ML21172A205
| ML21172A205 | |
| Person / Time | |
|---|---|
| Site: | 07100086 |
| Issue date: | 06/17/2021 |
| From: | Watts P Alpha Omega Services |
| To: | Document Control Desk, Office of Nuclear Material Safety and Safeguards |
| References | |
| Download: ML21172A205 (46) | |
Text
June 17, 2021 ATTN: Document Control Desk Director, Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards United States Nuclear Regulatory Commission Washington, DC 20555-0001
Subject:
Changes to the AOS QA program for radioactive material packages; §71.106
Reference:
No. 0086 Revision 9; Docket No. 71-0086 Pursuant to the requirements stated in 10CFR 71.106(b), a quality assurance program approval holder may change a previously approved quality assurance program without prior NRC approval, if the change does not reduce the commitments in the quality assurance program previously approved by the NRC. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the NRC every 24 months, in accordance with §71.1(a).
In accordance with the NRC letter dated August 7, 2015 received by AOS, we are submitting the changes made to our quality assurance program, Document No. PR9000 Revision H, date of implementation January 20, 2021. The changes that have been made to the quality assurance program are administrative clarifications, which do not reduce our commitment previously made to the NRC; or changes to provide compliance with the recent amended portion of §71.38 and the addition of §71.106.
The previous submittal for changes was made to USNRC June 24, 2019 and acknowledged and tracked as submission number 27846; and recorded in ADAMS as Accession Number ML19175A107 (copy attached).
All correspondence relative to this biennial submittal shall be sent to:
Mr. Troy Hedger, President Alpha-Omega Services, Inc.
9156 Rose Street Bellflower, CA 90706 Sincerely, Alpha-Omega Alpha- O ega Services, Inc.
a Om Paul Pa ul D Watts aul Watttts Quality Assurance
Enclosure:
AOS Quality Assurance Program - Radioactive Material Transport Packages, Document No. PR9000 Revision H Copy to: FM9006.1-012021-012 file Radiologic Health Branch, California Dept. of Public Health 9156RoseStreetP.O.Box789Bellower,California,U.S.A90706 CustomerService(800)3467894(562)8040604Fax:(562)8040610
www.alphaomegaserv.com
Date: 06-17, 2021 Page 1 of 5
CHANGES TO THE AOS QA PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES; §71.106 DOCKET NO. 71-0086 REVISION 9
(06-17-2021) Page 2 of 5
CHANGES TO THE AOS QA PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES; §71.106 DOCKET NO. 71-0086 REVISION 9 TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. H (01-20-2021)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
§71.101 Cover Page Revision was changed from G to read, H Provides compliance with the amended Date of Implementation was changed from portion of 10CFR 71.38; and the June 21, 2019 to read, January 20, 2021 addition of 10CFR 71.106, effective July Revision Block: Added H; FM9006.1-012021- 13, 2015 012 The changes made in Revision H -
Footer was changed as follows: identified below do not reduce the previous commitments made by AOS, Revision was changed from G to, H; and which have been approved by the Date was changed from 06-21-2019 to read, USNRC.
01-20-2021
§71.101 Index of Added Revision Bars to Index of Records; Administrative clarification Records Section 1.0; Section 2.0; section 3.0; Section Identifies those sections of the QA 4.0; Section 6.0; Section 7.0; Section 8.0; Program affected by the current Section 11.0; Section 12.0; Section 13.0; revision.
Section 15.0; Section 17.0; Section 18.0; Section 19.0; and Section 21.0
§71.103 1.11 2nd line: Correct but, to read, but Administrative clarification - corrected typographical error only
§71.105 2.5 4th line: Correct safety; to read, safety, Administrative clarification - corrected typographical error only
§71.105 2.9 3rd line: Correct previously-approved to read, Administrative clarification - corrected previously approved typographical error only
§71.105 2.10.3 3rd line: Correct are to read, is Administrative clarification - corrected typographical error only
§71.107 3.1.7 2nd line: Correct procedures; to read, Administrative clarification - corrected procedures, typographical error only
§71.109 4.3 3rd line: Delete, edition(s), and change to Administrative clarification read, suppliers accredited to an accepted Enhances wording for approval document revision of ISO/IEC-17025 requirements and controls.
§71.113 6.1 2nd line: Correct quality, and to read, quality Administrative clarification - corrected and typographical error only
§71.115 7.3.4 1st sentence: Delete edition(s), and change to Administrative clarification read, suppliers accredited to an accepted Enhances wording for approval document revision of ISO/IEC-17025 a requirements and controls.
commercial grade survey.
2nd sentence: Add the following: Controls for approval are based on NRC-endorsed industry guidance, providing on reliance
§71.117 8.4 4th line: Correct controlled; to read, Administrative clarification - corrected controlled, typographical error only
§71.123 11.8 1st line: Correct are to read, is Administrative clarification - corrected typographical error only
§71.125 12.2.5 1st sentence: Change from For suppliers of Administrative clarification calibration services approved by ISO/IEC- Enhances wording for approval 17025 accreditation to read, For requirements and controls.
approved suppliers accredited to an accepted document revision of ISO/IEC-
(06-17-2021) Page 3 of 5
CHANGES TO THE AOS QA PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES; §71.106 DOCKET NO. 71-0086 REVISION 9 TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. H (01-20-2021)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS) 17025 providing calibration services - at the time 6th line: Correct met; to read, met
§71.127 13.2 2nd line: Correct procedures; to read, Administrative clarification - corrected procedures, typographical error only
§71.131 15.4.2 1st line: Correct completed and to read, Administrative clarification - corrected completed, controlled, typographical error only
§71.131 15.8 Change title from 10CFR Part 21 - Reporting Administrative clarification of Defects and Noncompliances to read, Enhances wording for applicable Regulatory Requirements Reportability - requirements to include 10CFR71.95.
10CFR Part 21 and 10CFR Part 71.95
§71.131 15.8.1 Re-write section to read as follows: Administrative clarification Applicable provisions for regulatory Enhances wording for applicable requirements reportability (10CFR21 / requirements to include 10CFR71.95.
10CFR71.95) shall be controlled in accordance with implementing procedures.
- a. 10CFR Part 21 shall be incorporated in applicable procurement documents.
- b. NCRs and CAPAs shall be evaluated for regulatory requirements compliance and reportability, when required.
- c. Postings to include: 10CFR21, 10CFR71.95, and the Law - Section 206.
§71.135 17.2 1st line: Correct required; to read, required, Administrative clarification - corrected typographical error only
§71.135 17.6 1st line: Correct procedures, and furnish to Administrative clarification - corrected read, implementing procedures typographical error only furnishing evidence
§71.137 18.5 4th line: Correct sources; to read, sources, Administrative clarification - corrected typographical error only
§71.101 19.0 2nd sentence: Re-write to read, This QA Administrative clarification - corrected Program meets the latest typographical error only edition/revision/version of the referenced documents, unless otherwise identified in any of the corresponding documents or regulatory control.
§71.101 19.6 1st line: Delete, February 1996 Administrative clarification Remove date of document to make the Reference generic; this is clarified by the requirement in 19.0.
§71.101 19.9 1st line: Delete, (2005 Edition) Administrative clarification Remove date of document to make the Reference generic; this is clarified by the requirement in 19.0.
§71.101 19.11 Re-write Reference to read, International Administrative clarification Standard ISO/IEC 17025 - General Requirements for the Competence of Testing
(06-17-2021) Page 4 of 5
CHANGES TO THE AOS QA PROGRAM FOR RADIOACTIVE MATERIAL PACKAGES; §71.106 DOCKET NO. 71-0086 REVISION 9 TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. H (01-20-2021)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS) and Calibration Laboratories; as provided in Remove date of document to make the NEI 14-05; and controls for approval based Reference generic; this is clarified by on NRC-endorsed industry guidance. the requirement in 19.0.
§71.101 19.12 Add
Reference:
Nuclear Energy Institute Administrative clarification Document No. NEI 14-05, Guidelines for Addition of Reference enhances the The Use of Accreditation In Lieu Of requirements of Reference No. 19.11 Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services
§71.101 21.0 Added Table of Changes - AOS QA Program Administrative clarification PR9000 Rev. H (01-20-2021) Identifies the individual changes and justification for actions made to those sections of the QA Program affected by the revisions.
(06-17-2021) Page 5 of 5
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages PR9000 Revision H QUALITY ASSURANCE PROGRAM Radioactive Material Transport Packages Date of Implementation: January 20, 2021 Revision D E F G H FM0018- FM9006.1- FM9006.1- FM9006.1- FM9006.1-FM No.
