ML19256F882
| ML19256F882 | |
| Person / Time | |
|---|---|
| Site: | 07100250 |
| Issue date: | 12/07/1979 |
| From: | TRANSNUCLEAR, INC. |
| To: | |
| Shared Package | |
| ML19256F880 | List: |
| References | |
| 14942, NUDOCS 7912270029 | |
| Download: ML19256F882 (41) | |
Text
.
E-1473 Revision 1 h
Uncontrolled Copy QUALITY ASSURANCE PROGRAM s
FOR DESIGN, MANUFACTURE, TEST, USE, MAINTENANCE AND REPAIR OF PACKAGINGS FOR TRANSPORT OF RADIOACTIVE MATERIALS equa
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1642 114 TRANSNUCLEAR, INC.
ONE NORTH BROADWAY, WHITE PLAINS, N.Y.
10601 4
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N912270DM9
REVISION LOG Fev. No, Date Approved Description 0
12/28/78 [bfh Original Issue 1
12/7/79 w/h) Revised per U.S. Nuclear Regulatory Commission letter, Charles E.
MacDonald, FCTC: RHO 71-0250, dated October 9, 1979.
s 1642 115 i
E-1473 Rev. 1 TABLE OF CONTENTS Page Introduction 1
1.
Organization 3
5 2.
Quality Assurance Program 8
3.
Design Control 12 4.
Procurement Document Control 15 5.
Instructions, Procedures and Drawings 17 6.
Document Control 18 7.
Control of Purchased Material, Equipment and Services 20 8.
Identification and Control of Materials, Parts and Components 23 9.
Control of Special Processes 24 10.
Inspection 25 11.
Test Control 27 12.
Control of Measuring and Test Equipment 28 1
13.
Handling, Storage and Shipping 30 14.
Inspection, Test and Operating Status 31 15.
Nonconforming Materials, Parts or Components 32 16.
Corrective-Action 34 17.
Quality Assurance Records 35 18.
Audits 37 1642 116 ii
E-1473 Rev. 1 INTRODUCTION The Code of Federal Regulations, Title 10, Part 71 (10 CFR 71) " Packaging of Radioactive Material for Trans-port and Transportation of Radioactive Material Under Certain Conditiont", requires in paragraph 71.51 that a licensee establish, maintain and execute a Quality Assurance Program (QA Program) satisfying each of the applicable criteria specified in Appendix E of 10 CFR 71.
A licensee is a person or organization that delivers licensed material in an approved packaging to a carrier-for transport.
The licensee is required to assure himself and the Nuclear Regulatory Commission that the QA Program, on which approval of the packaging is based, has been implemented.
The present document describes how Transnuclear, Inc.
(TN), as a licensee, intends to satisfy these requirements.
As a licensee, TN has QA responsibility for all phases of design, manufacture, test, use, maintenance, and repair of any packaging which TN delivers to a
carrier for transport of licensed material.
This QA responsibility exists whether TN has contractual responsibility for each of the individual phases or not.
For example, if TN Intends to transport material in a packaging which was designed and fabricated by others without TN involvement, TN shall assure itself that these activities were performed, where applicable, in accord with the quality assurance requirements of 10 CFR 71, Paragraph 71.51.
On the other hand, if a packaging is designed and fabricated by TN or under contract to TN, TN shall assure that the QA Program, as described
.erein, is implemented during these phases.
Organizations that perform such work under direct contract to TN are 1
1642 117
E-1473 Rev. 1 identified herein as major participating organizations.
They may provide hardware, services or both.
The presQnt document describes TN's generic QA Program for the design, manufacture, test, use, maintenance and repair of the packagings in accordance with 10 CFR 71, Paragraph 71.51. 5 Additionally TN's applications for NRC package approval shall also contain specific provisions, as required.
These specific provisions shall consider the complexity and the proposed use of the packaging and its components.-
Supplemental requirements may be added or the applicability of certain of the 18 criteria of Appendix E of 10 CFR 71 may be deleted.
The organization of this document follows that of Appendix E, 10 CFR 71, in that sections are numbered and titled the same as the corresponding 18 criteria of Appendix E.
1642 ll8 2
E-1473 Rev. 1 1.
ORGANIZATION The organizational structure which has been set up at TN to establish and implement its QA Program is shown in Fig.
1.
The. authority and duties of the personnel performing activities affecting the safety related functions of pac' agings are described below.
c The Chief Engineer is the person responsible for establishing the QA Program.
He reports directly to the President of TN.
The President shall approve the QA Program and any revisions thereto.
