ML21238A007
| ML21238A007 | |
| Person / Time | |
|---|---|
| Site: | 07109365 |
| Issue date: | 08/11/2021 |
| From: | Bower J Robatel Technologies |
| To: | Document Control Desk, Office of Nuclear Material Safety and Safeguards, Division of Fuel Management |
| References | |
| Download: ML21238A007 (18) | |
Text
August 11, 2021
ATTN: Document Control Desk, Director Division of Fuel Management Office of Nuclear Material Safety and Safeguards US Nuclear Regulatory Commission Washington, DC 20555-0001
SUBJECT:
BIENNIAL CHANGE REPORT FOR ROBATEL TECHNOLOGIES, LLC QUALITY ASSURANCE PROGRAM DESCRIPTION (QAPD) 0952
Document Control Desk, Director,
In accordance with requirement 10 CFR 71.106, please find attached a revision of Robatel Technologies, LLC current QAPD, Revision 4, dated 11 August 2021. Please be advised that the revisions that have been made since the previous submission of Revision 2 on 30 August, 2019, do not reduce Robatel Technologies, LLC quality assurance commitments to 10 CFR Part 71, Subpart H.
If you need additional documentation or have any questions regarding this submission or Robatel Technologies, LLC quality assurance program, please contact myself at 540-989-2878 or jbower@robateltech.com or Charlie Campbell, Quality Assurance Manager at 803-507-0277 or ccampbell@robateltech.com.
Sincerely,
Digitally signed by Jared Bower
',4 &-. __,_.,,.,oate:2021.oa.1115:36:16
-04'00'
Jared Bower Chief Executive Officer Robatel Technologies, LLC
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ROBATEL TECHNOLOGIES, LLC
5115 Bernard Dr, Suite 304 Roanoke, VA 24018
QUALITY ASSURANCE PROGRAM DESCRIPTION 10 CFR 71 Subpart H for
Packaging and Transportation
- of Radioactive Material
Revision 4
Digitally signed by Charlie Campbell Date: 2021.08.12 01:57:12 12 Aug 2021 Approvals: -04'00' Date: -----
Charlie Campbell Acting QA Manager
, A ~ Digitally signed by Jared Bower A *Date: 2021.08.12 08:05:03 ' "'04'00' 12 Aug 2021 Approvals: Date: -----
Jared Bower Chief Executive Officer (CEO)
Quality Assurance Program Description (QAPD)
REVISIONS
Rev. Date Comments 0 January Original Release 15,2012 1 November Changed cover page: deleted Teo Grochowski, Jr. as Chief 20,2014 Operations Officer replaced with Christopher Dane; updated address; replaced loao 2 September Made various clerical updates, changed Christopher Dane to 1,2017 Dominique Sanchette 3 February Section Revision 27, 2020 0.0 Specified RT and Robatel wherever appearing in this document represent Robatel Technologies, LLC 0.0 Clarify the following: RT is approved to conduct 1 O CFR Part 71 activities in accordance with this QAPD. The Nuclear Regulatory Commission..
(NRC) issued an approval letter on March 21, '
2012.
1.0 Specified Quality Assurance Program Document (QAPD) 2.0 Correct typos Added sianature authoritv for the CEO 3.0 Clarified evaluation of Quality Level suppliers 4.0 Corrects typos and errors 7.0 Clarification of statements 15.0 Clarify notification to affected organizations 18.0 Clarified annual audit ATTACHMENT Add QP-02-02 A Obsoleted QP-02-03 Added QP-03-04 Added QP-04-02 Added QP-04-03 Page 16 Deleted... For Information Only...
Deleted... QA Program Implementing Procedures (continued)
Page 16 Added QP-07-03 Page 17 Deleted... For Information Only...
Deleted... QA Program Implementing Procedures (continued)
Page 18 Deleted... For Information Only...
Deleted... QA Program Implementing Procedures (continued)
Paae 18 Added QP-15-03 Page 18 Deleted... For Information Only...
