ML19289D846

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QA Program Per 10CFR71
ML19289D846
Person / Time
Site: 07100271
Issue date: 12/19/1978
From:
EGGERS, RIDIHALGH PARTNERS, INC.
To:
Shared Package
ML19289D844 List:
References
NUDOCS 7903190086
Download: ML19289D846 (15)


Text

.

RiolHAtaH EGGERS & ASSOCIATES

-riVIO PPM NO: 79 REV: 1 POLICIES AND PROCEDURES MANUAL

-- m J. EFFECTI22:

Dec. 19, 1978 PAGE:

1 C

P, _;

CORPORATE QUALITY ASSURANCE PROGRAM 1

1.0 PURPOSE This policy sets forth the commitment of Ridihalgh, Eggers and Associates (REA) to comply with the applicable Quality Assurance Criteria of Appendix B to Title 10 Code of Federal Regulations, Part 50 (10CFR50) with the Quality Assurance Criteria of Appendix E to 10CFR71, and with all contractual requirements.

REA is responsible for the development, implementation, and validation of a continuing maintenance plan for equipment and/or its operation to achieve stated objectives for users of such equipment.

2.0 APPLICAB,ILITY The commitments of this policy apply to activities affecting design, engineering analysis, the quality of structures, systems, and components which are (1) identified by REA as safety-related equipment items, (2) identified by Appendix E of 10CFR71, and (3) identified by other Federal Regulations applied in a graded approach, i.e., to the extent consistent with their importance to safety and/or contractual requirements.

3.0 DEFINITIONS Quality Assurance - comprising all those planned and systematic actions necessary to provide adequate confidence that a system or component will meet the regulatory requirements and perform satisfactorily in service.

Component - a part, assembly, or combination of parts, subassemblies, and assemblies mounted together to perform a design function.

Systems - composed of piece parts, components, subassemblies, and assemblies to perform a design task.

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PPM NO: 79 REV:1 EFFECTIVE:Dec. 19, 1978 PAGE:

2 4.0 RESPONSIBILITIES 4.1 The President of REA is responsible for the maintenance of an effective quality assurance program for REA.

4.2 The Manager of Quality Assurance for REA'is delegated responsibility for the implementation of and ensuring compliance with the REA Corporate Quality Assurance Program.

4.3 The Management Quality Assurance Review Committee is responsible for evaluating the sufficiency and effectiveness of the quality assurance program.

4.4 The organizations whose activitias affect quality are responsible to assure their procedures implement the objectives of this policy.

5.0 COMPANY POLICY CONCERNING OUALITY ASSURANCE 5.1 Organization This section sets forth the policy of REA concerning organization for the assurance of quality.

It also delineates those organizations, within REA, whose activities make a direct contribution to the quality assurance function.

The assurance of quality at REA is an interdisciplinary function which involves several disciplines.

Furthermore, quality assurance encompasses many diversified functions and activities and extends to various job levels, including all executives and all employees whose activities affect quality.

The implementation of quality assurance throughout the various functions of design, engineering analysis testing, procurement, and construction at REA, must therefore, be considered the direct responsibility of the organization performing the work and cannot be considered the sole domain of any single quality assurance group.

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PPri 110: 79 REV: 1 EFFECTIVE: Dec. 19, 1978 PAGE:

3 Persons or organizations charged with the development, the enforcement or the measurement of the sufficiency and effectiveness of the quality assurance program shall have thd authority and organizational freedom necessary to effectively discharge those responsibilities.

Such persons or organizations shall be independent of direct pressures of cost, schedule or production, and their authority and organizational freedom shall be sufficient to (1) identify quality problems; (2) intitiate, recommend, or provide solutions; (3) verify implementation of solutions; and (4) withhold and segregate nonconforming material or other action for maintaining program integrity.

Furthermore, they must have direct access to responsible management at a level where appropriate action can be mandated.

Persons performing such quality assurance functions as checking, verifying or reviewing the work of another (functions which do not encompass the development, enforcement or measurement of the sufficiency or effectiveness of the REA Corporate Quality Assurance Program), shall have authority and organizational freedom to a degree sufficient to properly discharge their assigned quality assurance responsibilities.

