ML20210P193
| ML20210P193 | |
| Person / Time | |
|---|---|
| Site: | 07100512 |
| Issue date: | 03/27/1986 |
| From: | Anderson C, Hamilton G, Manion W NUCLEAR ENERGY SERVICES, INC. |
| To: | |
| Shared Package | |
| ML20210P190 | List: |
| References | |
| 26866, 80A9086, NUDOCS 8605130119 | |
| Download: ML20210P193 (100) | |
Text
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Nuclear Energy Services Shelter Rock Road l
Danbury, Connecticut 06810 (203) 796-5000 This Manual is the property of Nuclear Energy Services. Reproduction or use of this Manual or parts thereof outside of Nuclear Energy Services is prohibited without'the expressed authorization of the NES Quailty Assurance Manager.
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STATEMENT OF POLICY This Quality Assurance Manual defines the Quality Assurance Program implemented by Nuclear Energy Services in performing activities described in this Manual. Each NES employee is responsible to perform work in strict accordance with the requirements of this Quality Assurance Program.
The Quality Assurance Program is in compliance with Title 10 of the Code of Federal Regulations, Part 50, Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants"; ANSI /ASME Standard N45.2," Quality Assurance Program Requirements for Nuclear Facilities"; and ANSI /ASME NQA-1, " Quality Assurance Program Requirements for Nuclear Power Plants."
This program is applicable to the design, procurement, manufacture, inspection, testing, installation and inservice inspection of nuclear components, including the furnishing of inservice inspection, consulting engineering and quality assurance v
services associated therewith.
Specific implementing Quality Assurance Program Plans and administrative procedures assist in implementing this Manual.
The responsibility for verification that this Quality Assurance Program is being properly implemented rests with the Quality Assurance Manager.
s Williad J. Manion, President Nuclear Energy Services
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SCOPE OF MANUAL Nuclear Energy Services performs the following safety-related work using the Quality Assurance Program described in this Quality Assurance Manual:
1.
Inservice inspection including preservice inspection and inservice testing.
2.
Engineering services including design of permanent and temporary plant equipment, systems and structures.
3.
Plant modification, maintenance, and installation activities, including those involving special processes.
4.
Quality Assurance services, including nondestructive testing, inspection, auditing, and training and certification of inspection personnel.
3.
Waste Management activities including radioactive waste cleanup, transportation and disposal activities.
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. oV Document 80A9086 Table of Contents Page1 of1 TABLE OF CONTENTS Section Title
_R ev.
Date SP Statement of Policy N/A N/A SM Scope of Manual 0
4/1/86 1.
Organization 0
4/1/86 2.
Quality Assurance Program 0
4/1/86 3.
Design Control 0
4/1/86 4.
Procurement Document Control 0
4/1/86 5.
Instructions, Procedures and Drawings 0
4/1/86 6.
Document Control 0
4/1/86 (O>
7.
Control of Purchased Material, Equipment and Services 0
4/1/86 8.
Identification of Materials, Parts and Components 0
4/1/86 9.
Control of Special Processes 0
4/1/86 10.
Inspection 0
4/1/86 11.
Test Control 0
4/1/86 12.
Control of Measuring and Test Equipment 0
4/1/86 13.
Handling, Storage and Shipping 0
4/1/86 14.
Inspection, Test, and Operating Status 0
4/1/86 15.
Nonconforming items 0
4/1/86 16.
Corrective Action 0
4/1/86 17.
Quality Assurance Records 0
4/1/86 18.
Audits 0
4/1/86 I
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Section i Page 1 of 6
- 1. ORGANIZATION 1.1 SCOPE This section describes the NES organization and the responsibility of personnel performing activities affecting quality.
Where responsibilities are assigned, sufficient authority is provided to assure satisfactory accomplishment of the assignment.
1.2 ORGANIZATION STRUCTURE The organization of NES is presented in the organization charts, Appendices A.1 n
and A.2.
NES is organized to support service line management.
Services include engineered products, engineering services, quality assurance services, inspection services, waste management, staff augmentation services, and plant betterment.
Overall administrative responsibility for each project is assigned to a Project Manager. Technical responsibility for each project is assigned to Task Engineers and/or Site Supervisors. Department and Group Managers are responsible to provide overall technical direction to project personnel. These personnel report through various administrative management positions as shown in the appendices to a Service Line General Manager.
Senior management is responsible for all subordinate activities affecting quality.
This in no way relieves subordinate personnel of assigned quality assurance functions.
All personnel performing activities affecting quality have direct access to such levels of management as may be necessary to perform the assigned functions.
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Section 1 Page 2 of 6 Quality Assurance activities within NES are the responsibility of the Quality Assurance Manager, who reports directly to the President. Quality Assurance personnel have sufficient authority and organizational freedom to identify quality problems, to initiate, recommend or provide solutions, to verify the implementation of solutions, and to control further processing of nonconforming items or unsatisfactory conditions until proper actions are accomplished.
When major problems or differences of opinion on quality matters cannot be resolved within the line organizations, these proidems are brought to the attention of the President for final resolution. Such resolutions meet client, code or regulatory requirements.
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1.3 ORGANIZATION RESPONSIBILITIES 1.3.1 President of NES The President is responsible for maintaining the overall organizational structure necessary for an effective Quality Assurance Program and for establishing NES quality policy through approval of this Quality Assurance Manual.
1.3.2 Quality Assurance Manager The Quali.ty Assurance Manager is responsible for the formulation, implementation, effectiveness and maintenance of the Quality Assurance Program in part through approval of this Quality Assurance Manual. He regularly reviews the status and adequacy of the Program through audits and through annual evaluations of QA Program effectiveness with senior management. The Quality Assurance Manager, or his representative, hc.s (a
the authority to stop work when indicated by significant quality problems.
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Document 30A9086 Section 1 Page 3 of 6 The Quality Assurance Manager exercises this authority through issue of a formal stop work order to responsible line or senior management, who upon receipt of the order, formally stop work activities within the scope of the order.
Reporting to the same level of management as other senior management personnel responsible for NES service lines, the Quality Assurance Manager has direct access to responsible management where appropriate action can be taken. The Quality Assurance Manager is sufficiently independent of the pressures of cost and schedule to assure proper implementation of the Quality Assurance Program. He is responsible to assure that verification Q
of conformance to established requirements is accomplished by individuals kJ and groups within the QA organization who do not have direct responsibility for performing the work being verified. Alternatively, such verification is performed by individuals or groups trained and qualified in QA concepts and practices and independent of the organization responsible for performing the work. Responsible for document control activities, the l
Quality Assurance Manager formally delegates his authority and responsibility for audits of document control to one of his subordinates to assure independence of this audit activity.
1.3.3 Executive Vice President; Service Line Vice Presidents These indiv,iduals are responsible for projects within their organizations and provide adequate resources of personnel to manage and implement support activities.
l 1.3.4 General Manager: Group Manager; Deprtment Manager: Technical n
Director U
These individuals are responsible for management of service line activities, for overall contract management of these activities in conformance with
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Document 30A9036 Section 1 Page 4 of 6 requirements of this Quality Assurance Manual, for schedular, technical and budgetary performance within their service line. As applicable they approve Quality Assurance Program Plans.
They provide adequate resources in terms of personnel to manage and implement support activities.
1.3.5 Project Manager The Project Manager is directly responsible for planning, controlling and coordinating work associated with the assigned project.
The Project Manager is the liaison between the customer and NES. He is the sole authority for making or modifying project commitments to the customer and is the focal point for Quality Assurance and internal support functions required for the assigned project.
The Project Manager prepares required project Quality Assurance Program Plans. He prepares and maintains project schedules and provides comprehensive project status and progress reports to NES management to assure a full response to customer requirements.
1.3.6 Task Engineer The Task Engineer is responsible to the Project Manager for satisfactory accomplishment of the project task workscope. He is directly responsible to the applicable service line ur department manager for performance of this work. The Task Engineer keeps the Project Manager and Department Manager informed as to the status of task performance.
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Document 80A9086 Section 1 Page 5 of 6 1.3.7 Site Supervisor The Site Supervisor receives technical and administrative support from, and reports to, the Project Manager or Department Manager.
Alternatively, the Project Manager is located at the jobsite and serves as the Site Supervisor.
The Site Supervisor is responsible for the day-to-day operation of site activities in accordance with the quality standards set forth in this Manual.
He directs site personnel in the performance of their duties and verifies the proper performance of quality related functions.
V 1.3.8 Document Control Supervisor The Document Control Supervisor is responsible for the release and
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distribution of work controlling documents in accordance with document control procedures to assure that they are of the latest approved revision and to assure that the documents are available for distribution to the point of use.
He is also responsible for the co!!ection, storage and maintenance of quality assurance records retained by NES.
1.3.9 Purchasing Manager t
Administrative control of purchases is provided by the Purchasing Manager.
Technical and quality requirements of the purchase are established and approved by responsible NES personnel. The Purchasing Manager provides V
data on available sources of supply and keeps current on available products.
The Purchasing Manager places safety related orders only with those vendors qualified for supply of such items or services.
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V Document 30A9036 Section 1 Page 6 of 6 1.4 DELEGATION The performance of an activity assigned by this Manual may be delegated by the responsible individual to any qualified person; however, the responsibility for that activity remains as described in this Manual.
1.5 RESPONSIBILITY MATRIX Appendix B lists a summary of primary responsibilities for the preparation and approval of quality documentation.
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Document 30A9036 Section 2 Page 1of5
- 2. QUALITY ASSURANCE PROGRAM 2.1 SCOPE This section describes the method by which NES establishes for each project a documented Quality Assurance (QA) Program meeting the requirements of 10CFR50, Appendix B, ANSI N45.2 and NQA-1.
2.2 GENERAL REQUIREMENTS This Manual establishes a basic Quality Assurance Program for NES and upon p
which NES builds a Quality Assurance Program unique to each project. The i
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Quality Assurance Manager and Service Line Management participate early in the QA Program definition stage of the project to determine and identify the extent to which Quality Assurance controls are to be applied to work activities.
The Quality Assurance Program is controlled and documented by written policies, procedures and instructions and is carried out for the life of the contract.
The Quality Assurance Program provides adequate control over activities affecting the quality of items and services to an extent consistent with their importance to safety, reliability and performance. Activities affecting quality are performed under controlled conditions and where necessary to achieve quality objectives, the use of special equipment, environmental conditions, skills or processes are provided. Personnel assigned to the project are indoctrinated and trained as necessary to achieve and maintain suitable job proficiency.
During the performance of the work the status and adequacy of the program are regularly assessed. Upon completion of the project and acceptance of the work p
by the customer, designated quality assurance records generated during V
performance of the project are made available to the customer or retained by NES, as required, as evidence of the quality of the work.
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Section 2 Page 2 of 5 2.3 SPECIFIC REQUIREMENTS 2.3.1 Project Scope NES projects are implemented through direction provided by a specific, written Quality Assurance Program Plan, this Quality Assurance Manual and implementing procedures.
Alternatively, NES may perform work entirely under the control of the customer's Quality Assurance Program.
2.3.2 Quality Assurance Program Plan Where a Quality Assurance Program Plan (QAPP) is required for a project, the Project Manager prepares and obtains approval of a QAPP in
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accordance with NES Procedure 80A9031, Procedure for the Preparation of Quality Assurance Program Plans. The QAPP includes specific details that are not included in this Manual and any contractual Quality Assurance requirements that are unique to the project.
A typical Quality Assurance Program Plan addresses the following topics:
1.
Project-unique Quality Assurance requirements, including exceptions and additions to existing quality procedures.
2.
Communication guidelines including required customer approvals for i
home office and field initiated changes.
3.
Design criteria and design bases, as applicable.
4.
Document distribution requirements, including identification of special document requirements.
oV Document 30A9086 Section 2 Page 3 of 5 5.
Identification of any mandatory inspection or hold points.
6.
A list of documents or categories of documents that are considered records for a particular project and a designation of those records to be stored by NES, those records to be turned over to the customer, and the retention period for those records maintained by NES.
7.
Specific project audit schedule (a calendar schedule may be issued separately).
3.
Identification of key project management personnel, normally the
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f Project Manager and authorized customer representative.
iL The project QAPP is issued as soon after project initiation as feasible. The specific target date for issuance on each project is estab!!shed by the NES Project Manager.
