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.
Step 1
Objective: Scoping.
Description: Determine size and extent of regulatory risk.
Inputs:
Inspection Report.
Regulatory Correspondence.
Corporate Intelligence.
Technical Input (Product/System).
Personnel Interviews.
Step 2
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.
Step 3
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.
Step 4
Objective: 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.
