So the Validation Department generate the protocol and the Quality Department are involved in reviewing the protocol. Having worked on various different projects it has become quite apparent that the quality review on any protocol is a very important review as it irons out all of the documentation mistakes that occur when the document is being generated.
On the other hand I often wonder if quality takes this review too far, and if they do why?
For example if you have a quality person reviewing an IQ or OQ protocol on a computer application, is it acceptable for them to review it having little knowledge of the application.
Does this lead to the quality person reviewing the protocol with an overly cautious approach to the point where the validation engineer is ready to pull their hair out in frustration.
A Simple Scenario
Lets take a very simple scenario. A test protocol usually has the following fields:
- Test Procedure
- Acceptance criteria
- Meets Acceptance Criteria Yes/No
- Performed by /Date
The column to take note of in this scenario is the Acceptance Criteria and the Performed by/Date field.
Lets discuss the acceptance criteria field first, this field usually contains the criteria that must be met in order to pass a test section. If the test is carried out and the acceptance criteria are not met then this usually results in a deviation or an event being raised.
I don’t think anyone has an issue with this scenario, but in terms of acceptance criteria what is acceptable?
Let take a simple example:
Test Procedure: Click the Yes radio button
Acceptance Criteria: Deviation message is displayed
Meets acceptance criteria: Yes
Performed by: Joe Soap 12/12/09
Is this acceptable from a quality perspective though, I mean when you sign the performed by section do you mean that the test has been completed or do you mean that the deviation message was displayed and the test was completed.
If the quality department are not happy with the latter then they will require a screenshot as evidence that the deviation message was displayed.
Do you see what I am getting at here; does this mean that screenshots are required for all acceptance criteria?
If so then your protocol will contain numerous attachments and a long review time.
Before your protocol is approved you really need to work closely with the quality department in order to understand what is acceptable from an acceptance criteria view point.
If you would like further assistance with protocol generation please feel free to contact Premier Validation