The FDA will look for entry points into your Quality Management System as a mechanism to highlight potential issues.

Some key examples of things that will be looked at which often provide willing entry points includes:
Deviations and logbooks.

Laboratory errors.

Change Control records.

These are all records and documents that provide a primary route into finding the things that are wrong with your system of manufacturing.

From these records the investigator can drill down to discover further issues and problems by looking at the following.


CAPAs and whether they are closed out if effective.

Training records.

Maintenance logs and calibration logs.

Analytical test records.

So, the goal should always be to make sure these are in good shape and that these system elements are receiving constant attention to prevent operational and potential problems during an inspection.

Important in an inspection are the roles of the staff at the facility.

The head of Quality for example should be the lead member and should facilitate the in-room interactions with the inspectors.

At least one individual should act as a scribe for the questions and requests. This person should make accurate records of everything asked and requested by the inspectors and any answers that the SMEs from the company give to the inspectors in relation to the questions asked.

Runners should be capable staff that can deliver questions to the Back Room where the documents are kept and from where the documents can be delivered to the inspection conference room.

Subject matter experts (SMEs), should be designated for each topic that will be discussed and each SME member should be trained and practiced in anticipated questions.

The Back Room staff, often referred to as “The War Room”, should be a mixture of QA document staff to prepare material for the inspectors and senior experts to prepare SMEs that will be charged with answering questions that have been posed by the inspectors.

The Management team needs to be on -hand to address specific and strategic issues and to address commitments that may need to be made to the inspection team on behalf of the company.

So, this team is the gate keeper to the company and depending upon how potential entry points are left open will depend upon how the inspectors may start to build a picture about the state of compliance of you site. It’s therefore imperative that this team works together to convey a state of control that reflects the actual control systems that the company has in place and operates during normal working operations. It should be noted that if this is done badly, a good site could create a false negative impression that could be costly.

Therefore, in the preparation periods its important to know and understand your exposure points and to either eliminate them or at the very least minimize them to some insignificant level.

Practicing the inspection process is perhaps the best way to obtain a read of how well set up the site is at any given moment, and using an outside consulting firm to perform this is the best way to duplicate those conditions and situations without creating problems. So, the key to success is to hold practice sessions and to drill the team on anything that could come up.

Although this is never full proof, it does provide enlightenment and has the added effect of bonding and welding the team together which is the most effective measure for continuous improvement. This should always be the goal following every inspection.