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QUALITY ASSURANCE MANUAL!

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QUALITY ASSURANCE MANUAL

TABLE OF CONTENTS

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INTRODUCTION June 3,1994

QUALITY POLICY June 3,1994

. QUALITY MANUAL MAINTENANCE AND DISTRIBUTION June 3,1994

QUALITY ASSURANCE PROGRAM (33.G.100, Rev.1) July 6,1994

APPENDIX A: QUALITY TERMS AND DEFINITIONS June 3,1994

APPENDIX B: CROSS-REFERENCE FOR NQA-1 June 3,1994,'

APPENDIX C: CROSS-REFERENCE FOR MIL-Q-9858A June 3,1994 !,

APPENDIX D: CROSS-REFERENCE FOR ADMINISTRATIVE PROCEDURES June 3,1994

|APPENDIX E: CROSS-REFERENCE FOR ADMINISTRATIVE PROCEDURES June 3,1994APPLICABLE TO USE OF PACKAGES FOR THE TRANSPORTOF RADIOACTIVE MATERIAL !,

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INTRODUCTION

MQS Inspection, Inc., a Delaware Corpora: ion,is headquartered in Elk Grove Village, Illinois. MQSlaspection,Inc. operates a third party inspection agency through a nationwide network of inspectionfacilities.

MQS Inspection, Inc. provides services for performing tests, inspections, nondestructive examina-tions, the development of quality programs, vendor surveillance, and other related services. 'Iheseservices are provided to a wide variety of clients in many different facets of the industrial andcommercial marketplace. MQS Inspection, Inc. does not manufacture any materials, parts, orcomponents.

The management of MQS Inspection, Inc. has made a commitment to continuous quality improve-ment. It is our goal to provide our clients with services that will be recognized as providing the bestcompetitive value. To reach this goal, MQS Inspection Inc. developed a quality management systemto better satisfy the needs of our clients and to improve management of the Company.

This manual provides documentation of the MQS Inspection. Inc. Quality system policies. Our qualitysystem complies with the requirements of the following documents:

ASME NQA-t-1992 Quality Assurance Program Requirements for Nuclear Facilities

MIL-Q-9858A Quality Program Requirements

ANSI /ASQC Q92 Quality Systems - Model for Quality Assurance in Production, installation, andServicing

API Spec Q1 API Specification for Quality Programs

Title 10 Code of Federal Regulations, Part 50, Appendix B

Title 10 Code of Federal Regulations, Part 21li Title 10 Code of Federal Regulations, Part 71

Each element of the above docmnents has been addressed in the MQS Inspection, Inc. QualityAssurance Program. Those considered not applicable to the services we provide have been noted as

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This manual provides the quality system requirements to be applied at every facility within MQSInspection, Inc. This manual will not provide detailed operating procedures, work instructions, ortest procedures. Each facility shall develop these documents to suit their needs while conformingand referring to the requirements stated in this manual.

Management Representative

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Rod Ret'pholdtVice President Laboratory OperationsMQS Inspection, Inc.

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OUALITY POLICY

MQS Inspection, Inc. will be recognized as providing the best value to our clients through a strategyof continuous improvement. It is the policy of MQS Inspection, Inc. to provide services that fullymeet our clients' expectations. MQS Inspection, Inc. has established an effective and economicalquality system to implement this policy. All employees are charged with the responsibility forimplementing and maintaining the quality system. ,

WHdgh V. I)oranPresidentMQS Inspection, Inc.

This policy has been formulated by the President of MQS Inspection, Inc. The policy is explainedand discussed at the QA indoctrination and training provided to all existing and new ea?ployees.

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OUALITY MANUAL MAINTENANCE AND DISTRIBUTIONi,

The contents of this manualare the responsibility of the Director of Quality Assurance. The Director- of Quality Assurance is authorized by the President of MQS Inspection, Inc. to develop, maintain,

and distribute the MQS Inspection, Inc. Quality Assurance Manual. The Quality Policy and QualityAssurance Manual are authorized by the President.

IRevisions to this manual may be requested by any employee or client of MQS Inspection, Inc.- Requests shall be forwarded to the Director of Quality Assurance for consideration andimplementation.'

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Copies of this manual shall be issued to all management personnel, each MQS Inspection Inc.4

.facility, and, upon request, to MQS Inspection, Inc. clients. For controlled distribution, a list of copy

'Jders is maintained by Quality Assurance. Only Quality Assurance or Quality Control is permitted'

7@ make and distribute copies of this manual. Copy holders are personally responsible for the upkeep ,

of their manual.

In some cases, it may be desirable to issue copies of this manual for information purposes only. In ;

such cases, it shall not be necessary to add the names of the receivers to the distribution list. For4

; this purpose, a copy marked " uncontrolled" shall be provided.

i Quality Assurance shall maintain a record of all revisions of this manual. A summary of QualityManual Revisions is included on the cover of this manual.j

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fWilmer G. Blankenship /Director of Quality Assuranc,

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QUALITY ASSURANCE PROGRAM

33.G.100

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OUALITY ASSUR ANCE PROGR AM ]

TABLE OF CONTENTS ,

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1.0 ORGANI2ATION 1

MANAGEMENT ORGANIZATIONAL CHART 4 -

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QUALITY ORGANIZATIONAL CHART . 5

2.0 QUALITY SYSTEM - 6

3.0 CONTRACT REVIEW 7 |:

4.0 DESIGN CONTROL 8

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5.0 DOCUMENT CONTROL 8

6.0 PURCHASING 9 ;

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7.0 CLIENT SUPPLIED EQUIPMENT AND MATERIALS 12'

8.0 PRODUCT IDENTIFICATION AND TRACEABILITY 13 |

9.0 CONTROL OF SPECIAL PROCESSES 14;

10.0 INSPECTION AND TESTING 14 |'

11.0 CONTROL OF MEASURING AND TEST EQUIPMENT 17

12.0 INSPECTION, TEST, AND EXAMINATION STATUS 18

13.0 NONCONFORMING MATERIALS. PARTS, OR COMPONENTS 18 3

14.0 CORRECTIVE ACTIONS 20 |

15.0 HANDLING, STORAGE, AND SHIPMENT 21 ,

16.0 QUALITY ASSURANCE RECORDS 21

17.0 AUDITS 24

18.0 TRAINING 26

19.0 STATISTICAL TECHNIQUES 27 ,

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1.0 ORGANIZATION i

|1.1 Reauirement

1.1.1 The executive management is ultimately responsible for establishing, implementing, andmaintaining the MQS Inspection, Inc. Quality System. Specific responsibilities includeformulating the quality policy, defining organization, assigning authorities andresponsibilities, appointing the Management Representative, periodically reviewing thequality system, and making available the resources and personnel necessary to maintainthe system.

1.2 Rennonsibilitiesr

1.2.1 The MQS Inspection, Inc. President is the Chief Operating Officer. He has theresponsibility for formulating the quality policy.<

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1.2.2 The President has appointed a member of the executive staff as the ManagementRepresentative. The Management Representative, irrespective of other responsibilities, 'has defined authority and responsibility for:

(A) Ensuring that quality system requirements are established, implemented, andmaintained in accordance with spplicable quality standards

(B) Reporting on the performance of the quality system to corporate management fora

review and as a basis for continuously improving the efficiency of the qualitysystem

(C) Acting as liaison with external bodies on matters relating to the MQS Inspection; Inc.'s quality system i

1.2.3 The Director of Quality Assurance (QA) is appointed by the President. The Director of |QA reports directly to the Management Representative and interfaces with facility |Managers. The Director of QA shall be responsible for development of the Quality ,

Assurance (QA) Program. He is also responsible for: |

(A) Development of amendments and/or revisions to the QA Program'

(B) Directing the development and implementation of Administrative Procedures for'

all facilities ),

(C) The performance of scheduled audits of the quality system implemented at each I

facility |. |

(D) Initiating or directing actions which result in solutions to quality problems andverifying results

(E) Determining and issuing stop-work directions with concurrence of the ManagementRepresentative

(F) Reviewing the QA program implementation and reporting the status to thePresident and Management Representative

i (G) Conducting QA Training of QC Manager

(H) Qualification and certification of audit personnel

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1.2.4 ' All corporate auditors shall be qualified and certified in accordance with writtenprocedures. Audit assignments shall be made by the Director of QA. Auditors shall-report directly to the Director of QA. Auditors shall be responsible for-

(A) Performing audits of MQS facilities

(B) Reporting audit results to the Director of QA

(C) Determining and issuing stop-work directions with concurrence of the Director ofQA

