C.02.006 After all it’s all about people!

I am always flabbergasted to see the mess whenever the fundamentals are neglected. When we forget to look for the root cause of any problem, we keep having the problem or worse, it gets amplified.

Regulatory training is a requirement. The regulation imposes training on the regulation. What a superb virtuous circle!

What do we do , year after year ? We re-train. Frequently on a very similar topic. Frequently with the same results as far as compliance is concerned.

Almost nothing.

Almost no impact. No real impact on the status of compliance in our plant.

After being involved with training and education in plants, I come to the conclusion that training is almost worthless. Unfortunately it is a finding supported by serious research. Great conclusion for a training consultant. Anybody looking for a great former-consultant? My CV is ready to be sent!

Just kidding.

Research has demonstrated that less than 10% of the content you so diligently prepare will be transfered to the participants. Oh, I?ve tried to improve on the delivery and the design. I’ve taken course in adult learning (andragogy!) and read tons of books on the subject. I improved and re-improved the whole package… the 10% (say 15% for the super-enthusiastic!) barrier holds true.

The 10% wall look indestructible!

AND WE KNOW IT ALL TOO WELL!?

But this does not prevent us to do it again. The « annual GMP refresher » frenzy hits us each time the regulatory pressure rises. Or when the pressure on the QA director gradually changes his/her natural colors!

When it is all over, when the results of the latest self-audit are released and we are forced to admit that the training results were less than brilliant (although the efforts invested were well meant), we tell ourselves that, anyway, we had to do it.

Check that item on the to-do list.

See you next year.

A lot of us trainers live in this culture of « check-it ». This malignant disease is present in several organizations, even rampant in some, is recurrent and, in some extreme cases, is not curable!

If we take a close look at the Canadian regulation, article C.02.006 (similar in essence to most other regs at that!) we can read that : « People are the most important element in any pharmaceutical operations, without the proper personnel, the right attitude and the right training, it is almost impossible to fabricate, package/label, test or store good quality products. » That is part of the rationale behind the regulation.

The regulation itself states that employees need to have « technical, academic and other training as the Director considers satisfactory ». That means the employees must be qualified to satisfy  the basic principle behind GMPS : public safety. Reading again the rationale of the regulation… « most important element ».

I love that part!

MOST IMPORTANT ELEMENT!

Quality is people! First and foremost. Quality is NOT about SOP and procedures first. PEOPLE first. Qualified people. Vigilant employees. To execute strictly regulated tasks contained in procedures. But again, PEOPLE first. That is the rule.

And our response to this truly great regulation? The Checkititis!

We must train? Let’s train!

Quick. And forget it.

Checkit, checkit, checkit!

Done!

Next?

Another compliance problem? Train, checkit, done.

Supervisors are not present enough on the shop-floor? Let’s train THEM. Train, check, done.

Checkititis, acute checkititis!

Is there another way? What about communicating more efficiently? The regulation state that constant vigilance must be observed to produce quality products. It is also clearly stated that without proper personnel and the right attitude, it is almost impossible to produce quality goods. Again, all this is mentioned in relation with our most precious asset, our employees.

Could it be more explicit? Could WE be more explicit with our employees? Could WE take a little more time to clarify the behaviours we expect on a daily basis, the values our organization tries to convey and to remind our employees of our ultimate mission : to serve the public?

Humans, our employees, are at the heart of our organizations, our products. Again, quality is people.

In spite of this, checkititis!

Let’s take a hard look at this .

IF…

Humans are at the heart of our quality,

Knowledge transfer is close to 10%,

We keep on propagating the checkitits for annual GMP refresher

THEN…

Our customers have a right to question our integrity and our desire to supply them with quality product.

I have mentioned only the PRINCIPLE of the regulation. Let us forget about the multiples interpretation sof the Canadian regulation. Indeed, how can we even think of the details when the fundamentals are not in place let alone respected.

Why bother selecting and hiring a highly educated employee if we cannot this person with a proper development plan coupled to a very specific technical training on a continuous basis.

Why bother working hard to periodically asses and evaluate knowledge (Kirkpatrick level 1, 2, 3, 4 and even ROI if you so desire!) if the results of such evaluations are not communicated clearly and completely to the management team? Or if the management team is only interested by number crunching strategies aimed at increasing the production data… Just a hypothetical situation of course…

Why should we put more effort to acquire government grants and subsidies which will be awarded with much advertisement and media presence if the main target of such training initiative are not even the beneficiaries?