The Chief Engineer shall approve Corporate QA Procedures and any revisions thereto. The minimum qualification requirements for the Position of Chief Engineer are a bachelor's degree in 1
engineering from an accredited institution and ten years of experience in engineering and quality assurance activities.
For each project one person from the TN organization 1
shall be assigned as the QA Engineer for that project.
The person who is assigned as the QA Engineer for a particular project shall have no other responsibilities on that project. He shall be functionally independent of any group or individual directly responsible for the activities which he monitors.
He shall have the authority and organizational freedom to enforce QA requirements, to identify problem areas, to recommend or provide solutions to QA problems, and to verify the effectiveness of the solutions.
As shown by the solid line in Fig.
1, he can communicate directly with the President.
The minimum qualification requirements for the position of Project QA Engineer are a bachelor's degree in engineering, 1
physical sciences, mathematics or quality assurance from an accredited institution and five years of experience in engineering activities with at least one year of experience in quality assurance activities.
3
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w COMMUNICATIONS ONLY PRESIDENT r
GENERAL CHIEF MANAGER ENGINEER OF OPERATIONS PROJECT PROJECT QUALITY MANAGER ASSURANCE ENGINEER
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E-1473
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Rev. 1 1
The QA Engineer has the following typical responsibilities:
Prepare TN's QA Program Plans and QA Procedures a.
for specific projects, b.
Verify that major participating organizations have approved QA Programs, as required.
s Approve QA Program Plans of participating organizations c.
for a project for which he has been assigned as 1
the QA Engineer.
d.
Verify that major participating organizations have QA procedures, as required.
Assure that TN design documents contain applicable e.
QA requirements.
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f.
Approve TN safety related procurement documents instructions, procedures and drawings.
g.
Assure that further processing, delivery, installation 1
or use of non-conforming items is controlled until proper disposition has occurred..
h.
Perform audits to verify that QA requirements are being met.
The QA Engineer may delegate the performance of one or more of these functions to other qualified individuals at TN, or from contractor organizations, who do not have direct responsibility for performing the work being monitored.
1642 121 5
E-1473 Rev. 1 A Project Manager or Project Engineer shall be res-ponsible to the Chief Engineer for all technical aspects of a project including issuing of procurement documents, preparation of licensing documents, fabrication and de-livery of the packaging and use of the packaging.
TN's General, Manager of Operations or his designee shall be responsible for all transport operations after delivery of a packaging to TN.
During the design and procurement phases, he reviews and provides input on transport and operations requirements.
A possible interrelationship between TN and another major participating organization is shown in Fig.
2.
The other organization could be a design agent, packaging manufacturer, supplier, sub-contractor or user.
The chart is provided to establish that any organization k
performing functions affecting quality must have a QA position with the required authority and organizational freedom as well as direct access to upper levels of management.
The chart also shows the requirement for direct communication between Quality Assurance of TN and the other organization.
As licensee, TN shall retain overall responsibility for the QA program.
Specific organization charts of major participating organizations shall be detailed in their respective QA documents, and shall be in full compliance with the QA requirements of 10 CFR Part 71.
1642 122 6
E-1473 Rev. 1 1
COMMUNICATIONS ONLY PRESIDENT s
CHIEF GENERAL ENGINEER MANAGER OF OPERATIONS PROJECT QUALITY MANAGER ASSURANCE
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GENERAL g
MANAGEMENT l
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PROJECT QUALITY MANAGEMENT ASSURANCE 8
OTHER PARTICIPATING ORGANIZATION FIG. 2 TYPICAL OVERALL ORGANIZATIONAL CHART 7
1642 123
E-1473 Rev. 1 2.
QUALITY ASSURANCE PROGRAM The program described herein is a generic program which shall be implemented by TN as a licensee who delivers a package to a carrier for transport of radioactive materials.
The program is intended to be in full compliance with the requirements of 10 CFR 71, Appendix E.
It is the policy of Transnuclear, Inc. to establish and maintain an integrated quality assurance system which governs the design, manufacture, test, use, maintenance and repair of packagings for transport of radioactive materials.
This system applies to all safety related packaging activities performed by TN, or its' contractors, to assure that the packagings meet the high standards of reliability and safety required during handling and transport. The quality assurance system utilizes Project QA Program Plans, Corporate QA Procedures and Project QA Procedures to define specific quality assurance requirements for implementation of the generic QA Program at TN.
Comparable plans and procedures shall be utilized by TN contractors.
