ML20098G327
| ML20098G327 | |
| Person / Time | |
|---|---|
| Site: | Calvert Cliffs  |
| Issue date: | 09/25/1984 |
| From: | Anuje A BALTIMORE GAS & ELECTRIC CO. |
| To: | Murley T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| References | |
| NUDOCS 8410040378 | |
| Download: ML20098G327 (54) | |
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/%o re.* s ja / y/.erhl 8k/8 BALTIMORE OAS AND 50-317 l ELECTRIC M.Q FORT SMALLWOOD ROAD COMPLEX P.O. BOX 1475 BALTIMORE. MARYLAND 21203 wAun AsamAnce September 25, 1984 Mr. T. E. Murley Regional Administrator U.S. Nuclear Regulatory Commission Region 1 631 Park Avenue King of Prussia, Pennsylvania 19406 SUBJE C: Reporting of Changes to the Quality Assurance Program Under the Requirements of 10 CFR 50.54 QA File MG 3.3 Our Reft QAO K-1460 Dear Mr. Murley -
As requested by your Mr. Napuda in our telecon of September 19, 1984, enclosed is a copy of Section 1B of the FSAR, Revision 3, submitted to the NRC on July 16, 1984 under the requirements of 10 CFR 50.71.
The changes made to the quality assurance program description in this revision were evaluated by us and it was determined that these changes did not reduce our commitments to the quality assurance program description previously accepted by the NRC.
As such, these changes were submitted to the NRC on July 16, 1984 as a part of the annual update of the FSAR in accordance with the requirements of 10 CPR 50.71, as required by 10 CFR 50.54, paragraph (a) (3).
If you have any questions on this subject, we would be pleased to discuss them with you.
Very truly yours, 8410040378 840925
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PDR ADOCK 05000317 Supervisor P
PDR Internal Audits and Programs Unit Quality Assurance Department Enclosure cca Messrs. G. Napuda, NRC Region 1 (with enclosure)
T. Foley, NRC (w/o encl.)
D. H. Jaffe, NRC (w/o encl.)
S. M. Davis (w/o encl.)
R. M. Douglass (w/o encl.)
R. C. L. Olson (w/o encl.)
V. F. Stricklin (w/o encl.)
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TABLE OF CONTENTS Section Page 1 B.1.
ORGANIZATION AND RESPONSIBILITIES IB-1 1B.2 QUALITY ASSURANCE PROGRAM IB-7 IB.3 DESIGN CONTROL 1B-12 1B.4 PROCUREMENT DOCUMENT CONTROL 1B-14 IB.5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 18-16 IB.6 DOCUMENT CONTROL IB-17 IB.7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND 1R-19 SERVICES 1B.8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND 18-23 COMPONENTS 1B.9 CONTROL OF SPECIAL PROCESSES 1B-24 1B.10 INSPECTION 1B-26 1B.11 TEST CONTROL IB-27 18.12 CONTROL OF MEASURING AND TEST EQUIPMENT 18-28 1B.13 HANDLING, STORAGE, AND SHIPPING 1B-30 1B.14 INSPECTION, TEST, AND OPERATING STATUS IB-30 1B.15 NONCONFORMING MATERIALS, PARTS, AND COMPONENTS IB-31 IB.16 CORRECTIVE ACTION IB-31 o
1B.17 QUALITY ASSURANCE RECORDS 18-32 IB.18 AUDITS 18-32
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~1B-1 BG&E COMPANY'S POSITION ON GUIDANCE CONTAINED 1B-34 IN ANSI STANDARDS LIST OF FIGURES Figure No.
1B-1 BALTIMORE GAS AND ELECTRIC COMPANY (BG&E)
CORPORATE ORGANIZATION IB-2 BG&E QUALITY ASSURANCE DEPARTMENT ORGANIZATION P
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IB-2 3
IB-32 0
IB-3 3
1B-33 3
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IB-40 2
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IB-41 0
IB-12 0
IB-42 0
1B-13 0
1B-43 0
IB-14 0
IB-44 0
IB-15 0
1B-45 0
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IB-46 0
IB-17 0
IB-47 0
IB-18 0
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IB-20 0
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- 1B.1 ORGANIZATION AND RESPONSIBILITIES General Responsibilities All levels of organization have definite and unique responsibilities in assuring safe,-
economical, and reliable operation of the Calvert Cliffs Nuclear Power Plant. Top level management is responsible for ensuring that policies are established, resources are authorized, management philosophy and commitments are communicated to lower levels of the organization, independent verification of management controls are performed, results are reviewed, and appropriate actions taken when necessary.
Middle level management is responsible for translating management policies, philosophy, commitments, and goals; applicable federal, state, and local rules and regulations; Operating Licenses, Technical Specifications, and the Final Safety Analysis Report (FSAR) into control programs for activities such as design, procurement, construction, testing, operation, refueling, maintenance, repair, modification, training, plant security, fire protection, records, independent verification, and corrective action. Middle level management is also responsible for defining, measuring, and modifying the overall effectiveness of control programs; taking appropriate action on the results; and keeping top management informed of the status, adequacy, and effectiveness of control programs, and matters which could have an impact on nuclear safety.
First line craf t and non-craf t supervisors are individually responsible for ensuring that appropriate procedures are understood and used to implement each activity described in the control programs; identifying problems, seeking solutions, verifying implementation of solutions; investigating root causes of problems and taking preventive actions; ensuring that conditions adverse to plant and personnel safety are promptly identified, reported, and corrected; detecting trends which may not be apparent to a day-to-day
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observer, recommending generic solutions for adverse trends to management, and taking appropriate actions, to achieve desired results; ensuring that employees assigned to do a job are properly qualified through appropriate training and experience; have properly qualified procedures, tools, equipment, and parts to do the job, and, ensuring that indepndent inspections of work are conducted in accordance with preestablished requirements. First line non-craft supervisors are responsible to ensure that procedures are written, reviewed, and approved; first !!ne craft supervisors may not have this responsibility. Non-supervisory personnel acting as job directors are responsible for ensuring that properly qualified procedures are understood and used; and ensuring that tools, equipment, and parts are on hand to do the job.
Nen-supervisory personnel are responsible for adhering to the established procedures, interpreting them conservatively in case of doubt, and recommending changes when necessary; taking appropriate action so as to minimize personnel injury and damage to the facility and to protect the health and safety of the public in the event of an emergency not covered by an approved procedure.
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Corporate Organization and Soecific Responsibilities The Corporate Organization Chart of the Baltimore Gas and Electric Company (BG&E) is
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shown in Figure IB-i. Persons responsible for the principal elements of the Company's A
Quality Assurance Procram are as follows:
Chairman of the Board President Vice President, Supply Vice President, Engineering and Construction Vice President, Electric Interconnection and Operations Vice President, General Services Manager, Quality Assurance Manager, Nuclear Power Manager, Production Maintenance Manager, Electric Engineering Manager, Project Management Manager, Electric Test Manager, Purchasing and Stores Manager, Real Estate and Of fice Services In addition to these individuals, two advisory groups perform quality-related functions for plant operations. These are the Plant Operations Safety and Review Committee and the Off-Site Safety Review Committee whose makeup and responsibilities are described in the Technical Specifications for the Calvert Cliffs Nuclear Power Plant.
1 A subcommittee of the Plant Operations Safety and Review Committee, the Plant Operating Experience Assessment Committee reviews the operating experience of Calvert Cliffs and other plants of similiar design to determine the applicability of
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significant events to Calvert Cliffs.
Chairman of the Board and President of the Company BG&Ets Quality Assurance Program for nuclear power plants is established under the authority of the Chairman of the Board and the President of the Company, who are responsible for establishing the overall Quality Assurance Policy. They assign project responsibilities to the organizations shown in heavy-lined boxes in Figure iB-1.
The Chairman of the Board assigns authority through the President to the Vice President, Engineering and Construction; the Vice President, Supply; the Vice President, General Services; and the Vice President, Electric Interconnection and Operations.
Responsibilities for implementing the Quality Assurance Program are delegated to designated Department Managers who report to the Vice Presidents of Engineering and 4
Construction, Supply, General Services, and Electric Interconnection and Operations.
Managers delegate their authority as required to implement their responsibilities.
Quality assurance matters that cannot be resolved by the Managers or Vice Presidents are brought to the attention of the President or the Chairman of the Board for resolution.
Vice President, Supply _
The Vice President, Supply is responsible for ensuring that the Quality Assurance Program is developed and administered. The authority to develop and administer the Quality Assurance Program is assigned to the Manager, Quality Assurance. The Vice REV.3 IB-2 m -4& h -
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President, Supply is also responsible for ensuring that the requirements of the Quality
- Assurance Program that relate to the operation and maintenance of the plant are implemented. This responsibility is carried out through the Manager, Nuclear Power; the Manager, Production Maintenance; and the Manager, Quality Assurance.
Manager, Quality Assurance The Manager, Quality Assurance is responsible for the detailed development, direction, and overall coordination of the Quality Assurance Program for the Calvert Cliffs Nuclear Power Plant. This responsibility includes
. 1.
Developing, distributing, and revising the Quality Assurance Manual for Nuclear Power Plants 2.
Reviewing and approving Quality Assurance Procedures and their revisions before they are issued for use 3.
Conducting quality assurance audits to verify that all quality assurance requirements are being implemented 4.
Following up audit responses to determine that action has been taken as required to correct noted deficiencies 5.
Taking necessary corrective action, which can include the stoppage of work when manufacturing, maintenance, or modification activities fail to comply with approved specifications, plans, or procedures. Such corrective action is arranged through appropriate channels and is delegated when necessary. When
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a unit is operating, the Manager, Quality Assurance may recommend to the Plant Superintendent that the plant be shut down. The Plant Superintendent has the final responsibility for the overall evaluation of all aspects and implications of shutting down an operating unit.
BG&E has established that the Manager, Quality Assurance should have at least six years of responsible experience in engineering, design, manufacturing, construction, quality assurance, or power plant operation, as well as a knowledge of regulations and standards related to nuclear power plants..
Personnel who report to the Manager, Quality Assurance are independent of depart-ments and employees responsible for performing specific activities, and have suffi-cient authority and crganizational freedom to identify quality problems; to initiate, recommend, or provide solutions through designated channels; and to verify implementation of solutions.
Quality Assurance Organization The organization of the Quality Assurance Department is shown in Figure IB-2. The Manager, Quality Assurance delegates responsibilities for accomplishing required quality assurance activities as follows:
1.
The Supervisor, Engineering Quality Assurance is responsible for a.
Planning and scheduling evaluations of supplier quality assurance programs.
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- Reviewing and approving the quality assurance provisions' of BG&E procurement documents for safety-related materials, components, parts,
' and services.
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The Supervisor, Internal Audits and Programs is responsible for Controlling, distributing, and revising the Quality Assurance Manual for
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Nuclear Power Plants, b.-
- Coordinating' the preparation of Quality ' Assurance. Procedures and -
tQuality Assurance Department Procedures.
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. Planning, scheduling, and the performance of internal audits, with the exception of those performed at Calvert Cliffs.
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The General Supervisor, operations Quality Assurance is responsible for auditing the safety-related activit.ies of Calvert Cliffs personnel and on-site contractors during operation,. maintenance, repair, modification, in-service inspection, and refueling of the. nuclear power plant. He assigns personnel to audit on-site safety-related activities; to verify by inspection the
- accomplishment of safety-related activities; and to maintain specified records accumulated during the design, construction, and operation phases.
4.
The organization of the Operations Quality Assurance Section is shown also in Figure - IB-2.
Personnel in' this Section are stationed at Calvert Cliffs to yy accomplish the following activities:
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a.
The Supervisor, Quality Assurance Auditing'is responsible to the General Supervisor, Operations Quality Assurance for performing surveillance and
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audits of safety-related activities associated with plant operation, maintenance, repair, refueling, and modification. He is assisted in this effort by Quality Assurance Specialists.
b.
The four Supervisors, Quality Control are responsible to the General Supervisor, Operations Quality Assurance for receiving inspection and the inspection, during maintenance, repair, modification, and refueling operations, of instrumentation and controls, electrical equipment and systems, and mechanical equipment and systems. They are assisted in
~ this effort by Receiving Inspectors, by. Quality Control inspectors from within their units, by inspectors from other Departments if technical expertise in a specific area is required, or by outside contractors if additional manpower is needed.
