0.
Test requirements and accept-ance criteria shall be based upon specified requirements contained in applicable design documents, certificates of compliance, mainte-nance or operating manuals, or other pertinent technical documents.
11.3.3 Test record content shall, at a minimum, identify the item tested, date of test, tester or data recorder, type of observation, results and acceptability, deviations noted and actions taken thereto, and person evaluating test results.
11.3.4 Test results shall be documented and evaluated by qualified indi-viduals or groups in accordance with EDP 8.0.
11.3.5 Prerequisites shall be considered and met as required in EDP 8.0.
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\\s 11.3.6 Test instrumentation shall be considered and provided for as required in EDP 8.0.
11.3.7 Test instrumentation calibration shall be performed in accordance with the requirements of EDP 18.0.
11.3.8 Suitable environmental conditions shall be provided for as required in EDP 8.0.
11.3.9 Special training or qualification of personnel who perform the testing shall be accomplished, as necessary, prior to performing the test.
11.3.10 Data-recording by qualified individuals or groups shall be as specified in the particular test procedure prepared in accordance with EDP 8.0.
Quality monitoring shall be in accordance with QAP 8.0 by individuals qualified in accordance with QAP 2.0.
O
Section Title Reviseon Effectrve Date Page 11.0 Test Control 0
10/28/86 3 of 3 11.3.11 Maintenance test programs as defined in project plans or procedures shall be established to ensure that packaging or other items remain usable and free of excessive radiation and contamination.
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i SECTioN REVISION EFFECTIVE DATE PAGE
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fgggg 12.0 0
10/28/86 1of2 V
ENGINEERING OlVISION ENGINEERING DIVISION Control of Measuring and Test Equipment OUALITY ASSURANCE MANUAL 12.1 General Requirement Measures shall be established and implemented to ensure that tools, gauges, instruments, and other measuring and test equipment used in activities affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits.
12.2 References 12.2.1 QAP 8.0, " Procurement Control."
12.2.2 EDP 18.0, " Preparation of Equipment Specifications."
12.3 Specific Requirements The following specific requirements have been established to implement the general requirement stated above and shall be imposed on NUS Subcontractors in accordance with QAP 8.0 and EDP 18.0.
12.3.1 Measuring and test equipment shall be calibrated, adjusted, and maintained at prescribed intervals or, prior to use, against certified equipment having known valid relationships to nationally recognized standards or the bases for calibration shall be documented.
12.3.2 When measuring and test equipment is found to be out of calibration, an evaluation shall be made and documented of the validity of pre-vious inspections or test results and of the acceptability of items previously inspected or tested.
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Sectum Title Revision Effectrve Date Page Control of Measuring and 12.0 Test Equipment 0
10/28/86 2 of 2 12.3.3 The intervals and methods of calibration for measuring and test equipment shall be defined based on the required accuracy, intended use, equipment stability, and other conditions affecting measurement control.
12.3.4 Measuring and test equipment shall be properly handled and stored to
)
prevent damage.
12.3.5 The date of each item's next planned calibration shall be maintained and the records shall be traceable to the item calibrated.
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I
SECTioN REVISloN EFFECTIVE DATE PAGE 13.0 0
10/28/86 1 of 3 p
N ENGINEERING OlVISION TITLE ENGINEERING DMSION Handling, Storage, and Shipping QUALITY ASSURANCE MANUAL 13.1 General Requirement Measures shall be established and implemented to control the handling, stor-age, shipping, cleaning, and preservation of materials, equipment, com-ponents, or packaging in accordance with written instructions to prevent deterioration or damage. Where necessary for. particular products, special protective environments shall be specified and provided.
Such environments include inert gas atmosphere and specification of moisture content levels and temperature levels.
13.2 References 13.2.1 QAP 8.0, " Procurement Control."
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13.2.2 EDP 18.0, " Preparation of Equipment Specifications."
13.3 Specific Requirements The following specific requirements have been established to implement the general requirements stated above and shall be imposed on NUS Subcontractors in accordance with QAP 8.0 and/or ECP 18.0.
13.3.1 Components which are sensitive, perishable, safety-related, or of high value shall be handled, stored, cleaned, packaged, and shipped to preclude damage or deterioration.