Specific QA Program Plans shall be prepared to detail the actual measures which are to be established and implemented for a particular packaging project or portion of a project.
Each specific project QA Program Plan shall identify the participating organizations, their inter-relationships, and the responsibilities of each of the participants.
The scope of specific QA Program Plans will differ based upon the type and complexity of the quality affecting activities to be performed.
Specific QA-Program Plans which have been developed by TN cover the following projects:
8 1642 124
E-1473 Rev. 1
-Design, Procurement, Fabrication and Acceptance of TN-8 and TN-9 Irradiated Fuel Packagings.
-Procurement of Lifting Beams for TN-8 and TM-9 Irradiated Fuel Packagings
-Support Services for Commor. wealth Edison Company, TN-9.1 Irradiated Fuel Packaging
-Design and Procurement of TN-125 Packagings for Transport of Radioactive Materials QA Program Plans for new projects shall be established at the earliest time consistent with the schedule for accomplishing activities on such projects.
Specific measures shall be established.in the QA Program Plans directly or by reference to Corporate QA Procedures, which are applicable to all TN projects, or to Project QA Procedures which are only applicable to specific k
projects.
The Corporate QA Procedures are used for 1
activities such as Drawing Control, Procedure Format, Document Transmittals, etc.
Project QA Procedures are used for specific project activities unique to a particular project.
The TN Project QA Engineer shall identify all QA procedures required during a particular phase of a project during the development of the QA Program Plan.
If QA procedures so identified do not yet exist, they shall be prepared as either Corporate or Project QA Procedures, approved, and issued prior to the performance of the activities covered by the procedures.
Preparation of the QA Program, and subsequent revisions thereto, are the responsibility of the Chief Engineer.
The President of TN shall approve the original QA Program and any subsequent revisions.
QA Program Plans for specific projects and any revisions thereto, shall be approved by the Project QA Engineer.
Corporate QA 9
1642 125
E-1473 Rev. 1 Procedures are approved by the Chief Engineer.
Project QA Procedures are approved by the Project QA Engineer.
The distribution of the generic QA Program is controlled by TN's Chief Engineer.
He is also responsible for the distribution of Corporate QA Procedures.
The Project QA Engineer is responsible for the distribution of Project 1
QA Procedures.
Hb assures that responsible organizations and individuals are aware of all mandatory QA requirements for project activities under their cognizance and that copies of the general and specific QA program, plans and procedures are distributed to them, as applicable.
Major orjanizations participating in a project shall have approved quality assurance programs including 1
written procedures and instructions to implem0nt their respective programs. Their programs, procedures and
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instructions shall be in full compliance with the applicable criteria of 10 CFR 71, Appendix E.
These QA programs shall be formally reviewed and accepted for use by the 1
TN Project QA Engineer prior to the initiation of activities affecting quality.
Specific project QA Program Plans prepared by major participating organizations shall be approved by the TN Project QA Engineer.
He shall perform audits and/or overchecks to assure that these programs and procedures are properly implemented by the participating organizations.
1 The Project QA Engineer is responsible for verifying on a particular project that all activities on safety-related systems, components and equipment are controlled by the QA program. In case of disputes with the TN Project Manager or others over quality matters he can request resolution by TN's President.
10 1642 126
E-1473 Rev. 1
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Safety related items shall be identified for each specific design and shall be submitted with an application for package approval.
The complexity and importance of these items shall be defined and any special requirements shall be described.
TN shall hold annual QA Review Meetings to assess
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the adequacy and effectiveness of the generic and specific Project QA Programs.
These review meetings shall be chaired by the President.
The Chief Engineer and QA 1
Engineers for ongoing projects shall attend.
These reviews shall be documented and chall include a list of follow-up action items, dasignating responsibilities and schedules for implementation.
TN and major participating organizations shall provide suitable conditions, environment and equipment
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for activities affecting quality.
Special controls,.
tools, equipment, etc. shall be provided to attain the appropriate level of quality.
Inspections, tests and other controls shall be implemented to assure that the appropriate. levels of quality are attained.
Perconnel performing activities affecting quality shall be properly trained and indoctrinated as to the purpose, scope and proper implementation of the QA Program, the specific QA Program Plan, and QA Procedures to assure pr fi iency for the tasks which they are to perform.
1 The proficiency of TN personnel performing activities affecting quality shall be maintained through a program of on-the-job training and indoctrination meetings as required.
1642 127 11
E-1473 Rev. 1 3.
DESIGN CONTROL TN shall establish measures to assure that regulatory requirements and packaging design have been or are correctly translated into drawings, specifications, procedures and instructions.
