• Melita Ball

June 11th 2020 Blog Post

(Re) Designing a Quality Management System:

Two (2) Critical Planning Mistakes and

How to Avoid Them


Now that we knowWHENwe should consider launching a Quality Management System (QMS) project, my next three blogs will focus on common critical mistakes in each project phase that will likely cause the project to fail completely or result in a non-optimized QMS.  Most importantly, though, you will learn how to avoid these mistakes and get the ROI you expect for your organization. 


Today, we will cover two critical and common mistakes that organizations make in thePlanning Phaseof the Project.  These mistakes are so critical to the overall success of the project that ignoring either one of them is likely to have disastrous outcomes.  How do I know?  Because I’ve spent the last 30+ years of my life designing and re-designing Quality Systems for Life Sciences companies all over the world.  Over that time, I’ve learned what works and what doesn’t.  I’ve also discovered that everything that causes these failures is (a) predictable and (b) avoidable.  So, let’s jump in.


If you missed the first two parts in this series, you can catch up<<here>>


Critical Mistake #1:

Not Securing Executive Management Support & Involvement


First things first … if the Executive Team responsible for the health and well-being of the Quality Management System doesn’t care enough or understand the critical importance to the business of an effective QMS, then no one else in the organization is going to care either.  It really is that simple.  Please note the use of the term “Executive Team” … I didn’t say “Management Team” … the mandate to implement or change a Quality Management SystemMUSTbe sponsored by the C-Suite of the organization.  Pushing something this critical to your overall business down into the organization as just another project will have disastrous effects.


The QMS is not and should not be owned solely by the “Quality” department within the organization.  The QMS touches every aspect of the business (Operations, Supply Chain, Information Technology, Human Resources, Management, Logistics, Business Development, Sales & Marketing, Design & Development, etc.) and needs to have Executive Leadership throughout its development and implementation to create bridges between these groups and break down roadblocks that will invariably pop up.  All of these groups should be

represented on thecore team for the project. If your project team reads largely like the organizational chart for your quality team, you’re doing it wrong!  Implementing a new QMS or changing an existing one is, at its core, an exercise in shifting existing paradigms to new ones to stay competitive in the marketplace.  This involves significant changes for lots of people.  A well thought out communication plan should be developed in parallel with the overall Project Management Plan and Project Schedule. 


Certainly, it is a necessary and extremely important shift that should occur regularly throughout the company’s life in order to stay competitive and on the cutting edge of technology; however, the human change element must be addressed early and often by the executive team for a successful outcome.  Sadly, many companies only see it as a “quality” project that is focused on delivering tasks to a timeline and, consequently, push it down and away from the Executive Team by assigning it to the Director or VP responsible for Quality instead of establishing executive-level sponsorship to ensure the success across the various functional areas within the company.


It should be noted that the Executive Team cannot simply “say” they are supporting the project … they need to demonstrate leadership and involvement throughout the process.


Critical Mistake #2:

Using Existing Personnel to Lead the QMS Project


No organization, regardless of size, complexity, or length of time in business, should try toleada project like this using existing personnel.  Here are a couple of the many reasons why:

  1. (Re) Designing and implementing a QMS is a fundamentally different exercise than working within or managing an existing QMS.Because of this, it requires a different set of skills.I cannot stress this enough! This would be the equivalent of saying that because Joe has lived in a house for many years and has fixed things on his own from time to time, that Joe is now qualified to lead a team of workers to build a brand-new house from the ground up or that he’s qualified to significantly remodel the house to meet all the new building codes. What do you think the ROI on that investment would be? Would you expect a highly successful outcome? The truth is that unless you happen to have someone on your team with the specific background, experience, and demonstrated success leading full-scale, complex, global organizations through creating or redesigning Quality Management Systems, chances are you don’t have the specific skill sets in-house that you need to be successful.

  2. You can’t shift a paradigm from within the existing paradigm! A paradigm shift requires an outside perspective. If you mandate existing personnel to go off and redesign the QMS, you will almost certainly end up with something very close to what you have today. They may make a few improvements here and there but they are just as likely to make critical mistakes that land you farther from the goal of becoming a more effective organization and may end up creating compliance issues in the process. The likelihood of the worst-case scenario goes up exponentially the further down in the organization you push the leadership on this project.Working teams can sense when those leading a project are out of their depth which creates another problem for the organization as a whole.

One note regarding utilizing existing personnel … I am not suggesting that existing personnel should not be involved in the project!  Quite the contrary, existing cross-functional personnel should make up the core and extended teams on the project.  The leadership for the project, however, should be outsourced.



As a consultant, I used to shy away from talking about this too much in fear that someone may think that I’m engaging in nothing more than a sales pitch for my services; however, we have had to rescue so many failed projects due to this mistake alone that I now choose to speak directly to this.  Avoiding this mistake can save you an enormous amount of money and time.  Having competent, experienced, outside leadership to work in concert with your executive team is so critical to the success of projects like this that it is only second to not engaging the executive leadership in the project.


Stay tuned for the next post in the series where we will discuss critical mistakes in theDesign Phaseof (Re)Designing the QMS.


As always, thanks for reading!  Stay safe and be well!


Thoughts? Please comment below …

Cheers!


Melita Ball

CEO and Principal Consultant


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