Surviving a Compliance Audit Program Inspection



Compliance audit program inspections are a fact of life for most companies. Preparing and understanding the expectations of the inspection are necessary for surviving the inspection with some scraps of sanity. If the inspection succeeds there are some important things to remember and do. If the inspection fails, there are some serious discussions and things to remember regarding the inspection.



Manufacturing Audits

Manufacturing facilities around the United States undergo compliance audit program inspections at least once a year. These inspections can also be conducted quarterly if there is a problem or if the specific manufacturing industry demands it. Pharmacy companies are more likely to be inspected quarterly than plastic companies, although if either fails the inspection, their chances of additional inspections are high.

The manufacturing facilities are audited on several levels. The first piece of the compliance audit program inspection often is involved in paperwork of the building. This includes the keeping of paperwork in a safe and organized manner for the appropriate period of time. The paperwork should all be filled out appropriately using pen and without the use of any evidence of white out. Any incomplete paperwork can be counted as a point against the inspection total.

The compliance audit program will often inspect the safety of the environment. This safety can include proper pinch point notices, safe work areas and a clean environment. It is a danger to the workers if the area is dirty or there is a lot of contamination on the floor. The area should be well maintained and the cleaning supplies should be well marked as to what is in each container.

Inventory will be checked on manufacturing compliance audit program inspections. There will be times in which the auditor will request to see the contents of a storage bin and verify those contents to what is actually in the bin. Any disrepair will count against the manufacturing company and their warehouses.

The processes used to create the products will also be audited. There are specific processes that ensure high quality products. A compliance audit program inspector will evaluate these procedures to ensure that the company is putting out the highest quality products possible and that no falsification is being done to bring the product into the standards that are normally reserved for the highest quality products.