However, when authority and organizational freedom are restricted for any person performing quality assurance functions, an established line of communication to responsible management must exist sufficient to prevent the suppression of those quality assurance functions.

Final responsbility for the effectiveness and sufficiency of the REA Corporate Quality Assurance Program shall reside with REA; however, REA may delegate the establishment and execution of the Program, or any part thereof, to other organizations. These organizations may, in turn, delegate responsibility for applicat'e portions of the Program to other organizations. Whenever such delegation occurs, the organizational structure for the assurance of quality of those to whom this responsibility is delegated shall, in principle, conform to this organizational policy to an extent consistent with the importance of their work to quality.

Organizational structuring for the assurance of quality by those to whom such responsibility has been delegated shall be subject to the approval of the delegator and the

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PPM NO: 79 REV:

1 EFFECTIVE: Dec. 19, 1978 PAGE:

4 delegator shall adequately monitor the implementation of the organizational structuring for compliance with such approval.

The President of REA is responsible for the maintenance of an effective quality assurance program for REA.

Responsibility for the establishment, administration and enforcement of the REA Corporate Quality Assurance Pro-gram has been delegated by the President to the Manager of Quality Assurance.

The Quality Assurance Department functions as a staff position reporting to the president, is independent of all other Company organizations, and assumes line responsibility for ensuring compliance with the REA Quality Assurance Policy.

Also reporting to the President, but having direct line responsibility for the equipment and operations is the Vice-President and General Manager of the Engineering Services.

Figure 1 indicates the organizational reporting authorities.

In addition to the above, an independent group whose primary responsibility is the assurance of quality at REA has been established. The group is:

The Management Quality Assurance Review Committee which has the responsibility to determine the sufficiency and effectiveness of the quality assurance program, assure compliance with the Company's Quality Assurance policy, and resolve quality problems and conflicts identified and referred to the committee for action.

The Presi-dent is chairman of the committee.

An REA manager, is one member, the Manager of Quality Assurance is secretary and a non-voting member.

Other members are appointed by the President.

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PPM NO:

79 REV: 1 EFFECTIVE: Dec. 19, 1978 PAGE:

5 5.2 R#dthalgh, Eggers and Associates Corporate Quality Assurance Program i

This section sets forth the policy of REA concerning the quality assurance program for REA.

This program consists of the quality assurance programs of (1) REA, (2) contractors, design / consultants, suppliers, etc. under contract to REA performing activities affecting quality, and (3) suppliers to the above organizations.

The quality assurance programs of organizations under contract to REA and the programs of their suppliers are subject to approval by the REA Manager of Quality Assurance prior to inclusion in the REA Program.

The REA Corporate Quality Assurance Program (REA Program) complies with the quality assurance requirements of 10CFR50, Appendix B; 10CFR71, Appendix E, and related statutory / regulatory and customer contractual requirements.

The programs of contractors, design / consultants, suppliers and subsuppliers which are a part of the overall REA program, comply with the importance of their work to quali ty.

Those portions of the REA Program attributable to organizations under contract to REA will terminate at the completion of their delegated work.

The REA Program is documented by this policy, and implemented through procedures or instructions.

These courses of action are delineated in writing, prepared prior to the start of an activity, specific in nature, bear management approval and shall be continuously controlled.

They are designed such that activities affecting quality are accomplished under suitably controlled conditions, which include (1) the use of appropriate equipment, (2) suitable environmental conditions for accomplishing the activity, and (3) assurance that all prerequisites for the given activity have been satisfied. 'They take into account the need for special controls, processes, test equipment, tools and skills to attain the required quality and the need for verification of quality by inspection and test.

The REA Program provides for the indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained.

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PPM N0: 79 REY: 1 EFFECTIVE: Dec. 19, 1978 PAGE:

6 Assessment of the status and adequacy of the REA Program and the effectiveness of the REA Quality Assurance Department is made at least annualy under the direction 6f the Management QA Review Comittee.

The REA quality assurance activities and those of organizations under contract to REA are audited by the REA Quality Assurance Department in accordance with an approved audit schedule.

Responsibility for the assessment of the qualtiy assurance activities of suppliers to REA contractors is inherent in their contractual requirements. All contacts by REA with any supplier to an REA contractor will only be through that contractor.