' Manager, Nuclear Power The Manager, Nuclear Power is responsible for directing the operation and the electrical and instrument maintenance of the Calvert Cliffs Nuclear Power Plant in accordance with BG&E and regulatory requirements.
The organization of the Nuclear Power Department is shown in Figures 12-1,12-2, and 12-3 of the FSAR. The Manager, Nuclear Power delegates responsibilities for accomplishing required activities as follows:
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- The Plant Superintendent is responsible for the operation, chemistry, and maintenance of electrical and control equipment at the Calvert Cliffs Nuclear REY.3 IB-4
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He-must ensure that these activities are conducted in accordance with' the plant operating license and Technical Specifications, the
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FSAR, and theLQuality Assurance Manual for Nuclear Power Plants and its A. E implementing Procedures..
The Plant S' uperintendent delegates responsibilities for accomplishing required activities as follows:
a.
The General Supervisor, Operations is responsible to the Plant Superintendent for the t operation of the plant, including the general supervision of all shift operating personnel, This responsibility covers the safety of applicable plant personnel and equipment, all fuel-handling and refueling activities,' and adherence to applicable license and regulatory requirements.
The General Supervisor, Operations - delegates primary management responsibility to the Shift Supervisor on duty to ensure the safe operation of the plant under all conditions. The Shift Supervisor maintains the broadest possible perspective on operational conditions that affect the safety of the plant. As the senior member of plant management on each shift, he-exercises the command authority of his position to take whatever steps he deems necessary during emergency situations to place and maintain in a safe configuration either unit that may be affected.
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- The General Supervisor, Electrical and Controls is responsible to the Plant Superintendent for the conduct of electrical.and instrument maintenance, repair, and modification needed to keep the plant and its
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facilities, systems, and equipment in safe and efficient working
. condition. He is responsible for planning and supervising or controlling the electrical and instrument maintenance activities conducted by plant
.1 maintenance personnel, also for ensuring that work is performed in a
accordance with' applicable Codes and Standards and that required maintenance records are kept.
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The General Supervisor, Chemistry is responsible to the Plant Superintendent for the chemistry and radiochemistry of the primary and secondary systems, and for maintaining radioactive ' effluents within accepted limits.
2.
.The General Supervisor, Planning and Support is responsible for planning and scheduling Nuclear Power Department activities and maintaining the Record Retention and Retrieval System.
3.
The General Supervisor,. Radiation Safety is responsible for ensuring the radi-ation protection of personnel at Calvert Cliffs.
4.
The-General, Supervisor, Training and Technical Services is responsible for providing technical support, training, operations safety analysis, and Fuel Management Services to the Nuclear Power Department.
5.
Additional details of the responsibilities of personnel who report to the Manager, Nuclear Power are contained in implementing Quality Assurance Procedures,. Nuclear Plant Procedures, and Technical Specifications for the
- Calvert Clifis Nuclear Power Plant.
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Manager, Production Maintenance The Manager, Production Maintenance is responsible for directing the mechanical s
maintenance of and the installation of major modifications to the Calvert Cliffs l
Nuclear Power Plant in accordance with Company and regulatory requirements.
Vice President, Engineering and Construction The Vice President, Engineering and Construction is responsible for ensuring that the l
requirements of the Quality Assurance Program that relate to the design of safety-related ' structures, systems, and components are implemented. This resoonsibility is l
carried out through the Manager, Electric Engineering and the Manager, Project Management.
Manager, Electric Engineering
-.The Manager, Electric Engineering is responsible for directing the efforts of personnel involved in design, modification, and engineering licensing activities for l
the Calvert Cliffs Nuclear Power Plant. These activities include nuclear, civil, mechanical, electrical, transmission, and environmental engineering.
Manager, Project Management The Manager, Project Management is responsible for planning, organizing, directing, and controlling the engineering, procurement, and construction of selected major modification projects at the Calvert Cliffs Nuclear Power Plant.
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Vice President, Electric Interconnection and Operations The Vice President, Electric Interconnection and Operations is responsible for ensuring that the requirements of the Quality Assurance Program that relate to the calibration of
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test equipment and the testing of protective relaying and metering controls for safety-related electrical power equipment are implemented. This responsibility is carried out l
through the Manager, Electric Test.
4 Manager, Electric Test The Manager, Electric Test is. responsible for directing the efforts of personnel in-volved in the calibration of test equipment and the testing of protective relaying and metering controls for the electrical power equipment of the Calvert Cliffs Nuclear Power Plant.
Vice President, General Services The Vice President, General Services is responsible for ensuring that the requirements of l the Quality Assurance Program that relate to the procurement of safety-related struc-tures, systems, and components and to plant security are implemented.
This l responsibility is carried out through the Manager, Purchasing and Stores and the Manager, Real Estate and Office Services.
Manager, Purchasing and Stores The Manager, Purchasing and Stores is responsible for directing the efforts cf personnel involved in the procurement of structures, systems, components, parts, and services related to the design, construction, fueling, maintenance, and modification of the Calvert Cliffs Nuclear Power Plant.
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Manager, Real Estate and Office Services The Manager, Real Estate and Office Services is responsible for plant security and for maintenance of security systems at the Calvert Cliffs Nuclear Power Plant.
1 IB.2 QUALITY ASSURANCE PROGRAM i
General Controls The Baltimore Gas and Electric Company's Quality Assurance Program for the Calvert Cliffs Nuclear Power Plant is applied to structures, systems, components, and activities that have been designated safety-related because they prevent accidents or mitigate the consequences of postulated accidents that could cause undue risk to the health or safety of the public.
This Program is governed by the Quality Assurance Manual for Nuclear Power Plants, which specifies assignment of responsibilities for implementation of the Program and i
establishes responsibilities for controlling and ensuring the quality of safety-related activities.
Controls have been established for specifying on a Quality List (Q-List) all structures, systems, and components that are subject to the requirements of the Quality Assurance Program and also for revising the Q-List.
The Statement of Authority in the Quality Assurance Manual for Nuclear Power Plants, signed by the Chairman of the Board, establishes the overall Quality Assurance Policy of
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the Baltimore Gas and Electric Company. This Statement sets the goal of safe and reli-(.
able operation of Calvert Cliffs; commits the Company to a Quality Assurance Program designed to ensure the plant's compliance with regulatory requirements, BG&E commit-ments, and established practices for reliable plant operation; and requires every person involved in safety-related activities to comply with the provisions of the Program.
The Policy is developed by the Vice Presidents of Engineering and Construction, Supply, General Services, and Electric Interconnection and Operations and implemented by the Quality Assurance Manager and the Managers of Electric Engineering, Electric Test, Nuclear Power, Production Maintenance, Project Management, Purchasing and Stores, and Real Estate and Of fice Services, through appropriate control programs.
l The Quality Assurance Program has established controls for BG&E and its contractors as required to ensure that the criteria of 10 CFR 50, Appendix B, will be met throughout the operations phase of the plant; i.e., during activities of tesFng, operation, mainte-nance, repair, modification, and refueling.
The Manager, Quality Assurance coordinates the development of the Quality Assurance Program and controls the issue and revision of the Quality Assurance Manual for Nuclear Power Plants. Each change to the Manual is issued with a transmittal notice, which is completed by the recipient and returned to the Quality Assurance Department to indi-cate that the documents listed on the transmittal have been received and incorporated into the recipient's Manual. The Manager, Quality Assurance ensures that the Program is revised as regulations, standards, results, or experience dictate. He also determines and evaluates the degree of compliance of safety-related activities with the requirements of the Quality Assurance Manual for Nuclear Power Plants and its implementing Pre- -
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dures. Audits are conducted regularly to ensure compliance with established ret N,_
ments, and the results of these audits are reported to responsible management pe--
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The Vice President, Supply ensures that activities of the Quality Assurance Department are audited regularly by personnel independent of the Department; they assess the effectiveness of the Department': :mplementation of BG&E's Quality Assurance I
Program.
The Vice President, Supply evaluates the report of the independent audit to determine if changes are required to the Quality Assurance Program.
He is responsible for negotiating such changes with the appropriate level of management and for sending to the Chairman of the Board a copy of the audit report and an account of the corrective action taken.
If a difference of opinion arises between Quality Assurance Department personnel and those of other Departments, the dispute is resolved as follows: The Supervisc of the Quality Assurance Unit involved first tries to resolve the matter with the organization responsible for conducting the activity, if a resolution cannot be obtained, the matter is referred up through the following management personnel until it is resolved:
1.
The Manager, Quality Assurance and the Manager responsible for performing the activity 2.
The Vice President, Supply and the Vice President responsible for conducting the activity 3.
The President or the Chairman of the Board To ensure that important activities are performed correctiv, BG&E conducts formal training programs for Company personnel with significant responsibilities. These pro-grams include both initial and continuing training and are conducted in accordance with written procedures or instructions. Department Managers are responsible for ensuring
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that the training needs of personnel in their Departments are identified, formal training
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programs to satisfy those needs are developed, and the training programs in accordance with the requirements of the Quality Assurance Manual for Nuclear Power Plants are implemented.
The Quality Assurance Program was developed to meet the requirements of the industry Standards, and the Regulations and Regulatory Guides of the Nuclear Regulatory Commission (NRC) listed below. Exceptions taken to guidance contained in these docu-ments and equivalent BG&E alternatives are stated in Table IB-1.
REGULATIONS 10 CFR 50.55a - Codes and Standards 10 CFR 50.59 - Changes, Tests, and Ex-periments 10 CFR 50, Appendix B - Quality Assur-ance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants 10 CFR 55 - Operators' Licenses REV.3 IB-8 4
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- 'i REGULATORY GUIDES INDUSTRY STANDARDS 1.8 - Personnel Selection and Training NRC endorses an industry Standard (September 1975)**
.or draf t without reservation l
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This endorses ANSI N18.1 (03/08/71) 1.16 - Reporting of Operating Infor-NRC takes exception to or provides mation (as specified in Calvert Cliffs additional guidance in a regulatory Technical Specifications) position statement 1.30 - QA Requirements for installation,
- BG&E takes exception to guidance Inspection, and Testing of Instrumenta-of fered and states alternatives tion and Electric Equipment (08/11/72)*
This endorses ANSI N45.2.4 (03/01/72) 1.33 - QA Program Requirements (Oper-ation, Rev. 2,02/78)**
This endorses ANS 3.2 (02/19/76)-
1.37 - QA Requirements for Cleaning of l
Fluid Systems and Associated Compo-nents of Water-Cooled Nuclear Power
- Plants (03/16/73)"
This endorses ANSI N45.2.1 (02/26/73)*"
1 1.38 - QA Requirements for Packaging,
'. Shipping, Receiving, Storage, and Han-
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dling of items for Water-Cooled Nuclear 3
. Power Plants (Rev. 2,05/77)"
This endorses ANSI N45.2.2 (12/20/72)"*
1.39 - Housekeeping Requirements for
. Water-Cooled Nuclear Power Plants (03/16/73)*
This endorses ANSI N45.2.3 (03/15/73)"*
1.54-- QA Requirements for Protective Coatings Applied to Water-Cooled Nuclear Power Plants (06/73)"
This endorses ANSI N101.4 (11/28/72)m ANSI N45.2.6 - Qualifications of Inspec-tion, Examination, and Testing Personnel for the Construction Phase of Nuclear Power Plants (1978)"*
1.64
. QA_ Program Requirements for the Design of Nuclear. Power Plants (10/73)*
This endorses ANSI N45.2.11, Draf t 3, Rev.1 (07/73)
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E REGULATORY GUIDES INDUSTRY STANDARDS 1.68 - Preoperational and initial Staitup
[y Test Pro rams for Water-Cooled Power A
Reactors 11/73)**
ANSI N45.2.5 - Supplementary QA Re-quirements for Installation, inspection, and Testing of Structural Concrete and Structural Steel During the Construction Phase of Nuclear Power Plants; Draft 3, Rev.1 (01/74)
ANSI N45.2.8 - Supplementary QA Re-quirements for Installation, inspection, and Testing of Mechanical Equipment and Systems for the Construction Phase of Nuclear Power Plants; Draf t 3, Rev. 2 (09/73)
ANSI N45.2.9 - Requirements for Col-lection, Storage, and Maintenance of Quality Assurance Records for Nuclear c
Power Plants; Draf t (10/76)***
1.144 - Auditing of Quality Assurance Programs for Nuclear Power Plants, Rev.1 (09/80)**
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This endorses ANSI N45.2.12 (1977)
ANSI N45.2.13 - QA Requirements for Control of Procurement of Equipment, Materials, and Services for Nuclear Power Plants; Draf t 2, Rev. 2, (10/73) 1.146 - Qualification of Quality Assur-ance Program Audit Personnel for Nu-clear Power Plants (Aug.1980).*
This endorses ANSI N45.2.23 (1978)***
Procedural Controls The Quality Assurance Program is documented in the Quality Assurance Manual for Nu-clear Power Plants. This Manual contains a Quality Assurance Policy that identifies the NRC regulatory requirements, Industry Standards, and specific Codes applicable to the eighteen criteria contained in 10 CFR 50, Appendix B. The Quality Assurance Policy also indicates action that will be taken by BG&E in response to these documents and to com-mitments made in the FSAR and Technical Specifications for the Calvert Cliffs Nuclear Power Plant. The Policy is approved by the BG&E Vice Presidents of Engineering and Construction, Supply, General Services, and Electric Interconnection and Operations.
