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NUCLEAR QUALITY ASSURANCE MANUAL. Revision 3 02/06/ PDF
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1 NUCLEAR QUALITY ASSURANCE MANUAL 02/06/2012 Reviewed by: 2/6/2012 For Robert E. Shirk, QA Manager Date per attached (Attachment 1) Approved by: 2/6/2012 George C. Van Wert, President Date ILRT Inc. unless marked with a Controlled Copy identification number in red below: Controlled Copy #:
2 FOREWORD ILRT Inc. provides engineering, training, and specialized technical services to industry and government. The Company offers a range of services needed by organizations involved in the design, construction, operation and maintenance of nuclear power plants. ILRT Inc. is committed to achieving high quality in all the services and related products it provides. The Company realizes this goal through selective employment of experienced engineers and technical specialists coupled with effective project management. In addition, the Company recognizes the fundamental importance of quality assurance practices in achieving this goal and has established a Nuclear Quality Assurance Program to provide for these practices. The primary responsibility for the quality of the services and related products provided by the Company rests with the individuals doing the work. Accordingly, all employees are responsible for understanding and implementing the Nuclear Quality Assurance Program practices applicable to their work. The President of ILRT Inc. has the overall responsibility for establishing the policies and requirements of the Nuclear Quality Assurance Program. Project Managers have the responsibility for implementing the Program. An appointed Quality Assurance Manager has the responsibility and organizational freedom to audit and verify the implementation of the Program, to identify quality problems, to initiate corrective actions, and to verify the implementation of corrective actions. The is the document that establishes the requirements of the Quality Assurance Program as it applies to nuclear safety-related work when the Company provides services and related products for clients involved in the design, construction, operation and maintenance of nuclear power plants. The addresses each of the 18 Criteria of Title 10, Code of Federal Regulations, Part 50, Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," and the referenced sections of ASME NQA , "Quality Assurance Program Requirements for Nuclear Facilities", Subpart 2.7, applicable to software used for safety related plant functions. The requirements of the are invoked on each project; consistent with client requirements, to the extent determined necessary by the Project Manager and the Quality Assurance Manager. Compliance with the requirements of the is accomplished through a series of Corporate (e.g. Quality Implementing Procedures QIPs ) and project level (e.g. Project Procedures Manuals PPMs) documents, as appropriate, which include necessary details and controls. The review process assures that the contents of implementing procedures conform to NQAM requirements. The requirements of the are invoked on each project; consistent with client requirements, to the extent determined necessary by the Project Manager and the Quality Assurance Manager. i
3 TABLE OF CONTENTS Section Page Record of Approval Cover Foreword i Table of Contents ii Record of Revisions iii Section 1 Organization 1-1 Section 2 Quality Assurance Program 2-1 Section 3 Design Control 3-1 Section 4 Procurement Document Control 4-1 Section 5 Instruction, Procedures and Drawings 5-1 Section 6 Document Control 6-1 Section 7 Control of Purchased Material, Equipment and Services 7-1 Section 8 Identification and Control of Materials, Parts and Components 8-1 Section 9 Control of Special Processes 9-1 Section 10 Inspection 10-1 Section 11 Test Control 11-1 Section 12 Control of Measuring and Test Equipment 12-1 Section 13 Handling, Storage and Shipping 13-1 Section 14 Inspection, Test and Operating Status 14-1 Section 15 Nonconforming Materials, Parts or Components 15-1 Section 16 Corrective Action 16-1 Section 17 Quality Assurance Records 17-1 Section 18 Audits 18-1 Section 19 Reporting Requirements 19-1 Section 20 Exhibits 20-1 Attachment 1 Approval s Att. 1 ii
4 RECORD OF REVISIONS Revision Number 0 This is the initial issue of the ILRT Inc. Revision Number 1 A general editorial revision of the manual to clarify position titles and responsibilities, delete outdated or inappropriate organizational references Revision Number 2 Page 2-1, Section References Incorporated a reference to incorporate an edition and section specific reference to NQA , Subpart 2.7. Previously the only reference to which edition was referenced was in paragraph The reference in was deleted. Page 18-1, Section , Audit Performance A limited revision to Section 18, Audits, to incorporate guidance and controls for the review and acceptance of third party audits. Revision addresses root cause to Audit Finding #2 of FP&L Audit JQA Revision Number 2.1 Exhibit 6, Nonconformance Report Added a section documenting the assessment of report-ability under 10CFR Part 21. Revision Number 2.2 Page 1-1, Section 1.2, Organization General Description Updated corporate location. (CAR100418A) Pages 16-1 & 2, Section 16, Corrective Actions Edited section to reflect merging of NCR & CAR Forms. Page 19-4, Section 19.5, Notifications Added a paragraph to address Part 21.21(B) which discusses evaluations beyond ILRT Inc. capabilities. (NUPIC 2010 Audit Finding V & NCR100422A) Exhibits Updated address and phone numbers on Exhibit 1 (Contract / Purchase Order Review Form). (CAR100418A) Deleted Exhibit 9 (CAR Form) and incorporated CAR tracking fields with Exhibit 6 (NCR Form). (Forces Part 21 review on CAR) iii
