• Melita Ball

July 7, 2020 Blog Post

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

In the last blog, we discussed two critical mistakes an organization can make in the Design 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 Implementation Phase.

The Implementation Phase is the phase where the new QMS processes and procedures will be released, training is conducted, internal and regulatory audits are performed, and the company goes live on the new Quality Management System.  Even if you’ve done everything right up to this point, these mistakes can have serious negative consequences on the project and adoption of the new Quality Management System.

Critical Implementation Mistake #1:

Not taking the time to write a detailed, comprehensive implementation plan

Implementing a new QMS seems rather straight forward but there can be lots of snags if every detail isn’t well thought out and coordinated.  Every implementation is different and dependent upon a number of factors including, but not limited to:

  • Number of sites

  • Location of sites

  • Dependencies between the sites

  • Computer systems implemented

  • Infrastructure

  • Regulatory authority dependencies

  • Employee roll-out & communication

Regardless of the complexity, the key is to develop a step-by-step plan that ensures the organization remains in a State of Control throughout the implementation process. 

If this is the first Quality System ever implemented and it is a single-site implementation, the process is much easier but should still follow a detailed implementation plan to ensure success.

Critical Implementation Mistake #2:

Not Securing Executive Management Involvement& Visibility During Implementation

Just as we discussed in the Planning Phase, this is the other point in the project where the Executive Team is critical for the long-term success of the Quality Management System. 

Employees should hear directly from the Executive Team early and often throughout the Implementation Phase to facilitate a more successful adoption of the new ways of working.  The core project team has been working very hard to design and create a system that is not only effective and in compliance but also one that is efficient and leverages all the conveniences of modern technology. 

Without this direct involvement, many employees will begin to question and potentially resist the new system.  Remember, most people do not like change and, consequently, are slow to adopt change. 

The Executive Leadership is the only group that can be a powerful positive influence (or the opposite) to help employees understand all the good things that will come out of a more

current and efficient system.  They can also help the organization understand what’s in it for them.  If done correctly, the employees working inside the system should be the biggest benefactors of the new system.  It should feel better to work within a more streamlined and modern system, it should make things easier to accomplish, it should be less burdensome than the old system.  If the new QMS doesn’t accomplish these things, it is likely that one or more of the previous critical mistakes were made and not corrected before going live with the new system.  Think of the Executive Leadership team as the bookends that hold all the important volumes of books together on the bookshelf.  If they provide visible leadership in the planning phase, all the design work can prop up to the first bookend.  If they provide visible leadership during implementation, that second bookend will hold everything in place and promote faster adoption.  If either bookend is removed or never placed, the books will eventually slide and fall into a heap on the floor. Join us for the next and last post in this QMS Series.  I will summarize what we’ve learned so far and provide some tips on maintaining the Quality Management System over time. As always, thanks for reading!  Stay safe and be well! Thoughts? Please comment below …


Melita Ball

CEO and Principal Consultant

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