Possibly the most critical aspect of the MVP is to establish a consistent approach to how issues arising during validation are handled.
Test Failure
The most obvious issue is a test failure.
The MVP describes the methods for documenting, assessing, and dispositioning test failures.
Small Team
The failure is typically assessed by a small team (e.g., quality representative and representative from the function using the software) to determine how to address the failure.
The failure could be a result of:
- The software failing
- An incorrect protocol
- The tester misinterpreting results
- Or the tester not following the protocol correctly
Resolution of software failures could include:
- Changing the software using proper change and configuration control methods defined in your lifecycle!
- Avoiding the issue procedurally (e.g., restricting users from accessing the feature)
- Accepting the failure (only if no risk)
- Or accepting the failure but instituting post-use controls to mitigate any issues (e.g. review and possible correction of data)