When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you willgather the requested data and forms, how prepared the facility is and with whom will the inspectors be interacting.
But you must also consider whether or not the personnel in the organization are properly prepared to communicate and interact effectively with the FDA investigator. You want your personnel to be familiar enough with the processes and procedures of the inspection to provide the best possible impression . In short, you need to help the quality assurance, auditing and operations teams understand what’s expected during a FDA and/or EU inspection. Of course, the best way to be ready for an inspection is for your company to have your processes, procedures and documentation under control and operating in a state of compliance with regulations.
Given a solid level of compliance as your baseline, there are additional steps an organization can take to help ensure any inspection runs as smoothly as possible. One critical and sometimes overlooked area is preparing staff to communicate properly and efficiently with inspection personnel. Good communication can lead to a relatively smooth inspection.
Therefore, you want to spend time preparing personnel for inspection just as you would spend time procuring space and setting up logistics. Communication with FDA officials should revolve around four communication pillars. The pillars are preparedness, patience,
directness and details.
Being prepared not only reduces the employees's stress levels during an inspection, it also provides a positive impression on the investigator. When an investigator sees that an employee is prepared, it shows that the company understands the importance of compliance and regulations. It conveys thoughtfulness and professionalism. In other words, preparedness provides a quiet confidence in handling requests, questions and inquiries because personnel will feel ready for the situation, questions and requests.
As stated before, inspections can be stressful. One of the reasons for the stress is that sometimes it seems like the requests from the inspector are endless. When caught up with all the requests, it is easy for some folks to become curt with an inspector and begin to resent the requests. If the person becomes visibly upset or stressed, this can be incorrectly perceived . You and your team need to cut the investigator some slack. Keep in mind that the investigator is attempting to learn a great deal about your company in a short period of time. So, you and your team need to be patient with the investigator at all times. Being patient with the investigator helps ensure that individuals are being responsive to the investigator's needs. If you cut off the investigator or become upset, you can impart the false impression that you are trying to hide something. Patience is always a virtue but it’s especially important in an inspection.
You always want to be direct and forthcoming with the inspector. You and your team should strive to answer FDA’s questions as directly as possible without providing unnecessary additional information. A good rule is to answer the question and then stop. If the inspector needs to know more, he or she will ask. Keep in mind that being direct involves accurately describing a process or an activity to an investigator. Being direct eliminates misinterpretations and misunderstandings about processes, procedures and policies.
You and your team need to provide the right amount of detailed information to the investigator when asked. Coach employees to answer questions in detail to ensure the investigator thoroughly understands the equipment or process being examined. If you or others say too little, the lack of information may not demonstrate an understanding of the operation, process or policy. Also, a lack of detail may be perceived as a lack of training or even a lack of confidence and may give the investigator a misconception about how the practice or procedures are followed or how fit the personal are for the task.
As you can see, readying for an inspection goes beyond logistics, data gathering and setting up office space. When you are running a compliant, efficient organization, the next step to help an inspection run smoothly is readying your team to communicate effectively by being prepared, patient, direct and detailed. The upfront work to train the team on effective communications will be well worth the effort.
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