The Manual also contains a series of individual Quality Assurance Procedures that implement actions identified in the Quality Assurance Policy. Quality Assurance Proce-dures cover the major activities related to operating a nuclear power plant, such as plant operation, plant maintenance, training, purchase of spare parts, calibrations, etc. Each REV.3 IB-10 9 hU
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.i Quality Assurance Procedure is prepared by one or more of the Departments responsible for conducting the activity. The Quality Assurance Procedure and revisions thereto are
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reviewed and approved by the Managers of all Departments responsible for or affected by V-any. activity described therein. The Manager, Quality Assurance reviews, approves, and issues all Quality Assurance Procedures and revisions thereto.
~ Quality Assurance Procedures specify interdepartmental relationships and departmental responsibilities as they relate to particular activities, regulatory requirements, and BG&E commitments.- One Quality Assurance Procedure controls the distribution and revision of the Manual. Others ensure that 1.
The need for special controls, processes, test equipment, tools, and skills is specified when necessary to ensure that required quality is attained in performance of the activity.
- 2.. Quality is verified by inspections and tests.
3..
Personnel who_ perform activities affecting quality achieve and maintain suitable proficiency through appropriate training and experience.
Department or lower-level implementing Procedures are prepared either by Departments such as Electric Engineering and Purchasing and Stores or by groups within Departments, such as personnel who report to the Plant Superintendent at Calvert Cliffs. The controls for review and issue of implementing Procedures are discussed in Sections 1B.5 and 1B.6.
Review of Operations Procedures require that the Calvert Cliffs Nuclear Power Plant shall be operated and
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maintained in accordance with the plant Technical Specifications and operating license.
The following organizations review plant operations to ensure that these Procedures are followed.'
The General Supervisor, Operations Quality Assurance assigned to the Calvert Cliffs Plant provides independent verification that the requirements contained in the Plant's operating license, FSAR, Technical Specifications, and Plant Procedures are met. This is accomplished through quality assurance audits.
2.
The Off-Site Safety Review Committee (OSSRC) provides independer.t verification by review that the Calvert Cliffs Nuclear Power Plant is operated in accordance with estab!!shed requirements.
The OSSRC, which functions under a written Charter, is composed of on-site and off-site personnel knowledgeable of in-plant operations, nuclear engineering, chemistry and radiochemistry, metallurgy, radio-logical safety, instrumentation and control systems, mechanical and electrical systems, quality assurance, and environmental factors.
The proceedings of all meetings are documented and sent to the Vice President, Supply, Committee members, and others designated by the Committee Chairman.
3.
The on-site Plant Operations and Safety Review Committee (POSRC) reviews matters pertaining to nuclear plant safety. This Committee screens subjects of potential concern to the OSSRC and performs preliminary investigations under the direction of the.Calvert Cliffs Plant Superintendent. The POSRC, which functions under a written Procedure, is chaired by the Plant Superintendent of the Calvert Cliffs Plant. The results of all meetings are documented and sent to the Manager, Nuclear Power, members of the OSSRC, and others designated by the Committee o
Chairman.
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Safety-related maintenance and repair are performed by plant maintenance personnel under the direction of the General Supervisor, Electrical and Controls, Nuclear Power Department, and the General Foreman, Production Maintenance Department according (j
to written Procedures or instructions prepared by the maintenance force and approved as stated in the Quality Assurance Manual for Nuclear Power Plants. These Procedures 1.
Ensure that quality-related activities, such as inspection and test, are performed with appropriate equipment and under suitable environmental conditions 2.
Indicate inspections and checks that must be made and records and data that must be kept 3.
Show where independent verifications of inspections or checks should be performed by specified personnel other than those performing the work When necessary, non-plant Company personnel or outside contractors are brought in to supplement the plant work force. In such instances, the approval of work procedures and the tagging of equipment are coordinated by a member of the organization responsible for the performance of the work.
Controls are established in the Quality Assurance Manual for Nuclear Power Plants to ensure that materials and parts used in the repair, maintenance, and modification of safety-related portions of the plant are appropriate for the service intended. Written Procedures are prepared for the storage and identification of materials and parts to en-sure that they do not deteriorate in storage and can be correctly identified before installation or use.
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assurance programs consistent with the importance of the end-product to safety.
1B.3 DESIGN CONTROL Control Plant modifications described in the FSAR and considered significant for nuclear safety are controlled by the Quality Assurance Manual for Nuclear Power Plants, which is written to ensure compliance with Regulatory Guide 1.9 and 10 CFR 50.59.
Alterations to the Operating License, including Technical Specifications, the FSAR, and the Emergency Response Plan, are subject to the same controls as are alterations to changes, tests, and experiments defined in 10 CFR 50.59.
Controls for changes, tests, and experiments conducted at Calvert Clifis vary according to the following:
1.
As the item or activity affected is or is not described in the FSAR 2.
As the item or activity affected has been classified safety-related or non-safety-related.
3.
As a safety analysis is or is not required IB-12
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As the proposed change, test, or experiment does or does not constitute an Unre
' viewed Safety Question or require a change to the Technical Specifications.
r To ensure compliance with 10 CFR 50.59, changes, tests, or experiments have been divided into categories. Three methods of treatment are allowed:
- 1.. Implementing the change, test, or experiment according to Company practice for operating power plants, or according to Procedures required by the Quality Assur-ance Manual for Nuclear Power Plants.
2.
Implementing the change, test, or experiment according to Company practice for operating power plants by using Procedures required by the Quality Assurance
' Manual' for Nuclear Power Plants but controlling the change, test, or experiment with a Facility Change Request so that the preparation and reporting of safety analyses are controlled.
3.
Controlling the change, test, or experiment with a Facility Change Request and not allowing the implementing activity to begin until the review requirements of 10 CFR 50.59 and 10 CFR 50, Appendix B, have been met.
, Changes, tests, or experiments which require approval by the Nuclear Regulatory Com-
' ' mission (NRC) are approved by the Plant Operations Saf.ty and Review Committee
. (POSRC) and by the Off-Site Safety Revie.w Committee (OSSRC).
7 7
Controls have been established to ensure that design changes to safety-related struc-tures, systems, and components are reviewed either by the organization that made the original design, or by s Responsible Design Organization that meets requirements specified in ANSI N45.2.11, Section 8.0.
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Responsible Design Organizations 1 Responsible Design Organizations, either on contract or within BG&E, ensure that 1.-
Applicable' regulatory requireme'nts and design bases are correctly translated into specifications, drawings, written procedures, and instructions.
2.
Appropriate _ standards for quality are specified in design documents,'and deviations and changes from such standards are controlled.
'3.
Suitable! design controls are used in applying principles of reactor physics; making F.
seismic,l stress, thermal, hydraulic, radiation, and accident analyses; ensuring com-patibility of materials; and providing accessibility for in-service inspection.
- 4. - Designs are reviewed to ensure that design characteristics can be controlled, inspected, and tested, and that inspection and test criteria are identified.
- 5. ' Interfaces, both external and internal, a're controlled for the activities of all partici-J l
pating organizations. -
6.
- Methods for verifying or checking, such as design reviews, alternative calculations, and qualification testing, are properly chosen and followed; the most adverse design l
conditions are specified for test programs used to verify the adequacy of designs.
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Individuals or groups responsible for design verification are other than the original l N designer and the designer's immediate supervisor.
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Design and specification changes are subject to design controls and approvals appli-cable to the original design.
J 9.
Design documents and revisions therete are distributed to responsible individuals and controlled to prevent inadvertent use of superseded material.
- 10. _ Design errors and deficiencies that adversely affect safety-related structures, systems, and componants are documented, and appropriate corrective action is taken.
11.
Design documents and reviews, records, and changes thereto are collected, stored, maintained, and controlled systematically.
12.
Standard off-the-shelf commercial or previously approved materials, parts, and equipment essential to the safety-related functions of structures, systems, and com-ponents are reviewed for suitability of application before they are selected.
13.
The persons or groups responsible for design reviews and other design verification activities and their authority and responsibilities are identified.
,14.
Design changes to non-safety-related items initiated and approved at the plant are controlled to ensure compliance with 10 CFR 50.59.
15.
Processes used to select suitable materials, parts, equipment, and processes for
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safety-related structures, systems, and components includes the application of per-
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tinent industry standards and specifications, material and prototype hardware testing programs, and design reviews.
1 B.4 PROCUREMENT DOCUMENT CONTROL Methods of Purchase
' Controls have been established to specify the sequence of actions to be followed in the preparation, review, approval, and control of procurement documents.
The acquisition and purchase of items or services by BG&E for the Calvert Cliffs plant are subject to controls that depend on 1.
The classification of each item or service as safety'-related or non-safety-related according to controls established by Electric Engineering personnel 2.
The method used for acquisition or purchase Acquisition and purchase of safety-related and non-safety-related items are initiated by a store order or requisition. Items classified non-safety-related and some non-safety-
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related services may be. acquired or purchased in the same manner as items or services j
required for fossil plants, but copies of store orders or requisitions are sent to the Elec-I iric Engineering Department or the Quality Assurance Department for verification of the non-safety-related classification.
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Four main approaches are taken to safety-related procurement:
C 1.
Specifying controls that must be exercised during the manufacture of a safety-related item, or during the conduct of a Safety-Related activity, to ensure that quality assurance requirements for that item or activity will be met. This is the Specification Method.
2.
Specifying tests or measurements that must be made after the manufacture of an item or the conduct of an activity, to establish that requirements for the item or activity have been met. This is the Verification, Method.
For this method, there is no requirement that a manufacturer have a quality assur-ance program, but if _ tests or measurements are made by an organization outside BG&E, the test or measurement services are controlled by the Specification Method, and the organization that conducts the tests or measurements is required to have a quality assurance program that ensures compliance with purchase documents.
3.
A variation of the Specification Method is used to obtain mass-produced standard items, such as gaskets,0-rings, and ball bearings, which are normally selected from a manufacturer's catalog and purchased from a local agent or distributor. This is the Catalog Method.
4 Another variation of the Specification Method is used to obtain items or services, which although they have a safety-related function, do not require any controls beyond those available on commercial items or services. This is the pommercial Quality, Method. It is used to obtain commercially available items or services when it has been established that sufficient competition within the industry and sufficient experience with the product ensure that variations in quality are not likely to prevent the item from performing its safety-related function.
Controls for Catalog Purchases Cont.ols have been established to ensure that, before placement of a purchase order for a Catalog Purchase, there is evidence of the following:
1.
An auditing organization such as CASE, another utility, a major contractor to BG&E, etc., has verified that the supplier has a quality assurance program that complies with 10 CFR 50, Appendix B, or similar requirements, to ensure that guidelines de-scribed in ANSI N45.2.13 for the Unique Order Method can be met.
2.
The manufactur:r has been producing a particular standard item for a sufficient pe-riod of time to establish a history of operating quality which indicates that the item's significant characteristics perform satisfactorily and that the manufacturer's quality assurance program is adequate to control these significant characteristics.
