The Life Cycle of a Deviation Explained with Industry Example [Video]

A deviation was reported by a microbiologist in the quality control department indicating a rise in the amount of bacterial count in samples taken from the surface of equipment and walls in the production area, specifically in Room 103.

All the other rooms and department have conformed to the required acceptance criteria.

Receiving the Deviation

Once the quality assurance department receives the deviation, it gives it an identifying number according to the deviation procedure and starts recording the deviation in the relevant database.

The deviation is assigned to Anna a member of the quality assurance department for investigation who is a qualified microbiologist.

Anna takes the responsibility of handling the deviation.

The deviation is categorized as a major deviation because it could affect the microbiological quality of the product and it could also cause contamination.

Handling the Deviation

Anna starts by investigating that the test was performed correctly and all the parameters of the test were respected by the microbiologist performing it.

Next, she goes to the room involved and interviews the responsible analyst Jim.

Jim had complained previously about the cleaning of the area and how the cleaning personnel are not doing their job correctly lately.

Anna requests extensive testing of other rooms and finds another result not conforming to the acceptance criteria.

Anna then correlates that one person has moved from one cleaning team to another and it was this team who were handling the cleaning.

As it turns out that person wasn’t using the appropriate detergent and disinfectant.

In fact, the label of the detergent used was correct but it contained another detergent which was confirmed when testing the detergent in the quality control laboratories.

Anna concluded that the dispensing of the detergent had errors and as a result investigated the reason for it.

Anna finds out that the person dispensing the detergent did not follow the procedure set by the quality assurance department.

The procedure states that only one type of detergent can be dispensed at a time, but that person was dispensing two types of detergent at the same time which caused the mix-up.