Remediating pharmaceutical quality systems

Much of our work involves helping companies remediate flawed quality systems. Find out the factors that can make your remediation project a success

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 organisational 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 organisational 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 organisational culture that needs to change to support quality initiatives. Unfortunately, without a true culture of quality built into the DNA of your organisation, 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 organisational 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.

Encouraging self-assessment

As part of our process, we encourage management to conduct a self-assessment of company policies and practices that influence employee behaviours. While most companies have stated values that support quality objectives, the extent to which management complies with these values determines employee behaviours.

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 recognise 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. Organisational values and principles, as well as an effective means to communicate them, are established by the top of the organisation.

  1. Does your company have a communication plan?
  2. Does your company communicate collaboration, openness and transparency?
  3. 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 organisational culture through open collaboration and communication. Recognising 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.

Featured Companies

NSF Health Sciences (more information, website)