3.
The pr-urement documents reference part numbers or descriptions, and additional requirt neats are specified as necessary, to ensure that items ordered can be identi-fled and that verification can be made that each item received is the item ordered.
4 M' hen applicable, the procurement document specifies that documents shall be supplied with items to establish that in-process tests, inspections, etc., have been made.
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Controls for Specification Purchase Controls have been established to ensure that safety-related items or services subject to
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the controls of the Specification Method are obtained only from vendors who have been A
approved by BG&E Responsible Design Organizations and Quality Assurance personnel.
BC&E Responsible Design Organizations ensure that, when applicable, the purchase spec-ification 1.
Contains or references technical requirements for the basis of design, including the applicable regulatory requirements, component and material identification require-ments, drawings, specifications, Codes and industrial standards, test and inspection requirements, and special process instructions for such activities as we' ding, heat treating, nondestructive testing, and cleaning.
2.
Identifies applicable requirements of 10 CFR 50, Appendix B, that must be complied with and described in the supplier's quality assurance program.
3.
Requires that major contractors designated as BG&E agents to purchase safety-related items or services must have procurement controls to ensure that they our-chase or acquire these items or services in compliance with applicable sections of ANSI N45.2.13.
4Property "ANSI code" (as page type) with input value "ANSI N45.2.13.</br></br>4" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process..
Identifies required documentation (i.e., drawingr, specifications, procedures, inspec-tion and fabrication plans, inspection and test records, personnel and procedure qual-ifications, and material chemical and physical test results) to be prepared, main-tained, and submitted, as applicable, to BG&E or the purchaser for review and approval.
5.
Identifies records that must be retained, controlled, maintained, or delivered to BG&E or the purchaser before use or installation of hardware.
l 6.
Specifies BG&E's or the procuring agency's right of access to supplier facilities and records for source inspectien and audits.
Assigned quality assurance personnel. review procurement specifications to verify the adequacy of _ quality requirements therein. This review determines that quality require-ments are correctly stated, inspectable, and controllable; that there are adequate acceptance and rejection criteria; and that these procurement documents have been pre-l pared, reviewed, and apprcved in accordance with quality assurance program require-ments. Records of the quality assurance review and approval of procurement documents are made and kept available for verification.
Changes made to procurement specifications are subject to the levels of review, approv-l al, and audit that were applied in preparing and processing the original documents.
The procurement documents for spare or replacement parts of safety-related structures, systems, and components are subject to controls at least equivalent to those applied for the original equipment.
I 1B.5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS i
Controls delineate the sequence of actions to be performed in the preparation, review, l
approval, and control of instructions, procedures, and drawings.
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Controls require that 1.
Methods for complying with each of the applicable criteria of 10 CFR 50, Appendix B, must be specified in instructions, procedures, and drawings.
. 2.
Instructions, procedures, and drawings must specify appropriate quantitative (such as dimensions, tolerances, and operating limits) and qualitative (such as workmanship samples) acceptance criteria for verifying that important activities have been satisfactorily accomplished.
Controls ensure that 1.
A Quality Assurance Policy is approved by the Vice Presidents of the Engineering and Construction, Supply, General Services, and Electric Interconnection and Operations Divisions.
2.
Quality Assurance Procedures are developed by Departments responsible for conducting particular activities, reviewed and approved by the responsible Department Managers (including the Manager, Ouality Assurance), and controlled by the Manager, Quality Assurance.
- 3.
Department Procedures are approved and contro!!ed by the responsible Departments and are approved for quality assurance content by a member of the Quality Assurance Department.
4.
Plant, Section, and Unit Procedures that control the topics, contents, review,
(
. approval, issue, distribution, and revision of Plant, Section, and Unit Procedures that specify how activities are to be performed are approved by a member of the Ouality Assurance Department.
5.
Other Plant, Section, or Unit Procedures that specify how activities are to be performed are controlled by the responsible organization and reviewed and approved
'vithin the responsible organization.
1B.6 DOCUMENT CONTROL Controls have been established for documents required to control the conduct of safety-related activities.
Controlled documents include the FSAR for the Calvert Cliffs Nuclear Power Plant; Quality Assurance Procedures in the BG&E Quality Assurance Manual for Nuclear Power Plants; Department, Section, Unit, and Plant Procedures that implement the Quality Assurance Procedures; specifications; and drawings.
Suppliers of materials, equipment, and services are required by procurement specifications to provide for control of documents, including instructions for manufacturing, inspection, and testing.
- Quality Assurance Procedures are required to 1.
Establish controls to ensure that regulatory requirements and BG&E commitments will be implemented 2.
Describe interdepartmental interfaces and establish controls for interdepartmental activities IB-17 L
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Specify how important activities, such as plant maintenance or in-service inspection, y
are to be performed, and give sufficient detail to control the performance of the
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activity or to ensure that requirements for lower-level procedures are clearly specified 4.
Be prepared and controlled in accordance with one Quality Assurance Procedure that describes the format, sequence of topics, contents, review and approval, issue and distribution, and requirements for revision and record retention During the review of each Quality Assurance Procedure, compliance with applicable criteria specified in 10 CPR 50, Appendix B, is verified and documented.
The Manager, Quality Assurance Department is responsible for issuing, revising, and controlling Quality Assurance Procedures.
Quality Assurance Procedures are developed by one of the departments responsible for the subject activities. Each Procedure is given a technical review by a member of one of these departments and a quality assurance review by a member of the Ouality Assurance Department. Each is approved by the Manager, Quality Assurance and by the Managers of Departments to which responsibility is assigned or which are affected by the Procedure.
Department Procedures are prepared when interfaces or activities within a Department 1
are not defined in a Quality Assurance Procedure or when they are needed to specify the content of Plant, Section, or Unit Procedures.
As needed, Department Procedures describe how requirements delineated in a Quality
(
Assurance Procedure will be implemented at the Department level. They describe the
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interfaces betweeen groups or units within a Department and specify requirements to be met by lower-level documents.
Individual Departments are responsible for preparing, issuing, revising, and controlling Department Procedures. These are prepared and controlled according to a Department Procedure that describes format, sequence of topics, contents, review and approval, issue and distribution, and requirements for revision and record retention.
Each Department Procedure is given a technical review by a member of the Department and a quality assurance review by a member of the Quality Assurance Department.
Plant, Section, or Unit Procedures are prepared to describe how requirements delineated for subgroups within a department will be implemented when these requirements are not delineated in sufficient detail in Quality Assurance Procedures or ' Department Procedures.
Functional groups within departments prepare, issue, revise, and control the Procedures that control their work. Group Procedures must be reviewed by a member of the Group, but are not reviewed by the Quality Assurance Department unless performance of the activities in question requires that a quality-control witness attest to compliance with the Procedures.
Group Procedures are prepared and controlled according to Control Procedures that describe format, sequence of topics, contents, review and approval, issue and distribution, and requirements for revision and record retention. Control Procedures are reviewed and approved by a member of the Quality Assurance Department.
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Organizations that issue instructions, procedures, specifications, or drawings are required to establish controls that ensure the following:
1.
Changes to a document are reviewed and approved by the organization that performed the original review and approval unless the Control Procedure designates another qualified responsible organization.
2.
Approved changes are promptly incorporated into instructions, procedures, drawings,
- and other documents associated with the change.
'3.
Obsolete or superseded. documents are controlled to reduce the possibility of inadvertent use.
Superseded documents retained for reference are marked and stored in separate files. Other superseded documents are removed from the files.
When changes to drawings or specifications are required, change requests are prepared by the organization that desires the change. Requests are reviewed and approved by BG&E Responsible Design Organizations.
IB.7 CONTROL OF PURCHASED MATERIAL, EOUIPMENT, AND SERVICES Responsibility w
. Personnel in the Electric Engineering and Qu'ality Assurance Departments determine x
whether contractors and suppliers who provide safety-related materials, components, equipment, and services are able to provide products and services of acceptable quality.
The quality of purchased material, equipment, components, and services is controlled by.
1 procurement documents, supplier selection, supplier surveillance, and receipt inspection.
Reviews, inspections,' surveillance, and audits are conducted by personnel competent in
-establishing whether or not a supplier is capable of. providing products of acceptable quality.
BG&E procurement documents require that 1.-
Certification must be furnished to identify a.
Purchased material or equipment by purchase order number
.b.
Specific procurement requirements (codes, standards, specifications, etc.) met by items 2.
Non-conformances to the requirements of procurement documents or BG&E-approved documents that consist of one or more of the following must be submitted to BG&E for approval of the recommended disposition:
a'..
Technical'or material requirements are violated.
b.
Supplier documents approved by BG&E are violated.
- c.
Non-conformances cannot be corrected by continuation of the original manu-7
- facturing process or by rework.
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The item does not conform to the original requirements even though it can be restored to a condition in which its capability to function is unimpaired.
CI Evaluation BG&E Responsible Design Organizations coordinate the review and approval of non-con-formances reported to BG&E by suppliers and ensure that dispositions of non-confor-mances are reviewed by the organizations responsible for the requirments that have been violated. For example, if a Quality Assurance program requirement has been violated, the Quality Assurance Department must review the supplier's disposition of the non-conformance.
Purchase orders placed by BG&E personnel for safety-related items or services con-trolled by procurement specifications are not placed with a supplier unless documents sent to Purchasing and Stores Department with the specification indicate that the supplier has been investigated as follows and found to have a satisfactory program or record:
1.
The Engineering Quality Assurance Unit has verified that the supplier has an imple-mented quality assurance program that complies with either quality assurance pro-gram requirements specified in the procurement specification or proposed procure-ment specification, or applicable sections of ANSI N45.2.13 or other r.ationally recognized standards and regulations, as appropriate.
The Quality Assurance Department evaluates the suppliers' overall quality assurance organization and program in accordance with applicable codes and standards or parts of 10 CFR 50, Appendix B. Reviews include consideration of company organization,
^
quality assurance procedures, qualification of quality assurance personnel, procedures for review and control of design documents, manufacturing procedures, l
calibration practices, acceptance criteria, required quality assurance records and their retention, and quality assurance requirements and controls imposed by the supplier on his subcontractors. Supplier evaluation is conducted by means of proce-dures or checklists that identify the quality assurance requirements of applicable codes or regulations.
Suppliers' quality assurance programs are evaluated in terms of at least one of the following:
The supplier's history of supplying items or services to meet procurement a.
requirements. If BG&E has had no experience with a supplier in the past two years, this supplier is asked to submit information for evaluation on a similar item or service (such as applicable drawings) or date of recent contracts with i
other utilities, with contractcrs to' other utilities, or with the NRC or other
. government agencies cr contractors working for such agencies.
b.
The supplier's current quality records, supported by documented qualitative and quantitative information that can be objectively evaluated by a review 1-and evaluation of his quality assurance program, manual, and procedures as appropriate.
l The supplier's technical and quality capability as determined by an audit made l
c.-
i at his plant to verify the extent to which his quality assurance program com-plies with regulatory cequirements and the extent to which it is implemented.
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BG&E Responsible Design Organizations have verified that the supplier is capable of f
supplying the goods or services specified in the procurement specification or pro-posed procurement specification.
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The depth of supplier evaluation varies according to the complexity and importance to
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safety of the item involved. For example, for certain mass-produced or off-the-shelf items, only a check of past performance on similar items may be necessary. On the other hand, for complex, important items, a very thorough review is performed.
Surveillance Supplier surveillance is performed if conformance with the requirements of the procure-ment'smcification for a particular item cannot be determined when the item is re-ceived. The purpose of such surveillance is to provide a sampling review of the imple-mentation of the supplier's quality assurance program or of the conformance of his product to requirements of the purchase specification. BG&E Responsible Design Orga-nizations and the Quality Assurance Department together determine the degree of supplier surveillance (including review, inspection, or audit) required during design, fabrication, inspection, testing, and shipping.
The BG&E policy on supplier surveillance is as follows:
1.
If it is determined that supplier surveillance is required during the manufacture of a safety-related item or the performance of a safety-related service, the item or ser-j vice may be obtained only by the Specification Method.
2.