112010-001 082015-004 032016-016 062019-010 012021-012 PR9000 Revision H Date: 01-20-2021 Page 1 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages Index of Records Section Description Page
--- Index of Records 2
--- Policy Statement 3 1.0 Organization and Responsibility 4 2.0 Quality Assurance Program 6 3.0 Design Control 9 4.0 Procurement Document Control 11 5.0 Instructions, Procedures, and Drawings 12 6.0 Document Control 13 7.0 Control of Purchased Material, Equipment and Services 14 8.0 Identification and Control of Materials, Parts, and Components 16 9.0 Control of Special Processes 17 10.0 Inspection 18 11.0 Test Control 19 12.0 Control of Measuring and Test Equipment 20 13.0 Handling, Storage and Shipping 21 14.0 Inspection, Test and Operating Status 22 15.0 Nonconforming Material, Parts, and Components 23 16.0 Corrective Actions 24 17.0 Quality Assurance Records 25 18.0 Audits 26 19.0 References 27 20.0 Organizational Chart 28 21.0 Table of Changes - AOS QA Program PR9000 29 PR9000 Revision H Date: 01-20-2021 Page 2 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages POLICY STATEMENT Alpha-Omega Services, Inc. (AOS) is engaged in the business of design, procurement, fabrication, assembly, testing, modification, maintenance, repair, and use of radioactive material transportation package activities that are safety-related or important-to-safety; and has the responsibility to protect the health and safety of the public and its employees. AOS has established a Quality Assurance Program (QA Program) for Radioactive Material Transport Packages (RAMP; packages) designed to comply with the requirements of 10CFR71 Subpart H. In the event that the program reduces the commitment as previously approved by the NRC, the proposed changes shall be reviewed and approved by the USNRC prior to implementation.
The management of AOS recognizes that the Quality Assurance personnel performing functions affecting quality are to be independent of all other functions. The administrator of Quality Assurance has been given the full authority and responsibility for establishing and maintaining the QA Program and implementing procedures; and for the control, administration and enforcement of all sections to maintain full compliance with the QA Program. The administrator of Quality Assurance has the organizational freedom to identify quality problems; initiate, recommend, or provide solutions; verify implementations of solutions; and to limit or control further processing, or delivery of a nonconforming item or unsatisfactory condition until proper disposition has occurred.
The CEO/President of AOS retains the overall authority and responsibility for the implementation of the Quality Assurance Program. Each and every employee is expected to perform the individuals assigned work activities in accordance with its established requirements and policies. The Program ensures that quality is achieved and maintained by those assigned responsibility for performing work; with achievement verified and documented by persons or organizations not directly responsible for performing the work.
When problems or differences of opinion on quality issues cannot be resolved through normal lines of communication, these issues are to be brought to the attention of the President for resolution.
Resolution shall always result in compliance with the applicable code, contract, and/or regulatory requirements as required.
The management of AOS is firmly committed to the requirements of this QA Program; and total participation of all personnel that represent this company is required.
Troy Hedger, Hed edg ed ger, CEO/President Alpha-Omega Services, Inc.
Date: 01-21-2021 PR9000 Revision H Date: 01-20-2021 Page 3 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 1.0 ORGANIZATION AND RESPONSIBILITY 1.1 General organization and responsibilities for the establishment and implementation of the Quality Assurance Program (QA Program) are defined and documented - including functional responsibilities, levels of authority, and lines of communication for activities that affect quality; and are described in detail by the implementing procedures.
1.2 Section 20.0, Organizational Chart; indicates organizational positions with primary responsibility to the quality activities as described in the QA Program.
1.3 The CEO/President (President) of AOS retains the overall authority and responsibility for the implementation of the Quality Assurance Program identified in the Policy Statement; and is responsible for the desired end result. Responsible for ensuring compliance with the program, regulatory, and customer related requirements.
1.4 The administrator of Quality Assurance (Quality Assurance; QA) reports directly to the President. Is responsible for the development, implementation and maintenance of the QA Program and implementing procedures; and conducts the annual review and assessment of the QA Program to advise management of its adequacy and effectiveness.
Quality Assurance is also responsible for providing administrative and functional guidance to the Quality personnel; and oversees customer and regulatory audits of the QA Program.
Quality Assurance is to be sufficiently independent from the pressures of cost, production, and scheduling when opposed to safety function considerations; has the authority to stop production and delivery; and has sufficient authority, access to work areas, and organizational freedom to:
1.4.1 Identify quality problems; 1.4.2 Initiate, recommend or provide solutions to quality problems through designated channels; 1.4.3 Verify implementation of solutions; 1.4.4 Assure that further processing, delivery, or installation or use is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred; 1.5 Director Regulatory Affairs reports directly to the President. Is responsible for assuring the regulatory requirements are met regarding the companys licensing and operating activities of the QA Program for Packages.
1.6 Vice President Operations reports directly to the President. Is responsible for the assembly of customer contract documents; acts as the liaison between the customer and responsible department managers; the timely review of inquiries and orders; and PR9000 Revision H Date: 01-20-2021 Page 4 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages preparation of procurement documents for materials, items and services in accordance with QA Program requirements.
1.7 Operations Manager / Engineer (Bellflower) reports directly to the Vice President -
Operations. Is responsible for the maintenance and operation of the Packages as required by the QA Program.
1.8 The administrator of Engineering (Engineering) reports directly to the President. Is responsible for execution of the QA Program for licensing and technical matters; for providing technical services and qualified personnel to support projects for Packages in accomplishing the required scope of work; to assure design activities comply with the applicable code, specification or standard requirements; and are responsible for the technical quality of engineering, licensing, fabrication, and design document activities.
1.9 To support the QA Program, subcontract personnel may consist of, but not be limited to Engineering, Quality Assurance, Inspection and Test (I&T), Nondestructive Examination (NDE), or Audit personnel. Subcontract personnel report to appropriate AOS management; and are responsible for the completion of quality activities for which they are trained and/or qualified, as required, in the applicable sections of the QA Program and appropriate implementing procedures.
1.10 When purchasing commercial grade calibration and/or testing services from a laboratory holding accreditation by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) in accordance with the provisions of regulatory requirements and other associated documents, AOS retains overall responsibility for assuring that said services meet applicable technical and regulatory requirements and that reasonable assurance of quality is provided; as provided by appropriate implementing procedures established by the QA Program.
1.11 Any individual designated responsibility in this QA Program may delegate the performance of that responsibility to a qualified individual within their department; but retains the overall responsibility for ensuring compliance with the requirements of the QA Program.
1.12 The manager or director of a department may perform any of the activities assigned to individuals within their department provided they are qualified to perform the activities.
PR9000 Revision H Date: 01-20-2021 Page 5 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 2.0 QUALITY ASSURANCE PROGRAM 2.1 AOS is responsible for the establishment, planning, implementation and maintenance of the QA Program as it pertains to the design, procurement, fabrication, assembly, inspection, testing, handling, shipping, storing, cleaning, operation, maintenance, repair and modification of Package systems and/or components that are safety-related or important-to-safety; under control of a license, certificate, or application for Certificate of Compliance (CoC) operated by AOS.
2.2 Suppliers used for performance of activities are subject to the requirements of the QA Program, they are qualified by AOS to ensure compliance; however, AOS retains the overall responsibility for the quality of those activities.
2.3 The QA Program is described in detail in this manual; and comprises of all planned and systematic actions to provide adequate confidence that all activities are in accordance with the rules and requirements identified by 10CFR Part 71 Subpart H 2.4 The QA Program provides for the accomplishment of activities affecting quality under controlled conditions, as applicable: utilizing appropriate equipment, special controls, processes, suitable environmental conditions, test equipment, tools, skills, and personnel to attain the required quality, to satisfy established prerequisites for given activities, and for verification of quality by examination, inspection, or test.
2.5 The QA Program is supported by implementing procedures (Standard Operating Procedures - SOP), and appropriate forms and exhibits specifically defining the methods of operation for various processes, controls, and examinations, personnel qualifications important to safety, which establish and implement processes to detect and control quality problems.
2.6 In the case of conflict between an existing instruction or procedure and the QA Program, the QA Program shall prevail; and the instruction or procedure shall be revised.
2.7 To assure the effective implementation of the QA Program a system of planned and periodic documented internal audits and a regular review of the status and adequacy of the QA Program are controlled in accordance with QA Program requirements.
2.8 Revisions to the QA Program shall be tracked and controlled in accordance with the applicable implementing procedures.
2.9 Revisions to the QA Program are subject to review and approval by the U.S. Nuclear Regulatory Commission (USNRC; NRC) prior to implementation; when the changes reduce the commitments made in the previously approved QA Program. The date of implementation for the QA Program revision shall be as follows:
PR9000 Revision H Date: 01-20-2021 Page 6 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 2.9.1 When changes do not reduce the commitments made to the NRC, the date of implementation shall be the approval date of the QA Program by AOS Management; and upon completion of all programmatic requirements (i.e.,
training, etc.).
2.9.2 When changes are made that reduce the commitments made to the NRC, the date of implementation is to be on or after the date of NRC approval; and upon completion of all programmatic requirements (i.e., training, etc.).
2.10 Changes made to the QA Program that do not reduce the commitments previously approved by the NRC shall be submitted to the NRC every 24 months (start date coincides with date of last approval), in accordance with regulatory requirements [i.e., § 71.1(a)].
