Compounding Risk Assessment Form
Assess compounding-related operational risk by providing the process details, key risk factors, controls, and follow-up actions.
Assessment Details
Compounding activity / process description
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Compounding type
*
Sterile compounding
Non-sterile compounding
Repackaging
Batch preparation
Other
Number of compounded items per day/week
*
Location / department
*
Submitted by / role
*
Risk Factors and Controls
Applicable Risk Factors
*
Workflow complexity
Ingredient variability
Frequent formulation changes
Manual calculations
Storage constraints
Staffing or training gaps
Equipment calibration issues
Labeling or verification steps
Environmental control limitations
Other
Overall Risk Severity / Likelihood
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Low
1
2
3
4
5
6
7
8
9
High
10
1 is Low, 10 is High
Impact
*
Low
1
2
3
4
5
6
7
8
9
High
10
1 is Low, 10 is High
Overall Risk Level / Prioritization
*
Please Select
Low
Moderate
High
Critical
Immediate attention
Review and Follow-up
Mitigation and Follow-up Actions
*
Confirm Assessment Completion
*
1
I confirm the assessment is complete and ready for final review
Submit
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