Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training. At this time, team management is evaluating where the team succeeded and where improvement is needed. It is interesting that the ICH Q10 Pharmaceutical Quality System guidance recommends pharmaceutical management take the same approach towards quality objectives. Section V of ICH Q10 states, “Management should have a formal process for reviewing the pharmaceutical quality system on a periodic basis. The review should include: a) Measurement of achievement of the pharmaceutical quality system objectives.” For quality control laboratory management, a measure of quality laboratory work is the rate of OOS data due to laboratory error. As errors in baseball lead to losing games, laboratory errors resulting in OOS events negatively impact the success of a QC laboratory team.
Section V.C (4.3) of ICH Q10 states, “The outcome of the management review of the pharmaceutical quality system and monitoring of internal and external factors can include (b) Allocation or reallocation of resources and/or personnel training.” Regardless of the number of All-Star baseball players on a team or the number of highly experienced analysts in a lab, skills training cannot be overlooked. Both baseball players and analysts need to be skilled in the fundamentals of their respective jobs. Analysts, with good fundamentals, are paramount in reducing OOS events due to a laboratory error. During initial training, analysts can get caught up in the complexities of software and instrumentation, because that is the “cool” stuff. However, to minimize errors in the lab, it’s the fundamental skills that result in victory. Laboratories with strong training programs that stress the importance of weighing correctly, proper quantitative transfer of materials, proper labeling, proper pipetting, and careful diluting are the laboratories with low laboratory error rates and winning quality system metrics.
Does your training program have annual fundamentals training to ensure that bad habits have not crept into your analysts’ laboratory techniques? Some might say retraining on fundamental laboratory skills is not a regulatory requirement and, therefore, wasted time. On the contrary, it is a small price to pay to avoid laboratory errors leading to OOS events. In spring training, even last year’s baseball All-Stars work on fundamentals.
As part of spring training, baseball coaches observe, evaluate, and instruct players on good techniques to minimize errors throughout the season. In the same way, laboratory management has the duty to ensure that laboratory analysts are observed, mentored, and coached so that laboratory skills are continuously honed. Accurate and reliable laboratory results have their foundation on the lab bench. Once an “error is committed” at the lab bench, this becomes a “game changer.” The resultant investigation puts a drain on laboratory resources and adversely affects laboratory performance metrics. To improve your laboratory performance, focus on training and coaching the fundamentals, and the metrics will reflect the effort. Pipette like a champion!
For further information and assistance on the topic of laboratory training, please contact Tim Rhines, Ph.D. at email@example.com.