rnii quality manual - emerson quality manual revision ab d9000115 january 1, 2011 page 2 of 47...

RNII QUALITY MANUAL

Document Number D9000115 Revision AB

January 1, 2011

RNII Quality Manual Revision AB D9000115 January 1, 2011

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QUALITY MANUAL CONTROL PAGE

Controlled Copy Number: Issued to: Organization: The RNII Quality Manual is a controlled document. It is subject to audit and recall and, therefore, should be carefully maintained and kept readily available. The person listed above is responsible for keeping it up-to-date. The quality manual is the property of Rosemount Nuclear Instruments, Inc. and must be returned upon request.


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RNII QUALITY POLICY & MANAGEMENT COMMITMENT

Top management supports all efforts to comply with this quality manual. The quality management system described in this manual is representative of RNII’s commitment to continual improvement, employee involvement, and customer satisfaction. Quality Policy

QUALITY POLICY

Total customer satisfaction is our primary goal.

Quality is everyone’s responsibility.

We apply continuous improvement to all that we do.

Management Commitment The leaders of Rosemount Nuclear Instruments, Inc. endorse the policies in this manual and certify that this manual correctly describes the quality management system. As indicated by the signatures below, top management affirms that it periodically reviews the status and adequacy of the quality management system.

_____________________________________________ Marc Bumgarner, Vice President & General Manager Rosemount Nuclear Instruments, Inc.

_____________________________________________ Duyen Pham, Quality Manager Rosemount Nuclear Instruments, Inc.


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TABLE OF CONTENTS

Section Title Page RNII Quality Policy & Management Commitment ...................................3 Table of Contents ...................................................................................4 List of Figures .........................................................................................5 Quality Manual Document Control ..........................................................6 Quality Standards Compliance Matrix ....................................................7 RNII Operating Procedures ....................................................................8 1 Organization ...........................................................................................9 2 Quality Management System................................................................ 11 3 Design Control ...................................................................................... 16 4 Procurement Document Control ........................................................... 19 5 Instructions, Procedures, and Drawings ............................................... 20 6 Document Control ................................................................................. 21 7 Control of Purchased Material, Equipment, and Services .................... 22 8 Identification and Control of Materials, Parts, and Components ........... 24 9 Control of Special Processes................................................................ 25 10 Inspection ............................................................................................. 26 11 Test Control .......................................................................................... 28 12 Control of Measuring and Test Equipment ........................................... 29 13 Handling, Storage, and Shipping .......................................................... 30 14 Inspection, Test, and Operating Status ................................................ 31 15 Nonconforming Materials, Parts, or Components ................................. 32 16 Corrective Action .................................................................................. 33 17 Quality Records .................................................................................... 34 18 Audits ................................................................................................... 36 19 Tender and Contract ............................................................................. 38 20 Customer-Supplied Product.................................................................. 39 21 Feedback and Improvement ................................................................. 40 Appendices: A Revision History .................................................................................... 42 B Terms and Definitions ........................................................................... 44


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LIST OF FIGURES

Figure Title Page 1.1 RNII Organizational Structure .................................................................9 2.2.5 RNII Quality Management System Process Model ............................... 12 2.5.1 RNII Quality Management System Documentation .............................. 13


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QUALITY MANUAL DOCUMENT CONTROL

1.0 MAINTENANCE RESPONSIBILITY The RNII Quality Manual is developed and maintained by the Quality Group. 2.0 APPROVALS The Quality Group submits changes for management approval. Final approval is given by: Vice President & General Manager, Rosemount Nuclear Instruments, Inc. Quality Manager, Rosemount Nuclear Instruments, Inc. 3.0 MASTER The master of the RNII Quality Manual is maintained by Central Services. The master cannot be removed from Central Services unless authorized by the Quality Manager. The on-line Quality Manual is maintained by the Quality Group. 4.0 ON-LINE VERSION The RNII Quality Manual is available on the company intranet. The on-line version may have a slightly different appearance resulting from the document format but it is a controlled copy of the master. Changes to the on-line document are made simultaneously with changes to the hard copy version. 5.0 CHANGE MECHANISM Proposed changes to the RNII Quality Manual are submitted per the quality system change process defined in RNII Operating Procedure 0210. 6.0 DISASTER BACKUP An electronic copy of the RNII Quality Manual is maintained by the Quality Group. 7.0 REVIEW Affected sections of the RNII Quality Manual are reviewed whenever Operating Procedures (OPs) are revised. This review ensures that the Quality Manual is consistent with OPs and actual practice.


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QUALITY STANDARDS COMPLIANCE MATRIX

RNII Quality Manual 10CFR50 Appendix B

NQA-1- 1994

ISO 9001:2008 CSA CAN3-Z299.1-85

IAEA 50-C-Q

KTA 1401 Section Title

1 Organization I 1 5.5.1, 5.5.2, 5.5.3, 6.1 3.2.1, 3.2.3,

3.2.4 201, 202 4.2, 4.3

2 Quality Management System

II 2

1.1, 4.1, 4.2.1, 4.2.2, 5.1-5.3, 5.4.1, 5.4.2, 5.6.1-

5.6.3, 6.2.1, 6.2.2, 6.3, 6.4, 7.1, 7.5.1

3.1, 3.2.2, 3.2.6, 3.3, 3.5.6.1,

3.5.6.2, 3.5.13

201 - 205 206, 209, 210, 309

3, 4.4, 5.5

3 Design Control III 3 7.2.1, 7.3.1-7.3.7 3.5.2 304, 305 5

4 Procurement Document Control

IV 4 7.4.2, 7.4.3 -- 306 - 310 6

5 Instructions, Procedures, and Drawings

V 5 7.5.1 3.5.13 209, 210 12

6 Document Control VI 6 4.2.3 3.5.3 209, 210 12

7 Control of Purchased Material, Equipment, and Services

VII 7 7.4.1, 7.4.3 3.5.5 306 - 310 6

8 Identification and Control of Materials, Parts, and Components

VIII 8 7.5.3, 7.5.5 3.5.11 302 7.3

9 Control of Special Processes

IX 9 7.5.2 3.5.14.1, 3.5.14.2, 3.5.14.3

206 4.4

10 Inspection X 10 8.2.4 3.2.5, 3.5.7, 3.5.8, 3.5.9,

3.5.20

301, 303, 309, 310

7

11 Test Control XI 11 -- 301, 303 7

12 Control of Measuring and Test Equipment

XII 12 7.6 3.5.4 303 10

13 Handling, Storage, and Shipping

XIII 13 7.5.5 3.5.12, 3.5.15 302 7.3

14 Inspection, Test, and Operating Status

XIV 14 7.5.3, 8.2.4 3.5.10 301, 303, 309, 310

7

15 Nonconforming Materials, Parts, or Components

XV 15 8.3 3.5.17.1, 3.5.17.2, 3.5.17.3

207 11

16 Corrective Action XVI 16 8.5.2 3.5.18 207 11

17 Quality Records XVII 17 4.2.4 3.5.16 210 12

18 Audits XVIII 18 8.2.2 3.5.21.1, 3.5.21.2

401 - 405 13

19 Tender and Contract -- -- 7.2.1, 7.2.2, 7.2.3 3.5.1 -- 5

20 Customer-Supplied Product

-- -- 7.5.4 3.5.19 -- --

21 Feedback and Improvement

-- -- 8.1, 8.2.1, 8.2.3, 8.4, 8.5.1, 8.5.3

-- 208 --


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RNII OPERATING PROCEDURES

OP TITLE 0150 Management Responsibility 0210 Quality Management System 0220 RNII Training 0310 Design Development 0320 Nuclear Product Baseline Documentation and Revision Control 0330 Numbering Convention 0340 Engineering Change Orders 0370 Engineering Project Files 0410 Procurement Document Control 0510 Manufacturing Procedures 0610 Document Control 0710 Selection and Approval of Suppliers 0720 Control of Purchased Safety-Related Components 0730 Receiving Inspection 0740 Service Agreements 0810 Product Identification and Traceability 0910 Special Processes 1010 Inspection 1020 Data Review and Certification 1110 Test Control 1120 Production Software Control 1210 Metrology 1310 Material Handling, Storage, and Shipping 1410 Inspection, Test and Operating Status 1510 Nonconforming Material Control 1610 Corrective Action 1620 Implementation of 10CFR Part 21 1710 Record Requirements 1810 Quality Audits 1910 Order Control and Contract Administration 2010 Customer-Supplied Product 2110 Continual Improvement