5.3 Design Control This section sets forth the policy of REA concerning the control of design.

It shall apply to design activities whether accomplished by REA or by other organizations to Vhich design responsibility has been delegated.

It is the policy of REA that design shall be accomplished within the framework of a system of design control.

This system shall be structured to provide assurance of design adequacy through the planned, controlled and documented application of reviewing, checking, re-evaluating or verifying processes. The system shall assure the incorporation of all regulatory requirements, design bases and appropriate standards of quality into design documents and provide for the control of deviations from such quality standards.

All characteristics of design such as physics, stress, thermal, hydraulic and accident analyses, compatibility of materials, accessibility for in-service inspection, maintenance and repair, and delineation of acceptance criteria for inspections and tests shall be performed within the framework of the system which shall, by independent re-evaluation, assure that selected materials, parts, equipment and processes are suitable for the indicated application.

Independent re-evaluation of design shall take the form of (1) a design review, (2) a check of the adequacy of design by a competent person (not involved with the original design) using alter-nate or simplified calculational methods, or (3) an implementation of a suitably controlled testing program, performed under the most adverse design conditions.

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PPtt N0: 79 REV: 1 EFFECTIVE: Dec. 19, 1978 PAGE:

7 Changes in design, including field changes, shall be subjected to the same rigorous examinations and re-evaluations as the original design, and shall be performed within the framework of the design control Design changes may be made by technically system.

competent personnel when delegated by REA but all such changes are approved by REA.

All changes are reviewed for compatibility with performance requirements, effectiveness, retroactivity, retrofit, and for changes required in the Qaality Assurance Plan.

5.4 Procurement Document Control This section sets forth the policy of REA concerning the control of procurement documents.

It shall be the policy of REA that (regardless of the organization initiating a purchase) the suppliers of materials, equipment or services shall receive controlled procurement documents which contain or reference all applicable regulatory requirements, appropriate design bases and other requirements necessary to produce a product or service which meets REA's quality requirements and fulfills REA's commitments.

In addition, procurement documents shall contain provisions which require suppliers and their subsuppliers to execute quality assurance programs in a manner and to an extent acceptable to REA.

Furthermore, procurement documents shall provide for the right of REA to audit its contractors on their implementation of these controls to his suppliers.

5.5 Instructors, procedures and Drawings This section sets forth the policy of REA with respect to instructions, procedures and drawings.

It is the policy of REA that all activities affecting the quality of structures, systems, components, and/or their operation, shall be accomplished in accordance with written, controlled instructions, procedures, or drawings of a type appropriate to accomplish the desired Such documents shall include necessary quality purpose.

standards so that the satisfactory accomplishment of quality relcted activities and services may be determined.

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PPM NO: 79 REV: 1 EFFECTIVE: Dec. 19, 1978 PAGE:

8 5.6 Document Control This section sets forth the policy of REA with respect to the control of documents.

It is the policy of REA that all documents prescribing activities affecting quality shall be controlled such that they are reviewed for adequacy and approved for release by authorized personnel, distributed in a manner which assures that the applicable issues are available and used at the work source.

Furthermore, the system of document control shall b' so structured that changes to quality related documents will receive the same degree of review and approval as the original documents although the reviewing and approval organization may be different.

5.7 Control of Purchased Material, Equipment and Services This section sets forth the policy of REA with respect to the control of purchased material, equipment and services.

It is the policy of REA to establish appropriate measures to assure that purchased materials, equipment or services conform to procurement document requirements.

It is recognized that suppliers of the above may differ greatly in size, organization and methods of quality administration.

REA shall, therefore, institute such evaluation, inspection, audit or assistance measures as may be necessary to assure (1) that suppliers are capable of performing the specified activities, (2) that objective evidence of the accomplishment of quality and procurement requirements is obtained, and (3) that shipment has not been detrimental to the item.

Furthermore, the measures shall provide that documentation attesting to the accomplishment of quality shall be received at the job site prior to installation of the item and that this documentation shall be retained as required by applicable regulations and in accordance with Records Management procedures.

