Procedures, procedures, close to my heart until we part !

DEATH BY SOP ! Sometimes I think that the FDA, HPFBI, MCA and WHO all have that in mind when they ask to see our procedures ! Most of us see the SOP as a regularoty requirement. And for good reasons ! But beyond the regs, we MUST see our procedures as a tool to stay compliant. Stay compliant, not for the agencies, but rather for our clients. And for a training department, the “clients” are a double edge sword.

I am talking knowledge transfer here. More than training, more than SOP, knowledge transfer is especially important today when we see our more experienced employees seriously thinking about retirement. How are we going to make sure that they share what they have accumulated in the past 30 years ?

Jim Vesper, in his excellent book “Documentation systems, clear and simple”, wrote that the documents we write and use should be designed with training in mind. After all, we should USE these documents !

It is therefore important to put as much effort into the content (regulatory requirement …) as into the container. The knowledge vehicle must be appropriate for the users. Not for the investigators ! I sometimes see SOPs that look like they were written by a Ph.D. , for a Ph.D. ! Obscure, complex, detailed to the extreme and plain …boring !  Mind you, I have nothing against Ph.D.’s . I know one or two who are very decent sentient beings, but SOP should be written for grade-4 students, i.e. a 10 year-old kid should be able to read it and understand it in order to perform the operations described.

On that subject, did you know that approximately 25% of the manufacturing work force in North America is considered illiterate (National Center for Education Statistics 2002)? Functionnally illiterate i.e. they will make you believe they can read but in effect, the only thing they read are the titles and a bunch of seemingly unrelated words. They have a great memory, are pretty good listeners but…they cannot make sense of all the words in a paragraph to procude a concept, an idea or , for that matter, an operational instruction !


Considering this, it is even more important to write in a clear and simple fashion. Ever heard of KISS ? Keep It Short and Simple. (We can also talk about the band but call me for that one!). Add to this the new kids on the block, the Gen Y, used to get their info on the internet, via You Tube, Wikipedia and Second life and your SOP will not last a very long time.The Gen G are also coming on board. G…as in GAME !

3 lives and you die ! 

NO. Just press RESET and start again.  These young mutants can multi-task, chat with 12 people at the same time, watch TV, their ipod and more ! Weirdly enough, they will discover rapidly that a contaminated product or a badly ajusted machine does NOT have 3 lives and does NOT have a RESET button…

Let’s face it : how can a younger worker used to skp lttr in his wrd to wrt fstr can understand multi-syllable words or decipher elaborate vocabulary ? Lets’ not be contemporaneous and open our eyes !

Then what ?

Let’s add images to words and stop thinking “read and understood” ! Why shouldn’t we take this opportunity to re-think the way we train ? The regs are there to protect the public . The new generation of employees have their family at heart. Maybe more than the older generation. (i.e. ours !) Or at least, the way they see the work/life balance is differrent than ours. (See ? I wrote work/life whereas they would write life/work!) Protecting the public has always meant protecting human life and preserving the quality of life. These words always ring true.

The younger generation, like all the others, want to contribute. For the first time in history, they probably have more ways to contribute than we have ever had ! The internet is in their blood ! They can all type…FAST !! (with only 2 fingers , mind you, but who cares, really ?). They crave interaction ! Just look at the popularity of Facebook, MySpace , Second Life and all the other networking web sites. We live in the Web 2.0 era ! Contribution and interaction are the rule !

Take this reality and look at the pharma perspective : rigor, even rigidity, change control, SOP….something does not fit ! And at the same time, the ever changing internet environment cannot, must not, be the way to deal with drugs. Let’s marry these two realities !

They know interactive technology.

We are used to a controlled environment.

They react at the speed of light.

We try to think of everything (paralysis per analysis…) before we change something.

They are experts at “new and improved”.

We are expert at “safe and effective.

What an opportunity !


Let’s use our most basic quality. What distinguishes us from the other animals …




Let’s talk !



Boileau said “What is well understood is enunciated clearly and the words to say it flow easily”. Boileau was a smart guy ! Well, he is dead now but hey, he was making a lot of good sense  then and still does today! Nowadays we could add “and by writing it simply we would perform accordingly !”

 Keep on reading : The second commandment!



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Par François Lavallée, M. Sc.


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