There is a high attention in the life science industry on qualification of equipment and validation of processes based on comprehensive risk management processes and the employees are usually well-trained in these tools. Errors and deviations are handled by using systematic problem-solving methods to reveal the true root cause(s) and identify the appropriate corrective actions.

The team members involved in the problem-solving process have normally good knowledge of the machines, tools, materials, methods and procedures.

When it comes to Manpower the knowledge is more limited.

The traditional way of looking at causes related to Manpower is that these errors are caused by unreliable people in well- designed systems.

To protect the system from the unreliable “human behavior” typical corrective actions are:

• Tighten procedures to reduce the bandwidth in which people operate
• Introduce more technology to monitor or replace human work
• Make sure that the “unreliable” person(s) do not contribute to system breakdown again by training, reallocation of position etc

Tighten procedures might reduce the risk for human errors but not necessarily. It can increase the mismatch between procedure and practice. More technology might remove risk for certain human errors but can introduce risks for other types of human errors.     

People are not unreliable, but we all have some human limitations which have impact on our decisions, actions and performance.

Examples of human limitations

• Attention – may be limited in duration or focus, especially if attention must be spread
• Memory – working memory is limited, especially when active processing of information is required
• Situation awareness – refers to a person’s perception of what’s happening around them
• Automaticity – consistent, over-learned responses may become automatic and completed without conscious thought
• Stress – occurs when there is a mismatch between what people are expected to do or cope with and the resources available to them
• Tiredness – caused by too much or too little to do, sustained activity, physical / emotional exertion, amount / quality of sleep, time of day
• Cognitive BIAS

When investigating human errors, it is important to evaluate if your system and/or processes are designed to fit human capabilities and limitations in perception and cognition.

To be able to do this, it requires that the persons involved in systematic problem-solving have some basic training in human behavior based on behavioral economics. I have not seen this yet as a requirement in any competency matrix.   

I hope that we in future will have much more focus on designing working environment, processes and quality management systems which supports the human nature with all our cognitive limitations and bias’.

I am convinced that it will pay-off by higher quality performance and more satisfied employees.

The post Knowledge about human behavior should be a key competence for quality professionals appeared first on Borgensgaard Consulting.

Check out this article, which recap very well why and how to address Human Error.

https://www.mastercontrol.com/gxp-lifeline/7-ways-to-reduce-human-error-on-the-drug-and-device-manufacturing-floors/

The post How to reduce Human Error on the drug and device manufacturing floor appeared first on Borgensgaard Consulting.

In the meanwhile, she is getting real life experience in the importance of #leadership. 

The café she is working for, is a brand-new café in a very good and well-known location in Copenhagen. She was hired in before opening and has been involved in the start-up activities. Last week she was feeling frustrated and overloaded as there was not enough time to serve all the customers and at the same time close some of the open start-up tasks. 

We had a very good discussion about prioritization, as there will most likely never will be enough time, to do everything, if you are ambitious or working for an ambitious company. We talked about the Eisenhower matrix, and how she should focus on the important tasks, and try to do them, before they become urgent. 

But how does she know, what is important and what is not or less important?

The café does not have a clearly defined vision or strategy, or it is not communicated to the employees. Without having a clear vision and a strategy, it is very difficult for the employees to prioritize in the daily work.

Let’s imagine that the owner has a vision that the café should be known for having the best service in Copenhagen.

 What is the best service?

The best service is subjective and will vary depending on which type of customers, you want to attract.

• Is it that you are being served a fast as possible?
• That the table setting is perfect?
• That the atmosphere is very informal and friendly, and the serving staff spend extra time to chat with you?

Even with a clearly defined vision and strategy, it is important that you translate it to concrete expected behavior 

E.g.: if you see a small stain on the tablecloth, it must be changed immediately or spend a couple of extra minutes with the customers and give them some good advised about things to do in Copenhagen.

In case there is time enough, you can and should do both – but when it is busy, it is important the employees know what are the most important.

If employees do not have the right tools to prioritize, they might get stress and loose the big picture. They become inefficient and start taking bad decisions, which will increase the overload. And then you have a negative spiral.

Does your company have a clear vision and strategy which is translated into actual behavior?

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