Regulatory inspections from the FDA are often nerve-wracking for a manufacturing company and its employees. An inspection can come along at any time, which is why you must be fully prepared for the possibility in order to perform well. The FDA wants to know that there are systems in place that allow your company to show exactly what is going into its manufacturing processes and that you are working to make things better if they are not yet perfect.

While this can seem daunting, it won’t be as difficult to manage if you practice gap analysis. With the help of process mapping, you will be able to show the FDA on your next inspection that you have done half the job for them already by making the processes used by your company transparent and easy to understand, even if they are not currently at their best level.

Why Use Gap Analysis?

Using gap analysis procedures will allow you to clearly identify the differences between manufacturing activities that are carried out daily in your company and the FDA’s expectations. By making a processing map, or a visual representation of the procedures, for both SOPs and the actual processes your employees use daily, you can clearly show what would often take pages of text to explain.

Some of the ways gap analysis can help you stay ahead of the curve when it comes to inspections are:

• You can identify where SOPs differ from what your employees are actually doing, allowing you to make changes or fix discrepancies before inspections.
• You can find out if these other procedures are more effective than SOPs or vice-versa, allowing you to create new processing maps with better, safer, and more effective procedures and make sure everyone in your company follows them.
• You can ensure that all of your employees understand every procedure necessary to manufacturing the product, allowing you to present a company with knowledgeable employees at every level and to make sure that no one department works in a vacuum, unaware of the other departments’ processes.
• You can identify problem areas that you might not have known about otherwise, allowing you to put a process in place to fix them. This way, if someone comes from the FDA before you are able to fix every issue, you can at least show the inspector that you have identified the problem already and have a plan in place in order to fix it.

Closing the Gap Between SOPs and Actual Procedures

Gap analysis has many ways of helping your company stay ahead of regulatory inspections. Because the margin for error is high with manufacturing companies that are as large as yours, and especially with those that create combination products, comparing the processes you claim to use and those your employees actually use is necessary. You could even find out there is a better way or ensure that changes are made, or in the process of being made, before a surprise inspection.

SOPs are often drafted in long-winded documents and only used during inspections. This can cause a company to have an actual manufacturing process that is extremely different from the SOPs they claim to use. This kind of discrepancy will look bad in an inspection, which is why using gap analysis in all the ways discussed above can help you provide a more accurate description of the true processes of your company.

Informed Employees are Confident Employees

Staying ahead of regulatory inspections will help you look and feel calmer when you are visited by the FDA, and it will make your employees less likely to be concerned. When gap analysis is used, everyone understands the manufacturing process better: you, the employees, and the FDA inspector. All of these issues are ones that a regulatory inspector will look to bring to light.

However, if you’ve already done the work for them, you will be one step ahead, putting you on track for a stellar inspection review.