In Week three lecture, we touched the topic of design change request which is a form that we need to submit based on the lates version of the DID, or DSD if a mistake where to be found in them. However, we did not go over what are the form requirements additional verification tests and period that it takes to be reflected on the project, and its impact of the project cycle.
In my experience, that is dependent on the project that is being worked on. If its a minor change, a team can add a rationale, justification, or upload a new revision of each of the documents to explain if there is no impact to verification testing or product launch. If the trace matrix has a major issue for the inputs and specifications that impacts the products final design and the initial prototypes are no longer production equivalent, then verification testing will need to be delayed until the production equivalent parts are created. If the verification test protocol does not reflect the ability to verify the product accurately based on the inputs, then a new protocol needs to be drafted and adopted for the project. If the inputs/specifications were noted to be incorrect post-launch of the product, the team would need to assess the impact of the change and possibly open a CAPA. If the team does pursue an additional change, the sustaining teams would need to remediate any issues with the product via change control dependent on the company.
Procedures need to be established and maintained by the company to document design changes. This is a requirement of the FDA. These procedures have to cover both direct design changes (these are set down through Document control) and verification deficiencies and corrective measures (set down by change control). Design changes are normally initiated by change requests. Each company can have its own forms/specifics for doing it as long as they comply with proper practices aligning with 21 CFR 820.30.
In Document Control: A history of design revisions has to be maintained with numbered documents and master lists. It is preferred if a person is assigned the responsibility of document control. Approval procedures and history have to be recorded too.
In Change Control: Change requests are made and then they can be approved or declined. Change request review procedures change from company to company. If accepted change orders will be created. verification and validation have to be repeated. A mechanism should be there to track all change requests and change orders.
