ML18066A568
| ML18066A568 | |
| Person / Time | |
|---|---|
| Site: | 07100952, 07109365 |
| Issue date: | 02/21/2018 |
| From: | Martin D Robatel Technologies |
| To: | Patricia Silva Document Control Desk, Office of Nuclear Material Safety and Safeguards |
| References | |
| Download: ML18066A568 (21) | |
Text
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RDBATEL February 21, 2018 Patricia Silva, Chief U.S. Nuclear Regulatory Commission Division of Spent Fuel Management Washington, DC 20555-0001 technologies
SUBJECT:
BIENNIAL CHANGE REPORT FOR ROBATEL TECHNOLOGIES, LLC QAPD 0952
Dear Ms. Silva,
Please let this letter stand as notice that Robatel Technologies' Quality Program is currently at revision 2. The revisions made were for administrative improvements and editorial changes only, no changes made reduced the commitments initially approved in September of 2012. You will find attached a copy of revision 2 noting the changes in red.
If you should have further questions or comments please feel free to contact me at 540-989-2878 or dmartin@robateltech.com.
Best Regards, l!~faaJ?L Donna Martin Operations Manager and QA coordinator 5115 Bernard Drive* Suite 304
- Roanoke, VA 24018 540/ 989.2878 www.robateltech.com
ROBATEL t<<hnologifi ROBATEL TECHNOLOGIES, LLC 5115 Bernard Dr, Suite 304 Roanoke, VA 24022 QUALITY ASSURANCE PROGRAM DESCRIPTION Approvals:
10 CFR 71 Subpart H for Packaging and Transportation of Radioactive Material Emily A. Mayhew Quality Consultant Date:--------
Date: _______
Dominique Sanchette Christopher Dane Chief Executive Operations Officer (CEO)
RDBATEL (QAPD)
Rev.
0 1
QAPD Rev. £+
2044 technologies January 15, 2012 November 20, 2014 September 1, 2017 Quality Assurance Program Description REVISIONS Comments Original Release Changed cover page: deleted Teo Grochowski, Jr.
as Chief Operations Officer replaced with Christopher Dane; updated address; replaced logo Made various clerical udpdates, changed Christopher Dane to Dominique Sanchette Page 2 of 19 Date: 9/1/201 ?November 20,
RDBATEL technologies (QAPD)
SECTION Quality Assurance Program Description TABLE OF CONTENTS TITLE PAGE
0.0 INTRODUCTION
.............................................................................................. 4 1.0 ORGANIZATION............................................................................................... 4 2.0 QUALITY ASSURANCE PROGRAM..................................................................... 5 3.0 DESIGN CONTROL.......................................................................................... 5 4.0 PROCUREMENT DOCUMENT CONTROL............................................................. 6 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS................................................ 7 6.0 DOCUMENT CONTROL..................................................................................... 7 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES.................... ?
8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS...... 8 9.0 CONTROL OF SPECIAL PROCESSES................................................................. 8 10.0 INSPECTION.................................................................................................. 8 11.0 TEST CONTROL............................................................................................. 9 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT........................................... 9 13.0 HANDLING, STORAGE AND SHIPPING.............................................................. 9 14.0 INSPECTION, TEST AND OPERATING STATUS................................................... 9 15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS.............................. 10 16.0 CORRECTIVE ACTION................................................................................... 10 17.0 QUALITY ASSURANCE RECORDS.................................................................... 11 18.0 AUDITS........................................................................................................ 11 A TI ACHMENT A, QA Program Implementing Procedures............................................... 12 QAPD Rev. i4 2044 Page 3 of 19 Date: 9/1 /201 ?No'lember 20,
RDBATEL technologi~*
Quality Assurance Program Description (QAPD)
0.0 INTRODUCTION
Robatel Technologies, LLC (RTRobatel) is located in Roanoke, Virginia and provides design engineering and fabrication services primarily in the areas of transport packages, hot cells, and waste processing systems.
This Quality Assurance Program Description (QAPD) provides the Quality Assurance (QA) requirements to be invoked by Robatel for purchase orders or contracts governed by 10 CFR 71, or that specifically require compliance to this QAPD. Each contract will be reviewed to determine regulated activities and the appropriate measures to be implemented.
This RTRobatel Quality Assurance Program Description (QAPD) has been generated to specifically establish the QA requirements to meet Subpart H of 1 O CFR Part 71 with respect to designing, fabricating, handling, shipping, storing, cleaning, assembling, inspecting, testing, operating, maintaining, repairing, and modifying packaging components important to safety.
