• Melita Ball

July 14, 2020 Blog Post

(Re) Designing a Quality Management System:

Summary & Wrap up

Since this has been a long series on Quality Management Systems, I thought I would summarize things for everyone in one last blog on this topic.

We started this series off by framing up why you would want to think about a new Quality Management System and when, exactly, would be a good time to launch such a project.  We learned that there are actually quite a few really good reasons for taking the plunge and a number of naturally occurring events that could help you maximize the timing. 

Here’s the list:

  • A new Company Marketing their First Product

  • A Merger or Acquisition

  • Consolidation of Business Units under one QMS

  • Issuance of a significant Warning Letter, Consent Decree, or other regulatory action

  • Turnover of Executive Leadership for the company

  • The Determination that your current QMS is not Effective

  • Business Drivers for greater efficiency, lower costs, become a leaner organization

  • Significant changes to regulations and standards that affect the QMS

We then looked at the three major phases of a QMS Project and identified common but critical mistakes that often plague these endeavors.  These are so critical to the success of the project that making any one of these mistakes could cost the organization a successful outcome.

In the Planning Phase, we discussed the critical mistakes of

(a) Not Securing Executive Management Support & Involvement,and

(b) Using Existing Personnel to Lead the QMS Project

In the Design Phase, we identified the critical mistakes of

(a) Choosing Not to Baseline the Core Project Team on the Regulations & Standards,and

(b) Start Designing the New QMS from the Existing QMS

In the Implementation Phase, we covered the critical mistakes of

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

(b) Not Securing Executive Management Involvement& Visibility During Implementation

As you can see, we started and ended with a focus on Executive Leadership, Involvement,

Support, & Visibility.  Implementing or changing a Quality Management System is no easy task and it certainly is not a “Quality Department” project.  Without the backing, support, and involvement of the entire organization, the project will likely fail and certainly will not produce the expected ROI without the cross-functional support of all parts of the organization. I hope you enjoyed this series.  If you would like to re-visit any of the blogs in this series, they are on the blog page of our company's website.<<HERE>>. Thoughts? Please comment below …


Melita Ball

CEO and Principal Consultant

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