The ABC’s of Medical Device Packaging

Those of us that work in medical device manufacturing and medical device packaging stumble across acronyms daily. If anyone from outside of our Industry would encounter our chatter it may indeed seem like a foreign language. Our esoteric alphabet flows freely IQ, OQ, PQ, QMS, CAPA… In quality management it makes sense to truncate complicated phrases and concepts into tight alphabetic bites, easily ingested by their users. Although these acronyms are intended to streamline verbal workflows they can sometimes overwhelm the workplace due to overuse. However, some of these perennial acronyms deserve a place in our Quality plan. I am drawn toward the acronyms designed to frame the thinking processes. These acronyms are a kind of a mnemonic device to help us remember steps in an analytical process. like the SWAT analysis for marketing, and the MMMM (four M) acronym intended on framing a Quality system in a manufacturing plan.

The four M’s stands for man, material, method and machine. Clearly these are the four constituents that play upon our Quality program. Occasionally it’s worth dusting off these old Six Sigma framed analytical tools and evaluate each one of the four M’s to discover where a new OFI (opportunity for improvement) may be coaxed out of hiding. As director of quality for our company, I start my day not looking for what is right but rather what is wrong in our firm. The four M’s quadrants give me a framework as to where I may look for these problems. As every quality manager knows or will learn, the questions are perhaps far more important than the answer. When we can frame our questions correctly we have a better chance of finding causation and ultimately remedy.

The four M’s Analysis is currently serving me well as I manage our ISO-17025 accreditation function. After we see our operation from the topographical vista of the four M’s analysis, we can begin to pull in tighter to gain higher resolution. When I’m speaking with medical device manufacturing engineers that call me for guidance on a non-compliant event in their packaging sector, I am often surprised with the questions that are being asked. As we all know the process of root cause analysis requires a Multi departmental approach to exploration and discovery. Many of these engineers are only bringing in one or two of the M’s usually machine and material, while completely ignoring the man and method aspect of failure. Medical device packaging has some unique challenges like the duality of making a strong seal that can also be easily opened by the end user. In order to keep the balance medical device manufacturers need to use management evaluation tools, and sometimes these mnemonic devices aid in organizing concepts. Acronyms streamline communication with other medical device packaging engineers as we immediately understand there meaning. With our unique language, we solidify concepts just as all of us quickly understand colloquial acronyms like ASAP or RIP. For medical device makers, we can expect acronyms to grow as the regulatory challenges build. I do believe however that it is prudent to not overuse these acronyms as we risk being overly esoteric and possible confusing concepts rather than creating clarity. I have read some medical device packaging validation that was bursting with so many acronyms they were impossible to interpret.

I encourage you to look outside of our industry for acronyms that may serve your medical device manufacturing function. We have adopted one from the self help guru Tony Robbins “CANI”. This acronym stands for Constant And Never-ending Improvement. It appears it was developed by Tony Robbins more than a decade ago and it was influenced by Dr. W. Edwards Deming.

I encouraged you to fold into your quality plan the four M analysis tool, although simple, it is a important way to quickly gain perspective and help your quality group pull together the correct questions when troubleshooting or developing any process in manufacturing. And by all means keep up with the acronyms especially the ones that drive clarity and build a framework mentality for your staff, TTYL...