I believe your post actually involves two different questions. You originally talked about project risks but then asked for an example of a product risk. Product risks refer to potential defects within the product itself. This could be something like designing a software that will need to continue to be updated after the product is initially launched. Project risks affect the schedule of developing a product. This is something that can be limited during the initial planning phase and can be directly addressed by using a spread sheet to list and manage all risks.
As it was mentioned in the lecture of this week, Risk management sometimes takes place after the deployment of the product. As a field application engineer, we write a FAR report based on eight disciplines problem-solving. D5, D6, and D7 which is verification of solution, corrective action, and preventive action. these three points have to be approved by upper management, PM of the product and sales representative. As it could affect the project planning. especially if these products for project qualification and corrective/preventive actions required adjustments for the mass production.
I have worked on a project where we had to design a system where we had to have all our lab equipment backed up to a encrypted server. Some of our challenges were the risks that came with having different equipment being accessible in the server. Our risk management was around user access and actually getting the software to integrate with the software we are using for the server. We eliminated the problem by using a third party software. There was a cost attached to it but we were able to have user privileges for the specific staff members we wanted and were able to get a daily back up of everything of all the data on the equipments.
An example for managing the risk for a medical device:
There is a medical device called "PEMF: Pulsed ElectroMagnetic Field", this device is being used for bone simulation (bone healing).
In terms of risk management, for example, risk of Toxicity, this could happen because PEMF stimulates cell metabolism functions. These functions include releasing toxins to be removed by your immune system. Cleansing crisis happens when the immune system becomes overloaded by detoxifying the body too fast and after measuring the risk, I found it is a high severity risk, in order to do Risk Mitigation, the patient should drink a large glass of water after each treatment to help the body flush the toxins.
So, now the severity of the measured risk reduced from high to low, to be accepted by QM.
Risk management is process of identifying, assessing, reducing and accepting risks. Efforts to avoid, mitigate and transfer risk can produce significant returns. In a project risk there is a compliance risk that can greatly effect causing significant cost of changing products and its process also legal structures due to change new laws and regulations. This risk can not be reduced to a great extent as the products it's processes and legal structures has be changed according to new laws and regulations. Identifying, assessing and then changing the process or products can migigate the risk and produce significant returns.
There are various risk comes associated with project management. Although, project risk the most understood one, product risk also play a tremendous impact in the feasibility of the project. Project risk involve such things as going over-budget, missing key milestones or deadlines, issues of resource availability, scope-creep, lack of support from higher management and so on. While product risk refers to a set of things that could go wrong with the service, software or whatever being produced by the project. In the same way that project risks are quantified (using likelihood and impact) product risks should also be categorized and measured. The main difference with a product risk is that it is normally, but not always, mitigated by appropriate testing (in contrast, a project risk cannot be mitigated by testing). There are many methods to address products risks, depending on the specificity of the risk itself. One method could be to test things to find out if there is anything wrong with them in order to eliminate or reduce the possibility that it will fail in production. Identifying and evaluating product risks for their relative probability and impact leads, during the earliest part of project and test planning, to a clearer picture of what needs to be tested and provides a means to help in determining the effort, skills and techniques required to achieve a product with minimal residual risk.
Risk management involves the identification, understand, control, and prevent failures that can result in hazards when people use medical devices. Risk analysis plays a key role in the development of medical devices. Risk management is necessary to ensure device usability, safety, and regulatory compliance. A risk -benefit analysis takes the probability of occurrence of harm and the consequences of that harm and justifies those based on the overall benefit of the medical device for the end user.
In the initial phases of my Senior Design project during my undergraduate degree, it was determined that Infra-Red LEDs (IREDs) were needed to illuminate the eyes of a subject for the device we were working on. They had been used before in a similar setting, but it was still important for us to design the device in a manner that would mitigate the risk as best as possible. First, we determined what the maximum safe power output of the IREDs was. Then we decided we should include a system for identifying if there were problems with the circuit. This was done by building the circuitry that provided power to the IREDs in such a way that the max output, even if ¾ of the lights failed and all of the current was going into one IRED, that the power output would be within safe limits. An LED was also added that would turn red if the circuit ever went into a fault of some sort. Eventually, it was discovered that the device could be used without the use of the IREDs, completely avoiding the risk. The process that we went through to ensure the device would be safe was a good way to understand how that process would work in the real world.
Working with the VA, I was required to predict any possible failed outcomes for the scripts I would write for data analysis. I had to be able to manage risk by identifying and verifying that all outputs of the script would display properly, are calculated correctly, and are exported under the correct variables to be published. Although the script may not necessarily be a product to be produced and sold, it is a tool that would be used in partnership for the verification of a possible product or study, therefore it is an essential piece in the project. Working with a team, I make sure to ask questions such as correct method of calculation, expected exported values, method of interpolation if needed, deadlines and any final changes that would expected. The importance of communication will address any possibility of risk in the future of the project.
When designing a medical device, poor selection of material can lead to a number of hazards or device failures. I am currently remediating a recall on an infusion pump that uses a low-quality internal plastic frame. This internal plastic frame was originally a high-quality plastic material but over the years the company downgraded the material in order to reduce production cost. As the company has already implemented, I would suggest managing this risk by means of avoidance. This can be accomplished by resorting to the original material used which posed no threat of failure. By replacing the frame with the higher-quality plastic material, the risk can be avoided.
A product risk related to medical devices would be something like improper execution of protocol. The purpose of protocol is to make sure there is proof of product production and that employees are aware of the process of manufacturing, cleaning, etc. If a technician, product assembler, or any other employee does not follow protocol as stated, it would raise concern about the state of the finished products and if they are able to be shipped out. I would use something like FMCEA, since it would consider the failure of not executing protocol and figuring out what the effect of it would cause in production.