DID WE TURN TO THE DARK SIDE?

Well all is not so dark. It is possible to accomplish great deeds by going back to the fundamental needs of our employees.

I was recently reading about OST, Open Space Technology. The principle behind OST is to open a discussion space. This discussion space allows every participant to say almost anything, on any topics while ensuring a high level of engagement and eventually generating surprising and admittedly quite original solutions to current problems and challenges.

Why surprising? Because the OST works much better when varied teams are involved. Ideally when no one knows the other participants, No bias, No prejudice, No common history, No common conflict. Participants would therefore feel free to just speak their mind up.

What a contrast with some of our current teams! Those teams, together with the same challenges, with the same solutions, have been at it for eons! Working behind the veil of the politically correct, this curtain of creativity-destroying administrative fog ultimately chocking our humanity.

Back to square one. Why not open a discussion space with our employees to discover what’s is wrong with our plants, our organization? Why not allow these people whose heart are so much involved with the success of our organization, their organization, so speak openly to make us more compliant, more resistant  and… more human?

Oh, of course, this process is uncertain. OST might uncover solutions that would affect our sacrosanct CONTROL!

OUCH!

I was listening a few months ago to Harrison Owen, the creator of OST, comparing our organizations to human gestation. Which fetus in his right mind would accept to get out of this comfortable womb to enter a cold and unknown world? Just try to imagine a situation where food is always present with absolutely no effort and pre-digested, a temperature-controlled environment, never too cold or too hot, a comfortable aqueous anti-shock system, a soft light… what a life!

And suddenly, an announcement : an important organizational change, a coming birth, a merger or what have you… Accompanied by a sudden change of environment, of temperature, of food intake and outtake. Ah, yes, you also must be aware that the change will be painful and will require a severe adjustment because you will have to go through a slightly confined passage that should adjust its size as you go along… In the absolute darkness until a blinding light will signal the end of the journey. Would you be ready dear sir, dear madam, to initiate the change now?

NEVER!

But nature is so well done. Progressively, the fetus will notice slight changes as the gestation approaches its end. The environment will become very tight and less comfortable. There is too much « baby » to fit in the womb! And the womb send a signal. A very toxic signal.

In these condition the baby to be born, although against his deep wishes, will undergo the final stage of the gestation and will « accept » his fate. I can imagine the whole situation as the poor thing starts his descent into our cold world… and thus opens itself to life!

A life different that the one it has known so far but oh, so wonderful!

This metaphor has a direct link with our organizations.

What if we were at the toxic stage? What if the time was just right to change our processes, training, production, QA processes? Would the current stagnation in some of our organization be the final stage of our re-birth?

We must admit that most of our companies function or survive thanks to well established systems. Norms, procedures, regulations, collective agreements or other invade et regulate our lives. We have a tendency to accommodate ourselves with all this because, hey, it worked before! The paycheck is always there on time. But look at the recent economic crisis. Things do NOT work so well. Regulations do NOT work so well. And people are always at the heart of it!

I believe we are all aware of our state of toxicity. Our organizations are sick. Are systems fail too frequently.

The acute checkititis must be cured!

CONCLUSION

Try OST with a group of employees. The larger the group the better. The principle of OST are simple to understand and put in place. Go to www.opensapceworld.org for the details or buy H. Owen book.

It’s easy and fun for the trainer.

It’s rewarding for the participants.

It’s an awesome and fast way to accumulate tons of ideas and action plans!

Ask the group about the training situation and let go of your usual control. Oh, and do not say a word once the ball start rolling. Just shut up. That is the hardest part.

Prepare for them a safe environment that will allow them to

talk

think

reflect

have fun

and create a new world!

Let them do all that and be prepared to be pleasantly surprised because after all, it’s all about people!

Have fun, learn well and stay compliant!

Keep on having fun educating your colleagues!

« Let’s be realistic, let’s demand the impossible. »   Che Guevara

« The real voyage of discovery consists not in seeking new landscapes, but in having new eyes. »   Marcel Proust

« You cannot teach a man anything. You can only help him discover it within himself. »   Galileo Galilei

Par François Lavallée, M. Sc.

 

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