Surveillance or audits are not normally conducted on suppliers who are making replacements for safety-related items originally supplied by them, unless BG&E Re-sponsible Design Organizations and Quality Assurance personnel agree that the i
impact of the item on plant safety requires BG&E verification that the requirements of the procurement specification are being met. When a supplier did not supply the original part and if the purchase of a safety-related replacement item requires the antrols of the Specification Method of purchase, the ability of the supplier to 7
supply the item to the requirements of the specification and the need for supplier -
surveillance are evaluated when the procurement specification is approved.
3.
If it is determined that suppiler surveillance or audits are required, these activities are conducted either by BG&E or by another organization approved by BG&E.
4.
Surveillance of suppliers during fabrication, inspection, testing, and shipment of ma-terials, equipment, and components is planned and performed in accordance with written procedures to ensure conformance to requirements of the ourchase order.
These procedures provide for instructions that specify the characteristics or pro-cesses to be witnessed, inspected or verified, and accepted; the method of surveil-lance and the extent of documentation required; and persons responsible for imple-menting these instructions.
5.
When surveillance is required, the purchase order requires the supplier to interface with the designated surveillance organization to ensure that the requirements of the specification are met.
6.
If a deviation from purchase order requirements is noted during surveillance, the BG&E representative has the authority to inform the supplier that a particular item is unacceptable.
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Receipt The Purchasing and Stores Department is responsible for receiving and storing materials, parts, and components.
Receiving inspection of material, equipment, and services is performed in accordance with the following:
1.
It is verified that the material, component, or equipment is properly identified and that this identification corresponds with the documentation received.
2.
Unless other procedures are specified in the shipping documents, items are visually inspected to verify that stated packaging and shipping requirements have been main-tained.
3.
Items are inspected upon receipt to verify that procurement requirements have been met.
4.
Procurement records are inspected and judged acceptable in accordance with pre-determined inspection instructions before installation or use of material, compo-nents, or equipment.
5.
Additional inspections or examinations are made if the item was not inspected at the st source.
Documents supplied with received items are reviewed to verify compliance with the requirements of the purchase documents.
Inspection Procedures require that 1.
Inspection records or certificates of conformance attesting to acceptance must be available at the nuclear power plant before material, components, and equipment may be released for installation or use. However, an unacceptable item may be given a " Conditional Release" if it can be made acceptable after installation but before the system that contains it is considered operational.
2.
The inspection status of items accepted and released must be identified before the items are sent to a controlled storage area or released for installation or further work.
A written record of the results of receiving inspection and the disposition of received items is maintained as part of the permanent plant records. All safety-related items issued bear an acceptance tag and have documentation to support their acceptability. If traceability is lost or the documentation review is unsatisfactory, an item becomes sub-ject to the controls established for non-conforming safety-related items.
Non-conforming items are handled according to documented procedures and, when prac-ticable, are placed in a segregated area to prevent inadvertent installation or use until proper disposition is made.
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IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 5 Purchase Controls established in procurement documents ensure that safety-related materials, parts, and. components, including partially fabricated sub-assemblies, are identified to prevent the use of incorrect or defective material. They include the following:
Requirements for identification by use of heat number, part number, or serial number, or by other appropriate methods, are stated in procurement documents, drawings, proce-
- dures, guidelines, checklists, or store orders. The identification is placed on the item or on' records traceable to the item so that the function and quality of th' em are not affected. This identification is maintained throughout fat.-ication, ste-t srection, in-stallation, and use. Requirements for identification are determineo ouring design or
~ design-change activities, with input as appropriate from operations personnel.
The Manager, Purchasing and Stores assigns personnel within his Department to purchase, identify, store, and issue items as specified by the procurement controls and to provide for maintaining the integrity of items and their traceability to associated documents during storage and issue.
BG&E contractors and their sub-contractors are responsible for establishing programs for identifying and controlling materials, parts, and components under their jurisdiction.
Identification of materials and parts important to the function of safety-related struc-
-tures, systems, and components can be traced to appropriate ' documentation such as
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drawings, specifications, purchase orders, manufacturing and inspection documents, de-
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viation reports, and physical and chemical mill-test reports.
a; Organizations that fabricate safety-related items are made responsible for verifying that correct identification of materials, parts, and components is documented before items -
s are raleased for fabrication, assembly, shipping, or installation.
Calvert Cliff's plant personnel are responsible for maintaining the same level of trace-ability of safety-related items during operation of the plant that was required during
. construction of the plant.
Receipt
' Purchased safety-related items received at Calvert Cliffs are inspected to verify that all requirements of the procurement documents have been met. If a discrepancy is ob-served, such as damage or missing documentation, information to this effect is recorded on-the receiving inspection report, and the discrepant item is tagged to indicate the non-conformance and placed in a separate " hold" area when practicable. If the item is acceptable, it is identified with a tag to indicate that it is approved for storage or in-stallation and use. When groups of items in storage are subdivided, each subgroup is tagged.-
If an item is found to be or is made discrepant during processing, a prominent " hold" tag is_ attached to the item, which is placed in a separate area when practicable.
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Acceptance tags show traceability to a purchase order, drawing, specification, store order, or assembly and installation record. As individual items are assembled, installed, and inspected, their acceptance-tag numbers are recorded in plant maintenance and operation records.
After satisfactory completion of all required tests and inspections, acceptance tags and associated records that verify traceability are kept as part of the plant records.
1B.9
' CONTROL OF SPECIAL PROCESSES Controls Controls have been established for writing, qualifying, approving, and issuing Procedures to control such special processes as welding, heat treating, and nondestructive testing used during the operation fo Calvert Cliffs. Special Process Procedures 1.
. Are prepared in accordance with applicable codes, standards, specifications, cri-teria, and other special requirements 2.
Ensure that special processes are performed by qualified personnel according to qualified Procedures that comply with applicable regulatory requirements 3.
Specify requirements for control, parameters to be considered, acceptable methods of documentation, and the codes, standards, specifications, or criteria which govern the qualification 4.
1 Define the necessary qualification of personnel, Procedures, or equipment when f
special processes are not covered by existing codes or standards er when quality re-(
quirements for an item exceed the requirements of established codes or standards.
)
BG&E contractors and their sub-contractors are responsible for controlling special pro-cesses used by them and for maintaining records to verify that special processes are per-formed in accordance with requirements established by the portions of their quality assurance programs that apply to special processes.
Qualification of Methods Procedures, equipment, and personnel connected uth special processes are qualified in accordance with applicable codes, standards, specifications, oc supplementary require-ments as follows:
1.
Welding activities conducted by BG&E are performed according to welding proce-
' dure specifications qualified in accordance with applicable welding requirements of the ASME Code. Each welding procedure specification is wrP. ten, qualified, and approved in accordance with a controlling documented procedure. Copies of welding procedure specifications are made available to welders and when required, to Authorized Inspectors. Before contracting for welding, the Principal Metallurgist reviews and approves non-BG&E welding procedure specifications and procedure qualification records in accordance with a written Procedure.
2.
Heat-treating requirements included in welding procedure specifications are estab-lished in conformance with heat-treating requirements of the applicable ASME Code.
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. Nondestructive Examinations are performed to written Procedures proved by actual demonstration, when practicable, to the satisfaction of the Principal Metallurgist
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and, when required, the Authorized Inspector. These Procedures are prepared ac-cording to appropriate sections of the ASME Code for particular examination methods. Procedures, personnel qualifications, and the records that verify the Per-formance of Nondestructive Examinations are kept as nuclear plant records.
Nondestructive Examination Procedures describing methods not described in the ASME Code and/or SNT-TC-1 A and its Supplements are at least equivalent to those recognized by the American Society of Mechanical Engineers and the American Society for Non-destructive Testing. Training programs acceptable to the Principal Metallurgist are developeo to ' complement these alternative methods and to establish the capability of personnel to perform the required examination according to BG&E Procedures and to the level of performance to which the individual will be certified.
Methods of Nondestructive Examination include, but are not restricted to, radiographic, ultrasonics liquid-penetrant, magnetic-particle, eddy-current, visual, and leak-testing examinations. Procedures are prepared to cover these evaminations in accordance with a Quality Assurance Procedure that details the spediac examination, requirements for approval, and contents of the Procedire, such as certification level, accept / reject criteria, examination coverage and sequence, surface preparation, test equipment, records required, permissible marking, cleanup requirements, and reference to applicable sections of the ASME Code.
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Qalification of Personnel
~ Special processes are performed by certified personnel using written process sheets, shop procedures, checklists, and travelers (or equivalent), with recorded evidence of verification as follows:
1.
BG&E welders, and welders under contract to BG&E, are qualified and certified in accordance with the requirements of Section IX of the ASME Code and the welding procedure specifications they will be using when welding. The Principal Metallurgist c
maintains records of the welding procedure specifications, including essential variables under which the welders _ are examined, and the results of the examinations. A welder is not permitted to weld safety-related items until an appropriate performance qualification record, a letter of certification, or, in an emergency, verbal clearance from the Principal Metallurgist, is on file at Calvert Cliffs.- Each welder is required to be requalified as specified in the applicable code.
2.
Non-BG&E' welders are not permitted to weld safety-related items until they are qualified and certified in accordance with Section IX of the ASME Code to the welding procedure specificetion they will be using.
3.
Nondestructive Examination personnel employed by or responsible to BG&E are certified according to applicable sections of the ASME Code and/or SNT-TC-i A and its Supplements. BG&E employees are trained and certified in accordance with a written Procedure. Non-BG&E personnel are qualified to Procedures approved by BG&E, and their qualifications and certifications of personnel are verified according to written Procedures.
Qualification records of procedures, equipment, and personnel associated with special processes conducted by BG&E are filed and kept current by the Principal Metallurgist.
The General Supervisor, Operations Quality Assurance provides independent verification that special processes are performed by qualified personnel.
18-25
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18.10 INSPECTION Activities that affect the quality of safety-related items are inspected as specified in
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approved instructions, procedures, and plans which set forth requirements and acceptance criteria to ensure that work is done in conformance with particular requirements.
Controls exercised during inspections ensure that
~
1.
Personnel who perform quality control inspections are independent of the personnel who performed the activity being inspected 2.
Inspection procedures or instructions, with necessary drawings and specifications for use, are available before inspection operations are performed 3.
In the case of special processes, inspectors are qualified, and their qualifications comply with applicable codes and standards 4.
Test and measuring equipment is calibrated within required limits 5.
Inspection Procedures, as applicable, specify objective acceptance criteria, prercq-uisites for performing inspections, limiting conditions, requirements for special equipment and quality control hold-points at which inspections are to be witnessed (6.
Appropriate inspection requirements are established for modification, repair, and replacement c
7.
Quality Assurance Department inspectors are qualified in accordance with appro-priate codes, standards, and Company training programs, and their qualifications and certifications are kept current 8.
Procedures for maintenance, modification, and receipt inspections are reviewed by quality control personnel to determine the need for independent inspection and the degree and method if such an inspection is required, and to ensure the identification of inspection personnel and the documentation of inspection results 9.
Procedures for Nondestructive Examination and Nuclear Fuel inspection are re-viewed by qualified personnel in the Nuclear Power and Production Maintenance Departments to dctermine the need for indepenaent inspection and the degree and l
method if such an inspection it required, and to ensure the identification of inspec-tion personnel and the documentation of inspection results 10.
Inspection results are recorded, evaluated, and retained l
Inspection procedures, instructions, and checklists used by quality control personnel pro-i l
vide the followi g:
1.
Identification of characteristics to be inspected.
. 2.
Identification of individuals or groups responsible for performing the inspection l
3.
Acceptance and reje.: tion criteria l
4.
Description of the method of inspection IB-26 hr;_4' m m w M
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5 7 Identification dncluding revision number) of required procedures, drawings and spec-o
- ifications :
- 6.'-
Identification of inspector or data recorder
' 7.
Verification of completion and certification of inspection
- 8. ' Record of results of inspection
- 9. _ Provision for identifying mandatory inspection hold-points for witness for an autho-
_rized inspector or BG&E inspection personnel
-10.
Provision for indirect control by monitoring processing methods, equipment, and per-sonnel if direct inspection is not possible 11.
Specification of necessary measuring and test equipment including requirements for accuracy..
The General Supervisor, Operations Quality Assurance is responsible for the preparation and implementation of Procedures for surveillance and inspection activities conducted by
.BG&E personnel in their areas of responsibility.