13.3.2 A final prerelease review of system, components, or packaging prior to delivery shall be performed.
This review shall ensure that packaging has been prepared for delivery in accordance with approved drawings, specifications, government regulations, O)
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DIRECTOR OF QUALITY' ASSURANCE DATE Virg fiiESIDENT AND G$NERAL MANAGER OkTE I U
Sectum Title Reviesen Effectrve Date Page V]
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13.0 Handling, Storage, and 0
10/28/86 2 of 3 Shipping certificates of compliance, or other specifying documents; that all required inspections and tests have been completed; that the items are properly identified; that the necessary shipping papers have been prepared; and, as applicable, that the package contains operating manuals, maintenance manuals, and generic procedures relating to the item's use.
Packaging which is being prepared for delivery to a carrier shall be reviewed to ensure that all conditions, including specified operations, inspections, tests, NRC and DOT requirements, necessary shipping papers, and, as applicable, draining and/or drying of package containments have been accomplished.
13.3.3 Special atmosphere or environmental controls shall be provided for p
in the appropriate procedures or Project Quality Assurance Plans as necessary.
13.3.4 Cleaning, preservation, and shipping of manufactured items or pack-aging shall be as required by individual design specifications, certificates of compliance, Project Quality Assurance Plans, or specific procedures generated on a project-specific basis.
13.3.5 Receipt and initial storage of materials, parts and components shall be in accordance with approved written procedures.
i 13.3.6 Withdrawal of materials, parts, and components from initial storage shall be in accordance with approved written procedures.
13.3.7 Materials with identified shelf lives shall be handled in accord-ance with the manufacturer's instructions or specific procedures which address those requirements.
13.3.8 Handling and storage of welding material shall be in accordance with approved written procedures.
Secten Title Revieeon Effective Date Page 13.0 Handling, Storage, and 0
10/28/86 3 of 3 Shipping 13.3.9 Handling, storage, and shipping of radioactive or contaminated equipment shall be in accordance with approved written procedures.
13.3.10 Requirements for marking or labeling items shall be established as necessary in accordance with approved written procedures.
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SECTioN REVISloN EFFECTIVE DATE PAGE I'
14.0 0'
10/28/86 1 of 2 Q)
Ci. F+;ORATKJN ENGINEERING DIVISION TITLE ENGINEERING DMS10N Inspection. Test, and operating Status OUALITY ASSURANCE MANUAL 14.1 General Requirement Measures shall be established and implemented to ensure that the required inspection and test activities, including maintenance, are performed and to ensure that items which have not passed the required inspections or tests are not inadvertently installed, used, or operated. Status of the required inspections or tests shall be maintained either on the item or in documents traceable to the item. Status indicators shall also provide for indicating the operating status, as by tagging, to prevent their inadvertent operation.
14.2 References 14.3.1 QN' 8.0,
" Procurement Control."
3 14.3.2 EDP 18.0, " Test Specification and Test Procedures."
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14.3 Specific Requirements The following specific requirerent s have been established to implement the general requirement stated above and shall be imposed on NUS Subcontractors in accordance with QAP 8.0 and/or ET 18.0.
14.3.1 The required inspections, tests, or maintenance activities shall be described in the particular Project Quality Assurance Plans or inspection and test plans.
14.3.2 The status of inspection, tests, maintenance, and other activities performed on items shall be maintained to the extent possible on the item or on documents traceable to the item by the use of tags, I
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,,/e T 717F5 iolal96 DIRECTOR OF QUALITY ASSORANCE
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Secten Title Reveneen Effectrve Date Page 14.0 Inspection, Test, and 0
10/28/86 2 of 2 p
g Operating Status markings, stamps, or travelers to ensure that required inspections are not inadvertently bypassed.
14.3.3 The required inspection and test shall be performed in accordance with approved written instructions, procedures or checklists.
14.3.4 Status indicators which indicate the operating status of items shall be affixed and removed in accordance with approved written instruc-tions, procedures, or checklists.
