Creating & Sustaining a Quality Culture: Part 2 – Making an Impact
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Quality Culture for Pharma, Biotech, Medical Device and R&D

Creating & Sustaining a Quality Culture: Part 2 – Making an Impact

Quality Management - 26 October 2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit

There are many ways that we can reinforce the quality culture of an organization. To illustrate this point, I’d like to share an example from my career:

During a visit from a major customer, I was accompanying a tour of the manufacturing facility. During the tour, I noticed a small puddle on the floor outside a blending room that recently been washed. While the tour moved on, I got a paper towel and wiped up the moisture. One of the clients commented to me later that their quality leader had remarked to their group that she was pleased to see that cleanliness and safety were everybody’s job.

I believe that, with rare exceptions, people want to do a good job and deliver quality products. In pharmaceutical manufacturing, sometimes there is little feedback to help people assess their work. Reviewing and analyzing customer complaints with all employees is critical to reinforcing the potential impact of quality deviations. Complaint review tends to be negatively focused, so it is equally important to share customer testimonials, whether verbal or written. The goal is to create a culture where we want to know about any quality issues, so we can take corrective action. This imbues a healthy element of transparency and helps everyone feel they are part of the quality team.

"The sharp-eyed packager who notices a sporadic printing defect, or the incoming component handler that notices some subtle shipping damage, or anyone that identifies a deviation from the norm should be praised in front of the rest of the team for demonstrating the quality commitment of the organization."

John Carkner
Sr. Consultant, SOLABS QA & Best Practices Unit

Organizationally, cross-training manufacturing and quality staff is a terrific way to instill a broader understanding of quality and productivity. Having manufacturing personnel deliver topics in quality training sends a powerful message in establishing the quality commitment of the organization. Sharing audit comments and corrective action should be part of GMP training.

Choose opportunities to celebrate “quality victories” by employees. The sharp-eyed packager who notices a sporadic printing defect, or the incoming component handler that notices some subtle shipping damage, or anyone that identifies a deviation from the norm should be praised in front of the rest of the team for demonstrating the quality commitment of the organization.

Investing in quality systems and equipment is important in establishing the quality culture. Although it is sometimes more difficult to demonstrate the return on investment, since quality costs are sometimes less specifically attributed, enlightened organizations will find that efficient quality systems are as important to cost effectiveness as efficient manufacturing processes.

Share the science behind quality control with employees whenever you have the chance. Explanation of metrics and their significance, discussion of new regulations and what they are intended to accomplish, and the questions that arise during training are all good opportunities to enhance an appreciation of that science. In short, as a leader, whatever your role, never miss an opportunity to emphasize quality and its importance to the organization’s success.

In the next part of this discussion, we will examine internal and external communication strategies that will advance the quality culture.


Other Blogs in the Creating & Sustaining a Quality Culture Series
Creating & Sustaining a Quality Culture: Introduction
Creating & Sustaining a Quality Culture: Part 1 – Living the Values
Creating & Sustaining a Quality Culture: Part 3 – Internal & External Messaging

About the Author
John Carkner has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site. When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.

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