The following are changes made to the QA Program that do not require NRC approval prior to implementation:
2.10.1 Administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items; 2.10.2 The use of a quality assurance standard approved by the NRC that is more recent than the quality assurance standard designated in the QA Program at the time of the change; 2.10.3 The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to functional relationships, authorities, or responsibilities; 2.10.4 The elimination of QA program information that duplicates language in the QA regulatory guides and QA standards to which the QA Program is committed on record; 2.10.5 Organizational revisions that ensure persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations; 2.10.6 Records of the QA Program changes are to be maintained and incorporated into the QA Program; and shall identify the following: Regulatory reference(s); QA Program reference(s); Changes (Before / After); and Justification (reason for change; basis for considering the change continues to satisfy the regulatory requirements).
PR9000 Revision H Date: 01-20-2021 Page 7 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 2.11 All personnel performing activities affecting quality shall be indoctrinated and trained in accordance with the implementing procedures for their responsibility to the QA Program as they relate to their duties.
2.11.1 Indoctrination and training shall be commensurate with scope, complexity, importance of the activities; and the education, experience, and proficiency of the person.
2.11.2 Records of personnel training and/or qualification shall be established, certified and maintained by Quality Assurance.
2.12 All personnel (including subcontractors) performing specialized activities shall be qualified, when required, in accordance with the appropriate implementing procedures.
2.12.1 Specialized activities may include, but not be limited to: Inspection and Test (I&T)
Personnel, Nondestructive Examination (NDE) Personnel, Lead Auditors, and Engineering Personnel.
2.12.2 Indoctrination and training shall be commensurate with scope, complexity, importance of the activities; and the education, experience, and proficiency of the person.
2.12.3 Records of personnel training and/or qualification shall be established, certified and maintained by Quality Assurance.
2.12.4 Recertification of personnel shall be completed within the designated intervals and accomplished by continued satisfactory performance, written examination, or capability demonstration of proficiency as determined by stated requirements.
PR9000 Revision H Date: 01-20-2021 Page 8 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 3.0 DESIGN CONTROL 3.1 Measures are established that assure the applicable regulatory requirements and the Package design for safety-related or important-to-safety activities specified in the license are adhered to; and are described in detail by the implementing procedures. Design control measures are applied as required to assure that the following items are correctly identified, as applicable: criticality physics, radiation shielding, stress, thermal, hydraulic, and accident analyses, compatibility of materials, accessibility for in-service inspection, maintenance and repair, features that facilitate decontamination, and delineation of inspection and test acceptance criteria.
3.1.1 Package design control establishes those measures that ensure all applicable codes, standards, specifications, regulatory requirements, inspection and test criteria, operational and maintenance requirements, handling and storage are correctly translated into specifications, drawings, procedures, and instructions.
3.1.2 Appropriate design codes and standards used in the Package design are specified in the design documents. When such codes and standards are not available, alternate approaches shall be identified in the design documents, and utilized in the formulation of the Package design activities.
3.1.3 During the design process Engineering designates specific safety classifications to items which affect material procurement; and is defined in the implementing procedures.
3.1.4 It provides for established measures for the inclusion of specified and appropriate quality standards to be included in the design documents, and that deviations from those standards are controlled.
3.1.5 Measures to control material, parts, equipment and processes are established for the selection and review of the suitability of the same; and are essential to the function of the material, parts and components of the packaging that are deemed important to safety.
3.1.6 Design analyses are sufficiently detailed and documented in order that a technically qualified person who is qualified in the subject can review and understand the analyses, to verify the adequacy of the results without recourse to its originator.
3.1.7 Computer programs that are used for design analysis or verification are controlled in accordance with the implementing procedures, which provide for verification of the accuracy of the computer results and to assess and resolve reported computer program errors.
PR9000 Revision H Date: 01-20-2021 Page 9 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 3.2 The implementing procedures identify and control the design interfaces and coordinates between participating design organizations.
3.3 All design documents (i.e., specifications, calculations, drawings, procedures, and instructions) are reviewed to verify the adequacy of the design and approved by designated individuals or groups other than those responsible for the original design using specified methods. Verification methods used to assure design adequacy may be one or more of the following: design reviews, alternate calculations, or qualification testing.
3.4 In the event that a testing program is used to verify the adequacy of the design, the conditions and requirements are specified.
3.5 When design control changes are necessitated, the same design control measures used for the revision are subject to the same controls utilized for the original design. Changes that affect the approved design conditions established by the regulatory authority are submitted for approval as required prior to implementation.
3.6 Control of design documents and revisions are handled in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 10 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 4.0 PROCUREMENT DOCUMENT CONTROL 4.1 Provisions and control of procurement documents have been established to ensure that all safety-related or important-to-safety, and quality assurance requirements are identified in the appropriate procurement documents; and are described in detail by the implementing procedures.
4.2 Procurement documents shall contain reference to, as required: scope of work, technical requirements, applicable regulatory requirements, material identification requirements, drawings, specifications, codes and standards, special process instructions, inspection and test requirements, supplier (and pass-on to sub-supplier) quality assurance program requirements, right of access, documentation, and nonconformance requirements.
4.3 Procurement documents for commercial grade calibration and/or testing laboratory services utilized in Safety Related activities from approved suppliers accredited to an accepted document revision of ISO/IEC-17025 are required to be in conformance with appropriate implementing procedures.
4.4 Documentation required by the supplier to perform activities affecting quality (e.g.,
drawings, specifications, procedures, fabrication and inspection plans, inspection and test records, personnel and procedure qualifications, results of chemical and physical tests on material) are to be prepared, maintained and submitted for approval.
4.5 Procurement documents are reviewed and approved by Quality Assurance and other personnel as required, prior to issuance.
4.6 Procurement of replacement parts required for the packaging that are important to safety are subject to the same control as the original parts; including designation of supplier status, technical and QA requirements; and approval of the procurement documents prior to issuance.
4.7 Changes made to procurement documents are subject to the same control as the original document. The originating organization prepares the change, with a change order or revision indicator and date; and presents to the responsible person for review and approval.
PR9000 Revision H Date: 01-20-2021 Page 11 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 5.1 Measures have been established to assure that all safety-related or important-to-safety activities that affect quality are performed in accordance with this QA Program are done using documents that include pertinent information for activities affecting quality. This information is disseminated in the form of instructions, procedures, and drawings, to describe the activity required with a level of detail commensurate with the complexity of the activity, and the need to assure consistent and acceptable results; and are described in detail by the implementing procedures.
5.2 Compliance with the approved instructions, procedures and drawings is mandatory to all personnel that perform safety-related or important-to-safety activities that affect quality.
5.3 The instructions or procedures include or reference the appropriate quantitative and/or qualitative acceptance criteria to determine that prescribed results have been attained.
5.4 The documents are to describe the required activity in a level of detail that is appropriate to the following considerations: the complexity of the task, significance of the item or activity, work environment, and worker proficiency and capability.
5.5 Documents provided to suppliers for the completion of the procurement of material, items or services are identified in the procurement documents or associated specifications.
PR9000 Revision H Date: 01-20-2021 Page 12 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 6.0 DOCUMENT CONTROL 6.1 Requirements are provided for the preparation, issuance and change of documents that prescribe safety-related or important-to-safety activities that affect quality and are controlled to assure that the correct documents are being employed; and this is described in detail by the implementing procedures.
6.2 Controlled documents may include, but are not limited to:
6.2.1 Design and fabrication specifications 6.2.2 Design and fabrication drawings 6.2.3 Special process specifications and procedures 6.2.4 Inspection and Test procedures 6.2.5 QA Program and implementing procedures 6.2.6 Operational test procedures and data 6.3 Documents that prescribe safety-related or important-to-safety activities that affect quality are reviewed and approved for technical adequacy, completeness, and incorporation of appropriate quality requirements prior to acceptance and issuance.
6.4 Document Control reports to the administrator of Quality Assurance; and is responsible for the execution of the company document control procedures, measures to assure only current documents are in use, and document storage, as a function of the QA Program.
6.5 Changes made to documents are subject to the same control as the original document in accordance with the applicable implementing procedures. The originating organization prepares the change, with a revision indicator and date; and presents to the responsible person or organization for review and approval.
PR9000 Revision H Date: 01-20-2021 Page 13 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES 7.1 Provisions have been established for documentation and control of material, equipment and services for safety-related or important-to-safety activities affecting quality when purchased either directly or through contractors or subcontractors, and to assure conformance to the established procurement documents; and are described in detail by the implementing procedures.
7.2 The selection of a suppliers capability, source evaluation and control, and objective evidence of quality, shall be determined prior to the issuance of an order. Approved suppliers are listed on the Approved Suppliers List (ASL) for the items or services provided.
7.3 Suppliers designated to provide items and/or services are controlled by the conduct of an audit/survey to determine supplier approval; which are performed by qualified personnel and documented as QA Records; and are based on one or more of the following criteria:
7.3.1 Compliance with the established requirements of 10CFR Part 71 Subpart H; 10CFR Part 50 Appendix B; ASME Section III, or other codes, standards, or specifications that are applicable to the scope of work to be performed.
7.3.2 Review of previous records to establish the suppliers past performance.
7.3.3 Survey of the suppliers facilities and review of the suppliers QA Program to assess and verify the adequacy and implementation of quality controls consistent with those requirements invoked.
