Developing and Sustaining a Quality Culture - Pharmaceutical Technology

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PharmTech Europe

Developing and Sustaining a Quality Culture
Employee training—at all levels—is crucial for moving forward with a successful risk- and quality-based manufacturing strategy.

Pharmaceutical Technology
pp. 64-66

Key elements of a successful transformation

From the assessment there should emerge clear recommendations for improvement, including quick wins, and goals for the short-, medium-, and long-terms. Because organizations differ, the particulars of these recommendations for transforming any given culture will vary. But there are some constants in the execution of such recommendations. A centralized project management framework should be put in place to help guide the planning and successful implementation of the recommendations.

To help drive and sustain changes, a compelling quality culture message must be developed—in effect, internally branding the effort. The message must be clear, relevant, understood by all, and designed to provide a point around which every employee can rally, motivating them to contribute to the effort. Best practices in human resources, organizational development, and leadership should be followed in order to maximize employee engagement, assure effective rewards and recognition, provide timely communication of progress, and institutionalize accomplishments. Finally, appropriate operational-excellence tools should be used to further help assure successful implementation and sustainability of these efforts—as well as to provide the metrics needed to monitor and report progress along the way.

What should the resulting high performing, sustainable quality culture look like? Again, the particulars may vary from company to company, but such cultures should share the following characteristics (see Figure 1):
  • Employees at all levels understand the organization's quality objectives, policies, and procedures and their individual roles in helping to achieve them.
  • Leadership at all levels is visibly engaged in supporting the development of a quality culture and effectively engages and motivates others to do the same—leading to self-motivated accountability and sustainability.
  • Effective communication, enterprise-wide sharing of best practices, engagement of all employees, and rewards and recognition for both teams and individuals maintain the momentum and enthusiasm required for sustainability.
  • The organization hires people who possess the quality values, norms and work practices the company desires.
  • Staged on-boarding and technical and quality training are deployed at the company, business unit, functional area, and individual levels.
  • Consistent and sustainable standards of quality are defined clearly and deployed across the organization in conjunction with quality and compliance systems that enable the organization to achieve those standards.
  • The organization distinguishes between people and processes as the root cause of mistakes, and instead of blaming people looks to correct processes.
  • Leaders and managers at all levels establish an environment of trust and collaboration in which challenging issues can be raised without fear of reprisal.
  • The organization institutionalizes a process for capturing, analyzing, and incorporating lessons learned from past successes and failures.
  • As the organization grows and changes, the quality culture is continually monitored and fine-tuned to ensure that it remains effective and sustainable.

The journey from quality culture assessment to transformation to sustainability need not take long or consume massive resources. But it does require the recognition that achieving quality and compliance is not a matter of a discrete, isolated process but of the larger environment in which it takes place.

Ian Uydess, PhD, and Chet Meyers, PhD, are managing consultants at Tunnell Consulting,


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