I believe that education is the solution to this problem, and I try to gently share my understanding of the concepts that underlie validation with anyone who shows a willingness to learn. Many people appreciate the extra time I take to help them, and this effort nearly always results in better performance of whatever validation related activity they perform.

By this I mean that it seems in some quarters inordinately difficult to persuade validation engineers that a template – YES even an approved one! – is still just a tool. It really is not the Holy Bible never to be modified or smartened up. For example, a very brief and realtively minor modification to an already qualified item does not necessarily HAVE to be a change control testing protocol consisting of the 47 pages which was initially required to fully qualify the equipment. Where 80% of the equipment’s functionalities will remain unaltered/unaffected by the proposed change, it really is OK to depart from creating a document where 80% of the test sheets carry the pre-printed and ingloriously incredible result “N/A”.
When as QA you have the audacity to point out following the QA review and comment phase that such draft documents are a little over-burdened with essentially blank pages when the testing proper consists only of perhaps 3 test sheets instead of the original 12 or 13, you are reminded that the document was created “using an approved template.” I consider this response to be evidence of intellectual laziness and hiding behind an shallow and self-defeating rule.

From an auditor’s perspective, there is nothing so annoying as leafing through page after useless page of Not Applicables – when you as the reader could have been informed on page 1 not only about what the protocol would contain (in the way of proof of success testing) but crucially WHAT it also WOULD NOT contain and WHY.

Whatever became of thinking through and owning the credibility of the document you are creating?
Is it really beyond simple comprehension that where 9 or 10 of the original test sheets are not impacted by the particular test being proposed, the template being used to create the document is ALLOWED TO BE modified to deliver a defendable and compliant document following the sequence outlined below?

The document author lists the test steps that will NOT be utilised as a consequence of the particular minor change to be performed defined by the associated Request for Change.

The author supports these test step absences with a clear and intelligible rationale in the doument’s introductory Purpose Section.
The nett result is we have a real live testing document that tells any reviewer WHY it exists;
it tells WHY the missing templated test steps have been omitted;
it DEFENDS their omission with a concise rationale; and finally, is only 12 very pertinent pages long instead of a proposed 47.
The integrity of the pursuit of delivering compliance is 100% respected – plus unnecessary and pointless paper consumption is avoided and the environment benefits. I see no losers.

Any thoughts?