7.3.4 Approval by a documented review of a suppliers ISO/IEC-17025 program accredited to an accepted document revision by the ILAC-MRA Accreditation Bodies for calibration and/or testing laboratories in accordance with appropriate implementing procedures, in lieu of performing a commercial grade survey.
Controls for approval are based on NRC-endorsed industry guidance, providing on reliance of the accreditation process and adherence to programmatic requirements. AOS is responsible for reviewing objective evidence for conformance to procurement documents to validate the service suppliers accreditation and review of actual certificates provided by the laboratory. AOS does not need to directly perform technical verification of data produced nor perform a commercial grade survey of the suppliers activities.
The effectiveness and control of quality performed by suppliers, contractors or subcontractors are to be assessed and documented by QA at intervals that are consistent with the importance, complexity and quantity of the product described.
PR9000 Revision H Date: 01-20-2021 Page 14 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 7.4 When required by procurement documents, suppliers are required to submit documentary and objective evidence required to complete activities affecting quality (e.g., drawings, specifications, procedures, fabrication and inspection plans, inspection and test records, personnel and procedure qualifications, results of chemical and physical tests on material) for review and approval to verify conformance to procurement documents. For procurement conditions not met by the suppliers, documentation is to be submitted for review and approval, to assure the technical and quality requirements have not been compromised.
7.5 Consideration regarding source verification and receiving inspection verification are to be consistent with the importance and complexity of the delivered material, equipment and services; and is described in detail by the implementing procedures.
7.6 When consultants are used in the performance of organizational responsibilities subject to the requirements of the QA Program, their requisite ability is determined by AOS to ensure compliance; the personnel are authorized by AOS to work under the QA Program; and verification of quality requirements is accomplished through internal audits.
7.7 Material furnished by the customer is to be controlled in accordance with the requirements of the QA Program. When required, the customer shall furnish material certification for job compliance review and inclusion with the job records. The material is to be receipt inspected in the same manner as for material procured by AOS. This material shall only be used for its intended customer and designated purpose.
7.8 When post-installation testing is required, post-installation test requirements and acceptance documentation shall be established by AOS, with technical input furnished by the supplier, as required.
7.9 When services are subcontracted (e.g., engineering, auditing, calibration, etc.) a verification of the technical data received shall be completed and objective evidence reviewed for conformance with the purchase document requirements. When the performance of the service warrants, surveillance and/or audit of the activity is to be considered. For calibration, the suppliers calibration results shall be controlled in accordance with the implementing procedures.
7.10 When dedication of commercial grade items or services is required, it shall be controlled in accordance with the implementing procedures.
7.11 Nonconformances identified are to be controlled in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 15 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 8.1 Methods and controls have been established to assure that all material, parts, and components to be used or installed for fabrication, assembly, maintenance and repair activities that are safety-related or important-to-safety have been correctly identified and controlled; and are described in detail by the implementing procedures.
8.2 Traceability is assured by the maintenance of heat/lot numbers, part numbers, serial numbers or other appropriate means; and the traceability is recorded physically on the item or in records maintaining traceability to the item.
8.3 These controls are also to assure the prevention of the use of incorrect or defective material, parts, or components in the items; and for those that have not received the required examinations, tests, or inspections.
8.4 Identification marks used shall be applied using methods and materials, which are legible and not detrimental to the item involved; and shall be located in areas not affecting or interfering with the function or quality aspects of the item. Identification marks used during storage of items shall be controlled, with provisions for maintenance or replacement due to damage from handling, aging, or environmental exposure.
8.5 Material determined to have a shelf-life or limited-life shall be controlled in accordance with the requirements of the implementing procedures.
8.6 Records of identification and control of materials, parts, or components are to be maintained in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 16 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 9.0 CONTROL OF SPECIAL PROCESSES 9.1 Controls have been established to assure that special processes performed by AOS or its approved suppliers, contractors, or subcontractors that are safety-related or important-to-safety are accomplished in accordance with specified requirements; and are described in detail by the implementing procedures.
9.2 Special processes include, but are not limited to, welding, heat treating, nondestructive examination, destructive testing; and are to be controlled and accomplished by qualified personnel using qualified procedures, including appropriate acceptance criteria, as required.
9.3 Special processes are to be completed in accordance with the applicable codes, standards, specifications, criteria, or other special requirements defined by project requirements and the QA Program. When special processes are not covered or where specified quality requirements exceed those of the existing codes and standards, the necessary requirements for personnel qualifications, procedures, or equipment are specified or referenced in procedures or instructions.
9.4 Adherence to the approved procedures and processes in executing special processes is the responsibility of the organization performing the same.
9.5 Records of all special process activities, procedures and personnel qualifications are to be maintained in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 17 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 10.0 INSPECTION 10.1 A program has been established for the inspection of safety-related or important-to-safety activities that affect quality, for the verification of conformance to documented drawings, instructions and procedures used for accomplishing the activity, and to provide for the timely identification, disposition, and recommended corrective action of nonconforming conditions; and is described in detail by the implementing procedures.
10.2 Inspections are to be performed by qualified personnel other than those who perform or directly supervise the work being inspected. Inspection personnel shall meet the requirements specified in QA Program requirements.
10.3 Inspection or surveillance, or indirect control by process monitoring methods shall be completed, as required; with both inspection and process monitoring being done when control of the inspection is inadequate without both.
10.4 Inspections are to be performed to written procedures controlled in accordance with QA Program requirements; and the results are to be documented.
10.5 Mandatory hold points of inspection activities shall be designated and documented accordingly. Work beyond a Hold Point shall not proceed without the approval of the organization assigning the Hold Point; or consent to waive the specified hold point shall be recorded.
10.6 Measuring and Test Equipment (M&TE) shall be selected to assure calibration status and of proper type, range, and accuracy to accomplish the inspection.
10.7 Records of inspections shall be completed, maintained and stored in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 18 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 11.0 TEST CONTROL 11.1 A program has been established for the performance of safety-related or important-to-safety tests required to demonstrate that structures, systems and components will perform satisfactorily in service, and to provide for the timely identification, disposition, and recommended corrective action of nonconforming conditions; and is described in detail by the implementing procedures.
11.2 Tests are to be performed by qualified personnel other than those who perform or directly supervise the work being tested. Test personnel shall meet the requirements specified in QA Program requirements.
11.3 Direct or indirect (process monitoring) inspection methods shall be completed as required.
Testing or surveillance, or indirect control by process monitoring methods shall be completed, as required; with both test and process monitoring being done when control of the test is inadequate without both.
11.4 Testing requirements are to be performed to written procedures controlled in accordance with QA Program requirements; and the results are to be documented.
11.5 Mandatory hold points of test activities shall be designated and documented accordingly.
Work beyond a Hold Point shall not proceed without the approval of the organization assigning the Hold Point; or consent to waive the specified hold point shall be recorded.
11.6 Test procedures are to specify provisions assuring that all prerequisites for the test have been met, adequate test instrumentation is available and used, and the testing is performed under suitable environmental conditions.
11.7 M&TE shall be selected to assure calibration status and of proper type, range, and accuracy to accomplish the test.
11.8 Test control for computer programs is in accordance with the implementing procedures.
11.9 Records of tests shall be completed, maintained and stored in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 19 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 12.1 Methods have been established for the identification, control, calibration and selection of Measurement and Test Equipment (M&TE) used in safety-related or important-to-safety activities affecting quality; and are described in detail by the implementing procedures.
12.2 All M&TE used shall be calibrated periodically and at scheduled intervals, or whenever the accuracy of the M&TE is suspect to assure acceptable accuracy to the stated requirements. Calibration methods and intervals shall be based on the type of equipment, stability characteristics, required accuracy, intended use, and other conditions affecting performance.
12.2.1 Calibration is to be done using certified master standards having known relationship to nationally recognized standards, where such standards exist.
Where none exist, the manufacturers recommended standard shall be documented and used.
12.2.2 Calibration of M&TE is to be performed by properly trained personnel, or by qualified suppliers.
12.2.3 Control of M&TE shall be done using unique equipment serial numbers, records, and calibration status indicators.
12.2.4 Calibration of M&TE shall be completed in accordance with written instructions or procedures which include the requirements for methods, tolerances and calibration intervals.
12.2.5 For approved suppliers accredited to an accepted document revision of ISO/IEC-17025 providing calibration services - at the time of receipt inspection AOS is to validate the contracted calibration or test service has been performed in accordance with the suppliers program and within their scope of accreditation, and that all purchase order requirements are met as provided by the appropriate implementing procedures.
12.3 When M&TE is determined to be out-of-calibration, an evaluation is performed and documented to determine the validity of inspections or tests performed, and to determine the acceptability of items inspected or tested since the last acceptable calibration. This is to be controlled in accordance with QA Program requirements.
12.4 Commercial equipment such as rulers, tape measures, levels, etc. do not require calibration and control measures when normal commercial practices provide the required accuracy.
12.5 Records of calibration are to be completed, maintained and stored in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 20 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 13.0 HANDLING, STORAGE AND SHIPPING 13.1 Methods have been established for the control of items in order to prevent damage, deterioration, or loss during all phases of safety-related or important-to-safety activities affecting quality; and are described in detail by the implementing procedures.
