For Incident Management, Pick Your Course and Complete It
June 8, 2021

Distance runners know that the first objective of a race is to complete it, and the second is to respect the integrity of the course. Then they work backward from those two objectives to prepare for pace, considering variables such as weather, managing for resiliency in training and the race, and heeding other factors.

If you think about an incident that you must manage in a life science company the same way, you’ll have a nice model for success with two exceptions. One, unlike the specific starting line for a race, the incident can start from a myriad of places inside or outside of your life science company. Two, the length of the race may be different depending on the nature and severity of the incident.

The Unpredictable Incident Starting Line

A patient may have a reaction to your therapy or medicine deemed an adverse event, and that information may be captured from the care provider, through a support path, or another mechanism. Regardless of the origination, it still must be captured and tracked into your system from the time of first notification and then follow a life cycle of investigation and action appropriate to the incident. For example, a receiving dock incident could result in damage of materials as result in a deviation from standard procedures for receiving materials.  Or, failing a material receipt quality test could result in a material non-conformance report. Those must be captured from the source and follow the appropriate level of follow-through and action.

Varying Conditions Impact SOPs

Similar to assessing race conditions, an incident must be categorized according to its severity and follow the life cycle associated with that severity according to your compliance program. If deemed low severity and impact, it may be captured and closed out as such, like a 5k. If deemed high severity and significant risk, it may look more like a marathon. The incident may require a full corrective action preventative action (CAPA) life cycle through close out with multiple parties inside and outside of your company, including corrections and approvals to SOPs and training and certification on those new approved SOPs. 

The Right Incident Life Cycle Management Tool

To enable your success in any type of race you encounter in your life science business, you need a tool that will help manage these incidents. Be sure to look for these critical elements:

  • The ability to capture incidents into your digitally enabled incident life cycle management system
  • The use of workflow to ensure the system is accessible and actionable for multiple parties to use as well as auditable and controlled 
  • The ability to categorize incidents based on type and severity, resulting in appropriate response plans and actions that are performed and captured digitally.
  • Tracking of time duration of all incidents from the beginning and by process step in order to visually see and escalate work that has to be performed within timeframes
  • Reporting and dashboards that make this transparent and easy for those that have the security to view and act on the incidents

If you are a pharmaceutical or biotech company interested in learning more about how to digitally enable your incident management, reach us at www.meritsolutions.com