I have been fortunate throughout my career to have worked for some really great companies. Of course, I’ve worked for some really ugly dogs too. Amongst the best, I can say was Advanced Cardiovascular Systems (ACS). It changed my life. ACS was a wholly owned subsidiary of Eli Lilly a pharmaceutical giant. ACS then became part of Guidant Corporation when Lilly divested itself of nine medical device companies taking six of the nine to create that entity. Guidant was pretty good too.
The one criticism I have made is that Guidant had far too many SOP’s and DOP’s—SOP was standard operating procedure, DOP was department operating procedure. It seemed like every time someone failed to do their job there was a claim of ignorance and out came a new operating procedure. Rather than courageously and fearlessly managing employee performance, creating a new operating procedure was as you might have guessed just a whole lot easier.
I was employed by ACS and then Guidant and eventually Abbott for roughly seventeen years (the catheter and stent business units of Guidant were acquired by Abbott around mid-2006). At one point for about two years during this time, I had even managed the Document Control function, so you can imagine my surprise when during my last week of employment three SOP’s magically showed-up on my training plan. I had never seen them before and they had been around for quite some time.
If I have learned anything at all, it is that you cannot describe or document all the things an employee is not supposed to do, nor is it possible for an employee remain fully aware of the existence of hundreds of operating procedures let alone the content contained therein even if these are on the employee’s training plan. The more requirements a company places into its operating procedures and the more operating procedures a company creates, the greater the likelihood of non-compliance.
In short, a quality management system (QMS) should have as few operating procedures as necessary. These should group relevant topics and should only describe the one or two authorized ways an activity is to be carried-out. They should contain a minimum amount of “what” and “when” material leaving the “how” for work instructions. I would add the phrase “and not a whole lot else” somewhere to the old axiom “say what you do and do what you say”. You can always do more but never less!