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SECTION 1 ORGANIZATION

This section identifies the groups within RNII that have responsibilities within the quality management system. 1.1 General The entire Rosemount Nuclear Instruments, Inc. (RNII) organization, illustrated in Figure 1.1, participates in the quality management system. Top management is responsible for the establishment and execution of the quality management system. The authority, responsibilities, and duties of persons and organizations are clearly established and delineated in writing. RNII may delegate to others, such as contractors, agents, or consultants, the work of establishing and maintaining the quality system, but responsibility is retained by RNII.

Figure 1.1. RNII Organizational Structure 1.2 Management Representative The quality manager has responsibility and authority for: a) ensuring that processes needed for the quality management system are established, implemented

and maintained; b) reporting to top management on the performance of the quality management system and any need

for improvement; and c) ensuring the promotion of awareness of customer and applicable statutory and regulatory

requirements throughout the organization. 1.3 Independence of Quality Personnel As shown in Figure 1.1, persons performing quality functions report to the quality manager and therefore have sufficient authority and organizational freedom to: a) identify quality problems; b) initiate, recommend, or provide solutions; and c) verify implementation of solutions.

President, RNII

VP & General Manager, RNII

Marketing / Sales

Accounting / Finance

Quality Engineering Operations / Contracts

Manufacturing


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1.4 Internal Communication Top management ensures that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 1.5 Provision of Resources RNII determines and provides the resources needed to: a) implement and maintain the quality management system and continually improve its effectiveness;

and b) enhance customer satisfaction by meeting customer and applicable statutory and regulatory

requirements.


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SECTION 2 QUALITY MANAGEMENT SYSTEM

This section describes the overall structure of the RNII quality management system; assigns responsibilities for the development, implementation and maintenance of the system; delineates the hierarchy of governing documents; and identifies the regulatory basis. 2.1 Management Responsibility 2.1.1 Management Commitment Top management shows evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements; b) establishing the quality policy; c) ensuring that quality objectives are established; d) conducting management reviews; and e) ensuring the availability of resources. 2.1.2 Customer Focus Top management ensures that customer and applicable statutory and regulatory requirements are determined and are met with the aim of enhancing customer satisfaction. 2.1.3 Quality Policy Top management ensures that the quality policy: a) is appropriate to the purpose of the organization; b) includes a commitment to comply with requirements and continually improve the effectiveness of the

quality management system; c) provides a framework for establishing and reviewing quality objectives; d) is communicated and understood within the organization; and e) is reviewed for continuing suitability. 2.2 Planning 2.2.1 General Requirements The organization establishes, documents, implements, and maintains a quality management system and continually improves its effectiveness. RNII: a) identifies the processes needed for the quality management system and their application throughout

the organization; b) determines the sequence and interaction of these processes; c) determines criteria and methods needed to ensure that both the operation and control of these

processes are effective; d) ensures the availability of resources and information necessary to support the operation and

monitoring of these processes; e) monitors, measures, and analyses these processes; and f) implements actions necessary to achieve planned results and continual improvement of these

processes.


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2.2.2 Quality Objectives Top management ensures that quality objectives, including those needed to meet the requirements for product, are established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy. 2.2.3 Strategic Planning The RNII strategic plan defines the organization's long-term objectives, outlines broad strategies and specific tactics, and specifies business measures and quality objectives. The strategic plan is updated by top management on an annual basis and is distributed and communicated to appropriate personnel. It may be revised and updated by top management periodically throughout the year. 2.2.4 Quality Management System (QMS) Planning Top management ensures that: a) the planning of the quality management system is carried out in order to implement the process

model shown in Figure 2.2.5, as well as to meet the quality objectives; and b) the integrity of the quality management system is maintained when changes to the quality

management system are planned and implemented. 2.2.5 Process Model RNII's Quality Management System process model is shown in Figure 2.2.5. The model provides a pictorial representation of the QMS processes and their interactions.

Figure 2.2.5. RNII Quality Management System Process Model.


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2.3 Scope of Quality Program The RNII quality management system meets the requirements of 10CFR50 Appendix B, NQA-1-1994, CSA CAN3-Z299.1-85, IAEA 50-C-Q, and ISO 9001:2008. In addition, the RNII quality system meets the intent of CSA N285.0-95 and KTA 1401, and satisfies the reporting requirements of 10CFR Part 21. RNII's quality management system: a) demonstrates its ability to consistently provide product that meets customer and applicable regulatory

requirements; and b) enhances customer satisfaction. 2.4 Application Top management identifies the structures, systems, and components to be covered by the quality management system. Activities affecting quality are controlled to an extent consistent with their importance to safety. 2.5 Documentation 2.5.1 General The quality management system documentation includes: a) documented statements of a quality policy and quality objectives; b) a quality manual; c) documented procedures required by the quality standards referenced in paragraph 2.3 above; d) documented procedures needed by RNII to ensure the effective planning, operation and control of its

processes; and e) records required by the quality standards referenced in paragraph 2.3 above. The development and extent of RNII quality system documentation is shown in Figure 2.5.1.

Figure 2.5.1. RNII Quality Management System Documentation.

Quality Manual

Operating Procedures

Department Procedures

Customer Requirements

Statutory & Regulatory

Requirements, Industry Standards

Other Documents: Drawings, Travelers,

Mfg Procedures Inspect Procedures


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2.5.2 Quality Manual RNII establishes and maintains a quality manual that includes: a) the scope of the quality management system; b) the documented procedures established for the quality management system, or reference to them; c) a description of the interaction between the processes of the quality management system (Figure

2.2.5). 2.6 Working Environment Activities affecting quality are conducted under suitably controlled conditions. Controlled conditions include: a) the use of appropriate equipment; b) suitable environmental conditions for accomplishing the activity, such as adequate cleanness,

temperature, humidity and lighting; and c) assurance that all prerequisites for the given activity have been satisfied. RNII provides and maintains the infrastructure needed to provide suitably controlled conditions. Infrastructure includes: a) buildings, workspace and associated utilities; b) process equipment (both hardware and software); and c) supporting services. The quality management system recognizes the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test. 2.7 Competence, Awareness, and Training RNII personnel are competent on the basis of appropriate education, training, skills, and experience. RNII: a) determines the necessary competence for personnel performing work affecting product quality; b) provides training or takes other actions to satisfy these needs; c) evaluates the effectiveness of the actions taken; d) ensures that its personnel are aware of the relevance and importance of their activities and how they

contribute to the achievement of the quality objectives; and e) maintains appropriate records of education, training, skills, and experience. 2.8 Management Review 2.8.1 General Top management reviews the quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews are maintained. 2.8.2 Review Input The input to the management review includes information on: a) results of audits; b) customer feedback; c) process performance and product conformity; d) status of preventive and corrective actions; e) follow-up actions from previous management reviews; f) changes that could affect the quality management system; and g) recommendations for improvement.