5 Revision Number 2.3 Forward Revised narrative to clarify link between NQAM and corporate/project implementing procedures in conforming to NQAM requirements. Page 18-2, Section 18.7 ISO Audit Exemption Added section reflecting practice of adding Calibration Labs accredited to ISO to the Qualified Supplier s List without an Audit providing they meet specific requirements in line with practices accepted by the USNRC (e.g. current Accreditation, accreditation obtained from an accrediting agency or company that is an ILAC MOU signatory. Page 17-1, Section 17-2 General Added fact that records may be paper or electronic to tie in details included in QIP Revision Number 3DRAFT Section Description of Change Changed By All General revision to address change in organizational structure and GCVW responsibilities. Predominantly to reflect move from Company Principal Responsible for Quality to a dedicated Quality Assurance Manager. Cover & Added note regarding how to identify if printed copy is a GCVW Footers Controlled Copy. Forward Revised narrative to replace Corporate Principal with Quality GCVW Assurance Manager. 1 Reassigned Vice President responsibilities to Quality Assurance GCVW Manager. 5 Revised assignments of preparer, reviewer, approver for quality GCVW procedures. Exhibits 1 Reorganized Sample Exhibits for Order Entry Contract Review, GCVW & 2 QA Review & NQAM Applicability, and Quality Plan to put commercial review on one page and quality review on a separate page. In past the two were mixed. Merged QA review with NQAM Applicability. Exhibit 8 Deleted Audit Finding Report Form from NQAM. Form exists in QIP and should only be maintained in one place. GCVW iv
6 1.1 Scope SECTION 1.0 ORGANIZATION This section of the describes the organizational structure, functional responsibilities, and levels of authority for the direction and execution of the ILRT Inc. Quality Assurance Program on nuclear safety-related work. 1.2 General Description ILRT Inc. is organized to provide engineering, staff support, training, and other specialized technical services to the nuclear industry. The Company management is comprised of a President, a Treasurer, and a Quality Assurance Manager. The corporate office is located in Palm Harbor Florida but some personnel are located regionally. A specific Project Organization is established for each safety-related Company project. The Project Organization is headed by a Project Manager and supported by management and other personnel as required. The Project Manager has the responsibility for managing the project and dealing directly with the client. A senior project team member not serving as the Project Manager will provide a peer review for quality related activities. All project tasks are performed by the Project Organization. Except for the specific responsibilities and authorities of the Corporate Organization as described herein, this manual is directed toward the Project Organization. 1.3 Corporate Organization The Corporate Organization is described above. Position responsibilities and authorities that affect the control of quality in Company activities are described as follows: President The President has the authority to issue directives, to make decisions, and to override the decisions of all other Company personnel. The President has the following specific responsibilities with respect to the Nuclear Quality Assurance Manual and its implementation: Approve the. Review periodically the adequacy and effectiveness of the Nuclear Quality Assurance Manual. Resolve disagreements or disputes on quality matters between Company personnel. 1-1
7 Quality Assurance Manager The Quality Assurance Manager reports directly to the President and has the overall responsibility for the implementation of the Nuclear Quality Assurance Manual. They have the authority and responsibility to: Implement the, when applicable. Direct quality-affecting activities. Review periodically the adequacy and effectiveness of the Nuclear Quality Assurance Manual. Report to the President, as necessary, conditions adverse to quality and other quality-related matters. Verifying that quality-affecting activities are performed in accordance with applicable procedures. Establish direct lines of communication with external organizations such as contractors and clients, as may be necessary, to assure proper implementation of the and to verify prompt resolution of quality-related problems. Develop, review, and issue the, quality implementing procedures, and revisions to these documents. Certify personnel performing quality functions as appropriate. Assist in QA training and indoctrination of Company employees and subcontractor personnel who are required to work to this manual as requested by the Project Managers. (The degree to which the training or indoctrination is provided shall be commensurate with the assigned duties and responsibilities of the individuals.) Initiate or recommend corrective actions. Concur with decisions relative to the applicability of the Nuclear Quality Assurance Manual to ILRT Inc. projects. Provide interface with client QA representatives by coordinating client audits and providing follow-up documentation, when required. Assist in the establishment and implementation of program(s) for qualification of suppliers and subcontractors providing safety-related items or services to a Project. Establish and implement a system for collection, storage, and maintenance of records required to furnish evidence of activities affecting quality and the procedures for turnover of the records to clients in accordance with regulatory and contractual requirements. Approve project quality requirements as identified in NQAM Applicability 1-2
8 forms and as stated in Project Quality Plans. Periodically assess the compliance with and effectiveness of the QA Program through a comprehensive system of planned and periodic surveillances and audits as required by Section 2 and 18 of this manual. Stop work on nonconforming items or where nonconforming practices are identified, when such action is warranted. Verify that corrective actions have been taken to resolve conditions identified by Nonconformance and Corrective Action Reports, Audit Finding Reports, and client reports. Review purchase orders associated with contracts requiring the application of the, from the standpoint of satisfying QA requirements Business Operations Business Operations provides administrative support functions to the company President and projects. Bookkeeping, human resource functions, accounts payable, and accounts receivables make up the majority of Business Operations functions Subsidiary Companies Any ILRT Inc. subsidiary company conducting nuclear safety-related activities or services shall operate under the authority of this Manual. 1.4 Project Organization A typical Project Organization is described below. The respective position responsibilities and authorities that affect the control of quality-affecting project activities are described as follows: Project Manager The Project Manager is responsible to the client for all project work. The Project Manager has the responsibility and authority to: Implement all applicable provisions of the and related procedures. Prepare and approve the Project Quality Plan Project Procedures after independent review. Maintain communications with the client on quality-affecting project activities. Issue quality-related documents and records to the client upon project completion. 1-3
