Nobody enjoys layoffs. Especially when your remaining staff feels ill-equipped to continue, let alone worry about compliance issues. I recently found this to be the case for a drug development and manufacturing company that implemented significant layoffs due to its financial situation.

QC Staff Morale Low … Asked to Do Much More with Much Less

Although they had hired a Director of Quality Control (QC), the workforce of the QC Department had been reduced by 50%. Not only that, but the QC Director also found that many SOPs needed major updates and revisions to reflect actual processes.

The layoff affected a large swath of the company—from QC to QA and Operations. Along with a serious morale issue, the remaining employees lacked practical support to help with labor-intensive tasks such as writing investigations, change controls, and notebook reviews.

Adding to all of this was senior company leadership’s expectations that the company continue at the original pace of business with significantly reduced staff numbers. This resulted in the remaining QC staff being required to handle more responsibility, for example, writing investigation reports.

Upon interview, it was noted that the Director wanted to ensure that his staff were properly trained and mentored. “For many of the remaining employees, it’s their first time working in a highly regulated industry,” he stated. “They lack outside industry experience, so they need an appreciation and understanding of the importance of their work.”

Outside Resources Help

The Director needed to quickly assess the situation and create a plan to meet milestone goals and keep operations moving. Part of this assessment involved hiring outside help to determine how best to restructure and maintain performance.

One of my first tasks was to calm people down and build up their confidence. It allowed me to understand the situation better and work on quickly creating the right strategy and a strong training program. It was important as an outside resource that I listen and help people feel heard and valued. This allowed me to understand the situation better and gain perspective.

Leadership and Cultural Assessment Leads to Action

The QC organization’s leadership and department was assessed with an organizational tool developed using the Baldrige Excellence Framework and Performance Excellence Tool as a baseline. This involved surveying 22 individuals across the company—from the chief compliance officer to scientists, stability coordinators, administrators, and lab members. The tool helped identify areas within the QC organization for improvement.

The review also assessed the competencies of personnel to identify ways to improve the work environment and create growth opportunities to ensure industry best practice performance. The findings informed the basis for action, feedback, and ongoing success and identified the following key points:

• The QC Department leadership was well-regarded and valued and provided a stabilizing factor in its operation, although the QC Director was seen as overtasked.
• The lack of automated processes and tools—a well-known deficiency—and the lack of acknowledgment and or/communication about potential improvements exacerbated issues.
• While the staff recognized the need for process improvements, they felt overwhelmed with routine work and unable to see a clear plan for tackling the issues. The findings provided a clear starting point to create a tailored, appropriate action plan that included an investigations training program, which helped staff handle additional responsibilities confidently and competently. The goal was to engage people in training that had an immediate impact while building collaboration. The training was designed to bring together representatives from different departments and have them work on real-world investigation scenarios. The lecturing was limited, with a focus on ‘hands-on’ training. People could brainstorm and problem-solve together—as they would during actual investigations.

As part of the closeout of the project, I collected feedback.

• Survey quotes included that having a “planned, systematic approach towards lab investigations” was the best/most valuable skill gained during the training.
• Participants noted how the training helped them “better brainstorm the root causes of a problem and narrow it down…” and offered tactics “… to write a good problem statement.”
• The majority noted that the content was “organized and easy to follow,” and people “… will be able to apply the knowledge learned.”

It was important to ensure that the time spent during training met the goal of engaging and teaching the team and giving them a sense of control over their investigations. As a result of the training, there were two reported outcomes:

1. 1The assessment and training helped to stem the attrition from the QA and QC teams. It gave them a voice, knowledge and control.
2. Following the training, the QA and QC teams felt more confident and capable when thinking about and writing up investigation reports.

Lessons Learned

• Communication will always be vital.
  Clearly, a lack of consistent and meaningful communication was a large concern within the QC organization. Employees did not feel they were aware of what changes were coming, and everyone suspected there was more they should know about what was happening.
• Communication improvement can occur quickly.
  In this case, it included both QC departmental regular communications and also more formal communications engaging with functions external to QC, including HR. There was value in senior leadership making an effort to visit the laboratory informally to shift the perspective of unengaged and uninterested QC parties.
• When creating a Quality plan, seek input from all stakeholders.
  A draft Quality Control Quality Plan was created and reviewed with the QC Leadership team, and it was revised to reflect inputs. As a living document, people felt they could make suggestions and revisions as they went along.
• Focus on criteria that improves processes and results, rather than individual performance.
  Such criteria are the foundation for integrating key performance and operational requirements within a results-oriented framework that creates a basis for action, feedback, and ongoing success. This approach focuses on helping an organization find ways to innovate and improve.