Once reviewed and accepted by the Nuclear Regulatory Commission (NRG), RobateRT! 1.§_W.U be-approved to conduct 10 CFR Part 71 activities in accordance with this QAPD. The Nuclear Regulatory Commission (NRC) issued an approval letter on March 21, 2012.
This Quality Assurance Program Description along with the QAP and implementing procedures meets and exceeds the requirements of:
Title 10, U.S. Code of Federal Regulations, Subpart H to Part 71 (10 CFR 71) and, American Society of Mechanical Engineers (ASME) NQA-1-1994 and 2008 with 2009 Addenda 1.0 ORGANIZATION The Robatel RTquality organizational structure, functional responsibilities, levels of authority, and lines of communication for activities affecting quality are defined within this Quality Assruance Program Document (QAPD} and implementing documents.
The responsibilities and authorities are presented in the Robatel RTQualityQA Program (QAP);
the QAP provides an organization chart and corresponding job descriptions that define job titles as well as the respective duties and responsibilities.
The Chief Executive Operations Officer has full authority over company functions and may delegate authority and responsibility for selected functions to other personnel or organizations.
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ROBATEL technologies Quality Assurance Program Description (QAPD)
The Quality Assurance Manager is vested with the authority and responsibility to ensure that activities affecting quality are performed and documented correctly to the established requirements.
The Quality Assurance Manager shall have sufficient expertise in the quality discipline to direct the quality functions as appropriate to the established requirements. The Quality Assurance Manager's responsibilities include the development, implementation and administration of the quality program and supporting procedures.
Qualified personnel perform monitoring activities and verification of regulatory, contractual, and/or technical requirements in accordance with controlled documents.
2.0 QUALITY ASSURANCE PROGRAM Robatel RT has a hierarchy of documents used to implement the total quality system. The hierarchy includes the QAPD followed by the Quality Assurance Program and lastly the Quality Procedures used to implement the QAPD and QAP.
These documents in total define the requirements to effectively and efficiently implement the requirements of 10 CFR 71 Subpart H as related to meet codes, standards, regulatory and contract requirements.
Activities within the scope of this quality system include Robatel engineering, manufacturing, research, testing and development related to nuclear applications for design, packaging and transportation of radioactive material.
Together, the Robatel RT hierarchy of documents provides for the planning and accomplishment of activities affecting quality under suitably controlled conditions. Controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that prerequisites for the given activity have been satisfied. Furthermore, this hierarchy provides for any special controls, processes, test equipment, tools, and skills to attain the required quality of activities and items and for verification of that quality. The Robatel RTorganization shall establish and implement processes to detect and correct quality problems.
3.0 DESIGN CONTROL Robatel RT assures the following activities: design characteristics are defined, controlled, verified, inspected, and tested; designs developed meet applicable regulatory requirements; and design activities are carried out in a planned, controlled, and orderly manner. The customer maintains design responsibility when Robatel works to customer drawings and specifications.
Robatel RT may subcontract design and fabrication activities to their affiliated company, Robatel Industries or other approved suppliers. In all cases of Level A or B procurement, the supplier performing the work must have an acceptable quality program to meet the required criteria of 10 QAPD Rev. i+
~
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RCBATEL technologif!s Quality Assurance Program Description (QAPD)
CFR 71 Subpart H. Acceptability will be determined by a QA Robatel audit and subsequently, the supplier placed on the RobateRTt Approved Supplier List (ASL). Subsequently, Robatel RT shall verify that design activities wera-areconducted in accordance with the RobatelRT-approved QA Program for that specific supplier.
4.0 PROCUREMENT DOCUMENT CONTROL Procurement activities are performed in accordance with approved procedures that implement the applicable requirements defined in the Robatel RT Program.
All suppliers of safety related products and services are supervised by means of adequate quality assurance measures. These include:
evaluation of the quality capabilities of potential suppliers periodic evaluations of suppliers by onsite audits and/or surveillances Procurement documents shall identify the scope of work, technical requirements, quality/safety program requirements, right of access, inspection and test requirements, special process requirements, documentation requirements, and reporting and disposition of nonconformances, as applicable to the item or service being procured.
Quality related purchase orders and request for quotes shall include requirements, as applicable, such as the following criteria:
Identification of the quality requirements for inspection and control, acceptance and rejection criteria, program and/or customer requirements, and invoking standards and codes (i.e. 10 CFR 21, etc).
Material information such as size, type or grade.
