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Quality management of suppliers can have a significant impact on your quality performance and compliance. One way to control suppliers, is to perform an onsite audit.

I have participated in more than 100 customer audits and it has been a mixed experience depending on the auditor’s competences. Most auditors were very well trained in the standards and regulatory requirements, but many of them had limited knowledge or experience with the manufacturing processes and the critical aspect of the components/products.

I think it is pity that companies (pharmaceutical, medical device and suppliers) spend some much time and money on auditing without providing the auditors knowledge about product and processes, so that they ask the important and critical questions and make the observations which are most critical to quality performance and compliance. It is not only beneficial to the “customers” but also to the “suppliers”.

Some suppliers might think, it is better that auditors knows as little as possible. My experience is the opposite. Experienced auditors, who are familiar with the products and processes, can help suppliers to focus on further development of areas of importance and avoid critical issues and complaints. Suppliers, who are using the input from the auditors in a positive way, can use it as a driver for higher quality performance and customer satisfaction and achieve competitive advance.

I have a lot of experience and learning’s from the past +25 years, that I plan to share by offering online courses. One subject on my list is audit of suppliers of primary plastic packaging for pharmaceuticals and plastic component for medical devices.

If you are interested in such an online course, please let me know and I will thank you with a 25% discount on your first online course. Follow the link for more details: Online Courses by Borgensgaard Consulting

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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.

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.

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