The Five Stages of Receiving a 483 Observation

The stages begin when the investigator expresses a concern with a particular process. As you listen, you begin your passage through the first stage of receiving a 483 observation, DENIAL. This cannot be happening. The past three inspections have not resulted in any observations. When the investigator leaves for lunch you begin to research the obscure regulation.

As you research the regulation you enter the second stage, ANGER. How could this investigator do this to me? He doesn’t understand our business and yet he is citing us for this obscure and ambiguous regulation.

The lunch hour has slipped by and you realize the investigator is correct. The close-out meeting is tomorrow morning and if you worked most of the night you could meet him at the door with corrective action that will knock his socks off. Perhaps if the corrective action is good enough one or two of the observations might be removed. This is the third stage or the BARGAINING stage.

When you realize the impressive corrective action idea will not work, you slip into stage four, DEPRESSION. If there were fewer meetings and more time available to study the regulations this never would have happened. Others go through the inspection process and receive no observations. Why me?

After the close-out meeting you thank the investigator and state that corrective action will be coming soon. You realize the best way to handle the observation is to consider it a challenge and develop comprehensive corrective action acceptable to all parties – the ACCEPTANCE stage.

DENIAL and ANGER will not help. Nor will BARGAINING with hasty but ineffective corrective action. A 483 observation does not equate to a dreadful facility (DEPRESSION). Take this observation and make it positive. ACCEPT the situation and develop effective action to improve compliance. For help in preparing for an inspection or with preparing corrective action to improve performance, contact Quality Source.