1. Equipment-Specific Considerations: Used when assessment covers multiple types of equipment with specific cleaning requirements

2. Product-Specific Requirements: Include when different products require varying cleaning validation approaches

3. Cleaning Agent Assessment: Added when multiple cleaning agents are used requiring specific risk considerations

4. Environmental Impact Assessment: Include when cleaning processes have significant environmental implications

5. Cost-Benefit Analysis: Optional section for evaluating economic aspects of cleaning validation options

6. Training Requirements: Include when specific training needs are identified for risk control implementation

1. Appendix A: Risk Assessment Matrix: Template for risk scoring and categorization

2. Appendix B: Cleaning Process Flow Diagram: Visual representation of the cleaning process steps

3. Appendix C: Risk Assessment Form Template: Standardized form for documenting risk assessments

4. Appendix D: Control Measure Checklist: Checklist for verifying implementation of control measures

5. Appendix E: Cleaning Validation Data Collection Forms: Templates for recording cleaning validation data

6. Appendix F: Review and Approval Log: Documentation of risk assessment reviews and approvals

7. Schedule 1: Equipment List: Detailed list of equipment covered by the risk assessment

8. Schedule 2: Cleaning Agents and Materials: Specifications of approved cleaning agents and materials

9. Schedule 3: Acceptance Criteria: Defined criteria for acceptable cleaning validation results