5.8 Identification and Control of Materials, Parts and Comoonents This section sets forth the policy of REA with respect to the identification and control of materials, parts and components.

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PPM NO: 79 REY: 1 EFFECTIVE: Dec. 19, 1978 PAGE:

9 It is the policy of REA to establish measures for the identification and control of materials, parts and components to prevent the use of incorrect or defective items.

5.9 Control of Special Processes This section sets forth the policy of REA with respect to the control of special processes.

It is the policy of REA to establish measures to assure that special processes such as welding, heat treating, and nondestructive evaluation, which affect the quality of structures, systems or components are accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications criteria and other special requirements.

5.10 Inspection This section sets forth the policy of REA with respect to inspection.

It is the policy of REA to establish and maintain a program for the inspection and verification of the quality of structures, systems, components, and/or their operation.

Inspection activities shall be accomplished through the use of written procedures, checklists, or other inspection aides which are based upon documented procedures, instructions and drawings.

Should inspection of materials or products be impossible or disadvantageous, indirect control by the monitoring of processing methods, equipment and personnel will be acceptable; however, where proper control is not obtainable by inspection or process monitoring alone, the two methods shall be used in combination.

When inspection procedures include mandatory " hold points," which require witnessing by inspector or his representative, work shall not proceed beyond such points without the consent of the inspector.

5.11 Test Control This section sets forth the policy of REA with respect to test control.

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PPM N0: 79 REV: 1 EFFECTIVE: Dec. 19, 1978 PAGE:

10 It is the policy of REA to establish and maintain a controlled program for the testing of structures, systems components, and/or their operation, to provide assurance that such structuras, systems, components, and/or their operation are satisfactory for service within the limits specified. The test and/or operating program shall assure that all required tests and/or operations are identified and performed in accordance with acceptance limits contained in applicable documents.

The testing or operating program shall include, as appropriate, (1) proof tests prior to installation, (2) pre-operational tests, (3) operational tests, or (4) applicable combination of these tests.

The program shall assure that prerequisites for a given test or operation are specified and met, that adequate test instrumentation is available, that the tests are performed under suitable environmental conditions and that the results of the tests are documented and evaluated by competent individuals to assure that test requirements have been satisfied.

5.12 Control of Measuring and Test Equipment This section sets forth the policy of REA with respect to the control of measuring and test equipment.

It is the policy of REA that procedures be written, approved and implemented to assure that tools, gauges, and instruments affecting the quality of items are properly identified, controlled, calibrated and adjusted at a stated frequency in order to maintain accuracy requirements.

5.13 Handling. Storage and Shipping This section sets forth the policy of REA with respect to handling, storage and shipping.

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PPri NO: 79 REV: 1 EFFECTIVE:_ Dec. 19. 1978 PAGE:

11 It is the policy of REA to establish measures for the control of handling, storage, shipping, cleaning and preservation of material and equipment in accordance with established instructions, procedures, design requirements, and applicable codes. and standards to prevent damage or deterioration.

When necessary for particular items, special coverings, special equipment, and special protective environments, such as inert gas atmosphere, specific moisture content levels, and temperature levels, shall be specified and provided.

Storage time limits will be specified when applicable.

5.14 Inspection, Test and Operating Status This section sets forth the policy of REA with respect to inspection, test and operating status.

It is the policy of REA to establish measures to assure that the status of tests and inspections pertaining to structures, systems or components is clearly indicated.

The indications shall be made by markings such as stamps, tags, labels, routing cards or other suitable means which are on or immediately adjacent to the item.

The measures shall provide for the identification of items which have satisfactorily passed required inspection and tests, where necessary, to preclude inadvertent bypassi_ng of such inspections and tests.

Furthermore, it is the policy of REA to identify structures, systems or components which are inoperable or not to be operated by the use of tags, locks or other suitable means to prevent inadvertent operation.

5.15 'Nonconformance This section sets forth the policy of REA with respect to nonconforming materials, parts, or components.

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PPM N0: 79 REV: 1 EFFECTIVE: Dec. 19. 1978 PAGE:

12 It is the policy of REA to establish measures to prevent improper operation or the inadvertent use or installation bf materials, parts, components, or systems which do not

' conform to the requirements of applicable standards, codes, license commitments, procurement specifications, or procedures. These measures shall, as appropriate, provide for the identification, documentation, segregation, disposition and notification to affected organizations.

