How Do You Build A System At A Life Sciences Company That Is "Fit For Purpose"?

A | BUILD ON THE FOUNDATION OF A RISK-MANAGEMENT PROGRAM, scale, and improve accordingly. No matter the organizational complexity or maturity, the fundamentals that always apply include:

1. a culture in which people are encouraged to disclose risks
2. consistent approach for categorization of risk (typically tied to patient safety) to allow comparison across enterprise to enable prioritization
3. risk assessment/mitigation plan owner to assure accountability
4. periodic updates of the risk assessments as they are dynamic
5. visibility to progress at the appropriate level to ensure obstacles are removed
6. a cross-functional team
7. risk facilitator expertise (contracted if needed)
8. tools used depend on magnitude and complexity of risk
9. process for tracking and managing periodic updates to the risk assessment/ mitigation plans can be manual or automated using software.

CHARLENE BANARD is head of global quality and technical operations at Shire. She has more than 25 years of industry experience.