| Activity | Risk (Hazard) | Risk Rating (Severity X Probability) | Proposed Action to Reduce Risk | Residual Risk Evaluation | Opportunities |
|---|
| Design & Development | Design flaw leading to device malfunction | High (4x3=12) | Implement rigorous verification & validation processes | Medium (4x1=4) | Improve design control processes |
| Marketing & Sales | Miscommunication of device capabilities | Medium (3x2=6) | Ensure regulatory compliance in advertisements | Low (3x1=3) | Enhance customer education |
| Purchase of Raw Materials | Supplier provides non-conforming materials | High (4x3=12) | Perform supplier audits and incoming inspections | Medium (4x1=4) | Establish a strong supplier qualification process |
| Manufacturing | Contamination due to improper handling | High (5x3=15) | Implement strict GMP and cleanroom protocols | Medium (5x1=5) | Automate critical processes |
| Packing & Packaging | Damage to device during packaging | Medium (3x3=9) | Use validated packaging materials and drop testing | Low (3x1=3) | Optimize packaging design |
| Transporting | Shock or vibration affecting device integrity | High (4x4=16) | Implement robust transportation protocols and tracking | Medium (4x2=8) | Improve logistics monitoring |
| Installation | Improper installation affecting performance | High (4x3=12) | Provide structured training for installation personnel | Low (4x1=4) | Develop self-installation guidelines |
| Periodic Maintenance | Failure to identify early signs of malfunction | Medium (3x3=9) | Establish preventive maintenance schedules | Low (3x1=3) | Implement IoT-based monitoring |
| Breakdown Maintenance | Delay in addressing critical failures | High (5x3=15) | Develop rapid-response maintenance teams | Medium (5x1=5) | Improve remote troubleshooting capabilities |
| Disposal | Environmental hazards from improper disposal | High (4x4=16) | Follow eco-friendly disposal and recycling guidelines | Medium (4x2=8) | Explore sustainable disposal alternatives |