2.3.2 -!uality Assurance Im, amenting Procedures Procedures are prepared as required by this Manual to implement the Quality Assurance requirements.
Procedures are prepared by qualified individuals with expertise in the area of procedure content and in accordance with the format established in NES Procedure 80A9024, S'pecificatio'n Format for Preparing Quality Assurance Procedures. Quality Assurance implementing procedures are reviewed and approved as required by the Responsibility Matrix of Appendix B.
2.3.4 QA Program Assessment by Company Management Company Management annually reviews / assesses the status and adequacy of the QA Program. This review / assessment is the responsibility of a team
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Document 30A9086 Section 2 Page 4 of 5 appointed by the President that does not include the Quality Assurance Manager, although the President may ask that the Quality Assurance Manager act in an advisory capacity. The review is conducted through the use of Audit Finding Reports, Audit Summary Reports, trend analyses, review of documentation, interviews, etc.
The review / assessment determines required corrective action and provides direction for upgrading the Quality Assurance Program to meet changing conditions and requirements. The results of these assessment actions are reviewed by the team with the President and the Quality Assurance Manager.
2.4 INDOCTRINATION AND TRAINING pN) 2.4.1 Quality Assurance Personnel Personnel performing Quality Assurance and Quality Control functions are trained, qualified and certified in accordance with written implementing procedures. Quality Assurance personnel include those performing audits, inspections or quality assurance reviews of procedures or documents under the direction of the Quality Assurance Manager. The Quality Assurance Manager may delegate the performance of certain Quality Assurance / Quality Control functions to personnel with service line organizations, such as inspection services or quality assurance services organizations, including the training, qualification and certification of individuals within the organization.
Such activities are described in implementing procedures approved by the Quality Assurance Marager. The activities are subject to audit by the Quality Assurance Manager.
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Document 30A9086 Section 2 Page 5of5 i
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2.4.2 General Indoctrination and Training l
Personnel whose duties affect quality of nuclear power p! ants have adequate qualifications to assure satisfactory performance of their '
assigned tasks.
Service line personnel whose activities affect quality participate in indoctrination and training programs to become farniliar with the purpose and intent of regulations, codes, standards, procedures and this Manual. These programs familiarize personnel with the Quality Assurance function as it relates to their work and its application at NES.
The Quality Assurance Manager is responsible for the scheduling and content of the training, alfhough the actual instruction may be. presented by others. Participation will be documented with a record of the date, objective, material covere'd, attendees and examination results, when applicable.
2.4.3 Personnel Certification Personnel requiring certification prior to performing quality functions are certified as meeting the requirements of the applicable personnel qualification procedure, such as for auditing, nondestructive examination or inspection.
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- 3. DESIGN CONTROL 3.1 SCOPE This section describes the measures in effect to assure that applicable design requirements, such as design bases, regulatory requirements, codes and standards are correctly translated into specifications, drawings, procedures or instructions in a manner to assure the quality of the design activity.
NES performs design of permanent plant components, systems, and structures, measuring, test and examination equipment including fixtures and calibration blocks; and other safety-related but non-permanent items. NES also performs
[V engineering analyses of safety-related and important-to-safety items and services.
3.2 GENL. SAL REQUIREMdNTS 3.2.1 Design Control Planning Planning of the project design activities is performed by the Project Manager and Department Managers, as applicable.
Project design control is provided in accordance with NES Procedure i
80A9029,' Project Control Procedure, NES Procedure 80A9092, ISI Engineering Log Book Control Procedure, NES Procedure 80A9093, Program Plan Preparation Procedure or other applicable procedure.
Design control measures are applied to the following items as applicable:
1.
Engineering analyses (e.g., nuclear, structural, thermal - hydraulic) 2.
Compatibility of materials
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L Document 30A9036 Section 3 Page 2 of 10 3.
Accessibility for inspection, maintenance and repair.
4.
Associated computer codes.
5.
Delineation of acceptance criteria for inspections, examinations and tests.
3.2.2 Design Documents The Project Manager defines the design documents (e.g.,
- reports, procedures, drawings, specifications) to bcprepared for the project.
The designated Task Engineers are responsible for preparing these m
documents.
Project design documents are listed on the project Master Document List.'
Approval of project design documents is in accordance with the approval matrix shown in Appendix B of this Manual.
Project design documents that become work controlling documebts (specifications, procedures and drawings) are controlled as outlined in Section 6 of this Manual.
3.2.3 Engineering Analyses and Verification Engineering analyses are performed using hand and/or computer calculation methods. All calculations are checked by an independent and qualified reviewer, although the reviewer may be from the same organization that :
performed the original analyses. The verification activity consists of, as a n
- minimum, review of the
- design,
' spot-checking of U
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(Q Document 30A9086 Section 3 Page 3 of 10 the calculations or analyses, and assessing the results against design objectives. The depth and extent of the verification activity is dependent on the scope, complexity and importance to safety of the design. Where tests are used as a verification method, test controls of Sectipn 11 of this Manual apply.
Where engineering analysis consists of exercise of prudent engineering judgment, key decisions are appropriately documented.
Design analysis calculations and key engineering decisions are documented
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under the responsibility of the Task Engineer.
3.2.4 Design Interface In the event that design interfaces exist either within NES or between NES and others, design coordination activities and interface controls are established in a Quality Assurance Program Plan. The Plan establishes procedures for the review, approval, release, distribution, and revision of documents involving design interfaces and for design review meetings.
3.2.5 Design Errors Errors dis' covered in approved design documents or methods (such as in computer codes) are suitably evaluated and documented, and actions are taken to assure that the design is not adversely impacted. Appropriate action is taken to correct design deficiencies so identified.
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Document 80A9086 Section 3 Page 4 of 10 3.3 SPECIFIC REQUIREMENTS 3.3.1 Permanent Plant Components, Systems and Structures 3.3.1.1 Design Criteria Design criteria are prepared by the Task Engineer and are incorporated in the Quality Assurance Program Plan. If issued as a separate project document, such as a formal design specification, the design criteria are reviewed and approved by the Project Manager, applicable Department Manager and the Quality Assurance Manager.
The design criteria include such items as design bases and regulatory requirements specified by the
- customer, performance objectives, functional requirements, material requirements, environmental and interface requirements, and quality requirements, as applicable,.
3.3.1.2 Engineering Analysis Engineering analysis is documented in calculation notebooks or
'in engineering log books.
1.
Calculation Notebooks - When notebooks are used to document engineering analysis, all calculations are entered therein. One or more calculation notebooks may
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Document 30A9036 Section 3 Page 5 of 10 and maintained in accordance with NES Procedure 30A9004, Calculation Notebook Procedure.
Design or analysis calculations are checked and verified as described in paragraph 3.2.3.
The project calculation notebooks are maintained by the Task Engineer until the project is formally closed out, at which time he sends the notebooks to the Project Manager for incorporation into the project close-out file.
2.
Engineering Log Books - When engineering log books are gU used to document engineering analysis, design calculation and key engineering decisions that affect the final design or design document are recorded therein in accordance with NES Procedure 30A9092, ISI Engineering Log Book Control Procedure.
Design or analysis calculations are checked and verified as described in Paragraph 3.2.3.
The engineering log books are prepared by the Task Engineer and reviewed and approved for administrative compliance by the Project Manager upon completion of the task or project.
3.3.1.3 Computer Codes
,q Computer codes used in the design process are verified prior to
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issuance of the design report.
Code verification (including reverification following code modification) is performed in
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Document 30A9036 Section 3 Page 6 of 10 accordance with NES Procedure 30A9010, Computer Code Documentation Control Procedure.
i 3.3.1.4 Design Review Project design reviews are held to evaluate the progress or results of design activities in engineering services activities, to assure that all aspects of the design have been properly considered, and to assure coordination among the responsible designers, Quality Assurance and the fabricator, if applicable.
These reviews are planned and documented in accordance with Ca~N j
NES Procedure 30A9029, Project Control Procedure or the following:
1.
The Project Manager specifies the number of internal design review meetings to be held for each formal design project in the project QAPP. There are three types of design review meetings as outlined below from which the Project Manager chooses dependent on the scope of the design activity.
A.
Design Initiation Meeting The objective of this meeting is to review in detail the design
- basis, objectives, functional requirements, proposed design, client requirements and interfaces, inputs, and overall design criteria.
This meeting assures that key NES personnel are Im) familiar with project scope and requirements.
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Mid-Design Meeting The objective of this meeting is to review design progress and to identify and resolve design problems.
C.
Final Design Meeting The objective of this meeting is to review the final design for compliance with customer requirements and project design criteria, and to discuss fabrication plans.
The Project Manager is responsible for calling and chairing the meetings and issuing the minutes which contain commitments and clearly defined due dates.
3.3.1.5 Inspections and Tests Necessary tests or inspections required to prove the design adequacy are performed in accordance with Sections 10 and 11 of this Manual.
3.3.2 Measuring and Test Equipment Design l
3.3.2.1 Calibration Blocks Design Calibration blocks are subject to design controls as described below:
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Design Criteria Criteria for calibration block design are identified in an engineering log book controlled in accordance with 3.3.1.2.2 above.
2.
Engineering Analysis Engineering analyses are docu.T.:nted by the use of an engineering tog book controlled in accordance with 3.3.1.2.2 above.
3.
Design Review Formal design review meetings are not required for calibration block design activities. The design review is accomplished through verification of engineering log books as specified in 3.2.3 and 3.3.1.2.2 above.
3.3.2.2 Other Measuring and Test Equipment Design Design control measures applied to development of measuring and test equipment are affected by provision of a suitable
' design specification (s) and through formal testing of completed equipment in accordance with Section 11 of this Manual.
Testing includes satisfying calibration requirements per the provisions of Section 11 of this Manual. Other design control provisions are not applicable.
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Document 30A9036 Section 3 Page 9 of 10 1.
Design Specification A design specification is prepared by the Task Engineer and approved by the Project Manager and Department Manager.
The design specification identifies essential parameters of the specified equipment, including those which must be demonstrated by functional testing.
2.
Test Procedure A formal test procedure is prepared by the Task Engineer and approved by the Project Manager, Department (g
Manager and Quality Assurance Manager prior to f.
functional testing of the equipment and in accordance with Section 11 of this Manual.
The test procedure includes, directly or by reference, such functional test requirements and acceptance criteria as are necessary to demonstrate that the equipment meets all criteria identified in the design specification, I
and applicable requirements for calibration of the equipment.
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Test Report The results of the functional test of the equipment are documented by the Task Engineer and approved by the Project Manager, applicable Department Manager and the Quality Assurance Manager.
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s Document 30A9086 Section 3 Page 10 of 10 3.3.3 Design Changes Changes to approved design criteria, reference parameters, design methods, models, material property data or assumptions are documented and justified in the appropriate design calculation notebook or engineering log book by the Task Engineer and approved by the General Manager or Department Manager and/or the Project Manager, as applicable.
Changes to approved final design documents under the control of the Document Control system are subject to the same controls as the original document. Revisions to final design documents are' initiated and processed as described in Section 6 of this Manual.
3.3.4 Records The Project Manager retains design documents for completed projects in accordance with customer requirements and applicable QAPPs.
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Section 4 Page 1 of 6
- 4. PROCUREMENT DOCUMENT CONTROL 4.1 SCOPE This section defines responsibilities and sets forth the measures that are followed to ensure that the necessary quality requirements are included or referenced in documents used to procure materials, equipment, and services.
The procedures outlined herein are applicable to procurement of materials, equipment, and services that can affect quality of the final product. Three categories of procurement are established:
O Category 1 - Items or services of a complex or critical'hature affecting nuclear plant safety where quality assurance program implementation is required.
Category 2 - Items or services of a commercial grade or of a simple nature affecting nuclear plant safety but where normal commercial practice provides adequate quality without imposition of quality assurance program requirements.
Category 3 - Other items and services, including non-safety items and services.
4.2 GENERAL REQUIREMENTS Procurement activities are performed in accordance with the NES Procedure 80A9007, Procurement Control.
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HEL4 O(d Document 30A9036 Section 4 Page 2 of 6 4.2.1 Procurement Documents The following documents are used in the process of procuring materials, equipment, or services, and are reviewed and approved as denoted in the Responsibility Matrix (Appendix B):
1.
