Phase 1 – Red Zone ‘Regulatory Distress’
The objective of Phase 1 is to build an understanding of the reason for, and scope of, the regulatory risk and develop an appropriate remediation programme. Early identification of the need for a Compliance Management Programme maximises the time available to ensure an appropriate response to the Regulator in the expected response time.
Description: Determine size and extent of regulatory risk.
Inputs: Inspection Report – Regulatory Correspondence – Corporate Intelligence – Technical Input (Product/System) – Personnel Interviews.
Objective: Action Plan.
Description: Develop a targeted action plan to address core concerns and implement immediate risk mitigation.
Inputs: Interim Risk Mitigation Controls – Corrective Action Plan – Available Resources and Expertise.
Objective: Remediation Programme.
Description: Develop a broader improvement plan to ensure sustained, enhanced compliance.
Inputs: Preventative Action Plan – Compliance KPIs and Risk Profile – Site Assessment.
Objective: Stage Gate 1: Internal Alignment.
Description: Secure internal alignment and endorsement of the remediation and communication plans.
Inputs: Stage Gate Criteria: – Clear Understanding of Regulatory risk – Targeted Corrective Action Plan – Risk Based Remediation Programme – Communication and Governance Plan.