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2.8.3 Review Output The output from the management review includes any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes; b) improvement of product related to and applicable statutory and regulatory requirements; and c) resource needs. 2.9 Planning of Product Realization 2.9.1 Quality Plan RNII plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of other processes of the quality management system. In planning the product realization, RNII determines the following, as appropriate: a) quality objectives and requirements for the product; b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the

product and the criteria for product acceptance; and d) records needed to provide evidence that the realization processes and resulting product meet

requirements. 2.9.2 Inspection and Test Plan An Inspection and Test Plan (ITP) is used to describe the inspections, tests, and verifications for a product or service. When its use is specified in a contract, an ITP is prepared and submitted to the customer for approval. Unless otherwise specified in the contract: a) the ITP is submitted following the award of the contract and before the applicable phase starts; and b) the ITP is updated during the life of the contract, if necessary. When specified per customer contract, additional documents are created such as: a) End of Manufacturing Report (EOMR) b) Follow Up Documents (FUD) c) and Project Quality Assurance Plan (PQAP).


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SECTION 3 DESIGN CONTROL

This section describes the activities for the development, implementation and control of RNII design activities associated with RNII products. 3.1 General The design control program includes RNII activities associated with the preparation and review of design documents, including the correct translation of design inputs into specifications, drawings and procedures. 3.2 Design Input The engineering manager ensures that organizations having design responsibility develop and implement procedures for the control of their design activities. These procedures ensure that: design activities are performed by qualified individuals; design inputs, including customer order information, are correctly translated into drawings and

specifications; quality standards are specified and included or referenced in design documents; design requirements can be inspected/tested to specified acceptance criteria; changes to design documents, including the reasons for the changes, are identified, approved by the

responsible design group, documented and controlled; design activities are prescribed in written form and provide sufficient detail and control to permit

reviewing, checking or verifying of results by qualified personnel equipped with adequate resources; and

design control measures provide for design analyses such as seismic, stress, thermal, hydraulic, radiation; associated computer programs; compatibility of materials; maintenance and repair; and delineation of acceptance criteria for inspections and tests.

All items and processes within the scope of the RNII quality management system are reviewed for suitability of application prior to selection and reconciliation with the requirements of the original design specification. If a replacement is required due to failure of a component, the suitability review considers causes of the failure of the existing component to ensure that the selected replacement is suitable for its intended function. Replacement items are analysed and tested to verify suitability, unless previous experience indicates that the design has a high probability of satisfactory performance. 3.3 Design Output The design engineer prepares and approves design documents. Design analyses and calculations are planned, controlled, legible and in a form suitable for reproduction, filing, and retrieving. Each analysis identifies the purpose, method, assumptions, design input, references, and engineering units, such that any technically qualified person can review and understand the analysis; and verify the results without recourse to the originator. The analysis should identify those characteristics of the design that are crucial to the safe and proper functioning of the equipment. Calculations are identified by subject (including the product or component to which the calculation applies), originator, reviewer, and date, or by other means that ensures retrievability.


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3.4 Design Verification Design verification is conducted to provide assurance that the design output meets the specified design inputs. Design documents requiring verification are identified by engineering prior to relying on the item to perform its intended function. Any changes to previously verified designs are documented and include the identification of the individuals performing the verification. Individuals or groups responsible for design verification are identified, and their qualifications, authority and responsibilities are identified in engineering procedures. Design verification is performed by competent individuals or groups, and are independent of those who performed the original design. Regardless of title, individuals performing design verification should not have: a) immediate supervisory responsibility for the person that performed the design work being verified; b) specified a singular design approach for the particular design work being verified; c) ruled out certain design considerations for the particular design work being verified; or d) established the design inputs for the particular design work being verified. If, in an exceptional circumstance, the designer's immediate supervisor is the only technically qualified individual available, the supervisor may conduct the review. The extent of design verification is a function of the item's importance to safety, the complexity of the design, the degree of standardization, the state-of-the-art, and the similarity to previous designs. Verification methods may include activities such as: Design reviews; Performing alternative calculations; and Design Verification Testing. 3.4.1 Design Reviews Planned reviews are conducted at appropriate stages of design to provide assurance that design documents such as drawings, calculations, specifications and analyses are correct and satisfactory for the application. Reviewers are appropriate to the design and the design stage. The results of design reviews are documented and measures are taken to ensure that issues are resolved and, if applicable, changes are incorporated into the design documents. Particular attention is given to ensure that: a) appropriate quality standards are contained in the documents; b) the technical information for the materials, components, equipment, and processes is contained in the

documents, and is suitable for the intended applications; c) errors and deficiencies in the design are identified and documented; and d) actions are taken to resolve any errors and deficiencies. 3.4.2 Alternative Calculations When alternative calculations are made, they must meet the same requirements outlined in section 3.4 above. They may utilize a simplified or less rigorous approach. 3.4.3 Design Verification Testing Design verification may also be achieved by activities during the preliminary and final stages of product development. These activities are discretionary and usually consist of informal hardware builds and/or testing. When design verification testing is used, it is identified and documented. Test results are evaluated by qualified engineering personnel.


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3.5 Design Validation 3.5.1 Qualification Testing Design validation is primarily achieved by performing qualification testing, using items manufactured with production processes and approved engineering procedures. Required testing is identified and documented. Testing is performed under conditions that simulate the most adverse design conditions. All pertinent operating modes are considered when determining these conditions. Qualification testing is performed in accordance with approved engineering procedures. These procedures incorporate, or reference, the requirements and acceptance criteria delineated in applicable design documents. In addition, procedures clearly delineate required prerequisites and provisions for data acquisition and documentation. Qualified engineering personnel evaluate test results. Any items that are modified during the course of testing are retested, or are otherwise validated to assure satisfactory performance. 3.6 Change Control Procedures are provided for the expeditious change to approved design documents. These procedures ensure that the impact of the change is considered, that required actions are documented, and that information concerning the change is distributed to affected personnel/organizations. Deviations from approved designs are approved by appropriate personnel. When a significant design change is necessary, the procedures delineating the design process and associated design verification activities are reviewed for adequacy and modified as necessary. The requirement for retesting is reviewed if the design is changed after testing. 3.7 Design Documentation The content of design documents is established and delineated in engineering procedures. Design documents are stored and maintained in accordance with documented procedures.


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SECTION 4 PROCUREMENT DOCUMENT CONTROL

This section describes the measures for the review and control of procurement documents to ensure that all technical, regulatory, and quality requirements are correctly stated. 4.1 General The procurement of materials, parts, equipment and services that are associated with RNII applications is controlled to ensure conformance to technical, regulatory and quality requirements. 4.2 Content of the Procurement Documents Procedures are established to ensure that procurement documents include the following items, as required: A statement of the scope of the work to be performed by the supplier. The basic technical requirements including applicable drawings, specifications, and special

requirements. Requirement that the supplier have a documented quality program consistent with appropriate

requirements of 10CFR50 Appendix B and adherence to the provisions of 10CFR Part 21. RNII right-of-access to the supplier's facilities and records for the purpose of source inspection and

audits. Identification of the documents to be prepared, maintained, submitted, or made available for review

and/or approval by RNII. Requirement for reporting and approving disposition of nonconforming items. Methods for approval of products, processes, and equipment. 4.3 Procurement Document Review Procurement documents for materials, parts, equipment and services are reviewed and approved to ensure that documents transmitted to prospective suppliers include all appropriate provisions. Approval is indicated by the reviewer’s name on the document or documents that convey technical and quality requirements to the supplier. 4.4 Changes to Procurement Documents Changes to procurement documents are subject to the same degree of control as the original documents.