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SECTloN REVISloN EFFECTIVE DATE PAGE F
15.0 0
10/28/86 1 of 2 D)
I CORPORATON
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ENGINEERING DIVISION TmE ENGINESING DMSION Nonconforming Materials, Parts, Components, or Services OUALITY ASSURANCE MANUAL 15.1 General Requirement Measures shall be established and implemented to control materials, parts, components, and services which do not conform to applicable codes, stand-ards, specifications, or other documented requirements in order to prevent their inadvertent or continued use, further processing, delivery, or installation.
15.2 References 15.2.1 QAP 7.0, "Nonconformance and Corrective Action."
15.2.2 QAP 8.0,
" Procurement Control."
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(V 15.2.3 EDP 18.0, " Preparation of Equipment Specifications."
15.2.4 EDP 21.0, " Procedure for Implementation of the Requirements of 10CFR21."
15.3 Specific Requirements _
The following specific requirements have been established to implement the general requirement stated above.
15.3.1 Reporting, identification, and documcStt ' ion requirements of non-conformances to ensure proper mr. ivy nc.
- attention, notification of a nonconforming condition, and,,r, pet ;r.umenting of the condition, which includes the corrective action and cause, shall be in accord-ance with QAP 7.0.
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15.0 Parts, Components, or 0
10/28/86 2 of 2 l
V Services 15.3.2 Segregation of nonconforming materials, parts, and components to ensure that they will not be inadvertently used shall be in accord-ance with QAP 7.0.
15.3.3 Disposition of nonconformances shall be prepared and approved by responsible individuals or groups in accordance with QAP 7.0.
15.3.4 Notification of affected organizations shall be in accordance with QAP 7.0.
15.3.5 Reinspection or retesting of nonconforming items following repair or rework shall be performed using the original acceptance criteria.
15.3.6 Nonconformances shall be closed and documented by the Director of Quality Assurance in accordance with QAP 7.0.
(v'_m 15.3.7 Trending of nonconformances to determine quality trends for manage-ment review and assessment shall be accomplished in accordance with QAP 7.0.
15.3.8 Nonconformances under the purview of 10CFR21 shall be reported, evaluated, dispositioned, followed up, and closed in accordance with EDP 21.0.
15.3.9 Nonconformance control in accordance with the foregoing provisions 15.3.1 through 15.3.8 for procured materials, components, and service shall be specified in NUSED procurement documents (QAP 8.0) and equipment specifications (EDP-18.0),
s-
SECTioN REVIStoN EFFECTIVE DATE PAGE C
16.0 0
10/28/86 1 of 2 Q)'
CCn-e-OF-iATION ENGINEERING DIVISION TITLE Corrective Action I
ENGINEERING DMS10N QUALITY ASSURANCE MANUAL i
16.1 General Requirement Measures shall be established and implemented to ensure that conditions adverse to quality such as deficiencies, deviations, defective material and equipment, or conditions concerning the use, maintenance, or repair of equipment, are promptly identified and corrected.
In the case of significant conditions adverse to quality, the cause of the conditions shall be determined and corrective action taken to preclude recurrence.
The identification of the significant conditions, the cause of the conditions, and the corrective action taken shall be documented and reported to the Vice President and General Manager of NUSED.
16.2 References O\\
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16.2.1 QF 7.0, "Nonconformance and Corrective Action."
16.2.2 QW 8.0,
" Procurement Control."
16.2.3 EDP 18.0, " Preparation of Equipment Specifications."
16.2.4 EDP 21.0, " Procedure for the Implementation of the Requirements of 10CFR21."
16.2.5 QA Manual Section 1.0, " Organization."
16.3 Specific Requirements The following specific requirements have been established to implement the general requirement stated above.
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DIRECTOR OF QUALITY ASStfRANCE DATE Vigs)TRESIDENT AND bENERAL MANAGER
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Section htte Reveeson Effecteve Date Page OT 16.0 Corrective Action 0
10/28/86 2 of 2 NJ 16.3.1 The causes of conditions detrimental to quality shall be promptly identified and reported to the appropriate levels of management in accordance with QAP 7.0.
16.3.2 Supplier reporting of corrective actions and NUSED follow-up of same to ensure that corrective actions are implemented and effective shall be in accordance with QAP 7.0 and QAP 8.0, and as may be addi-tionally stipulated in equipment specifications per EDP 18.0.
