Executive Summary
The pharmaceutical and biopharmaceutical industries are heavily regulated to ensure product quality, safety, and efficacy. However, even with strict guidelines, human error remains a significant challenge. The traditional approach to reducing human error has been to intensely train and aim for zero errors and hope that employees will never make mistakes again. However, this approach is neither realistic nor practical. Instead, a mindset shift towards accepting that errors are something humans do, coupled with the use of AI-technologies that see errors, when they happen, can significantly help reduce human error in GMP operations.
“Image recognition is about pixel by pixel analysis in order to recognize a particular object. A new technology
is entering the market: Video-based AI Error Recognition recognizes anomalies and patterns in video data
and interprets them just like a human eye and brain. This new technology has the potential to disrupt
how errors on the shop floor are prevented, recognized and corrected.”
Marc Vorderman, Director Europe, Novatek International
Detecting Error: Time is Key
It is a rule of thumb: Detecting errors when they happen will always considerably decrease follow-up costs. A customer recently gave me a great analogy of why time is such an important factor. He told me: Imagine you’re building a house. You’re laying the sewer pipes into the foundations, but unknown to you one of the pipes is blocked by a dead hedgehog. Would you rather find out:
- Just before you pour the concrete, or
- After the house is finished and the new owner tries to use the bathroom?
Human error in GMP operations can manifest in various ways, such as incorrect gowning, equipment misuse, or specific contamination-prone activities in the cleanroom like placing hands on a surface or overreaching an open flask. Like in the example with the hedgehog in the pipe, an unidentified error may lead to contamination, which can cause huge follow-up costs. On the other hand, an instantly identified error could easily avert the damage.
Aim for Detecting Errors When They Happen
Humans are not perfect, and errors can occur even with the most conscientious individuals. While GMP guidelines aim to minimize human error, there are still instances where employees deviate from standard operating procedures, leading to potential quality or safety issues. One of the challenges of reducing human error lies in identifying and addressing the root causes of these deviations. Often, inefficient processes, time pressure, or simply a mindset that prevents mistakes or shortcomings from being openly addressed are considered the root case..
But are these really the issues? After all, humans will always be humans and we better appreciate them for their skills, creativity and commitment. And leave the monotonous work to a friendly cobot.
What will alleviate the situation, like with all efficient learning methods, is instant on-the-job feedback like this supportive AI companion will give. It will add to minimizing errors. AI technology who looks out for threats is a perfect companion to humans who,after all are not supposed to do monotonous activities. They will always appreciate this valuable support.
ABOUT JAN WANSINK
Managing Director, Co-Founder at DeepEyes GmbH
Jan heads DeepEyes consulting and is always happy to talk about your requirements.
Contact: consulting@deepeyes.co
