Creating a Culture of “Quality Beyond Compliance”

Posted by Anelis Aurand-Araos

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If your job is to develop and produce medicines to prevent disease and mitigate suffering around the world, quality is the guiding principle of your business model.

Recently, we studied this issue and presented our thoughts and recommendations to our leadership team. Because quality control is an issue that affects more than just our industry — I’m thinking of the outbreaks of E coli and norovirus recently devastating Chipotle restaurants in the U.S. — we thought that sharing some of her insights would be especially valuable.

All operations must strive for sustainable production of the highest possible quality. To achieve this, a policy must be in place to constantly improve the processes, systems and skills needed to enhance the stability and predictability of operations and to ensure product quality at all stages and a competitive cost. The challenge in most manufacturing environments will always be to balance customer commitment and cost competitiveness without compromising quality and safety.

Three major principles underlie this policy:

  • Value stream mapping and risk management
  • Continuous compliance with key performance indicator (KPI) metrics (e.g., right first time > 99%)
  • External and internal inspections and continuous inspection readiness as a foundation

Assuring-Pharmaceutical-Technology-Transfer-Success-eBook The best policies will never be successful if they are approached without the right behaviors, so producing quality begins with instituting a strong quality culture. All levels of the organization, from leadership to line management to production staff, must be mindful of quality at all times. Here are six behaviors to help keep quality consistently top of mind.

Think quality always

Train your brain to make quality the top priority and keep clients and their patients at the heart of everything you do. Always have the impact on patients (or customers, if you’re Chipotle) in mind when making decisions that could affect product quality. Be certain staff at all levels understand current good manufacturing practice (cGMP) regulations and why they are important.

Speak up for quality

Staff at all levels must be encouraged to speak up for quality and make suggestions on how to improve it. If you see a problem potentially impacting quality, say something immediately. To enable this, leadership must create a safe environment for open communication.

Jointly own problems

Use cross-functional collaboration to solve problems; consider all problems as “our problem.” Everybody is responsible for quality — not individual associates or departments. Everyone must take ownership and contribute to problem solving.

Always ask why

Always strive for excellence and think beyond the obvious. Invest adequate time to determine root causes; don’t always accept the first solution. Share knowledge and connect with experts on best practices within and across sites and functions.

Build Skills

Take pride in your work and keep skills up to date. Fully absorb cGMP requirements and get the required training for your roles as well as for allied areas. Stay up to date on the latest regulatory and business requirements and establish well-defined training goals and objectives.

Embrace Change

Finally, all improvement requires change, and change often causes resistance by those affected. Be inspired to accept the challenge to make things better by understanding why change is needed and understanding your role in facilitating that change. Have a positive mindset to encourage yourself and others through the change process, then plan for and manage change systematically.

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Topics: quality, Corporate Culture

Anelis is the Director of Scientific Affairs and Chief Compliance Officer at WellSpring, and has over ten years of pharmaceutical industry experience in Regulatory Affairs, Quality, and Scientific roles. At the University of Florida, Anelis earned her Bachelor of Science in Chemistry, as well as Master of Science in Pharmaceutical Outcomes and Drug Regulatory Affairs. She also earned a Master of Science in Analytical Chemistry at Southern Connecticut State University. In her role at WellSpring Pharmaceutical, Anelis is responsible for the overall corporate quality, compliance, scientific & regulatory affairs direction and strategic guidance for the US and Canadian businesses.

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