16.3.3 Corrective action measures shall be such that recurrence of the non-conforming condition is precluded.
16.3.4 Persons or organizations responsible for corrective action follow-up, resolution, and closure shall be as specified in Q4P 7.0.
16.3.5 If corrective action is determined to be unacceptable to preclude
'd recurrence of significant or repetitive conditions adverse to qual-ity, the Director of Quality Assurance, Engineering shall take appropriate action to control or prevent further processing of the work until such time that the nonconforming conditions are corrected (QA Manual Section 1.0).
16.3.6 Corrective actions under the purview of 10CFR21 shall be reported, evaluated, dispositioned, followed, and closed in accordance with EDP 21.0.
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SECTioN REVISION EFFECTIVE DATE PAGE 17.0 0
10/28/86 1 of 4 bs)
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ENGINEERING OlVISION TITLE ENGINEERING DMSION Quality Assurance Records QUALITY ASSURANCE MANUAL 17.1 General Requirement Measures shall be established and implemented to ensure that sufficient records that furnish documentary evidence of quality are specified, pre-pared, and maintained. Quality assurance records shall be complete, legi-ble, identifiable, and retrievable.
Typical quality assurance records maintained by NUSED are provided in Figure 5.
Other quality assurance records shall be identified in the project QA Plans and NUSED procedures.
17.2 References 17.2.1 QAP 3.0 Quality Assurance Records 17.3 Specific Requirements The following specific requirements have been established to implement the general requirement stated above.
17.3.1 Quality assurance records to be retained shall be identified in individual QA plans and NUSED procedures referenced therein.
Control of QA records shall be as specified in QAP 3.0.
17.3.2 Quality records shall be legible and completed and processed in a timely manner to reflect the work accomplished to avoid unnecessary delay when the record is needed.
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17.3.3 Quality assurance records shall be indexed and classified as either lifetime or nonpermanent and have indices prepared for them in accordance with QAP 3.0.
o Lifetime records include records pertaining to fabrication of the package and those of a particular item while it is installed in the packaging or stored for future use.
o Nonpermanent records are those that show evidence that an activ-ity has been performed but do not meet the criteria for lifetime records.
17.3.4 The receipt, retrieval, and disposition of quality assurance records shall be in accordance with QAP 3.0.
r' 17.3.5 The access, storage, preservation, and safekeeping of quality assur-
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ance records shall be in accordance with QAP 3.0.
The individuals in each organization responsible for receiving records and assessing the current status of same shall be as described in the Project Quality Assurance Plans.
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Figure 5.
Typical NUSED Quality Assurance Records Record Category
- Lifetime
- Nonpermanent Project Procedures X
Project QA Plan X
QA Manual X
Design Records
- Design Input Requirements X
- Design Specifications X
- Engineering Drawings /BOM's X
- Design Change Notices X
- Field Change Requests X
- Design Document Status Report X
- Documentation Distribution List X
- Non-Code Analyses X
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- Calculations X
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- Computer Program Analyses X
- "Q" Lists X
Procurement Records
- Vendor Preaward Surveys X
- Procurement Specifications X
- Purchase Order and Supplements X
- Inquiry / Request for Quotation X
- Bidders List X
Manufacturing Records
- Construction Guidelines X
- Fabrication Specifications X
- Inspection & Test Records X
- Test Procedures X
- Test Specifications X
- Packaging Prerelease Checklist X
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- Welding Procedure Specifications X
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- Welding Procedure Qualifications X
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- Welder Qualifications X
- Calibration Procedures / Records X
- Vendor Drawings / Procedures X
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Figure 5.
Typical NUSED Quality Assurance Records (Continued)
Record Category
- Li fetime
- Nonpermanent
- Source Inspection Release / Vendor Data Package X
- Equipment Installation Specifications and Records X
Other
- Nonconformance Reports X
- Miscellaneous Quality Notices X
- QA Audit Reports X
- Corrective Action Reports X
- Personnel Qualification Records -
(after termination)
X
- Training and Re-training Records -
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(after termination)
X
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- Client-Submitted Documents X
- Correspondence X
- Progress Reports X
- NOTES
- 1) NUSED-generated documents and records shall be turned over to the client for permanent storage at the conclusion of the project unless otherwise stipulated in the client procurement documents.
