RNII QUALITY MANUAL. Document Number D Revision AB January 1, 2011

Transcription

1 RNII QUALITY MANUAL Document Number D January 1, 2011

2 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. Page 2 of 47

3 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. Page 3 of 47

4 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 Organization Quality Management System Design Control Procurement Document Control Instructions, Procedures, and Drawings Document Control Control of Purchased Material, Equipment, and Services Identification and Control of Materials, Parts, and Components Control of Special Processes Inspection Test Control Control of Measuring and Test Equipment Handling, Storage, and Shipping Inspection, Test, and Operating Status Nonconforming Materials, Parts, or Components Corrective Action Quality Records Audits Tender and Contract Customer-Supplied Product Feedback and Improvement Appendices: A Revision History B Terms and Definitions Page 4 of 47

5 LIST OF FIGURES Figure Title Page 1.1 RNII Organizational Structure RNII Quality Management System Process Model RNII Quality Management System Documentation Page 5 of 47

6 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 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. Page 6 of 47

7 QUALITY STANDARDS COMPLIANCE MATRIX RNII Quality Manual Section Title 10CFR50 Appendix B NQA ISO 9001: Organization I , 5.5.2, 5.5.3, 6.1 CSA CAN3- Z , 3.2.3, IAEA 50-C-Q KTA , , Quality Management System II 2 1.1, 4.1, 4.2.1, 4.2.2, , 5.4.1, 5.4.2, , 6.2.1, 6.2.2, 6.3, 6.4, 7.1, , 3.2.2, 3.2.6, 3.3, , , , 209, 210, 309 3, 4.4, Design Control III , , Procurement Document Control IV , Instructions, Procedures, and Drawings V , Document Control VI , Control of Purchased Material, Equipment, and VII , Services 8 Identification and Control of Materials, Parts, and Components VIII , Control of Special Processes IX Inspection X , , , 3.5.7, 3.5.8, 3.5.9, , 303, 309, Test Control XI , Control of Measuring and Test Equipment XII Handling, Storage, and Shipping XIII , Inspection, Test, and 301, 303, XIV , Operating Status 309, Nonconforming Materials, Parts, or XV , , Components Corrective Action XVI Quality Records XVII Audits XVIII , Tender and Contract , 7.2.2, Customer-Supplied Product Feedback and Improvement , 8.2.1, 8.2.3, 8.4, 8.5.1, Page 7 of 47

8 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 Record Requirements 1810 Quality Audits 1910 Order Control and Contract Administration 2010 Customer-Supplied Product 2110 Continual Improvement Page 8 of 47

9 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. President, RNII VP & General Manager, RNII Marketing / Sales Quality Engineering Operations / Contracts Manufacturing Accounting / Finance 1.2 Management Representative Figure 1.1. RNII Organizational Structure 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. Page 9 of 47

10 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. Page 10 of 47

11 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 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 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 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 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. Page 11 of 47

12 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 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 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 Process Model RNII's Quality Management System process model is shown in Figure The model provides a pictorial representation of the QMS processes and their interactions. Figure RNII Quality Management System Process Model. Page 12 of 47

13 2.3 Scope of Quality Program The RNII quality management system meets the requirements of 10CFR50 Appendix B, NQA , CSA CAN3-Z , IAEA 50-C-Q, and ISO 9001:2008. In addition, the RNII quality system meets the intent of CSA N 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 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 Statutory & Regulatory Requirements, Industry Standards Quality Manual Operating Procedures Customer Requirements Department Procedures Other Documents: Drawings, Travelers, Mfg Procedures Inspect Procedures Figure RNII Quality Management System Documentation. Page 13 of 47

14 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 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 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. Page 14 of 47

15 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 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 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). Page 15 of 47

16 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. Page 16 of 47

17 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 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 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 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. Page 17 of 47

18 3.5 Design Validation 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. Page 18 of 47

19 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. Page 19 of 47

20 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. Page 20 of 47

21 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. Page 21 of 47

22 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. Page 22 of 47

23 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. Page 23 of 47

24 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. Page 24 of 47

25 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. Page 25 of 47

26 SECTION 10 INSPECTION This section describes the control measures for all inspection activities 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 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 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 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. Page 26 of 47

27 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 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. Page 27 of 47

28 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 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 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 Test Results Test results are documented and evaluated by qualified personnel to ensure that test requirements have been satisfied 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 Computer Programs Computer programs may be used to perform production testing. Custom-designed software is controlled according to written procedures. Page 28 of 47

29 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 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 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 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 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 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. Page 29 of 47

30 SECTION 13 HANDLING, STORAGE, AND SHIPPING This section describes the requirements for proper handling, storage and shipping of items to prevent damage and deterioration 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 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 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 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 Packaging To the extent necessary to ensure conformance to specified requirements, packing, packaging and marking processes, including the materials used, are controlled Shipping Any special environmental protection required by the end item during transit is maintained to prevent damage to the shipped item 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. Page 30 of 47

31 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 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 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. Page 31 of 47