9 The principal working contact with the client is through the Project Manager. However, the client also has direct access to the President and the Quality Assurance Manager Project Staff Project Staff members report to the Project Manager. They are required to be familiar with the provisions of the and the Project Quality Plan and are responsible for complying with implementing procedures. All personnel assigned to a Project doing safety-related work, regardless of location, fall under the authority of this Manual and the applicable Project Quality Plan. The Project Quality Plan may define the location of the personnel assigned to a project Corporate Quality Function The Corporate quality functions associated with a project are performed as described in paragraph by the Quality Assurance Manager. 1.5 Repetitive-Task Projects Some projects performed by ILRT Inc. are repetitive in nature. An example of such a project is Integrated Leak Rate Testing (ILRT) projects. For this repetitive type project, a generic Project Quality Plan may be written, with Appendices or supplemental Project Procedures as appropriate for details of a specific project. 1-4
10 SECTION 2.0 QUALITY ASSURANCE PROGRAM 2.1 Scope This section describes how the ILRT Inc. is implemented to control quality-related activities on Company projects falling under the applicable requirements of the listed references. 2.2 References CFR50 Appendix B - Quality Assurance Criteria for Nuclear Power Plants ANSI/ASME N Quality Assurance Program Requirements for Nuclear Facilities ASME NQA Quality Assurance Program Requirements for Nuclear Facilities Subpart 2.7, Quality Assurance Requirements for Computer Software for Nuclear Facility Applications, 2.3 Definitions The definitions contained in the references are applicable throughout this manual unless a specific exception is made. 2.4 General This defines the requirements of the ILRT Inc. Quality Assurance Program as it relates to nuclear safety related work. It is presented in 19 sections as follows: 18 sections corresponding to and addressing each of the 18 Criteria of 10 CFR 50, Appendix B, ANSI/ASME N45.2, applicable sections of ASME NQA and one section addressing the requirements of 10CFR21. ILRT Inc. provides services and, on occasion, related products to the nuclear industry. (Normally the company does not produce, install, replace, repair, or otherwise handle hardware products other than for temporary use during integrated leakage rate tests.) Some of the sections of this manual are not applicable to Company services or projects but are provided in the event that a project falls into any of these areas. The sections not normally required for a typical project are: Section 8 Section 9 Section 10 Identification and Control of Materials, Parts and Components Control of Special Processes Inspection Section 14 Inspection, Test and Operating Status Specific instructions and requirements for complying with applicable QA criteria for each project for which applicability is determined as described in Section 2.5 are contained in the Project Quality Plan and implementing procedures, as described in Section 5. Procedures may include Quality Implementing Procedures (QIPs), Quality Instructions (QIs), Operating 2-1
11 Procedures (OP), and specific Project Procedures (PPs or PPMs). QIPs define how the administrative requirements of the Nuclear QA Manual are to be implemented, and address the subjects common to all project activities of the Company. OPs implement the QA Manual requirements from a technical standpoint. QIs contain detailed instructions that support various QIP or OPs. PPs / PPMs describe how the quality-related activities of specific work tasks are performed. 2.5 Applicability The applicability of the to each Company project shall be determined and affected as follows: NOTE: 1. The requirements of Section 1 through 18 are applicable to company projects as determined by a specific applicability review. 2. The requirements of Section 19 are applicable to all Company nuclear activities as described herein. When a contract document is received, it is delivered to the President who assigns a Project Manager for review and contract setup. That individual assumes Project Manager responsibilities for the contract and reviews the document to identify and evaluate the specific project tasks, complete the order entry and commercial review, and to identify any provisions for quality assurance. The documented review is then provided to the Quality Assurance Manager for concurrence and approval to start quality related tasks. The Project Manager documents the results of the quality assurance applicability review by checking the appropriate block on the QA Review and NQAM Applicability form, Exhibit 2, prepared for that project. If application of the Company's Nuclear Quality Assurance Manual is specified by the contract document, the "ILRT INC." block on the form is marked as YES. If application of the client s quality assurance program is required the "Client" block is marked as YES. If application of quality assurance is not required, the ILRT INC. and Client blocks are marked NO, and the only mandatory quality assurance requirements applicable to the project are those defined in Section 19. Following the Project Manager s review, the contract and review documents are forwarded to the Quality Assurance Manager for formal review and verification of appropriate assignment of QA status. A documented review of contract documents for commercial items is conducted by Business Operations or the President. If the "ILRT INC." block is checked, the Quality Assurance Manager also reviews and approves the Project Quality Plan (Exhibit 3). Contract review results and comments are recorded on the associated exhibits. If the is applicable, a Project Quality Plan is required, and the following actions are taken: The Project Manager or designee completes a 2-2