Other inspections are conducted randomly to verify that overall plant operations are being conducted according to approved Procedures and to ensure that the use of jumpers "t
is properly documented; that equipment is returned to operating status after test, modi-fication, or repair; that instruments are properly calibrated; and that personnel who per-
- form tests are properly trained and qualified.
-In-service inspectionsIare performed on pressure-containing components within the reactor coolant system boundary according to requirements of the Technical Specifica-
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. tions.
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.In-sarvice inspections and examinations on components designated Class I or Class II by s-the ASME Code are witnessed or otherwise verified.by' an authorized Code Inspector who is responsible for ensuring that the work is performed by qualified personnel according to
- written. qualified Procedures.
Records of in-service inspections, results, corrective action : required and taken, inspection standards required for repair, and results of
' inspection of repairs are maintained and compared with the' results of subsequent examination.
18.11'
= TEST CONTRO!_
_ To demonstrate the ability of, safety-related structures, systems, and components to function as designed, they are subjected to a program of surveillance and operational testing. Procedures specify the systematic development, review, approval, and conduct of tests and review of test results. Conditions such as failures, malfunctions, deficien-
- cies, deviations, and non-conformances discovered during testing are documented and evaluated.
Whenever testing is required to demonstrate that safety-related material, parts, com-
. ponents, or systems will perform satisfactorily in service, a test program is established i-. J
' and Procedures are used that have been written and approved in accordance with basic j.
- requirements.
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The Nuclear Power Department conducts tests to verify that plant behavior conforms to l
design criteria, ensure that failure and substandard performance are identified and con-l trolled, and demonstrate satisfactory performance after plant modification and mainte-
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nance activities.
Written Test Procedures are developed, reviewed, and approved before testing is per-formed. They specify instructions for testing, methods of test, test equipment, and instrumentation; and for the following as applicable:
1.
Adequate and appropriate equipment 2.
Preparation, condition, and completeness of item to be tested 3.
Suitable and controlled environmental conditions 4.
Mandatory inspection hold-points for witness by BG&E inspection or authorized inspector personnel 5.
Provision for data collection and storage 6.
Acceptance and rejection criteria Methods of documenting or recorJing test data and results 7.
2 8.
Provision for ensuring that test prerequisites have been met Test results are documented and evaluated; they are accepted or rejected by a qualified, responsible individual or group.
With the exception of completed surveillance tests performed without malfunctions or
} out-of-specification data, results of tests are reviewed and evaluated by the Plant
' Operations and Safety Review Committee and accepted and approved by the Plant Superintend:nt. Test records are kept in sufficient detail to make poss;ble an evaluation of test results and to show how individual tests demonstrate that safety-related structures, systems, and components and the plant as a unit can operate safely and as designed. Safety-related test records are retained as plant history records.
18.12 CONTROL OF MEASURING AND TEST EQUIPMENT Calibration controls have been established to prescribe the technique and frequency of calibration, maintenance, and control of measuring and test instruments, tools, gauges, fixtures, reference and transfer standards, and nondestructive test equipment used in measuring, inspecting, and monitoring safety-related components, systems, and struc-tures during the operations phase of Calvert Cliffs.
Personnel of the following functional organizations control, calibrate, and adjust mea-suring and test equipment:
Electric Test Department Nuclear Power Department --Electrical and Controls
--Operations
--Radiological Support 1B-28
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Department
-Mechanical Maintenance
-Calibration controls require each group to identify measuring and test equipment and
' calibration test data related to it..
- Written procedures are prepared and implemented to ensure that' tools, gauges, instru-
.ments, and related test and measuring devices are of proper accuracy to verify confor-j_
mance.to' established requirements.
Manufacturer's Procedures' are used for calibration when available; otherwise; a Proce-
.. dure is prepared for each category of measuring and test equipment as necessary.' These i
Calibration Procedures contain the following information:
- 1.. Identification of the item to be calibrated and its period of calibration
, ~
2.'
.. Standards to be used, specific test-points, and checks, tests, and measurements to be made
- 3.
Acceptance criteria to be used and special precautions to be taken when necessary.
Measuring and test equipment.that requires calibration is assigned an identifying serial number. instruments are calibrated at specified intervals according to the required
- accuracy, purpose, degree of usage, stability characteristics, and other conditions that
,p affect the measurement.
4
-When particular_~ equipment is found out of calibration, an evaluation is made to deter-mme any effect on items previously accepted on the basis of using that equipment.
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/ Test and measuring equipment that cannot be' adjusted to required tolerances during cali-t 7
. bration is identified and placed in a designated segregated area; if the' equipment can be f
used in limited applications, the limitations are identified.
The status 'of each item controlled under the calibration system is recorded and main-tained. Equipment is marked or records of calibrations are maintained to indicate cali-0
'bration status. An interval of calibration is established for each item of measuring and test equipment and recorded on a master record of calibrations prepared as a calibration J:
' schedule.
~l Veasuring and test equipment is contro!!ed to prevent the use of uncalibrated or defec-
~ tive equipment, the spread of radioactive contamination, the introduction of impurities E
~ into high-purity systems, and damage to or loss of equipment. Identification tags are placed on measuring and test equipment to indicate such special conditions as radioactive cleanliness, special limitations, or failure to meet established calibration requirements.
1 Measuring and test equipment is calibrated and adjusted at specified intervals, or before use,, against certified standards.
Reference and transfer standards are traceable to
-nationally recognized standards; or, where national standards do not exist, provisions are
. established to document the basis for calibration.
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i 1B.13 HANDl.ING, STORAGE, AND SHIPPING Appropriate. and special requirements for handling, preservation, storage, cleaning, packaging, and shipping of-safety-related items are specified in procurement documents.
Procedures have been established to ensure that the handling, preservation, storage, cleaning, packaging, and shipping of safety-related items are performed in accordance with specified requirements to reduce the likelihood of damage, loss, or deterioration by such environmental conditions as temperature or humidity.
Special. handling, preservation, storage, cleaning, packaging, and shipping activities associated. with safety-related items are performed-by suitably trained personnel in
- accordance with specific written procedures.
Controls have been established for the safe storage of hazardous materials. Items with a
-limit'ed shelf-life are controlled-to ensure that they will not be used in safety-related
- applications after expiration of designated shelf-life periods.
- 1B.14 INSPECTION, TEST, AND OPERATING STATUS
- Controls have been established for the application and removal of status indicators such 3
e l as tags, markings, labels, and stamps to ensure that the inspection, test, and operating status of safety-related structures, systems, and components is clearly indicated at all times.'
Procedures are prepared to identify and control inspection, testing, and operating status
(
by the use of logs, forms, and tags that identify.the inspection, test, and operating status
(
-- o f s structures, systems, and components; control the use of indicators, including the a
authority for their application and removal; control bypassing operations, such as jumping y
or temporary removal of electrical leads; and _ identify non-conforming, inoperative, or
. malfunctioning structures, systems, or components.
s
- +
Incoming materials and parts are inspected, tested, and controlled according to written procedures. Materials and parts are inspected for quality of physical characteristics and compliance with documentation; those that meet ' acceptable criteria are appropriately
- identified.
Senior Shift Personnel are responsible for aligning, isolating, and appropriately tagging equipment and systems so that activities affecting quality can be performed.
The Supervisor, Operations Quality Assurance performs surveillance to verify that the inspection, testing, and operating status of structures, systems, and components are properly identified and controlled during operation, maintenance, and testing of the plant.,
The bypassing of required inspections, tests, and other critical operations is controlled to ensure that bypassed inspections or tests are properly documented and that the effect of
- bypassing the inspection or test is evaluated by the organization responsible for specifying the inspection or. test. Controls have been established to ensure that the status of non-conforming, inoperative, or malfunctioning safety-related structures, systems,'or components is identified to prevent inadvertent use.
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1B.15 NON-CONFORMING MATERIALS, PARTS, AND COMPONENTS Controls have been established for identifying, documenting, segregating, reviewing, reporting, and disposing of non-conforming materials, parts, components, or services.
All persons involved.who recognize Conditions Adverse to Ouality are responsible for reporting such conditions. promptly to supervisory or Quality Assurance personnel.
Conditions Adverse to Quality are evaluated to determine whether work shall be stopped or the condition reported to the NRC.
Non-conformance controls require preparation by Quality Assurance personnel of a Non-conformance Report that describes the non-conformance. Non-conformance Reports are submitted to Responsible Departments for resolution. Designated Ouality Assurance personnel have responsibility and authority for approving the resolution of non-conformances.
A Non-conformance Repo: c is not closed out until the Ouality Assurance Department has-verified that the Responsible Department has specified and completed corrective and preventive action as necessary.
The acceptability of rework, repair, or replacement of materials, parts, components, systems, and structures is verified by rein'necting the item as originally inspected or by y
using a method at least equivalent to the original inspection method, and such inmection, rework, and repair procedures are documented.
Items classified as non-conforming are identified by non-conformance tags - and segregated when practicable, to prevent inadvertent installation or use until the.non-conformance. has been properly dispositioned.
Only-Quality Assurance Department personnel are authorized to attach, remove, or alter a non-conformance tag. Tags are removed only af ter satisfactory resolution of the non-conformances.
Non-conformance Reports are periodically analyzed by personnel of the Operations Quality Assurance Section to show quality trends; results are sent to the Off-Site Safety Review Committee.
1B.16 CORRECTIVE ACTION 1
Controls have been established to ensure that Conditions Adverse to Ouality are identified and that corrective action is initiated to preclude recurrence.
l Non-conformances are evaluated to determine the need for corrective action. 'rhe Plant Superintendent is informed of a non-conformance that might require the NRC to be
- notified. He evaluates the'information and reports it as necessary. To preclude the recurrence of conditions adverse to plant safety, prompt corrective action is initiated when a non-conformance is identified.
Non-conformances are documented on Non-conformance Reports that cannot be closed out until Responsible Departments specify
. appropriate corrective-and preventive action and the Quality Assurance Department
-verifies that such action has been taken.
Non-conformances found during audits or surveillances conducted by BG&E are documented by Quality Assurance Department personnel, who verify that Responsible Departments.have taken adequate corrective action to prevent recurrence.
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The foregoing controls ensure that adverse conditions significant to quality, the cause of
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the conditions, and the corrective and preventive action taken are reported to appropriate levels of both off-site and on-site management.
1B.17 QUALITY ASSURANCE RECORDS Controls have been est!blished to ensure that Quality Assurance records are maintained to provide documentary evidence of the quality of safety-related items and activities.
Applicable design specincations, procurement documents, test Procedures, Operational f
Procedures, QA Procec:ures, Technical Specifications, and other documents specify records that should be generated, supplied, or maintained by and for BG&E.
Quality Assurance records are classified as lifetime or non-permanent.
Lifetime records, maintained for particular items for the life of the Calvert Cliffs plant, for particular items have significant value in relation to demonstrating capability for safe operation; maintaining, reworking, repairing, replacing, or modifying an item;
~
4 determining the cause of an accident or malfunction of an item; and providing required
. baseline data for in-service inspection.
Non-permanent _ records, which show evidence that a safety-related activity was
. performed in a'ccordance with _ applicable requirements, are. retained for periods isufficient-to ensure BG&E's ability to reconstruct significant events and to satisfy
, applicable regulatory requirements. Retention periods are specified in the Technical TSpecifications or in Procedures that control the performance of activities.
Procurement documents specify supplier responsibilities for the generation, retention, 1and submission to BG&E of Quality Assurance documentation related to the fabrication,
. inspection, and test of safety-related items and services.
Inspection and test records contain the following as appropriate:
1.
-Description of the type of observation 2.
Date and results of inspection or test c
3.
Information related to noted discrepancies, including action taken to resolve them
)
l 4._
Identification of inspector or recorder of data i
5.
Statement as to acceptability of results.
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Controls have been provided to ensure that records are protected from possible i
~ destruction.
.Within established time-intervals, completed lifetime records cre transmitted to the Nuclear Plant Documents Unit for incorporation ino the Record Retention and Retrieval System.
- IB.18 AUDITS Internal audits are performed by the BG&E Quality Assurance Department to ensure that activities and Procedures established to implement the requirements of 10 CFR 50, Appendix B comply with BG&E's overall Quality Assurance Program.
