Metrics, the Foundation and Emotions

Metrics,

This one word can cause many emotions, fear, trembling, excitement, or dread!

I have experienced all of these emotions when it comes to metrics.

That Pareto Chart ascending or descending in at a particular elevation or curve can have a profound effect upon us!

The FDA has recognized the importance of Quality Management System Metrics in recent years and has published Guidance Documents and calls to action for the Pharmaceutical, Biotech and Medical Device Industries.

As an auditor when I review a Quality Management System which clearly defines a companies focus on metrics and trend analysis, I usually see a well implemented Quality System that is very proudly shown and is producing clear results.

As a Quality Manager, while I sometimes dreaded “Metric Season” and some of the data mining which is associated with metric reporting, I was also excited about what those metrics would show and how they would help hold the organization accountable to it’s quality objectives.

The Foundation

The FDA, in a post on it’s website titled Measuring Quality Drives Excellence states that “Modern manufacturing includes robust quality metrics programs as a foundation for continual improvement of product and process quality.”

Metrics are a foundation for continual improvement of product and process quality!

In other words they are the starting point (foundation) for continual improvement within a quality system.

Metrics can clearly show a proactive approach to quality issues without waiting for a quality incident to drive change, these are considered reactive organizations and can cause more scrutiny by auditors and inspectors.

Foundations are important in a brick and mortar building, and according to the FDA are equally important to the quality of our products!

Matt Hermon

Senior Quality Auditor