12 Applicability form as shown in Exhibit 2, indicating whether each section is (1) "Applicable, in accordance with 10 CFR 50, Appendix B," or "ASME NQA-1," (2) "Applicable, limited to specific project requirements", or (3) "Not Applicable," consistent with the quality assurance requirements specified in the contract. a. "Applicable, in accordance with 10 CFR 50, Appendix B" or "ASME NQA- 1": The client has invoked 10 CFR 50, Appendix B or ASME NQA-1 quality assurance requirements in the contract. Project quality-related activities associated with the specific work tasks shall be performed, reviewed, and documented in full compliance with the designated sections of the Nuclear QA Manual, the Project Quality Plan, and implementing quality assurance procedures. b. "Applicable, limited to specific project requirements": 10 CFR 50, Appendix B or ASME NQA-1 has not been invoked in full by the client, but some quality assurance requirements have been either specified in the contract or designated by the cognizant Project Manager. In this situation, the designated sections of the QA Manual shall be used on a limited basis for controlling quality-affecting project activities, as identified in the Project Quality Plan. The Project Manager shall indicate any exceptions to specific provisions in the QA Manual sections invoked in the Project Quality Plan. c. "Not Applicable" 10 CFR 50, Appendix B or ASME NQA-1 has not been invoked and does not apply. The Project Manager shall sign and date the form when each section has been checked, and forward it to the Quality Assurance Manager for review and approval The Quality Assurance Manager reviews the Applicability form along with the contract and all reference documents, and takes the following action: a. Documents the review by checking the appropriate blocks on the bottom section of the form, and indicating any recommendations in writing. b. Signs and dates the form, and returns the original and attachments to the Project Manager for retention with the project records. c. Obtains concurrence, or resolution of, recommendations from the Project Manager, and signs the form, indicating "Final Approval." The completed form with all backup documentation attached is filed with the project records, normally as a section of the Project Quality Plan. 2.6 Project Quality Plan 2-3
13 Following the determination of applicability of the Nuclear QA Manual, as described in Section 2.5, the Project Manager prepares a Project Quality Plan by reviewing the project task requirements and identifying the description of each on a Project Quality Plan form, Exhibit 3. The applicable sections of the Nuclear QA Manual, as listed on the Quality Assurance Manual Applicability form, are listed. The applicable implementing procedures, instructions corresponding to each listed task description or required QA Manual section, are identified in the "Applicable Procedure" column. Any exceptions to the applicable sections of the Nuclear QA Manual are listed in the appropriate space provided. The form is signed and dated by the Project Manager, then reviewed, approved, signed and dated by the Quality Assurance Manager. This completed document summarizes the applicability of the Nuclear QA Manual, project task requirements, and implementing procedures for controlling the quality-related project activities, and shall be included in the Project Quality Plan and filed with the project records, in accordance with Section Exceptions or Changes to Contract Documents Any exception taken by ILRT Inc. to a client contract/purchase order requirement, or any change to the contract document, will be documented. Exceptions or changes may be documented on the Contract Setup Worksheet, in a letter/memorandum to the client, on form(s) provided by the client, or on Exhibit 7, Notice of Exception/Change to Client Procurement Document. Documentation of exceptions or changes will be filed with the project records. 2.8 Assessment of Nuclear QA Manual Implementation It is the responsibility of the President to assess the implementation of the Nuclear Quality Assurance Manual by commissioning an audit of the program and a report of the results. This assessment is performed on a regular basis, approximately every two years. Revision to the and its review by the President and Quality Assurance Manager will satisfy the requirements for reporting the status and effectiveness of the manual. Implementation effectiveness of the Nuclear QA Manual, including compliance to the applicable criteria of 10 CFR 50, Appendix B or referenced sections of ASME NQA , and other applicable Codes and specifications, is further assured through periodic programmatic or project audits performed by the Quality Assurance Manager or a qualified designee. 2.9 Revisions to the Nuclear QA Manual Revisions to the shall be reviewed by the Quality Assurance Manager and approved by the President Nuclear QA Manual Distribution The Quality Assurance Manager is responsible for the issue, recall, revision, and reissue of the Nuclear QA Manual. The Nuclear QA Manual is a controlled document. When 2-4
