Your company just received a Warning Letter from the FDA, now what?
The need for a fast, efficient, and highly effective remediation strategy has jumped to the top of your company’s priority list. To start, it is critical that regulatory response projects are resourced appropriately to ensure maximum success -- a combination of internal expertise supplemented with external resources. The question many Quality leaders struggle with is whether or not to backfill the day-to-day responsibilities of those internal employees while they are assigned to the remediation.
Here are five reasons why backfilling is crucial to the success of your FDA remediation project and to the health of your organization as a whole:
1. Places Critical Priorities First
Employees working on the remediation planning and execution need to be completely focused on the task at hand. You have talented employees who are key to the remediation and it is essential that those employees are fully engaged and dedicated to achieving the milestones established by the company and the FDA. Juggling day-to-day responsibilities along with remediation requirements is counter-productive to this goal.
2. Retains Your Top Employees
The last thing you need during a remediation is to see valuable employees walking out the door. Employee morale is always important, but even more so during the trying times following an FDA Warning Letter. Having employees take on extra duties while maintaining their normal responsibilities often results in overwork, stress and dissatisfaction. According to Forbes, overloading your top talent with too many responsibilities is a key reason employees quit .
Your staff is talented, and human, and there is only so much one person can do at a high level. You can offer your employees incentives to stick with the increased pressure, but this could establish a precedent for future projects requiring increased workload. Backfilling during a remediation serves to mitigate the extra work, ultimately leading to increased morale and greater retention of your top talent.
3. Minimizes Additional QC Problems
The fact that you are in a remediation likely means you already have at least one quality control issue. You don’t want to create more problems. Your company’s processes and execution will be scrutinized under a microscope more than ever, so heightened compliance and attention to detail are critical.
However, mistakes can happen when employees are struggling to balance their day-to-day roles with the tight deadlines associated with remediation efforts. Despite the best of intentions, these missteps could lead to more costly issues down the road. Backfilling your day-to-day operations can help keep your ship sailing smoothly while your top talent is attending to the remediation efforts.
4. Affords a Fresh Perspective
While a successful remediation is the primary objective, backfilling day-to-day responsibilities offers additional benefits beyond the remediation. Backfilling with external compliance staffing can result in a healthy and productive challenge of the status quo. It presents an opportunity to reassess day-to-day roles, processes, and procedures to maximize operational performance.
These are new people with different experiences and fresh perspectives which can bring about positive change to your organization.
5. Identifies New Quality Talent
This is the perfect opportunity for you to assess the talent pool outside of your organization. Hiring can be tricky and timing is key. Take advantage of the remediation to build a bench of talent for key roles in your department. Observe how outsourced staff work within your organization and expand your network through your compliance consultants. Perhaps you’ll find your next superstar!
Bottom line -- Remember the big picture while you’re planning a remediation effort and think twice about the consequences before you try to save a few bucks by overworking your team. You have one chance to get it right.
Are you going through a remediation and need staff? Click HERE to check out our talent-pool or schedule a free assessment.