The design shall consider, but shall not be limited to the following design aspects: criticality, shielding, stresses, thermal and hydraulic performance, accident conditions, compatibility of materials, accessi-bility for in-service inspection, maintenance and repair.
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Measures shall be established for the selection of suitable materials, parts, equipment, and processes for 1
safety-related structures, systems and components.
Valid industry standards and specifications shall be utilized to the greatest practical extent.
k Written instructions, procedures and/or plans shall icentify the methods of control for the design of the packaging.
These documents shall identify the safety related items, regulatory requirements, spplicable codes or standards, design criteria and measures -for coordination and control of design interfaces, and appropriate quality standards.
Deviations from applicable codes and standards shall be identified and controlled.
Design calculations and drawings shall be prepared and checked in accord with approved procedures. The ade-quacy of the design may be verified by test of a proto-type or scale model.
Materials, parts and equipment which are standard, commercial (of f the shelf) or which 1
have been previously approved for a different application shall be reviewed for suitability prior to selection.
1642 128 12
E-1473 Rev. 1 In addition, the design shall be formally reviewed by individuals or groups, other than those who performed the original design.
These reviews shall be in the form of Design Review Meetings fer packaging designs which are developed by TN.
For such designs, the Project Manager shall schedule and chair review meetings.
These meetings shall be held to confirm that various aspects of the design have been properly considered, including conformance to license requirements when applicable.
The Project Manager and Project QA Engineer shall review design documents to assure that the. design characteristics of the packaging can be controlled, inspected, and tested and that appropriate inspection and test criteria have been identified.
The Design Review Meetings shall also assure that there has been, is and will be appropriate coordination between organizations participating in the design, quality control, fabrication, and testing of the packaging.
7 Any errors or deficiencies in the design or design documents, including the design process, that could adversely affect safety-related components or sub-components of a packaging shall be documented, and corrective action shall be taken in accordance with Section 16 of this Program.
TN shall assure that measures are established and implemented to verify that the fabrication and assembly drawings, prepared by the Manufacturer are consistent-with design documents.
For packagings of TN design, TN shall review all fabrication drawings, approve design changes and establish procedures for the documentary control of design changes.
I642 129 13
E-1473 Rev. 1 All design changes, including field changes, shall be subject to the same or equivalent design control measures as are applicable to the original design.
TN shall establish measures to assure that the approved design and operating conditions are not changed unless the ef fect of the changes on the design are evaluated and app' roved. For any change which affects the basis for the Certificate of Compliance of a packaging, approval for the change shall be obtained from the Nuclear Regulatory Commission prior to its use under the modified conditions.
1642 130 14
E-1473 Rev. 1 4.
PROCUREMENT DOCUMENT CONTROL Procurement documents shall be prepared which clearly define all design requirements including quality assurance requirements, and shall reference all applicable documents, including codes, standards, regulatory requirements and the package design, as specified in the application for approval. These documents shall serve as the principal technical documents for the procurement of materials, spare parts, components, equipment or services to be used in the manufacture, test, use, maintenance or repair of the packaging.
These documents may be prepared by TN or by one or more major participating organizations, e.g. Design Agent, Manufacturer, etc.
Each of these organizations shall have a documented, approved quality assurance program which shall be supplemented by detailed procedures and instructions as required to assure adequate control for preparing safety related procurement documents.
Changes and revisions to these documents shall be reviewed 1
and approved in-an equivalent manner as the original document in accordance with documented procedures.
These programs shall also include measures to qualify / accept the quality assurance programs of their suppliers and subcontractors for safety related equipment, materials or services.
Procurement documents shal-1 also address the applicability of the provisions of 10 CFR 21, Reporting of Defects and Noncompliance.
Safety related procurement documents prepared and/or 1
issued by TN shall be reviewed by the Project QA Engineer to determine that appropriate quality requirements are 15 1642 131
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E-1473 Rev. 1 correctly stated, inspectable and controllable.
The QA Engineer shall also verify that adequate acceptance and rejection criteria are identified and that the procurement document was prepared, reviewed and approved in accordance with the applicable procedures.
The QA Engineer's written approval of the procurement documents shall signify that he has verified these items prior to the release of the procurement documents.
TN's safety related procurement documents shall identify which documents (e.g. drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemical and physical test results of materials) are to be prepared by a supplier and which documents are to 1
be submitted to TN or its agents for review, information and/or approval.
