I think it is important to look at risk from several different methods. My company uses a Risk Management Summary, Failure mode, effects and criticality analysis, Process Failure Mode Effects Analysis, and Design Failure Mode and Effect Analysis for our products. A combined view of all these quality system documents really help most engineers wrap their heads around what the main issue is and how it can be mitigated. Critical analysis examines potential product/service features against a list of critical factors, evaluates feature priorities, and helps determine what organization or internal function is responsible for the critical factors.

Hi,
I did some research and in my opinion the best way to address risks is pseudo-quantitative method is probably the risk matrix, which classifies the likelihood of a risk in one category and the consequences in another category. The combination of the likelihood and consequence categories corresponds to a risk level, usually a color such as red, orange, yellow, and green. A risk matrix is sometimes called a pseudo-quantitative method because the categories may be determined from numbers.

Irene Lloyd

Hi, I agree with Irene on using quantitative methods. I found a good research paper on using this method in medical devices. The research says that the method is widely used in pharmaceuticals but it goes over its benefits in devices.

https://www.clinicalkey.com/#!/content/journal/1-s2.0-S107663321400186X

- Lamiaa Abdelaziz

I agree with all of the methods mentioned but I believe the task analysis and error use analysis methodology is the best way to address usability risks. The task analysis helps to identify and document the environment in which the task is conducted, the operators involved, the information required to perform the task, and the sources of information.After the task analysis, the error use analysis is conducted.The use errors are generated by analytically determining what can go wrong from the user’s end when interacting with the system. Based on the probability of occurrence of user errors and hazards, hazard estimates are computed. I believe this new process seems the most systematic and thorough, therefor the best for addressing usability risks.To add, I believe another thing that could help reduce the usability risk is if risk management was a life cycle process. This would allow feedback and complaints from the user to be taken into account and then risk management could fix the product accordingly, after it has already been on the market.

As we all learned in risk management, Failure Modes and Effects Analysis (FMEA) and fault tree analysis (FTA) is a valuable tool used to evaluate errors in medical device designs. In my opinion if risk analysis evaluated earlier there is a chance where potential errors can be corrected or they can identify it later so they can correct the flaws or errors. These two are the best method in risk management.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/ucm119190.htm

When in research and development it is easy to overlook usability as a concern because you may be very familiar with the technology. You understand how everything should be done and why. However most people wont understand the science behind how it works. Aside from technical tools that are used to evaluate risk, I believe one of the most important things is simply perspective and not assuming people know what you know. Giving clear instructions on how to use something and getting the right message to the user is crucial, but first you need to identify what the message is that you need to get across most.

I believe that the Task Analysis and the Use Error analysis is a good way to asses product design risks. Older models tend to neglect the psychological aspects of the individual user. Also, traditional human factors methods only detect errors that just happen to occur during testing with no real systematic way of identifying or assessing use error. The Task Analysis and the Use Error analysis both prioritize the errors. After a rating session, inter-rater reliability is measured to ensure that it is reliable and trustworthy to use to analyze the assessment. TA-UEA can also be used in conjunction with FMECA to address use issues. This method moves risk management beyond treating the user as a causal agent of system failure and places a large focus on the process being analyzed. This usually helps in the risk analysis stage and is the most effective way to develop a successful product.

I believe that thorough documentation of failures and tests with attention to a variety of components would be the best way to analyze risk. Often times, failures due to one cause can indicate weaknesses in different parts of the design. By monitoring the reason for failure along with other aspects of the design, it is possible o improve the product holistically and make it safe for use.

My research into Task Analysis and Use Error Analysis seems that it is a good way to attempt to mitigate risk that stems from the actual handling and use of the products. IT involves breaking down the function into as many steps as possible and then identifying the risks at each step. This allows for the manufacturer to see exactly where risks might arise. The one major drawback is that no one can truly account for human error. You can design against it as much as you want but humans will find a way to mess it up. For that reasons other risk management strategies need to be employed. The TA-USE strategy should be included as one part of the risk management strategy, but there must be other parts as well.

If the risk has been deemed acceptable enough to reach the end user then I believe the best way to mitigate the risk is to have a scrupulously detailed Instructions For Use (IFU). Sometimes companies will have to determine if a risk has been addressed "As Far As Reasonably Practicable". If it has been agreed to have reached that point then the cost to modify the design of the product or the manufacturing process would probably outweigh the corresponding decrease in risk. The next best way to address the risk would be to warn the customer of the dangers of misuse through the IFU, and specify step-by-step procedures for how to correctly use the product. Especially in what's known as the contraindications section, this explains all of the detrimental possibilities of negligent use and when the customer should not be using the product. The problem is if there is a way to misuse the product, someone out there will do it, and so the IFU needs to cover the company legally by being extremely thorough.