Who makes the best SME (subject matter expert) during an FDA inspection?

A Subject Matter Expert (SME) or domain expert is a person who is an expert in a particular area or topic. When faced with the FDA or another regulatory agency, we tend to call on SMEs that are most intimate or familiar with the details of the process or product in question. In some cases, we reach too deeply into the organization to an individual that has comprehensive knowledge of technical/processes, but not effective at explaining this information. Thus, we open the door to unnecessary questions. So how do you pick the best SME to speak to the auditor or investigator? One option is to start with the functional area or business leader for the area in question. This can be somewhat tricky, depending on how involved the leader is in the operation and how much they understand about the activity. Having the manager as an SME sends a strong signal to the auditor/investigator that the management team is actively involved in day-to-day operations. While it is not expected that this manager knows every detail of every process, the manager should be able to explain the organization (structure and function), as well as a high-level overview of the processes. Starting at this higher level can be a great advantage. It is a true demonstration to the investigator of management commitment. An effective functional leader can also help steer the conversation to the appropriate processes and procedures. While this is an effective tactic, it is still important to ensure you have SMEs available who are intimately familiar with the actual project, product and/or process. At some point, the discussion will probably get down into the technical weeds. The key to success is to ensure the SME is well prepared for questions, regardless of his/her level within the organization.
Here are a few valuable pointers for preparing the SME to be interviewed:
• The SME should be able to describe how he/she fits into the organization – this includes describing the individual role, as well as how the function fits into the overall organization structure. The SME should be prepared with a current organization chart and job description.
• We all know that first impressions count. This is especially true during the course of the FDA inspection. The SME should have supporting documentation well organized prior to coming into the room with the inspector.
• If the SME topic is supported by data and/or reports, a current version of the information should be generated prior to going into the inspection. This gives the SME an opportunity to review the data in the report, be comfortable that the output is accurate and that any discrepancies or issues can be explained.
While the information gathered as part of the prep work may not actually be required during the investigation, it is better to have it prepared and readily available in advance.
Make it easy for the inspector NOT to have to ask questions because the documentation is clear.
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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