ISO 9001 2015 Clause 8.3 Design and Development PDF

8. Operation 8.3 Design and development of products and services General 8.3.1 Has the organization established, implemented and maintained a design and development process that is appropriate to ensure the subsequent provision of products and services? Design and developmen...

8. Operation 8.3 Design and development of products and services General 8.3.1 Has the organization established, implemented and maintained a design and development process that is appropriate to ensure the subsequent provision of products and services? Design and development planning In determining the stages and controls for design and development, does the organization consider: a) the nature, duration and complexity of the design and development activities? b) the required process stages, including applicable design and development reviews? c) the required design and development verification and validation activities? d)  the responsibilities and authorities involved in the design and development process? e)  the internal and external resource needs for the design and development of products and services? f)  the need to control interfaces between persons involved in the design and development process? g) the need for involvement of customers and users in the design and development process? h) the requirements for subsequent provision of products and services? i) the level of control expected for the design and development process by customers and other relevant interested parties? j) the documented information needed to demonstrate that design and development requirements have been met? AS9100-D: When appropriate, the organization shall divide the design and development effort into distinct activities and, for each activity, define the tasks, necessary resources, responsibilities, design content, and inputs and outputs. Design and development planning shall consider the ability to provide, verify, test and maintain products and services (reference output of 8.1 a). ASME BPVC.XIII_2023 Appendix III: 2-3 Drawing, Design Calculations, and Specification Control. Procedures exist which assure that the latest applicable drawings, design calculations (design calculations are not required for PRT or certificate scopes with no design responsibility), specifications and instructions, required by the Code, as well as authorized changes, are used for manufacture, assembly, examination, inspection and testing. Procedures include provision for review of customer supplied documents for Code compliance For Section 8.3.2 VIII Div 1, provision exists for review and use of User's Design Requirements Form, or other document with equivalent information. Provisions for procedures that will ensure that any computer program used for preparing calculations or conducting analysis meets the requirements of the Code. The procedures shall ensure that prepared calculations or analysis is verified as follows: (a) The computer program calculations or analysis shall be verified to show that it produces correct solutions for the encoded mathematical model within defined limits for each parameter employed. (b) The encoded mathematical model shall be verified to show that it produces correct solutions to the physical problem associated with the particular application. NOTE: For (a) and (b), verification against examples found in ASME PTB-4, ASME Section VIII, Division 1 Example Problem Manual may be sufficient to show that verification is met. In lieu of (a) and (b) above, the computer programs may be verified by the results confirmed by design analysis for each application. Provisions exist for individuals engaged in design activity while under the responsible charge shall: (a) be qualified to meet the following minimum requirements by the Manufacturer as described in the Quality Control System: (1) Description of how knowledge is determined of the design requirements of this Division for the application of the Certification Mark with the appropriate Designator (2) Description of how knowledge is determined of the Manufacturer’s or Assembler’s quality program (3) Have training commensurate with the scope, complexity, criticality, or special nature of the design activities to which oversight is to be provided (b) Description of documentation generated and maintained containing objective evidence of meeting the qualifications for the experience and training obtained (c) Be permitted to engage in any design activity required by this Division or any supplemental User’s Design Requirements provided on Form U-DR-1 or Form U-DR-2 (or equivalent document) Description of minimum requirements for education, years of experience and frequency of activity required to maintain qualifications for those that are engaged in design activities, including those in responsible charge. The title of the document used to identify the persons that are qualified to exercise control of design work performed by others. QMS Clause Requirements 8. Operation NQA-1 / 10 CFR Part 50-Appendix B: III Design Control. Design measures are established and implemented for the translation of design requirements into design documents, which include: a. Design Inputs are identified, reviewed for suitability, and approved. 8.3.2 b. Review engineering/production documents for inclusion of appropriate technical and quality requirements. c. Verify inclusion of identified design bases, (regulatory requirements, Code requirements, codes, standards, EQ/Seismic report numbers, analyses etc.) in design/quality documents. d. Assure the P.O. requirements that cannot be met by supplier are promptly communicated back to the customer Design and development inputs Does the organization determine the requirements essential for the specific types of products and services to be designed and developed? Does the organization consider: a)  functional and performance requirements? b)  information derived from previous similar design and development activities? c)  statutory and regulatory requirements? d)  standards or codes of practice that the organization has committed to implement? e)  the potential consequences of failure due to the nature of the products and services? 8.3.3 f)  when applicable, the potential consequences of obsolescence (e.g., materials, processes, components, equipment, products). Are inputs adequate for design and development purposes, complete and unambiguous? Are conflicting design and development inputs resolved? Does the organization retain documented information on design and development inputs.? NOTE: The organization can also consider as design and development inputs other information such as benchmarking, external provider feedback, internally generated data, and in- service data. NQA-1 / 10 CFR Part 50-Appendix B: III Design Control. Design Inputs (both technical and quality) have been identified and documented, their selection reviewed and approved, are an adequate basis for design verification measures, and for evaluating design changes Design and development controls Does the organization apply controls to the design and development process to ensure that: a) the results to be achieved are defined? b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements? c) verification activities are conducted to ensure that the design and development outputs meet the input requirements? d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use? e)  any necessary actions are taken on problems determined during the reviews, or verification and validation activities? f)  documented information of these activities is retained? g)  progression to the next stage is authorized. 