14 controlled copies of the Nuclear QA Manual are distributed, a receipt acknowledgment form is requested from each holder of controlled copies. Controlled copies may be issued as hard copies identified as such in red ink on the cover page, or as read-only electronic copies (e.g., such as a downloaded pdf file, or a labeled CDROM issued by the Quality Assurance Manager or designee. Editable (Microsoft Word) copies on CDRW disks or similar media will NOT be considered Controlled Electronic Copies). Copies of receipt acknowledgments are maintained for the most current revision of the QA Manual. An ed receipt acknowledgment is considered adequate for both electronic and hard copies of QA Manuals and current revisions. The Quality Assurance Manager may issue uncontrolled copies of the manual for information only. Copies shall be clearly indicated as "Uncontrolled" or "For Information Only." Any copy issued in any form not supported by a documented receipt shall be considered as For Information Only Personnel Assignments The assigned Project Manager makes all project personnel and project work assignments Project Personnel Qualifications/Certifications The qualification requirements for project personnel are the responsibility of the Project Manager. The contract or the Project Manager may establish the requirements. Any required certifications shall be the responsibility of the appropriate certifying body. Verification of Qualification/Certification is the responsibility of Business Operations. Business Operations shall maintain documentation of the employee Qualification/ Certification and the accompanying verification Project Personnel Indoctrination and Training Indoctrination/Training The Project Manager is responsible to ensure that the project personnel have been provided appropriate indoctrination and training to the applicable portions of the ILRT Inc. and implementing procedures. Prior to any project personnel performing quality-related activities under the auspices of this manual, it is the responsibility of the Project Manager to ensure they are indoctrinated and trained. The objective of this indoctrination and training is to familiarize project personnel with the various aspects of quality assurance relative to the individual's job functions. Assistance as required may be obtained from the Quality Assurance Manager. The indoctrination/training shall, as a minimum, include the following: ILRT Inc. (applicable sections) Project Quality Plan and applicable procedures Other applicable codes and standards 2-5
15 Those personnel not directly related to the quality aspects of projects will be provided with indoctrination and training on quality subjects that can indirectly affect the quality or contractual requirements of the projects. These personnel may include Business Operations personnel. Training shall be initial, biennial, or major quality program change, whichever is first. Completion of quality assurance indoctrination/training shall be documented in writing for each individual by the Project Manager and maintained in the project records Technical Training The need for technical training for project personnel is evaluated by the Project Manager and provided on an as needed basis. The Project Manager is responsible for conducting project technical training (e.g., unique work instructions, unusual technical/interface requirements, etc.). This is not intended to be general engineering or skills training, but unique to the project being performed Project Organizational Responsibilities The Project Manager is responsible for the quality of all work performed by the Project Organization under his jurisdiction. The Project Manager shall make individuals who are assigned tasks cognizant of quality and technical requirements. The project shall be organized to meet the quality requirements, as applicable Project Manager Addition or Replacement In the event of a change of Project Manager, the incumbent Project Manager shall take the following actions: Arrange for a formal turnover/indoctrination session for the newly assigned Project Manager. The turnover or indoctrination session shall be documented and cover the following topics as a minimum: (a) (b) Project performance status: Contract requirements Project commitments Task completion status Project schedule Personnel assignments, responsibilities, and qualifications Project Quality Plan summary and status: Explanation of Project Quality Plan Review of Project Procedures and Quality Implementing Procedures Project QA audit/surveillance status and results Nonconformance/corrective actions (closed and outstanding) Interface with client QA program/personnel In the event that the incumbent Project Manager is not available to fulfill the 2-6
16 requirements of above, the President or Quality Assurance Manager shall perform the steps required by Quality Assurance Auditor Qualification and Training It is the responsibility of the Quality Assurance Manager to assure those ILRT Inc. Quality Assurance Auditors, or auditors supplied by outside agencies, are properly qualified and certified in accordance with applicable procedures. ILRT Inc., in accordance with Section 17 of this manual and applicable procedures shall maintain records of auditor qualification and training QA/QC Qualification and Certification of ILRT Inc. Personnel At times, ILRT Inc. performs nuclear related services for clients who require that ILRT Inc. certify employees for a particular service to be provided (e.g., NDE services, test surveillance, inspectors). There is a body of codes, standards and rules that govern the qualifications of the personnel who conduct the testing, review test results and certify people as qualified to perform particular functions. These certifications are normally required to be in accordance with one or more industry standards such as ANSI N A Level III Examiner is responsible for developing procedures, and instructions for performance of certifications. These procedures and instructions constitute the "Quality Assurance and Quality Control Qualification and Certification Program." A Level III Examiner is also responsible for performing the certifications in a timely fashion. The Quality Assurance Manager is responsible for maintaining the certification records in duplicate files. The cognizant ILRT Inc. Project Managers shall identify the personnel to be certified to a Level III Examiner and shall provide the Examiner the requisite supporting documentation attesting to the individual's qualification for certification and for performing the work assignment Staff Certifications It is the responsibility of the Project Manager to assure that staff certificates of qualification are provided to the client, when required Resolution of Disagreement The next higher level of authority shall normally resolve differences of opinion on quality requirements between the Quality Assurance Manager and Project Managers/Project Engineers, or Project Staff Subcontractors' Quality Assurance Programs To assure that contractors providing items or services under the scope of this manual have acceptable Quality Assurance Programs, specific requirements for these programs shall be contained in subcontract procurement documents. Subcontractor QA Programs are 2-7