1.2.5 The Quality Control (QC) Manager is appointed by the Director of QA for the purposeof administering the requirements of the Quality Assurance Program and interfaces withFacility Quality Control (QC) Monitors. The QC Manager reports directly to the Directorof QA on matters relating to quality and is responsible for:

(A) Development of Administrative Procedures and their subsequent revisions and/oramendments

(B) Monitoring of personnel qualifications and certifications

(C) Providing assistance to the Director of QA in the auditing of facilities

(D) Determining and issuing stop-work directions with concurrence of the Director ofQA

(E) Conducting QA indoctrination and training of QC Monitors ||

1.2.6 The Document Control Manager is appointed by the QC Manager and reports directly |te the QC Manager on matters relating to quality. The Document Control Manager is |responsible for: |

|(A) Preparing QA/QC documents for distribution -

(B) Maintaining a master file of all documents developed by the QA/QC facility

(C) Distribution and recall of all documents issued by the QA/QC facility

(D) Maintaining records of all documents issued by the QA/QC facility

(E) Maintaining corporate records of personnel qualifications and certifications

1.2.7 The facility Managers are ultimately responsible for the quality performance of their j

facility. Each facility Manager is charged by the President with the responsibility forassuring that all services provided shall conform to contractual require::mnts. Eachfacility Manager shall identify in-house verific1 tion requirements, provide adequateresources, and assign qualified personnel for verification activities. Verification '

activities shall include inspections, tests, examinations, monitoring of personnel andprocesses, and internal audits of the facility's quality system. Audits of the facility'squality system and processes shall be carried out by personnel independent of thosehaving direct responsibility for the work being performed.

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1.2.8 A Quality Control Monitor is appointed by the QC Manager or Director cf QA for each ;

facility for the purpose of assisting in the implementation and surveillance of the quality |

)system established at their facility. They report directly to the facility Manager andinterface with facility personnel and the QC Manager. They are responsible for: ;

'i'(A) Development of Administrative Procedures and amendments to comply with |

specific requirements applicable to their Facility i

(B) Performing internal audits of facility operations and reporting status to the facility ;

Manager j

(C) Qualification of suppliers j

(D) Conducting QA training of facility personnel:'

(E) Reporting quality problems to the Director of QA or QC Manageri

(F) Determining and issuing stop-work directions with concurrence of the QA Director

(G) ' Acting as liaison with external bodies on' matters relating to their facility's quality ;system

1.2.9 The facility Supervisor (s) is/are appointed by the facility Manager. The Supervisor (s)is/are responsible for ensuring that qualified personnel are assigned to test, inspection, ,

'and examination activities, equipment is properly calibrated, test results are properlydocumented, signed, and dated and quality records are maintained.

1.2.10 Facility Level III personnel are ultimately responsible for the technical performance of I

personnel assigned to their respective areas. They are also responsible for providing. !

personnel training and procedures to control test, inspection, and examination functionsand ensuring that suitable quality plans are developed to meet client requirements. ,

1.2.11 The individual (s) assigned responsibility for implementing the QA Program may delegate ,

any or all of the work to others but shall retain responsibility therefore. All personnelassigned responsibility for performing work shall assure that quality is achieved and i

maintained. ;

1.2.12 The Quality System adopted to satisfy the requirements of this Quality Program shall be !

reviewed annually by the Company's executive management. The purpose of the review -

is to assess the effectiveness and continuing suitability of the quality system. The-Management Representative is responsible for scheduling and conducting the reviews ;

; and maintaining records of the reviews. These management reviews shall include the ;

assessment of the results of facility audits conducted by the QA Department.|

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PRESIDENT .

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EXECUTIVE VP VP CONTROLLER RADIATION VP

VP - MARKETING LAB SAFETY TECHNICAL >

OPERATIONS OFFICER OPERATIONS-

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MQS Inspection, Inc.

Quality Organizational Chart

MQSPRESIDENT

VP

LABORATORY

OPERATIONS

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DIRECTOR OF

QUALITYASSURANCE

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QC AuditorsManager

DocumentControlManager

Corporate

Facility Operations

Manager

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Supervisor Level 111 QC Monitor|-

Technicians

Approved . . W jf

Pfeside , MQS Inspection, Inc.

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2.0 OUALITY SYSTEM '

2.1 Reauirement

2.1.1 Each MQS Inspection, Inc. facility shall establish and maintain a documented QualitySystem as a means to ensure that all services provided conform to specified requirements.

2.2 Resoonsibility

2.2.1 The facility Managers are responsible for:

(A) Establishing the quality system for their facility

(B)' Preparation of their facility's Administrative Procedures in accordance with thismanual to include any client requirement

-(C) Identification and acquisition of any controls, processes, inspection equipment,resources, and skills that may be needed to achieve the required quality

(D) Updating, as necessary, of quality control, inspection, examination, and testingtechniques, including the development of new instrumentation

(E) Clarification of standards of acceptability. for all features and requirements,.

including those which contain a subjective element

(F) Identification and preparation of quality records

2.2.2 The facility Managers may delegate qualified personnel to perform any or all of theduties listed above provided they retain the responsibility for all work performed.

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2.2.3 All personnel who manage, perform, and verify work affecting quality are responsiblefor implementing the quality system.

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| 2.2.4 - The QC Monitor is responsible for coordinating, monitoring, and auditing the system attheir assigned facility.

2.2.5 The Director of QA is responsible for auditing the implementation of the quality systemat each facility.

2.3' Ouality System Elements

2.3.1 As a minimum the Quality System shall consist of the following subsystems:

(A) Document Control

(B) Control of Equipment. Materials, and Services

(C) Process Control

(D) Qualification and Certification of Personnel

(E) Audits and Corrective Actions

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: 2.4 Documentation

2.4.1 The Quality System is defined in the following documents:

(A) Quality Manual

(B) Operating (Administrative) Procedures

(C) Quality plans (Work Orders)

(D) Work instructions

2.4.2 These documents collectively define a quality system that complies with the applicablesections of all codes, standards, and specifications listed in the introduction to this-manual.

2.5~ Verification .

! 2.5.1. Implementation of the quality system is assessed regularly by way of internal andexternal audits and management reviews.

3.0 CONTR ACT REVIEW

3.1 Reauirement

3.1.1 All orders, requests for quote, and contracts shall be reviewed to ensure that clientrequirements are adequately defined, well understood, and documented. The review shallalso assess if the facility has the capacity to meet the contract requirements.

3.1.2 The review shall also give consideration to the commercial terms and conditions that thefacility is accepting.

3.2 Responsibility

3.2.1 Marketing has the responsibility for national contract review. Assistance from localfacilities and other departments shall be provided.

3.2.2 The facility Manager and/or Supervisor routinely reviews all contracts, requests forquote, and orders submitted to their facility. The facility sales person shall be includedin the review when deemed necessary by the facility Manager.

3.2.3 The facility Level III reviews customer prints and specifications, when appropriate, to' ensure technical specification compliance is maintained.

3.3 Review

3.3.1 Each contract or order shall be reviewed by the facility Manager and/or Supervisor.Where no written statement of requirement is available for an order received by verbalmeans, the facility Manager or Supervisor shall ensure that the order requirements areadequately defined by the client before acceptance of the order.

3.3.2 When applicable, the facility Level til shall review the contract or order for technicalspecification requirements.

3.3.3 Requirements which differ from those considered standard shall be resolved prior toacceptance of a contract or order.

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3.3.4 Amendments to contracts or orders shall receive the same review as the original contract,

or order.

3.3.5 All client requirements, including changes to the contract or order, shall be recordedon the work order. The work order shall be retained as a record of contract review and,if applicable, client change order.

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4.0 DESIGN CONTROL

4.1 The requirements for addressing Design Control are not applicable to the services offered.

- by MQS Inspection, Inc. in that the Company does not design or manufacture any parts; or components.

5.0 DOCUMENT CONTROL.

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5.1 Reauirement r

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5.1.1 The preparation, review, approval, issue, and change of documents that specify qualityrequirements or prescribe activities affecting quality shall be controlled. The documentcontrol system shall assure that correct documents are being employed and that obsolete . i

documents are removed from all points of issue anri use. Documents which are <.

controlled shall include the Quality Assurance Manual, Quality Assurance Program, |kAdministrative Procedures, work instructions, and changes thereto.

5.2 Responsibility.

5.2.1 A Master List or an equivalent document control system shall be maintained by the '

. Quality Control Manager and the Quality Control Monitor to identify the current revisioni of documents in order to preclude the use of nonapplicable documents. !

