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 …
CEO and Principal Consultant
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