Pregnant pause is a technique used during FDA inspection so that the answering staff do not answer questions more that required and get in to trouble.
Inspectors are very good at asking questions to know details and catch if something is not right during the conversation. It is said that when you are lying you can not tell the same thing again and again.
It is commonly observed that they’ll ask a question and then they’ll keep quiet. None of us like silence, so usually will rush in with answer and will answer the question. If we don’t know we might say we don’t know and then they don’t say anything. Then quickly most of the time we start babbling on, will start talking and giving all kinds of stuff trying to be helpful. That’s the worst thing you can do.
The best to thing to do is answer the question if you know it, and you tell him, I don’t know what you don’t and then be quiet, wait for them to ask the next question. Your escort should be able to step in at this point in time and resolve the matter if necessary . If they want to ask you or the operator additional questions , then they rephrase and ask another question. Don’t try to second guess them. Answer the question only, much like in the quarter wall.
Companies need to train their staff facing FDA inspectors when to talk and when not to and how much to talk. Train them how and where to remain silent and where to respond. If they know it, ask to answer them directly or point to the escort to answer. Remain silent if already answered, may be you can ask, is this all you want, but do not say more than required. Wait for the next question.
Related Training – FDA Inspection Readiness