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l provide a comprehensive independent verification and evaluation of quality-related activities and Procedures. Audits ensure the effective and proper implementation of
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BG&E's Quality Assurance Program. They are scheduled on the basis of the importance to safety of activities being performed.
Supplier audits are performed to evaluate quality assurance programs, procedures, and activities. Audits of major suppliers are made early enough to ensure compliance with all aspects of BG&E's procurement documents.
Additional audits are performed as required.to ensure that all requirements of BG&E's Quality Assurance Program are properly implemented according to procurement documents.
Audits of designated activities as required by the Technical Specifications are performed under cognizance of the Off-Site Safety Review Committee.
Audits are performed in accordance with pre-established written procedures or checklists by qualified Quality Assurance personnel who have no direct resoonsibility for the work being audited.
Technical specialists from other BG&E departments and outside consultants may assist as necessary in performing audits. Audits include objective evaluation of quality-related practices, procedures, instructions, activities, and items, as
~
c well as review of documents and records.
Reports of audits are analyzed and documented. Results that indicate the existence of quality problems or a lack of effectiveness in the Quality Assurance Program, including. l 9
the need for re-audit of deficient areas, are reported to the. Manager and Supervisor of the audited activity. Controls have been established for verifying that corrective action 4 --
is taken promptly to correct noted deficiencies.
To ensure that BG&E's Quality Assurance Department complies with the requirements of
(.
BG&E's Quality Assurance Program, an independent management audit of Quality
. Assurance Department activities is performed annually by a Joint Utility Management Audit Team.
4 d'
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TABLE IB-1 BALTIMORE GAS AND ELECTRIC COMPANY'S POSITION ON GUIDANCE CONTAINED IN ANSI STANDARDS Revision of Industry Standards Applicable to the BG&E QA Program Requirement Some of the Industry Standards !!sted in Section IB.2 identify other Standards that are required, and some Regulatory Guides define the revisions of those Standards that are acceptable to the NRC.
Response
The Baltimore Gas and Electric Company's Quality Assurance Program was devel-oped to respond to the specific revision of the documents listed in Section IB.2 and is not necessarily responsive to other documents listed in the referenced Industry Standards.
ANS 3.2 - 1976
- Item 1 3
Requirement Section 2.0 defines "Onsite Operation Organization" and " Operating Activities."
Both definitions imply that the same organization performs both operations activities and maintenance activities.
Response
BG&E's Production Maintenance Department performs mechanical maintenance and modification; the operating organization at Calvert Cliffs performs maintenance on elec-trical equipment and on instrument and control equipment.
Item 2 Requirement Section 5.2.15 requires that plant procedures shall be reviewed by an individual knowledgeable in the area affected by the procedure every two years to determine if changes are necessary or desirable.
Response
BG&E applies this requirement of a two-year review to all plant procedures except test procedures performed less often than every two years or at unspecified frequencies. These are reviewed no more than 60 days before perfcrmance.
IB-34 73: m s
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Reason Technical Support Procedures (TSPs) and others like them are written for a one-time-only performance and kept for reference for future similar tests. If they are used again, they are reviewed and modified to meet conditions existing at the time of perfor-mance.
.Some Surveillance Test Procedures (STPs) are performed every three to five years.
They too are reviewed before each performance to ensure that' they are compatible with existing conditions and responsive to current needs.
Requirement -
_ Subsection 3.2 outlines requirements for demineralized water.
Response
BG&E specifications for demineralized water are different than the specifications
= outlined in the standard.
Reason' BG&E specifications for demineralized water are consistent with guidelines provided by the Nuclear Steam Supply System supplier.
BG&E specifications are generally more restrictive than those specified by ANSI N45.2.l.
ANSI N45.2.2 - 1972 Item 1 -
Requirement Subsection 2.4 could be interpreted to mean that on-site and off-site personnel who perform any inspection, examination, or testing activities related to the packing, shipoing, receiving, storage, and handling of items for nuclear power plants shall be qual-ified in accordance with ANSI N45.2.6.
Response
Baltimore Gas and Electric Company requires that only persons who are responsible for approving items for acceptance shall be qualified in accordance with ANSI N45.2.6, and that personnel who verify that storage areas meet requirements will be qualified to either ANSI N45.2.6 or ANSI N45.2.23.
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Reason Our receipt inspection procedures require persons who approve items for accep-tance to be qualified in accordance with ANSI N45.2.6. QA inspectors or auditors verify that storage areas meet requirements. All other inspection, examination, and testing activities are subject to review by persons qualified to ANSI N45.2.6.
Item 2
~
Requirement The second sentence of Subsection 2.4 requires that Off-site inspection, examination, or testing shall be audited and monitored by personnel who are qualified in accordance with ANSI N45.2.6.
Response
BG&E uses personnel qualified in accordance with ANSI N45.2.23 to perform au-diting and monitoring functions.
Reason The qualification requirements for auditors cannot always be met by persons quali-Z fled to ANSI N45.2.6.
Item 3 Requirement d
Subsection 2.7 requires that activities covered by the Standard shall be divided into four levels, though recognizing that within the scope of each level there may be a range of controls depending on the importance of the item to safety and reliability.
Response
Personnel of BG&E's Electric Engineering Department will determine 1.
the level of protective measures to be applied to each item, either on an indi-vidual basis when preparing procurement documents or generically for Cata-log, Commercial Quality, etc., Methods of Purchase; 2.
if the packaging and shipping of an item from the supplier should conform to one of the levels described in ANSI N45.2.2, or if the normal packaging and shipping methods used by general industry will provide suf ficient protection; 3.
the level of protection to be applied to an item during storage by BG&E per-sonnel after receipt.
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l Reason BG&E's position is as follows:
1.
For Commercial Quality items, it is not always possible to specify the level of packaging, as most items are purchased after they have been shipped by the manufacturer to his local agent, the wholesaler.
2.
It is not always necessary or practical to retain the packaging used for ship-ment when the item is in storage.
Item 4 Requirement Subsection 3.0 specifies detailed requirements for packing items for each level de-fined in Subsection 2.7.
Response
BG&E has replaced Section 3.0 with the following:
1.
Packaging for Shipment to BG&E Personnel of BG&E's Electric Engineering Department shall ensure that pro-curement documents either indicate that the normal methods of packaging C
and shipment used by industry in general are acceptable for the items being procured or specify the level of protection assigned to the item and the re-quirement that the supplier conform to applicable requirements for items in that classification defined in Regulatory Guide 1.38, Rev. 2 - March 1977.
2.
Packaging for Storage by BG&E In general the packaging used by the supplier to shio items to BG&E need not be retained af ter the item is received by BG&E, provided that the item is stored in an area that meets the requirements for a storage area for the level of protection assigned to the item. Special or unique items, however, may require special protective measures. For such unusual items, the Department that initiated the purchase, together with Electric Engineering, shall identify if any of the requirements of Section 6.4.2 of ANSI N45.2.2 - 1972 apply.
Reason This substitution will ensure that the item will receive adequate protection during shipment and storage, thus eliminating unnecessary restrictions and enabling BG&E to use commercial sources to the utmost.
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Item 5 Requirement Section 4.0 defines shipping requirements related to the protection levels assigned to items.
Response
BG&E has replaced Section 4.0 with the following:
Shipping to BG&E BG&E will invoke the require nents for shipping specified in Section 4.0 of ANSI N45.2.2 - 1972 only when Electric Engineering Department personnel have specified in procurement documents that the item shall be packaged in confor-mance with ANSI N45.2.2, Section 3.0.
Shipping from BG&E Items shipped from BG&E need not conform to any of the requirements of ANSI N45.2.2, but the organization that packs and handles the item shall provide roughly the same level of protection that the item was given during shipment to BG&E.
Reason If Engineering personnel have determined that the supplier's methods of packaging
(
are acceptable, they have already determined that the supplier's methods of shipping are
(
' adequate. As items are shipped from BG&E only for repair, the detailed reauirements specified in Section 4.0 of ANSI N45.2.2 are not necessary.
Item 6 Requirement Subsection 6.4 gives detailed requirements for care of items in storage, according to the protection levels assigned to the items.
Response
BG&E does not require items to be, stored in the packing used for shipment if the storage level in the area provides the same protection as the level of packing assigned to the items. Caps, covers, etc., will be required only if specified by Electric Engineering personnel during the procurement process. If an item is taken from one storage area to another, however, the persons who move it are responsible for ensuring, as applicable, that additional packing is supplied to give adequate protection during transportation.
Reason The degree of protection given an item during storage should be tailored to the importance of the item tr, safety and the probability of deterioration during storage; to base storage requirements purely on the categories in Subsection 2.7 of ANSI N45.2.2 -
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1972 is impractical BG&E requires Electric Engineering personnel to specify requirements more clesely related to the actual function of items and to storage
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conditions.
F Item 7 Requirement Subsection 7.3.3 requires compliance with a series of ANSI documents.
i
Response
BG&E controls for the use of hoisting equipment are compatible with the Standards listed in Subsection 7.3.3 of ANSI N45.2.2, although at the discretion of the Plant Super-intendent they need not be compatible with documents referred to in these documents.
Reason Lower-level documents referred to in the documents listed in Subparagraph 7.3.3 will not necessarily affect the ability of BG&E personnel to properly handle Safety-Re-lated items and could lead to confusion.
Item 8 R,eguirement Subparagraph 7.4 gives requirements for establishing a regular inspection program for hoisting equipment and rigging, including a method of identifying acceptable items.
Resoonse BG&E does not test hoisting equipment and rigging on a regular basis but tests rigging equipment before use; neither does it indicate which items of rigging are accept-able for use.
Reason It is impractical and unnecessary to establish controls for periodically testing rig-ging that will be used infrequently and could be tested many times without being used. It is far more practical to inspect or test equipment before use. There will then be no need
~
for a method of indicating acceptable items, and non-acceptable items can be identified by a Non-conformance Tag.
ANSI N45.2.3 - 1973 Item 1
=
Requirement Subsection 2.1 outlines housekeeping cleanness requirements for five designated zones.
REV.2 1B-39 u1 1
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Response
)
BG&E has established three classes for cleanness requirements. There is no class equivalent to the ANSI Zone 1.
Requirements of ANSI Zones 4 and 5 have been consolidated into BG&E's class 3.
Reason 1.
ANSI Zone I level of cleanliness applies to new construction activities.
2.
Where required, smoking restrictions are posted for BG&E's class 3 areas.
Item 2 Requirement Subsection 2.1 requires for Zones I, II, and III, that a written record of the entry and exit of all personnel and material shall be established and maintained.
Resoonse BG&E has established the following methods for personnel and material
^. accountability:
1.
Written accountability.
2.
Where possible tethering of tools and materials to permanent olant structures
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or persons.
3.
Post-maintenance closeout inspections.
Reason BG&E's three methods of accountability offer the same level of control as that required by the standard.
ANSI N45.2.6 - 1978 Item 1 Requirement Subsection 1.2 states in part, The requirements of this standard apply to personnel who perform inspection, examination, and tests during fabrication prior to and during receipt of items at the construction site, during construction, during preoperational and start-up testing, and during operational phases of nuclear power plants.
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2 Response-A Personnel of BG&E's Quality Assurance Department who perform inspections, examinations, and tests at the plant site during operational phases of the nuclear power plant are required to be qualified in accordance with ANSI N45.2.6. All other BG&E per-sonnel who perform inspection, examination, and te' ting functions associated with nor-s mal onerations of the plant are qualified either to ANSI N45.2.6 or to ANSI N18.1 - 1971.
- Reason-A 1.-
-The individuals' who perform inspection, examination, and testing functions associated with normai operation of the plant, such as maintenance and cer-tain technical reviews,'are normally qualified to ANSI N18.1 - 1971.
- 2.
Some testing activities conducted during normal operation of the plant, such as surveillance testing, do not require that test personnel meet the require-ments specified in Paragraph 4.5.3 of ANSI N18.1 for technicians. Personnel qualified to ANSI N45.2.6 are adequately qualified to conduct such testing.
Response-B BG&E does not always require supplier personnel performing inspection or test activities to comply with the requirements of N45.2.6 but evaluates the need for invoking
~~
N45.2.6 on the supplier during the review of procurement documents. The requirements are_not applied to Commercial Quality or Catalog methods of procurement.