13.2 Special handling, storage and shipping requirements for a project are to be performed in accordance with written procedures, which shall address the need for special coverings, special equipment and tools, marking and labeling that is used to adequately maintain and preserve items, or indication of the presence of special environments or the need for special controls, as required.
13.3 Personnel performing special handling and lifting operations with equipment are to be experienced and trained in the use of said equipment.
PR9000 Revision H Date: 01-20-2021 Page 21 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 14.0 INSPECTION, TEST AND OPERATING STATUS 14.1 Methods are provided for determining the status of safety-related or important-to-safety inspection and test activities; and are described in detail by the implementing procedures.
14.2 Procedures are established and identify and provide as applicable: criteria, procedure, equipment, personnel qualifications, acceptance criteria, and control documentation.
14.3 Procedures provide for means of identification through the use of stamps, tags, labels, or other suitable methods.
14.4 The status of nonconformances is to be controlled in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 22 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 15.0 NONCONFORMING MATERIALS, PARTS, AND COMPONENTS 15.1 Provisions have been established for preventing items and activities that do not conform to specified requirements from inadvertent installation or use. Controls provide for the identification, documentation, evaluation, segregation (when practical), disposition, and proper notification to affected organizations; and are described in detail by the implementing procedures.
15.2 Nonconformances are to be documented in writing on a Nonconformance (NCR) Report; and presented to appropriate organizations for review, acceptance and disposition.
15.3 Nonconforming items are to be identified and segregated, when practical, to prevent the inadvertent installation or use until properly dispositioned. Identification is by tagging, marking or other methods that do not adversely affect the end use of the item; and shall be legible and easily recognizable.
15.4 Dispositions of the nonconformance shall be: Accept-As-Is, Repair, Rework or Reject/Scrap/Return to Supplier.
15.4.1 Technical justification and independent verification to assure compliance with the design, regulatory and contractual requirements for the acceptance of a repair or accept-as-is disposition shall be documented.
15.4.2 Items dispositioned as Repair or rework are to be completed, controlled, and verified by re-inspection or re-testing to the original acceptance criteria, as required by documented and approved methods; unless the disposition established an alternate acceptance criteria.
15.5 Dispositions shall in no way negate regulatory, code, specification, design, or technical requirements.
15.6 Nonconformances and associated work is to be completed and accepted prior to closure.
15.7 Nonconformance reports and associated documentation are to be maintained in accordance with QA Program requirements.
15.8 Regulatory Requirements Reportability - 10CFR Part 21 and 10CFR Part 71.95 15.8.1 Applicable provisions for regulatory requirements reportability (10CFR21 /
10CFR72.95) shall be controlled in accordance with implementing procedures.
- a. 10CFR Part 21 shall be incorporated in applicable procurement documents.
- b. NCRs and CAPAs shall be evaluated for regulatory requirements compliance and reportability, when required.
- c. Postings to include: 10CFR21, 10CFR &1.95, and the Law - Section 206.
PR9000 Revision H Date: 01-20-2021 Page 23 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 16.0 CORRECTIVE ACTION 16.1 Methods have been established for the prompt identification and correction of conditions adverse to quality and corrected as soon as practical; and are described in detail by the implementing procedures.
16.2 The identification of a significant condition adverse to quality, the cause of the condition, and the corrective actions taken shall be documented; and are reported to the appropriate levels of management.
16.3 Completed corrective and preventive actions are to be verified prior to closure.
16.4 Corrective Actions are to be documented in writing on a Corrective and Preventive Action (CAPA) Report; and presented to the responsible organization for determination of action and response. Corrective actions shall in no way negate regulatory, code, specification, design, or technical requirements.
16.5 Corrective actions, associated work and objective evidence is to be completed and accepted prior to closure.
16.6 Corrective and Preventive Action reports and associated documentation are to be maintained in accordance with QA Program requirements.
PR9000 Revision H Date: 01-20-2021 Page 24 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 17.0 QUALITY ASSURANCE RECORDS 17.1 Documentary evidence has been provided for safety-related or important-to-safety items and activities completed that affect quality, and that meet the specified quality requirements. QA records shall be identified, generated, authenticated, and maintained; and their final disposition specified. These requirements are described in detail by the implementing procedures.
17.2 Records are to be specified in the appropriate documents, as required, e.g., design specifications, procurement documents, test and operational procedures. They are to be legible, accurate and traceable to the associated items and activities; and shall be authenticated.
17.3 Appropriate procedures describe in detail specific requirements for the control of documents and records which are maintained by electronic media, including: generated format, hardware and software requirements, security measures, network back-up, and storage and retention requirements.
17.4 QA records are identified and retained as Lifetime or Non-Permanent records by AOS or its customers, as appropriate. Records are identified, indexed, stored, and maintained in accessible locations. Storage of such records shall be done in locations and facilities designed to prevent damage, deterioration, or loss.
17.5 In addition to the requirements in the implementing procedures, any other applicable regulatory requirements must be adhered to.
17.6 QA records are maintained for periods specified by the implementing procedures furnishing evidence for safety-related and important-to-safety structures, systems or components (including design, procurement, manufacturing, and assembly records).
17.6.1 QA records for 10CFR Part 71 activities are retained for a period beyond the date of last engagement in the activities under the scope of the QA Program for the following:
- 1. Records of each shipment of licensed material shall be maintained for 3 years after that shipment [10 CFR 71.91(a)].
- 2. Records providing evidence of packaging quality shall be maintained for 3 years after the life of the packaging [10 CFR 71.91(d)].
- 3. Records describing activities affecting packaging quality shall be maintained for 3 years after this Quality Assurance Program approval is terminated [10 CFR 71.135].
PR9000 Revision H Date: 01-20-2021 Page 25 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 18.0 AUDITS 18.1 A system has been established for conducting audits of company and supplier safety-related or important-to-safety activities that affect quality, to verify compliance with all applicable regulations, codes and standards; and to determine their effectiveness and compliance with the appropriate QA Program. These requirements are described in detail by the implementing procedures.
18.2 Planned and periodic audits of all aspects of the QA Program and suppliers quality programs shall be conducted in accordance with pre-determined schedules, and supplemented with additional audits or surveillances, when necessary. All applicable elements of the QA Program are audited at least once each year.
18.3 Appropriately trained personnel shall meet the requirements specified in the QA Program requirements; and shall not have direct responsibility in the area being audited.
18.4 Audits are established by developing an audit plan; to identify the personnel, scope, requirements, and applicable documentation.
18.5 Audits are conducted using written checklists; and audit personnel are to obtain sufficient objective evidence to determine effective implementation and effectiveness. The audit is to include an evaluation of the results of previous QA Program audits and results of audits from other sources, and significant changes in personnel, the organization, or the QA Program.
18.6 An audit report is completed and includes identification of the objective evidence established and recorded, and the effectiveness of implementation. The results of the audits are reported to the appropriate level(s) of management for the area(s) audited.
18.7 Corrective actions resulting from audits are undertaken by responsible management; schedules are established, and results are verified for implementation and closure; and to determine the necessity for performance of appropriate follow-up, including re-audit of deficient areas, when necessary.
PR9000 Revision H Date: 01-20-2021 Page 26 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages
19.0 REFERENCES
The following referenced documents are integral, in whole or in part, as a basis for the QA Program. This QA Program meets the latest edition/revision/version of the referenced documents, unless otherwise identified in any of the corresponding documents or regulatory control.
19.1 10CFR Part 21, Code of Federal Regulations, Title 10 - Reporting of Defects and Noncompliance 19.2 10CFR Part 50 Appendix B, Code of Federal Regulations - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants 19.3 10CFR Part 71 Subpart H, Code of Federal Regulations - Packaging and Transportation of Radioactive Material, Quality Assurance 19.4 USNRC Regulatory Guide 1.28 - Quality Assurance Program Requirements (Design and Construction) 19.5 USNRC Regulatory Guide 7.10 - Establishing Quality Assurance Programs for Packaging Used In The Transport of Radioactive Material 19.6 NUREG/CR-6407 - Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety 19.7 ASME NQA Quality Assurance Requirements for Nuclear Facility Applications 19.8 ANSI N45.2 - Quality Assurance Program Requirements for Nuclear Facilities (and associated daughter standards as they apply to packaging activities) 19.9 IAEA Safety Requirements No. TS-R-1, Regulations for the Safe Transport of Radioactive Material 19.10 IAEA Safety Guide No. TS-G-1.1 (ST-2), Appendix IV - Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Materials, Quality Assurance in the Safe Transport of Radioactive Material 19.11 International Standard ISO/IEC 17025 - General Requirements for the Competence of Testing and Calibration Laboratories; as provided in NEI 14-05; and controls for approval based on NRC-endorsed industry guidance 19.12 Nuclear Energy Institute Document No. NEI 14-05, Guidelines for The Use of Accreditation In Lieu Of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services PR9000 Revision H Date: 01-20-2021 Page 27 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 20.0 ORGANIZATIONAL CHART The AOS organizational structure for the QA Program supporting Radioactive Material Transport Packages (NOTE: This chart is generic to the AOS organization; a detailed organization chart is illustrated in SOP PR9001.1):
PR9000 Revision H Date: 01-20-2021 Page 28 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages 21.0 TABLE OF CHANGES - AOS QA PROGRAM PR9000 TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. E (08-19-2015)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
REVISE TO READ: Administrative clarification Alpha-Omega Services, Inc. (AOS) is engaged Strengthens the fact that the QA POLICY in the business of design, procurement, Program is associated to the radioactive STATEMENT fabrication, assembly, testing, modification, material transport business conducted
--- maintenance, repair, and use of radioactive 1st paragraph; by AOS.
