An important part of creating any product intended for use in any regulated industry vertical is that the manufacturer should have identified all of the risks involved in using the device. Then, they must have done their best to mitigate those risks before their product ever goes out to the marketplace. With this in mind, PTC bundled a Risk Management module as part of some of their off-the-shelf solutions to be used with Windchill Requirements, Validation & Source. For this article I am going to dive deeper into Risk Management.
Risk Management, as defined in ISO 14971, among other things covers the following: Risk Analysis, Risk Evaluation, and Risk Control.
Risk analysis consists of the following three steps:
Once you have analyzed the risks associated with your new product, you need to perform an evaluation of the risks. Risk Evaluation consist of the following three items:
Any risks that are either Unacceptable risks, or risks that require further investigation, need Risk Control.
The risks can be controlled in the following manner:
Of course, once you have completed those three parts (Risk Analysis, Risk Evaluation and Risk Control), you need to evaluate overall residual risk acceptability before you can move forward with the product. All of this would be bound together in a Risk Management Report that can be signed off by the appropriate stakeholders.
PTC, in order to implement this in their given solution for Windchill Requirements, Validation and Source, chose to create three new document domains called Hazard, Risk, and Risk Control Measure to handle the Risk Analysis, Risk Evaluation, and Risk Control steps respectively. The diagram below explains how each of the three new domains are traced to each other and how they can connect into the Requirements Management portion of the given solution.
As you can see, Hazards in the Hazard document are the result of the Risk Analysis step. These Hazards are traced via the “Caused By” trace relationship to Risk document. You perform your evaluation of each risk within the Risk document. Those risks that require mitigation are traced by the “Mitigated By” trace relationship to the Risk Control Measure document. These control measures are integrated into Requirement Specification, Design Specification, and Test Protocol via the “Implemented By” and “Verified/Validated By” trace relationships.
The PTC out-of-the-box risk management solution is a good starting point for most companies. SPK and Associates focuses on tailoring the Windchill RV&S architecture to meet your specific business needs. We’ve done this for several large and small medical device manufacturers. Call us today to implement/transform your risk management process leveraging Windchill RV&S.