Purchase Requisition The Purchase Requisition lists requirements necessary to prepare a Purchase Order, including technical reference and applicable revisions; it may also list recommended or preferred vendors. The
(~S originator of the Purchase Requisition is responsible for obtaining V
approvals.
2.
Request for Proposal (RFP)
The Request for Proposal contains an adequate description of the items, including (by statement or reference) the latest revision of all applicable drawings and specifications, other quality assurance requirements as stated in paragraph 7.3.2, and any other information necessary for potential vendors to evaluate the RFP with respect to price, delivery and technical content.
3.
Purchhse Order (PO)
The Purchase Order represents the final document that places the order with the selected vendor according to information as specified on the Purchase Requisition. Purchase Orders are placed by the Purchasing Manager with only those vendors appearing on the v
Approved Vendor List for Category 1 items or services, or with other vendors for Category 2 and 3 procurements.
pu Document 30A9036 Section 4 Page 3 of 6 4.2.2 Contents of Purchase Order Dependent on the requirements of the item or service being purchased, the Purchase Orders contain the following:
1.
An adequate description of the items ordered including reference to the applicable drawings and/or specifications.
2.
Copies of the applicable revisions of applicable drawings and/or specifications.
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3.
Copies of the applicable revisions of applicable Quality Assurance specifications or requirements for vendor QA Program implementation.
4.
Requirements for the selected vendor to impose the NES Quality Assurance requirements on sub-tier vendors.
5.
Requirements for NES and client access to the vendor's facility for surveillance and/or inspection for Category 1 and 2 procurements.
6.
For Category 1 procurements, requirements for Quality Assurance Program evaluation, inspection and where specified, approval by NES.
7.
As applicable, provisions that evaluation audits by NES do not constitute acceptance nor in any way relieve the vendor of his contractual obligation or responsibility to furnish end products that meet all contractual requirements.
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Section 4 Page 4 of 6 8.
A definition of the records to be prepared, maintained, submitted or made available for review and approval.
9.
Instructions on record retention and disposition.
10.
For Category I and 2 procurements, requirements for submittal of certifications and/or test and inspection records prior to or with delivery of the item (s) or service.
11.
Requirements for reporting of defects and noncompliances per 10CFR21, as applicable.
O 4.2.3 Purchase Order Changes Changes to the Purchase Order are processed in the same manner as the original Purchase Order.
4.2.4 Procurement Records Purchase Order records are maintained by the Purchasing Manager.
4.3 SPECIFIC REQUIREMENTS Procurement doc'ument requirements for the defined procurement categories are specified in the following subsections.
4.3.1 Category 1 -Items and Services Affecting Nuclear Power Plant Safety Category 1 purchases are defined as those of a critical or complex nature that affect plant safety.
Category 1 items and services are defined
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Document 80A9086 s yi Section 4 Page 5 of 6 in NES Procedure 80A9007, Procurement Control.
Category I
requirements include:
1.
Preparation of a formal procurement specification detailing the quality and technical requirements, and referencing applicable drawings, documents, etc.
2.
Preparation of a Purchase Requisition and approval by the Project Manager or Department Manager.
3.
Preparation of a Purchase Order (or Request for Proposal when deemed necessary) containing a transcription of technical and quality
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requirements from the approved Purchase Recuisition.
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Placement of the Purchase Order only with vendors on the Approved Vendor List developed in accordance with Section 7 of this Manual.
5.
Approval of the Purchase Order by the Quality Assurance Manager for compliance with quality requirements, prior to release of the order.
4.3.2 Category 2 - Items and Services Requiring Vendor Certifications Category 2 items and services are defined as those items where quality attributes can be satisfied by material or other certifications provided by the vendor. Category 2 requirements include:
1.
Definition of procurement requirements, including the necessary certifications in the Purchase Requisition and subsequently in the (m
Purchase Order.
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Document 30A9036 Section 4 A
Page 6 of 6 2.
Approval of the Purchase Requisition by the Project Manager or Department Manager.
3.
Review and approval of the Purchase Order by the Quality Assurance Manager to assure proper category assignment and inclusion of applicable quality documentation requirements.
4.3.3 Category 3 - Non-Safety Related Items and Services Category 3 items and services are defined as not safety related, j
Requirements for Category 3 procurement are found in NES Procedure 80A9007, Procurement Control.
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i 1
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Document 30A9036
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Section 3 Page 1of5
- 5. INSTRUCTIONS, PROCEDURES AND DRAWINGS 5.1 SCOPE This section describes the measures used by NES to assure that activities affecting quality are prescribed by documented instructions, procedures or drawings of a type appropriate to the circumstances and to assure that such activities are accomplished in accordance with those requirements.
5.2 GENERAL REQUIREMENT NES communicates requirements for work affecting quality through this Quality b
Assurance Manual, specifications, drawings, procedures, Quality Assurance d
Program Plans, Inservice Inspection Program Plans and Inservice Testing Program Plans. These documents are reviewed and approved in accordance with the Responsibility Matrix of Appendix B.
Through this review and approval activity, NES assures that the documents contain appropriate qualitative and quantitative acceptance criteria thus defining quality work.
Quantitative criteria such as dimensions, tolerances, and operating limits and qualitative criteria such as workmanship standards are specified as necessary to define satisfactory work' performance and quality compliance.
5.3 SPECIFIC REQUIREMENTS The following documents are prepared to affect communication of project requirements, as applicable to the type of project:
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Document 30A9036
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Section 5 Page 2 of 5 5.3.1 Specifications Specifications define requirements for an item not included on the item drawing. Specifications include one or more of the following: applicable documents and drawings, manufacturing requirements, inspection and test requirements, acceptance criteria, handling and shipping requirements, and administrative requirements. Specifications are developed, reviewed and approved as specified in Sections 3 and 4 of this Manual. Specifications for items to be fabricated through Engineering Services responsibility are developed in accordance with NES Procedure 80A9059, Procedure for Preparation of Project Fabrication Specification.
O 5.3.2 Drawings Drawings show dimensions, acceptance criteria, tolerances, materials and other requirements of the design necessary to fabricate, assemble and inspect the item or to locate and examine items. Applicable specifications are listed on the drawing, where appropriate.
Drawings are developed, reviewed and approved as specified in Section 3 of this Manual.
5.3.3 Procedures Procedures define requirements to accomplish a specific sequence of operations, examinations or tests. Procedures include one or more of the following: applicable codes, documents and drawings, detailed sequence of operations, examinations or
- tests, special process requirements, acceptance
- criteria, inspection requirements and administrative requirements. Quality Assurance procedures define routine activities to accomplish quality objectives and are prepared in accordance with the NES O
Procedure 80A9024, Specification Format for Preparing Quality Assurance G
l
6 fm Document 30A9086 V)
Section 5 i
Page 3 of 5 Procedure.
Applicable administrative procedures to be used with this Manual are listed in Appendix C.
5.3.4 Quality Assurance Program Plan (QAPP)
QAPPs define information necessary in supplement of this Manual and the applicable QA implementing procequres for a specific project. The Plan includes the detailed requirements outlined in, and is developed and approved as described in Section 2 of this Manual.
5.3.5 ISI and IST Program Plans ISI and IST Program Plans contain examination or test sequences and b
schedules, detailed examination and testing procedures, appropriate Code classes for each component of the nuclear power plant, diagrams and system drawings delineating the identification and extent of areas subject to examination, definitions of personnel and equipment qualifications, access provisions, report and record formats, calibration block details, program schedules, and any specific exceptions to applicable Regulatory Guides, Codes and NRC Bulletins. ISI and IST Program Plans are prepared in accordance with NES Procedure 30A9093, Program Plan Preparation Procedure.
l 5.3.6 Work Travelers or Process Control Sheets I
In those instances where the importance and complexity of an activity requires the preparation and implementation of a traveler or process control sheet, such documents are used to control operations, inspections and documentation.
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Document 30A9086
/O' Section 5 Page 4 of 5 5.3.6.1 Travelers or Process Control Sheets Contain:
a)
Identification of the systems, structures, components or activities, including necessary reference to other process control sheets.
b)
Issue and revision records and necessary approvals.
c)
Identification of procedures used in the performance of the activity, such as WPSs, cleaning, or NDE procedures.
d)
Material (item) identification.
e)
Records of operations performed including necessary inspections and acceptances.
f)
Records of inspections, tests and examinations including Hold
- Points, g)
Records of nonconformances and dispositions, including references to Nonconformance Reports and signoff of reinspections/ retests.
h)
Identification of or reference special processes to be performed in conjunction with these activities.
i)
Requirements for or reference to traceability or identification and marking requirements, p
j)
Requirements for or reference to inspection, examination and U
test provisions including accept / reject criteria and Hold Points.
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Document 30A9036 Section 5 Page 5of5 k)
Special requirements such as for special handling equipment, for radiation protection provisions for workers, for preservation or protection of items and other requirements necessary to provide a quality activity.
5.3.6.2 Travelers or Process Control Sheets are controlled in accordance with a Procedure (s) developed for the project.
This Procedure (s) contains applicable requirements for development, approval, release and distribution of the document to assure communication of latest approved requirements to users of the document. As such, travelers and process control sheets are not subject to the requirements of Section 6 of this Manual.
5.3.7 Revisions Revisions to the documents described in paragraphs 5.3.1 through 5.3.5 are subject to the same review approval and document control measures as the original.
HELW Document 30A9086 f'N Section 6 V
Page 1 of 3
- 6. DOCUMENT CONTROL 6.1 SCOPE This section sets forth the measures in effect to assure that controlled documents including changes thereto are reviewed and approved for release and distributed to and used at the place of work. Documents subject to the provision of this section include:
1.
NES Quality Assurance Manual 2.
Design and Fabrication Specifications 3.
Procedures 4.
Design Drawings 5.
Quality Assurance Program Plans 6.
Master Document Lists r
8.
Desiga Reports 9.
Revisions to the above Calculations, audit reports, documents related to design computer codes and Nonconformance Reports are controlled as stated in Sections 3, 7,15 or 18, as applicable.
6.2 GENERAL REQUIREMENTS 6.2.1 Review and Approval The review and approval responsibilities of personnel involved in the development of controlled documents are identified in Appendix B, Responsibility Matrix.
Detailed requirements related to the means of O'd development of controlled documents are identified 'in the applicable section(s) of this Manual.
/.M A's i
Document 80A9086 Section 6 Page 2 of 3 6.2.2 Project Controlled Documents Documents that are to be controlled for a specific project are listed in the project Master Document List.
6.2.3 Customer Approval For a specific project any special requirements for document control (e.g.,
customer approval for release) are identified in the project Quality Assurance Program Plan.
6.2.4 Procedure Controlled documents are processed and/or revised in accordance with NES Procedure 80A9003, Document Control Procedure.
6.3 SPECIFIC REQUIREMENTS 6.3.1 Controlled Distribution The Document Control Supervisor is responsible for document control activities within NES and maintains a controlled distribution list identifying assigned holders of controlled document copies. The Document Control Sugiervisor is responsible for the issuance of controlled documents and revisions.
6.3.2 Document Transmittal and Recall p1 Transmittal of controlled documents and revisions is accomplished utilizing gm) a transmittal form requiring receipt acknowledgement by each recipient.
1
HEN Document 80A9086 (V
i Section 6 Page 3 of 3 Receipt acknowledgements on revised documents include the statement that the recipient attests to the latest revision having been received and the obsolete document having been either marked " obsolete" or destroyed.
Transmittals are non-permanent records and may be destroyed for obsolete revisions of documents.
For external distribution of project-related documents, the Project Manager is responsible for forwarding the document and transmittal form to the assigned individual.
6.3.] Externally Generated Documents (EGD)
Externally generated documents containing design input used in engineering 3
services projects are controlled by the Project Manager who receives the documents and maintains a log of externally generated documents. Design input derived from EGD is controlled in accordance with Section 3 of this Manual.
6.3.4 F_ield Changes for NDE Procedures Field initiated revisions to NES nondestructive examination procedures are prepared and controlled in accordance with NES Procedure 80A9097, Preparation and Control of NES Generic Nondestructive Examination Procedures, NES Procedure 80A9060, Inservice Inspection Field Change Procedure, or NES Procedure 80A9098, Quality Assurance Services Field i
Change Procedure.
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Document 30A9086 Section 7 Page 1 of 7
- 7. CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES 7.1 SCOPE This section de=cribes the measures in effect at NES to assure that purchased materials, equipment and services conform to the procurement documents.
These measures include source evaluation and selection, inspection at the source, inspection upon delivery and review of objective evidence furnished by the
- vendor, em
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Requirements are defined in accordance with the procurement categories of Section 4 of this Manual.
7.2 GENERAL REQUIREMENTS 7.2.1 Approved Vendor List An Approved Vendor List is maintained by the Quality Assurance Manager listing those vendors qualified to supply Category 1 items or services to NES. The Purchasing Manager orders Category 1 items or services only from those vendors appearing on the Approved Vendor List.
)
7.2.2 Selection of Swrces For inclusion on the Approved Vendor List, an evaluation is required for selection of sources that is based on either historical quality performance data, source surveys or audits, or source qualification program.
This evaluation is documented.
oO Document 30A9036 Section 7 Page 2 of 7 7.2.3 Audits During supply of the item or service, audits are performed consistent with the importance to safety, complexity, or quality of the item or service.
7.2.4 Source Inspection Verification of vendors activities during performance of the work is planned and performed with required Quality Assurance personnel participation in accordance with written procedures to assure conformance to Purchase Order requirements. Shipping releases are used to control material release from a vendor's facility where required.
7.2.5 Receiving Inspection Receiving inspection is perforraed to assure that items are properly identified and correspond to the purchase document and the receiving documentation; that items and acceptance records satisfy the inspection instructions prior to use; that specified records are available at the point of use of the item.
t 7.2.6 Commerci I Grade Items For commercial grade items where specific quality assurance controls appropriate for safety applications cannot be imposed in a practicable manner, verification requirements are established to assure adequate quality.
od Document 30A9036 Section 7 Page 3 of 7 7.3 SPECIFIC REQUIREMENTS 7.3.1 Vendor Evaluation and Selection Vendors are selected on past performance or by a preliminary evaluation by the Purchasing Manager, Quality Assurance Manager, Project Manager and/or other cognizant NES personnel.
The preliminary evaluation determines whether the vendor has the basic capability and willingness to conform to the requirements of NES and the customer, including compliance with 10CFR21, as applicable.
Dependent upon the workscope, a vendor's Quality Assurance Program may
~~J be reviewed to determine acceptability and,a survey may be performed of the vendor's facility.
A Purchase Order for Category 1 procurement is awarded only to vendors listed on the Approved Vendor List. To be so qualified, a vendor meets at least one of the following criteria:
1 1
1.
Historical quality data is available to verify the vendor's qualifications, e.g., ASME Certificate, industry acceptance, acceptability of technical product data, and the supply of l
quality items / services within 12 months.
2.
On critical and complex types of fabrication or services, where special vendor qualifications are required, a thorough source evaluation of the vendor is made.
The source evaluation includes a capability verification performed by qualified and j
)
certified audit personnel to evaluate the vendor's quality system and organization. Surveys are performed in accordance with written checklists approved by the Quality Assurance j
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Document 80A9086 Section 7 Page 4 of 7 Manager. The auditor may request technical assistance from the service line personnel to assist in determining the vendor's capability in areas such as facilities, equipment, personnel, and -
technical expertise.
Acceptable vendors and their capability limits are documented on the Approved Vendor List (AVL). Remaining on the AVL is dependent upon the vendor's ability to continually perform and supply quality items and services, and upon the results of periodic audits.
7.3.2 Vendor Requirements for Category 1 Procurement O
Vendors are required to maintain a documented Quality Assurance Program consistent with the complexity and quality requirements of the items or service to be supplied.
s Vendors provide objective evidence that items delivered to NES or the customer meet all quality requirements.
Vendors report all nonconforming items to NES using an approved Supplier Nonconformance Report (SNR). The nonconformance report is sent to, the attention of the Project Manager and clearly describes the nonconformity, its cause, and the vendor's corrective action. The nonconformance report is signed by the vendor.
The Project Manager processes the SNR in accordance with Section 15 of this Manual.
If required on the Purchase Order or referenced documents, vendors successfully complete a qualification program prior to producing the production items for'NES.
V Document 30A9086 Section 7 Page 5 of 7 Vendors submit all required documents, as stated or referenced on the Purchase Order, to the Project Manager.
7.3.3 Audits for Category 1 Procurements During performance of a contract, audits of the vendor are performed by the Quality Assurance Manager or his designee consistent with the importance, complexity, and quantity of purchased item (s). These audits serve to assure the required quality of the item (s) and provide objective evidence that the vendor is meeting quality requirements of the Purchase Order and paragraph 7.3.2 of this Manual. The planned vendor audits and schedule are included in the Project Quality Assurance Program Plan, or on the NES audit schedule as described in Section 18.
All audits are performed in accordance with the NES Procedure 80A9022, Quality Assurance Audit Procedure. Lead Auditors are qualified in accordance with the NES Procedure 80A9026, Qualification and Certification of Quality Assurance Program Audit Personnel.
7.3.4 Source Inspections Source inspections are performed by a qualified NES Inspectcr whenever it is necessary to assure the required quality of the item (i.e., when the quality of the item cannot be adequately verified by review of test reports, i
receipt insl ection or other means).
Hold points for source inspections are established by the Project Manager with input from the Task Engineer and specified in the Project Quality Assurance Program Plan or Fabrication Specification.
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The NES Inspector performs source inspection in accordance with the requirements of the project QAPP, the project drawings, specifications and
m umme (O) v Document 30A9086 Section 7 Page 6 of 7 procedures, as applicable.
If the source inspection is complex (e.g.,
requires special instrumentation, special techniques, etc.) the NES Inspector is provided with a written Inspection Plan. The Plan is prepared in accordance with the NES Procedure 80A9034, Procedure for Preparation of Inspection Plans and Reports and is ~ approved by the cognizant Department Manager, the Project Manager, and the Quality Anurance Manager.
After performing the source inspection, the NES Inspector immediately notifies the NES Project Manager of, the inspection results.
The NES Project Manager is responsible for a dc-cision, in consort with the Task Engineer, whether to r51 ease the vendor for continuing production.
v)
The NES Inspector prepares an Inspection Report with!n 5 working days in accordance with the requirements of the Project QAPP ce the Project Inspection Plan.
The report is submitted to the Project ' Manager far approval and to the Quality Assurance Manager for review.
If the Inspection Report indicates full compliance with the Project requirements, the Project Manager approves the report and prescribes further action, e.g., " Release for Sipment". If the Inspection Report indicates noncompliance,
~ oject Manager provides for a
Nonconformance Report to be initsated by NES. Subsequent action is in accordance' with the Nonconformance Report proce:ssing procedure (see Section 15).
7.3.5 Receipt Inspection
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Vendor-supplied items are subjected to inspection upon receipt by NES as specifiefin Section 10 of this Manuai. Items accepted and released are 1
O Document 30A9086 Section 7 Page 7 of 7 identified as to their inspection status prior to removal to a controlled storage area or releasing them for installation or further work.
When items are accepted based on a certificate of conformance, the basis for the validity of the certificates is established.
7.3.6 Spare and Replacement Part Procurement Procurement controls for spare and replacement parts for structures, systems and components are such that the quality is equal to or greater than the quality of the original item, or as required to preclude repetition of defects.
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Document 30A9086 h
Section 8 v
Page 1 of 2
- 8. IDENTIFICATION OF MATERIALS, PARTS, AND COMPONENTS 3.1 SCOPE This section describes the controls to assure that materials, parts and components including partially fabricated items are identified and controlled to assure that identification, where required by code, specification or industry standard, is maintained on the item or on records traceable to the item throughout installation or use. These measures are designed to prevent the use of incorrect or defective items.
Identification and control of measuring and test equipment including NDE l
equipment is subject to the controls of Section 12 of this Manual. Identification and control of nonconforming items is described in Section 15 of this Manual.
8.2 GENERAL REQUIREMENTS 8.2.1 Permanent Plant Identification and Control The Project Manager or Site Supervisor assures that safety-related j
permanent plant items to be installed in the facility are identified and controlled. Procedures governing identification and control of permanent plant items are prepared to project requirements by the Project Manager and implemented by the Department Manager or Site Supervisor as applicable. '
8.3 SPECIFIC REQUIREMENTS 8.3.1 Identification Requirements j
[)
Identification of materials and parts important to the safety-related function of structures, systems and components within the scope of this
119 5 m
Document 30A9086 Section 8 Page 2 of 2 Mandal are traceable to appropriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, nonconformance reports and physical and chemical test reports. Physical identification is used to the maximum extent possible, but where such identification is impractical or insufficient, other appropriate means are used. Identification may be on the item or on records traceable to the item.
3.3.2 Identification Marking When identification marking is required, the marking is clear, unambiguous f
and indelible. The method of marking is such as not to affect the function p
of the item and is chosen to prevent subsequent obliteration or masking if
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on-piece marking is essential. Identification marking is transferred to each piece as items are subdivided.
3.3.3 Material Traceability When required by customer requirements, codes or standards, unique material traceability to specific inspection and test records is provided.
3.3.4 Vendor Controls As applicable, comparable requirements for identification and control of vendor supplied items are imposed in procurement documents prepared in accordance with Section 4.
8.3.5 Verification of Identification Correct identification of items is verified and documented upon receipt (p/
d from vendors or prior to shipment to customers, as applicable.
11EP.E Document 30A9086 Section 9 V)
Page 1of8
- 9. CONTROL OF SPECIAL PROCESSES 9.1 SCOPE This Section describes the controls that are applied to nondestructive examination, welding, heat treatment and chemical cleaning to assure that such processes are performed by qualified personnel using procedures meeting the applicable code, specification, industry standard and customer requirements.
Special processes beyond those listed, or for those not covered by existing codes or standards, or where item quality requirements exceed those of established codes or standards, are defined in procedures.
Such procedures describe qualification of personnel and equipment.
A 9.2 GENERAL REQUIREMENTS 9.2.1 Special processes are those processes where direct inspection is impossible or disadvantageous.
Special processes performed by NES include nondestructive testing, welding, heat treatment and chemical cleaning.
9.2.2 Special processes are performed in accordance with procedures prepared and approved in accordance with Appendix B.
9.2.3 Special processes are performed under controlled conditions using qualified procedures and personnel.
9.2.4 Documentation of the qualification of personnel and procedures is maintained in accordance with applicable codes, standards, and procedures.
Qualification data is filed and kept current.
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HEN Document 30A9036
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c Section 9
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Page 2 of 8 s
9.3 SPECIFIC REQUIREMENTS 9.3.1 Nondestructive Examination 1.
Nondestructive Examination Procedures NES generic nondestructive examination procedures are prepared, approved and controlled in accordance with NES Procedure 80A9097, Preparation and Control of NES Generic Nondestructive Examination Procedures.
Generic and project-specific NDE procedures are prepared, reviewed and approved in accordance with Appendix B.
Field changes to approved NDE procedures are field issued provided Level III approval is obtained, as described in applicable procedures.
xs Qualification of NDE procedures is as described in NES Procedure 80A9090, Qualification of NDE Procedures (Const. Insp.) or NES Procedure 80A908is, Procedure for the Qualification of NDE Procedures.
Nondestructive examination procedures contain:
a)
The specific application of the procedure as to the type of examination and the components, piping and materials to be
, examined.
b)
Reference to the codes, standards, specifications, drawings or procedures applicable to the specific examination.
c)
Procedure and personnel certification requirements.
d)
Examination accept / reject criteria, as applicable.
ME5 Document 30A9036 g!
Section 9 tV Page 3 of 3 e)
Examination documentation requirements.
f)
Disposition instructions for data taken with equipment found to be out of calibration.
2.
Nondestructive Examination Personnel Nondestructive examination is performed by personnel trained, qualified and certified in accordance with NES Procedure 30A9068, Procedure for Certifying Nondestructive Examination Personnel for liquid penetrant, magnetic particle, radiographic, ultrasonic, eddy j
current examinations and leak testing. This procedure meets the requirements of the American Society for Nondestructive Testing's Q
recommended practice SNT-TC-1 A and applicable requirements of the ASME Boiler and Pressure Vessel Code Section XI.