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SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS

This section describes the activities for the preparation, review, approval, and use of procedures, instructions, drawings, and specifications that define and/or control activities affecting the quality of the product. 5.1 General Activities that affect quality are prescribed by clear and complete documented procedures and instructions of a type appropriate to the circumstances and are accomplished in accordance with these documents. Activities may be prescribed by specifications, work instructions, drawings, travelers, planning sheets, operating manuals, test procedures, or other written document provided that the activity is adequately prescribed. 5.2 Preparation of Procedures Procedures include appropriate quantitative and qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished. 5.3 Review and Approval All procedures are reviewed to ensure that they are adequate for the intended purpose and that all technical and quality requirements have been included. Procedures are reviewed by knowledgeable personnel other than the preparer and are approved by authorized individuals prior to initial use. Reviewers have access to pertinent background information and have an adequate understanding of the requirements of the process being documented. 5.4 Changes to Procedures Changes to procedures are reviewed and approved in the same manner as the original document.


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SECTION 6 DOCUMENT CONTROL

This section describes the activities for the control of documents associated with activities affecting the quality of items and products within the scope of the RNII quality management system. 6.1 Preparation, Review, Approval, and Issuance The control system is documented and provides for the: a) identification of documents to be controlled; b) assignment of responsibility for the preparation, review, approval, and issuance of documents; c) review of documents for adequacy, completeness, and correctness; d) distribution of documents; e) marking of obsolete/outdated documents; and f) removal of obsolete/outdated documents from all points of use to preclude their inadvertent use. 6.2 Controlled Document Categories Control measures are applied to the following documents: RNII Quality Manual Operating procedures Department procedures Drawings and specifications Manufacturing procedures Inspection and test procedures Product qualification procedures and test reports Procurement documents Documents of external origin Quality records 6.3 Document Changes Changes are reviewed and approved by the organization that performed the original review and approval, unless other organizations are specifically designated. The reviewer has access to pertinent background information upon which to base an approval and has an adequate understanding of the requirements and intent of the original documents. Where practicable, the nature of the change is identified in the document or the appropriate attachments.


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SECTION 7 CONTROL OF PURCHASED MATERIAL,

EQUIPMENT, AND SERVICES

This section describes the requirements for control of purchased items and services. It also includes requirements for source selection, supplier performance evaluation, and verification of conformance. 7.1 General The source selection and evaluation of suppliers of purchased materials, parts and services that are associated with RNII products is controlled to ensure conformance to the technical and quality requirements of the procurement documents. 7.2 Procurement Planning Procurement activities are planned and documented to ensure a systematic approach to the procurement process. The systematic approach includes: a) selection of procurement sources; b) bid evaluation; c) preparation, review, and change control of procurement documents; d) acceptance of items or services; e) control of supplier nonconformances; f) evaluation of supplier performance; g) verification (surveillance, audit, inspection); h) corrective action; and i) quality records. 7.3 Selection and Approval of Suppliers The selection of suppliers is based on evaluation of their capability to provide items or services in accordance with the requirements of the procurement documents, including the quality system and any quality requirements. Measures for evaluation and selection of procurement sources are documented and may include: a) the establishment of rights-of-access to the supplier's facility, for RNII and its customers, to verify that

subcontracted items conform to specified requirements; b) an evaluation of the supplier's history in providing identical or similar product; c) an evaluation of the supplier's current quality records, supported by qualitative or quantitative

information that can be objectively evaluated; and d) an evaluation of the supplier's quality and technical capability, based on a review of its facility,

personnel, and the implementation of its quality program. Acceptable suppliers are placed on RNII's Nuclear Supplier List (NSL). Suppliers are evaluated on an ongoing basis, including review of receiving inspection data, delivery performance; and audits/surveys.


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7.4 Supplier Interface Depending on the complexity or scope of the procurement, RNII initiates interface activities with the supplier, which may include: a) establishing an understanding with the supplier concerning provisions and specifications of the

procurement documents; b) reviewing documents created by the supplier during activities to fulfill procurement document

requirements; c) identifying and processing necessary change information; d) establishing methods for document exchange; e) identifying methods for processing supplier requests for deviations from procurement documents; and f) supplier audits. 7.5 Acceptance of Items or Services Inspection and/or test are used to accept items from suppliers. These methods are supplemented as necessary by supplier audit. Documented evidence that items conform to procurement requirements is available prior to unconditional release of the item for use. This documentation identifies specific requirements such as codes, standards, or specifications met by the furnished items and any accepted deviations to requirements. Items lacking complete quality documentation may be conditionally released provided items are identified and usage traceability is maintained in case of subsequent rejection. 7.6 Control of Supplier Nonconformances When nonconformances of either items or documentation are identified, the items are segregated, identified and handled in accordance with documented procedures. 7.7 Commercial Grade Items Commercial grade items procured for safety related applications are controlled according to the documented commercial grade dedication process. Commercial grade items are: a) not subject to design or specification requirements unique to nuclear facilities; b) used in applications other than nuclear facilities; and c) to be ordered from the manufacturer/supplier on the basis of specifications set forth in the

manufacturer’s published product description. 7.8 Control of Counterfeit and Fraudulent Material Counterfeit and fraudulent material is controlled through supplier audits and surveys, receiving inspection, and commercial grade item dedication.


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SECTION 8

IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS

This section describes the requirements for identification and control, to prevent a loss of traceability or the use of incorrect or defective items. 8.1 General Control measures are applied to items such as materials, consumables, parts, components, or partially fabricated subassemblies. 8.2 Identification Drawings and procedures provide instruction on methods for item identification. When identification is required and physical marking of the item is either impractical or insufficient, other means, such as physical separation or procedural control, are employed. Identification may be on the item or on records traceable to the item, as appropriate. Where required, item traceability (heat number, part number, serial number, etc.) is controlled and maintained throughout manufacturing, assembly, rework and use of the item. Identification markings are clear, unambiguous, and indelible and are applied in a manner that has no effect on the function of the item. Tags may be used to provide identification. When tags are employed, the tag will retain the marking, withstand weathering, deterioration, and handling effects. 8.3 Specific Requirements Where identification is required, markings are transferred to each part of an item when subdivided. Markings are not to be obliterated or hidden by surface treatment or coatings, unless other means of identification are substituted. Traceability of items to specific inspection records are controlled and maintained when required by codes, industry standards or specifications. Items having limited storage or operating life are identified and controlled to preclude inadvertent use of expired items. 8.4 Loss of identification When the identification or traceability of an item is lost, the item is controlled according to documented procedures.


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SECTION 9 CONTROL OF SPECIAL PROCESSES

This section describes the measures to control special processes. 9.1 General A special process is a process in which the results are highly dependent on the control of the process, or the skill of the operator, or both, and in which the specified quality cannot be readily determined by inspection or test of the product. RNII special processes include, but are not limited to, welding, brazing, and soldering. 9.2 Process Control Measures are established to ensure that special processes: a) are controlled; b) are performed by qualified personnel using qualified procedures; and c) are controlled and accomplished in accordance with applicable codes, standards, specifications,

criteria, and other requirements. 9.3 Personnel Qualification Qualification requirements are identified for personnel performing each type of special process. Ongoing qualification requirements are also established. 9.4 Procedures Special process procedures are qualified in accordance with section 5 and include, as appropriate: a) a statement of prerequisites, precautions and limitations applicable to the performance of the special

process; b) the equipment to be used and, if applicable, the calibration criteria; c) instructions for setting process parameters, as required, to ensure adequate results; d) the acceptance criteria; e) suitable maintenance of the equipment to ensure continuing process capability; and f) statement of codes, specifications, standards or other special requirements applicable to the

qualification of the process. 9.5 Records Qualification records are maintained for personnel, process procedures, documentation, and equipment according to the requirements of applicable codes and standards.