Nonconforming items shall be reviewed and accepted, rejected, or reworked in accordance with documented procedures.

5.16 Corrective Action This section sets forth the policy of REA with respect to corrective action.

It is the policy of REA to promptly identify and correct conditions such as failurcs, malfunctions, defective material or equipment, or non-:onformances which are adverse to the quality of structures, systems, components, or operations.

Should the adverse condition be deemed significant, measures shall assure that the cause of the condition is determined, and that corrective action is taken to preclude recurrence.

The identification of the significant condition adverse to quality, the cause, and the corrective action taken are to be documented and reported to appropriate levels of management.

5.17 Quality Assurance Records This section sets forth the policy of REA with respect to quality assurance records.

It is the policy of REA to maintain sufficient records which furnish evidence of activities affecting the quality of structures, systems, and components in accordance with regulations and established Records Management records retention procedures.

These records shall, as a minimum, include operating logs and the results of inspections, tests, reviews, audits, monitoring of work performance and materials analysis together with their necessary supporting data such as qualifications of personnel, procedures and equipment.

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PPM NO: 79 REV:

1 EFFECTIVE: Dec.19,1978 PAGE:

13 Inspection and test records -shall, as a minimum, iden.ify the inspector or data recorder, the type of observation, the results-and the action taken in connection with any deficiencies noted. All records shall be' identifiable and retrievable.

5.18 Audits This section sets forth the policy of REA with respect to audits.

It is the policy of REA to implement a program of planned and periodic audits to verify compliance with all aspects of the REA Program and to determine the effectiveness of the REA Program. The audit program, conducted by the REA Quality Assurance Department, shall be implemented in accordance with its approved audit procedures, by appropriately trained personnel who have no responsibility in the areas audited. Audit results shall be documented, submitted to appropriate management personnel for corrective action as required and all necessary follow up of corrective action verified.

The sufficiency and effectiveness of the REA Program is to be assessed at least annually under the direction of the REA Management QA Review Committee.

Records of audits and audit results shall be retained as program records in accordance with established retention schedules.

6.0 OPERATIONS AND MAINTENANCE Because the quality Assurance controls covering operations and maintenance of spent fuel transport packaging and other related products are unique from the design and fabrication of these packages or products, a list of check points for verifying that appropriate planned actions are accomplished prior to the use of the package or device is attached in Appendix A.

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PPM NO: 79 REY:

1 EFFECTIVE: Dec. 19. 197 PAGE:

14 FIGURE 1 REA and Contractor Organization Chart i

i PRESIDENT i

RIDIHALGH, EGGERS AtlD ASSOCIATES VICE PRESIDE?lT ENGIflEERIllG SERVICES l

l PROJECT MAtlAGER QUALITY ASSURAtlCE PROJECT EllGIflEER I

i 8

SUBCONTRACTORS

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PPM N0: 7o REV: 1 EFFECTIVE: Dec.19, 1978 PAGE:

15 APPEllDIX TO CORPORATE QUALITY ASSURANCE PROGRAM. - APPENDIX. A QUALITY ASSURANCE CONTROLS FOR OPERATIONS AND MAINTENANCE The following check list shall be used by Quality Assurance during program design and fabrication to ensure that appropriate planning is accomplished prior to actual product use in the field (check list with details to be included in Manuals and Instructions):

1.

Before and After Use Inspections 2.

Loading 3.

Unloading 4.

In-Transit 5.

Periodic Maintenance

- Each time - before and after

- Monthly.& Quarterly

- Annually & Other Periods 6.

Special Inspections 7.

Moving " Empty Cask" to/from location 8.

Special & Standard Tools and Fixtures 9.

Spares 10.

Lifting Devices - inspections 11.

Records for Cask and related equipment, logs, and other documentation 12.

Initial training and retraining 13.

Trailer maintenance and inspections (as applicable) 14.

Overall responsibilities of User and of Owner 15.

Storage (when not in usel 16.

Field Technical Assistance 17.

Standard Repairs 18.

Other

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