Five Building Blocks of Pharma Quality

Feb. 26, 2016
Addressing essential themes to transform quality from good to great


McKinsey contends that it is important for companies to set out a clear vision for quality improvement, using powerful examples to show why it is meaningful for all employees. How can a pharmaco move beyond compliance and short-term issue fixes to a step change in quality using new technologies, new science and new management techniques? What is the right design for a quality system if it is to meet regulatory requirements but also be lean, simple and agile? What best practices can pharma adopt from mature industries such as automotive, aerospace and semiconductors? How can they design their operating models, organizations and culture so that they sustain quality best practices?


Many pharmacos focus their quality improvements on manufacturing. However, those efforts should span the full value chain. Quality excellence starts with product and process development, where it’s critical to have a scientifically sound review and quality assurance process that creates clear, measurable and objective quality standards and accounts for risk-benefit trade-offs of a particular product or treatment. Quality excellence should also extend to external suppliers — increasingly important given the global span of today’s supply chains. Proactive collaboration with suppliers and external manufacturers will help companies address and prevent significant issues. In manufacturing, quality improvement efforts should address operations fundamentals — increasing process capabilities and robustness and underscoring process execution with a robust quality presence on the shop floor. Good shop-floor process maturity can simultaneously deliver high quality, operational excellence and short lead times.


Winning in quality relies on good execution and on a robust culture of quality. Quality organization design may often be a top-of-mind concern, but we find it doesn’t influence performance as much as execution and governance do. Culture is the fundamental ingredient in achieving good quality performance and enabling further improvement and change. Transparency of cost and performance is also essential, yet few pharmacos measure quality performance with leading indicators that cover fundamental operations. And fewer still gauge how quality is upheld on the shop floor.


The pharma industry is struggling with a big uptick in quality problems and much more regulatory scrutiny — challenges that can lead to significant short-term expenses and costly strategic consequences. If not handled properly, remediation efforts may fall well short of stakeholders’ expectations. For companies that face regulatory challenges, the total cost of remediation is often far greater than realized — knowing the total cost upfront can help quality executives make better choices earlier in the remediation programs — before making major commitments.

Quality remediation can be done successfully without creating overhead that has to be “leaned out” later. Leading pharmacos apply proactive systematic approaches to identify and mitigate the top quality risks and ensure that business functions coordinate their activities.


Overhauling quality activities is not only for companies in crisis; every pharmaco can and should do so. Companies that can currently claim good quality should not become complacent but push for higher levels of performance and greater risk preparedness. They should seek out compelling change stories that motivate and inspire employees to strive for continuous improvement.

This article was originally published in the book entitled: Flawless: From Measuring Failure to Building Quality Robustness in Pharma, which can be found at and search by book title or the link above.

For the entire feature article published in Pharmaceutical Manufacturing's March 2016 issue, click here.

About the Author

Andrew Gonce | Paul Rutten and Vanya Telpis