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SECTION 10 INSPECTION

This section describes the control measures for all inspection activities. 10.1 General Inspection is performed on activities affecting quality to verify conformance to related design drawings, specifications, and other controlled documents. Inspection of material, products, or activities is performed for each work operation where necessary to ensure quality. Personnel assigned to perform inspection, witnessing, or monitoring of characteristics for acceptance are other than those who performed or directly supervised the work being accepted. In addition, these personnel do not report directly to the immediate supervisor responsible for producing the work being accepted. Inspection activities are performed by qualified personnel using documented procedures. On-the-job training is used to teach new inspectors. A qualified inspector observes and supervises inspections performed by persons during on-the-job training. Only a qualified inspector can sign off an inspection operation. Inspection requirements are translated into inspection procedures, plans, or checklists, and specify the characteristics to be inspected and the inspection methods to be employed. Where a sample is to be used to verify acceptability of a group of items, the sampling procedure is based on recognized standard practices. 10.2 In-Process Inspection In-process inspection of items is performed for each work operation where necessary to ensure quality. When inspection is impossible or disadvantageous, indirect control by monitoring processing methods, equipment, and personnel is provided. Both inspection and process monitoring is provided when control is inadequate without both. 10.3 Final Inspection Final inspection includes a review of the results and resolution of any nonconformances. Final inspection makes the determination as to the conformance of the item to specified requirements. Authorized personnel approve and document the acceptance of the item. Items are inspected for completeness of markings, calibration, adjustments, protection from damage and other characteristics as required to verify the quality and conformance of the item to specified requirements. Production records are examined for adequacy and completeness if not previously examined. No product is released for shipment until all of the activities (including associated data and documentation) specified in the quality plan or documented procedure has been satisfactorily completed. 10.4 Hold and Witness Points Appropriate hold and witness points are specified in work controlling documents. When a hold point has been reached, work does not proceed beyond that point until inspection is either performed or waived by a quality department representative.


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10.5 Records Inspections are documented and records are kept in sufficient detail to provide adequate information about the inspection program. As a minimum, inspection records identify the: a) item or activity inspected; b) date of inspection; c) inspector; d) result or acceptability; and e) applicable drawing, specification, procedure, or work instructions. 10.6 Statistical Techniques Sampling plans are used as a tool to monitor product quality. Lot sampling may be conducted for the purpose of accepting or rejecting an entire lot. Sampling plans are determined, documented, and referenced in the inspection procedure. Where statistical techniques are used for acceptance of product, they are referenced on the inspection and test plans.


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SECTION 11 TEST CONTROL

This section describes the actions for the control of testing to demonstrate that RNII nuclear qualified products will perform satisfactorily in service. 11.1 General Testing required to demonstrate that RNII nuclear-qualified products will perform satisfactorily in service is identified and documented. Testing may be performed using computer programs. 11.2 Test Procedures Testing is conducted in accordance with controlled, written procedures that are based on customer and design requirements. As appropriate, test procedures: a) state test purpose and objectives; b) list important references; c) include provisions for assuring that prerequisites and suitable environment conditions have been met; d) include provisions for assuring that adequate instrumentation is available and used; e) provide instructions to be followed in performance of the test, including hold or witness points; f) list acceptance criteria; and g) include provisions for recording test results. Prerequisites include the following, as applicable: calibrated instrumentation, appropriate equipment, trained personnel, condition of test equipment and the item to be tested, suitable environmental conditions, and provisions for data acquisition. 11.3 Test Results Test results are documented and evaluated by qualified personnel to ensure that test requirements have been satisfied. 11.4 Test Records Records of qualification testing are maintained to indicate: a) the item tested; b) date of test; c) identity of tester or data recorder; d) type of observations made; e) results and/or acceptability; f) test deficiencies and action taken in connection with any deviations noted; and g) person(s) evaluating the test results. 11.5 Computer Programs Computer programs may be used to perform production testing. Custom-designed software is controlled according to written procedures.


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SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT

This section describes the requirements for the calibration control of equipment used to acquire design data or to verify conformance to specified requirements. 12.1 General Measures are established to ensure that tools, gages, instruments, and other measuring and testing equipment used in activities affecting quality are properly controlled, calibrated, and adjusted at specified intervals to maintain accuracy within required limits. The metrology program meets the pertinent requirements of ANSI Z540 and is verified through surveillance and scheduled audits. Records of the results of calibration and verification are maintained. 12.2 Calibration Measuring and test equipment is calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is recorded. 12.3 Control Where necessary, measuring and test equipment is: a) identified to enable the calibration status to be determined; b) safeguarded from adjustments that would invalidate the measurement result; and c) protected from damage and deterioration during handling, maintenance, and storage. Calibration control measures are not required for rulers, tape measures, levels, timers, and other equipment that provide general-purpose commercial equipment accuracy. 12.3.1 Out-of-Tolerance Equipment Equipment is tagged or otherwise removed from service until corrective measures are completed, if: a) it is found to be out-of-tolerance during calibration; b) it has not been properly maintained or calibrated; c) it has been subjected to possible damage; or d) it is lost. All items inspected, tested or calibrated with that device since the last evaluation are identified and evaluated to either re-establish the acceptability of the items or to establish that a condition adverse to quality exists. The results of the investigations and evaluations are documented. Conditions adverse to quality are treated in accordance with section 16 of this manual. 12.4 External Calibration Service External calibration laboratories that provide calibration services to RNII are approved, through periodic audits, for placement on the RNII Nuclear Supplier List (NSL). An audit is performed prior to initial use of the supplier, and on a triennial basis thereafter to verify the supplier’s continued compliance to ANSI Z540.


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SECTION 13 HANDLING, STORAGE, AND SHIPPING

This section describes the requirements for proper handling, storage and shipping of items to prevent damage and deterioration. 13.1 General Handling, storage, shipping, cleaning and preservation of equipment and materials are performed in accordance with established procedures, instructions and drawings in order to maintain conformity to requirements. When necessary, measures such as special coverings, special coatings, preservatives, special protective environments, protective packaging, cleaning, special handling tools, and special equipment are specified and used. 13.2 Preservation Special material control procedures are prepared for critical, sensitive, perishable, or high value items to describe activities related to the preservation of those items. 13.3 Handling For all items that require special handling, procedures include a description of the handling from point of receipt to point of assembly. Operators of special handling and lifting equipment are qualified or trained in the use of the equipment. Handling is performed in a way that avoids damage to equipment or injury to personnel. 13.4 Storage Storage areas or stockrooms are designed to prevent damage to, or deterioration of, product pending use or delivery. Methods for authorizing receipt and issue from these areas are defined. Items in storage areas or stockrooms are periodically inspected to assess condition and shelf life expiration. 13.5 Packaging To the extent necessary to ensure conformance to specified requirements, packing, packaging and marking processes, including the materials used, are controlled. 13.6 Shipping Any special environmental protection required by the end item during transit is maintained to prevent damage to the shipped item. 13.7 Marking Instructions for marking and labeling for packaging, shipment, handling and storage of items are established as necessary to adequately identify, maintain and preserve the item. Marking includes indication of the presence of special environments or the need for special controls if required.


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SECTION 14 INSPECTION, TEST, AND OPERATING STATUS

This section describes the requirements for identifying the status of inspections, tests and manufacturing processes of RNII products. 14.1 General Measures are established to indicate the status of RNII inspections and tests performed upon individual items or RNII product for shipment. Status is indicated by use of markings such as stamps, tags, labels, routing cards or other suitable means. These measures prevent the inadvertent use of nonconforming, inoperative or malfunctioning components or products and indicate that required inspections and tests have been performed. 14.2 Procedure The process for identifying and documenting the inspection, test and manufacturing status from point of material receipt to shipment is specified in written procedures. These procedures describe the: a) methods for altering the sequence of required tests, inspections and manufacturing operations; b) means for establishing that required inspections and tests are performed to ensure the acceptability

of products or services throughout the production cycle; c) system of tags or stamped impressions or other physical means used to identify final acceptance of

product; and d) control status indicators, including the authority for applying and removing tags, stamps, or other

physical means of identifying the inspection status. Inspection and test stamps are issued to inspectors and contain their identification.