material transportation package activities that 1st sentence This change does not reduce the are safety-related or important-to-safety; and has the responsibility to protect the health and commitment made by AOS; and which safety of the public and its employees was previously approved by NRC REVISION D:
AOS has established a Quality Assurance Program (QA Program) for Radioactive Material Transport Packages (packages) designed to comply with the requirements of 10CFR71 Subpart H; and the program is reviewed and approved by the USNRC prior to Provides compliance with the amended implementation. portion of 10CFR 71.38; and the POLICY REVISION E: addition of 10CFR 71.106, effective July
§71.38 STATEMENT AOS has established a Quality Assurance 13, 2015
§71.106 1st paragraph; Program (QA Program) for Radioactive This change does not reduce the 2nd sentence Material Transport Packages (packages) commitment made by AOS; and which designed to comply with the requirements of was previously approved by NRC 10CFR71 Subpart H. In the event that the program reduces the commitment as previously approved by the NRC, the proposed changes shall be reviewed and approved by the USNRC prior to implementation.
Administrative clarification POLICY Correction of improper language, and STATEMENT CHANGE obtain strengthens the commitment to the QA
--- 2nd paragraph; TO READ, maintain Program 2nd sentence, This change does not reduce the 5th line commitment made by AOS; and which was previously approved by NRC CHANGE TO READ:
Administrative clarification The President of AOS retains the overall Separates management commitment POLICY authority and responsibility for the from employee commitment; and STATEMENT implementation of the Quality Assurance strengthens employee commitment to
--- Program. Each and every employee is 3rd paragraph; the QA Program expected to perform the individuals 1st sentence This change does not reduce the assigned work activities in accordance with its established requirements and policies. commitment made by AOS; and which was previously approved by NRC ADD 2nd SENTENCE TO READ:
Administrative clarification QAP Responsible for ensuring compliance with
§ 71.101 Provides additional responsibilities of Section 1.3 the program, regulatory, and customer the President of AOS related requirements.
PR9000 Revision H Date: 01-20-2021 Page 29 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. E (08-19-2015)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
This change does not reduce the commitment made by AOS; and which was previously approved by NRC Administrative clarification CHANGE When suppliers are Strengthens commitment to QAP requirements of the QA Program
§ 71.105 TO READ, Suppliers used for performance Section 2.2 This change does not reduce the of activities are commitment made by AOS; and which was previously approved by NRC Administrative clarification CHANGE It further Strengthens commitment to QAP requirements of the QA Program
§ 71.105 TO READ, The QA Program Section 2.4 This change does not reduce the commitment made by AOS; and which was previously approved by NRC REVISION D:
Revisions to the QA Program are subject to review and approval by the U.S. Nuclear Regulatory Commission (USNRC; NRC) prior to implementation. The date of implementation for the QA Program revision is to be after the date of NRC approval; and upon completion of all programmatic requirements (i.e., training, etc.).
REVISION E:
Revisions to the QA Program are subject to review and approval by the U.S. Nuclear Provides compliance with the amended Regulatory Commission (USNRC; NRC) portion of 10CFR 71.38; and the prior to implementation; when the changes addition of 10CFR 71.106, effective July
§71.38 QAP reduce the commitments made in the 13, 2015
§71.106 Section 2.9 previously-approved QA Program. The This change does not reduce the date of implementation for the QA Program commitment made by AOS; and which revision shall be as follows:
was previously approved by NRC 2.9.1 When changes do not reduce the commitments made to the NRC, the date of implementation shall be the approval date of the QA Program by AOS Management; and upon completion of all programmatic requirements (i.e., training, etc.).
2.9.2 When changes are made that reduce the commitments made to the NRC, the date of implementation is to be after the date of NRC approval; and upon completion of all programmatic requirements (i.e., training, etc.).
Advance Section 2.10 and those Provides compliance with the amended paragraphs following one level. portion of 10CFR 71.38; and the ADD SECTION 2.10, AS FOLLOWS: addition of 10CFR 71.106, effective July
§71.38 QAP Changes made to the QA Program that do 13, 2015
§71.106 Section 2.10 not reduce the commitments previously This change does not reduce the approved by the NRC shall be submitted to commitment made by AOS; and which the NRC every 24 months (start date was previously approved by NRC PR9000 Revision H Date: 01-20-2021 Page 30 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. E (08-19-2015)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS) coincides with date of last approval), in accordance with regulatory requirements
[i.e., § 71.1(a)].
The following are changes made to the QA Program that do not require NRC approval prior to implementation:
2.10.1 Administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items; 2.10.2 The use of a quality assurance standard approved by the NRC that is more recent than the quality assurance standard designated in the QA Program at the time of the change; 2.10.3 The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there are no substantive change to functional relationships, authorities, or responsibilities; 2.10.4 The elimination of QA program information that duplicates language in the QA regulatory guides and QA standards to which the QA Program is committed on record; 2.10.5 Organizational revisions that ensure persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations; 2.10.6 Records of the QA Program changes are to be maintained and incorporated into the QA Program; and shall identify the following: Regulatory reference(s); QA Program reference(s); Changes (Before /
After); and Justification (reason for change; basis for considering the change continues to satisfy the regulatory requirements).
ADD THE FOLLOWING:
Recertification of personnel shall be Administrative clarification completed within the designated intervals Strengthens the commitment for the and accomplished by continued proficiency of specialized personnel
§ 71.105 2.12.4 satisfactory performance, written This change does not reduce the examination, or capability demonstration commitment made by AOS; and which of proficiency as determined by stated was previously approved by NRC requirements.
PR9000 Revision H Date: 01-20-2021 Page 31 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. E (08-19-2015)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
REVISION D:
Procurement documents are reviewed and Administrative clarification approved by Engineering and by Quality Requires approval of procurement Assurance, as required, prior to issuance. documents by Engineering and/or other QAP
§ 71.109 REVISION E: disciplines, as required.
Section 4.4 Procurement documents are reviewed and This change does not reduce the approved by Quality Assurance and any commitment made by AOS; and which other personnel as required, prior to was previously approved by NRC issuance.
Administrative clarification CHANGE Suppliers Provides the establishment of QAP requirements that the information is to
§ 71.115 TO READ, When required by procurement be required by procurement documents Section 7.5 documents, suppliers This change does not reduce the commitment made by AOS; and which was previously approved by NRC CHANGE M&TE Administrative clarification QAP This change does not reduce the
§ 71.121 TO READ, Measuring and Test Equipment Section 10.6 commitment made by AOS; and which (M&TE) was previously approved by NRC Administrative clarification CHANGE Inspections Correction of typographical error QAP
§ 71.123 TO READ, Tests This change does not reduce the Section 11.2 commitment made by AOS, and previously approved by NRC Administrative clarification CHANGE If Strengthens the stated commitment QAP
§ 71.125 TO READ, When This change does not reduce the Section 12.3 commitment made by AOS, and previously approved by NRC REVISION D:
In complying with the requirements of the quality assurance criteria document specified, the applicable provisions of 10CFR21 -
Reporting of Defects and Noncompliances shall be controlled in accordance with the implementing procedures. Administrative clarification REVISION E: Strengthens the commitment and QAP ADD THE FOLLOWING: requirements for 10CFR Part 21
§ 71.131 15.8 10CFR Part 21 - Reporting of Defects applicability Section 15.8 and Noncompliances This change does not reduce the 15.8.1 The applicable provisions of commitment made by AOS, and 10CFR21 shall be controlled in accordance previously approved by NRC with implementing procedures, and include the following:
- a. Part 21 shall be incorporated in applicable procurement documents.
- b. NCRs and CAPAs shall be evaluated for Part 21 compliance.
PR9000 Revision H Date: 01-20-2021 Page 32 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. E (08-19-2015)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
- c. Postings to include: 10CFR21, and the Law Section 206.
Advance Section 17.3 and those paragraphs following one level.
ADD SECTION 17.3, AS FOLLOWS: Administrative clarification Appropriate procedures describe in detail Provides additional commitment for QAP specific requirements for the control of electronic media storage and retention
§ 71.135 documents and records which are Section 17.3 This change does not reduce the maintained by electronic media, including:
commitment made by AOS, and generated format, hardware and software previously approved by NRC requirements, security measures, network back-up, and storage and retention requirements.
