Issues with protocols come in several ‘flavors’ as well.
Master Validation Plan
The MVP describes how to deal with each.
Obvious typos are the easiest to deal with.
Typically, the tester can make the correction (redline – using good documentation practices – we’ll discuss in the Data Integrity section later) and continue testing.
Test Step Change
If the issue is with the test step (e.g., instructions are incorrect or out of sequence), the tester may be permitted to make the change (again, using good documentation practices) as long as the integrity of the test is maintained.
This is getting into subjective decision-making by the tester which is something we want to avoid.
The approach is generally determined by the maturity of the test team.
Inexperienced Testers
Inexperienced testers would typically be given less freedom.
The company may require that an independent reviewer review the changes at the conclusion of testing to confirm the change was appropriate (the reviewer would annotate the changes with the rationale and justification).
Stop Testing
If the issue requires changes to the test steps that do impact the integrity of the test, it’s probably most appropriate to stop testing and update the protocol.
For example, the tester could realize that the test doesn’t actually verify the requirement.
Attempting to redline this would be difficult and would likely result in a messy validation (which is always questioned by auditors / inspectors).