Surviving the backroom during an FDA inspection

During one of my early inspection experiences with the FDA,  I found myself working with a team who felt they didn’t need a backroom setup to review documents prior to bringing them to the investigator.  Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.

The investigator requested a specific document which was brought into the room. During the review, the investigator asked to speak to the individual who had signed the document. Unfortunately, there was no one in the room who could identify the signature. Things started to deteriorate quickly from that point on. It was obvious that while they were able to locate the document, there were issues within the document, creating more questions and concerns from the investigator. I found myself stepping out of the inspection to set up a mini backroom process to screen the documents prior to sending them to the investigator. Granted, if there were errors in documents, there was no time to fix them, but at least we were able to explain and address them.  

In another inspection, the team had worked through backroom situations in past inspection, BUT hadn’t practiced the logistics for over three years. Additionally, there had been much employee turnover, so some of the Subject Matter Experts (SME) were no longer available. There were two investigators located in separate rooms. While the scribe and observer were in place, the coordination activity in the backroom was in turmoil. Requests for documents were coming in quickly. SME’s weren’t prepared to address the
questions or discuss the topic.  The key to success in the back room (also known as the war room) is to have a strong quarterback. Some organizations believe they should have their most knowledgeable QA staff facilitate in the actual audit room. While the facilitator role is important, the real success of the inspection hinges on the leader of the backroom. The backroom lead must demonstrate several key
core competencies.

As you can imagine, there are at least two activities from each room being performed simultaneously – the scribe is taking notes and the observer is capturing the mood and tone of the investigator interactions. Ideally, these individuals are set up with computers with chat or internal conferencing
functions with the back room. Overhead projectors  should be set up to allow these communications from the investigator rooms to be displayed for everyone in the backroom.  The leader in the backroom must keep current with the activities going on in all investigation rooms, as well as coordinating the requests coming into the backroom. The leader in the backroom should have the following core competencies:

• Leadership – keep the room organized and assign clear roles and responsibilities
• Ability to delegate – as needs are identified, assign them to the appropriate responder
• Understanding of business processes and interrelationships between the processes –the quality manualshould clearly identify the interrelationships between the functions andprocesses. Know which SME needs to be contacted for what.
• Effective audit skills –monitoring notes from the scribe and observer in the investigation rooms. Look for key comments that can trigger requests for information/evidence from the audit perspective.
• Multitask – When there are multiple investigation rooms in use to support multiple investigators at the same time, the back room leader needs to keep current with the action in all rooms.  The investigators in different rooms may be looking at the same process from different perspectives. The backroom leader must recognize this and assure requests for documentation and SMEs are giving consistent responses.

If you haven’t practiced your FDA inspection plan recently, I urge you to do so.  If you are a new leader in your organization, review the plans with your team to ensure they are current.  There are organizations that will do mock inspections to give you the opportunity to practice and work out the kinks. You know the old saying, “practice makes perfect.”  While practice won’t make your inspection perfect, it will help your company be more effective and present a better image to the investigators to demonstrate you are in control of your processes. 

 About The Author
B. Christine Park is a quality systems consultant with expertise in the
implementation and remediation of sustainable and regulatory compliant quality
systems. She has led the successful implementation of quality systems in large
corporations, as well as small startup companies. Her industry experience and
background supports compliant yet practical, pragmatic quality systems. She can
be contacted at 678-480-5411 and cpark928@mindspring.com

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