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- 2) Vendor-generated documents and records shall be maintained / finally disposi-tioned as provided for in individual design specifications and/or fabrication specifications. All essential QA records relating to fabrication, assembly, inspection, test, and release normally become part of the vendor data package which accompanies the completed product at time of shipment.
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- 3) Retention periods may vary depending upon client-stipulated requirements.
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SECTioN REVISloN EFFECTIVE DATE PAGE 18.0 0
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- gogie, OUALITY ASSURANCE MANUAL 18.1 General Requirement Measures shall be established and implemented to ensure that a comprehensive system of planned and periodic audits is performed to verify the compliance and effectiveness of all aspects of the quality assurance program.
18.2 References 18.2.1 QAP 1.0 Qualification of Auditors 18.2.2 QAP 3.0 Quality Assurance Records 18.2.3 QAP 4.0 Internal Quality Assurance Implementation Audit and Periodic Surveillance 18.2.4 QAP 5.0 External Quality Assurance Audit
%.J 18.3 Specific Requirements The following specific requirements have been established to implement the general requirement stated above.
18.3.1 NUSED management shall ensure that the necessary training, funding, manpower, and support to implement audits of the quality assurance program are provided for.
18.3.2 Audits shall be performed by qualified quality assurance personnel to ensure the necessary authority and organizational independence.
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18.3.3 NUSED auditors shall be qualified in accordance with QAP 1.0, which meets the requirements of NQA-1, Supplement 2S-3, " Supplementary Requirements for the Qualification of Quality Assurance Program Audit Personnel."
18.3.4 Schedules for management, internal and external audits shall be established by the Director of Quality Assurance, Engineering in accordance with QAP 4.0 and 5.0.
The schedule for internal audits shall be sufficiently comprehensive to allow for the audit of all program elements during the course of a year.
18.3.5 Internal and external audits of activities of short duration during the design and fabrication stages of packaging progress shall be scheduled to ensure that the applicable program elements are audited at least once during the life of the activity to verify
(N that work is being controlled by an NRC-approved QA program.
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18.3.6 External audits of the elements of approved suppliers' quality assurance programs shall be conducted on a triennial basis. This three-year period shall begin with the performance of an audit when sufficient work is in progress to demonstrate implementation of their quality assurance program having the required scope for purchases placed during the three-year period.
18.3.7 Management audits of NUSED program implementation shall be con-ducted in accordance with QAP 4.0 at least once every twelve months. This function may be accomplished by the NUS Corporate QA organization or as alternately arranged by the NUSED Vice President and General Manager.
18.3.8 The responsibilities of the lead auditor and the audit team members with respect to evaluation and issuance of audit reports and the conduct of the audit shall be as described in QAP 4.0 and QAP 5.0.
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v 18.3.9 Preparation of the audit plan, which includes the selection of the audit team members, shall be in accordance with QAP 4.0 and QAP 5.0.
18.3.10 Audits shall be performed in accordance with documented checklists prepared in accordance with QAP 4.0 and QAP 5.0.
18.3.11 Preaudit and postaudit conferences for both internal and external audits shall be conducted in accordance with QAP 4.0 and QAP 5.0.
18.3.12 Reporting and response requirements which include imposed time constraints for issuing the audit report, the requested date for audit finding responses, and the schedule for initiation and completion of the corrective action shall be in accordance with QAP 4.0 and QAP 5.0.
Responses shall clearly state the corrective (v}
action taken to prevent recurrence of the nonconformance, 18.3.13 Follow-up action to ensure timely response, evaluation of the response, and corrective action verification, which may include reaudit of the deficient area, shall be performed in accordance with QAP 4.0 and QAP 5.0.
i 18.3.14 Records to be maintained in support of the audit shall be those records described in QAP 1.0, 3.0, 4.0, and 5.0.
18.3.15 The President and General Manager shall ensure that audit findings are responded to and that corrective action resulting from findings during audits is accomplished in a timely manner.
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