Visual examination personnel are certified either to the requirements of ASME Code Section XI or to ANSI N45.2.6, as applicable. For personnel certified to the former, NES Procedure 30A9069, Nuclear Inservice Inspection Procedure for the Certification of Visual Examination Personnel is applicable.
For the latter, applicable procedures are as listed in Appendix C.
Level,Ill nondestructive examination personnel are qualified through prior experience, training and examination. Examinations include written, specific and practical portions and meet as a minimum the i
1975 Edition of SNT-TC-1A.
Later editions may be applied by contract. Level III personnel may certify other LevelIII personnel and do certify Level I and 11 personnel.
Project prepared Quality Assurance Program Plans define any personnel certification requirements beyond those defined above.
l
HELET Document 80A9086 p) t Section 9 V
Page 4 of 8 9.3.2 Welding 1.
Welding Procedures Welding Procedure Specifications (WPSs) are prepared, qualified and approved under the responsibility of the Project Manager in accordance with NES Procedure 80A9081, Preparation of Welding Procedure Specifications.
This Procedure includes specific requirements for the qualification of WPSs to codes and specifications applicable to the work.
Welding Procedure Specifications include applicable data such as:
w
)
/
a)
Welding processes employed b)
Joint design including backing use c)
Base metal to be joined d)
Thicknesses qualified e)
Filler metals to be used f)
Positions qualified g)
Welding progressions to be used h)
Preheat and interpass temperatures i)
Post weld heat treatment times and temperatures j)
Shielding and backing gas flows and composition k)
Electrical characteristics including polarity, transfer modes, and electrode wire feed rates 1)
Technique parameters including weave widths, gas cup sizes, back gouging, oscillation, etc.
m)
Other essential and nonessential variables Procedure Qualification Records (PQRs) are prepared as required in support of WPS qualification to document qualification parameters v
and specimen test results.
HELE Document 80A9086 Section 9 p)
C Page 5 of 8
- 2..
Welder and Welding Operator Qualifications Welders and welding operators are qualified under the responsibility of the Project Manager in accordance with NES Procedure 80A9100, Qualification of Welders and Welding Operators.
This Procedure defines the applicable requirements for:
a)
Qualification processes b)
Thickness limitations c)
Backing use d)
Welding progressions e)
Welding position <
f)
Electrical characteristics g)
Other welders and welding operator essential and nonessential variables h)
Test requirements for welded specimens i)
Requalification including maintenance of qualification Welder or welding operation qualification records are prepared and maintained to document the qualification and testing of welders and operators in accordance with applicable code and specification requirements.
3.
Control of Filler Metals Welding filler materials (including fluxes, inserts, and electrodes) are controlled to assure that materials used are in accordance with WPS requirements, and where required by code or specification requirements, to assure that material traceability is provided to the point of use of the material. The Procedure (s) governing control of
)
filler materials includes applicable requirements for:
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l Document 30A9036
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Section 9 v
Page 6 of 3 a)
Controlled storage and issue of filler materials b)
Storage conditions including special environmental controls to protect materials susceptable to damage due to moisture or temperature.
c)
Responsibility for filler material protection and issuance d)
Limitations on issue of material subject to moisture damage e)
Return of unused material f)
Where required for control, accounting of quantities of materials issued and returned 4.
Welding Records g
Welding documentation is included in work travelers or process C
control sheets described in Section 5 of this Manual.
Welding documentation includes applicable data such as:
a)
Welder (s) or welding operator (s) employed b)
WPS numbers for WPSs used c)-
Weld joint data such as pipe diameters, thicknesses,- weld reinforcement, or sizes d)
Backing data e)
Base metals joined f)
Initial signoffs and dates for preparation and approval g)
. Hold point signoffs and dates for inspections performed h)
Weld (s) identification including system or component identification i)
Reference to Nonconformance Reports written on unacceptable welding practices or activities j)
Other data necessary to document satisfactory accomplishment of welding g)
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Document 30A9086
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Section 9
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Page 7 of 8 9.3.3 Post Weld Heat Treatment (PWHT)
Post weld heat treatment activities are controlled under the responsibility of the Project Manager to Procedures prepared in accordance with Project requirements. These Procedures include applicable requirements for:
a)
Control equipment b)
Identification of PWHT parameters including heating rates, holding times and temperatures, cooldown rates, and provisions for accumulated heat treatment limitations c)
Personnel qualification requirements d)
Methods of temperature measurement including thermocouple placement and location O
g j
e)
Methods of heat application and insulatiun v
f)
Review and acceptance of PWHT results g)
Special precautions such as for personnel protection and for avoidance of chimney effects h)
Inspection and monitoring of PWHT activities i)
Documentation requirements including requirements for time-temperature recording chart validation and recording of inspection, and monitoring results 9.3.4 Vendor Controls Requirements for vendor special processes are specified in procurement documents developed in accordance with Section 4 of the Manual. Controls of vendor supplied special processes are such as to produce an equivalent level of quality assurance as is specified above.
OO
HEPR Document 30A9036 Section 9 Page 8of3 9.3.5 Requalification When questions arise as to the validity of the qualification of special process procedures, personnel or equipment, appropriate measures are taken to assure validity including requalification.
These requirements apply to both NES and vendor activities.
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TIEP.E Document 30A9086 (3
Section 10
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Page 1 of 3
- 10. INSPECTION 10.1 SCOF2 This section describes the controls applied to assure that activities affecting quality are subject to inspection consistent with the necessity to verify quality through inspection.
10.2 GENERAL REQUIREMENTS 1.
Inspection is provided for each work operation where necessary to verify quality.
Inspections are performed by appropriately trained personnel other than those who performed the activity inspected. Such persons do
()
not report directly to the immediate supervisors responsible for the work inspected.
2.
If inspection of processed items is impossible or disadvantageous, indirect control by monitoring of processing methods, equipment and personnel is provided.
Both inspection and process monitoring are provided when necessary.
3.
Where sampling is used to verify a group of items or activities, the sampling procedure is based on recognized standards and provides adequate justification of sample size and selection processes.
4.
Mandatory hold points are established on vendor activities where necessary to establish NES witness or inspection of vendor work activities. Work does not proceed beyond a designated hold point until formal release is provided by NES.
O V
11EN Document 30A9036 p)
Section 10 (V
Page 2 of 3 10.3 SPECIFIC REQUIREMENTS 10.3.1 Source Inspection 1.
When required for Category 1 procurements, source inspection is performed in accordance with a written source Inspection Pian prepared and approved as defined in Appendix B and implemented by appropriately trained and qualified personnel.
Inspection Plans identify at a minimum:
A.
Inspector qualification B.
Identification of the item to be inspected C.
Instrument calibration requirements D.
Reference design documents qb E.
Accept / reject criteria F.
Hold points G.
Documentation and reporting requirements 2.
NES and customer hold points are specified in the Quality Assurance Program Pian for the project, or in the appropriate NES specification or purchase order. Hold points are established at each point where it is necessary to perform an objective evaluation of hardware or documentation prior to proceeding with further activity. Processing of items does not proceed beyond a specified hold point until approval is obt,ained from the Project Manager in the case of project releases or from the customer in the case of customer releases.
10.3.2 Receiving Inspection Procurement Category I and 2 items are received and inspected to assure complete compliance with the procurement documents.
11EP.5 Document 80A9086
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Section 10 Page 3 of 3 1.
Category 1 Items are inspected to verify compliance with procurement specifications as required by Section 4 of this Manual. Inspections are performed by appropriately trained personnel in accordance with plans and procedures, such as defined in NES Procedure 80A9033, Inservice Inspection Program Receiving Inspection Procedure.
Inspection or test procedures and reports are maintained by the Project Manager.
2.
Category 2 Items are inspected by appropriately qualified department personnel to verify coinpliance with the certification requirements of the Purchase Order.
Inspection records, consisting of accepted certifications and a copy of the Purchase Order (noting satisfactory inspection), are maintained by the Department Manager or Project Manager.
3.
Additional Inspections Source and/or Receipt inspection as described in this Manual constitute the inspections needed to verify product or service acceptance. If additional inspections are deemed necessary by the Quality Assurance Manager, they are performed in accordance with a specific written inspection plan.
4.
Nonconformances Items determined to be nonconforming during inspection are reported O)
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in accordance with Section 15 of this Manual.
HELW Document 80A9086
[mU'}
Section 11 Page 1 of 4
- 11. TEST CONTROL 11.1 SCOPE This section describes the controls implemented by NES to assure that testing is performed where required to demonstrate that items will perform satisfactorily in service, and that test programs are prescribed by written procedures containing or referencing acceptance criteria of applicable design documents.
11.2 GENERAL REQUIREMENTS 1.
NES test programs are described in Functional Test Procedures or Test Plans prepared and approved as described in Appendix B. Where a vendor is responsible for performance of testing, NES specifications describe the necessary controls, test parameters and acceptance limits for the program.
The Project Manager is responsible for the scope and content of the test program.
2.
Test programs cover all required tests including, as appropriate, prototype qualification tests, proof tests, and operational tests to demonstrate satisfactory functioning or performance of items.
3.
Test procedures include prerequisites for assuring proper
- test, requirements for adequate instrumentation and requirements for administration of the test including necessary surveillance by NES and customer personnel. Prerequisites for test include such items as calibi ted instruments, appropriate equipment, trained personnel, condition of test equipment, condition of the item to be tested, suitable environmental conditions, and provisions for data collection.
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112 5 Document 80A9086 (g)
Section 11 Page 2 of 4 4.
Test results are documented by cognizant test personnel and evaluated by the Project Manager to assure that test requirements have been satisfied.
11.3 SPECIFIC REQUIREMENTS 11.3.1 Test Procedures or Plans Test procedures or plans include, as applicable:
1.
Scope of the test.
2.
The requirements and acceptance limits.
[b 3.
Test prerequisites and conditions for the test including calibrated instrumentation, adequate test equipment and instrumentation including their accuracy requirements, completeness of the item tested, suitable and controlled environmental conditions, provisions for data collection and storage.
4.
Test sequence including any mandatory hold points for witness by vendor, customer or NES including NES Quality Assurance personnel.
5.
Acceptance and rejection criteria.
6.
Methods for documenting or recording test results and data.
I1.3.2 Conduct of Test p
Tests are conducted in accordance with Test Procedures or Plans under the V
responsibility of the Task Engineer and under designated surveillance by
H E P. E Document SOA9086
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Section 11 C/
Page 3 of 4 the Quality Assurance Manager. Functional testing necessary to verify design adequacy of critical items is witnessed by qualified Quality Assurance personnel, 11.3.3 Test Reports Test reports prepared and approved in accordance with Appendix B contain, as a minimum:
1.
Actual test procedures.
2.
Completed data sheets or inspection records.
(A) 3.
Reference to pertinent laboratory notebooks, test records.
U 4.
Accuracy and calibration status of measuring and test equipment used.
5.
Dates of key test events.
6.
Identification of individuals involved in test, including persons responsible for performance and verification of tests.
7.
Actions regarding deficiencies,if any.
8.
An evaluation of the test data against the acceptance criteria and a statement as to the acceptance of the overall test.
9.
Required NES/ customer approvals.
O v;
Distribution of test reports includes the customer and the Project Manager.
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Section 11 C/
Page 4 of 4 11.3.4 Vendor Test Control Test program requirements are incorporated in the appropriate NES specifications which are approved by the Quality Assurance Manager and the cognizant General Manager. Test procedures are prepared for each test identified in the NES specifications and/or Purchase Order. These procedures are reviewed and approved by the Project Manager and the Quality Assurance Manager. The assigned Task Engineer prepares the test procedures for those tests performed by NES at the vendor's facility, customer's site or at NES.
The test procedures include, as a minimum, the items identified in paragraph 11.3.1 above.
A test report is prepared and approved in accordance with the Responsibility Matrix, Appendix B.
The Project Manager distributes test reports.
Test reports contain, as a minimum, the items identified in paragraph 11.3.3 above.