Deleted... QA Program Implementing Procedures (continued)
Added QP-08-04
QAPD Rev. 4 Page 2 of 17 Date: 08/11/2021
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4 11 Aug 3.0, Page 5 Inserted "A" to identify Quality Level 2021 4.0, Page 6 Corrected Typo 6.0, Page 7 Corrected Typo 7.0, Page 7 Clarified comment regarding approval of suppliers 18.0, Paae 11 Defined Quality Level A suooliers
QAPD Rev. 4 Page 3 of 17 Date: 08/11/2021 Quality Assurance Program Description (QAPD)
TABLE OF CONTENTS
0.0 INTRODUCTION
................................................................................................................................. 5
1.0 ORGANIZATION................................................................................................................................. 5
2.0 QUALITY ASSURANCE PROGRAM...................................................................................................... 6
3.0 DESIGN CONTROL............................................................................................................................. 6
4.0 PROCUREMENT DOCUMENT CONTROL.......................................................... :................................. 7
5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS............................................................................... 7
6.0 DOCUMENT CONTROL...................................................................................................................... 8
7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES................................................. 8
8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS................................ 9
9.0 CONTROL OF SPECIAL PROCESSES.................................................................................................... 9
10.0 INTERNAL INSPECTION...................................................................................................................... 9
11.0 TEST CONTROL................................................................................................................................ 10
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT........................................................................ 10
13.0 HANDLING, STORAGE, AND SHIPPING CONTROL........................................................................... 10
14.0 INSPECTION, TEST, AND OPERATING STATUS................................................................................. 10
15.0 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS.......................................................... 10
16.0 CORRECTIVE ACTION....................................................................................................................... 11
17.0 QUALITY ASSURANCE RECORDS...................................................................................................... 11
18.0 AUDITS............................................................................................................................................ 12
ATTACHMENT A, QA PROGRAM IMPLEMENTING PROCEDURES............................................................... 13
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0.0 INTRODUCTION
Robatel Technologies, LLC (RT or Robatel) 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 Robatel Quality Assurance Program Description (QAPD) has been generated to specifically establish the QA requirements to meet Subpart Hof 10 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.
RT is approved to conduct 1 O CFR Part 71 activities in accordance with this QAPD. The NuGlear Regulatory Commission (NRC) issued an approval letter on March 21, 2012. This Qqality 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 quality organizational structure, functional responsibilities, levels of authority, and lines of communication for activities affecting quality are defined within this Quality Assurance Program Document (QAPD) and implementing documents.
The responsibilities and authorities are presented in the RT QA 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 Officer has full authority over company functions and may delegate authority and responsibility for selected functions to other personnel or organizations. The CEO has signatory authority for the employees and may perform duties in case of absences or vacancies of positions.
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.
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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, contr,;3ctual, and/or technical requirements in accordance with controlled documents.
2.0 QUALITY ASSURANCE PROGRAM
Robatel Technologies, LLC (RT) has a hierarchy of documents used to implement the total quality system. The hierarchy includes the QAPD followed by the Quality Assurance Program Quality Procedures and quality forms 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 '.'I I transportation of radioactive material.
Together, the Robatel 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 organization shall establish and implement processes to detect and correct quality problems:*
3.0 DESIGN CONTROL
Robatel Technologies, LLC 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 Technologies, LLC may subcontract design and fabrication activities to approved suppliers. In all cases of Level A procurement, the supplier performing the work shall have an acceptable quality program to meet the required criteria of 10 CFR 71 Subpart H. Acceptability will be determined by QA audit for Quality Level A suppliers and subsequently, the supplier placed on the RT Approved Supplier List (ASL). Method and extent of evaluation of Quality Level B suppliers is determined at the time of procurement. Subsequently, RT shall verify that design activities are conducted in accordance with the RT-approved QA Program for that specific supplier.
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4.0 PROCUREMENT DOCUMENT CONTROL
Procurement activities are performed in accordance with approved *procedures that implement the applicable requirements defined in the 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 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 (e.g.10 CFR 21).
- 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 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.
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
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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 Technologies, LLC controls preparation, issue, and change of documents that specify I 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 does not perform manufacturing processes itself; instead, RT utilizes selected manufacturers who are approved, and placed on the approved suppliers list (ASL), before the order is placed.
In special cases, RT may place an order prior to audit and approval of a supplier; however, RT will approve such supplier prior to work 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.
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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
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 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 Robatel 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 Technologies. Implementation of the supervising steps is
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documented in the preliminary checking documents and, insofar as necessary, in the corresponding records.
11.0 TEST CONTROL
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
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 shall establish measures to control the handling, storage, shipping, cleaning, and preservation of materials/equipment to be used in packaging. Specific instructions must be 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).
