Design and Development Controls Quiz
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Questions and Answers

What must be included in the test plans or specifications for verification and validation?

  • Identification of the test item and relevant acceptance criteria (correct)
  • Detailed procedure descriptions only
  • Observations and results from previous tests
  • Only the test objectives and resources used

    • Which of the following requirements must be observed according to the design and development completion process?

  • Acceptance criteria may be set post-testing
  • The requirements in the test plan must not be altered
  • Improvisation in test procedures is acceptable
  • The test item configuration must be verified (correct)

    • What role do qualified personnel play in the test program?

  • They execute the tests as outlined in written procedures (correct)
  • They document tests without prior experience
  • They evaluate the environmental conditions post-test
  • They create test procedures without supervision

    • Which of the following items is NOT required in documented test records?

    <p>Guidelines for future tests</p> Signup and view all the answers

    According to the ASME Section III Code, what is a crucial aspect of test procedures?

    <p>They must be documented to ensure consistency in test results</p> Signup and view all the answers

    What condition must be met for test instrumentation during testing?

    <p>Adequate test instrumentation must be available and used</p> Signup and view all the answers

    What type of tests must the test program include prior to installation?

    <p>Proof tests along with preoperational tests</p> Signup and view all the answers

    Which aspect is NOT included in the requirements for a test program?

    <p>Application of common testing methodologies</p> Signup and view all the answers

    Which of the following is NOT a control applied to the design and development process?

    <p>Identification of user demographics</p> Signup and view all the answers

    What is the purpose of conducting verification activities in design and development?

    <p>To confirm that design outputs meet input requirements</p> Signup and view all the answers

    Which statement accurately describes the relationship between design reviews and validation activities?

    <p>Design reviews and validation have distinct purposes.</p> Signup and view all the answers

    What should be done when verification findings result in design modifications?

    <p>The modified design must be verified before being released.</p> Signup and view all the answers

    What is necessary for documented information of design and development activities?

    <p>It must be retained and accessible for future auditing.</p> Signup and view all the answers

    Which aspect is essential for verifying design adequacy?

    <p>Engaging individuals or groups that did not perform the design.</p> Signup and view all the answers

    What must happen regarding progression to the next stage of design and development?

    <p>It requires authorization indicating readiness.</p> Signup and view all the answers

    Which of the following is most critical for the review of design analyses?

    <p>A technically qualified individual should verify the results.</p> Signup and view all the answers

    Study Notes

    Design and Development Controls

    • Implementation of controls in the design and development process is critical to define intended results effectively.
    • Regular reviews assess the ability of design outputs to meet specified requirements.
    • Verification activities confirm that design outputs satisfy the input requirements, ensuring quality in the design process.
    • Validation activities verify that the final products or services meet specified application requirements and intended use.
    • Prompt corrective actions must be taken on any problems identified during reviews, verification, and validation.
    • Documentation of all activities related to design and development must be retained for accountability and traceability.
    • Advancement to the next project phase requires explicit authorization based on the successful completion of prior stages.

    Distinct Purposes of Reviews, Verification, and Validation

    • Design reviews, verifications, and validations can occur separately or concurrently, tailored to organizational needs.
    • Measures should be established to identify and manage design interfaces, ensuring the adequacy of the design.
    • Verification is to be conducted by individuals or groups independent from the original designers to ensure objectivity.
    • Each verification method must be clearly documented, whether it involves design review, alternate calculations, or tests.

    Design Analyses and Verification Requirements

    • Design analyses must be reviewed by qualified individuals for quality assurance of results.
    • Detailed documentation is necessary: purpose, methods, assumptions, inputs, references, and units must be included.
    • Maintain traceability of calculations by subject, originator, reviewer, and date for accountability.

    Testing for Verification and Validation

    • Testing processes must be planned, controlled, reviewed, and documented to prove compliance with requirements.
    • Test plans must identify test items, necessary resources, objectives, conditions, parameters, and acceptance criteria.
    • Test procedures must clearly describe methods of performing tests and the documentation of results.
    • Ensure the correct configuration of items for testing, adhering to test plans and procedures.
    • Acceptance criteria defined in the test documentation must be met for successful verification.

    Control of Monitoring and Measuring Devices

    • Monitoring and measuring devices used during testing must comply with predefined control measures to ensure accuracy and reliability.

    Completion of Design and Development Phase

    • Upon completion, reports, calculations, and test results must demonstrate compliance with specification requirements under all operational conditions.

    NQA-1 / 10 CFR Part 50-Appendix B Guidelines

    • Establish a comprehensive test program to ensure the performance of structures, systems, and components (SSCs) in service.
    • The test program should include proof tests before installation, preoperational tests, and operational tests for nuclear facilities.
    • Tests must follow written procedures incorporating design requirements and acceptance limits, executed by qualified personnel.
    • Comprehensive documentation of testing activities is required, detailing items tested, test dates, personnel involved, observations, results, and actions taken for deviations.

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    Description

    Test your understanding of the design and development controls that ensure organizational objectives are met. This quiz covers defining results, conducting reviews, and implementing verification and validation activities. Enhance your knowledge of effective control measures in design processes.

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