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Document 30A9086
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Section 12 Page 1 of 3
- 12. CONTROL OF MEASURING AND TEST EQUIPMENT 12.1 SCOPE This section describes the controls employed to assure that measuring and testing equipment used in activities affecting quality is of the proper type, range and accuracy for the measurement or test and to assure that such equipment is controlled, calibrated and adjusted at prescribed intervals or times so as to estabilsh valid relationships to nationally recognized standards.
These controls are not intended to imply a need for special calibration and control measures on rulers, tapes, levels and such other devices, if normal commercial practices provide adequate accuracy cf the device.
OV 12.2 GENERAL REQUIREMENTS 12.2.1 Procedures Written procedures used for control of measuring and test equipment are prepared as described in Section 5 of this Manual.
12.3 SPECIFIC REQUIREMENTS 1.
The Department Manager, Project Manager or Site Supervisor is responsible,to assure that controls of measuring and test equipment are fully implemented and in accordance with procedures described in paragraph 12.2.1.
2.
Measuring and test equipment used to determine product conformance is controlled and calibrated and is permanently marked with a distinctive serial number for traceability and identification.
9 a
Document 30A9086 p
Section 12
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Page 2 of 3 3.
Measuring and test equipment calibration interval requirements are based upon the type of equipment, the stability characteristics, the required accuracy, purpose of use, degree of usage, NES experience, and other conditions affecting measurement control. The equipment is labeled with a calib' ration sticker or label to indicate the calibration and due dates and the identification of the individual who performed the calibration.
Calibration records show accomplishment, as-found condition and identification of the standard used for each calibration.
4.
Calibration is performed under suitable environmental conditions.
Calibration of measuring and test equipment is performed using standards that are traceable to National Standards, where such standards exist, or other suitable standards, such as State Weights and Measures Standards.
Where no National Standards exist, the basis for calibration is documented.
/
Certification documents are maintained on file for Master Standards that are used for calibration. Calibration standards have an accuracy four times as great as the accuracy of the equipment being calibrated except where limited by the state of the art, in which case, the basis for calibration is documented.
5.
Tolerances of calibration are in accordance with the equipment manufacturer's instructions, NES experience, government standards and the state of the art. Where such information is not available, the basis for calibration tolerances is documented.
6.
Measuring and test equipment found to be out of calibration is recalibrated, repaired or replaced, as applicable. When measuring and test equipment is found to be out of calibration, the equipment is tagged or segregated and a Nonconformance Repoct is prepared.
An initial evaluation is made and documented by the Department Manager or Project Manager of the validity of previous inspections, examinations or tests and
]v of the acceptability of items previously inspected or tested with equipment
HERN Document 80A9086 O
Section 12 V
Page 3 of 3 found to be out of calibration. Corrective actions are documented on the Nonconformance Report prepared in accordance with Section 15 of the Manual.
7.
Measuring and test equipment is kept in safe storage and issued from an area (s) designated by the Department Manager / Project Manager or Site Supervisor. Equipment issue, return and usage data shall be entered and maintained on calibration records.
A system of recording measuring and test equipment usage data is established and maintained to provide use traceability for measuring and test equipment.
The system includes a method of identification to document equipment usage to applicable control checklist, data sheet or other specific identification.
G 8.
Users of controlled measuring and test equipment are instructed in the use of the equipment and instructed to immediately return for calibration any equipment that is dropped, damaged or suspected to be out of calibration.
9.
Calibration standards and equipment sent to others for calibration requires certification stating that the calibration standard (s) used is traceable to National Standards or other suitable standards.
O
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(~N Document SOA9036 V
Section 13 Page 1 of 2
- 13. HANDLING, STORAGE AND SHIPPING 13.1 SCOPE This section describes the controls applied to assure that handling, storage and shipping practices are in effect to prevent damage, deterioration or loss of items within the control of this Manual.
13.2 GENERAL REQUIREMENTS The Department Manager, Project Manager and Site Supervisor are responsible for items in the possession of NES and for the application of sound handling, storage and shipping practices to prevent damage, deterioration or loss of items b
in accordance with written procedures or instructions.
13.3 SPECIFIC REQUIREMENTS 13.3.1 Nondestructive Examination Equipment and Materials Calibration blocks are stored in a secure manner and care is exercised during handling, storage and shipping to avoid damage, deterioration or loss. Other NDE equipment is stored and handled in accordance with manuf acturer's instructions.
Consumabid NDE materials are protected using the fo!!owing guidelines:
1.
Film - Film is stored in a clean, cool, dry location,is protected as necessary from radiation and is used prior to the manufacturer's expiration date.
<m) 2.
Processing Chemicals - Processing chemicals are protected against freezing and are stored Indoors.
HEL'i Document 30A9036 p)
Section 13 Page 2 of 2 Nd 3.
Liquid Penetrant Materials - Penetrant materials are stored under cover and fire protection requirements are observed.
Traceability requirements for penetrant materials are maintained.
4.
Magnetic Particle Powder - Powders are stored in a clean, dry location with traceability maintained.
5.
Ultrasonic Couplant - UT couplant is protected from freezing and traceability is maintained.
Further requirements for controls of equipment / materials protection are as specified in the applicable QAPP.
(m) 13.3.2 NES Equipment a
NES fabricated equipment or equipment under NES control is handled, stored and shipped in accordance with sound handling, storage and shipping practices. When necessary to protect sensitive or easily damaged items, special handling, storage or shipping procedures or instructions are prepared by the Project Manager.
13.3.3 Vendor Controls Specific requirements for handling, storage, and shipping are included in the applicable NES Specification and/or Purchase Order. When required by the NES Specification or Purchase Order, procedures are prepared by the vendor and submitted to the Project Manager for approval.
Measures necessary to meet the handling, storage, and shipping requirements are incorporated in the vendor's manufacturing documents.
(
The vendor is responsible for assuring that these requirements are met (3j during production.
If items are cleaned prior to shipping, procedures include measures to maintain the required level of cleanliness.
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Document 30A9086 Section 14 Page 1 of 3
- 14. INSPECTION, TEST AND OPERATING STATUS 14.1 SCOPE This section sets forth the requirements for the identification of inspection, test and operating status to assure that inspections and tests are performed and that the acceptability of items requiring inspection and test is known throughout manufacturing, installation and operation.
14.2 GENERAL REQUIREMENTS 1.
The inspection and test status of items is maintained through the use of
(,/
status indicators such as physical marking on items or on records traceable to items, or physical location controls such as segregation. Status is controlled to assure that only items passing required inspections or tests are used, installed or operated. Nonconforming items are clearly identified as nonconforming as required in Section 15.
2.
Procedures prepared to control inspection, test and operating status includet A.
Controls on status indicators.
B.
Authority for application and removal of status indicators.
C.
Measures to prevent inadvertent operation of items.
v
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Section 14
'V Page 2 of 3 14.3 SPECIFIC REQUIREMENTS 14.3.1 Nondestructive Examination Equipment Initial operating status of nondestructive examination equipment is established and indicated on test records. Subsequent operating calibration activities are performed to maintain the operating status of the equipment and these activities are documented on either operating calibration records or on records of calibration controlled per Section 12 of this Manual.
Calibration block acceptance is indicated by use of an " Inspection Log",
which is used to document the status of calibration block adequacy during g
inspection and test.
LJ 14.3.2 Consumable Materials The inspection status of consumable material is indicated (signature, date, accept / reject) on a copy of the Purchase Order.
14.3.3 Construction / Modification / Installation Activities The inspection or test status of items under construction, modification, or installation is indicated through the use of travelers or process control sheets as described in Section 3 of this Manual. These work packages provide instructions and references for performing key activities and planned inspection points including attestation to acceptability or references to Nonconformance Reports issued in accordance with Section 15 of this Manual.
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Document SUA9036 Section 14 k
Page 3 of 3 4
1.
14.3.4 Vendor Controls i
The Project Manager imposes requirements for vendor' controls of inspection, test and operating status in procurement documents. These documents require vendors to provide an effective system for identifying i
and documenting the inspection and test status of items during
}
manufacture, inspection and test.
/
This program precludes the possibility of any item inadvertently bypassing a required manufacturing process, inspection or test and inciddes the applicable requirements of paragraph 14.2.1.
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Document 30A9086
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Section 15
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Page 1of5 1
- 15. NONCONFORMING ITEMS 15.1 SCOPE This section describes the controls applied to control items, services or activities that do not conform to previously established requirements and that render the quality of an item, service or activity unacceptable or indeterminate.
15.2 GENERAL REQUIREMENTS 1.
Any NES employee may identify and document nonconformances through the use of a Nonconformance Report.
Audit personnel may identify nonconformances found during audits in accordance with Section 18 of this Manual.
2.
Procedures are available in accordance with Appendix C of this Manual describing the controls applied to nonconforming items or activities.
Procedures require nonconformance identification, se5regation, disposition and notification to affected organizations.
Nonconforming items are reviewed and accepted, rejected, repaired or resolved in accordance with these procedures. In addition, procedures include:
A.
Responsibility and authority for disposition of nonconforming items.
B.
Requirements that repaired or reworked item be reinspected in accordance with these procedures.
C.
Requirements for controlling further processing of nonconforming items.
U
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Section 15 Page 2 of 5 D.
Documentation requirements for items dispositioned "use-as-is" or " repair" to assure customer acceptance.
E.
Requirements for documenting the "as-built" condition of resolved or repaired items.
15.3 SPECIFIC REQUIREMENTS 15.3.1 Nonconformance Processing 1.
Identified nonconformances are reported on a Nonconformance Report.
Nonconformances ide.ntified by NES are documented and processed in accordance with NES Procedure 80A9082, Company CN Nonconformance Control.
V 2.
Nonconformances identified by a supplier are documented and processed in accordance-with the NES Procedure 80A9008, Supplier
^
Nonconformance Report Processing Procedure.
3.
Nonconforming items are clearly identified and segregated and are not further processed, delivered or installed until the.
nonconformance is dispositioned.
Segregation is used where practical. Whether segregated or not, the item is clearly identified as nonconforming.
~
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4.
Nonconformance Reports are i rwarded to the Department Manager to determine the disposition.
The nonconformance may be dispositioned "te:.vork", " repair", "use-as-is", or " replace".
j 5
The Project Manager reviews the disposition and signifies his concurrence and approval by signing the report, and forwards the V
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112 5
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Document 30A9036 V
Section 15 Page 3 of 5 Nonconformance Report to the Quality Assurance Manager for review and approval.
5.
The Nonconformance Report must be approved by the Quality Assurance Manager before the items are finally dispositioned. If the Quality Assurance Manager indicates that 10CFR21 applies, action is taken in accordance with Procedure NES 80A9036, Procedure for Compliance with 10CFR21.
6.
Quality Assurance verifles the implementation of dispositions where
~ quired and signs the Nonconformance Report to indicate satisfactory completion of verification.
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7.
Completed Nonconformance Reports are maintained by the Quality Assurance Manager. Copies are maintained by the Project Manager and placed in the project file.
15.3.2 Customer-Initiated Nonconformance Reports Should a customer originate a Nonconformance Report, the Project Manager initiates an NES Nonconformance Report to provide control during processing. The report is processed as outlined in this Section.
Final dispositions, verifications, and corrective action are forwarded to the customer by the Project Manager.
15.3.3 Vendor Controls NES procurement and qualification activities provide requirements for vendor control of nonconforming items. Such requirements include:
Ci Qi 1.
Control of the identification, documentation and segregation of nonconforming items to preclude further processing, delivery or installation pending notification of affected individuals and/or
Document 30A9036
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Section 15 Page 4 of 5 organizations, review of the nonconformances, and approval of disposition.
2.
Documentation identifying the
- item, the inspection requirements that the item does not meet, the nonconformance, and the disposition of the nonconformance and providing for signature approval of the disposition.
3.
Identification of the individuals and/or organizations, including NES as customer, who have the responsibility and authority to approve dispositions, depending on the nature of the nonconformance and the proposed disposition.
4.
Segregation of nonconforming items by controlled physical pV separation of such items from acceptable items or by tagging, when physical separation is impractical, to preclude the use of the nonconforming item.
5.
Reinspection or reexamination of repaired and reworked items in accordance with initial criteria unless test results or other conditions indicate the need for new criteria and the documentation of the reinspection or reexamination and results, l
6.
Control of the repair and/or rework of nonconforming items.
7.
Reporting nonconformances to NES.
l 8.
