Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.
Reprinted with author's permission from http://www.enkap.com/profiles/blogs/surviging-the-backroom-during-an-fda-inspection.
During one of my early inspection experiences with the FDA, I found myself working with a team that felt it 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 team members 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.
"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.' Even if 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."
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 back room was in turmoil. Requests for documents were coming in quickly. SMEs 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 back room. 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 conferencingfunctions 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 back room must keep current with the activities going on in all investigation rooms, as well as coordinating the requests coming into the back room. The leader in the back room 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 manual should clearly identify the interrelationships between the functions and processes. Know which SME needs to be contacted for what.
- Effective audit skills - Monitor 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 backroom 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." Even if 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.
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 firstname.lastname@example.org.