The procurement documents shall also specify which documents are to be retained, controlled and maintained by the supplier for specified periods and which records shall be transmitted to TN prior to use of the packaging.
Duplicate records may be maintained for specified periods by both the supplier and TN to facilitate permanent record storage.
Procurement documents shall also include requirements to insure that TN or its agents have reasonable rights of access to the supplier's facility and records for inspection and audit prior to contract award, and source inspection and audits during and after completion of fabrication.
1642 132 16
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E-1473 Rev. 1 5.
INSTRUCTIONS, PROCEDURES AND DRAWINGS Methods for complying with each of the applicable 18 criteria of 10CFR71, Appendix E for activities affecting quality during design, manufacture, test, use, maintenance and repair shall be.specified in instructions, procedures and/or drawings. They shall be prepared, reviewed, approved and controlled in accord with written document control procedures.
These instructions, procedures and drawings shall include quantitative and/or qualitative acceptance criteria to permit verification that activities affecting quality have been satisfactorily accomplished.
1 The QA Engineer on a project shall review and approve Project instructions, procedures and drawings which ar prepared by TN.
These documents may include, but are not limited to specifications, drawings, special process, calibration, test, operating, maintenance and repair instructions and procedures and any changes thereto.
I642 133 17
E-1473 Rev. 1 6.
DOCUMENT CONTROL TN shall establish and implement procedures to control the issuance of TN documents which prescribe activities affecting quality.
These procedures shall define document control measures to assure adequate review, approval, release and distribution of original documents and subsequent revisions.
These documents may include, but are not limited to design specifications, drawings, procurement documents, and special process, test and operating procedures.
A specific QA Plan for each project shall identify the persons, groups and/or y
organizations responsible for reviewing and approving documents and their revisions for that project.
Major participating organizations shall establish and implement document control procedures in accord with their approved QA program.
Changes to documents shall be reviewed and approved by the same organizations that performed the original review and approval unless otherwise delegated by_TN or a major participating organization.
Approved changes shall be included in the applicable drawings, procedures, y
instructions or other documents prior to the implementation of the change.
The Project Manager shall be responsible for cne control of Project documents which are issued by TN.
He shall also be responsible for the receipt and distribution of Project documents to and from participating organizations.
He shall maintain an up-to-date file of all Project records.
18 1642 134
E-1473 Rev. 1 Documents shall be available at the location where 1
activities affecting quality are performed prior to commencing the work.
For certain types of documents which are issued by TN, the Project Manager shall maintain Master Lirts to identify current, revisions.
He shall update and distribute these lists to responsible personnel to preclude the use of superseded documents.
Major participating organizations shall utilize the same or equivalent measures.
1642 135 t
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E-1473 Rev. 1 7.
CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES Measures shall be established and implemented to assure that all' purchased material, equipment, and services conform to procurement documents.
An engineering source evaluation of prospective supplier's facilities shall be performed by the TN Project 1
Manager to confirm that the organization has the technical capability to supply safety related equipment, materials or services in accordance with the project's design, manufacturing, quality assurance and procurement requirements.
The TN Project QA Engineer-shall perform source evaluation audits of potential suppliers in accordance 1
with TN Corporate QA Procedures to verify that they can comply with the criteria of 10 CFR 71, Appendix E that are applicable to the material, equipment, or service being procured.
The resultant reports of the engineering source ev luations and source evaluation audits shall be filed 1
and retained in accordance with Section 17 and the applicable QA procedures.
1 The Project QA Engineer ; hall inspect and audit contractors and sub-contractors at suitable intervals to verify that they comply with quality requirements and to assess the effectiveness of their QA program.
Suppliers shall provide objective evidence that packagings and associated items, including repaired or spare parts, meet all quality requirements.
All items 20 1642 136
E-1473 Rev. 1 shall be properly identified.
Appropriate records shall be ava.able prior to use or installation to permit verification of conformance with procurement documents.
These records shall be retained accessibly (See Section 17).
The supplier shall furnish to TN all documentation which identifies all procurement requirements which have toge,ther with nonconformance reports dis-not been met positioned " accept as is" or " repair".
These documents shall be reviewed by the Project Manager and TN's design agent (if applicable)- to assure conformance with the license application.
The Project QA Enginer shall accept these documents in writing.
Supplier's certificates of conformance for safety related material and components furnished to TN shall be periodically evaluated by audits, independent inspections or tests to assure that they are valid.
The frequency I
and extent of these evaluations shall be related to the safety importance of the procured material or equipment.
1 An acceptance test program approved by TN shall be performed for each packaging, in accordance with the requirements of the certificate of compliance and/or the packaging application.