Making the documentation of nonconformances disposition ("use as is" or " repair") part of the quality record of the items.
i Note: Completed copies of Nonconformance Reports written V
by NES to document and disposition a supplier's noncompliance are forwarded to that supplier.
Document SOA9086
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Section 15 Page 5of5 15.3.4 Corrective Action Nonconformance Reports include a brief statement ci cause, corrective action, and action to prevent recurrence of the nonconforming condition.
The Quality Assurance Manager reviews and evaluates nonconformances to determine the need for initiating any additional corrective action as outlined in Section 16 of this Manual.
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Section 16 Page 1 of 2
- 16. CORRECTIVE ACTION 16.1 SCOPE This section describes the controls in effect to assure that conditions adverse to quality such as failures, malfunctions, deficiencies, deviations, and defective material and equipment are promptly identified and corrected. In the case of significant conditions adverse to quality, the cause of the condition is identified and corrected to preclude repetition.
16.2 GENERAL REQUIREMENTS The Quality Assurance Manager identifies and documents the existence of conditions adverse to quality through audits, review of Nonconformance Reports (v) and through trend analysis. He assures that the requirements of this Section are fulfilled and documented through corrective action, and furnishes to the President a report of results of trending.
The Quality Assurance Manager (and NES Management, if appropriate) extends these requirements to vendors supplying items or services to NES.
16.3 SPECIFIC REQUIREMENTS 1.
The Quality Assurance Manager reviews on a regular basis NCRs and Audit Finding Reports (AFRs) after they have been closed out to determine whether further corrective action is or is not necessary.
A log is maintained of NCRs and AFRs that have been reviewed. The Quality Assurance Manager submits a trend analysis to the President on an annual basis.
2.
Significant or recurring nonconformances are identified by the Quality s
(a)
Assurance Manager by initiating a Corrective Action Request (CAR,
HEL4 Document 30A9086 3[V
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Section 16 Page 2 of 2 Exhibit 16.1) to determine the cause and eliminate the recurrence of these nonconformances.
The Project Manager, QA Department personnel, or other NES Managers may also identify s'e_h a condition to the Quality Assurance Manager causing initiation of the same action. The Quality Assurance Manager identifies the department responsible to participate in investigation and determination of the cause.
3.
The General Managers, Project Managers and other NES Managers, as appropriate to the conditions, participate in the investigation and make available other required personnel to determine the csuse and develop appropriate corrective action.
4.
After approval by the Quality Assurance Manager of the corrective action, the appropriate manager initiates required corrective action and reports its implementation and results within the time allotted. The allotted time is appropriate to the condition.
5.
The Quality Assurance Manager verifies completion of required corrective action and attainment of desired results and prepares and furnishes a complete report of corrective action to the President.
6.
If the condition is identified with material or services furnished by a vendor, the Quality Assurance Manager requests action on the vendor's part consistent with the above requirements.
If the subcontractor fails to comply with these requirements, he is removed from the Approved Vendor List.
v
11EN E2HIBIT 16.1 T
g CORRECTIVE ACTION REQUEST APPENDIX B CRITERIA NO.
Audit Responsible No.: QAA-Organization CAR No.:
REQUIREMENT:
I OBSERVATION:
i i
REOOMMENDED ACTION: (Optional) l Potential for reporting per 10 CFR Part 21: Yes No l
If yes, action required:
Evaluated by:
Date:
i Auditor:
Date:
Finding Acknowledged by:
Date:
i RESPONSE DUE DATE:
Cause Code:
i CORRECTIVE ACTION:
SiMILAR VERSIONS WHICH REQUIRE THE SAME 1
INFORMATION ARE ACCEPTABLE.
ACTION TO PREVENT RECURRENCE:
i Scheduled i
Response
Prepared by:
Response
Completion Date:
Date:
I RESPONSE EVALUATION: Accept Reject VERIFICATION REQUIRED:
Yes No If yes, type of verification required:
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Evaluated by:
Date:
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Verified by:
Date:
)
CAR Closed:
Closed by:
Date:
p Document 80A9086 t
Section 17 Page 1 of 3
- 17. QUALITY ASSURANCE RECORDS 17.1 SCOPE This section describes the controls that are in effect for the collection, storage and maintenance of quality assurance records. Sufficient records are prepared as work is performed to furnish documentary evidence of the quality of items and activities affecting quality. Documents are considered records only when stamped, initialed or signed and dated by authorized personnel. Records may be originals or reproduced copies.
17.2 GENERAL REQUIREMENTS Quality Assurance records are prepared consistent with code, customer and regulatory requirements for the work. Records include the results of reviews, inspections, tests, audits, monitoring of work performance, material analyses, equipment logs and other documents which provide objective evidence of the quality of item and activities.
Records also include the qualifications of personnel, equipment and processes, as appropriate. Inspection and test records include the date of inspection or test, the identity of the inspector or data recorder, the type of observation, the results, the acceptability, and 'those actions taken in connection with any deficiency noted. Records are identifiable, legible and retrievable.
Records are collected, stored and maintained in accordance with NES Procedure 80A9099, Procedure for Identification, Storage and Retention of Quality Assurance Records.
17.3 SPECIFIC REQUIREMENTS p
17.3.1 Inprocess Record Keeping During the course of project work, the Project Manager or Site Supervisor controls project-specific quality assurance records in a manner that
HEP.5 Document 30A9036
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Page 2 of 3 provides ready identification, protection and retrieval. Unique customer requirements for record collection, maintenance and storage are included in the QAPP, as applicable.
17.3.2 Project Close-Out Within three months after completing the project, the Project Manager organizes the project close-out file in accordance with the NES Procedure 80A9009, Project Close-Out File Procedure, when required. The contents of the close-out file is specified in the Project Quality Assurance Program Plan.
Unless specified otherwise, the close-out files are maintained for a p
minimum of two years. At the end of that time, the Department Manager,
'd subject to review and approval by the Quality Assurance Manager, determines if the records should be retained longer or be destroyed. He notifies the Project Manager who will advise the customer.
Prior to destroying the records, customer concurrence is obtained so that he has the 1
opportunity to take possession of the quality assurance records.
Requirements for archive samples, if applicable, are included in the Project Quality Assurance Program Plan.
The archive samples, are prepared by the vendor and submitted to the Project Manager with a complete description of the sample history (material lot identification and certificatio'n, component fabrication histories, etc.).
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Document 30A9086
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Section 17 Page 3 of 3 17.3.3 Records Correction Corrections to records include the identity of the person making the correction and the date of the correction. The correction is made so as not to conceal or obliterate original data.
17.3.4 Safekeeping Procedures, personnel certifications and nonconformances are stored in the home office, with copies kept at the applicable site, if required by the project. Where dual storage is required to prevent less of records, such maintenance is provided in the home office.
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11EL4 Document 30A9036 cs(d
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Section 13 Page 1 of 6
- 18. AUDITS 18.1 SCOPE This section describes the auditing program in effect to assure the effectiveness of and adherence to the NES Quality Assurance Progran., This program provides a comprehensive system of planned and documented incernal audits to verify compliance with all aspects of the Quality Assurance Progs am.
18.2 GENERAL REQUIREMENTS Audits are conducted as early in the life at an activity as practical, on intervals consistent with the schedule for accomplishing the activity, and commensurate with the status and importance of the activity.
Audits are performed in accordance with NES Procedure 80A9022, Quality Assurance Audit Procedure by qualified personnel certified in accordance with 1
NES Procedure 80A9026, Qualification and Certification of Quality Assurance Program Audit Personnel. Auditors do not have direct responsibility for areas j
audited. Audit results are documented by audit personnel and are reviewed by management having responsibility for the area audited.
Responsible management takes action to correct revealed deficiencies.
18.3 SP~.CIFIC REQUIREMENTS 18.3.1 Internal Auditing 1.
The internal audit program is planned and implemented by the Quality Assurance Manager, in accordance with NES Procedure 30A9022. Audits are formally scheduled so that each section of the Manual is audited at least once within the calendar year. Project V
audits are scheduled based on requirements of the QAPP. Problem
11E5 Document 30A9086 m[d
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Section 18 Page 2 of 6 areas that may develop are audited at increased frequencies as considered necessary to assure control. Internal auditing frequencies are increased when necessary to assure effectiveness and implementation of significant changes to the QA Program.
The Quality Assurance Manager issues the audit schedule to appropriate levels of management.
2.
Audits are conducted by audit teams headed by a Lead Auditor who coordinates the audit efforts and makes ' audit assignments to the team members. Personnel other tnan Quality Assurance Department personnel may be utilized as team members to provide technical expertise.
)
3.
Audits are performed by Quality Assurance personnel on an unscheduled basis with checklists when conditions adverse to quality are considered to exist that require review by audit. The Quality Assurance Manager reviews these audit reports and determines if there is a need to immediately schedule a reaudit of the activity.
4.
Personnel performing audits are qualified to evaluate the area being audited and do not have direct responsibilities in the areas being audited. Prior to each audit, the Lead Auditor meets with the audit team, reviews findings of previous audit (s), makes audit assignments j
and coordinates the preparation of checklists for conduct of the audit.' Audit checklists are reviewed by the Lead Auditor to assure that the requirements of applicable documents and pertinent requirements have been included. Audit checklists shall be approved by the Quality Assurance Manager.
5.
Management of activities to be audited shall be notified a reasonable amount of time in advance of the scheduled audit by copy of an audit
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Document 80A9086
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Section IS Page 3 of 6 plan except as noted in 3. above. Audits proceed in accordance with prepared plans and checklists. These plans may be varied by the Lead Auditor, for example, if the audit reveals the need for additional audit coverage or if less coverage is warranted due to inactivity in the audit area. Objective evidence is examined for compliance with QA Program requirements.
During the audit, team members complete their checklists and note their findings. Based on these findings, the Lead Auditor coordinates the preparation of the Audit Report and Audit Finding Reports, as applicable. The audit report is forwarded to the Quality Assurance Manager by the Lead Auditor.
The Quality Assurance Manager discusses the Audit Finding Reports with the Lead Auditor and retains the audit checklists used by the team.
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6.
Assuring completion of corrective action and follow-up on audit findings is the responsibility of the Quality Assurance Manager. To accomplish these actions, the following steps are taken:
A.
The Quality Assurance Manager issues the Audit Finding Reports (AFRs) to the cognizant supervisor (s) of the area (s) audited.
By copy of this report, the cognizant supervisor determines the cause, proposes both remedial and preventative corrective action and obtains concurrence of this corrective action from the Quality Assurance Manager and cognizant
' management within thirty days.
The cognizant supervisor initiates corrective action.
Copies of the audit report are forwarded to the customer and responsible NES management.
B.
Monthly, Quality Assurance reviews the outstanding AFRs and corrective action responses and, when applicable, close.s the OQ corresponding AFRs indicating satisfactory completion of
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i Document 30A9086 Section 18 Page 4 of 6 corrective action.
The method used to verify satisfactory completion of corrective action is entered on the AFR. AFRs that cannot be closed receive further follow-up and corrective action, as appropriate; e.g., performance of a follow-up audit or requesting additional action. Open AFRs are kept in an active file until resolved.
i C.
Monthly, the Quality Assurance Manager, based on the results-e of the review,' issues the Audit Finding Summary Report -
showing completed corrective actions and any open AFRs.to j
responsible management and the President.
1 D.
A copy of the closed AFRs are sent to responsible management.
- !O E.
Quarterly, the Audit Finding Summary Report includes the results of trend analysis and notes significant trends, should any exist.
These trends shall serve as a basis for management assessments of the QA. Program and may provide a-basis for additional audits or other management action.
1 7.
Follow-up actions, including reaudit' of deficient areas, are taken when necessary.
18.3.2 External Auditing l.
External audits are conducted as required on vendors to assure compliance with quality requirements.
The planning and implementation of these audits is described in NES Procedure 30A9022 and is the responsibility of the Quality Assurance Manager.
External audits are formally scheduled, and performed every 18 l
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1 Document 30A9086
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Page 5 of 6 months for those vendors under contract who are actively performing work or once within the life of the contract, whichever is shorter.
Other vendors are audited triennielly.
2.
These audits are conducted to satisfy one or more of the following requirements:
A.
To assure adequate implementation of the vendor's Quality Assurance Program, following award of contract and initiation of work.
