• Melita Ball

June 25, 2020 Blog Post

(Re) Designing a Quality Management System: 2 Critical Design Mistakes and How to Avoid Them

In the last blog, we covered the two most critical mistakes an organization can make in the Planning Phase of a Quality Management System (Re)Design Project. If you missed it, you can read it<<HERE>>.  Today, we will move to the next phase of the project, the Design Phase.

The Design Phase is the phase where the project team will draft and frame up the new QMS processes, procedures, and make critical decisions on what kinds of tools and systems they will use to maintain it over time.  In the modern era, there’s really no reason for any

company (large or small) to try to implement a paper-based QMS.  Computer systems and applications play a critical role in your QMS and should be designed into the system upfront and not retro-fitted into the QMS after go-live.  More on that in a later blog...

So, what are some common critical mistakes in the Design Phase that will likely cause the project to fail completely or result in a non-optimized QMS; and, how do we avoid these mistakes to achieve the ROI you expect for your organization?  Remember, these are common failures that are predictable and avoidable so, let’s get to it.

Critical Design Mistake #1:

Choosing Not to Baseline the Core Project Team on the Regulations & Standards

This seems like a logical, simple, and common-sense thing to do when your entire project goal is to design and implement a Quality Management System that meets the requirements of the applicable Regulations, Standards, and your business.  In my experience, though, most companies don’t bother doing this easy step to give their project a much better chance of success.  Why? Some of the typical reasons that are often cited to me are:

  • We don’t have time

  • The team already knows the regulations

  • These are quality managers, they do this everyday

In reality, we have found that taking the few days it takes to accomplish the base-lining activity actually speeds up the project in significant ways.  A proper launch accelerates the learning curve not just on the regulations and standards but promotes team building, cooperation, alignment, and helps those who may be skeptical or resistant to change adapt faster.  The exercise helps the team come together on common ground from the beginning and downplays individuals who would otherwise try to sway the efforts toward their own pet procedures. 

Instead, we focus everyone’s attention on the actual requirements rather than on what they perceive they need or currently have.  We also find that the assumption thatthe team already

knows the regulations because they currently work within a QMS is a terrible assumption to make.  In fact, we find quite the opposite.  It’s true that many people currently working within a QMS know the ends and outs of that QMS but that’s typically where the knowledge stops.  Especially since we try to get a diverse representation of the organization and not just the “Quality Department.” 

To the last reason listed, I would point back to the previous critical mistake in the Planning Phase.  The project team should not be staffed by all the “quality managers” in the first place.  In my experience, the ultimate adoption of the redesigned Quality Management System by the organization is directly proportionate to the diverse representation on the core team.  If it’s perceived as just a “Quality Project,” the results are unfortunate and predictable. Critical Design Mistake #2: Start Designing the New QMS from the Existing QMS If you have already determined that you need to re-design your Quality Management System because it’s not working for your organization, it seems logical that you wouldn’t want to start with the things you currently have.  However, similar to the critical design mistake #1 above, we find that this is exactly where most companies start and very likely one of the common causes of failure.  When we ask, here’s what people typically say …

  • It’s easier

  • It’s faster

  • It’s cheaper

In reality, we have found the exact opposite to be true.  Remember in my earlier blog in this series when I said the most difficult thing you could possibly try to do is to change a paradigm from within the existing paradigm?  Let’s look at the “easier” argument.  Starting with what you have becomes a frustrating exercise in justification.  Folks begin with assumptions from their current paradigm and that makes installing a re-designed QMS much more difficult.  The discussions naturally lead to justification for why, for instance, a procedure was written as a 150-page dissertation that provided so much detail that the person required to use it needed a PhD or 15 years’ experience to navigate it.  Eventually, people will erroneously convince themselves that the 150-page procedure is exactly (or very closely) what they still need … so much for shifting the paradigm and getting the ROI needed.  These debates and discussions over existing procedures, that you’ve already determined aren’t working, take an enormous amount of time, energy and money and very often lead to very little change.  The end result is not “faster” or “cheaper” … we’ve seen projects that insist on this approach take as much as 150% longer to implement and spend almost double for the project with LESS benefit in the end.  If the executives could see the high price they are paying for little ROI based on the simple decision to waste time evaluating what you have and using it as your base, they may think twice before blindly accepting the easy, fast, and cheap arguments. Alternately, you could focus your efforts on creating a renewed QMS based on current regulations, standards, best practice, and regulatory guidance that will actually work for your company and save a ton of money and time in the process.  You’ll also be in a much better position to achieve the ROI of an easier, cheaper, and faster way to do business in this highly regulated industry. Stay tuned for the next post in the series where we will discuss critical mistakes in the Implementation Phase of (Re)Designing the QMS. As always, thanks for reading!  Stay safe and be well! Thoughts? Please comment below …


Melita Ball

CEO and Principal Consultant

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