5.2.2 Changes to documents shall be reviewed and approved by the same organizations thatperformed the original review and approval unless specifically designated otherwise. The.

reviewing organizations shall have access to pertinent background information uponwhich to base their review and approval. The reviewing organizations shall have an,

adequate understanding of the requirements and intent of the original document.;

5.3 Document Preoaration. Anoroval. and issue

5.3.1 Procedures developed and implemented for document control shall assure that applicabledocuments, including changes, are reviewed for adequacy and approved for release by,

authorized personnel. All documents shall be maintained and distributed in a controlledi manner to assure that correct and applicable documents are available and used at the

location where the prescribed activity is performed.

5.3.2 Document control procedures shall provide for:

(A) Identification of documents to be controlled,

(B) Identification of personnel, positions, or organizations responsible for preparing,reviewing, approving, and issuing documents

(C) Review of documents for adequacy, completeness, and correctness prior to approval,

and issuance,e

: (D) Documentation method to be employed to assure compliance with this Program

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5.3.3 Documents may be in the form of hard copy media, or in electronic or other media.

5.4 Document Channes

5.4.1 Changes to documents, other than those defined as minor changes in 5.4.2, are consideredas major changes and shall be reviewed and approved as required by 5.3.

5.4.2 Minor changes to documents, such as inconsequential editorial corrections, shall notrequire that the revised documents receive the same review and approval as the originaldocuments. To avoid a possible omission of a required review, the type of minor changesthat do rnt require such a review and approval and the persons who can authorize sucha decision shall be clearly delineated in the document control procedure.

5.4.3 Changes to the Quality Assurance Program requested by clients shall be by writtenrequest to the Director of QA. Changes requested by clients to AdministrativeProcedures or work instructions may be completed locally and submitted to the clientproviding the Director of Quality Assurance or Quality Control Manager is notified ofthe changes.

'5.4.4 All changes are subject to Corporate approval.

5.5 Submittal

5.5.1 Copies of the Quality Assurance Manual, Administrative Procedures, and example workinstructions shall be submitted if specifically requested by a client or a prospective client.Controlled copies of these documents shall be submitted only if specifically requested.The copyright and all other rights to these documents are retained by MQS Inspection,Inc. and the use thereof in competition with MQS Inspection, Inc. is prohibited.

5.6 Anoroval

5.6.1 Written approval of the Quality Assurance Program and/or its component parts isrequested of all clients requesting documents for approval.

5.7 Invalid and/or Obsolete Documents

5.7.1 Invalid and/or obsolete documents shall be promptly removed from all points of issueor use, or otherwise assured against unintended use,

5.7.2 Any obsolete documents retained for legal and/or knowledge preservation purposes shall,

be suitably identified.

5.7.3 These requirements shall apply to all internal documents and, to the extent applicable,documents of external origin such as standards and client supplied documents.

6.0 PURCil ASING-

6.1 B.tnuirement

6.1.1 All equipment and materials which have calibration, performance, or conformance,

characteristics established by code, standard, contract, or this program are recognizedas having quality requirements and a record of procurement shall be maintained.

6.1.2 The services offered by MQS Inspection. Inc. are of such a nature that all equipment andmaterials used are considered commercial grade items. Assurance that items conformto procurement documents is accomplished through receiving inspection. All equipmentand materials shall be checked for conformance to the code, standard, or requirementsspecified on the procurement document.

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6.1.3 The performance of all equipment and materials shall be verified prior to use. Allequipment to be used shall be identified in an approved procedure and/or technique.

6.1.4 The applicable procurement requirements shall be extended to include organizations thatprovide services that impact on the quality of the services provided by MQS Inspection,Inc.

6.2 Resoonsibility

6.2.1 The facility Manager shall be responsible for final approval of all procurements for theirfacility. The Manager may delegate qualified personnel to make procurements on theirbehalf. All delegations of authority shall be made in writing.

6.2.2 Verification of quality requirements shall be the responsibility of the QC Monitorassigned to the cognizant facility. The QC Monitor shall be responsible for assuring that

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all purchased equipment, materials, nnd services meet the quality requirements stated onthe procurement documents.

6.2.3 Source verification and audit activities, when required to evaluate a suppliersperformance, shall be accomplished by qualified personnel assigned to check, inspect,audit, or witness the activities of suppliers.

6.2.4 The QC Monitor shall maintain a list of approved suppliers. The list shall be reviewedand approved at least annually by the facility Manager.

6.3 Suoolier Selection

6.3.1 The selection of suppliers shall be based on evaluation of their capability to provideitems or services in accordance with the requirements of the procurement documentsprior to award of contract. The selection of suppliers, and the type and extent of controlexercised, shall be dependent upon the type of product or service and, whereappropriate, on records of suppliers' previously demonstrated capability andperformance.

6.3.2 Procurement source evaluation and selection procedures shall be implemented by thepurchasing facility and shall provide for identification of the purchaser's organizationalresponsibilities for determining supplier capability.

6.4 Purenasina Data

6.4.1 Each procurement document shall contain data clearly describing the product or serviceordered, including, where applicable:

(A) The type, class, style, grade, or other precise identification

(B) The title or other positive identification, and applicable issue of specifications,drawings, process requirements, inspection instructions, and other retevant technicaldata, including requirements for approval or qualification of product, procedures,process equipment, and personnel

6.4.2 Applicable technical requirements shall be specified in the procurement documents.Where necessary, these requirements shall be specified by reference to specific drawings,specifications, codes, standards, regulations, procedures, or instructions, includingrevisions thereto that describe the items or services to be furnished. The procurementdocuments shall provide for identification of test, inspection, examination, andacceptance requirements of the purchaser for monitoring and evaluating the supplier'sperformance.

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6.4.3 Procurement documents shall require that the supplier have a documented quality !

. assurance program that implements portions or all of the requirements of this Program. ;

The extent of the program required shall depend upon the type and/or use of the item !

or service being procured. The procurement documents shall require the supplier to',

incorporate appropriate quality assurance program requirements in subtier procurement {dr,cuments.

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6.4.4 at each tier of a procurement, as applicable, the procurement documents shall provide ;

for access to the supplier's facilities and records for inspection or audit by the purchaser. |his designated representative, and/or other parties authorized by the purchaser. ;

- 6.5 Procurement Document Review |

6.5.1 A review of the procurement documents and changes thereto shall be made to assure that !i

; . documents transmitted to the prospective supplier (s) include appropriate provisions to'

assure that items or services will meet the specified requirements.'

; 6.5.2 Reviews shall be performed and documented to provide objective evidence of |satisfactory accomplishment of such review prior to release,

i 6.5.3 Changes made as a result of the bid evaluations or precontract negotiations shall be ;

incorporated into the procurement documents. The review of such changes and their i

effects shall be completed prior to release. This review shall incit;de the following ,

considerations: !st

j (A) Appropriate requirements specified in 6.4

(B) Determination of any additional or modified criteria,

I (C) Analysis of exceptions or ' changes requested or specified by the supplier anddetermination of the effects such changes may have on the intent of the procure-

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ment documents or quality of the item or service to be furnished,

6.5.4 - Reviews required by this section shall be performed by personnel who have access to ,

pertinent information and who have an adequate understanding of the requirements and'

intent of the procurement documents. ]-

6.5.5 Any amendments to the procurement documents shall be approved by the same personnel 4

that performed the original review and approval unless specifically designated otherwise i,

by the facility Manager. |f 6.6 Verification of Purchased items or Services |, <

6.6.1 Purchased items shall be inspected as necessary to verify conformance to specified I

requirements, taking into account source verification and audit activities and thedemonstrated quality performance of the supplier. Receiving inspection shall be !,

performed in accordance with established procedures and inspection instruction to verifyby objective evidence such features as proper configuration; identification; dimensional,

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physical, and other characteristics; freedom from shipping damage; and cleanness.t

6.6.2 in certain cases involving procurement of services only, such as third party inspection,.

engineering and consulting services, and installation, repair, overhaul calibration, ormaintenance work, the purchaser may accept the service by any or all of the followingmethods:

(A) Technical verification of data produced

; (B) Surveillance and/or audit of the activity

(C) Review of objective evidence for conformance to the procurement documentrequirements such as certifications, stress reports. etc.

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6.6.3 Activities performed to verify cont'ormance to requirements of procurement documentsshall be recorded. Source surveillances and inspections, audits, receiving inspections, (nonconformances, dispositions, waivers, and corrective actions shall be documented. The |

QC Monitor shall assure that this documentation is evaluated to determine the supplier's ;

quality assurance program effectiveness.

