Project 2
Risk Analysis articulates three steps: risk identification, assessment and estimation
- Risk Identification, is the systematic process for detecting and validating all risks and/or sources of risk. It produces a comprehensive list of risks classified in Global – Those that affect the market and Elemental those that are specific of the project/company.
- Risk Estimation that calculates the probabilities of occurrence of each event and their impact.
- Risk Management establishes an appropriate framework with a specific set of goals and objectives. It recognizes selects and implements appropriate actions to control risks.
Here is an example of a risk assessment table for a medical device family, such as infusion pumps, that includes the requested information:
| Activity | Risk (Hazard) | Risk Rating (Severity X Probability) | Proposed Action to Reduce Risk | Residual Risk Evaluation | Opportunities |
|---|---|---|---|---|---|
| Design and development | Device failure due to design defects | High | Conduct thorough testing and analysis during the design process | Low | Improved product reliability |
| Marketing and sales | Misleading or false advertising | High | Ensure that all marketing materials accurately and fairly represent the product | Low | Increased customer trust |
| Purchase of raw material and services | Poor quality raw materials leading to device failures | High | Implement a thorough supplier evaluation and selection process | Low | Improved product reliability |
| Manufacturing | Injuries to workers due to unsafe working conditions | High | Implement safety protocols and regularly assess and improve upon working conditions | Low | Reduced injury rates |
| Packing and packaging | Damage to devices during transportation | High | Implement proper packing and handling procedures to protect the devices | Low | Reduced returns and customer complaints |
| Transporting | Accidents or delays during transportation | High | Use reputable and reliable transportation companies and implement contingency plans for unexpected events | Low | Reduced delivery delays |
| Installation | Device malfunction or injury due to incorrect installation | High | Provide thorough installation instructions and training to technicians | Low | Improved product performance and safety |
| Periodic maintenance | Device malfunction or injury due to incorrect maintenance | High | Provide thorough maintenance instructions and training to technicians | Low | Improved product performance and safety |
| Breakdown maintenance | Device downtime due to unexpected failures | High | Implement a preventative maintenance plan and keep spare parts on hand for quick repairs | Low | Reduced downtime |
| Disposal | Environmental damage due to improper disposal | High | Implement a proper disposal plan in accordance with regulations | Low | Reduced environmental impact |
In this table, the risk rating is calculated by multiplying the severity of the risk by the probability that it will occur.
For example, if the severity of a risk is rated as high and the probability is rated as low, the risk rating would be "Low." This is because the likelihood of the high severity risk occurring is low.