8.3.4 NOTE Design and development reviews, verification and validation have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization. Measures are established and implemented for the identification and control of design interfaces and the verification of design adequacy. a. Review design records for evidence that the verification is performed by individuals or groups other than those who performed the design. b. Assure that the verification method to be used is identified. (design review, alternate calculations, or tests) c. When the verification method used is qualification test, verify that a prototype unit is tested under the most adverse design conditions. d. If the design is modified to resolve verification findings, the modified design is verified prior to release for use. Design Analyses are reviewed by a technically qualified individual to verify the adequacy of the results without recourse to the originator. a. Sufficient detail as to purpose, methods, assumptions, inputs, references, and units. b. Calculations are identifiable by subject, originator, reviewer, and date. c. For ASME Section III Code work, verify design certification personnel (CEs/RPEs) are qualified QMS Clause Requirements 8. Operation When tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed, and documented to ensure and prove the following: a. test plans or specifications identify the test item being tested and the resources being used, define test objectives and conditions, parameters to be recorded and relevant acceptance criteria; b. test procedures describe the test methods to be used, how to perform the test, and how to record the results; c. the correct configuration of the test item is submitted for the test; d. the requirements of the test plan and the test procedures are observed; e. the acceptance criteria are met. Monitoring and measuring devices used for testing shall be controlled as defined in clause 7.1.5. At the completion of design and development, the organization shall ensure that reports, calculations, test results, etc., are able to demonstrate that the design for the product or service meets the specification requirements for all identified operational conditions. 8.3.4.1 NQA-1 / 10 CFR Part 50-Appendix B: XI. Test Control. A test program shall be established to assure that all testing required to demonstrate that structures, systems, and components (SSCs) will perform satisfactorily in service is identified. The test program shall include, as appropriate, proof tests prior to installation, preoperational tests, and operational tests during nuclear power plant or fuel reprocessing plant operation, of SSCs; be performed in accordance with written test procedures which incorporate the requirements and acceptance limits contained in applicable design documents; be executed by qualified personnel; be documented and evaluated to ensure that test requirements have been satisfied; include provisions for assuring that all prerequisites for the given test have been met, that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions. include, as appropriate, proof tests prior to installation, preoperational tests, and operational tests during nuclear power plant or fuel reprocessing plant operation, of SSCs. have documented test records that identify the item tested, date of test, tester or data recorder, type of observation, results and acceptability, action taken in connection with any deviations noted, and the person evaluating test results. Design and development outputs Does the organization ensure that design and development outputs: a)  meet the input requirements? b)  are adequate for the subsequent processes for the provision of products and services? c)  include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria? d)  specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision? e)  specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items; f)  are approved by authorized person(s) prior to release. The organization shall define the data required to allow the product to be identified, manufactured, verified, used, and maintained. NOTE: Data can include: 8.3.5 − the drawings, part lists, and specifications necessary to define the configuration and the design features of the product; − the material, process, manufacturing, assembly, handling, packaging, and preservation data needed to provide and maintain a conforming product or service; − the technical data and repair schemes for operating and maintaining the product. Does the organization retain documented information on design and development process? Design methods, materials, parts, equipment and processes that are essential to the function of the item, including safety function, are selected and reviewed for suitability of application. Verify the final design: Is relatable to the design input by documentation in sufficient detail to permit design verification. Specifies required inspections and tests and includes or references appropriate acceptance criteria. Identifies assemblies and/or components that are part of the item being designed. When the final design includes an assembly or component part that is a commercial grade item, the critical characteristics to be verified and acceptance criteria satisfy the requirements are verified. QMS Clause Requirements 8. Operation Design and development changes Does the organization identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure The organization shall implement a process with criteria for notifying its customer, prior to implementation, about changes that affect customer requirements. Does the organization retain documented informatio n on: a)  design and development changes? b)  the results of reviews? c)  the authorization of the changes d) the actions taken to prevent adverse impacts.? Design and development changes shall be controlled in accordance with the configuration management process requirements. 8.3.6 Measures are established and implemented to control design changes, including changes for spare/replacement parts or construction/fabrication drawings. a. Review revised design documents, (e.g. calculations, drawings, stress reports), to verify that design changes are made using design control measures equal to those of the original design. b. Review design changes to verify that they were reviewed and approved by the same organization as originally reviewed and approved the design, or by other knowledgeable, qualified and designated organizations. c. Verify that design changes or the cumulative effect of multiple changes (i.e. in materials substitutions) have been adequately evaluated to assure that performance (i.e. EQ/seismic), interchangeability and qualification (i.e. test and equipment) are not adversely impacted. d. Verify that Design changes for licensed items also trigger 10CFR71 or 10CFR72 license drawing changes. EN ISO / IEC 80079-34: See 8.2.4: The Ex authorized person(s) identified in 5.3 shall be involved in any changes (e.g. changes to the manufacturer’s documentation, quality management system or marketing documents) that could affect Ex Product compliance. QMS Clause Requirements