Mandated and disruptive changes to people, process, or technology
Exposure to personal liability
A collaborative approach to audits leads to:
Clear understanding of regulatory requirements and business needs as they evolve
Reduced risk of non-compliance
Reduced non-compliance costs
Expedited audits that bring value rather than disruption
Module 1: Audit Scoping
The Purpose
Determine audit team.
Identify audit scoping plan.
Key Benefits Achieved
Clear definitions of team member roles and responsibilities.
Proper audit scoping.
Activities:
Outputs:
1.1
Define audit roles and responsibilities
Defined roles and responsibilities
1.2
Develop audit scoping email
Completed audit scoping email
Module 2: Audit Preparation
The Purpose
Gather required documentation.
Prepare facilities and staff.
Key Benefits Achieved
Prepared documentation.
Prepared facilities and staff.
Activities:
Outputs:
2.1
Documentation gathering
List of required documentation
2.2
Facilities walkthrough and review
List of facilities requirements
2.3
Staff prep tactics
List of tactics for dealing with the auditor
Module 3: Post Audit
The Purpose
Clarify and remit findings
Key Benefits Achieved
Downgraded findings
Clarified recommendations
Activities:
Outputs:
3.1
Review auditor report
3.2
Draft follow-up email
Follow-up email to auditors
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