Get Risk Management Series - Part 6: Estimating Probability Of Occurrence

This guide provides a clear and supportive approach to filling out the Risk Management Series - Part 6: Estimating Probability of Occurrence online. By following the outlined steps, users of all levels can accurately complete the form, ensuring effective risk assessment in the medical device industry.

Follow the steps to complete the form accurately and efficiently.

1. Press the ‘Get Form’ button to access the document, allowing you to begin the process of filling it out online.
2. Identify the key components of the form. The sections will involve estimating the Probability of Occurrence of Harm, where you will need to define specific hazards and potential harms related to your medical device.
3. Clearly define the hazards associated with your device. Ensure you understand how each hazard could potentially lead to harm and outline the sequence of events that may occur.
4. Estimate the Probability of Occurrence of Harm, focusing on identifying the probability for each harm based on both qualitative and quantitative criteria. Ensure this is expressed on a 'per use' basis for accuracy.
5. Consider the two components: the probability of the hazardous situation occurring (P1) and the probability of this situation leading to harm (P2). Clearly separate these within your analysis.
6. Compile all results and ensure that each section is completed with care. Double-check to make sure that all definitions and probabilities align with industry standards listed in the ISO 14971:2007.
7. Save your changes, then choose to download, print, or share the completed document as necessary based on your specific organization’s processes.

Get started today by filling out the Risk Management Series - Part 6 online to ensure effective risk management for your medical device.