17 subject to review prior to contract award and during contract life. Sections 4 and 7 of this manual further define this activity Inspection and Test Requirements Appropriate requirements shall be imposed on contractors in procurement documents to assure that inspections and tests are performed with appropriate equipment and under suitable environmental conditions. The project staff, prior to use, reviews inspection and test procedures for these activities, and the work activities shall be monitored for conformance to the procedures. Refer to Sections 10, 11, and 12 for further guidance Management Review of QA Program An effectiveness review of the ILRT Inc. Nuclear QA Program is conducted under the direction of the President once every two years as a minimum. To assure its continued effectiveness, the review results are reported in writing to the President and the Quality Assurance Manager Annual QA Program Assessment The Quality Assurance Manager shall provide to the President a documented assessment of the program on an annual basis. This assessment shall include an evaluation of the adequacy of the program and the effectiveness of its implementation. The assessment shall be detailed enough to cover all of the relevant activity during the period and include recommendations for changes or improvements Applicability of Nuclear QA Manual Revisions The Nuclear QA Manual revision in effect at the beginning of a project, as identified in the Project Quality Plan, remains in effect throughout the life of the project. Subsequent revisions to the Nuclear QA Manual do not apply to a project unless the revision is made to correct a deficiency in the Program that might adversely affect the project, as determined by the Quality Assurance Manager. (Project Managers may implement a revision to the manual on an existing project by revising the Project Quality Plan, obtaining concurrence of the Quality Assurance Manager, and notifying the client.) 2-8
18 3.1 Scope SECTION 3.0 DESIGN CONTROL This section of the manual describes the measures established to assure that design bases, regulatory requirements, codes, and standards are correctly translated into engineering and design activities, and for the preparation, verification, review, approval, issue, and revision of design documents, including application or project-specific software, when design control is specified in the Project Quality Plan. 3.2 General Design encompasses the processes by which the details of structures, systems and components are generated. The design control program of ILRT Inc. has been established to assure that all engineering and design activities are carried out in a planned, controlled and orderly manner. Engineering and design activities are governed by the Project Quality Plan and implementing procedures, which define the requirements for translating applicable regulatory requirements and design bases into technical specifications, drawings, written procedures and instructions. Design activities are the responsibility of, and are performed by, the Project Organization, unless otherwise identified in the Project Quality Plan. 3.3 Design Input The basic document that identifies the applicable design inputs such as, regulatory requirements, design bases, codes and standards, and other criteria is the Project Quality Plan. The initial issue of the Project Quality Plan is not intended to provide all the detailed requirements to be incorporated into design documents, but to provide sufficient basic requirements to permit the design process to proceed. As additional criteria are developed, they are incorporated into the Project Quality Plan or incorporated into project specific procedures. Changes from approved design inputs, including the reason for the change, shall be documented and controlled in accordance with the approved Project Quality Plan and applicable implementing procedures. 3.4 Design Process The design process consists of activities performed to translate the design inputs into the product of the design effort. These activities include the performance of design calculations and analyses and the preparation of drawings, specifications, test procedures and installation instructions, in accordance with the approved Project Quality Plan and applicable procedures. All design activities shall be documented in sufficient detail to relate the design back to the design input, and thereby provide the basis for: Technical Checking Document Review Design Verification Auditing 3-1
19 Controls shall be imposed on the following design related activities as a minimum: Inclusion of Quality Standards and Acceptance Criteria Applicable PPs and/or the Project Quality Plan shall impose the requirements for the inclusion of appropriate quality standards and acceptance criteria on the project. Controls for documenting and approving changes to specified quality standards, including documentation of reasons for such changes, shall be included in the Project Quality Plan or PPs Interfaces Between Participating Organizations A system of design interface control shall be established in the Project Quality Plan or implementing procedures to assure the appropriate reviews, approvals, release, distribution, and revision of design documentation are performed during the transfer of these documents between interfacing internal and external organizations. Controls shall be established to prevent the inadvertent use of superseded or outdated design documents Selection of Materials, Parts, Equipment, Software and Processes The suitability and compatibility of materials, parts, equipment, software and processes essential to the function of the structure, system or component