When 95% probability provides 16% certainty.


Whenever you are 99% certain, starting doubting your results and look back at your dat with Bayes in mind.

Quality culture : Lessons from a defeat


How a recent political defeat can enlighten us on quality culture.

Mean lean, average lean : on which side to lean on ?


Lean programs are great! As long as the whole concept is implemented. Tools for humans. Not the other way around.

The roots of a quality culture


Building a culture takes times. Maintaining it takes care and nurturing. Lessons from the bamboo.

How expensive is cost-cutting?


Cost-cutting is costly! Most of the time. But we do it anyway. To get the early rewards and to hope it will stop soon. Bad news : it won’t. Stop thinking cost. Start thinking smart.

Reg-less, NOT reckless quality


Do we focus on the details of the regulations or its essence? Do we make sure the level of compliance in our organisations is aligned with our true purpose or simply ensure that all the requirements…

Quality gurus : who’s next?


Quality guru wanted!! The great from the pas are dead. Who will take the baton and lead the way?

The first commandment : procedures you shall write


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 !

C.02.006 Interpretation 5 : GMP refresher


How can it be clearer? Human Performance Improvement (HPI... yep, training groups are progressively called HPI teams) personnel are frequently asked what is the target audience for a given course or…

C.02.006 Well-shoed shoe-maker


Do you know the internet? Not the one we use for online shopping but the one that is full of information about compliance. I was looking through the Health Canada web site recently, looking for some…

The Seventh Commandment : Competence (Training, Education an Experience) You Shall Have


Nobody will argue that Tiger is a great golfer. And he tees-off perfectly. TEEing-off perfectly is the way to start a great golf game. Receiving the right Training, Education and Experience is,…

The Fourth Commandment : Your Work You Shall Validate


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 Third Commandment : Your Work You Shall Document


Ever heard of documentation errors? New employees are trained on good documentation practices as soon...

The 10 commandments


Each month, Aliter Concept offers a reflection on a theme asociated with GMP. Never had to understand, always interesting (well, most of the time!) and opiniated -Hey! Nobody said it is a perfect…