Basic technical requirements such as specifications, drawings, codes, industrial standards, hold points, inspections or tests.
Documentation requirements such as inspection records, test records or certification documents.
A statement that allows QA personnel, or designee(s) to have the right of access to supplier facilities for source inspection and/or audit activities as appropriate.
Quality related purchase orders and requests for quotes shall be reviewed prior to release by qualified management and QA personnel, or their respective designee(s}, to assure compliance with the applicable section of the QA program and procedures.
Changes to procurement documents shall be subject to the same review and approval as the original documents.
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RCBATEL (QAPD)
QAPD Rev. i+
20-M technologies Quality Assurance Program Description Page 7 of 19 Date: 9/1/2017November 20,
RCBATEL t<<hnologies Quality Assurance Program Description (QAPD) 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS Activities affecting quality shall be prescribed by and performed in accordance with documented instructions, procedures, or drawings of a type appropriate to the applicable contract services.
These documents shall include (or reference) appropriate quantitative and qualitative acceptance criteria for determining that the prescribed activities have been satisfactorily accomplished.
The activity shall be described to a level of detail commensurate with the complexity of the activity and the need to assure consistent, acceptable results. The need for written procedures or instructions, as well as their level of detail, shall be determined based upon complexity of the task, significance of the item or activity, work environment, and worker proficiency and capability (education, training, experience).
Based on design drawings, production drawings will be prepared if no definitive production drawings were prepared with the safety report. These production drawings may be prepared by Robatel insofar as sufficient knowledge and experience concerning production processes and possibilities. If experience concerning production processes and possibilities is not sufficient, the manufacturer of the packaging may be entrusted with the development of the production documents.
Approved written procedures assure that all applicable documents conform to the appropriate specifications and pertinent regulations. Good engineering judgment is used when specific specifications or regulations do not exist.
All work activities are coordinated with QA personnel to ensure that the work-controlling documents incorporate appropriate inspection and hold points to verify that initial work, planned work, effective repairs, or rework have been performed satisfactorily.
6.0 DOCUMENT CONTROL Robatel RT controls preparation, issue, and change of documents that specify quality requirements or prescribe activities affecting quality such as instructions, procedures, and drawings in order to ensure that correct documents are being employed. Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel, and subsequently, distributed and used at the location where the activity is performed.
7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES Robatel RT does not preform manufactureing processes containers tRem)!selfves; instead, Robatel RT utilizes selected manufacturers who are audited, approved, and placed on the HSt--ef approved suppliers list (ASL}, or who are audited and approved before the order is placed.
QAPD Rev. 2_4 2044 Page 8 of 19 Date: 9/1/201 ?November 20,
RCBATEL t<<hno/ogies Quality Assurance Program Description (QAPD)
In special cases, Robatel Rt may place an order prior to audit andtapproval of a supplier; however, Robatel RT will audit andtapprove such supplier prior to supplier i.t *.iork startwork starting.
The procurement of material, equipment,. and services shall be controlled to ensure conformance with specified requirements. Such control shall provide for the following as appropriate: source evaluation and selection; evaluation of objective evidence of quality furnished by the supplier; source inspections; audit; and examination of services upon delivery or completion. Procurement procedures describe the procurement process leading to contract award for items and services, and they identify the responsible organizations.
8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS The identification and control of materials, parts and components shall be in accordance with approved procedures, instructions and/or checklists to assure that identification is maintained (either on the item or records traceable to the item) to preclude use of incorrect or defective items.
When required by applicable specifications or customer requirements, the identification of materials, parts, and components shall be traceable to the appropriate documentation such as drawings, purchase orders, shop travelers, inspection documents, nonconformance reports and physical/chemical test reports.
The procedures shall identify the appropriate criteria and responsibilities in order to assure the correct identification of items is verified and documented in accordance with section 10.0 of the QAP and applicable implementing procedures.
Identification requirements shall be established when applicable during the generation of drawings and specifications to assure that the location and method of identification is not detrimental to the material, and does not affect the form, fit, function or quality of the item.
9.0 CONTROL OF SPECIAL PROCESSES Special processes that control or verify quality, such as those used in welding, heat treating, and nondestructive examination, are performed by qualified personnel using qualified procedures in accordance with specified requirements.
10.0 INTERNAL INSPECTION Robatel RT performs inspections to verify conformance of an item/activity to specified requirements, or to verify continued acceptability of items already in-service. Characteristics subject to inspection and inspection methods shall be specified.