TN or its agents shall perform receiving inspections on safety related components and equipment furnished to TN, to assure that the component or equipment is properly identified and corresponds to the receiving documentation.
The inspections shall verify that the component or equipment conforms to the requirements of previously established criteria.
These inspections shall be performed utilizing previously established inspection instructions.
Fabrica-tion records, acceptance test records and certificates of conformance shall be available at TN's facilities prior to first use of the component or equipment by TN.
21 1642 137
E-1473 Rev. 1 Safety related component and equipment suppliers shall have QA programs which contain measures equivalent to the above, and in addition assure that accepted material, components and equipment are identified as to their 1
inspection status prior to forwarding them to a controlled storage area or releasing them for further work or installation.
Nonconforming materials, parts or components shall be controlled in accordance with Section 15.
I642 138 22
E-1473 Rev. 1 8.
IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS Measures shall be established and implemented to identify and control materials. parts, and components.
These measures shall assure identification of an item
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by an appropriate means during the fabrication, install-ation and use of the item and shall prevent the inadver-tent use of incorrect or defective items.
The requirements for identification shall be established during the pre-paration of procurement specifications and design drawings.
1 The methods and location of identification information shall be selected so as to not adversely affect the fit, function or quality of the items being identified.
The identification and control of safety-related items shall be traceable through procurement, fabri-cation, inspection and test records.
Correct identifi-cation of components, materials and components shall be 1
verified and documented prior to release of the equip-ment, materials or components for fabrication, assembly shipping and installation.
1642 139 23
E-1473 Rev. 1 9.
CONTROL OF SPECIAL PROCESSES Measures shall be established and implemented for the control of special processes used in the manufacture and repair of packagings.
These processes include welding, non-destructive testing and other processes special to a specific packaging.as identified in the application for packaging approval.
Special processes shall be performed in accordance with approved written procedures.
Personnel who perform special processes shall be formally trained and qualified in accordance with applicable codes, standards or specifi-cations.
Qualification records of procedures and personnel shall be filed and kept current by the organization which performs the special process.
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1642 140 24
E-1473 Rev. 1 10.
INSPECTION Measures shall be established and implemented to inspect materials, parts, processes or other activities affecting quality to verify conformance with documented instructions, procedures, specifications, drawings, or other procurement documents.
These inspections sinall be performed by personnel other than those who performed the activity being inspected. Inspectors shall be qualified in accordance with the applicable codes, standards, and the training programs of TN or its contractors.
Inspector qualifications and certifications shall'be maintained current and these records snall be retained in accordance with Section 17 of this Program.
Inspections shall be performed in accord with approved, written instructions and procedures.
The instructions
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and procedures shall include and address acceptance criteria; identify-the characteristics-and activities to be inspected; identify the individcals or groups responsible for performance of en' inspection operations; describe 1
the method of inspection; record evidence of completion and verifying of a manufacturing, inspection or test operation; and record the identity of the recording inspector or data recorder and the results of the inspection operation.
When direct-inspection is not possible, provisions shall be established for-indirect control by monitoring processing methods, equipment, and personnel.
Mandatory hold points shall be established for inspections or witnessing, as required.
Work shall not proceed beyond a hold point without the consent of the designated inspector.
1642 141 25
E-1473
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Rev. 1 Modifications and/or repairs to and replacements of safety related components or equipment shall be inspected 1
in accordance with the original design and inspection requirements or acceptable alternatives.
1642 142 26
E-1473 Rev. 1 11.
TEST CONTROL A program shall be established and implemented to perform required proof, acceptance and operational tests, as identified in procurement documents and the application for package app,roval.
The tests shall be performed by qualified personnel in accordance with approved, written instructions, precedures and/or checklists.
Test procedures shall incorporate er reference the applicable requirements and acceptance,
limits contained in the design and procurement documents; instructions for performance of.the test; test prerequisites such as test equipment requirements, personnel qualification 1
requirements, fabrication or operational status of the item to bt tested, and the provisions for data recording
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and retention; and mandatory inspection hold points to allow witnessing by TN or it's agents.
Test results shall be documented and evaluated.
They shall demonstrate that acceptance criteria have been met.
Acceptance of test results for a specific project shall be acknowledged in writing by the TN Project Manager for that project or his designee.
1 Tests performed after modifications, repairs or replacements of safety related components or equipment shall be performed in accordance with the original design and testing requirements or acceptable alternatives.
1642 143 27
E-1473 Rev. 1 12.
