Creating & Sustaining a Quality Culture: Part 1 – Living the Values
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Creating & Sustaining a Quality Culture: Part 1 – Living the Values

Quality Management - 5 October 2016

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

There are two important elements to effective communication in the workplace: the content to be communicated, and the demonstration of that content. If a policy change is communicated, then leaders of the organization, both managers and the informal ‘opinion leaders’ must be seen to implement the change. People often use the phrase ‘walking the talk’ to characterize these elements.

Leading by example is very important in establishing a quality culture, and demonstrating the integrity of the organization in making quality decisions. If safety glasses are required to enter laboratory areas, and senior managers, or long-time employees “forget” to wear them on occasion, it creates an impression that rules and policies are not that important. While this example may seem trivial, I once had an auditor from an important potential new client begin the exit interview with a comment that he saw an employee entering a lab without their safety glasses, and this created concern about adherence to policies.

"Having good procedures and clear policies is the start of creating a quality culture. Demonstrating a commitment to the tenets of a quality culture every day is equally important. All of the program design and training of employees can be jeopardized by leaders of the organization if they don’t follow through with their actions."

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

A commitment tracking system is also an important contributor to sustaining the quality culture. If corrective actions require procedural or policy changes, then monitoring the ongoing commitment to the change is vital to the reputation and effectiveness of the quality unit. Commitment tracking demonstrates the ability to make positive changes, monitor their effectiveness, and ensure that there is no lapse in attention to the required change. Nothing is as damaging to the quality culture as making the same mistake repeatedly, despite corrective action.

The easiest quality decisions are the obvious ones – a clear line between pass and fail, or meeting versus not meeting a specification. The tougher decisions, and the ones that will demonstrate the organization’s quality culture are in the “gray areas”- where no clear line has been crossed, but there is a concern that the product is not consistent with previous production. A willingness to ask questions, even when we may not like the answers, shows that quality is a real commitment of the organization.

Having good procedures and clear policies is the start of creating a quality culture. Demonstrating a commitment to the tenets of a quality culture every day is equally important. All of the program design and training of employees can be jeopardized by leaders of the organization if they don’t follow through with their actions.

In the next blog in the ‘Creating and Sustaining a Quality Culture Blog Series’, I will expand on making an impact in quality communication, both internally and externally to the organization.


Other Blogs in the Creating & Sustaining a Quality Culture Series
Creating & Sustaining a Quality Culture: Introduction
Creating & Sustaining a Quality Culture: Part 2 – Making an Impact
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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