GMP Inspections: How to and Why
How to and Why?
GMP inspections and audits raises the food safety standard of your facilities and help demonstrate your dedication to providing safe, high quality food products. Before elaborating on how to conduct an inspection let’s first get clear on the differences between and inspection and an audit
What is an inspection?
An inspection is a snapshot of what you are seeing at a particular time. It can identify potential issues or deviations from established procedures or also show the things we are doing well. An inspection should be unannounced to get the best outcome. This will allow you to see the operation or area as it is normally, and not in a prepared state for the inspection. Inspections tend to be more physical in nature and should focus on equipment, the overall facility condition and personnel practices going on around you at that time. We should spend more time with detailed checks on the shop floor rather than only on the records.
What is an audit?
An audit on the other hand, evaluates documented programs to verify how formalized the programs are, whether they have been written and complied with, whether the activities are recorded appropriately to support the scope and function of the prerequisite programs in the plant. So we spend more time reviewing records and documents in addition to observing the practices and plant condition. For risk mitigation or reduction, audit programs can identify potential problems before they occur. If you operate your organization in a manner that does not meet customer and regulatory requirements, what do you think will happen? It is likely that you will be making what is called in regulatory terms a “violative” product, which means contaminated product that is likely to be a food safety hazard.
Having a strong internal audit program will uncover and correct food safety issues before they become significant ones.
How do GMP inspections complement audits and why are they important?
Inspections are physical activities to confirm that conditions are compliant on a day-to-day, week-to-week basis. An inspection might trigger a need to audit records in greater detail to pinpoint when they had been effective and then became non-compliant. Conversely, an audit record on the floor might uncover a condition that would prompt you to go into a physical inspection mode (for example, signs of pest infestation). If a company relied solely on auditing records without a physical inspection component, it is unlikely that the end result would achieve regulatory or external audit and inspections compliance.
Bottom line: plant records must accurately reflect the actual conditions and those records must always be verified by a physical inspection.
Key steps for conducting a GMP self-inspection:
- Have a procedure or understanding of the standard which will be used.
- Gather resources need to conduct the inspection e.g. notepad, camera. This would also include tools like flashlights that contribute to a detailed inspection.
- Establish how frequent inspections should occur
- Emphasize on the product zones
- Include exterior grounds and receiving areas
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