So, do you think you have it all covered?


I’ll be frank. My role in helping organisations improve their quality systems is a bit of a paradox and faces a continual dilemma. 

 

Let me explain..

 

Quality professionals repeatedly extol the need to uncover the “unknown – unknowns”  and apply risk management rigorously to prevent patient harm. 


Every quality leader generally reiterates that risk management is a concept that runs throughout their quality management system, from design to distribution.

 

But paradoxically a significant number of the clients I work with have something in common.


They all had compliance issues exposed during regulatory inspections. Issues they did not anticipate coming. 

 

Often they go from appearing in control, to questioning the very foundation of some of their approaches within their QMS, be it risk management, CAPA, problem investigation, or control change control.


Given a little push, often the house of cards can collapse.


Despite this, generally the reply I get when I offer fresh-eyes and insight from the best-practice I see applied by their peers is: 

 

“No thanks, I think we’ve got this all under control. ”

 

My thoughts are usually - well we all generally think we’ve got everything under control, until we haven’t. In business as in life.

 

The questions I’m left with are: 

 

Why do quality professionals not always practice what they preach ? 

 

Why do they sometimes appear reluctant to accept limited outside help and potentially new perspectives ?  Perspectives that would at worst just validate their belief they have everything in order, and at best protect them significantly ? 

 

Ernest Hemingway said that people go bankrupt in two ways - “Gradually, then suddenly “. 

 

I’d argue the same can happen to quality systems. 

 

They can go from appearing in-control, until they are not.




Often when stress tested through inspection the appearance of control is no more than a visage.

 


Share by: