Podcast
Questions and Answers
What must an organization do before implementing changes that affect customer requirements?
What must an organization do before implementing changes that affect customer requirements?
- Conduct a market analysis before notifying the customer
- Notify the customer prior to implementation (correct)
- Implement the changes without any notifications
- Notify the customer after the changes are implemented
Which of the following is NOT a documented information requirement related to design and development changes?
Which of the following is NOT a documented information requirement related to design and development changes?
- Authorization of the changes
- Design and development changes
- The results of reviews
- Actions taken to market the changes (correct)
How should design changes for spare parts be controlled?
How should design changes for spare parts be controlled?
- Using a different process from the original design
- By implementing the original design control measures (correct)
- Only through verbal communication
- By a separate team with no formal procedures
What should be verified regarding the reviewers of design changes?
What should be verified regarding the reviewers of design changes?
What impact should be evaluated for design changes involving material substitutions?
What impact should be evaluated for design changes involving material substitutions?
Which regulation is relevant for design changes in licensed items?
Which regulation is relevant for design changes in licensed items?
Who must be involved in any changes that could affect Ex Product compliance?
Who must be involved in any changes that could affect Ex Product compliance?
What is a core purpose of retaining documented information on design changes?
What is a core purpose of retaining documented information on design changes?
Study Notes
Design and Development Changes
- Organizations must identify, review, and control changes throughout the design and development phases to ensure conformity to requirements is maintained.
- A process needs to be established for notifying customers regarding changes that affect their requirements before implementation.
Documented Information Retention
- Documented information regarding design and development changes should be retained, including:
- Details of design and development changes.
- Results of reviews conducted on those changes.
- Authorization records for the changes.
- Actions taken to mitigate adverse impacts from changes.
Configuration Management Process
- Design and development changes must be controlled according to established configuration management process requirements.
- Measures should be implemented to control design changes for:
- Spare or replacement parts.
- Construction and fabrication drawings.
Review and Verification of Changes
- Revised design documents (calculations, drawings, stress reports) must be reviewed to ensure adherence to original design control measures.
- Design changes must be reviewed and approved by the same organization that originally approved the design or by other qualified entities.
- Cumulative effects of design changes (e.g., material substitutions) should be evaluated to confirm no negative impacts on performance, interchangeability, and qualification.
- Changes to licensed items should trigger updates in license drawings, specifically conforming to regulations like 10CFR71 or 10CFR72.
Compliance Involvement
- Ex authorized persons must be engaged in any changes related to manufacturers' documentation, quality management systems, or marketing documents that could impact Ex Product compliance, as per EN ISO / IEC 80079-34 standards.
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Description
Test your knowledge on the design and development changes in organizations. This quiz covers the identification, review, and control of changes that may impact conformity to requirements as well as customer notification processes. Brush up on your understanding of documented information retention in product and service development.
