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The video in this article is part of a unit in our online QMS courses (see below) that looks at how to implement a Quality Management System and, in this video, we look at the first principle associated with such implementation – that of adequately assigning roles and responsibilities.

The establishment and operation of an effective Quality Management System requires, in the first instance, appropriate design and development. Having designed our Quality Management System we should now consider the effective implementation of that system.

We need confidence and assurance in the effective operation of our system – this confidence and assurance will be gained through the systems we put in place and, most importantly, through the people that operate within these systems. Hence the absolute need to define the roles and responsibilities individuals have within these systems.

In the UK’s Orange Guide (containing EU GMP) of 2002 it was stated that “the great majority of reported defective medicinal products has resulted from human error or carelessness, not from failures in technology”. Not the fault of technology but the fault of the individual. Our fault! But perhaps such individual failing is more the result of a failure to adequately set down roles and responsibilities.

Whilst the system performance ultimately depends on the people operating within it relatively little is said, in general terms, about the need to define their roles and responsibilities. See video below to understand why this is critical:

This video is taken from Unit 3 of our Pharma QMS online course and our QP QMS course.

Also visit this article about the role of key GMP personnel.

You can see more viseos from our QMS online courses by visiting our Vimeo site.


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