It has been said that you can categorize entrepreneurs, engineers, and inventors as either starters or finishers. And although this may be a tad of an oversimplification, I do feel that this broad category seems to encapsulate the core of many personality types and management styles. I have a friend that is always starting on the next great idea du jour, but never sees any of his ideas and projects to fruition. His endless “in the works” mode is an interesting juxtaposition of my “steady at it to victory or defeat” mindset. It is important to remember that if you are championing a medical device packaging validation program, there is no question that this is a game for finishers.
I know I’ve spoken on this topic before, but it continues to show up in the encounters I have with medical device packaging quality teams. The message is clear when it comes to sterile device packaging. When you’re done, you’re not done. Too many medical device quality groups seem to push in for a moment, validate a packaging process, and then disappear into the woods leaving the task of adherence to a less trained and less equipped segment of the business.
Whilst working with medical device manufactures I’ve had the opportunity to perform a post-mortem on several failed medical device packaging validation programs that resulted in a loss of sterility in distribution. Often at the end of the root cause, we found a process and regulatory Ghost Town, whereas the author of the validation was no longer closely involved with the day to day monitoring of the medical device packaging validation plan.
Many times, maintenance groups, and unqualified lower level employees have been given the responsibility of performing engineering duties without the skill set to do so. It is vital that quality teams that set in place a medical device packaging program have a framework setup where those downstream will be able to conduct their plan and maintain validation compliances. They also need to make sure that any predecessors will have the ability to make sense of their validation when they have gone away. It is far easier to deal with what is going on through competent management strategies than to try to figure out what went on through an uncomfortable CAPA, or non-conformance event.
The message is clear, when you start a medical device packaging validation it is your baby and you simply cannot pass it over to line workers or maintenance staff. Own your medical device packaging validation and thwart the diminution of a process that is unwatched.