Many of us have been faced with this beast that needs taming: a regulatory agency has conducted an inspection of your facility. Their observation is that the backlog of investigations at your site is unacceptable.
How did we get here? An increase in investigations, and therefore an increase in a backlog of overdue investigations, can occur for a myriad of reasons, some of which may include:
- A novel therapy has been developed
- A new, innovative automated system has been introduced to the facility
- Expansion of manufacturing
- An increased output results in increased investigations and related events (deviations, Change Controls, Corrective and Preventive Actions [CAPAs], complaints, etc.)
While these are all reasons a backlog can occur, it is important to note that none of these are acceptable reasons to have a backlog of investigations at your site in the eyes of regulatory bodies. So, when faced with an influx of backlogged investigations, how can we ensure it is “tamed”?
How to Tame the Beast
First and foremost, the best way to start taming an increasing backlog of investigations is to recognize that the risk exists in your organization. This is best done by identifying key metrics and Management Review. If you routinely review your metrics with respect to investigations and related events and meet to outline risks, you have greater insight into the health of the organization.
Second, is to make a commitment not only to the regulatory agency but a commitment to your own organization to reduce and remove the beast that is “Investigation Backlog”.
Finally, plan and manage the reduction of backlogged investigations to ensure timely closure and project success. Can Project Management be your saving grace, your “Beauty”? It can, and here is how: reach out to a trusted partner and get support from the experts – ProPharma Group.
How to Find The Beauty
Not only can the closure of backlogged investigation be treated as a project, but it should be treated as a project. Here is why:
- Initiation: A Project Manager (PM) initiates the project and outlines the scope, deliverables, and success rate of a project. This is all done ahead of investigation subject matter experts ever setting foot onsite. The PM is able to quickly mobilize the appropriate resources for the project, onboard, and train them on the appropriate procedures and processes.
- A PM assesses the project and determines if the site has an appropriate process for investigating, or if our process (which has stood the test of time and aligns with the goals of the project) better aligns with client’s processes.
- A PM appropriately assesses the risk, the resources, and the success of the project. Where your organization may want to bring in experts to complete investigations, the PM holistically assesses the project and ensures sufficient resources (investigators and reviewers/approvers) are available along with an assessment of a multitude of other risks.
- Planning: A PM appropriately plans all aspects of the project. Based on this plan, during the execution phase the PM has available measurements and metrics to outline the successes or risks of the projects. Measurement and metrics easily translate into dashboards and communication tools for use at every level of the organization.
- Execution: Executing is smooth and successful due to appropriate Project Management, Project Initiation, and Project Planning.
- Monitoring and Closure: The Project Manager acts as the communicator, the buffer, and the problem solver within the organization to ensure successful closure of such an Investigation Backlog Reduction project.
Having the right partner can ensure a job well done, and can be the key to a project completed compliantly and expeditiously, allowing you to focus on your overall Quality Management Systems and good standing with the regulatory agencies.
ProPharma Group can be your Compliance and Quality Assurance partner with respect to completing the investigations and eliminating the backlog, but we can also partner with your organization from a project management perspective, to appropriately plan and manage the project to closure. Contact us today to learn more about our team of experts and how we can help support your project.
