Relating Guidance to Process Control and an overarching “Quality Management System”

It is easy to think of how a QMS functions and is implemented as simply the natural outcome of necessary compliance to the existing guidance. This tendency creeps into our heads the longer we work in this industry - some new guidance is updated so we tweak and edit the QMS to reflect the changed expectations.

Too often we think of the pharmaceutical quality management system as several core process and procedures, such as:

• Document management

• Change control

• Training management

• Audit management

• CAPA management

• Deviation management

This has a danger or relegating QMS ownership to the quality assurance department alone.

This “compliance led” view of PQS is actually quite limiting in its scope and can lead companies (and individuals) to think a PQS is simply a list of things “we have to do” as opposed to a tool that when used correctly will enhance technical product quality, ensure product delivery and ensure compliance as a side effect.

Enabling Process Control

A mental model I find more helpful is to relate QMS activities to overall maintaining a state of control and the necessary feedback loops to make it work. For now I am not going to expand into Statistical Process Control. Starting to talk SPC without first laying some groundwork causes many people to run in fear of integrals and excel functions.

Below is a simple quality management process control model adapted from the automotive industry. If you don’t think its relevant just remember that automotive companies also build products that if made incorrectly have the potential to kill or maim their customers, are in a highly regulated market with margins that are tighter than they would like. We can lead excellent quality management thinking from others…..