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Janssen Biologics

Successful improvement with Human RCA (Root Cause Analysis)

Elisabeth van den Hout is a technical specialist at Janssen Biologics b.v. In this developer and producer of drugs, Good Manufacturing Practice (GMP) is of paramount importance. There are strict rules on quality and product safety in this industry. If there are deviations from GMP rules, then Van den Hout explores the reasons for these with her colleagues and whether there are consequences.

Analyzing and learning from non-conformeties

If there are deviations from the rules, then the production process is investigated by Van den Hout's department. "We look at the [workplace] in such a case, to see what has been different, or the impact on the product, whether it is preventable and whether it should be revalidated. There is often a multidisciplinary approach to a situation", says Elisabeth. The studies serve a dual purpose. Deviations and the associated approach should be internally registered and approved by two signatories. This data may be asked for later by the inspection bodies. At least as important as registering an event, is to analyze and learn from the case.

Elisabeth van den Hout: “We use CoThink Event Mapping to get structure in our findings with a group of about eight colleagues. We describe the problem, look at what the consequences are and we dig until we have found the cause.  In this way, we search for the source of the problem, using '5 Whys' analysis as part of the Event Map. In this way, we also shed light on possible solutions, or which barriers should have prevented the situation and whether they have been broken, or whether there should just be new ones." In this way, the team describes objectively what has happened.

The Human Factor

If it turns out that human behaviour is one of the causes of the incident, we work our way through, using the RATIO Human Performance Analysis (HPA) tool, to find out what the cause of that behaviour.  [hpa] Van den Hout also has a focused approach to this: "With this method, we dig through to the cause of the behaviour. We do this mainly to examine the process where the error occurred." Recently there was another incident. Van den Hout: "There was an undesirable situation caused by human behaviour. But it turned out, the colleague had received minimal information and there were no checks on the output. He was also not aware of the consequences, and our colleague got no feedback on his actions; so he also did not know that he was not doing it right. " The knowledge gained is used to establish preventive measures and to follow up. The process is therefore improved. Van den Hout: "Because we kept to the facts, it was about process and not about the people. This allows people to be more open and we quickly put our finger on the sore spot."

Combination of method and motivation

This success shows the importance of a well-trained facilitator. The facilitator uses the best methods from his / her RATIO toolbox and combines this with the ability to evoke cooperation. The meetings have an impact by giving real attention, asking the right questions, listening carefully, and by visualizing the structure. It is nice to see that the facilitators in Janssen Biologics are reaping the benefits of their training.

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