The People Factor – Where 80% of the Solutions to Quality Issues Reside

The pharmaceutical industry needs to use our training and left-brain strengths to face, solve and improve the “People Factor” inside our manufacturing facilities.

By Gerard Creaner, CEO, GetReskilled

We are an industry of scientists and engineers and we naturally define the problems we face in technical terms – and then get stuck solving them. We write new SOPs (Standard Operating Procedures), we design new production processes, we specify and install new manufacturing equipment, we find ways of doing it all faster…the list goes on. Why however, do we avoid looking at the People Factor, where 80% of the solutions to quality issues reside?

This is not unique. We are continually reminded that we are in the business of saving lives – we are in a life critical industry. It is a very serious business underpinned by very complex technologies where people’s lives are at stake and so we convince ourselves of the primacy of technical solutions when looking to solve problems. But we are not alone. When considering the range of high-tech industries out there with huge regulatory compliance drivers, you don’t have to look much furtherthan NASA, which also falls into the category of a life critical industry.

NASA was originally developed to put a man on the moon and get him back again. We can only begin to imagine the complexity of the problems they had to solve. Many of us saw Tom Hanks in Apollo 13, which, although a cinematic experience, gave viewers insight into NASA’s incredible response capability during a crisis, when people’s lives were at stake. In our industry we face our own crisis points, with people’s lives at stake. For example,drug shortages are currently leaving patients adrift, and quality issues have been identified as one of the root causes of this problem. Yet still it puzzles this author. Why are we still not looking at one critical area - the people who make the medicine?

NASA continually strives to be better, like we do for our patients, by pre-empting problems before they arise.

Dr Ed Hoffmann, NASA’s Chief Knowledge Officer, when speaking at the Knowledge Management 2015 Conference in Dublin, Ireland this year, noted that 80% of the solutions to the issues that NASA faces are to be found in the People Factor – and when NASA speaks, from a true leadership position in both life critical and high-tech industries, we should listen and learn. According to Ed Hoffman, even though NASA knows the rich vein where “people” solutions can be found, NASA finds it very difficult to mine this particularly rich seam of gold – and all because the engineers and scientists who make up their industry are not comfortable in what they consider the touchy-feely area of behavioral traits.

The pharmaceutical industry is no different! We’re much happier defining the problems we face in technical terms and then facing the challenge of solving them. Sure there are technical solutions to these problems but we need to strike the right balance between solving 100% of the technical problems and 0% of the People Factor ones, just because the people factor solutions take us out of our “comfort zone.”

An example of addressing the People Factor is the Behavioral Positioning System™ tool (BPS), which measures and strengthens the Quality Behavioral Traits of the workforce who come into direct contact with your manufacturing process. BPS, combines an easy-to-use online assessment tool that measures the quality conscientiousness profile of the manufacturing team, with GMP specific video learning, that is delivered in short snippets of video which can be shown every day in the locker rooms, prior to operators coming on-shift. The video learning uses the “why?” approach to tie quality activities with clear reasons for why those activities are so important, which has been shown to strengthen their quality performance reliability. BPS then goes one step further into the “touchy-feely” realm and ties real-life patient health challenges to the quality behavior as well.

NASA and the pharmaceutical industry have some life critical concerns in common. Going across the aisle to hear this world-renowned technical organization’s recognition of our mutual limitations, as scientists, engineers, to problem-solving in the People Factor realm should feel alternately challenging and inspiring Let’s use our training and left-brain strengths to face, solve and improve the “People Factor” inside our manufacturing facilities.

BPS - the Behavioral Positioning System, is a partnership between cut-e, a world leader in design and implementation of online testing and questionnaires and GetReSkilled, a world leader in online video-based capability building for production line operators.

 

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