I6.6.4 Receiving inspection shall be coordinated with review of supplier documentation when

procurement documents require such documentation to be furnished prior to receivinginspection. (

6.7 Control of Suoolier Nonconformances

6.7.1 MQS Inspection, Inc. shall not accept any item, product, or service that does not meetprocurement document requirements. Records shall be maintained of all suppliersubmitted nonconformances.

6.7.2 Verification by the purchaser shall not absolve the supplier of the responsibility toprovide acceptable product nor shall it preclude subsequent rejection by the purchaser.

6.8 Procurement Records

6.8.1 Procurement documents may be issued to a supplier for each procurement or may beissued as a standing order against which procurements shall be made. All procurementtransactions shall be recorded and these records shall be maintained as nonpermanentrecords. Copies of procurement documents issued to a supplier shall be maintained untilallitems listed on the document have been accepted in accordance with 6.6.

7.0 CLIENT SUPPLIED EOUIPMENT AND M ATERIALS

7.1 Reouirement

7.1.1 Client supplied equipment and materials shall be calibrated, certified, and maintainedin the same manner as other purchased items. When specified in a contract, specialhandling instructions from clients shall take precedence over the Company's standardprocedures.

7.2 Resoonsibility

7.2.1 Each facility shall verify upon receipt that all client supplied equipment and/or materialsconforms to specified requirements. Verification by MQS Inspection, Inc. does notabsolve the client of the responsibility to provide acceptable equipment and/or materials.

7.3 Controls

7.3.1 All equipment and materials shall be stored and maintained in a manner that ensures theintegrity of the items for their intended purpose.

7.3.2 Any item that is lost, damaged, or otherwise unsuitable for use shall be recorded andreported to the client.

7.3.3 When client supplied equipment and/or materials are to be used for any test, inspection,and/or examination, a statement to this effect shall be included on the appropriate workorder and test report.

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8.0 PRODUCT IDENTIFICATION AND TR ACE ABil.lTY

8.1 Reauirement,

8.1.1 Procedures shall be developed and implemented for controlling and identifying materials,parts, and components, including partially fabricated assemblies throughout theexamination process and during shipment.

8.2 Resoonsibility.

8.2.1 Each individual involved in the examination process, including receiving inspection andshipping, shall be responsible for assuring traceability of all items and materials undertheir control.,

8.2.2 The QC Monitor shall monitor all operations to assure compliance with this requirement.

8.3 Identification Methods

8.3.1 Procedures developed for identification and control of materials intended for internaluse shall assure that identification is maintained either on the material or on recordstraceable to the material. These measures shall be designed to prevent the use ofincorrect or defective materials and those which have not received the requiredexaminations, tests, or inspections. The identification of all material used in theexamination, inspection, or testing process shall be recorded on the applicable test report.

8.3.2 Items of production (client's component /part) shall be identified from the initial receiptof the items up to and including shipping or return of items to the client. Thisidentification shall relate an item to an applicable design or other pertinent specifyingdocument. Items already examined and approved must be separately identified or ;

segregated from items awaiting examination. items examined and approved shall be kept I

identified until such time as their identity is necessarily obliterated by processing. Theidentification of all items shall be recorded on the applicable work order.

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8.3.3 Physical identification shall be used to the maximum extent possible. Where physicalidentification on the item is either impractical or insufficient, physical separation,procedural control, or other appropriate means shall be employed.

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8.3.4 ldentificatian markings, when used, shall be applied using materials and methods which l

provide a clear and legible identification and do not detrimentally affect the functioni or service life of the item or material. Markings shall be transferred to each part of an

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identified item or material when subdivided and shall not be obliterated or hidden by |

surface treatment or coatings unless other means of identification are substituted.

I8.4 Soecific Reauirements l

18.4.1 When specified by codes, standards, or specifications that include specific identification '

or traceability requirements (such as identification or traceability of the item toapplicable specification and grade of material; heat, batch, lot, part, or serial number;or specified inspection, test, or other records) the program shall be designed to providesuch identification and traceability control.

8.4.2 Provisions shall be made for the control of item identification consistent with the planned' duration and conditions of storage, such as:

(A) Provisions for maintenance or replacement of markings and identification recordsdue to damage during handling or aging

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8.4.2 (Continued)

(B) Protection of identifications on items subject to excessive deterioration due toenvironmental exposure

(C) Provisions for updating existing records |1

9.0 CONTROL OF SPECI AL PROCESSES i

9.1 Reauirement ,

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9.l.1 All special processes are controlled and performed in accordance with writteninstructions. Special processes are defined as any test, inspection, or examinationservices, including nondestructive examinations, offered by MQS Inspection, Inc.

9.2 Resoonsibility

9.2.1 All special processes shall be performed by qualified personnel using qualifiedprocedures in accordance with specified requirements. It is the responsibility of thepersonnel performing the special process to adhere to the approved procedures andprocesses.

9.3 Process Control

9.3.1 Processes shall be controlled by instructions, procedures, drawings, checklists, travelers,or other appropriate means. These means shall assure that process parameters arecontrolled and that specified environmental conditions are maintained.

9.3.2 Each special process shall be performed in accordance with appropriate writteninstructions which include or reference procedure, personnel, equipment, and materialqualification requirements.

9.3.3 Qualification of personnel, procedures, equipment, and materials shall comply withspecified requirements.

9.3.4 Conditions that are necessary for accomplishment of the process shall be included inwork instructions. These conditions shall include proper equipment and/or materials,controlled parameters of the process, and calibration requirements.

9.3.5 The requirements of applicable codes and standards, including acceptance criteria forthe process, shall be specified or referenced in the work instructions.

9.3.6 Records shall be maintained as appropriate for the currently qualified personnel,processes, equipment, and materials of each special process.

9.3.7 For special processes not covered by existing codes and standards or where qualityrequirements specified for an item exceed those of existing codes or standards, thenecessary requirements for qualifications of personnel, procedures, equipment, ormaterials shall be specified or referenced in the work instructions.

10.0 INSPECTION AND TESTING

10.1 B.tagirement

10.l.1 Inspection and testing is conducted when purchased equipment and materials or client'sparts are received, at significant stages of processing, and prior to return of client's parts.The objective of inspections and testing is to verify conformance with specifiedrequirements. Equipment, materials, and client's parts are prevented from use ordispatch until the required inspections, tests, and/or examinations are completed.Records of inspections, tests, and examinations are established and maintained asevidence that equipment, materials, and client's parts comply with stated requirements.

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10.2 Resoonsibility

10.2.1 The facility Manager or Supervisor shall ensure that received equipment, materials, orparts are not used or processed until they have been inspected or verified as conformingto specified requirements. When incoming equipment or materialis released for urgentuse,it shall be positively identified and recorded by the facility Manager or Supervisorin order to permit immediate recall and replacement in the event of nonconformance tospecified requirements.

10.2.2 Personnel performing inspections, tests, or examinations shall process parts as requiredby the quality plan (work order) and/or documented procedures. They shallidentify allnonconforming items and document all inspections, tests, and examinations.

10.2.3 The inspection of operations is conducted by the Quality Control Monitor at thelaboratory or project location. These individuals shall be independent of productionactivities during any inspection of operations. Additional individuals may be utilizedto conduct inspections when necessary providing they are independent of any productionresponsibility at the time of the inspection. The Director of Quality Assurance orManager of Quality Control may include process and/or personnel inspections in theiraudit activities.

10.2.4 The client shall be responsible for the disposition of their parts.

10.3 Insoeetion Hold Points

10.3.1 If mandatory inspection hold points are required beyond which work shall not proceedwithout the specific consent of the client's designated representative, the specific holdpoints shall be indicated in appropriate documents. Consent to waive specified holdpoints shall be recorded prior to continuation of work beyond the designated hold point.

10.4 Insocction Plannina |

10.4.1 Planning for inspection activities shall be accomplished and documented in the qualityplan (work order). The documentation shall identify characteristics, methods, applicablecodes, standards and specifications, and acceptance criteria, and shall provide forrecording objective evidence of inspection results.

10.4.2 Where a sample is used to verify acceptability of a group of items, the samplingprocedure shall be specified by the client and documented in the work order.

10.5 Receivine insoection

10.5.1 All equipment, materials, and parts, including client's parts, components, or materials,are subject to a receiving inspection.

