An important part of any inspection readiness SOP is training subject matter experts to handle investigator interviews. FDA investigators can draw conclusions from what your SMEs say, what they don’t say, even the way they do or don’t say it.

Investigators typically ask several different kinds of questions that present varying levels of risk. Prepare your SMEs to recognize and respond to the following types.

• Close-ended questions are narrowly focused and require only very brief answers; often a simple “yes” or “no” will do. They are usually employed to verify statements and address uncomplicated issues, for example, “Do you have a training program?  Do you have a CAPA procedure?  Is this your signature?” SMEs should avoid providing a broader response when they are asked a closed question.
• Open-ended questions are designed to encourage the SME to talk and provide as much information as he or she wishes. They are very broad, such as “What can you tell me about …?” or “What do you think about …?” Investigators often use open-ended questions to obtain more detail while reviewing complicated or sensitive areas.  Instruct SMEs to provide fact-based answers, not responses based on opinion.
• Leading questions are phrased to suggest what kind of answer the investigator is seeking, such as “You don’t believe that process is effective, do you?” An investigator may ask this type of question to see how the SME is going to react. As with open-ended questions, SMEs should refrain from providing their opinions and respond with just the facts.
• Nondirective or neutral questions, such as “How do you like your job?” may appear in the early stages or throughout an inspection. Investigators often use these types of questions to establish basic facts and identify potential issues. Train your SMEs to keep in mind that their responses are never off the record during an inspection and they should always answer in an official manner. 
• Assumptive questions—possibly the trickiest kind—are designed to put the interviewee at ease and imply that the investigator already knows and accepts the answer, so the SME feels free to provide information he or she might otherwise not have shared. An example of an assumptive question might be, “So your CAPA system does not require an investigation for all non-conformances?” Instruct SMEs to listen very carefully to these types of questions to ensure that the investigator’s understanding is correct.
• Restatement of questions—The investigator may ask the same question multiple times of the same SME or different SMEs.  This is done to confirm facts and to ensure he or she is receiving consistent answers. Make sure that other SMEs are kept aware of the content of previous discussions so that they do not make statements that contradict previous answers.

Knowing when to stop talking is one of the most important skills SMEs should learn. Just as important, once the investigator has finished asking the question, SMEs should ensure they have understood it. Train SMEs to repeat the question to verify that they have understood it. When in doubt, asking for clarification is important and necessary to ensure that SMEs provide accurate, correct answers to an investigator.

In next week’s issue, we’ll cover how to train SMEs by simulating inspection interviews.

Contact Information:
Dave Gallup
GMPTraining.com, Inc.
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dagallup@gmptraining.com
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