Remediation of Quality Systems: Refining Quality Culture

Quality system remediation requires significant resources and a full review of quality culture. NSF experts can help you achieve a successful outcome.

Much of NSF’s consulting work involves helping companies remediate flawed quality systems. This is usually done because of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies become desperate and willing to do “whatever it takes” without a full understanding of what that means. “Whatever it takes” often means simply deploying internal and external resources to design and document a new quality management system. This is a significant resource commitment by management, but without considering the cause of the flaw, the effort is doomed to fail.

Quality Culture: The Most Common Flaw

In our experience, one of the answers to “How did this happen?” is almost universally organizational quality culture. Most companies are surprised by this answer and find it difficult to imagine. Many will tell you and truly believe they are committed to quality. In fact, most companies make the pursuit of quality part of their corporate mission statements. However, failing to address organizational culture as a root cause during the remediation initiative will foretell an unsuccessful outcome. We often meet senior leaders of firms who are willing to invest in quality systems and processes, but we find they do not understand that there is an underlying issue in the organizational culture and that change is necessary to support quality initiatives. Unfortunately, without a true culture of quality built into the DNA of your organization, most quality improvement projects will fail. Worse still, such a failure could lead to even more aggressive and difficult regulatory enforcement action.

Expert Guidance for Quality System Design

We possess the experience, skills and methodology needed to help a company design and document a world-class quality system. We also learned very early on that this methodology must address the imperative of organizational cultural alignment, which is the most difficult part of a remediation project. Many individuals are drawn to the health care industry by altruistic desires to help people. Consequently, health care companies are bewildered and aghast at the suggestion that their cultures may not support quality principles. After all, what health care company does not want to produce high-quality products? It is no wonder that a company would challenge a consultant’s suggestion that attention to the corporate culture is necessary.

One aspect of the NSF process is to encourage a self-assessment by company management of the policies and practices that influence employee behaviors. While most companies have stated values supportive of quality objectives — the easy part — it is management’s compliance with them that is determinative in influencing employee behaviors.

  • Does management override the quality assurance unit’s decision to delay product release?
  • Does management cut funding of the quality function before, or to a greater extent than, that of other functions?
  • Does management recognize and reward quality achievements as it does financial ones?
  • Does management effectively balance its capital needs and initiatives with its commitment to quality?

An integral element of the NSF methodology addresses management’s responsibility to “walk the talk” and model the company’s quality values. Among other things, we encourage the most senior executive managers to have at least one performance element related to quality. Our goal is for each member of the company’s senior executive management team to have as intimate a knowledge of the state of the company’s quality system as he or she does of its financial condition.

Remediation Projects Focused on Organizational Values

During a remediation project, NSF consultants are on-site, working collaboratively with you to create a new system and coaching and mentoring throughout the process. Organizational values and principles, as well as an effective means to communicate them, are established by the leaders of the organization.

  • Does your company have a communication plan?
  • Does the company communicate — and demonstrate — collaboration, openness and transparency?
  • Does the communication plan clearly define process ownership and who owns the process?

During the planning process, we can effectively counteract the negative impacts of organizational culture through open collaboration and communication. Recognizing that an antagonistic corporate culture can have its greatest negative impact at this point, our overall approach is designed to address cultural issues early in the process. This enables the company to operate in a quality-supportive coaching and mentoring environment, assuring ultimate success.

NSF Health Sciences Quality System Remediation Experts

Lynne Byers | Vice President

Over 35 years’ extensive pharmaceutical manufacturing management and QA experience, and fully conversant with current EU and FDA GMP regulations and requirements.

Rachel Carmichael | Executive Director, Pharmaceutical Services
Over 20 years’ experience in pharmaceutical manufacture, control and quality management, including nearly 11 years as a GMDP inspector for the MHRA.

Peter Gough | Vice President
45 years’ experience in pharmaceutical law, manufacturing, QC and quality systems.

Catherine Kay | Executive Director
Over 22 years’ pharmaceutical operations management, technical and QA experience; passionate about developing people and creating learning organizations, with continuous improvement embedded in daily operation.

David Waddington | Executive Director
Broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for global supply, including solids, liquids, sterile products, food supplements and natural products.

Jim Morris | Executive Director
Over 25 years’ pharmaceutical management experience in both plant operations and corporate offices.

Andrew Papas | Vice President of Regulatory Affairs
30 years’ experience in the industry, providing leadership and guidance on global regulatory affairs, quality and drug development programs.

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