Inspection results shall be QAPD Rev. 2_4 2044 Page 9 of 19 Date: 9/1/2017November 20,
RDBATEL technologies Quality Assurance Program Description (QAPD) documented. Inspection for acceptance shall be performed by qualified persons other than those who performed or directly supervised the work being inspected.
The manufacturer will develop the preliminary checking documents based on the manufacturer's specification and the drawings of the packaging to include the following criteria:
List of materials, Fabrication and control follow-up plan (in part also named construction control follow-up plan, according to the manufacturer's choice),
Welding plan, and If applicable, completion drawings (e.g. forging drawings).
The supervision of fabrication through RTRobatel is determined in the preliminary checking documents. The checking steps are carried out under the responsibility of the person responsible for acceptance appointed by Robatel TechnologiesRT. Implementation of the supervising steps is documented in the preliminary checking documents and, insofar as necessary, in the corresponding records.
11.0 TEST CONTROL Robatel RT proof, acceptance and operational tests are controlled by approved written instructions, procedures, or drawings of a type appropriate to the activity.
Tests shall be planned and executed to collect data such as for siting or design input, verify conformance of an item or computer program to specified requirements, or demonstrate satisfactory performance. Characteristics to be tested and test methods to be employed shall be specified. Test results shall be documented and their conformance with test requirements and acceptance criteria shall be evaluated.
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT Robatel RT assures tools, gages, instruments and other measuring and test equipment used in activities affecting quality are properly controlled, calibrated and adjusted to maintain accuracy within required limits.
13.0 HANDLING, STORAGE, AND SHIPPING CONTROL In accordance with procedures and/or instructions and to prevent damage or deterioration, Robatel Rt shall establish measures to control the handling, storage, shipping, cleaning, and preservation of materials/equipment to be used in packaging.
Specific instructions must be QAPD Rev. 2.4-2044 Page 10 of 19 Date: 9/1 /201 ?November 20,
ROBATEL tKhnologl@s Quality Assurance Program Description (QAPD) provided as necessary for particular products and/or special protective environments (e.g., inert gas atmosphere, specific moisture content, and temperature levels).
14.0 INSPECTION, TEST, AND OPERATING STATUS Procedures are established to ensure that the inspection, test, and operating status of materials, items, structures, systems and components throughout fabrication, installation, operation and test are clearly indicated by suitable means (e.g., tags, labels, cards, form sheets, checklists, etc).
15.0 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS Procedures are established to control materials, parts, and components that do not conform to requirements in order to prevent their inadvertent use in manufacturing operations or during service.
Nonconforming items include those items that do not meet specification or drawing requirements.
Additionally, nonconforming items include items not fabricated or tested (1) in accordance with approved written procedures, (2) by qualified processes, or (3) by qualified personnel when use of such procedures, processes or personnel is required by fabrication, test, inspection or other quality assurance requirements.
Nonconforming items are identified andlef segregated to prevent their inadvertent use until properly dispositioned. The identification of nonconforming items is by marking, tagging or other methods that do not adversely affect the end use of the item. The identification is legible and easily recognizable.
When identification of each nonconforming item is not practical, the container, package, or segregated storage area is identified appropriately.
When a Nnonconforming condition/items is identified it is-afe documented on ~ Nonconformance Reports (NCRs) and affected organizations are notified. These reports include a description of the nonconforming condition. Nonconforming items are dispositioned as use-as-is, reject, repair, or rework.
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ROSATEL tKhno/ogies Quality Assurance Program Description (QAPD)
Inspection or surveillance requirements for nonconforming items following rework, repair or modification are detailed in the NCRs and approved following completion of the disposition.
16.0 CORRECTIVE ACTION Procedures are established to ensure that conditions adverse to quality such as failures, malfunctions, deficiencies, deviations, defective material and equipment are promptly identified and corrected. In the case of significant conditions adverse to quality, the cause of the condition is determined and corrective action{sl to prevent recurrence are taken.
Conditions adverse to quality are documented in ~ Corrective Action Reports (CARs) and reported to the appropriate level of management. When necessary, follow up is performed to verify that the corrective action requirement{sl have been completed and are effective.
17.0 QUALITY ASSURANCE RECORDS The control of Quality Assurance records shall be established by Robatel RT consistent with the schedule for accomplishing work activities. Quality Assurance records shall furnish documentary evidence that items or activities meet specified quality requirements.
Quality assurance records shall be identified, generated, and maintained, and their final disposition specified. Record control requirements and responsibilities for these activities shall be documented.
