Quality Doesn’t Matter! Say it isn’t so!

Quality Doesn’t Matter! Say it isn’t so!

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Suppose you have just delivered a Quality Management Solution (QMS) to your customers, and immediately afterward, you receive an invitation to a webinar titled “Why Quality Doesn’t Matter.” What do you do? You sign up!

The anticipation of what Dr. Marla Phillips, Ph.D., Director of Xavier Health, Xavier University, might impart based on this webinar title, was exciting, maybe even a little bit anxiety- inducing. After all, quality is what we strive for, and it’s been the focus of industry for decades. In Life Sciences, not only are we striving to improve quality, we are equally focused on ensuring our global regulatory compliance.

It’s all in the Q

The Quality Department is not only named after, but it is responsible for a term that instills feelings of angst, as it is often seen as an inhibitor of progress and efficiency. Additionally, quality isn’t easily defined or universally understood, according to Dr. Phillips. It is often defined as “product that meets specifications.” But what if the specifications are not well written? If we meet the requirements of a specification that is not well written, do we still have a quality product? If we look at it from a patient viewpoint, quality might be defined as a product that cures the disease it’s intended to cure. But what if it causes another disease? Is it still a quality product?

These theoretical considerations prompted the questions posed in this webinar session:

  • If we can’t define quality, how can we improve it?
  • Do we even need to improve quality?
  • How do we get quality to become a cross-functional effort, especially when everyone’s view of quality is different?

To focus in on the reality of how difficult it is to define quality, we were asked to think about how our colleagues at all levels in our organization would respond to the question, “If I asked you to improve quality today, what would you do differently?” The answers we would receive would vary wildly.

So we need to ask the right questions within our organizations. Think about how differently our colleagues in the organization would respond if we posed this question instead: “If I asked you to improve the Right-First-Time rate in everything you do tomorrow, what would you do differently?” The answers we would receive would be very specific, focused, and pertinent to their respective role.

It’s an Attitude

Right-First-Time is more than a metric, it’s an attitude. It IS quality. Dr. Phillips stated that if we focus on Right-First-Time, compliance becomes the natural outcome and cross-functional partners become co-owners. At Pilgrim Quality Solutions, we would enhance this statement just a bit by saying that if we focus on Right-First-Time, quality and compliance become the natural outcomes and cross-functional partners become co-owners.

The next questions posed in Dr. Phillips’ presentation were “How do we get our organizations to change their quality mindset, and how does Quality become an organizational asset?” It starts with communicating the value of quality to the organization, in terms that the business understands. This means the Quality group needs to speak to each role in the organization in a language they understand. Examples given during this session include the switch from talking about the number of open CAPAs, the number of failures, and the number of 483 observations, to talking about the number of days off market, the number of man-hours wasted or saved, and the improvement in net profits.

The need for a common language, a common understanding, and therefore common goals, is the only way to get everyone in an organization on the same page, working towards the same goal. Speaking the language of the business is key if quality is to become understood and co-owned throughout an organization rather than by the Quality department alone. In the previously published Pilgrim blog titled The Case for Quality System Transformation, we discussed the importance of making a business case for the transformation of our Enterprise Quality Management Systems (regulatory compliance is key for Life Sciences organizations) in a language the business understands, including the Right-First-Time metric, along with metrics for First Pass Yield, On-Time Deliveries, and many others.

Make quality [little ‘q’] Matter

To make quality [little ‘q’] matter to our organizations, the Quality function [big ‘Q’] needs to change its focus. Quality needs to move away from attempting to influence using fear tactics, and work on conveying value to cross-functional partners within the organization and those in the extended supply chain such as suppliers and patients.

Quality needs to speak the language of the business. When they define quality by focusing on Right-First-Time, and other metrics that measure the means attached to results — time off market, production downtime, profit, and product efficacy — only then will quality and compliance become the natural outcome. The bottom line is that we need to communicate the impact of quality to all constituents that participate in an organization’s extended supply chain.


Ebook: Finding Your Path to Quality Nirvana


Recording: The Case for Quality System Transformation



Kari Miller

Regulatory & Product Management Leader, Pilgrim Quality Solutions

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