CONTROL OF MEACURING AND TEST EQUIPMENT Measures shall be established and implemented to assure that tools, gages, instruments and other measuring and testing devices used in activities affecting quality are properly coqtro.11ed, calibrated and adjusted to maintain accuracy within necessary limits.
These measuring devices shall be calibrated at scheduled intervals against certified standards having known, valid relationships to national standards. All calibrations shall be performed in accordance with approved written procedures.
Measuring and test equipment shall be identified and traceable to the calibrat' ion records, and shall be labeled or tagged indicating the next required calibration date. Standards utilized for calibration of measuring
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and test equipment shall have an uncertainty requirement of no greater than one-fourth of the tolerance of the equipment being calibrated, unless limited by the state of the art of the equipment or calibrating standard.
1 When measuring and test equipment is found to be out of calibration, measures shall be taken and documented to determine the validity of inspections performed during the period the equipment was out of calibration.
The complete status of all measuring and test equipment under the cal-ibration system-shall be recorded and main-tained.
at Test equipment shall be subjected to a ptoof test to demonstrate that it performs its intended function prior to its use for testing packaging components or the complete packaging.
1642 144 28
E-1473 Rev. 1 Operational checks shall be performed on test equip-ment, as required, to assure that the equipment is still functioning properly prior to actual testing of packaging components or the complete packaging.
1642 145 29
E-1473 Rev. 1 13.
HANDLING, STORAGE AND SHIPPING Measures shall be established and implemented to assure that all materials, components, assemblies, spare parts, special tools, equipment and the packaging itself are handled, stored, packaged and shipped in a manner which prevents damage, loss of identity or deter _aration.
These activities shall be carried out in accordance with written approved procedures.
When necessary, storage procedures shall address special requirements for environmental protection such as inert gas atmospheres, moisture, temperature levels, etc.
Shipping procedures shall assure that all conditions f
of the Certificate of Compliance are satisfied prior to delivery of radioactive material to a carrier for transport in an approved package.
1642 146 30
E-1473
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14.
INSPECTION, TEST AND OPERATING STATUS Measures shall be established and implemented to assure that the status of required inspections and tests of packagings and associated items are clearly indicated by some suitable means, e.g.
tags, labels, cards, form sheets, check lists, etc.
The status of nonconforming items is of particular concern (see Section 15).
By passing of required inspections, tests, or other critical operations shall be controlled in accordance 1
with written procedures or instructions by the TN QA Engineer and/or TN's inspection agent.
Where appropriate, the operating status of components
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of the packaging, e.g.
valves, switches, etc. shall be indicated to prevent inadvertent operation.
The application and removal of status indicators shall be in accord with approved written instructions and procedures.
1642 147 31
E-1473 Rev. 1 15.
NONCONFORMING MATERIALS, PARTS OR COMPONENTS Measures shall be established and implemented to control materials, parts, and components which do not conform to requirements so as to prevent their inadver-tent use in subsequent manuf acturing operations or during service.
These measures shall be described in approved written instructions and procedures.
The nonconforming items shall include items which do not meet specification or drawing requirements, as well as items which are not fabricated or tested in accordance with approved written procedures or by qualified processes or by qualified personnel, where the use.of such procedures, processes or personnel is required by the fabrication, test, inspection
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or quality control documents.
Nonconforming items shall be identified and segregated to prevent their inadvertent use.
Nonconformance reports shall be utilized for the procedural control of nonconfor-mances.
They shall describe the nonconformances and provide for their disposition.
Inspection requirements for nonconforming items following rework, repair or modification shall be detailed in the nonconformance reports which shall be approved and signed following completion of the disposition. The acceptability of the 1
rework or repair of nonconforming materials, parts, and components shall be verified by reinspecting and/or retesting the reworked or repaired item to the original requirements, or by a method which is at least equal to the original inspection and/or testing method. Inspection, testing, rework, and repair precedures shall be documented and controlled.
32 1642 148
E-1473 Rev. 1 Nonconformance reports shall be utilized to notify other affected organizations.
Items which are not in 1
conformance with TN approved documents shall be reviewed by TN's Project Manager and QA Engineer.
Their disposition shall be approved by TN's QA Engineer.
Nonconformances with documents such as fabrication details, which may not require TN approval, may be resolved without TN s
approval by major participating organizations, as appropriate, in accord with their approved QA programs.
Nonconformance reports shall be made part of the inspection records.
They shall also be reviewed periodically to identify quality trends.
The results of these reviews shall be reported to management for their assessment.
