The current lack of shop-floor experience in the management ranks together with a lack of training of operations personnel and their disconnection from quality responsibility are manifesting themselves in inefficient processes and recalls and warning letters, veteran manufacturing operations director Larry Kranking stressed at the ISPE Tampa meeting in late February.
Kranking explained that in his early days in the industry, most of the supervisors started out on the floor – even if they were recent college graduates – learning to run and understand the equipment. “They had to really be able to make decisions along the way in relation to how the equipment was reacting versus the quality,” he pointed out.
“Forty-three years later, I am amazed at the number of supervisors and management that have no clue how to run equipment.” When looking at the findings in recent 483s and warning letters and the numbers of recalls, the veteran operations director “cannot help but think it is because we have lost the ability of people to make decisions on quality – to be able to react to a quality issue quickly so it does not reach the recall stage or become a warning letter.”
Kranking, currently the President and CEO at Coldstream Labs, drew on his 43 years of industry experience – including executive positions at Eisai, Boehringer Ingelheim and Hoffmann LaRoche, and a one-year stint as chairman of ISPE – in discussing who owns quality, the importance of training, the reasons companies find themselves in regulatory trouble, and the importance of company culture and leadership.
He delved into the relationship between company culture and quality outcomes and the specific roles that management, quality and operations personnel play in achieving them.
Kranking’s insightful analysis included: ● the importance of understanding product science to good facility design and operations ● how management, operations, quality and poorly-written SOPs contribute to the circumstances that lead to recalls and warning letters ● the importance of operator training and why cutting training budgets is ill-advised ● the pharma industry’s unfavorable position versus other industries regarding quality metrics ● manufacturing accounting and equipment maintenance practices that lead to poor quality product, and ● how the appropriate use of root cause analysis coupled with the institution of quality by design (QbD) and process analytical technology (PAT) will be key drivers of product quality improvement going forward.
“Culture trumps strategy,” he emphasized. “You have to have the right culture. You have to have people that understand quality. At Disneyland, everybody, from the CEO on down, would never walk past something – a piece of paper on the ground. Even the CEO at Disney will bend over and pick that piece of paper up.” [Editor’s Note: See IPQ “The News in Depth” Dec. 8, 2011 for coverage of a related discussion of the influence of company culture on quality outcomes that took place at a quality systems/ICH Q10 conference in Arlington, Virginia in early October.]
Kranking stressed that “quality is a culture, and culture is the filter through which all strategy passes.” Good leaders, he commented, are effective mentors, and “that is the antithesis of command and control. We have to be mentors. I find that there are not enough mentors and coaches in the supervisory and management levels, and that is a real problem.”
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