Things can go wrong.

Everybody – even inspectors and auditors realize this.

Problems Always Arise

Despite our best efforts, problems arise with the protocols or during testing.

These can’t be ignored or whitewashed.

Honest and Accurate

The best way to deal with them is honestly and accurately.

We’ll talk first about test failures.

Document the Failure

The first order of business is to document the failure.

Most companies have an issue tracking system that facilitates capture, identification, and tracking.

It’s important to fully document the deviation:

• What equipment was being used
• What the environment was when the deviation was encountered
• Who identified the deviation (in case additional information is needed)?
• The steps leading up to the deviation and/or the steps necessary to reproduce the deviation

The next step is for the team to investigate, analyze, and decide upon the disposition of the deviation.

The investigation and analysis is beyond the scope of this course but the disposition is important to discuss.

Risk Drives Everything

As has been the theme throughout a number of these lessons, risk drives pretty much everything.

Not all issues found during testing need to be corrected prior to launch if the risk justifies that leaving them in will not adversely affect safety or efficacy.