The tenth commandment : You shall be in compliance

The end of our journey!

Well, at least the first part of the journey since I have been re-creating and expanding this newsletter from the original French newsletter that I have been writing for the last 3 years… A back catalog of 2 years will always be waiting and most of my original readers in French want to read this one in English! I have been writing GMP newsletter since 1999 on a monthly basis. Yep, you can say that I have a strong urge to write!

I often wonder why I need to write like that. I write a GMP chronicle in French every month, one on time management (French only… let me know if I need to translate this one too!) and this one. I have a one week break every month. Strangely enough, I look forward to the end of that week. Not really a week off in fact, as I also write a quarterly newsletter on Communities of practice for our Trainers association and a not-so-quarterly newsletter on health and safety for another group I facilitate.

Why do I write? First and foremost, for the pure joy of thinking about topics I cherish. Yes, thinking. We do not think enough. We do a lot of acting… sorry, we act a lot… hmmm… not so different after all. We move and change things. We do a lot of activities, but not all of them are productive (the activity trap… oups… I am slipping into time management now). But thinking? Not enough. Writing forces me to pause and review concepts, putting them in relation to each other, browse the internet for some more info etc.,etc. A great activity. Really. Oh, and the writing. I just hate this part because it is so slow! And the spellchecking. I will pass on that one.

Well, after all, writing on a weekly basis is all about compliance. Research ,Discipline, Reviewing because you, dear readers, request it.

Compliance

1. The act of complying; act of doing as another wishes; act of yielding to a request or command.

I just love the dictionary! What a great source of inspiration and re-alignement.

First a distinction : To comply is not the same as to be compliant. The first is a command; the second is a state of being. Too frequently are we ask to comply and to implement a series of corrective actions to do so. Compliance is not just a series of new procedures and complex control systems. Compliance can and must be a way of living, a work philosophy.

Comply or die! Almost literally since plants have been shut down for lack of compliance. And again and again, corrective actions were put in place to alleviate the dreaded « NC » rating (Non compliant) or 483, warning letter and what have you.

Every pharmaceutical company has an obligation to comply to the GMP regulation. At least to the minimal set of requirements of the GMP. Boy, do we make an effort to be minimally compliant sometimes! All because of the requirement to do so. To DO so. Look at the list of observations.

Missing this and missing that.

Failure to follow procedures.

Contamination control is deficient.

Etc., etc.

Missing actions, deficient actions.

Oh and a few comment about management. Or the lack of.

And what about attitude, GMP awareness, desire to excel?

TO COMPLY is a matter of following the rules, the numerous rules and procedure. It is a matter of auditors vs auditees. The inspection war! Hey, we even call the audit preparation room the war room in some companies! Failure to comply is therefore a failure to follow the rules and regulations. It is like losing the war. Who wants to lose a war? Who wants the casualties associated with a war?

TO BE COMPLIANT, is a different matter.

What does that mean for most people? Unfortunately, most people will probably see not difference at all between TO comply and TO BE compliant.

What a pity! What can we do about this?

If TO COMPLY is a matter of action.

TO BE COMPLIANT is a matter of thinking before acting, thinking during the action and thinking after the action.

Where as TO COMPLY is close to the robotic way of doing things – just follow the rules and PLEASE!, do not complain! -TO BE COMPLIANT is more akin to a deep reflection on ones action. Preparing the work and planning the most minute details requires more that a procedure, it presupposes a passion and a dedication to the right thing, the right way at the right time.

Dedication, passion. Unique to the human mind and the human heart.

Why do we tell stories to our employees to make them tick the right way? Why de we need a human drama before acting for the right reason? Because human think with their brains AND their heart! To forget this important concept is to foreclose any true compliance.

Tell anyone to follow a rule and the human brain will do what it does best : troubleshooting! A few minutes later, most normal adult will have found a way around it. Especially if one needs to fill a dozen documents before doing anything! Especially if doing the right thing the right way will generate a tedious investigation process resulting in the one employee being suspended.

That’s real life! Not fiction.

Now the thorny question: WHY? Why are our employees, and our plants, not compliant? Why don’t we know?

Communication is always a challenge in large companies. In all companies! It is even a challenge in our families!

Communication is key to compliance.

The first question we should ask to our employees is how can we HELP them be and stay compliant. I am certain we would be quite surprised to learn what would affect their behavior. Behavior is key as it is observed. By the auditors and everybody else. Behavior of our executives inside and outside the boardroom is also observed and has tremendous impact on the behaviors our employees.

A few key actions are therefore in order to make sure our companies become compliant. Actions that are not directly related to Good Manufacturing Practices.

Implement a new rule, a simple rule : morning GMP talks! Let the employees tell you what they worry about. Most of the time, simple and easy changes will make a difference and drive their will to be compliant up the roof! Our employees know a lot about REAL compliance, day-to-day compliance. Durable and logical solutions will come from the shop floor and labs. Not from the top office.

I apologize to those who put their heart and soul into SOP and procedures. They do exceptionally good work. But bureaucracy has never been a proven way to change things. Large organization must implement some controls, but at the heart of it, people make a difference, not procedures.

How can we really be in compliance? How can we really respect all those rules? By working on the fondamentals : humans.

S.R. Covey said : « When mores are sufficient, law are unnecessary. When mores are insufficient, laws are unenforceable »

The actions that are required to change behavior and mores are not directly related to Good Manufacturing Practices. Unless you define GMP as Good Management Practices.

Hey that’s a thought!

Have fun, learn well and stay compliant!

Keep on having fun educating your colleagues!

« In the last analysis, what we are communicates far more eloquently than anything we say or do. »   S.R. Covey

« The way we see the problem is the problem. »   S.R.Covey

« You can’t talk your way out of what you’ve behaved yourself into. »   S.R. Covey

Par François Lavallée, M. Sc.

© Copyrighted material Aliter Concept 2015. Please do not print or copy without permission from the author.

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