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:
- a culture in which people are encouraged to disclose risks
- consistent approach for categorization of risk (typically tied to patient safety) to allow comparison across enterprise to enable prioritization
- risk assessment/mitigation plan owner to assure accountability
- periodic updates of the risk assessments as they are dynamic
- visibility to progress at the appropriate level to ensure obstacles are removed
- a cross-functional team
- risk facilitator expertise (contracted if needed)
- tools used depend on magnitude and complexity of risk
- 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.