Reason-B BG&E's position is as follows:
1.
For replacement itemi purchased by the Catalog, Commercial Quality, and Verification Methods of procurement, the purchaser is unable to specify the qualification requirements' for inspection, examination, and test personnel because the items are manufactured before placement of the Purchase Order.
2.
For the Specificatioa Method obprocur'ement, the qualification requirements -
for inspection, examination, and test personnel are determined by a.
Item status (new or replacement) b.
complexity and importance of item c.
manufacturer's QA program approval level (Appendix B, N45.2, etc.)
Response-C BG&E does dat require personnel who perform specific limited and repetitious in-spection. functions, such as inspection for removal or replacement of snubbers, to be trained as required by N45.2.6.
Reason-C Inspections, examinations, or tests that are repetitious or of limited scope need not F
be performed by individuals qualified to the requirements of ANSI N45.2.6 provided that they receive instruction in the following:
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Activities to be verified 2.
- Acceptance criteria 3.
Method of documenting results 4.
Methed of reporting deficiencies The person responsible for the inspection activity ensures that such instruction is given to inspectors before they perform specific inspection functions, and that both this training and the acceptability of the results of the inspection are documented.
Response-D When lt is necessary to monitor the activities of a supplier, BG&E uses personnel
~
qualified as auditors in accordance with ANSI N45.2.23 or inspectors in accordance with
-- ANSI N45.2.6. -
Reason-D -
Both ANSI N45.2.6 and N45.2.23 establish training requirements suitable for moni-toring supplier activities.
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Item 2 Requirement Table I specifies that Level III personnel shall be capable of qualifying Level III
. personnel.
Response
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' When there is only one Level If*,osition or when a new Level III position is created,
- BG&E personnel with the title General Supervisor or higher qualify Level III personnel.
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~ Reason t
' BG&E personnel in these grades are capable of certifying Level III personnel with-out being trained as Level 111 inspectors. -
L Item 1 Requirement Section 4.0 titled " Receipt," gives instructions for receipt controls.
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BG&E applie's these requirements only to the receipt of records by the Plant His-
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l tory File.
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Reason Most records received by such organizations as Incoming Inspection, Engineering, etc., are not shipped in a manner that makes these requirements applicable. These re-quirements are applicable, however, when the records are finally turned over to the Plant History File.
Item 2 -
Requirement Subsection 5.6.1, item (1) states that "no pipes other than those providing fire pro-tection to the storage facility are to be located within the facility."
Response
The BG&E storage facility is controlled by the following statement: "no pipes or ducts other than those providing fire protection, HVAC, and electricity to the storage facility are to be located within the facility."
Reason Unless electrical and HVAC penetrations are allowed, the records cannot be prop-erly protected during storage.
Item 3
- Requirement Subsection 5.6 allows only the dual facility defined in Subsection 5.6.2 as an alter-natice to the single facility defined in Subsection 5.6.1.
Reponse BG&E allows the following alternative storage requirementt 'y organizations other than the Plant History File:
Organizations that originate records and do not transfer them to the Plant History File within 30 days of completion shall establish one of the following three controls as alternatives to the requirements specified for the Plant History File:
1.
Duplicate Storage Either A or B:
A. Within 30 days of completion of a record, a duplicate record file shall be established. This activity shall be controlled by procedures which provide for the following:
1.
Assignment of responsibility for records 2.
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Description of filing system 4.
An index of the filing system 5.
Rules governing access to and control of files 6.
Methods for maintaining control of and accountability for records re-moved from the file 7.-
Method for filing supplemental information and disposing of superseded or obsolete records 8.
Method for preserving records to prevent deterioration 9.
Method for maintaining specially processed records that are sensitive to light, pressure, or temperature 10.
Transfer of duplicates to the Nuclear Plant Documents Unit within two years of completion of records B. Make arrangements with at least one other department that receives a copy of each document to subject this other copy to the controls specified above.
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Fire-resistant Building Storage
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1.
Records shall be stored in steel cabinets located in a fire-resistant building or a non-combustible building with a fire suppression system.
2.
The procedural controls defined for duplicate storage shall be applied.
r 3.
Non-fire-resistant Building Storage Within non-fire-resistant facilities, records shall be stored in UL one-Sour-minimum fire-rated storage cabinets and be subject to the procedural con-trols defined for duplicate storage.
BG&E defines a Fire-resistant Building as follows:
A facility constructed to resist the initiation or spreading of fire; non-combustible and/or fire-suppressive materials used; building certified as fire-resistant by the Fire Prevention Unit of BG&E's Finance Depart-ment Reason Although these alternatives are compatible with standard methods of handling rec-ords, they do not materially decrease the level of protection afforded to the records.
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ANSI N45.2.23 - 1978 Item 1 Requirement 2.3' Qualification of Lead Auditors
~Section 2.3.1 requires prospective Lead Auditors to obtain a minimum of ten credits under the scoring system defined in paragraphs 2.3.1.1-2.3.1.4.
Response
BG&E has revised the scoring system as follows:
Education and Experience The prospective Lead Auditor shall have accumulated a minimum of ten credits under the following scoring system:
s 1.0 Education (4 credits maximum) 1.1 For the Associate degree for an accredited institution, score one credit, if the degree is in engineering, physical sciences, mathematics, or qua-lity assurance, score two credits. Or, for the Bachelor degree from an accredited institution, score two credits; if the degree is in engineering, physical sciences, mathematics, or quality assurance, score three cred-its.
1.2 For the Master degree in engineering, physical sciences, business man-agement, or quality assurance from an accredited institution, score one credit.
1.3 For the successful completion of part of the required curriculum for an
+
Associate, Bachelor, or Master degree, score a corresponding percent-age of the credits specified above for the degree.
1.4 For the successful completion of Navy Nuclear Training, its equivalent in another armed service, or the training required for becoming a li-censed operator in a commercial nuclear power plant, score two credits.
2.0 Experience (9 credits maximum) 2.1 Technical Experience (5 credits maximum)
For experience in engineering, manufacturing, construction, operation, or maintenance, score one credit for each full year.
2.2 Nuclear Experience If two years of technical experience have been in the nuclear field, score one additional credit.
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- 2.3 Quality Assurance Experience If two or more years of the technical experience have been in quality assurance or quality control, score two additional credits. Persons whose work activities are controlled by the Quality Assurance Program E
but'who are not full-time members of the QA organization may be awarded ha!f the credits that would be given to a person with specific quality assurance experience.
- 2.4 Audit Experience
~ If two or more years of the technical experience have been in auditing, score one additional credit.
2.5 Supplemental Experience Persons who have a proportion of the experience specified in 2.1-2.4 may be awarded a corresponding percentage of the credits specified.
3.0 Training (2 credits maximum)
. Persons who have successfully completed the training requirements of ANSI
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N45.2.23 may be given two credits.
4.0. Rights of Management (2 credits maximum) 3 3-The QA Manager may grant additional credits for other performance factors
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~ f applicable to auditing as follows:
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4.1 - For certification of competence in engineering or science related to nuclear power plants, or in quality assurance specialties, issued and approved by _a State' Agency or National Professional or Technical Society, score two credits.
4.2 For. nuclear experience in excess of 2 years, score one credit for each
.o two years experience.
4.3 For practical experience that can be related to power plants, in excess of 5 years, score one credit for each two years of experience.
L Reason BG&E is in agreement with the basic purpose of ANSI N45.2.23--that is, to estab-lish minimum educational or experience requirements for Lead Auditors. We think, how-
. ever, that the system of credits outlined in ANSI N45.2.23 tends to reduce the size of the pool of potential replacement auditors without making redeeming improvement in the capabilities of persons selected.
+
We calculated the credit score of 11 of our present Lead Auditors at the time they were appointed Lead Auditors. Six had completed Navy Nuclear Training and spent several years in the Navy Nuclear Program. Four of these scored only 8 credits total, including 2 credits allowed by paragraph 2.3.1.4 of ANSI N45.2.23 for rights of management based on their having completed the BG&E QA training programs for Lead Auditors.
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y One of our auditors, with neither nuclear nor power plant experience, had a credit
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- engineer with over 5 years design experience.
. score of 12 because he held a Bachelor's degree in engineering and was a professional.
Because.all of the:e individuals have acted as Lead Auditors satisfactorily for several years, it appears that the credit system should be revised slightly to allow for the differences in education and experience of prospective Lead Auditor candidates.
~We consider the flaw in the current system to be the emphasis on educational re-quirements that will allow a person with a Master's degree and no nuclear or power plant experience to become a Lead Auditor, but will exclude a person who has no degree, even
-.though he may have.20 years' experience in operating or maintaining nuclear or power plant systems.
The practical balance between education and experience will vary with individuals and particular work assignments. Any attempt to establish rigid requirements is likely to allow some unsuitable candidates to meet the qualification requirements while excluding some acceptable candidates.
-For these reasons, we think that the supervision of prosoective Audit Team Leaders should be given more flexibility in determining whether, for a particular individual, edu-cational or professional qualifications are more significant and valuable than past exper-e ience.
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The present credit system, while recognizing the Associate degree, gives no credit for completion of the nuclear training programs. We think that someone who has taken
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Navy Nuclear Training or its equivalent in another armed service, or someone who has s
A completed the training required to become a licensed operator in a commercial nuclear
- power plant, should receive the same credit as a person who has an Associate degree from an accredited institution in engineering, physical sciences, mathematics, or quality
. assurance.
The points now awarded for education are related to the effect that formal courses might have on the ability of individuals to comprehend the regulations or the technical aspects of activities being audited. The point system makes no allowance for the fact that such knowledge comes gradually and not upon receipt of a degree. Persons who have completed part of a degree course should receive a percentage of the credits allowed for
. that course.
The requirements for training specified in ANSI N45.2.23, paragraph 2.3.2, would seem to ensure that prospective Lead Auditors will meet the requirements of paragraph
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2.3.1.4 dealing with the rights of management. We think, therefore, that all prospective l
Lead Auditors should qualify for these two credits.
Similarly, the present system recognizes the effect that working in a OA Program will have on the ability of a person to comprehend regulations and technical require-i-
ments. Persons who are not assigned as ' full-time members of the Ouality Assurance l.
Organization, however, receive similar exposure if they perform act.lvities controlled by a QA Program. We therefore allow such persons half the credits specified for quality assurance experience.
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1 Item 2 1
Requirement.
3.3 - Requalification -
Lead Auditors who fail to maintain their proficiency for a period of two years or
.more shall' be~ required to requalify. Requalification shall include retraining in
<accordance with the requirements of paragraph 2.3.3, reexamination in accordance with paragraph 2.3.5, and participation as an Auditor in at least one nuclear quality assurance audit.
Response
BG&E requalifies Lead Auditors on the basis of the satisfactory performance of one audit, as observed by a qualified Lead Auditor.
Reason The purpose of the training specified in paragraph 2.3.3 of the Standard is to ensure that candidates understand the fundamentals of auditing and the requirements for activi-l ties to be audited. The fact that persons have not maintained their proficiency does not i
mean that they need complete re-training; it means only that they have not been able to l
- review and study the applicable Codes, Standards, Procedures, instructions, and other documents related to Quality Assurance. Programs and program auditing. BG&E con-
- siders that the satisfactory performann of an audit under the observation and guidance-of a qualified Lead Auditor should ensure that persons with lapsed certification will review and understand the pertinent documents.
ANSI N101.4 - 1972 Requirement.~
4 Section 1.2 specifies applicability requirements for the Standard.
Response
BG&E requires that only activities performed inside containment structures and re-slated to protective coatings applied to ferritic steels, aluminum, stainless steel, zinc-coated (galvanized) steel, concrete, or masonry-surfaces shall conform to applicable Sections of ANSI N101.4.
I Reason -
Deterioration of protective coatings applied to surfaces outside containment struc-F
- tures would have no detrimental effects on the safe operation of the plant.
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Baltimore Gas and Electric Comoany Q U A LIT Y ASSURANCE DEPARTM ENT ORG A NIZ ATION i..
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Quality Assurance Department r
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Quality Assurance Quality A ssurance Audits 8 Programs
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Ouality Assurance Quality Control Quality Control Quality Control Q u ality Control
- p Auditing Electrical / t & C Modifications Mechanical Surveillance /
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