Administrative clarification ADD 3RD SENTENCE: Provides additional commitment for QAP Storage of such records shall be done in record storage and retention
§ 71.135 Section 17.4 locations and facilities designed to prevent This change does not reduce the damage, deterioration, or loss. commitment made by AOS; and which was previously approved by NRC ADD THE FOLLOWING:
17.6 QA records are maintained for periods specified by the implementing procedures, and furnish evidence for safety-related and important-to-safety structures, systems or components (including design, procurement, manufacturing, and assembly records).
17.6.1 QA records for 10CFR Part 71 Administrative clarification activities are retained for a period beyond Provides for identification of the record the date of last engagement in the maintenance specified by the USNRC QAP activities under the scope of the QA Quality Assurance Program Approval
§ 71.135 Program for the following:
Section 17.6 document (NRC Form 311)
- 1. Records of each shipment of licensed This change does not reduce the material shall be maintained for 3 years commitment made by AOS, and after that shipment [10 CFR 71.91(a)]. previously approved by NRC
- 2. Records providing evidence of packaging quality shall be maintained for 3 years after the life of the packaging [10 CFR 71.91(d)].
- 3. Records describing activities affecting packaging quality shall be maintained for 3 years after this Quality Assurance Program approval is terminated [10 CFR 71.135].
REVISION D:
Audits are conducted using written checklists; Administrative clarification QAP and are to provide sufficient objective Clarification of typographical error evidence to determine effective
§ 71.137 Section 18.5 This change does not reduce the implementation and effectiveness.
1st sentence commitment made by AOS, and REVISION E:
previously approved by NRC Audits are conducted using written checklists; and audit personnel are to obtain sufficient PR9000 Revision H Date: 01-20-2021 Page 33 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. E (08-19-2015)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS) objective evidence to determine effective implementation and effectiveness.
Administrative clarification Update of current AOS organizational QAP Replace Organizational Chart with current structure
§ 71.101 Section 20.0 structure This change does not reduce the commitment made by AOS, and previously approved by NRC ADD:
TABLE OF CHANGES - AOS QA PROGRAM PR9000 Provides compliance with the amended Add matrix; to identify the following: portion of 10CFR 71.38; and the addition of 10CFR 71.106, effective July QAP 10CFR71H Section Reference
§ 71.106 (c) 13, 2015 Section 21.0 PR9000 Section / Paragraph Reference This change does not reduce the Changes commitment made by AOS; and which Justification (Reason for change; basis for was previously approved by NRC concluding the change continues to satisfy 10CFR71H Requirements TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. F (3-28-2016)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
Provides compliance with the amended portion of 10CFR 71.38; and the addition of 10CFR 71.106, effective July 13, 2015 Revision F was Revision E This change does not reduce the Implementation Date changed to read, March commitment made by AOS; and which
--- Cover Page 22,2016 was previously approved by NRC Revision Block: Added F; FM9006.1-032016-The following changes were made in 0xx response to CAPA FM9016.1-032016-002 (03-09-2016) and CAPA FM9016.1-032016-003 (03-08-2016) as a result of comments from the NRC Inspection 1.0 1.6 Operations Manager was Customer
§ 71.103 1.6 Service Same as above 1.7 1.7 Added Director of to Service Added Paragraph 3.1.1, During the design process Engineering designates specific safety classifications to items which affect 3.0
§ 71.107 material procurement; and is defined in the Same as above 3.1.3 implementing procedures.
Paragraphs 3.1.4 through 3.1.7 were previously 3.1.3 through 3.1.6 7.0 Deleted Paragraph 7.2 (became paragraph
§ 71.117 Same as above 7.2 3.1.3)
PR9000 Revision H Date: 01-20-2021 Page 34 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. F (3-28-2016)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
Paragraphs 7.2 through 7.11 were previously 7.3 through 7.12 Added, NOTE: This chart is generic to the AOS organization; a detailed organization
§ 71.103 20.0 chart is illustrated in SOP PR9001.1): Same as above Revised AOS Organizational Chart Added Table of Changes for Revision F (03-
--- 21.0 Same as above 22-2016)
PR9000 Revision H Date: 01-20-2021 Page 35 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. G (06-21-2019)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
§71.101 Cover Page Revision was changed from F to read, G Provides compliance with the amended Date of Implementation was changed from portion of 10CFR 71.38; and the March 28, 2016 to read, June 21, 2019 addition of 10CFR 71.106, effective July Revision Block: Added G; FM9006.1-062019- 13, 2015 010 The changes identified below do not Footer was changed as follows: reduce the previous commitments made by AOS to the NRC which have Revision was changed from F to, G; and been approved Date was changed from 03-28-2016 to read, 06-21-2019
§71.101 Index of Added Revision Bars to Index of Records; Administrative clarification Records Policy Statement; Section 1.0; Section 4.0; Identifies those sections of the QA Section 7.0; Section 12.0; Section 19.0; Program affected by the revisions.
Section 20.0; and Section 21.0 This does not reduce any previous commitment made to the NRC which has been approved.
§71.101 Policy 1st paragraph, 5th line; added the acronym, Administrative clarification Statement RAMP Provides an acronym which is for 3rd paragraph, 1st sentence changed from The Radioactive Material Transport President of AOS to read, The Packages; corrects managerial title CEO/President of AOS Strengthens the fact that the QA Added CEO/ to signature line Program is associated with the radioactive material transport business conducted by AOS.
This does not reduce any previous commitment made to the NRC which has been approved.
§71.103 1.0 1st sentence changed from The President of Administrative clarification 1.3 AOS to read, The CEO/President Identifies change to the organizational (President) of AOS structure of implemented by AOS
§71.103 1.0 1st sentence changed from Regulatory Affairs implemented including titles and is responsible to read, Director reportability.
1.5 Regulatory Affairs reports directly to the Strengthens the AOS organization of President. Is responsible for the RAMP QA Program.
§71.103 1.0 1st sentence changed from Operations This does not reduce any previous Manager is responsible to read, Vice commitment made to the NRC which 1.6 President Operations reports directly to the has been approved.
President. Is responsible for
§71.103 1.0 1st sentence changed from Director of 1.7 Services is responsible to read, Operations Manager / Engineer (Bellflower) reports directly to the Vice President - Operations. Is responsible for
§71.103 1.0 1st sentence change from or Audit 1.9 personnel; and are responsible to read, or Audit personnel. Subcontract personnel report to appropriate AOS management; and are responsible
§71.101 1.0 Added Section 1.10 Administrative clarification
§71.103 1.10 PR9000 Revision H Date: 01-20-2021 Page 36 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. G (06-21-2019)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
§71.109 When purchasing commercial grade Identifies the requirements established
§71.115 calibration and/or testing services from a by NEI 14-05 Rev. 1 and associated
§71.125 laboratory holding accreditation by an documentation for USNRC provisional accrediting body recognized by the recognition of ISO/IEC 17025, 2017 International Laboratory Accreditation Edition for the transition period defined Cooperation (ILAC) Mutual Recognition by ISO (11-30-2020).
Arrangement (MRA) in accordance with the Strengthens the requirements for provisions of regulatory requirements and acceptance of the use of accredited other associated documents, AOS retains calibration and testing laboratories in overall responsibility for assuring that said lieu of performing a commercial grade services meet applicable technical and survey; and meeting established regulatory requirements and that regulatory requirements and providing reasonable assurance of quality is additional QA requirements as provided provided; as provided by appropriate in the appropriate QA implementing implementing procedures established by procedures.
the QA Program. This does not reduce any previous Re-numbered remaining Sections to 1.11 and commitment made to the NRC which 1.12 has been approved.
§71.109 4.0 Added Section 4.3 Administrative clarification 4.3 Procurement documents for commercial Identifies the requirements established grade calibration and/or testing laboratory by NEI 14-05 Rev. 1 and associated services utilized in Safety Related activities documentation for USNRC provisional from approved suppliers accredited to the recognition of ISO/IEC 17025, 2017 accepted edition(s) of ISO/IEC-17025 are Edition for the transition period defined required to be in conformance with by ISO (11-30-2020).
appropriate implementing procedures. Strengthens procurement document Re-numbered remaining Sections to 4.4 activities that establish regulatory through 4.7, inclusive requirements for meeting the provisions of NEI 14-05 Rev. 1; and as provided in the appropriate QA implementing procedures.
This does not reduce any previous commitment made to the NRC which has been approved.
§71.115 7.0 Added Section 7.3.4 Administrative clarification 7.3.4 Approval by a documented review of a Identifies the requirements established suppliers ISO/IEC-17025 program by NEI 14-05 Rev. 1 and associated (accepted editions) accredited by the ILAC- documentation for USNRC provisional MRA Accreditation Bodies for calibration recognition of ISO/IEC 17025, 2017 and/or testing laboratories in accordance Edition for the transition period defined with appropriate implementing procedures, by ISO (11-30-2020).
in lieu of performing a commercial grade Strengthens commercial grade supplier survey; providing on reliance of the approval activities that establish accreditation process and adherence to regulatory requirements for meeting the programmatic requirements. AOS is provisions of NEI 14-05 Rev. 1; and as responsible for reviewing objective provided in the appropriate QA evidence for conformance to procurement implementing procedures.
documents to validate the service This does not reduce any previous suppliers accreditation and review of commitment made to the NRC which actual certificates provided by the has been approved.
laboratory. AOS does not need to directly perform technical verification of data produced nor perform a commercial grade survey of the suppliers activities.