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SECTION 15 NONCONFORMING MATERIALS, PARTS,

OR COMPONENTS

This section outlines the process for identifying, documenting, evaluating, segregating and dispositioning nonconforming materials, parts and assemblies. 15.1 General All nonconforming items are identified and documented. Records are maintained to indicate the nature of the nonconformance, the disposition, and the acceptability of the item to specified requirements. 15.2 Procedures The control of nonconformances is documented in procedures; and includes the methods for documenting, segregating, evaluating, tracking, dispositioning, correcting, reporting, closing and notifying affected organizations. These procedures contain provisions to ensure that nonconformances, such as defective material, items, or customer-returned product, are properly identified. These procedures provide for independent review of nonconformances and disposition. 15.3 Identification and Segregation Nonconforming items are identified to preclude inadvertent or unauthorized use. Whenever practical, the nonconforming item is segregated from conforming items. 15.4 Evaluation and Disposition Nonconforming items are evaluated to determine their capability to perform their intended function. The impact on form, fit, function, reliability and safety of the end product is considered during the evaluation process. All nonconformances are evaluated for their potential impact on the qualification of the product. Nonconforming items are dispositioned by authorized personnel. Reworked items are inspected/tested to the original criteria. The reinspection/retest may be confined to the area of the nonconformance. 15.5 Customer Approval When required by the contract, use-as-is dispositions are submitted to the customer for approval. 15.6 Part 21 Review Committee The RNII Part 21 Committee reviews nonconformance data (production and field returns) for trends that may be reportable under the requirements of 10CFR Part 21. Unusual nonconformances are referred to the RNII quality manager or another member of the Part 21 committee.


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SECTION 16 CORRECTIVE ACTION

This section describes the activities associated with the corrective action system, which is used to identify, evaluate, report, document, and correct conditions that are adverse to quality. 16.1 Conditions Adverse to Quality Conditions adverse to quality are identified promptly and corrected as soon as practicable. All RNII employees are responsible for identifying and reporting conditions adverse to quality. Conditions adverse to quality may be formally documented as described in written procedures. 16.2 Significant Conditions Adverse to Quality A significant condition adverse to quality exists when: a) a serious failure or breakdown in the implementation of the RNII quality program occurs; b) a significant deviation from performance specifications is discovered; c) a known deficiency is not resolved in a timely manner; or d) a repetitive or adverse trend exists. 16.3 Corrective Action When a significant condition adverse to quality exists: a) the cause of the condition is determined and corrective action is taken to preclude recurrence; b) follow-up action is taken to verify implementation and effectiveness; c) the process is documented; and d) the condition, corrective actions, and status is reviewed by top management.


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SECTION 17 QUALITY RECORDS

This section describes the requirements for the control of records associated with activities affecting the quality of RNII products. 17.1 General Quality records are maintained to provide evidence of activities affecting quality. Written procedures provide direction for the identification, preservation, and archiving of records. 17.2 Record Classification 17.2.1 Lifetime (Permanent) Records Lifetime records are those records, associated with RNII nuclear-qualified product, that meet one or more of the following criteria: a) those which would be of significant value in demonstrating capability for safe operation; b) those which would be of significant value in maintaining, reworking, replacing, or modifying an item; c) those which would be of significant value in determining the cause of an accident or malfunction of an

item; or d) those which provide required baseline data for in-service inspections. Lifetime records are maintained for the life of an RNII nuclear-qualified product while it is installed in a customer facility or stored for future use. Written procedures identify all lifetime records and specify record retention requirements. 17.2.2 Non-permanent Records Non-permanent records are those required to show evidence that an activity was performed in accordance with the applicable requirements but need not be retained for the life of the item because they do not meet the criteria for lifetime records. Retention periods for non-permanent records are of sufficient duration to ensure the ability to reconstruct significant events. Written procedures identify non-permanent records and specify record retention requirements. 17.3 Record Categories As a minimum, control measures are applied to the following categories of quality records: Drawings, specifications, and design reviews Procurement documents Results of inspections, tests, audits and material analyses Qualification of personnel, procedures and equipment Travelers, travel cards, and procedures Audit reports, and corrective action reports Customer files Customer feedback


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17.4 Identification of Records At a minimum, written procedures: a) identify the records to be controlled; b) identify the organization responsible for the records; and c) specify the minimum retention period for each record type. 17.5 Control of Records Each group organizes and maintains its records consistent with record retention requirements. 17.6 Archiving Before initiating long-term storage of records, the responsible department ensures that: a) procedure requirements, applicable to each record, have been fulfilled; b) each record is legible, completely filled out, and identifiable to an item or activity; and c) each record is stamped, signed, initialed, or otherwise authenticated, and dated. 17.7 Storage Records are stored in facilities, containers, or a combination thereof. Those facilities or containers are constructed and maintained in a manner which minimizes the risk of damage or destruction from: a) natural disasters such as winds, floods, or fires; b) environmental conditions such as high and low temperatures and humidity; or c) infestation of insects, mold, or rodents. 17.8 Maintenance of Records a) Records are protected from damage or loss. b) Records are retrievable. c) The methods for record changes are documented. d) Provisions are made for specially processed records (such as radiographs, photographs, negatives,

microfilm, and magnetic and optical media) to prevent damage from excessive light, stacking, electromagnetic fields, temperature, and humidity.

17.9 Customer Access Where contractually required, quality records are made available for evaluation by the customer or the customer's representative, for an agreed upon period.


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SECTION 18 AUDITS

This section describes the requirements for a comprehensive system of planned and periodic audits to verify the compliance and effectiveness of the quality management system implemented by RNII and its suppliers. 18.1 General RNII personnel conduct pre-planned audits to determine compliance with the provisions of the RNII quality management system. The quality manager selects and assigns qualified auditors who are independent of any direct responsibility for performance of the activities being audited. Audits are performed to: a) determine that the RNII quality management system has been developed and documented in

accordance with specified requirements; b) verify, by examination and evaluation of objective evidence, that the documented system has been

implemented; c) report on the effectiveness of the quality management system; d) identify conditions adverse to quality; e) identify deficiencies in the quality management system; and f) verify correction of identified conditions adverse to quality found during an audit. 18.2 Audit Scheduling Audits are scheduled at a frequency commensurate with the status and importance of the activity and are initiated as early in the life of an activity as practical, consistent with the schedule for accomplishing the activity, to ensure timely implementation of quality requirements. Audit history is considered during the planning process. The audit system has provisions for conducting audits on short notice and for conducting unannounced audits. Additional, or supplementary, audits may be conducted: a) when significant changes are made in the RNII quality management system; b) when it is suspected that safety, performance, or reliability of an item is in jeopardy due to

deficiencies in the RNII quality management system; c) when a systematic, independent assessment of program effectiveness or item quality, or both is

considered necessary; or d) to verify the implementation of corrective actions taken in response to previous audit findings. 18.3 Auditor Selection Personnel selected for auditing assignments have experience and training commensurate with the scope, complexity or special nature of the activities to be audited. Auditors have appropriate training or orientation to develop their competence for performing required audits. Auditors are trained, qualified and certified in accordance with documented procedures.


