Management system guidance
8.3 Design and development of products and services
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8.3.6 Design and development changes
This requirement is directly comparable to ISO 9001:2008 Clause 7.3.7 - Control of Design and Development Changes. It is important to control design changes throughout the design and development process and it should be clear how these changes are handled and what affects they have on the product. If you need a procedure and forms to help control your business's design and development process, click here.
You should seek and record evidence that your organization has retained documented information concerning:
- Design and development changes;
- The results of reviews;
- The authorization of changes;
- Actions taken to prevent adverse impacts.
Your organization should begin identifiying, reviewing and controlling of design changes including the implementation of a process to notify the customer when changes affect the customer requirement e.g. customer communication, notifications of change, requests for deviation, and contract amendments.
The Engineering Manager in conjunction with the Design Manager is responsible for evaluating the risks and the impact of design changes against the criteria. The Engineering Manager logs all change requests in the Design Change Request Log, performs an evaluation and either approves or denies the request.
Major changes are also evaluated by any affected stakeholders. All change requests serve as design and development inputs for design and development changes. Design documentation is updated to accurately reflect the revised design.
It is as important to control design changes throughout the design and development process and it should be clear how these changes are handled and what effects they have on the product. Ensure control over design and development changes, design changes must be:
Configuration control can be managed via alteration requests, notice of change, amendments, deviations, waivers, concessions, part revision changes, part number changes, change categories, service bulletins, modification bulletins, airworthiness directives, engineering communication notice, product change boards.
Design and development changes (after the original verification and validation) have to be 'verified and validated as appropriate' (as well as reviewed) and to 'include evaluation of the effect of changes on constituent parts and products already delivered'.
If the organization chooses not to perform re-verification and re-validation on every design change, then the auditor should expect to see some very well-defined criteria as to when the activity needs to occur.
Retain documented information that includes design change history, evaluation of change results, authorization of change and actions taken in relation to subsequent activities that are impacted by the change.
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Monitoring, measurement, analysis and evaluation
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