shall be assured through the use of applicable industry standards, approved specifications, and internal design reviews, as defined in the appropriate procedure or Project Quality Plan Internal Design Reviews Internal design reviews shall be performed during the design process, as defined in the Project Quality Plan or applicable PPs, to assure acceptability of the design. These reviews shall normally consist of checking and approval of calculations, system descriptions, design specifications, stress reports, drawings, procurement specifications, and other documents at various stages of completion. Errors and deficiencies identified shall be documented and appropriate corrective action instituted to preclude repetition. Any corrections shall be re-reviewed. Computer programs may be utilized for design analysis without individual verification of the program for each application provided: a. The computer program has been verified to show that it produces correct solutions for the encoded mathematical model within defined limits for each parameter employed; and b. The enclosed mathematical model has been shown to produce a valid solution to the physical problem associated with the particular application. 3-2
20 3.5 Design Verification When required by the nature of the work, and upon completion of design, a verification of overall design adequacy shall be performed by individuals or groups other than those who performed the original design work (although they may be from the same organization), in accordance with the Project Quality Plan and applicable implementing procedures, to assure compliance with applicable design bases, regulatory requirements, codes, and standards. The responsibilities of personnel performing these reviews shall be identified. The extent of the design verification required is a function of the importance to safety, the complexity of the design, the degree of standardization, the state of the art, and the similarity with previously proven designs. The design verification may be accomplished through one or more of the following methods: Independent review of design documents. Alternate calculations selected to verify correctness of the original calculations or analysis. Qualification testing of a prototype under the most adverse design conditions. All qualification testing shall be performed in accordance with a written program having provisions for test procedures, review and approval by the design organization, qualitative and quantitative acceptance criteria, review of test results by the design organization, and evaluation of the need for retest when design criteria changes. (Refer to Section 11.0 of this manual.) The results of all design verification activities shall be documented, with the identification of the verifier clearly indicated, and reviewed by cognizant project management personnel in accordance with applicable procedures and the Project Quality Plan. 3.6 Design Changes All changes to design, including field originated changes or changes required due to design verification action, shall be justified and receive the same level of review, approval and design verification performed for the original design, based on the importance of safety of the change under consideration. Design changes should be reviewed and approved by the person or organization that performed the review and approval of the initial issue of the design document or by other equally qualified personnel or organizations. The personnel or organization(s) designated to perform the review and approval of changes shall be competent in the specific area of interest and have access to the background information and data related to the document being changed. Design changes shall be reflected in drawings, specifications and other design documents. Where a significant design change is necessary because of an incorrect design, the Project Manager and the Quality Assurance Manager shall review the design process and verification methods and initiate corrective action as necessary. 3-3
21 3.7 Technical Reports Technical reports may be used to document ILRT Inc.'s design efforts and shall meet the following requirements: Identification Content Technical reports shall be identified as a minimum by (a) document title, issue date, and revision status; (b) client and project number; and (c) unique report number. Technical reports shall include the following information as appropriate: Review 3.8 Controlled Documents Identification of design inputs incorporated in the final design. Identification of design assumptions incorporated in the final design. Identification of computer codes (and revision status) utilized. References to calculations, analyses, examination and test results, and other information that represents the basis for the report. Identification of applicable drawings resulting from the design addressed in the report, or drawings used in performing the evaluation. Demonstration of compliance with applicable specification and/or regulatory requirements. Technical reports shall be reviewed and checked for accuracy by individuals other than those who prepared the document and by those who are technically competent in the subject area. The review shall include steps to confirm that (a) applicable technical specification requirements have been met, (b) the report fulfills the objective criteria, and (c) the results are consistent with input data and are reasonable. All review comments shall be resolved, and all review actions documented. (A memo to file is considered adequate documentation.) Approved design documents that are required to accomplish a task or are the results of a task, and revisions thereto, are to be handled as controlled documents. The distribution to responsible project personnel and/or the client, shall be in accordance with the Project Quality Plan and applicable procedures, to prevent inadvertent use of superseded material. (Refer to Section 6 of this manual.) 3-4