10.5.2 For equipment and materials that are intended for internal use, the scope of the j

inspection shall include but is not limited to: |

(A) Review of material certifications. test records, compliance certificates, and othersuch documentation delivered with the items

(B) Visual inspection to detect any damage or other visible quality problems

(C) Performing any required testing or calibrations required

(D) Recording any applicable results

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10.5.3 All' parts or materials to be processed (client's parts, components or materials) shall beinspected for identification and freedom from shipping damage.

10.5.4 All equipment, parts, and materials passing the receiving inspection shall be identifiedand released for use or processing .

10.5.5 All nonconforming items shall be controlled in accordance with 13.0.

10.6 In-Process insoection

In-process inspections shall be performed for work activities where necessary to verify10.6.1-quality. If in-process inspection is impossible or disadvantageous, indirect control bymonitoring of processing methods, equipment, materials, and personnel shall be provided.Both in-process inspection and process monitoring shall be provided when control isinadequate without both.

10.6.2 Inspection and process monitoring methods, when used, shall be performed in asystematic manner to assure that the specified requirements for control of the processand accuracy of test results are being achieved throughout the duration of the process.

Controls, where required, shall be established and documented for the coordination and10.6.3sequencing of these activities at established inspection points during successive stages ofthe process.

10.7 Finni Insnection

10.7.1 All nonconformances identified with the test, inspection, or examination process shallbe resolved prior to final inspection. Final inspections shall include a records review ofthe results and identification of nonconformances identified by prior tests, inspections,or examinations. The final inspection shall be planned to arrive at a conclusion regardingconformance to specified requirements.

10.7.2 Completed items shall be inspected for completeness, markings, calibration, adjustments,protection from damage, or other characteristics as required to verify the quality andconformances of the item to specified requirements. Quality records shall be examinedfor adequacy and completeness if not previously so examined.

10.7.3 The acceptance or rejection of the client's item shall be documented and approved byauthorized personnel in accordance with the applicable work instructions.

10.7.4 Modifications, repairs, or replacements of items performed subsequent to final inspectionshall require reinspection or retest, as appropriate, to verify acceptability,

10.g Records

10.g.1 Records shall, as a minimum, identify:

(A) Item inspected

(B) Date of inspection, test, and/or examination

(C) Inspector

_(D) Personnel(E) Type of observation

(F) Results or acceptability

(G) Reference to information on action taken in connection with nonconformances(H) Procedure / specification reference

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11.0 CONTROL OF MEASURING AND TEST FOUIPMENT

11.1 Reouirements

11.1.1 All tools, gages, instruments, and other measuring, inspection, testing, and examinationdevices used ir. scrivities affecting quality shall be controlled. The established controlsshall assure that the required measurements accuracy is known and appropriateequipment is selected to perform the measurements.

11.2 Resoonsibility

11.2.1 It is the responsibility of the personnel using controlled measuring and test equipmentto adhere to the requirements stated herein. The QC Monitor of each facility shallmonitor compliance with this requirement.

11.3 Selection

11.3.1 Selection of measuring and test equipment shall be controlled to assure that such itemsare of proper type, range, accuracy, and tolerance to accomplish the function ofdetermining conformance to specified requirements.

11.4 Calibration and Control

i1.4.1 Measuring and test equipment shall be calibrated, adjusted, and maintained at prescribedintervals, and/or prior to use, against certified standards having known validrelationships to nationally recognized standards. If no nationally recognized standardsexists, the bases for calibration shall be documented.

I1.4.2 The methods and interval of calibration for each item shall be defined, based on the typeof equipment, stability characteristics, required accuracy, intended use, and othetconditions affecting measurement control. When measuring and test equipment is foundto be out of calibration, an evaluation shall be made and documented of the validity ofprevious inspection or test results and of the acceptability of items previously inspectedor tested. Out-of-calibration devices shall be tagged, segregated, and not used until theyhave been recalibrated. If any measuring or test equipment is consistently found to beout of calibration, it shall be repaired or replaced. A calibration shall be performedwhen the accuracy of the equipment is suspect.

I1.4.3 Calibration mn not be required for rulers, tape measures, levels, and other such devices,if normal commercial eouipment provides adequate accuracy.

11.4.4 Measuring and test equipment and measurement standards shall be calibrated and utilizedin an environment controlled to the extent necessary to assure continued measurementsof required accuracy. When applicable, compensating corrections shall be applied tocalibration results obtained in an environment which departs from standard conditions.

11.4.5 Written procedures shall be prepared or provided and utilized for calibration of allmeasuring and test equipment and measurement standards used to assure the accuracyof measurements involved in establishing product conformance. The procedures maybe a compilation of published standard practices or manufacturer's written instructionsand need not be rewritten. As a minimum the procedures shall specify:

(A) Details of equipment type

(B) Frequency of calibration

(C) Calibration method(D) Acceptance criteria

(E) Action to be taken when results are unsatisfactory

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11.5 Handline. Stornee. and Use

i11.5.1 Measuring and test equipment shall be properly handled and stored to maintain accuracy.

11.5.2 . Equipment shall be used in a manner which ensures that measurement uncertainty isknown and is consistent with the required measurement capability,

11.6 Records'

!!.6.1 Records shall be maintained and equipment shall be suitably marked to indicatecalibration status.

12.0 INSPECTION. TEST. AND EX AMINATION STATUSi

12.1 Recuirement

12.1,1 The status of all inspection, test, and examination i.ctivities shall be identified on theitems or in documents traceable to the items or materials where it is necessary to assure o

that required inspections, tests, and examinations are performed and to assure that itemsor materials which have not passed the required inspections, tests, and examinations arenot inadvertently installed or used.

12.2 Reanonsibility

12.2.1 The person performing a given test, inspection, or examination shall document the resultsand indicate the status as required. Each facility Supervisor shall assure that all requiredinspections, tests, and examinations have been performed prior to the items or materialsbeing used or released for shipment.

12.3 Svntem of Identifyine Stal.us;

12.3.1 Measures shall be established and documented to identify inspection, test, and examina-tion status. Such measures shall provide means for assuring that all required activities <

are performed and that the acceptability of items with regard to activity performed isknown. Nonconforming items shall be clearly identified.

12.3.2 The status of inspections, tests, and examinations shall be indicated by the use ofmarkings such as stamps, tags, labels, routing cards, or other suitable means.

12.3.3 Procedures shall be developed and implemented for control of status indicators includingthe authority for application and removal of tags, markings, labels, and stamps.

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13.0 NONCONFORMING M ATERI ALS. PARTS. OR COMPONENTS

13.1 Reauirement'

13.1.1 All materials, parts, or components to be used by the testing facility which do notconform to requirements shall be controlled in order to prevent their inadvertent use orinstallation. ,

13.1.2 Materials, parts, or components tested, inspected, and/or examined by the Company atthe request of the client, which are found to be in noncompliance with applicable !

specifications. shall be identified and/or segregated where possible. Documentation of ,

nonconforming items will be provided where test methods permit. I

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13.2 Renoonsibility i

13.2.1 Personnel performing the required inspections, tests, or examinations shall be responsible ,

for the prompt detection, recording, and verification of all nonconforming items and '

materials.!

13.2.2- The facility Manager shall be responsible for the technical review and disposition of all'

nonconforming items and materials intended for internal use.

13.2.3 The disposition and resolution of nonconforming materials, parts, or components tested I

by the Company at the request of the client shall be the responsibility of the client, j5

13.3 Identification

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13.3.1' identification of nonconforming items shall be by marking, tagging, or echer methodswhich shall not adversely affect the end use of the item. The identification shall belegible and easily recognizable. If identification of each nonconforir.ing ite:n is not ,

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practical, the container, package, or segregated storage area, as approntiate, shall beidentified.

13.4 ' herenation (items Intended for internal Use) ;

13.4.1 Nonconforming items shall be segregated, when possible, by placing them in a clearlyidentified and designated hold area until properly dispositioned. When segregation is -

impractical or impossible due to physical conditions,'such as size, weight, or access4

limitations, other precautions shall be employed to preclude inadvertent use of anonconforming item. ;

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13.5 Dinoosition fitems Intended for internal Use)

13.5.1 Nonconforming characteristics shall be reviewed and recommended dispositions of ,

nonconforming items shall be proposed and approved in accordance with documented .

procedures. Further processing, installation, or use of a nonconforming item shall be'controlled pending an evaluation and an approved disposition by authorized personnel.i

13.5.2 Personnel performing evaluations to determine disposition shall have demonstrated |competence in the specific area they are evaluating, have an adequate understanding of :the requirements, and have access to pertinent background information.

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13.5.3 The final disposition, such as use-as-is, reject, repair, or rework of nonconforming itemsshall be identified and documented. .

13.5.4 Technical justification for the acceptability of a nonconforming item, dispositionedrepair or use-as-is, shall be documented. The as-built records shall reflect the accepteddeviation.

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13.5.5 Repaired or reworked items shall be reexamined in accordance with applicable *

'procedures and with the original acceptance criteria unless the nonconforming item_ disposition has established alternate acceptance criteria. ,

13.6 Reportine ;

13.6.1- The identification'of conditions adverse to established levels, the cause of the condition,i

and the corrective action taken shall be documented and reported to appropriate levels iof management.

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13.7 Reportine of Defects and Noncomnliance (10CFR21)

13.7.1 Deviations identified in nuclear materials, parts, or components through test andinspection operations of MQS Inspection. Inc. shall be reported to the client or licenseefor evaluation.

13.7.2 The report of deviations shall be acknowledged by the signature of the recipient.

13.7.3 The disposition of the deviation shall be completed by the client or licensee and theCompany notified if reexamination is required.

13.7.4 MQS Corporate Management maintains the right to report any deviation directly to theCommission (NRC).

13.7.5 Suppliers of commercial grade items are exempt from the provisions of this part to theextent that they supply commercial grade items (see 6.6).

14.0 CORRECTIVE ACTIONS

14.1 Reauirement

14.1.1 All conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations,defective materials and equipment, and nonconformances, shall be promptly identifiedand corrected as soon as practical.

14.2 Resoonsibility

14.2.1 The Quality Control Monitor shall be responsible for investigating, identifying, andreporting nonconforming conditions to the appropriate levels of management. They shallalso be responsible for verification that appropriate corrective actions have beenimplemented and submitting all relevant information on the necessary corrective actionto management. Corrective actions shall be implemented by the facility responsible forthe process involved.

14.3 Process

14.3.1 Procedures shall be developed and implemented to assure that all conditions adverse toquality, including unsatisfactory practices, are identified and corrected by responsiblemanagement and technical personnel.

14.3.2 All nonconformities that have been identified from the analysis of finalinspection, testreports, and customer complaints shall be investigated.

14.3.3 In the case of a significant condition adverse to quality, the cause of the condition shallbe determined and corrective action taken to preclude recurrence. The identification,cause, and corrective action for significant conditions adverse to quality shall bedocumented and reported to appropriate levels of management.

14.3.4 Follow-up action shall be taken to verify implementation and effectiveness of correctiveactions.

14.3.5 A significant condition shall be defined as any condition that would allow acceptanceof nonconforming materials, parts, or components.

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15.0 HANDLING. STOR AGE. AND SIIIPMENT

15.1 Reauirement

15.1.1- The handling, storage, shipping, cleaning, packaging, and preservation of all materialsand items shall be controlled to prevent damage or loss and to minimize deterioration.These controls as applicable shall also be applied to materials, equipment, and itemsintended for internal use.

15.2 Resoonsibility

15.2.1 The QC Monitor shall direct all handling, storage, and shipment activities to assurecompliance with this section.

15.3 Process

15.3.1 Handiing, storage, and shipping of items shall be conducted in accordance withestablished work and inspection instructions, drawings, specifications, shipmentinstructions, or other pertinent documents or procedures specified for use in conductingthe activity.

15.3.2 When required for particular items, special equipment (such as containers, shockabsorbers, and accelerometers), and special protective environments (such as inert gasatmosphere, specific moisture content levels, and temperature levels) shall be specifiedand provided, and their existence verified.

15.3.3 When required for critical, sensitive, perishable, or high-value articles, specificprocedures for handling, storage, packaging, shipping, and preservation shall be used.

15.3.4 Special handling tools and equipment shall be utilized and controlled as necessary toensure safe and adequate handling. Special handling tools and equipment shall beinspected and tested in accordance with procedures and at specified time intervals toverify that the tools and equipment are adequately maintained. Operators of specialhandling and lifting equipment shall be experienced and/or trained in use of theequipment.

!15.3.5 Designated storage areas or stock rooms shall be used to prevent damage or deteriorationof product pending shipment or use,

15.4 Markinn

15.4.1 Instructions for marking and labeling for packaging, shipment, handling, and storage ofitems shall be established as necessary to adequately identify, maintain, and preserve theitem, including indication of the presence of special environments or the need for specialcontrols.

16.0 OUALITY ASSUR ANCE RECORDS

16.1 Reauirement

16.1.1 Sufficient records shall be maintained to furnish evidence of activities affecting quality.

16.2 Resoonsibility

16.2.1 The facility that generated the required records shall be responsible for their validation,indexing, distribution, identification, classification, retention, correction, preservation,safekeeping, retrieval, and disposition.

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16.3 Records Administration

16.3.1 A records system (s) shall be established by the organization responsible for ~ recordretention at the earliest practicable time consistent with the schedule for accomplishingwork activities and in compliance with the general requirements of this section. Therecords system (s) shall be defined, implemented,and enforced in accordance with writtenprocedures, instructions, or other documentation.

16.3.2 The applicable design specifications, procurement ' documents, test procedures,operational procedures, or other documents shall specify the records to be generated,supplied, or maintained. Documents that are designated to become records shall belegible, accurate, and completed appropriate to the work accomplished.

16.3.3 Documents shall be considered valid records only if stamped, initialed, or signed'anddated by authorized personnel or otherwise authenticated. This authentication may takethe form of a statement by the responsible individual or organization. Handwrittensignatures are not required if the document is clearly identified as a statement by thereporting individual or organization. These records may be originals or reproducedcopies.

16.3.4 The records shall be indexed. The indexing system (s) shall include, as a minimum,record retention times and the location of the record within the record system.

16.3.5 The records shall be distributed, handled, and controlled in accordance with writtenprocedures.

16.3.6 Records and/or indexing system (s) shall provide sufficient information to permitidentification between the record and the item (s) or activity (ies) to which it applies.

16.3.7 Records shall be classified as QA or QC in accordance with the criteria given in (A) and(B) below.

(A) QA records are those that meet one or more of the following criteria:

(1) Those which would be of significant value in demonstrating capability

(2) Those which would be of significant value in maintaining, reworking,repairing, replacing, or modifying an item

(3) Those which would be of significant value in determining the cause of anaccident or malfunction of an item

(B) QC records are those required to show evidence that an activity was performedin accordance with the applicable requirements but do not meet the criteria forQA records

16.3.8 Records shall be retained in accordance with the above classifications, QA records arerequired to be maintained as required by the client or five years, whichever is longer.The retention period for nonpermanent records shall be two years.

16.3.9 Records may be corrected provided the corrections are reviewed and approved by theoriginating organization. The correction shallinclude the date and the identification ofthe person authorized to issue such correction.

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16.4 Receiot

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16.4.1 The individual or organization responsible for receiving records shall provide protectionfrom damage or loss during the time that the records are in their possession.4

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16.4.2 Each organization responsible for the receipt of records shall designate a person ororganization responsible for receiving the records. The designee shall be responsible for ,

organizing and implementing a system of receipt control of records for permanent and<

temporary storage. As a minimum, a receipt control system shallinclude the following:,

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(A) A method for designating the required records>

(B) A method for identifying records received

-(C) Procedures for receipt and inspection of incoming records

16.4.3 Each receipt control system shall be structured to permit a current and accurateassessment of the status of records during the receiving process.

I16.5 Storane. Preservation. and Safekeeoing

16.5.1 The records shall be stored in predetermined location (s) that meet the requirements ofapplicable standards, codes, and regulatory agencies. Prior to storage of records, awritten storage procedure shall be prepared and responsibility assigned for enforcing the"

requirements of that procedure. This procedure shall include, as a minimum, thefollowing:>

(A) A description of the storage facility

; (B) The filing system to be used

(C) A method for verifying that the records received are in agreement with the; transmittal document and that the records are legible

(D) A method of verifying that the records are those designated (see 16.4.2).

(E) The rules governing access to and control of the files, ,

'(F) A method for maintaining control of and accountability for records removed from

the storage facility

(G) A method for filing supplemental information (see !6.3.9) and disposing ofsuperseded records'

16.5.2 Records shall be stored in a manner approved by the organization or organizations ;

responsible for storage. In order to preclude deterioration of the records the following !

requirements shall apply:.

(A) Provisions shall be made in the storage arrangement to prevent damage frommoisture, temperature, and pressure.

