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  • Mattie718 replied to the topic Changing Control in the forum Project Management Process and Medical Device Development 6 years, 7 months ago

    There are many reasons why a certain product or process will require changes during its life cycle. One example could be cost. To attain certain tight tolerances, material purity, or other favorable physical characteristics, companies may have to pay a lot more money. If it is able to be determined that the acceptability criteria can be changed to allow for cheaper parts, then that may be a logical choice. Other times, product failure or complaints can result in immediate corrective and preventive action which could result in changes to a certain design feature. This is to ensure the safety and success of the product in the future. Whether mandatory or preferential, all changes will need to go through a formal Change Order procedure which Engineers will have to submit. This usually consists of what the change is, why it was changed, and how it could affect the functional performance or risk level of that product. Sometimes it may even go to an in-depth design review which will have certain department representatives attending the meeting so they all agree that there will be no unintended repercussions in the form of violating quality standards or regulatory rules.