Building Pharma Quality: From The Top-Floor To The Shop-Floor

Vikas Bhadoria, Senior Partner and Vivek Arora,Associate Partner, McKinsey & Company, emphasise on the need to build a strong quality culture, which will lead to superior performance and can build a company’s reputation to world-class levels

Building and maintain-ing high-quality prod-ucts and processes is top priority for CEOs across industries, more so in the pharmaceutical sector where the foremost objective is to ensure patient safety. Qualityrelated events have put several companies in a spot, impacting not only sales and market valuation but also their reputation.

Senior managements across companies emphasise that quality is their most important business objective, and highlight it in important internal and external stakeholder interactions. Companies have been making substantial investments in quality including remediation, in order to upgrade technology and infrastructure, build highprofile leadership teams, onboard domain experts and hire more resources.

However, non-compliance observations from recent regulatory audits, show issues similar to those flagged twothree years ago. While some of these are technical and relate to product quality and the reliability of standard operating procedures, others indicate gaps in day-to-day activities such as data management, investigations, material management, and other shop floor practices.

A closer look suggests that the managements’ efforts have not necessarily translated into mindset and behaviour change at the shop-floor.

Only a few have been able to build a quality culture where everyone from the ‘top-floor to shop-floor’ takes ownership of quality and feels responsible for it. This requires shifting deep-rooted mindsets and behaviors which have been built over years.

Stepping back from pharma, iconic global companies attribute their inimitability to culture which is lived by everyone in the organisation. Google’s culture of innovation touches all of its employees, some of whom have generated ideas that have transformed the world of technology. Toyota’s culture of lean and continuous improvement makes it one of the most efficient and respected manufacturing companies.