Wednesday, September 07, 2011

The Fallacy of People Problems and How to Resolve Them

PharmaPro blog by Jamie Weiss posted 2 September 2011

Statistics in pharmaceutical manufacturing suggest that 80 percent of all reportable deviations are “people problems,” deficiencies of human performance. Despite the pervasiveness of people-caused problems the specific causes attributed are few in number: failure to follow standard operating procedures, skipped or mis-sequenced steps and improper documentation.

But do all of the problems classified as “human factors issues” really indicate a deficiency on the part of a person? Perhaps not. Even classic “people problems,” such as skipping a step in the standard operating procedure (SOP), needs to be examined. This means knowing who the person was, what they did, when it happened etc.. But this requires people to report issues and this can have consequences. Even if they do not fear reprimand, they are likely to be given ownership of the problem and expected to come up with a solution. However, if they keep quiet the chances are production will continue, no one can know and the person does not get landed with the extra work.

When we do look at problems we will sometimes find that people are doing jobs that they are not qualified to do. The test question is: “Could this person do this task if their job or their life, depended on it?” If the answer is yes, then there is no deficiency in the performer. However, for each of us some tasks are simply out of our capabilities and no amount of training would improve our performance.

In this case, retraining is not the option, replacing is. People cannot be expected to do what is impossible for them to learn. Next, consider the response. This asks, “How clear is the desired behaviour that we want from the performer?” “Are we asking for a quantum leap in performance or just a slight tweak?” The response often exposes problems caused by changing the SOP. Perhaps the standards are unclear, the changes too drastic or the expectations unreasonable. If it cannot be changed, training will be required on a constant basis.

The performance system model leaves room for retraining as a corrective action to a people problem, but only when the deficiency is in the performer and even then, only some of the time. Some people are simply not trainable, some skills are not transferable and the optimal solution is rarely “more of the same.” Instead, most corrective actions for performance problems involve addressing the system itself. In short, the solution lies with management to communicate clearly that quality in all its aspects is the priority. This is not done with words and slogans but with rewards, measures ,metrics and behavior. And finally, the solution lies with addressing the common people problem with as much rigor and analytical precision as the most challenging mechanical or biochemical problem.

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