Taking Ownership Individual Task Flow
By Mike Raia Posted December 20, 2018
PharmExec.com recently published an excellent article called "5 Ways to Shape a Regulatory Affairs Workforce for the Future," written by Janssen R&D Global Regulatory Affairs exec, Karin Van Baelen. In it, Van Baelen discusses five key components for building a GRA team that has a balance of agility and consistency, with the ability to both learn and experiment while remaining accountable.
I was drawn to a specific quote within her fifth component, which was about "Being Resourceful and Responsible" and the importance of employees "Taking ownership for actions as it relates to individual task flow allows for a productive and efficient workplace and overall team success." While this is a hallmark of good employees in any organization, it's especially true of employees whose actions can have a significant regulatory impact downstream. Mistakes and missed steps in critical processes can result in significant fines for the organization upon audit.
This is why we often point to the importance of using a workflow automation system to manage task flow and provide a complete audit trail of which employee took which action at which time. When the stakes are high, as in a highly-regulated industry like pharma, it's critical to ensure standard operating procedures with task automation and then be able to prove your compliance when subjected to an audit.
The act of regimenting task flow with automation helps reduce mistakes by removing doubt from employee decision making. The steps for any workflow are laid out in advance so employees know exactly which steps to take and when. In addition, because completing one task triggers the next, employees don't need to know what to do next. For instance, once a document has been reviewed and approved by one employee, they don't need to know who the next reviewer is. The document is simply moved along to the assigned recipient, which could be an individual or a group. This is a much more efficient and accurate way to sequence any task flow.
The bottom line is that it's much easier to take responsibility for assigned tasks when an employee can focus on the task at hand and not worry about managing the flow directly.