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18.4 Internal Audits Internal audits of activities are performed with a frequency commensurate with their importance to safety and in such a manner as to ensure that an audit of all elements of the RNII quality management system is completed at least triennially. The quality manager prepares the internal audit schedule on an annual basis. The schedule is reviewed and revised, as necessary, to ensure that coverage and schedule reflect current activities. The audit schedule indicates the activities to be audited. 18.5 Supplier Audits Including Commercial Grade Surveys Suppliers of safety related items or services will be audited at intervals consistent with the importance, complexity, and quality of the products or services supplied. The quality manager reviews and approves the schedule for supplier audits. 18.6 Reporting Reports are signed by the lead auditor and issued to the audited organization. The contents of the report: a) describe the audit scope; b) identify auditors and persons contacted; c) summarize audit results and include a statement on the effectiveness of the quality program elements

audited; and d) describe each reported adverse audit finding. Audit findings are documented in accordance with the requirements of section 16. 18.7 Response and Follow-up Management of the audited organization or activity responds to corrective actions resulting from audit findings in accordance with the requirements of Section 16. Follow-up action, including re-audit of deficient areas, is taken as necessary to verify and document the implementation and effectiveness of the corrective action. 18.8 Records Audit records include audit plans and audit reports. Corrective action records are maintained separately.


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SECTION 19 TENDER AND CONTRACT

This section describes the steps to determine and understand and applicable statutory and regulatory requirements prior to the organization’s commitment to supply a product. 19.1 Determination of requirements The organization determines: a) the requirements specified by the customer, including the requirements for delivery and post-delivery

activities; b) the requirements not stated by the customer but necessary for specified or intended use, where

known; c) the statutory and regulatory requirements related to the product; d) any additional requirements determined by the organization; and e) any additional warranty provisions. 19.2 Review of requirements RNII reviews requirements related to the product. This review is conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that: a) product requirements are defined; b) contract or order requirements differing from those previously expressed are resolved; and c) the organization has the ability to meet the defined requirements. Where the customer provides no documented statement of requirements, and applicable statutory and regulatory requirements are confirmed by RNII before acceptance. Where product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirement. 19.3 Customer communication The organization determines and implements effective arrangements for communicating with customers in relation to: a) product information; b) inquiries, contracts or order handling, including amendments; and c) customer feedback, including customer complaints. 19.4 Records Records of the results of the review and actions arising from the review are maintained.


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SECTION 20 CUSTOMER-SUPPLIED PRODUCT

This section describes the requirements for inspection, storage, and control of customer-supplied hardware. 20.1 General Two types of hardware are supplied to RNII by its customers: Parts or components provided for installation/inclusion with shipment of RNII products. RNII products returned to RNII for rework or failure analysis. 20.2 Parts and Components 20.2.1 Verification and Identification Upon receipt, incoming customer-supplied hardware is inspected or otherwise verified for completeness and proper type and to detect any damage that may have occurred in transit. (Inspection by RNII does not absolve the customer of the responsibility to provide acceptable hardware.) Further incoming inspections and tests are carried out as specified in the contract and the applicable inspection procedure. Hardware is identified/labeled as directed by the receiving inspection procedure to ensure separation from other similar hardware. 20.2.2 Storage Customer-supplied hardware is treated in the same manner as outlined in Section 13 of this quality manual. 20.2.3 Nonconforming Hardware Any customer-supplied hardware found to be nonconforming upon receipt, or which subsequently becomes nonconforming, lost, or otherwise unsuitable for use will be promptly reported to the customer in writing. 20.3 Field Returns 20.3.1 Rework of RNII Products Documented procedures are established and maintained for performing rework of RNII products that are returned by the customer. The procedures include measures to ensure that rework processes are documented and that reworked product meets specified requirements. 20.3.2 Failure Analysis Documented procedures are established and maintained for performing failure analysis of returned RNII products. A failure analysis report will be written to document the findings.


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SECTION 21 FEEDBACK AND IMPROVEMENT

This section describes the RNII activities for measurement, analysis, and improvement of the quality management system. 21.1 General RNII plans and implements the monitoring, measurement analysis and improvement processes needed to: a) demonstrate conformity of the product to requirements; b) ensure conformity of the quality management system; and c) continually improve the effectiveness of the quality management system. Applicable methods, including the use of statistical techniques, are outlined in written procedures. 21.2 Monitoring and Measurement 21.2.1 Customer Satisfaction RNII monitors information related to customer perception as to whether the organization has met and applicable statutory and regulatory requirements. The primary methods used by RNII include customer feedback and third-party surveys. Customers have several alternative means for providing comments, opinions, and suggestions. Customer Feedback Customer feedback is captured during communication between RNII and its customers. All documented feedback is reviewed to identify trends and opportunities for improvement. Third-party Surveys Customer surveys are conducted by third-party organizations. Survey results are used to measure customer satisfaction, and to determine areas for improvement as indicated by customer dissatisfaction or suggestions. 21.2.2 Processes Suitable methods for the monitoring and measurement of quality management system processes are determined and implemented. The methods used demonstrate the ability of the processes to achieve the planned results. When planned results are not achieved, corrective action is taken, as appropriate, to ensure conformity of the product to requirements. 21.3 Analysis of data Appropriate data is determined, collected, and analyzed to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement can be made. This includes data generated as a result of monitoring and measurement, and from other relevant sources. Data analysis provides information relating to: a) customer satisfaction; b) conformance to product requirements; c) characteristics and trends of processes and products, including opportunities for preventive action;

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21.4 Improvement 21.4.1 Continual Improvement RNII continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action, and management review. 21.4.2 Preventive Action Actions are determined to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. Documented procedures are established to define requirements for: a) determining potential nonconformities and their causes; b) evaluating the need for action to prevent occurrence of nonconformities; c) determining and implementing action needed; d) records of results of actions taken; and e) reviewing preventive action taken. 21.5 Quarterly Quality Review Management holds quarterly meetings to review quality measures and objectives.


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APPENDIX A REVISION HISTORY

Revision AA: July 21, 2003 The RNII Quality Manual was updated to address the quality system requirements imposed by ISO 9001:2000. At the same time, additional changes were made in order to: a) consolidate or clarify existing content; or b) better reflect actual practice. General changes: Revise RNII Quality Policy. Change review of quality manual from “annual” to “when OPs are changed”. Reformat to eliminate blank pages. Eliminate supplements – move content to another section or create new section.

SECTION DESCRIPTION

Introduction - Add “Quality Manual Document Control” page. - Revise Compliance Matrix to add document revisions, update references. - Revise list of Operating Procedures to reflect current procedures.

1 - Move “Management Review” to section 2. - Add “Internal Communication”.

2

- Add “Management Responsibility”, “Planning”, “Working Environment”, and “Planning of Product Realization”.

- Expand “Management Review”. - Add figure showing QMS process model.

3 - Eliminate “Detailed Analysis” and incorporate into “Design Output”. - Add “Design Validation” to clarify distinction between verification & validation.

4 No significant changes. 5 No significant changes. 6 Expand list of controlled documents to reflect current requirements. 7 No significant changes. 8 No significant changes. 9 No significant changes. 10 Add “Statistical Techniques”. 11 Add “Computer Programs”. 12 Delete “Software/Comparative References”. 13 No significant changes. 14 Delete “Inspection Status”. 15 No significant changes. 16 Move “Preventive Action” to section 21.

17 - Expand list of record categories. - Remove some details related to storage, preservation, and safekeeping and move

to operating procedure. 18 No significant changes.

19 - Change title from “Contract Review” to “Tender and Contract”. - Add "Customer Communication".

20 Expand discussion to include “Field Returns”.

21 - New section to address ISO 9001:2000 requirements. - Incorporate “Preventive Action” from section 16.


