INSIGHT: Does your Risk Management still lead to Unthinkable Consequences?
When you’ve been around manufacturing as long as I have, it’s inevitable to have moments when you wonder whether the latest “thing” is nothing more than a shell game.
I remember in the mid-90’s when Six Sigma and its various belt levels was all the rage. One of my best contacts at one of our best customers announced proudly to me one day that he’d gotten his Black Belt. I remember saying to him, “You know, one day you’re going to have to give me the 10,000-foot view on this so I can understand it better.”
We had our sit down a week later and he took about 2 hours going through it with me. I asked my questions throughout so when he was finished, he said, “What do you think?” I’ve never had good filters so saying the first thing that came to mind while scratching my head, I said, “Well, we used to call this stuff common sense.”
You probably know his response but I’ll give it to you anyway, “Yeah but Randy, people don’t have that any more.”
For several years now, Risk Management has been at the forefront of concern and in the Medical Device business it should be. It has its own guidance in the form of ISO 14971 and in a QS will commonly be integrated with Design Control. What’s unfortunate is that we have become so ‘regulation-minded’ that we’re spending more time worrying about a Reg or its definition than we are worrying about what’s important to the design, the process and most importantly the patient.
I just read a good, albeit a bit tedious, article on the subject and an important point made early in the article is to state a definition of Risk – “A possible event or incident that, if it occurs, will have an impact on the organization’s objectives.” The author covers a lot of valuable issues. For example: Why do we assume that risk occurs only at the lowest levels of an organization, shift responsibility for it to those levels but never give the people responsible, the authority to ask even the obvious question of why something is being done a certain way? I probably misspoke when I said the article was a bit tedious because that’s a problem of my personality style. Regardless, it’s worth the read. Why? Here’s a piece of his final sentence, “… we need to move from ‘doing risk management’ and start managing risk.” Touché.