(B) Records shall be firmly attached in binders or placed in folders or envelopes for 1

storage in steel file cabinets or on shelving containers. I

(C) Provisions shall be made for special processed records (such as radiographs, )photographs, negatives, microfilm, and magnetic media) to prevent damage from

; excessive light, stacking, electromagnetic fields, temperature, and humidity.

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16.5.3 ~ Measures shall be established to preclude the entry of unauthorized personnel into thestorage area. These measures shall guard against larceny and vandalism. Measures shallbe taken to provide for replacement, restoration, or substitution of lost or damagedrecords.

16.5.4 Records shall be stored in facilities constructed and maintained in a manner whichminimizes the risk of damage or destruction from the following:

(A) Natural disasters such as winds, floods, or fires

(B) Environmental conditions such as high and low teeperatures and humidity

(C) Infestation of insects, mold, or rodents

16.6 Retrieval

16.6.1 Storage systems shall provide for retrieval of information in accordance with plannedretrieval times based upon the record type. Records maintained by a supplier at hisfacility or other location shall be accessible to the purchaser or his designated alternate.

16.7 Discosition

16.7.1- For records accumulated at various locations, the custodian shall inventory the submittals,acknowledge receipt, and process these records in accordance with this Program. Variousregulatory agencies have requirements concerning records that are within the scope ofthis Program. The most stringent requirements shall be used in determining the finaldisposition.

Nonpermanent records shall not be disposed of until the following applicable conditionsare satisfied:

(A) Items are released for shipment

(B) Regulatory requirements are satisfied

(C) Warranty consideration is satisfied

(D) Purchaser's requirements are satisfied:

17.0 AUDITS 1

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17.1 Reauirement

17.1.1 Planned and scheduled audits shall be performed to verify compliance with the QualityAssurance Program and to determine its effectiveness.

17.2 Resoonsibility

17.2.1 The Quality Assurance Department shall be responsible for conducting all external audits,reporting the results of the audits, and evaluating the audit responses.

17.2.2 The QC Monitor shall be responsible for conducting internal quality audits of theirassigned facility, They shall also be responsible for reporting results of the audits tothe facility Manager and evaluating audit responses.

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17.3.1 Internal and external quality assurance audits shall be scheduled in a manner to providecoverage and cooedination with ongoing Quality Assurance Program activities. Auditsshall be scheduled at a frequency commensurate with the status and importance of theactivity. The audit schedule shall be reviewed periodically and revised as necessary toassure that coverage is maintained current. Regularly scheduled audits shall be l

supplemented by additional audits of specific subjects when necessary to provide |

adequate coverage.

17.4 Preonration

17.4.1 The auditing organization shall develop and document an audit plan for each audit. Thisplan shall identify the audit scope, requirements, audit personnel, activities to be audited,organizations to be notified, applicable documents, schedule, and written procedures orcheckthts.

17.4.2 The auditing organization shall select and assign auditors who are independent of anydirect responsibility for performance of the activities which they will audit. In the case ;

of internal audits, personnel having direct responsibility for performing the activities [being audited shall not be involved in the selection of the audit team. Audit personnelhall have sufficient authority and organizational freedom to make the audit process

mnningful and effective.

17.4.3 An audit team shall be identified prior to the beginning of each audit. This team shallcontain one or more auditors and shall have an individual appointed to lead the teamwho organizes and directs the audit, coordinates the preparation and issuance of the audit ,

report, and evaluates responses. The audit team leader shall ensure that the audit team '

is prepared prior to initiation of the audit.

17.5 Performance

17.5.1 Audits shall be performed in accordance with written procedures or checklists as earlyin the life of the activity as practical and shall be continued at intervals consistent with jthe schedule for accomplishing the activity. Elements that have been selected for auditshall be evaluated against specified requirements. Objective evidence shall be examinedto the depth necessary to determine if these elements are being implemented effectively. I

Audit results shall be documented by auditing personnel and shall be reviewed bymanagement having responsibility for the area audited. Conditions requiring promptcorrective action shall be reported immediately to management of the audited organiza-tion. 1

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17.6 Reoortine

17.6.1 Reports of external audits shall be issued by the Director of QA to corporatemanagement and the Manager of the audited facility. The QC Monitor shall issue areport of internal audits to their facility Manager.

17.7 Resoonse j

i17.7.1 Management of the audited organization or activity shall investigate adverse audit ;

findings, schedule corrective action, identify the root cause, including measures to :prevent recurrence, and notify the appropriate organization in writing of action taken i

or planned. The adequacy of audit responses shall be evaluated by or for the auditing |organization. j

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17.8 Follow-Uo Action

17.8.1 Actions taken to correct adverse audit findings shall be verified.

17.9 Records

17.9.1 Audit records shall include audit plans, audit reports, written replies, and the record ofcompletion of corrective action.

17.9.2 Audit records shall be maintained for a minimum of two years.

18.0 TRAINING

18.1 Reauirement

18.1.1 All personnel performing activities affecting quality shall be qualified on the basis ofappropriate education, training, and experience as required.

18.2 Responsibility

18.2.1 The training, qualification, and certification of personnel performing inspections, tests,and examinations shall be the responsibility of a Level 111 certified in the applicablemethod.

18.2.2 The Director of QA shall be responsible for training audit personnel.

18.2.3 The facility Supervisor shall be responsible for job assignments based on employees'capability, experience, and certification.

13.2.4 The Director of Q A, QC Manager, and Quality Control Monitors shall be responsible forconducting QA indoctrination and training of personnel.

18.3 Procedure

18.3.1 The facility Manager and/or Supervisor shallidentify training needs of their personnel.They shall set training priorities and determine what resources are needed to ensure thatshort-term and long-term training is provided.

18.3.2 All personnel responsible for performing quality affecting activities shall receive QAindoctrination and training. The purpose of the training program is to familiarizeemployees with the quality system, stressing the importance and meaning of QualityAssursnce/ Quality Control as it applies to the employee's position. The following itemsshall be covered in the training program.

(A) Objectives of the Quality Assurance Program

(B) Quality Assurance organization and how it affects the duties and responsibilities of *

the employee

(C) Contents of the Quality system documents with specific emphasis placed on thosedocuments which most directly affect the employee's position

18.3.3 The facility Level ill shall continually review and update job descriptions, job duties,and qualifications necessary to ensure that high standards of performance are maintained _

that will ensure quality services. |

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18.3.4 Training shall be conducted when:

(A) The employee's duties and/or responsibilities change ;

(B) A change in the quality system documentation affects the employee's position I

(C) Required by Code, standards or clients

18.3.5 All personnel shall be qualified and certified in accordance with the facility's written ,

procedure.

18.4 Records

18.4.1 Documentation of training programs shall include:

(A) Objectives and content of the program

(B) Attendees

(C) Date(s) of attendance

(D) Instructor|

18.4.2 The QC Department shall maintain records of personnel training qualification andcertification.

19.0 STATISTICAL TECHNIOUES :

19.1 Reauirement

19.1.1 Where appropriate, each facility shall establish procedures for identifying adequatestatistical techniques required for verifying the acceptability of process capability and 3

product characteristics.

19.2 Responsibility

19.2.1 The facility Manager shall identify when and where statistical techniques shall beapplied.

19.2.2 The QC Monitor shall verify that all statistical techniques are employed in accordancewith written procedures.

19.3' Process Analvsis and Statistical Samolin_g

19.3.1 When required statistical techniques are employed in process analysis and statisticalsampling. Personnel using statistical techniques are provided with charts, tables, andother instructions in the use of the techniques.

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APPENDIX A

QUALITY TERMS AND DEFINITIONS |i

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This section contains certain terms and their definitions that are important to the understanding of Jthis Quality Assurance Program and the related procedures and documents. j

Acceptance The quality or state of being accepted, in that results of test, inspection, or :

examination results within specified limits may meet acceptance.'

Amendment An addendum or change in a procedure to allow its use in special situations.

Approval An act of endorsing or adding positive authorization or both. I

Audit An activity to determine, through investigation, the adequacy of and adherence ,

to established procedures, instructions, specifications, codes, and standards or i

other applicable contractual and license requirements, and the effectiveness of !

implementation. j

Calibration To determine the deviation from a standard so as to ascertain proper correction I

factors and/or adjust accordingly.'

Certification The action of determining, verifying, and attesting in writing, to thequalifications of personnel or materials.

Client That firm of person engaging the services of the Company.