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
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(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 and/or 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 nonconforming condition/item is identified it is documented on Nonconformance Report (NCR) 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.
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 actions 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 corrective action requirements have been completed and are effective.
17.0 QUALITY ASSURANCE RECORDS
The control of Quality Assurance records shall be established by Robatel 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.
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18.0AUDITS
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 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 RTQAP shall be audited at a minimum of annually. Audits of Quality Level A 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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ATTACHMENT A, QA PROGRAM IMPLEMENTING PROCEDURES (For Information Only)
Implementing Title Regulatory Document(s) From 10 CFR 71 Position Description Subpart H
Quality Assurance §71.103 1 Responsibilities for the establishment and Program (QAP), Quality implementation of the quality assurance QAP, Section 1 Assurance program are defined. The organization functional responsibilities, levels Organization charts Organization structure, of authority, and lines of communications for activities affecting quality are documented. The organization chart provides an outline of the organizational structure.
QAP, Section 2 §71.105 2 Describes how the quality assurance QP 02-01 Quality program is planned, implemented, and QP 02-02 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.
QAP, Section 3 §71.107 3 Design inputs are specified and translated QP 03-01 Package into design documents. Design interfaces and controlled. Individuals QP 03-02 Design are identified than those who designed the item or QP 03-03 Control other design adequacy.
QP 03-04 computer program verify Design changes are governed by control measures commensurate with those aoolied to the oriqinal desiqn.
QAP, Section 4 §71.109 4 Applicable design bases and other QP 04-01 Procurement requirements necessary to assure QP 04-02 Document adequate quality are included or referenced and QP 04-03 Control in documents for procurement of items 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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ATTACHMENT A (continued)
Implementing Title Regulatory From 10 CFR 71 Description Document(s) Subpart H Position
OAP, 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 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 acceptable results.
QAP, Section 6 §71.113 6 The preparation, issue, and change of QP 06-01 Document documents that specify quality Control 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.
QAP, Section 7 §71.115 7 The procurement of items and services are QP 07-01 Control of controlled to ensure conformance with requirements. Such control shall QP 07-02 Purchased specified for the following as appropriate:
QP 07-03 Material, provide evaluation Equipment, and source evaluation and selection, Services of objective evidence of quality furnished by the Supplier, source inspection, audit, and examination of items or services upon deliverv or comoletion.
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@ RCJBATEL technologies Quality Assurance Program Description (QAPD)
ATTACHMENT A (continued)
Implementing Title Regulatory From 10 CFR 71 Description Document(s) Subpart H Position QAP, Section 8 §71.117 8 Controls are established to assure that only QP 08-01 Identification correct and accepted items are used or and Control of installed. Identification is maintained on Materials, the items or in documents traceable to the Parts,and items, or in a manner that assures that Components identification is established and maintained.
QAP, Section 9 §71.119 9 Special processes that control or verify QP 09-01 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 soecified reauirements.
QAP, Section 1 0 §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 acceotance.
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
- I I 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.
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ATTACHMENT A (continued)
Implementing Title Regulatory From 10 CFR 71 Description Document(s) Subpart H Position 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 Equipment maintained to required accuracy limits.
QAP, Section 13 §71.127 13 Handling, storage, cleaning, packaging, QP 13-01 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 conductinq the activitv.
QAP, Section 14 §71.129 14 The status of inspection and test activities QP 14-01 Inspection, are identified either on the items or in Test, and documents traceable to the items where it Operating is necessary to ensure that required Status 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.
QAP, Section 15 §71.131 15 Items that do not conform to specified QP 15-01 Non-Conforming requirements are controlled to prevent QP 15-02 Materials, inadvertent installation or use. Controls QP 15-03 Parts, or shall provide for identification, Components documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected orqanizations.
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Quality Assurance Program Description (QAPD)
ATTACHMENT A (continued)
Implementing Title Regulatory From 10 CFR 71 Description Document(s) Subpart H Position QAP, Section 16 §71.133 16 Conditions adverse to quality are identified QP 16-01 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.
QAP, Section 17 §71.135 17 The control of quality assurance records is QP 17-01 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.
QAP, Section 18 §71.137 18 Audits are performed to verify compliance QP 18-01 Audits to quality assurance program requirements, QP 18-02 to verify that performance criteria are met, QP 18-03 and to determine the effectiveness of the QP 08-04 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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