Gastonia North Blog

Medical Device Recruiters

Insight: The conundrum of how systems interact

I’ve been in the Medical Device business for a lot of years and every day is a learning experience.  Many years ago, I was on a trip with a major client headed to another Contract Manufacturer (that was the business I was in at the time) who was to become a shared supplier.  The shop was really nice, clean, well-maintained equipment, an obvious commitment to quality; all the things you’d want to see in a high-end manufacturing site.

In the shop where I worked, we’d recently implemented SPC and glancing at various workstations during this visit, it was clear this new supplier used it too.  As we roamed the facility to get a feel for the place, my client/counterpart asked an operator what the computer and connected inspection device were used for. “SPC” the operator answered proudly.  ‘What do you do with it?’ my client asked. “We collect data!” answered the operator.  ‘And what do you do with the data?’ was the next question responded to with, “We collect it!”

Clearly not satisfied with the interaction, the client asked to talk with the Quality Manager and asked him, ‘What do you do with your SPC data?’  “Well, it’s collected from the various workstations and fed back into the Quality Department where it’s stored.”  ‘But what do you do with it?’ my evermore frustrated companion asked, “We collect it” replied the quality person.

You know where that story went and you should also know that, because we were on our way to a facility of the company I worked for the next day, I made a clandestine call that night to ensure my coworkers were better prepared!  SPC isn’t a data collection system and I’m sure you know that.  It’s a tool used to collect data that is then analyzed for things like trends, effectiveness of UCL and LCL, etc.

This story came to mind as I was reading an article tying Regulation, Quality Systems and Data Integrity together.  It was bound to happen because as technology advances, the tools used in all three of those segments offer more concise control.  But with that conciseness comes a huge risk; analysis paralysis.

We like to stay current with trends and in tune with the important evolutions in the Device space and, of course, many of those are driven by regulation.  We also understand that there’s no “one size fits all” solution to a problem which makes the challenge to every department of the organization seem insurmountable on occasion.  We don’t put these articles in front of you as a singular solution but the only way for any of us to stay current is to read and read a lot!

We do know recruiting.  The unemployment rate was 3.8% in May, labor participation rates are rising and this is all combining to create an exceptionally difficult market in which to find talent.  There’s no magic wand but there are a lot of ways we’re helping our clients fulfill their needs.  Call us.

The Link Between Regulation, Quality Systems and Data Integrity, Part 1