Procedures shall be established and implemented to report defects and noncompliances in accord with the
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provisions of 10 CFR 21.
16L2 149 33
E-1473 Rev. 1 16.
CORRECTIVE ACTION Measures shall be established and implemented to assure that conditions adverse to quality are promptly identified and corrected to preclude repetition.
s Personnel responsible for quality assurance shall periodically review nonconformance reports and operating reports relating to failures, malfunctions and deficiencies to assess the need for corrective actions.
They shall advise their respective managements of such needs, document decisions and appropriate courses of action, and perform the necessary follow up to verify that the corrective actions have been taken.
1642 150 34
E-1473 Rev. 1 17.
QUALITY ASSURANCE RECORDS For each packaging, or other safety related component 1
or equipment, a program shall be established and implemented to assure that sufficient written records are maintained to furnish evidence of activities affecting quality.
These records include, but are not limited to, design records, records of use and the results of reviews, inspections, tests, audits, monitoring of work performance, materials analyses, and related procedures such as qualifications of personnel and equipment.
The record program shall be based on ANSI N45.2.9 " Requirements for Collection, Storage, and Maintenance of Quality Assurance Records for Nuclear Power Plants".
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Quality assurance records shall be collected by the originating organization as the documents are completed.
They shall be stored by these organization (s) until delivery of the packaging, component or equipment.
The requirements and responsibilities for record transmittals, record retention, and maintenance by the originating organiza tion (s) prior to completion of the work shall be in accordance with the applicable codes, standards, procurement documents, and the organizations' QA program.
Approved, written procedures shall be utilized to control and maintain QA records.
1 Inspection and test records shall contain, where applicable, the description of the type of observation; evidence of the completion and verifiestion of a manufacturing, inspection, or test operation; the date and results of the inspection or test; any information related to conditions adverse to quality; the identification of the inspector, 35 1642 151
E-1473 Rev. 1 data recorder, or test operator; and evidence of the acceptability of the test or inspection results.
The record program shall identify which types of records are to be transmitted to TN for retention at TN and which ones shall be retained by the originating organization in accord with procurement document requirements, Section 4.
" Lifetime" records shall be retained by TN.
The records shall be identified, indexed and stored in 1
accessible locations. The record storage facility shall be constructed, located and secured in accordance with written procedures to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature and humidity.
Alternatively, duplicate storage of records at two separate and segregated locations may be utilized to prevent loss or destruction.
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Maintenance of records at TN shall be in accord with written approved procedures.
These procedures shall address duration of storage, responsibilities for safekeeping, preservation, and disposition of nonpermanent records.
Maintenance of records at participating organizations shall be in accord with their approved program.
1642 152 36
E-1473 Rev. 1
<^
18.
AUDITS A comprehensive program of planned and periodic audits shall be established and implemented by TN to verify compliance with all aspects of the TN QA Program and to determine its effectiveness.
The audit program shall include auBits by TN of it's suppliers' QA programs,
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procedures and activities to verify and evaluate that the suppliers' procedures and activities are meaningful 1
and comply with the overall QA Program.
Suppliers of safety related equipment, material or services to TN shall implement a program to verify compliance with all aspects of their QA program and to determine its effec-tiveness.
1 The audit program shall describe the areas to be
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audited, such as design activities, fabrication, testing, use, maintenance and repair of packagings.
The schedule for such audits shall be based upon the safety importance of the activities being audited.
The audits shall be performed by qualified personnel not having direct responsibilities in the areas being a'ud i ted.
The audits shall be conducted in accord.with written approved procedures and/or check lists.
Audit results shall be documented, and shall be reviewed with personnel having responsibility for the area audited.
Agreements on corrective actions and schedules for implementation shall be established and recorded.
Reaudits of deficient areas shall be scheduled on a timely basis to verify implementation of agreed upon corrective actions.
Audit reports shall include an 1
objective evaluation by the auditor of the quality re-lated practices, procedures and instructions for the 37 1642 153
E-1473 Rev. 1 area or activity being audited and the effectiveness of their implementation.
Audit reports shall be distributed to management.
The reports shall be reviewed for indications of adverse trends which could affect quality.
If the results of such assessments so_ indicate, pertinent sections of the QA program shall be revised.
Audits of project activities for which TN has direct responsibility shall be performed by the project QA 1
Engineer, except for audits of activities under his cognizance.
The latter shall be perfor~med by qualified personnel, nominated by TN's President, who have no responsib'lity for the activities being audited.
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1642 154 38 m,
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