Who makes the best SME 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 for food and beverage quality control
, we tend to call on SMEs that are most intimate or familiar with the details of the process or product in question.
Either way, you can open the door to a very successful inspection or many unnecessary questions. It’s all in how you tell the story with the evidence at hand, either manually or with audit management software.
So how do you pick the best SME to talk to the auditor or investigator? In some cases, we reach too deeply into the organization to a technical individual that is good at process but not good at explaining to someone else. In other cases, you might choose someone at a management level without enough detail background or knowledge in the actual topic being investigated.
Option one 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 a SME sends a strong signal to the auditor/investigator that the management team is actively involved in the process. 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 - such as with process management software - can be a great advantage. It is a true demonstration to the investigator of management commitment. A good functional leader can also help steer the conversation to the right processes and procedures.
While this is a good tactic, it is still important to be sure 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 be sure 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 the questions because the documentation is clear.
About the Author: Christine (Chris) Park is a seasoned Quality Assurance professional with a wealth of experience in establishing and remediating quality systems of all sizes. Using a pragmatic approach to compliance and quality assurance, Ms. Park has successfully focused on results-oriented solutions that integrate quality into the daily business activities of organizations.
Ms. Park's direct experience includes facilitating product and process risk assessments, change management, product and process validation plans and protocols.
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