18.0 AUDITS Procedures shall be established to provide for a comprehensive system of planned and documented audits including audits of suppliers. These audit procedures specify the conduct of internal audits of facility and site activities to verify compliance with the applicable aspects of the Robatel RT QAP, and to determine the effectiveness of the program.
Audits shall be scheduled to provide coverage and coordination with ongoing QAP activities commensurate with the status and priority of the activity. All applicable elements of the Robatel RT QAP shall be audited at teast a minimum of annually. Audits of suppliers shall be conducted on a triennial basis unless more frequent audits are deemed appropriate.
Audits shall be performed in accordance with pre-established written procedures using checklists and conducted by trained and certified personnel having no direct responsibilities in the areas being audited. Objective evidence shall be examined for compliance with QAP requirements.
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2044 Page 12 of 19 Date: 9/1 /2017November 20,
RDSATEL (QAPD)
QAPD Rev. i4 2G-14 tKhnologles Quality Assurance Program Description Page 13 of 19 Date: 9/1 /201 ?November 20,
Robatel Technologies, LLC (QAPD)
Quality Assurance Program Description Implementing Document(s)
Quality Assurance Program (QAP),
QAP, Section 1 Organization charts QAP, Section 2 QP 02-01 QP 02-02 QP 02-03 QAP, Section 3 QP 03-01 QP 03-02 QP 03-03 QP 03-04 QAP, Section 4 QP 04-01 QP 04-02 QP 04-03 QAPD Rev. 0 ATTACHMENT A For Information Only QA Program Implementing Procedures Title Regulatory From 10 CFR 71 Position Description Subpart H
§71.103 1
Responsibilities for the establishment and Quality implementation of the quality assurance Assurance program are defined. The organization Organization structure, functional responsibilities, levels of authority, and lines of communications for activities affecting quality are documented. The organization chart provides an outline of the organizational structure.
§71.105 2
Describes how the quality assurance Quality program is planned, implemented, and Assurance maintained. Identifies the activities and Program items to which it applies. The program provides control over activities affecting quality to an extent consistent with their importance. The program includes monitoring activities in a manner sufficient to provide assurance that the activities affecting quality are performed satisfactorilv.
§71.107 3
Design inputs are specified and translated Package into design documents. Design interfaces Design are identified and controlled. Individuals Control other than those who designed the item or computer program verify design adequacy.
Design changes are governed by control measures commensurate with those aoolied to the oriainal desian.
§71.109 4
Applicable design bases and other Procurement requirements necessary to assure Document adequate quality are included or referenced Control in documents for procurement of items and services. To the extent necessary, procurement documents require Suppliers to have a quality assurance program consistent with the applicable requirements of the QAP.
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RCBATEL ttthnologies (QAPD)
Quality Assurance Program Description ATTACHMENT A For Information Only QA Program Implementing Procedures (continued)
Implementing Title Regulatory Document(s)
From 10 CFR 71 Position Description Subpart H QAP, Section 5
§71.111 5
Activities affecting quality and services are QP 05-01 Instructions, prescribed by, and performed in QP 05-02 Procedures, accordance with, documented instructions, And Drawings procedures, or drawings that include or reference appropriate quantitative or QAP, Section 6 QP 06-01 QAP, Section 7 QP 07-01 QP 07-02 QP 07-03 QAP, Section 8 QP 08-01 QAPD Rev. i.t 2-044
§71.113 6
Document Control
§71.115 7
Control of Purchased
- Material, Equipment, and Services
§71.117 8
Identification and Control of Materials, Parts, and Components Page 15 of 19 qualitative acceptance criteria for determining that prescribed activities have been satisfactorily accomplished. The activity is described to a level of detail commensurate with the complexity of the activity and the need to assure consistent and acceotable results.
The preparation, issue, and change of documents that specify quality requirements or prescribe activities affecting quality such as instructions, procedures, and drawings are controlled to ensure that correct documents are being employed. Such documents, including changes thereto, are reviewed for adequacy and approved for release by authorized oersonnel.
The procurement of items and services are controlled to ensure conformance with specified requirements. Such control shall provide for the following as appropriate:
source evaluation and selection, evaluation of objective evidence of quality furnished by the Supplier, source inspection, audit, and examination of items or services upon deliverv or comoletion.
Controls are established to assure that only correct and accepted items are used or installed. Identification is maintained on the items or in documents traceable to the items, or in a manner that assures that identification is established and maintained.