22 3.9 Technical Computer Programs The actions of selecting or developing, modifying, verifying, and maintaining technical computer programs used for nuclear safety related work shall be performed in accordance with the Project Quality Plan and applicable procedures. Technical Computer Programs are classified into two categories; (1) Production Computer Programs, (2) Project Computer Programs, based on the following criteria: Production Computer Programs a. An ILRT Inc. owned and maintained proprietary program fully verified and available for use on ILRT Inc. projects. They are developed, verified, modified and maintained by ILRT Inc. b. A commercially available vendor developed and maintained program that has been verified, approved and authorized for use on ILRT Inc. projects Project-Specific Computer Programs 3.10 Records Those programs developed, verified, and maintained for a specific project by project personnel. When project-specific modifications are made to a standard program, the modified version becomes a project-specific version of the program. Public-domain programs can be verified as project-specific programs when their use is restricted to one project. Project-specific programs/versions developed for one project shall not be used on another project, unless the program/version is reverified and subsequently maintained by the second project. If required as part of the contract, the client will be included in the review and approval process of project-specific programs. Design documents and reviews, records, and changes thereto shall be collected, stored and maintained as part of the Official Project Records in accordance with the Project Quality Plan and applicable procedures. These records shall be turned over to the client at project completion. (Refer to Section 17.0 of this manual.) 3-5
23 SECTION 4.0 PROCUREMENT DOCUMENT CONTROL 4.1 Scope This section of the manual describes the measures employed in the preparation, review, approval, and control of the documents required for purchasing nuclear safety-related items, equipment, software, or services, when procurement document control is specified. 4.2 General Procurement documents subject to the requirements herein may consist of procurement specifications, purchase requisitions, contract letters, service contracts, purchase orders, and other binding instruments. 4.3 Procurement Document Content Procurement documents, which consist of written descriptions of items or services to be purchased shall include or reference the following information and requirements as applicable: Scope of work to be performed by the supplier Approved design drawings and/or technical specifications List of applicable codes, standards and regulatory requirements Specific supplier and subcontractor quality assurance requirements Special process instructions for activities such as welding, heat treating and nondestructive examination Provisions for access to suppliers' facilities for source inspection and quality assurance audits Hold points and notifications for source inspections Computer software application and requirements for control and reporting of errors per ASME NQA Subpart 2.7, Subsection 10 PROCUREMENT. Documentation to be submitted by the supplier, such as: - Technical reports, drawings, calculations. - Inspection and test records - Material test reports - Appropriate quality assurance program requirements for subtier suppliers. All procurement documents shall be uniquely identified by numbers assigned by the Project Manager, consistent with the requirements of the Project Quality Plan and applicable implementing procedures. 4-1
24 4.4 Procurement Document Review and Approval The Project Manager is responsible for the initiation of the procurement document, inclusion of appropriate technical requirements and conditions, and for review and approval. The Quality Assurance Manager shall review the procurement document to verify that procurement document control is specified and adequate, that all quality requirements are clearly delineated, and that the supplier has been approved for use in accordance with Section 7 of the manual. 4.5 Bid Evaluation If the item or service is to be purchased through bid action, an invitation for bid is prepared and issued to prospective suppliers by the Project Organization Bids submitted by prospective suppliers are evaluated by the Project Manager and staff, consistent with client requirements, and considering the following criteria: Technical ability to provide items or services Ability to conform to delivery schedule Proposed exceptions or deviations Proposed price Proposed warranty The supplier shall have a documented quality assurance program that implements the applicable portions or all the requirements of this manual. The Quality Assurance Manager or other approved outside agency shall determine the acceptability of the supplier's Quality Assurance When the successful supplier is selected, the Project Manager notifies the client Upon the receipt of required approvals, a purchase order is prepared and issued by the Project Manager Qualification of suppliers is required prior to issue of the purchase order. (Refer to Section 7 of the manual.) 4-2
25 4.6 Control of Changes All changes to quality-related project generated procurement documents are controlled in respect to reviews and approvals, and are released in accordance with an approved procedure and the following: Changes are documented on a Change Notice Form, as illustrated in Exhibit The change notice preparer evaluates the change with respect to its effect on the product item or services, and summarizes the findings on the form in the space provided for Review of Change Effect on Product Changes are reviewed, approved, and released in the same manner as the original document The Project Manager is responsible for notifying the selected supplier or prospective suppliers of all approved changes and for transmitting the applicable change notices The Project Manager reviews all changes and assigns appropriate follow-up actions to project personnel where necessary. 4.7 Reference to 10 CFR 21 Any purchase order for Basic Components (as defined in 10 CFR 21) shall include a requirement that 10 CFR 21 applies to the vendor for all activities performed under the purchase order. The purchase order shall also require written notification of any defects to ILRT Inc. within five working days of the completion of the defect evaluation. 4-3