Ever heard of documentation errors? New employees are trained on good documentation practices as soon as they are hired, but too frequently do we still see documentation errors on the floors, in the labs… and in the offices! We train them on the multiple documents they will have to use and also explain that these documents are a garantee for the public. These documents are a proof of our integrity and our commitment to provide safe and effective drugs.

Hmm… commitment… absolute compliance, faultless… For a reason that is not too clear to me sometimes, these words do not seems totally… well… really heart-felt.

When we look at the state of our documents, the real documents, the one that our employees used on a daily basis, we cannot fail to see the same errors being repeated again and again. The same deviations to the same documentation rules. The same simple rules of documentation.

We have to ask oursoulves a little about the deep motivation of our employees. Are they really committed to compliance? It certainly does not SEEM to be the case if we look at the sheer numbers of documentation mistakes that have to be corrected on a daily basis. Why? Our documents are numerous, complex, of varied forms and formats, filled-in under pressure and all in all, from company to company, approximately 99% error free.

99% perfect.

Only 1% of them have a documentation error to be corrected. We are talking here about 1% among millions of data entries. Not bad after all! Calculate the number of documents that circulate in your site (including change control, SOP, batch record, deviation reports, etc.), multiply this by the average number of data entries for each document (a comment, a name, a number, a signature, a time, a weight, a volume added, an initial, etc.) and divide this number by the number of individuals in the company. The numbers I usually come up with is between 7 500 and 20 000 data entries per individual per year. And all this is 99% perfect.

Well, you must have read other numbers on the internet. 1% error is the equivalent (Canadian numbers) of 100 000 letters lost every hour in Canada, 200 unsafe landing at the Montreal airport annually and the list goes on… Our documentation performance in the pharmaceutical industry does not deserve a medal.

Oh well, I can hear some well intentioned managers say that all theses mistakes are CORRECTED before the batch is released. Ok, I can take this. But aren’t we always talking about quality and this “right the first time” motto? Correcting the mistake is like asking the pilot who crashed at the airport to put the plane back in the air and re-land it.. safely this time. In real life, you do not get a second chance. You cannot push “reset” and have three more lives. We are not in a video game…

The rules of documentation can help us document systematically. These rules are simple, simple to understand, simple to apply and implement everyday. They are so obvious and useful that people tend to use them at home too! Unfortunately, they do not solve the problem of documentation errors. They are a part of the solution and not the whole solution.

If one considers the tools offered to our employees to document properly one has to wonder why they cannot do better! Procedures? Yep, numbers of them! Training on documentation? Yes sir! At least once a year in some companies. Rules of documentation? Simple and easy. Something must be missing….

What about not having a decent pen?
What about complex documents?
What about too many documents?
What about documents designed for QA instead of line employees?
What about the somewhat heavy process to improve those numerous documents? Change control in some company is quite a beast to tackle with!
What about the number of time one has to initial, date, sign, add a comment in a document or worse yet, in a multi-lined table!!! And do not forget to cross-out any, and I mean ANY blank space!

Our documentation processes are complex. Our documents are complex and the results of several audit-related modifications… So complex that we lose sight of the real purpose of some forms. Too frequently, these self-inflicted audit-induced revisions were done before the auditors left the premises and promised to be an interim change… 5 years ago… Until the next audit comes or a burst of documentation errors makes itself visible… Spontaneously appearing out of thin air. Yeah right.

And I will not touch on the subject of the photocopied-photocopy that was photocopied from a photocopied photocopy… So many copies of copies that you have to bend you neck to see clearly the angled form and oh, yes… These 8-font prints that used to be more than a evil-looking smear in the lower left corner… Was that a lot number? No wonder our employee and dazed and confused sometimes.

Those same employees, stuck with this paperwork and frequently blamed for their lack of professionalism and rigor, those employee who most of the times just want to do their job in the best way possible. They will do everything to do it right. And the human brain is immensely creative to find ways around obstacles, genuinely creative!

I sometimes wonder if we, as leaders and managers, would go to the same kind of effort to ensure everything is adequate? GMP are a lot more than just a series of rules and procedures. GMP are a way of life. Most employees have an intuitive understanding of this. But then, what is our roles in this? Our roles, as managers and leaders, is to make sure our employees can do the work they are paid for. We must help them perform. After all, and we sometimes forget this, THEY make the company going. As far as documentation is concerned we must ensure that :

The documentation rules are respected
The documents they use are adequate
Any problem is documented and addressed swiftyl
Any document requiring a change is treated quickly!

Therefore, the follow-up is the real crux of the matter. Oups… MANAGEMENT DEFICIENCIES again…

Follow up is where it all fails. Forget about training design when looking for the cause of failure of that new documentation program. Forget about flawed forms? Forget about re-training employees. Forget about measuring the details of your documentation errors.

Just follow-up. Every day. With each team. In every production room, every lab, every workshop. Just follow-up. Help your team document properly. Review their documents with them. Play the auditor and review a few batch records yourself. Ask why it was not done adequately. Just follow-up. And keep at it!

This is your job. First and foremost. Stay close to the real world. We shall follow-up with growing confidence. We shall follow-up in the field and in the labs. We shall follow-up in the warehouse and in the workshops. We shall never surrender!! Hmm. I got carried away here!

For more information on Documentation rules take a look at the wiki on Good documentation rules http://perfectdocs.pbwiki.com and feel free to modify it!

Have fun, learn well and stay compliant!
Keep on having fun educating your colleagues!
Continue with the Fourth COmmandment
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Par François Lavallée M. Sc.


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