“Are good manufacturing practices or facility inspections conducted periodically, and are findings, corrective actions, and follow ups documented and available for review?”
SCS Global Services GMP Audit, Clause 2.8.46
There are two popular approaches to GMP self-inspections:
Select the most relevant sections of the current Good Manufacturing Practices (cGMP, 21 CFR 117 Subpart B) and make a laundry list of things with acceptance criteria unique to each individual line item; or
Create a standard for acceptance and apply it to categories of surfaces and functions
Approach #2 provides for the greatest efficiency (the checklist can be only 1 page or less) and accommodates for staff of all levels to contribute to the self-inspection. There are two big reasons why:
Most people don’t read more than 1 page
Easier to remember, teach and follow
To establish a standard, we boil down the cGMP to (4) key terms that anyone on the floor can learn and apply, CCSF:
It is cleanly (free of filth), organized (in their designated locations), and safe (from contamination, cross-contact and infestation)
Can be Disassembled (if needed) and made Accessible (for cleaning hard-to-reach surfaces)
In good repair (free of defects) and appropriate (fit for its intended use in the food facility)
It works (it functions as intended), Maintained (serviced as needed) and Adequate (to achieve its purpose)
Your employees are your eyes and ears in the facility, for which reason the GMP self-inspection format needs to be made easy to understand and simple to communicate. The cGMP in pdf format are over 10 pages long, which most of your staff will likely never read and few will be able to apply. CCSF distills those pages into four simple concepts, which, when paired with images for each room in your facility, enable participation from every level in your organization.
Have a question?