Sometimes when a company receives an inspection from a regulatory agency, the inspector may provide some verbal comments or recommendations.  So, the question is, “How does your company handle these comments?”

It is recommended to do the following once the inspector leaves:

  1. Immediately after the inspection, write down all the verbal comments that you remember.  It is important to do this as soon as the inspection is completed so as to recall what was said that is fresh in your mind.
  2. Assemble the appropriate personnel who may be able to shed some light as to the comment and the validity of the comment to your application.
  3. Then do one of THREE things:
  • After evaluation of the comment and the execution of it makes sense and is not overbearing, go ahead and make it part of your policy; or,
  • Evaluate and do something that was felt by your group to be sufficient or comparable to what was recommended that you feel is valid and can contribute to the quality of your program; or
  • Do nothing.  It is felt by the group that the comment does not apply to your situation and that it implementing the recommendation does not enhance the program.

All the actions; however, need a justification as to WHY the action was taken.  This justification is to be written in a Memorandum for Record (MFR) and filed with the inspection letter so it is available for the inspector to review on the next inspection.  

One example of how this works is the following:  A verbal comment was received from an inspector that the storage area for the gauges needed to have a higher gate to prevent ingress and egress and removal of the gauges.  After careful review by the staff of this comment, it was felt that the inspector’s concern of more security was valid; however, simply chaining the gauges together and locking them to the storage shelf will prevent unauthorized removal of the gauges.  This was much simpler and less costly, yet provided the same result….better security.  A picture of before and after should be made and attached to the MFR.