PR9000 Revision H Date: 01-20-2021 Page 37 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. G (06-21-2019)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
§71.125 12.0 Added Section 12.2.5 Administrative clarification 12.2.5 For suppliers of calibration services Identifies the requirements established approved by ISO/IEC-17025 accreditation - by NEI 14-05 Rev. 1 and associated at the time of receipt inspection AOS is to documentation for USNRC provisional validate the contracted calibration or test recognition of ISO/IEC 17025, 2017 service has been performed in accordance Edition for the transition period defined with the suppliers program and within by ISO (11-30-2020).
their scope of accreditation, and that all Strengthens commercial grade supplier purchase order requirements are met; as approval activities that establish provided by the appropriate implementing regulatory requirements for meeting the procedures. provisions of NEI 14-05 Rev. 1; and as provided in the appropriate QA implementing procedures.
This does not reduce any previous commitment made to the NRC which has been approved.
§71.101 19.0 Added Section 19.11 Administrative clarification 19.11 International Standard ISO/IEC 17025 - Identifies the requirements established General Requirements for the Competence by NEI 14-05 Rev. 1 and associated of Testing and Calibration Laboratories; documentation for USNRC provisional Second Edition 2005-05-15 and/or Third recognition of ISO/IEC 17025, 2017 Edition 2017-11 [as provided in NEI 14-05 Edition for the transition period defined Revision 1 (Guidelines for the Use of by ISO (11-30-2020).
Accreditation in Lieu of Commercial Grade Provides referencing documents that Surveys for Procurement of Laboratory establish the regulatory requirements Calibration and Test Services, August for meeting the established 2014); and regulatory requirements requirements of NEI 14-05 Rev. 1; and (USNRC Provisional Recognition of the as provided in the appropriate QA International Standard implementing procedures.
Organization/International This does not reduce any previous Electromechanical Commission Standard commitment made to the NRC which No. 17025, General Requirements for the has been approved.
Competence of Testing and Calibration Laboratories, 2017 Edition; re: ADAMS Accession No. ML19056A451)]
§71.103 20.0 Revised the AOS Organizational Chart to Administrative clarification coincide with changes made to QA Program Provides an update to the current AOS Section 1.0 RAMP organizational structure Administrative clarification Identifies change to the organizational structure of implemented by AOS implemented including titles and reportability; and revision to the Organizational Chart Strengthens the AOS organization of the RAMP QA Program.
This does not reduce any previous commitment made to the NRC which has been approved.
§71.101 21.0 Added Table of Changes - AOS QA Program Administrative clarification PR9000 Rev. G (06-14-2019) Identifies the individual changes and justification for actions made to those PR9000 Revision H Date: 01-20-2021 Page 38 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. G (06-21-2019)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS) sections of the QA Program affected by the revisions.
This does not reduce any previous commitment made to the NRC which has been approved.
TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. H (01-20-2021)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
§71.101 Cover Page Revision was changed from G to read, H Provides compliance with the amended Date of Implementation was changed from portion of 10CFR 71.38; and the June 21, 2019 to read, January 20, 2021 addition of 10CFR 71.106, effective July Revision Block: Added H; FM9006.1-012021- 13, 2015 012 The changes made in Revision H -
Footer was changed as follows: identified below do not reduce the previous commitments made by AOS, Revision was changed from G to, H; and which have been approved by the Date was changed from 06-21-2019 to read, USNRC.
01-20-2021
§71.101 Index of Added Revision Bars to Index of Records; Administrative clarification Records Section 1.0; Section 2.0; section 3.0; Section Identifies those sections of the QA 4.0; Section 6.0; Section 7.0; Section 8.0; Program affected by the current Section 11.0; Section 12.0; Section 13.0; revision.
Section 15.0; Section 17.0; Section 18.0; Section 19.0; and Section 21.0
§71.103 1.11 2nd line: Correct but, to read, but Administrative clarification - corrected typographical error only
§71.105 2.5 4th line: Correct safety; to read, safety, Administrative clarification - corrected typographical error only
§71.105 2.9 3rd line: Correct previously-approved to read, Administrative clarification - corrected previously approved typographical error only
§71.105 2.10.3 3rd line: Correct are to read, is Administrative clarification - corrected typographical error only
§71.107 3.1.7 2nd line: Correct procedures; to read, Administrative clarification - corrected procedures, typographical error only
§71.109 4.3 3rd line: Delete, edition(s), and change to Administrative clarification read, suppliers accredited to an accepted Enhances wording for approval document revision of ISO/IEC-17025 requirements and controls.
§71.113 6.1 2nd line: Correct quality, and to read, quality Administrative clarification - corrected and typographical error only
§71.115 7.3.4 1st sentence: Delete edition(s), and change to Administrative clarification read, suppliers accredited to an accepted Enhances wording for approval document revision of ISO/IEC-17025 a requirements and controls.
commercial grade survey.
PR9000 Revision H Date: 01-20-2021 Page 39 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. H (01-20-2021)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS) 2nd sentence: Add the following: Controls for approval are based on NRC-endorsed industry guidance, providing on reliance
§71.117 8.4 4th line: Correct controlled; to read, Administrative clarification - corrected controlled, typographical error only
§71.123 11.8 1st line: Correct are to read, is Administrative clarification - corrected typographical error only
§71.125 12.2.5 1st sentence: Change from For suppliers of Administrative clarification calibration services approved by ISO/IEC- Enhances wording for approval 17025 accreditation to read, For requirements and controls.
approved suppliers accredited to an accepted document revision of ISO/IEC-17025 providing calibration services - at the time 6th line: Correct met; to read, met
§71.127 13.2 2nd line: Correct procedures; to read, Administrative clarification - corrected procedures, typographical error only
§71.131 15.4.2 1st line: Correct completed and to read, Administrative clarification - corrected completed, controlled, typographical error only
§71.131 15.8 Change title from 10CFR Part 21 - Reporting Administrative clarification of Defects and Noncompliances to read, Enhances wording for applicable Regulatory Requirements Reportability - requirements to include 10CFR71.95.
10CFR Part 21 and 10CFR Part 71.95
§71.131 15.8.1 Re-write section to read as follows: Administrative clarification Applicable provisions for regulatory Enhances wording for applicable requirements reportability (10CFR21 / requirements to include 10CFR71.95.
10CFR71.95) shall be controlled in accordance with implementing procedures.
- a. 10CFR Part 21 shall be incorporated in applicable procurement documents.
- b. NCRs and CAPAs shall be evaluated for regulatory requirements compliance and reportability, when required.
- c. Postings to include: 10CFR21, 10CFR71.95, and the Law - Section 206.
§71.135 17.2 1st line: Correct required; to read, required, Administrative clarification - corrected typographical error only
§71.135 17.6 1st line: Correct procedures, and furnish to Administrative clarification - corrected read, implementing procedures typographical error only furnishing evidence
§71.137 18.5 4th line: Correct sources; to read, sources, Administrative clarification - corrected typographical error only
§71.101 19.0 2nd sentence: Re-write to read, This QA Administrative clarification - corrected Program meets the latest typographical error only edition/revision/version of the referenced documents, unless otherwise identified in any of the corresponding documents or regulatory control.
PR9000 Revision H Date: 01-20-2021 Page 40 of 41
CONTROLLED COPY Quality Assurance Program - Radioactive Material Transport Packages TABLE OF CHANGES - AOS QA PROGRAM PR9000 REV. H (01-20-2021)
JUSTIFICATION PR9000 10CFR71H (REASON FOR CHANGE; BASIS FOR SECTION/
SECTION CHANGES CONCLUDING THE CHANGE PARAGRAPH REFERENCE CONTINUES TO SATISFY 10CFR71H REFERENCE REQUIREMENTS)
§71.101 19.6 1st line: Delete, February 1996 Administrative clarification Remove date of document to make the Reference generic; this is clarified by the requirement in 19.0.
§71.101 19.9 1st line: Delete, (2005 Edition) Administrative clarification Remove date of document to make the Reference generic; this is clarified by the requirement in 19.0.
§71.101 19.11 Re-write Reference to read, International Administrative clarification Standard ISO/IEC 17025 - General Remove date of document to make the Requirements for the Competence of Testing Reference generic; this is clarified by and Calibration Laboratories; as provided in N the requirement in 19.0.
EI 14-05; and controls for approval based on NRC-endorsed industry guidance.
§71.101 19.12 Add
Reference:
Nuclear Energy Institute Administrative clarification Document No. NEI 14-05, Guidelines for Addition of Reference enhances the The Use of Accreditation In Lieu Of requirements of Reference No. 19.11 Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services
§71.101 21.0 Added Table of Changes - AOS QA Program Administrative clarification PR9000 Rev. H (01-20-2021) Identifies the individual changes and justification for actions made to those sections of the QA Program affected by the revisions.
PR9000 Revision H Date: 01-20-2021 Page 41 of 41