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Revision AB: January 1, 2011 The RNII Quality Manual was updated to address the quality system requirements imposed by ISO 9001:2008. At the same time, additional changes were made in order to: a) consolidate or clarify existing content; or b) better reflect actual practice. General changes: For requirements, explicitly added applicable statutory and regulatory requirements.

SECTION DESCRIPTION

Introduction

- Updated Vice President & General Manager and Quality Manager Information - Updated the Quality Standards Compliance Matrix. Updated from NQA-1-1989

(Basic) to NQA-1-1994. Updated from ISO 9001:2000 to ISO 9001:2008. Added IAEA 50-C-Q and KTA 1401.

- Removed OP 1930 Facility Access Control. 1 Updated Figure 1.1. RNII Organizational Structure.

2 - Updated “Working Environment”. - Updated Figure 2.2.5 - Added reference to EOMR, FUD and PQAP

3 No changes. 4 No significant changes. 5 No changes. 6 No changes.

7 - Updated from “ASL” Approved Supplier List to “NSL” Nuclear Supplier List. - Clarified ongoing evaluation of suppliers. - Added “Control of Counterfeit and Fraudulent Material.”

8 Clarified record control is also required. 9 No changes. 10 No changes. 11 No changes. 12 Change from “device” to “equipment.” 13 Added conformity to requirements. 14 No changes. 15 No changes. 16 No changes. 17 No changes.

18

- Changed from “External Audits” to “Supplier Audits Including Commercial Grade Surveys.”

- Clarified “Reporting” - Clarified Suppliers of safety related items.

19 Add additional warranty provisions to “Determination of Requirements.” 20 No changes. 21 Changed from “Steering Committee” to “Quarterly Quality Review.”


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APPENDIX B TERMS AND DEFINITIONS

ANSI American National Standards Institute ASME The American Society of Mechanical Engineers CSA Canadian Standards Association NQA-1 An ASME document describing the quality assurance program requirements for nuclear facilities. Acceptance Criteria (NQA-1) Specified limits placed on the performance, results, or other characteristics of an item, process, or service defined in codes, standards, or other requirement documents. Audit (NQA-1) A planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation. Basic Component (10CFR Part 21) (1)(i) When applied to nuclear power plants licensed pursuant to 10CFR part 50 of this chapter, basic component means a structure, system, or component, or part thereof that affects its safety function necessary to assure: A) the integrity of the reactor coolant pressure boundary; B) the capability to shut down the reactor and maintain it in a safe shutdown condition; or C) the capability to prevent or mitigate the consequences of accidents which could result in potential offsite

exposures. (ii) Basic components are items designed and manufactured under a quality assurance program complying with 10CFR part 50, appendix B, or commercial grade items which have successfully completed the dedication process. (3) In all cases, basic component includes safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others. Calibration (Z299) Comparing two instruments, measuring devices, or standards, one of which is of known accuracy. Characteristic (NQA-1) Any property or attribute of an item, process, or service that is distinct, desirable, and measurable.


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Commercial Grade Item (10CFR Part 21) (1) When applied to nuclear power plants licensed pursuant to 10CFR part 50, commercial grade item means a structure, system, or component, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical characteristics of the item cannot be verified). Commercial Grade Item (NQA-1) An item satisfying the following: a) not subject to design or specification requirements that are unique to nuclear facilities; b) used in applications other than nuclear facilities; c) to be ordered from the manufacturer/supplier on the basis of specifications set forth in the

manufacturer's published product description (for example, a catalog). NOTE: Commercial grade items affecting safety of licensed nuclear facilities are subject to alternate requirements per 10 CFR Part 21.

Condition Adverse to Quality (NQA-1) An all-inclusive term used in reference to any of the following: failures, malfunctions, deficiencies, defective items, and nonconformances. A significant condition adverse to quality is one which, if uncorrected, could have a serious effect on safety or operability. Continual Improvement (ISO 9000) Recurring activity to increase the ability to fulfill requirements. Contract (Z299) The written covenant and other documents agreed to and legally binding between the customer and supplier which specify requirements and conditions that must be met to successfully complete the work. Corrective Action (NQA-1) Measures taken to rectify conditions adverse to quality and, where necessary, to preclude repetition. Customer Feedback Information relayed to the organization through any means that relates to the products and service provided by the organization. Customer Satisfaction (ISO 9000) Customer's perception of the degree to which the customer's requirements have been fulfilled. Design Process (NQA-1) Technical and management processes that commence with identification of design input and that lead to and include the issuance of design output documents. Inspection (NQA-1) Examination or measurement to verify whether an item or activity conforms to specified requirements. Dedication (10CFR Part 21) (1) When applied to nuclear power plants licensed pursuant to 10CFR part 50, dedication is an acceptance process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended safety function and, in this respect, is deemed equivalent to an item designed and manufactured under a 10CFR part 50, appendix B, quality assurance program. Design Input (NQA-1) Those criteria, parameters, design bases, regulatory requirements, or other design requirements upon which detailed final design is based.


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Design Output (NQA-1) Drawings, specifications, and other documents used to define technical requirements of structures, systems, components, and computer programs. Deviation (NQA-1) A departure from specified requirements. Document (NQA-1) Any hard copy or electronic (text or graphic) information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results. Effectiveness (ISO 9000) Extent to which planned activities are realized and planned results achieved. Item (NQA-1) An all-inclusive term used in place of any of the following: appurtenance, assembly, component, equipment, material, module, part, structure, subassembly, subsystem, system, or unit. Nonconformance (NQA-1) A deficiency in characteristic, documentation, or procedure that renders the quality of an item or activity unacceptable or indeterminate. Nuclear Supplier List (NSL) A list of suppliers whose capability to provide materials and services has been evaluated and approved. Objective Evidence (NQA-1) Any documented statement of fact, other information, or record, either quantitative or qualitative, pertaining to the quality of an item or activity, based on observations, measurements, or tests which can be verified. Preventive Action (ISO 9000) Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. Procedure (NQA-1) A document that specifies or describes how an activity is to be performed. Procurement Document (NQA-1) Purchase requisitions, purchase orders, drawings, contracts, specifications, or instructions used to define requirements for purchase. Quality Assurance (NQA-1) All those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. Quality Management System (ISO 9000) Management system to direct and control an organization with regard to quality. Quality Objective (ISO 9000) Something sought, or aimed for, related to quality. Quality Policy (ISO 9000) Overall intentions and direction of an organization related to quality as formally expressed by top management. Quality Record (NQA-1) A completed document that furnishes documentary evidence of the quality of items and/or activities affecting quality.


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Repair (NQA-1) The process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though that item still does not conform to the original requirement. Rework (NQA-1) The process by which an item is made to conform to original requirement by completion or correction. Special Process (NQA-1) A process, the results of which are highly dependent on the control of the process or the skill of the operators, or both, and in which the specified quality cannot be readily determined by inspection or test of the product. Specification (ISO 9000) Document stating requirements. Supplier (NQA-1) Any individual or organization who furnishes items or services in accordance with a procurement document. An all-inclusive term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator, consultant, and their subtier levels. Surveillance (Z299) The continuing evaluation, analysis, and verification of a supplier's records, methods, procedures, products, and services, to assure that requirements are met. Tender An offer or proposal made for acceptance. An offer of a bid for a contract. Top Management (ISO 9000) Person of group of people who directs and controls an organization at the highest level. Traceability (NQA-1) 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 (NQA-1) A disposition permitted for a nonconforming item when it has been established that the item is satisfactory for its intended use. Validation (ISO 9000) Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. Verification (ISO 9000) Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. Verification (Z299) Independently reviewing, inspecting, examining, measuring, testing, checking, witnessing, monitoring, or otherwise establishing and documenting that products, processes, services, and documents conform to specified requirements.