Date: 9/1/201 ?November 20,
RDBATEL tKhnologi~s (QAPD)
Implementing Document(s)
QAP, Section 9 QP 09-01 Quality Assurance Program Description Title Regulatory From 10 CFR 71 Description Subpart H Position
§71.119 9
Special processes that control or verify Control of quality, such as those used in welding, heat Special treating, and nondestructive examination, Processes are performed by qualified personnel using qualified procedures in accordance with specified requirements.
ATTACHMENT A For Information Only QA Program Implementing Procedures (continued)
Implementing Title Regulatory From 10 CFR 71 Description Document(s)
Subpart H Position QAP, Section 10
§71.121 10 Inspections required to verify conformance QP 10-01 Internal of an item or activity to specified Inspection requirements or continued acceptability of items in service are planned and executed.
Characteristics subject to inspection and inspection methods are specified.
Inspection results are documented.
Qualified persons other than those who performed or directly supervised the work being inspected perform inspections for acceptance.
QAP, Section 11
§71.123 11 Tests required to collect data such as QP 11-01 Test Control design input, to verify conformance of an item or computer program to specified requirements, or to demonstrate satisfactory performance for service are planned and executed. Characteristics to be tested and test methods to be employed are specified. Test results are documented and their conformance with test requirements and acceptance criteria are evaluated.
QAP, Section 12
§71.125 12 Tools, gages, instruments, and other QP 12-01 Control of measuring and test equipment used for Measuring activities affecting quality are controlled, And Test calibrated at specific periods, adjusted, and maintained to required accuracy limits.
QAPD Rev. i4 2044 Equipment Page 16 of 19 Date: 9/1/2017November 20,
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Implementing Document(s)
QAP, Section 13 QP 13-01 Quality Assurance Program Description Title Regulatory From 10 CFR 71 Description Subpart H Position
§71.127 13 Handling, storage, cleaning, packaging,
- Handling, shipping, and preservation of items are Storage, and controlled to prevent damage or loss and to Shipping minimize deterioration. These activities are Control conducted in accordance with procedures or instructions specified for use in conductina the activitv.
ATTACHMENT A For Information Only QA Program Implementing Procedures (continued)
Implementing Document(s)
OAP, Section 14 QP 14-01 OAP, Section 15 QP 15-01 QP 15-02 QP 15-03 QAPD Rev. i 4
~
Title From 10 CFR 71 Subpart H
§71.1 29 Inspection, Test, and Operating Status
§71.131 Non-Conforming Materials, Parts, or Components Regulatory Position Description 14 The status of inspection and test activities are identified either on the items or in documents traceable to the items where it is necessary to ensure that required inspections and tests are performed and to ensure that items that have not passed the required inspections and tests are not inadvertently installed, used, or operated.
Status is maintained through indicators, such as physical location and tags, markings, shop travelers, stamps, inspection records, or other suitable means.
15 Items that do not conform to specified requirements are controlled to prevent inadvertent installation or use. Controls shall provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected orqanizations.
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Implementing Document(s)
QAP, Section 16 QP 16-01 QAP, Section 17 QP 17-01 Title Regulatory From 10 CFR 71 Description Subpart H Position
§71.133 16 Conditions adverse to quality are identified Corrective promptly and corrected as soon as Action practicable. In the case of a significant condition adverse to quality, the cause of the condition is determined and corrective action taken to preclude recurrence. The identification, cause, and corrective action for significant conditions adverse to quality are documented and reported to appropriate levels of management.
Completion of corrective actions is verified.
§71.135 17 The control of quality assurance records is Quality established consistently with the schedule Assurance for accomplishing work activities. Quality Records assurance records shall furnish documentary evidence that items or activities meet specified quality requirements. Quality assurance records are identified, generated, and maintained, and their final disposition specified. Record control requirements and responsibilities for these activities are documented.
ATTACHMENT A For Information Only QA Program Implementing Procedures (continued)
Implementing Document(s)
QAP, Section 18 QP 18-01 QP 18-02 QP 18-03 QP 08-04 QAPD Rev. i4 2,Q.44 Title From 10 CFR 71 Subpart H
§71. 137 Audits Regulatory Description Position 18 Audits are performed to verify compliance to quality assurance program requirements, to verify that performance criteria are met, and to determine the effectiveness of the program. Personnel who do not have direct responsibility for performing the activities being audited perform these audits in accordance with written procedures or checklists. Audit results are documented and reported to, and reviewed by, responsible management. Follow-up action is taken where indicated.
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