Do You Have a Quality Culture?

Perspectives on the value of creation and assessment of quality culture

By David Keeling, Paul Rutten and Vanya Telpis, McKinsey & Company

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Measuring quality culture is essential to improving mindsets and behaviors in pharma companies. The challenges to measuring culture are significant, but our research demonstrates that they can be overcome. While there is no ultimate metric for culture, good measures are available, each with proven correlation to quality outcomes. Indeed, companies with a strong quality culture are distinguished by their ability to measure culture and apply those insights to culture improvement efforts.

More than ever, quality culture is top of mind for pharma industry stakeholders. Industry leaders recognize that quality culture is essential to ensuring good quality, following the examples of advanced industries, such as automotive and aerospace. Industry associations are conducting research on the effectiveness of tools for building and sustaining a quality culture. And regulators publicly stress the importance of instilling a culture that prioritizes continuous improvement of quality. For example, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, has spoken at many industry events in recent years about the agency’s intent to use the regulatory process to foster a quality culture from the shop floor to the executive suite.

But even as the industry embarks on this journey toward a better quality culture, some stakeholders do not yet regard the assessment and measurement of culture as the key foundational step. Many are convinced that quality culture cannot or should not be measured. We strongly disagree. In fact, we believe that quality culture is not only measurable, but also the most important indicator of a pharma company’s quality performance, strongly correlated with impact. As a result, we see measuring, and paying attention to what the measures indicate, as important cultural signals.

We developed our perspective during the past decade in the course of our work with many companies in pharma and our partnership on quality metrics with ISPE. Our research has demonstrated the feasibility and value of assessing and measuring pharma’s quality culture.

MEASURING QUALITY CULTURE IS CONTROVERSIAL, BUT NECESSARY

Industry stakeholders who are skeptical about the feasibility of measuring culture have two main concerns. First, they believe that measuring behavior can lead to unintended consequences by incentivizing people to change their behavior in order to improve the measurement. For example, a company that measures operators’ degree of involvement in quality work could be incentivized to shift more quality responsibilities to those operators — even if they don’t have the required capabilities. Second, the stakeholders are concerned that focusing on improving a measure can make it a less reliable signal. For example, suppose a company measures preventive maintenance as a positive signal of prevention-focused mindsets. Operators will perform more and more preventive work, which may needlessly increase the amount and complexity of maintenance workloads and ultimately undercut the value of preventive maintenance as a positive signal.

These concerns are valid and must be considered when designing or choosing the right measures. But the need to manage potential pitfalls should not deter companies from measuring quality culture. In the absence of baseline measurements, cultural improvement initiatives can target the wrong levers.

That’s why cultural change efforts should begin with quantifying both the baseline status and the future-state aspiration. By identifying the gap between the baseline and aspiration, the company can design initiatives to foster the required mind-set and behavioral changes. Once these initiatives are implemented, measurement would again help assess the impact and the progress toward the aspiration. Importantly, the measurement of culture must be done with the understanding that the goal is to promote improvement, not to reward static performance.

Measurements are essential for successful transformations in any context. Transformation success is not a given: two-thirds of transformations fail to achieve their objectives, as McKinsey research shows. CEOs and other executives indicate that metrics are a key factor contributing to the success of those relatively few transformations that do achieve their goals. The same research finds that approximately 70% of successful transformations have clear, unambiguous metrics for tracking progress and impact, compared with only 15% of unsuccessful transformations.

DEFINING AND ASSESSING QUALITY CULTURE
We believe a quality culture can best be observed in behaviors. Therefore, we used our experience with cultural transformations and input from pharma quality leaders to define a quality culture as one manifesting the following behaviors:
• Explicit prioritization of quality throughout the organization, including top-down communication and role modeling
• Open and transparent discussion of quality issues throughout the organization, including bottom-up communication and engagement
• Emphasis on truly resolving problems, finding the right root causes and addressing them to avoid future issues
• Focus on prevention and building in quality, rather than on firefighting
• Awareness of quality’s importance, empowerment to make quality decisions and take ownership of quality, and shared accountability.

The quality mindsets and behaviors also must be consistent with the company’s operating strategy and management infrastructure — only a congruous combination makes good quality possible and sustainable.

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  • Asking "Do you have a quality Culture?" is putting folks on the spot. Question I would ask is " Do you (chemist or chemical engineer) have an absolute understanding of fundamentals of chemistry and chemical engineering and can you apply them to the processes you develop and commercialize from the get go? If one does not have rudimentary understanding of 2+2=4, they will struggle to get the right answer. Individuals create quality process and products through their application of knowledge. If they cannot create and commercialize such processes that produce quality products from the get go culture does not matter. Properly trained folks make the culture. Quality is not a magic wand. It is an individual effort that becomes the company collective. It is not a culture but individual effort of many who have the knowledge to create excellence.

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  • Thank you for the comment! We certainly agree that processes, knowledge and training allow people to know and do the right thing. Capabilities is one aspect of the culture we highlighted, and it's a critical one to prevent problems and resolve them effectively. But as you also point out, knowing the right thing to do, and doing the right thing are two different things. Ford said "Quality Culture is doing the right thing when no one is looking." We are asking: "even with the right processes, the right process knowledge, and the right process training, are you sure you have a culture that stimulates individuals to do it right when no one is looking?"

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  • I do not know who submitted the reply. Are they afraid of their identity? Individuals with the right knowledge and desire will sell their ideas do the right thing. If they have knowledge but no desire, knowledge has no value. My point is people make the culture and companies don't. Company is a body and people with the right knowledge make the body. If ideas are not entertained and encouraged knowledge has no value. Is that the case in pharma?

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  • Hi Girish, comment came from Vanya from McKinsey

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  • Thanks. To Vanya's comment I would say if the company does not have the right people then the company has a problem. Linked might be of interest. Experts predict PAT/QbD and CM adoption may take 10 years, with smaller generic players to drop out of the market if unable to innovate in time. https://www.cphi-online.com/current-drugs-pipeline-is-discouraging-and-news048848.html

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