B.
To evaluate significant changes in the vendor's Quality Assurance Program and implementation of these changes.
C.
To identify possible nonconformances in the vendor's Quality Assurance Program.
D.
To assure effective control of nonconformances by the vendor, including documentation of nonconformances, design review, authorization of dispositions, inspection of repairs and corrective action to prevent recurrence.
E.
To assure that the vendor is maintaining an adequate quality program that meets customer and NES requirements.
3.
The audit team and Lead Auditor concept is used as in paragraph 18.3.1.2. The Lead Auditor prepares an audit checklist, reviews the items on the checklist and findings of previous audit (s) with the team, and makes audit assignments prior to the audit. Audit checklists relate to the product and system or organization to be audited. The Quality Assurance Manager reviews and approves the audit checklist prior to the audit.
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Based on the audit results, the team prepares the preliminary results while at the vendor's facility. At the close of the audit, findings are discussed with the vendor to ensure their accuracy. Any corrective actions immediately needed are discussed and implementation requested by the Lead Auditor.
5.
The Quality Assurance Manager reviews the audit findings with the Lead Auditor upon completion of the audit. The Quality Assurance Manager is responsible for obtaining any needed corrective actions and is assisted in this regard by the Purchasing Manager, Project Manager, or Service Line General Manager as appropriate.
6.
The Quality Assurance Manager issues the formal audit report to the f) vendor and other responsible NES management. The audit report is
%J forwarded to the vendor by the Quality Assurance Manager requesting corrective action response (s), as stated in the report, within thirty (30) days.
Follow-up and verification of corrective action is performed within sixty (60) days of the audits. A final audit report is issued by the Quality Assurance Manager within ninety (90) days of the audit, noting corrective actions taken and any open items.
Copies of the final report are forwarded to the vendor, Project Manager, and responsible NES Management. AFRs are distributed as they are closed.
7.
Reaudits are performed at the discretion of the Quality Assurance Manager and Quality Assurance maintains complete audit report files.
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APPENDIX A.1 V
CORPORATE ORGANIZATION CHART REV5 ION O President Planning &
Marketing Operations Quality Senior Executive Assurance Vice President Vice President Manager Purchasing Document Manager Control Supervisor Plant Betterment Waste Management Engineering Services Services Services General Manager General Manager Sr. Vice President Engineered Site Boston Products Engineering Office General General General Manager Manager Manager Technical Services Inspection Services Vice President General Manager Staff Augmentation Plant Automated QA Services Services Operations Operations NES/Dynacon General Manager General Manager Director Director President
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APPENDIX A.2 TYPICAL PROJECT ORGANIZATION REVISION O l
r Technical Q'uEty]
l Department Project
.,_,, __,j Assurance i Manager Manager di,anagerI ip______
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Task Engineer Site Engineer i
Line Responsibility *
Staff Responsibility / Technical Direction *
-QA Coordination
- Staff and line responsibilities may be reversed on certain projects between the Project Manager and the Technical Department Manager, but Technical Direction is retained in every case by the Technical Department Manager.
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APPENDIX B RESPONSIBILITY MATRIX REVISION O j
E xec. S r.
Gen. Dept.
Task QA Document Type Pres.
M gr.
P.M. Eng.
M gr. Other 1
QA Manual A
A A
QAPP A
A P
A Implementing Proc.
A*
A*
A*
A*
A*
A*
A l
Proi. Review Meeting Min.
P QA Indoctrination & Training P
Design Reports A*
A A
P j
Design Procedures A*
A A
P A
Design Drawings A*
A A
P Design Specifications A*
A A
P A
)
Design Criteria A*
A P
Calculation Notebooks A
P 1
Eng. Log Books A
A P
1 Test Procedures or Test Plans A
A P
A Funct. Test Reports A
A P
A Purchase Requisitions A*
A*
A*
2 Purchase Orders A*
3 i
Procurement Specifications A
A 151 Program Plans A
A P
A IST Program Plans A
A P
A Special Process Procedures A
P A
NDE Procedures A
A*
P A
4 d
NDE Field Changes 4, 5 Prog. Plan Field Changes A*
A*
A*
6 Approved Vendors List P,A Source Inspection Reports Inspection Plans A
A A
7 Inspection Reports 7
Test Results E
8 Vendor Test Procedures A
A Vendor Test Report A
A A
Test Report A
P A
Handling, Shipping and Storage Procedures.
A P
A Vendor Handling, Shipping and Storage Procedures A
Nonconformance Reports D*
D*
A 9
Trend Analysis P,A Corrective Action Requests D*
D*
D*
P,A Audit Checklists A
10 Audit Reports A
10 Audit Finding Reports D*
D*
A 10 Audit Finding Summary Report P,A ABBREVIATIONS: P - Prepare A - Review and Approve D - Disposition L - Limited E - Evaluate F - File Copy
- - As applicable NOTES: 1.
A - Independent Reviewer
- 5. P - Examiner 8.
P - Test Personnel 2.
P - Requisitioner
- 6. P - Qualified 9.
P - Any Employee 3.
P - Purchasing Manager Individual 10.
P - Auditor 4.
A - Level III
- 7. P - Inspector
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APPENDIX C IMPLEMENTING PROCEDURE INDEX REVISION 0 Section Number Title 2
80A9031 Procedure for the Preparation of Quality Assurance Program Plans 2&5 80A9024 Specification Format for Preparing Quality Assurance Procedure 3
80A9004 Calculation Notebook Procedure 3
80A9092 ISI Engineering Log Book Control Procedure 3
80A9010 Computer Code Documentation Control Procedure 3
80A9029 Project Control Procedure 3&5 80A9093 Program Plan Preparation Procedure 4
80A9007 Procurement Control 5
80A9059 Procedure for Preparation of Project Fabrication Specifi-cation 6
80A9003 NES Document Control Procedure 6
80A9060 Inservice Inspection Field Change Procedure 6&9 80A9097 Preparation and Control of NES Generic Nondestructive Examination Procedures 6
80A9098 Quality Assurance Services Field Change Procedure 7 & 18 80A9022 Quality Assurance Audit Procedure 7 & 18 80A9026 Qualification and Certification of Quality Assurance Program Audit Personnel 7
80A9034 Procedure for the Preparation of Inspection Plans and Reports 9
80A9032 Procedure for Qualification of Inspectors 9
80A9090 Qualification of Nondestructive Examination Procedures (Const. Insp.)
9 80A9084 Procedure for Qualification of Nondestructive Examination
)
Procedures 9
80A9068 Procedure for Certifying Nondestructive Examination Personnel 9
80A9069 Nuclear Inservice Inspection Procedure for the Certification of Visual Examination Personnel 9
80A9081 Preparation of Welding Procedure Specifications 9
80A9100 Qualification of Welders and Welding Operators 10 80A9033 Inservice Inspection Program Receiving Inspection Procedure 15 80A9082' Company Nonconformance Control 15 80A9008 Supplier Nonconformance Report Processing Procedure 15 80A9036 Procedure for compliance with 10CFR Part 21 17 80A9099 Procedure for Identification, Storage, and Retention of Quality Assurance Records 17 80A9009 Project Close-Out File Procedure Od
HEL%i REVISION 0 J
GLOSSARY Accept-As-Is See "Use-As-Is" AFR Audit Finding Report Approval An act of endorsing or adding positive authorization or both.
As-Built Data Documented data that describes the condition actually achieved in a product.
Includes revised or marked-up drawings and specifications.
Audit A planned and documented activity performed to determine by investigation, examination, and evaluation of objective evidence the adequacy of and adherence to established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation. An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance.
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V Calibration Comparison of a device (such as an instrument) with an appropriate standard of known and higher accuracy of closer tolerance in order to eliminate by adjustment or document any variation in the accuracy of the device being compared.
Certificate of Compliance A written statement, signed by a qualified party, (C of C) attesting that items or services are in accordance with specified requirements and accompanied by additional information to substantiate the statement.
Certified Test Report (CMTR)
A written and signed document, approved by a qualified party, that contains sufficient data and information to verify the actual properties of items and the actual results of all required tests.
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CAR Corrective Action Request j
Certificate of Conformance A written statement, signed by a qualified party, certifying that items or services comply with specific requirements.
Certification The act of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures,
'or items in accordance with applicable requirements.
e d
Characteristic Any property or attribute of an item, process, or service that is distinct, describable, and measurable.
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.g GLOSSARY (Continued)
Close-out (Clear)
Documentation to show that the designated requirement has been met.
l Corrective Action Measures taken to rectify conditions adverse to quality and, where necessary, to preclude repetition.
CRA Change Request and Authorization Defect Any nonconformance, deviation, or deficiency of an item or activity from specified requirements.
Design Technical management processes which commence with identification of design input and which lead to and include the issuance of design output documents.
Design Check Review of design to assure complete and correct interpretation of design input and the completeness and accuracy of drafting effort.
Design Review A deliberately critical examination and evaluation g2 ensuring that designs clearly, accurately, and completely ed describe technical requirements of the item in sufficient detail for the appropriate design phase.
Deviation Written authorization to depart from a requirement for a specified number of items or a specified period of time.
Disposition The action required to close-out a nonconformance report.
Documentation Any written or pictorial information describing, defining, specifying reporting, or certifying activities, requirements, procedures, or results.
Drawing Check Review of drawings by drafting room personnel, other than-the assigned drafting technician, to assure conformance with drafting practices and specified requirements.
Examination An element of inspection consisting of investigation of materials, components, supplies, or services to determine conformance to those specified requirements which can be determined by such investigation.
Examination is usually nondestructive and includes simple physical manipulation, gaging, and measurement.
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Inspection Examination or measurement to verify whether an item or
\\j activity conforms to specified requirements.
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V GLOSSARY (Continued)
Inspector A qualified inspector employed by NES whose duties include the verification of quality related activities.
Item Any level of unit assembly, including assembly, component, part, structure, subassembly, subsystem, system, or material.
Measuring and Test Equipment Devices or systems used to calibrate, measure, gage, (M&TE) test, or inspect in order to control or to acquire data to verify conformance to specified requirements.
Nonconformance The condition of a characteristic, documentation, or procedure which renders the quality of an item or activity unacceptable or indeterminate.
Nonconformance Report A form used to document a nonconformance, its (NCR) disposition, and its close-out.
Objective Evidence Any documented statement of fact, other information, or record, either quantitative or qualitative, pertaining 7
to the quality of an item or service based on
- )
observations, measurements, or tests which can be V
verified.
Overcheck An additional check to the usual activity, such as additional nondestructive examination by a supervisor after the normal examination by an assigned technician.
Procedure A document that specifies or describes how an activity is to be performed.
Qualification (Personnel)
The characteristics or abilities gained through training or experience or both, as measured against established requirements such as standards or tests, that qualify an individual to perform a required function.
Quality Assurance (QA)
All those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service.
Quality Assurance Program Plan The limited program established in accordance with the (QAPP) documented requirements for a specific project.
Quality Assurance Record A record which furnishes documentary evidence of the required and obtained quality of items or activities affecting quality. A document is considered a quality assurance record when the document has been j
completed.
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GLOSSARY (Continued)
Quality Control Those quality assurance actions which provide a means to control and measure the characteristics of an item, process, or facility to established requirements.
Repair The process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safety is unimpaired even though that item still does not conform to the original requirement.
Report Document that gives information for record purposes.
Review A deliberately critical examination of planning, design, construction, and/or operation of a facility, component, item, or service.
Rework The process by which a nonconforming item is made to conform to prior specified requirements by completion, remachining, reassembling, or other corrective means.
Special Process A process, the results of which are highly dependent on the control of the process and the skill of the operators and in which determination of the desired quality cannot be made readily by means of inspecting the product which results from the process.
Surveillance Monitoring or observatic-to verify whether an item or activity conforms to specified requirements.
Testing The determination or verification of the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating conditions.
Traceability The ability to trace the history, application, or location of an item and like items or activities by means of recorded identification.
Use-As-Is A disposition which may be imposed for a nonconformance when it can be established that it will not result in an adverse condition and that the item under consideratien will continue to meet all engineering functional requirements including performance, maintainability, and safety.
Verification An act of conforming, substantiating, and assuring than an activity or condition has been implemented in conformance with specified requirements.
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