2017 ISPE/FDA/PRQI Quality Manufacturing Conference

Within the pharmaceutical industry quality is more than a competitive advantage; it is our commitment to those who rely upon our products.  The degree to which quality is embedded in an organization’s culture can make the difference in meeting that commitment.

Quality needs to be looked at holistically, from an operating model level down to how employees think and act.  Standards and policies can define the requirements that must be achieved in how products are designed, made, and delivered; but processes also need to be in place, including monitoring, escalation, correction, and accountability, to result in a system of continuous improvement.

It must also be recognized that systems are run by people and the internalization of quality by those people ingrains quality into the culture.  Employees need to be challenged to demonstrate how they can own quality in meaningful, measurable, and sustainable ways.

While having a robust quality system and culture in place is important, the healthcare landscape is changing fast and organizations need to continually advance their capabilities in order to remain compliant and competitive. The question is whether we are changing fast enough.  Are we just catching up versus taking a much-needed leap into the future?

The pharmaceutical industry is just now focusing on the importance of data and metrics, whereas the technical industry has done this already for years.  In order for our industry to be looked upon as innovative, we need to accelerate and start working on leading edge innovation today. The future should look different and we should start thinking about the next steps. Imagine a future world where innovation truly enables reliable quality, every time, all the time, and our quality systems can become agnostic to culture and people changes.

While our environment changes, so does our relation to the customer, and so must the way we work. We need to be customer-focused because what they look for first is quality and reliability. Therefore is it important that quality be end-to-end and be considered at the early stages of new product development. End-to-end quality is a complex matter, with many different meanings; however, we need to embrace them all in order to better serve our customers.

We also need to manage competing goals harmoniously in order to be truly successful.   This is often a delicate balancing act, such as delivering quality AND making products affordable; integrating quality in the business AND having full control; wanting to be agile AND requiring consistent, measurable quality; and wanting to be customer-centric AND maintaining internal focus on compliance with the rules. The key is to manage these competing goals without inhibiting the commitment to continuous improvement.

As we set our sights towards manufacturing of the future, beginning the process of product development with quality in mind will also help us to be better innovators and manage non-traditional technologies of the future such as continuous manufacturing, 3-D printing, etc.

Likewise, we need to keep our sights on how can we enable more proactive quality management as clinically relevant drug product specifications evolve. For example, Breakthrough Therapy Designations provide accelerated approval of products with narrow and limited clinical studies and we need to be prepared for the widening of specifications as data evolves post approval.  This is where the roles of real world evidence and post market surveillance become paramount.

Lastly, we must operationalize metrics to enable continuous improvement.  Ultimately, organizations should want their metrics to be proactive showing not only the drivers, but also the “drivers of the drivers” to help implement the right actions to prevent recurrence.  Thoughtful consideration should be given to setting targets, as well as digging into the analytics.  If your outcomes are always perfect, challenge yourselves and develop a new metric with new targets that will drive continuous improvement in your organization.  And to be truly successful, develop that quality culture mindset throughout your organization.


Francois Sallans is the Chief Quality Officer of Johnson & Johnson and a keynote speaker at the 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference.  Sallans’ presentation, Quality and Innovation: The Johnson & Johnson Experience, on 5 June 2017 will provide a general overview of J&J’s quality philosophy/approach as a social responsibility, provide important elements to having a quality mindset, and highlight some of J&J’s recent innovations and progress towards manufacturing of the future.

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