Challenge: Hitting a staffing roadblock

A leader in In-Vitro Diagnostics (henceforth referred to as the Client) reached out to QualityHub to overcome resource constraints and return to compliance. This pioneering company is known for its sophisticated diagnostics systems for acute patient treatment. Despite its success, the Client was still plagued by long-standing systemic issues. Due to FDA enforcement, the Client committed to performing a retrospective review and remediation of approximately 30,000 legacy complaint records. The Client also committed to completing the project under an aggressive deadline — a challenge compounded by limited staffing and a lack of experience. 

The Client’s inexperience with a project of this magnitude, and lack of internal resources, left them unable to independently develop and implement a strategic plan. Thus, they would be unable to get into compliance, properly monitor and control activities, or verify that critical success factors could be met. 

Knowing they needed assistance, the Client asked QualityHub to mobilize a team of experienced technical specialists to implement a comprehensive strategy, helping them overcome this challenge. 

Approach: Experienced staffing with a strategic purpose

To move forward, we engaged our Subject Matter Expert and Program Manager to assess the previously identified issue. We evaluated the current process to understand the complexities and nuances of the situation. Going a step further, we analyzed the current workflow and performed time studies to determine throughput time, which resulted in capacity analysis studies and resourcing needs.

Based on the preliminary analysis and legwork, we assembled a team of approximately 20 highly skilled temporary professionals alongside a program manager with years of experience and needed product expertise. We collaborated with the Client to develop the project strategy, protocol, tools and templates. We also met with key stakeholders for buy-in and alignment. During a 12-month time frame, QualityHub oversaw and monitored the implementation of the strategy and assisted with any needed course corrections and training. Activities included initial project set-up, onboarding, training, implementation, and project closure.

Results: Stronger process and staffing

Using our process, team, and oversight, the Client was able to efficiently and effectively process the approximate 30,000 complaint files on schedule. When re-inspected by the FDA, the Client passed the follow-up inspection with no issues.

Moreover, the Client gained better processes and stronger systems, employees improved their technical and regulatory knowledge, and quality and compliance sustainability were strengthened.

Since conclusion of the project and implementation of new processes, the Client has been able to maintain compliance, manage workload demand, meet deadlines, report Medical Device Reports on-time, and staff a team of technical experts.