Commercial An item satisfying (A),(B), and (C) below:Grade item

(A) Not subject to design specification requirements that are unique to nuclearfacilities

(B) Used in applications other than nuclear facilities

(C) Is to be ordered from the manufacturer / supplier on the basis ofspecifications set forth in the manufacturer's published product description(for example, catalog)

i Component A piece of equipment or item such as a vessel, piping, pump, valve, or structurewhich will be combined with other components to form an assembly unit. ;

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Conformance Meeting the physical characteristics (within tolerances) prescribed by a specifica-,

tion or standard.

Contractor An organization under contract for furnishing items or services. It includes the |terms, vendor, supplier, sub-contractor, fabricator, and sub-levels of these where

; appropriate,,

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Controlled The regulation of documents in that their issue, use, and revision and retrieval ,

'is res: rained.

Corrective An action taken to eliminate the causes of an existing nonconformance, defect I

Action or other undesirable situation or condition.

Correction A change to a document which does not change the technical contents but changessomething which was in error, i.e., spelling, numbering errors, punctuation,omissions. (See Revision.) ,

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Defective A material or component which has one or more characteristics that do notcomply with material specified requirements.

Deficiencies - The state of lacking of quality or element, resulting in a situation that is not upto standard.

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Document A communication, instruction, report, or record wherein the contents are writtenand subsequently become evidence.

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Documentation Any written or pictorial information describing, defining, specifying, reporting, - I

or certifying activities, requirements, procedures, or results.;

Esamanal u An element of inspection consisting of investigation of materials, components,supplies, or services to determine conformance to those specified requirementswhich can be determined by such investigation. Examination is usuallynondestructive and includes simple physical manipulation, gauging, andmeasurement. |

Facility A Company laboratory, field office, project, or function that is built orestablished to service a particular purpose. -

Guidelines Particular provisions which are considered good practice but which are not!mandatory in programs intended to comply with this standard. The term "should"

denotes a guideline; the term "shall" denotes a mandatory requirement.,

laspection A phase of quality control which by means of examination, observation ormeasurement determines the conformance of materials, supplies, components,parts, appurienances, systems, processes, or structures to predetermined qualityrequirements.

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| Item Any level of unit assembly, including structure, system, subsystem subassembly, !

; component, part, or material.t

Material A substance or combination of substances such as penetrants, powders, film,i couplants, etc., used in testing, inspection, and examinations.

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! Method Refers herein to the various disciplines of test, inspection and examination] processes, such as radiography, ultrasonics, etc.

Modification A planned change in design or operation and accomplished in accordance with4 the requirements and limitations of applicable codes, standards, specifications,

.|; licenses, and predetermined safety restrictions.t

Monitor (QC) A qualified person employed by the Company having authorized jurisdiction atfacility whose duties include the verification of quality related activities or

j installation or both. >

1 Monitoring To watch, observe or check a process or procedure as a part of regulating quality.

I Nonconformance A deficiency in characteristic, documentation, or procedure which renders the !quality of an item unacceptable or indeterminate. Examples of nonconformance'

; include physical defects, test failures, incorrect or inadequate documentation, or |!deviation from prescribed processing, inspection, or test procedures.

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Part An item which has work performed on it and which is attached to and becomes ;

part of a component before completion of the component.

! Preparation Preparing a document for issue: (typing, formatting...)(Documentation)

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Procedure A document that specifies or describes how an activity is to be performed. It may'

include methods to be employed, equipment or materials to be used, and sequence ;

of operation.

Procurement Contractually binding documents that identify and define the requirements which'

Documents . items or services must meet in order to be considered acceptable by the purchaser.

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Qualification The characteristics or abilities gained through training or experience or both that(Personnel) enables an individual to perform a required function.

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i Receiving Taking delivery of an item at a designated location.

Records All records generated from test and inspection and quality assurance activities. |4

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Repair The process of restoring a nonconforming characteristic to a condition such thatthe capability of the item to function reliably and safely is unimpaired eventhough the item still nay not conform to the original specification.

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j Report A document that records information for record purposes.

Revision A change in a procedure or document to update or improve. A revision changesthe technical contents of the document. (See Correction.) |

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Rework The process by which a nonconforming item is made to conform to a priorspecified requirement by completion, remachining, reassembling, or other,

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! corrective means.

Shall This word is a directive indicating a mandatory requirement.i !

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Should This word is a suggestion indicating a desirable recommendation that is not| necessarily mandatory,

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Specification A concise statement of a set of requirements to be satisfied by a product, amaterial or process indicating whenever appropriate, the procedure by means ofwhich it may be determined whether the requirements given are satisfied.;

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i Standard The result of a particular standardization effort approved by a recognizedauthority.

Supplier A firm that supplies items or services as ordered.

Surveillance Witnessing or monitoring an operation or system.

System A group of subsystems united by some interaction or interdependence, performingmany duties but functioning as a single unit.

Technician A qualified person who uses a procedure, equipment, and/or materials to performcertain tests and examinations. 1

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Testing The determination or verification of the capability of an item to meet specifiedrequirements by subjecting the item to a set of physical, chemical, environmental,or operating conditions.

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Uncontrolled Referring to documents that are not regulated in their distribution, use, orretrieval. 3

Verification An act of confirming, substantiating, and assuring that an activity or condition ,

has been implemented in conformance with the specified requirements.

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APPENDIX B1

CROSS-REFERENCE FOR NOA-1

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: 1 Organization 1.0

| 2 Quality Assurance Program 2.0 ,

3 Design Control 4.04 Procurement Document Control 6.05 Instructions, Procedures, and Drawings 2.0

: 6 Document Control 5.0,

3 7 Control of Purchased Items and Services 6.0! 8 Identification and Control of items 8.0

9 Control of Processes 9.0.;

1 10 Inspection 10.0

.! 11 Test Control 9.012 Control of Measuring and Test Equipment i 1.0 .

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13 Ilandling, Storage, and Shipment 15.0 - '

14 Inspection, Test, and Operating Status 12.0

15 Control of Nonconforming items 13.0'

16 Corrective Action 14.0

[ 17 Quality Assurance Records 16.0' 18 Audits 17.0

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CROSS-REFERENCE FOR MIL-O-9858A

MIL-O-9858 A 33.G.100. Rev. I :'

3.1 Organization 1.0'

3.2 Initial Quality Plan 3.03.3 Work Instructions 2.4

4 3.4 Records 16.03.5 Corrective Action 14.03.6 Costs Related to Quality N/A'

4.1 Drawings, Documentation, and Changes 4.0'

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4.2 Measuring and Test Equipment 11.04.3 ' Production Tooling Used as Media of Inspection 11.04.4 Use of Contractor's Inspection Equipment 9.3.24.5 Advanced Metrology Requirements 3.05.1 Responsibility (Control of Purchases) 6.25.2 Purchasing Data 6.46.1 Materials and Materials Control 10.56.2 Production Processing and Fabrication 9.0,

6.3 Completed Item Inspection and Testing 10.7,

6.4 Handling, Storage, and Delivery 15.06.5 Nonconforming Materials 13.06.6 Statistical Quality Control and Analysis 19.06.7 Indication of laspection Status 12.07.1 Government Inspection at Subcontractor or Vendor Facilities 6.4.47.2 Government Property 7.0'

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4 APPENDIX E ,

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CROSS REFERENCE FOR ADMINISTRATIVE PROCEDURES APPLICABLE TO USE OF,

PACKAGES FOR THE TRANSPORT OF RADIOACTIVE MATERIAL j

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3.0 Contract Review N/A.

4.0 Design Control N/A5.0 Document Control 30.G.7 & 30.G.10

6.0 Purchasing 30.J.5,

! 7.0 Client Supplied Equipment and Materials N/A8.0 Product identification and Traceability 30.J.2 & 30.J.5

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9.0 Controlof Special Processes 30.J.2,30.J.5,30.J.7, & 30.J.8i 10.0 Inspection and Testag 303.2,30J.5,30J.7, & 30.J.8

{ 11.0 Control of Measuring and Test Equipment 303.2, 303.3, 303.4, & 30.J.7

| 12.0 fayiaa. Test, and Fv=ia=' ion Status 30J.2,30.J.5, & 30J.8

| 13.0 N-v= forming Materials, Parts, or C -ig- - a 30J.2,303.5, & 303.814.0 Corrective Actions 30.G.6

15.0 13 dia . Storage, and Shipment 303.2 and 303.51 16.0 Quality Assurance Records 303.2

17.0 Audits 30.G.5'

;18.0 Traming 30.G.3 & 30.G.419.0 StatisticalTechniques N/A'

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