The Fourth Commandment : Your Work You Shall Validate
DONE BY : ____________
VERIFIED BY : _____________
How many times should we verify our work? And the work of our colleagues? And why? After all, are we not competent to do things the right way, are we not responsible for our work? And our colleague? Is he not also responsible for his work? Is he not also competent?
Double verifications are part of our environment, our very own pharmaceutical environment, and has been part of it for a very long time. And they are not about to disappear. Although sometimes almost invisible to some people… At least, that could be the reason for their tendency to forget to sign! …Ah, routine work, when you hold me!
Double verifications did appear for a very simple reason. Single verification were just not enough! Single verifications are still valid… up to a certain point. And, honestly, single verifications could very well be sufficient in several instances. What about the other instances?
WHAT OTHER INSTANCES?
Let’s ponder this. When could one perform and inadequate verification? I can think of multiple scenarios :
– When overtime blurs our eyesight.
– After one (or more) nights of caring for the youngest child’s gastroenteritis.
– When traffic jams elevate your blood pressure (and your boss’!) on your way to work and lower your judgment.
– When you spouse is preoccupied and thus preoccupies you!
– When your boss wants the job done… yesterday.
– When migraine squeezes your brains to a formless pulp.
– When, when, when your are not up to par for the job you are supposed to do.
I will not even mention the dense and numerous documents that were recently issued by QA to make sure the team stays compliant and perfectly aligned with the recent audit findings, the frequent production delays, the new employees who really, but really, does not get it! In short, several situations will prevent any normal human being from doing the right things, the right way at the right time, every time. The same situation will also prevent any other normal human being from verifying the right things, the right way at the right time, every time.
Making mistakes is a very human thing… So goes the old proverb. And that is part of the reason why the second verification is so important. To prevent some mistakes to occur. There are many horror stories we could use to tell our employees how important their role is when performing the second verification. At the same time, those employees should be consulted to make sure we do not OVER DO IT!
Several double verifications could be eliminated to the satisfaction of our employees and auditors. Double verification for eveything send a very clear message : EVERYTHING is as important as EVERYTHING else. And it is NOT the case! Some steps are crucial. Some steps are mildly important. To say that everything is life-threatening in our processes is a false truth. You know it. Your employees know it. The investigators know it too. The way we handle our double verifications is a sign of the way we understand our processes. And the way we control them. THIS is important!!!
Compliance MUST become a tool to produce better products in a safe and effective way. Compliance must become a lever to become more productive. Being productive AND compliant is NOT a dichotomy. It is possible.It is realistic. IF we involve the right people, doing the right things, the right way and at the right time.
Well, that is one of the interpretation of the fourth commandment. Validate your work and the work of others to garantee a safe and effective product to our customers. But then commandement are also subject to interpretation and this one contains a word that probably elicited a different response in most people.
Validation. The big word.
Validation, hard and ugly for a lot of people.
Validation, painful but necessary.
Necessary BUT very, very painful!!
Validation, one of the most important things we can do to ensure our customers that what we do, what we sell, what they ingest, inject or spread is always, ALWAYS done the same way. Whenever the work shift, whoever the team players, day after day, month after month, our products stay the same.
Validated processes, validated analytical methods, validated equipments, validated computer systems, PLC etc., etc. On top of this, add all the IQ, OQ, PQ and any other Q you can think of and BINGO… Rock solid garantee for your products. Take your pill in confidence. You will never have any problem. Never. Promise. All those validation ensure that our products are perfect.
REALLY? Can we really claim loud and clear that BECAUSE everything is validated, everything is, by extension, perfectly safe?
What about that recent piece of information I read in a FDA bulletin (2008-094-15) about this drug (no sir, I will not write any name…) that was supposed to help patients during a diagnostic procedure by relaxing the throat muscles, but, in some undivulged cases, could also kill them. I am sure that the process had been validated, as were the equipement etc., etc. But somebody « forgot » to put this information in the documents… Fortunately, this cases are far and few in between the rest of the good stories. But the fact remains : Validation, validated studies, validated equipment are not the ultimate garantee.
The only validation that is our conduit to perfect products is the human validation. The final verification done by a human being, a consciencious human being who considers all the procedures and the plethora of tiny details that are not documented anywhere and using the intuition that is so unique to the humain brain and heart.
DONE BY : ____________
VERIFIED BY : _____________
2 simples lines.
2 of the most important lines in every document.
2 lines that are a witness of our compliance and respect towards the public.
2 lines that are the reflection of our organization’s human capital.
2 lines to demonstrate that our human capital has also been validated… educated, trained and certified.
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Par François Lavallée M. Sc.
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