Inspection Series: Outside of the Audit Room

This is the second installment of the Inspection Series Publication where we go through topics to prepare and expect during an FDA Inspection or other internal/external audits. This is only a guide and your experience will vary depending on who is inspecting your processes and what type of product you are manufacturing.

While preparing documents and logs are important before an audit, it is critical to train your employees on how to interact with the auditor/inspector. Though most of an audit occurs inside of a closed meeting room, there will likely be a time when the auditor will want to walk through a process or question subject matter experts (SMEs). This could be as simple as having SMEs enter the audit room or it could be as involved as walking through the manufacturing line. Either way, you’ll want to be prepared for any type of employee interaction.

Keep Answers to Questions Concise

Train your employees on how to answer questions in a concise and direct manner. All employees should avoid going off on tangents that may either (a) lead auditors down confusing investigation paths or (b) agitate an auditor that is looking for a specific answer. If an employee doesn’t know the answer to a question, that’s totally ok. Don’t give an answer that you “think” is right or something you’ve “heard” from your teammates. The right answer is to say that you don’t know but that you can find out. Auditors understand that people are sometimes nervous around auditors or that one person may not know all the answers. Just make sure to answer questions as accurately and concisely as possible.


Re-Read Relevant Procedures

Though it’s ok to not know all the answers, your team should know their respective procedures inside and out. A Complaint Specialist should know the entire Complaint Handling Procedure by heart. A Manufacturing Engineer should be an expert on manufacturing procedures. Encourage all employees to read and re-read relevant procedures that affect their day-to-day work. This is an easy way to avoid having the auditor raise the question, “How come this person hasn’t been trained on this procedure?” Bonus Tip: Read through and understand recent changes to those procedures as well.


Clean Up Work Areas

One of the best things your team can do is to complete a “walk-through” to make sure that desks are reasonably organized, clean and professional. It doesn’t have to be perfect, but a messy work area signals to an auditor that quality may be compromised. This is exceptionally important in the manufacturing, service and operation departments since those teams are touching finished goods that interact with customers and patients. The R&D department and their respective laboratories are sometimes given a free pass since a messy workstation may actually be the work of some innovative technology. Regardless, before an audit, it is highly recommended to do a walk-through and make sure work stations are orderly.


Label Locations

As part of the walk-through, make sure that ambiguous locations are labeled appropriately. If product is located in an area that isn’t labeled, auditors can question the integrity of your processes. How can your team distinguish good product from bad product when it’s not in an assigned location at all times? Identification and traceability is a demanding requirement from the FDA Part 820 — Quality System Regulations. When in doubt, label it!

Final Note

In addition to keeping auditors happy, keep your employees happy! Happy employees are more invested in the processes and the medical devices they are building, which ultimately lead to good audits. Auditors want to see engaged employees that understand quality policies and practice them.

If you need help preparing for audits, let us know!


About Us

FastQS develops cloud-based quality management solutions to keep medical device companies compliant with the regulations.