Monday, September 2, 2013

Pareto Principle at work in Biotech

In the latest FDAzilla post, guest blogger and regulatory professional - Greg Hattoy - talks about 5 ways to prepare for a regulatory audit.

The first idea is that small things can build into big things and that management needs to have a pulse on what's going on. It isn't so much that there's something small out there that's wrong with your plant (like rust on the bottom of the fermentor) that that it becomes big (like your fermentor gets a hole in the bottom of it from the rust).

I've seen this in action where immediate- and short-term fixes are executed in a way that causes long-term maintenance chores. For example:
  • The intended design of post-inoculation additions was among the suspect causes of bioreactor contamination.
  • In the name of mitigating this potential risk via process of elimination, post-inoc additions were changed away from the intended design.
  • True cause of microbial contamination was later deemed to be something else.
  • Due to "don't fix what ain't broke" and heavy workload, the modified additions were never changed back.
You get enough of these decisions and a well-engineered plant encumbers itself and slips farther away from good engineering practices.

His second idea is that there are "Big Wins." This is absolutely consistent with the Pareto Principle where 80% of the effects can be explained by 20% of the causes, and though Greg states that it my fly in the face of the "small things add up" thesis, it actually doesn't. Here's why:

Every biotech professional from worker bee on up to the top of management has their list of 100 to-do's. Everybody is loaded down and their email inbox just looks like a constant scroll.

There actually aren't 100 different problems that need to be solved. It's actually something like 12 real problems. The majority of the effect/response (80%) is caused by a minority of the causes/factors (20%).

There are people who tackle this list according to priority: #1...done. #2...done. #3....done. And by the end of the day, the top 10 items get subtracted off the list (and another 10 get added).

Then, there are people who look at the list and go, "Gosh, #3, #7, #13, #49, #62, #85 are all related. If I spend time tackling the true root cause, I can hit six birds with one stone!" And when you go about solving problems in this manner, you can use the Pareto principle in your favor:

You can solve 80% of your problems by fixing 20% of what's wrong.

Obviously, there are times when you need to tackle the list sequentially. But this ought to be a minority of the time compared to tackling your to-do list strategically.

Critics of the sensible approach say that walking away from regulatory inspections has more to do with the personality of the inspector.  For that, there are ways of gathering regulatory intelligence.   But for the rest of us, following defensible plan is the most sensible approach for preparing for a regulatory audit.

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