Biological Safety Model Quality System

 A properly designed quality system will provide clear direction to staff, a consistent work product, enhance communication between operations and management, and give direction under pressure because important decisions have already been made. Without quality systems departments flounder over who's job is what and staff will write their own operating procedures on Post-It Notes or 3x5 recipe cards.

Personal Experience
When I designed the Biological Safety Quality System I had the idea of pre-communication between management and staff in mind. I remembered from experience the difficulties of introducing a 'new' test into corporate practice or explaining the cause of 'failure' to a disappointed engineer. I also remembered the chaos and floundering that came with repeating a test over and over again, hoping it would come out differently. I wanted to design a system that would help resolve these problems, make the day-to-day worklife of the biological safety professional easier, and the expectations of management more likely to be fulfilled.

Model System
The model quality system is written for a dummy company so you can see how it will work. It is provided to you as editable Word files so you can add your own headers and customize the procedures to suit your needs. It's also provided as paper documents in a three-ring binder, so you can orient yourself as you revise. Click here to obtain your copy.

NJ Stark, PhD
President, Clinical Device Group