FDA/Quality Metrics

Management of FDA-Guidelines: How to implement Quality Metrics?

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It is very important to set up a specific and precise formula for calculation of each quality metric, just to ensure that all sites make the data for the quality metrics the same ways. Else you will compare apples with pears when you look across all your sites.

Preferably quality metrics should be calculated at least quarterly, rather than yearly. The data should be part of the Product Quality Review (PQR) or Annual Product Review (APR) procedure and be reported to the quality management review for the entire company for each year, at least.


Think Quality! How to Implement Quality Metrics

This can be illustrated in an example from a mid-sized company where the implementation of quality metrics was used as part of changing the quality culture of the company. In fact, the quality metrics not only improved quality performance but also quality awareness throughout the organisation because it turned quality into a regular activity repeated frequently and with many people involved across the organization. We hope to have given you a high-level flavor of quality metrics and why it makes good business and compliance sense to compile a number of quality metrics.

So whether or not the regulation will come into force and how the implementation will be, we think it is a good idea to establish quality metrics.

Some companies have done it already and there is plenty of experience to build on — but there are still many companies reluctant to put it into practice. Maybe your company is one of them?

* * Hasse Herlevsen is director of rightQA.dk, Alleroed/Denmark. Gert Moelgaard is senior consultant of Moelgaard Consulting, Lyngby/Denmark.