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Remediating Pharmaceutical Quality Systems
Much of NSF International’s pharma consulting work involves helping companies remediate flawed quality systems.
This usually occurs as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do whatever it takes without a full understanding of what that means. While expansive in concept, “whatever it takes” often ends up meaning deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.
How Did This Happen?
The answer to this question is almost universally organizational culture.
Most companies are surprised by this answer and find it difficult to imagine. Most companies truly believe they are committed to quality, and most 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 not create a successful outcome. We often meet senior leaders of firms who are willing to invest in quality systems and processes, but we find that they do not understand that there is an underlying issue in the organizational culture that needs to change 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.
Our Role in the Remediation Process
Our experts have the experience, skills and methodology needed to help a company design and document a world-class quality system. We also learned very early that this methodology must address the imperative of organizational cultural alignment and this is the most difficult part of a remediation project. As an example, many individuals are drawn to the health sciences industry by altruistic desires to help people and may be surprised by the idea that their cultures may not support quality principles. After all, what health care company doesn’t want to produce high-quality products? We provide tools to help companies look at their cultures more analytically.
As part of our process, we encourage management to conduct a self-assessment of company policies and practices that influence employee behaviors. While most companies have stated values that support quality objectives, the extent to which management complies with these values determines employee behaviors.
Ask these questions:
- Does management override the quality assurance unit’s decision to withhold product release?
- Does management cut funding of the quality function before, or to a greater extent than, others?
- Does management recognize and reward quality achievements as it does financial ones?
- Does management effectively balance its needs and initiatives with its commitment to quality?
The Importance of Understanding Your Own Quality System
An integral element of the NSF International methodology addresses management’s responsibility to “walk the talk” and model the company’s quality values. We encourage the most senior executive managers to have at least one performance element related to quality. Our goal is that each member of the company’s senior executive management team has as intimate a knowledge of the state of the company’s quality system as he or she does its financial condition.
During a remediation project, our consultants work collaboratively on-site with the company to create a new system, coaching and mentoring throughout the project. Organizational values and principles, as well as an effective means to communicate them, are established by the top of the organization.
- Does your company have a communication plan?
- Does your company communicate collaboration, openness and transparency?
- Does the communication plan clearly define who owns the process?
Reaching A Successful Conclusion
During the planning process, we can be effective in counteracting 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, we address cultural issues early in the process. This enables the company to operate in a quality-supportive coaching and mentoring environment, assuring ultimate success.