Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or prefer to use and why?
FMEA is ideally used for risk management as it gives an idea as to where and how the product might fail and what impact each of the failures will cause on the overall project.
Also, rate each risk according to its occurrence and identify the tests that could be conducted to avoid them.
We used FMEA in our company when we were trying to create a design and materials for our Fundus camera.
In my experience, FMEA has been the most beneficial tool to use for risk management. Every product in my company has a D(esign)FMEA and a P(rocess)FMEA associated with it to document which failure modes were considered, when their risk index is, and what mitigations were put in place to keep the failure mode from occurring. There are other tools that are useful when conducting a failure analysis or root cause analysis, such as a fishbone diagram or "the 5 why's". A fishbone diagram analyzes cause and effect based on major categories that may have caused the problem (e.g. Manpower, Measurement, Materials, Methods, Environment, Machines). The "5 why's" method looks into cause and effect of the problem to 5 causes back (e.g. I was late for work because I overslept because my alarm didn't go off because my clock was reset because the power went out because I forgot to pay the power bill).
In my experience we tend to use FMEAs more. We use them as described by Dr. Simon in his lectures and also for determining risk in non-conformances. When we have process deviations we use the FMEA format to list all the failure modes, occurrence, cause, severities, and controls. We list out additional actions to take. Additional actions for non conformances can be additional sampling and testing to lower the risk. If the executed actions show that the risk of something occurring is low then we adjust the occurrence and accept the non conformance as is.
I'm not sure if other companies use FMEAS in a similar manner for non-conformances.
I have used many of the tools mentioned including brainstorming, fish bone diagrams and FMEA. i think it is important to know when to use them in the right situation. For example if you are doing it to resolve a product issue when it is in the market, surveys and interviews with marketing, customers might be a good start, followed up with the fish bone diagram outlining potential areas and then a deep dive with FMEA. If you are doing a prospective analysis of a new product, brainstorming with a diverse group of internal engineers and production, QA folks may be more appropriate.
I will say having used FMEAs a lot, they do take a lot of effort and time with the right people. Need to plan properly before jumping into it.
There are many tools and techniques for Risk identification. Documentation Reviews
- Information gathering techniques
- Brainstorming
- Delphi technique – here a facilitator distributes a questionnaire to experts, responses are summarized (anonymously) & re-circulated among the experts for comments. This technique is used to achieve a consensus of experts and helps to receive unbiased data, ensuring that no one person will have undue influence on the outcome
Some of the basic tools used are
1. SWIFT Analysis - Standing for “Structured What-If Technique” where the project members apply a systematic, team-based approach in proposal environment, where the team investigates how changes from an approved design, or plan, may affect a project through a series of “What if” considerations. This technique is particularly useful in evaluating the viability of Opportunity Risks.
2. Probability matrix - It is a method for establishing severity of risk in Qualitative Risk Analysis. It is Risk Matrix providing a practical means of ranking the overall severity of a risk by multiplying the likelihood of risk occurrence against the impact of the risk, if it occurs.
These techniques provide a practical approach to analyse probability and severity of risk.
I have mainly used FMEA. Because, it is a proactive tool, technique and quality method that enables the identification and prevention of process or product errors before they occur. Here are the benefits of FMEA:
- Captures the collective knowledge of a team
- Improves the quality, reliability, and safety of the process
- A logical, structured process for identifying process areas of concern
- Reduces process development time, cost
- Documents and tracks risk reduction activities
- Helps to identify critical-to-quality characteristics
- Provides historical records; establishes a baseline
- Helps increase customer satisfaction and safety
I have also used the fishbone diagram. A fishbone diagram helps you to find the cause of the problem. It gives you a comprehensive list of causes to find the root of the problem. This tool provides you with a better understanding of the problem and makes sure you don’t just partially solve a problem. The fishbone diagram considers all possible causes of a problem, instead of focusing on the obvious one, and groups causes to identify the source of the variation.
Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or prefer to use and why?
I think it really depends on what you're trying to accomplish. I've used all three that you have mentioned; FMEA, Brainstorming, and Fish Bone Diagram.
- FMEA is a great general risk reference. The analysis on risk has already been done for you when you're looking at the FMEA.
- Brainstorming is a great tool for figuring out potential causes of an issue as well as figuring out what potential risks may be present
- Fish Bone Diagram is a wonderful tool to identify where a specific problem has occurred.
I find each one beneficial for different purposes
Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or prefer to use and why?
On my personal experience, the brainstorming , FMEA and Fish borne diagram are all important but To begin the brainstorming process, you must assess the risks that could impact our project. This starts with reviewing the project documentation, looking over historic data and lessons learned from similar projects, reading over articles and organizational process assets. Anything that can provide insight into issues that might occur during the execution of the project. Once you’ve done your research, start brainstorming with anyone who might have insight.
When thinking back upon my previous projects from academia, I realize my project teams always followed the same process when performing risk management. We would initially get together as a team and have a brainstorming session in order to list as many potential risks as possible. Sometimes we would have two or even three brainstorming sessions to ensure we maximized the list of potential risks regarding each project. Brainstorming was essential for our risk management process because it quickly provided our team with a large list of risks that we would need to analyze. Next, we would create a risk matrix for each of the risks that were previously brainstormed and categorize them from low to high risk. We would then analyze each risk by creating a FMEA table to officially determine the severity, probability, and actual cause of each risk. Moving forward, I would probably include a fish-bone diagram in order to provide a strong root cause analysis. In my opinion, each of the risk management tools discussed are important for a project. I think it is most important to apply two or three of these tools to a project to diversify the analysis of risk.
My opinion based on my experience at Duyar Vana company in Istanbul, Turkey, I worked at the manufacturing department. The company uses both Failure Mode Effects Analysis (FMEA) and Fish Bone Diagram to do risk analysis. As an engineer at manufacturing section, I have noticed the fishbone diagram was easier to analyze the risks and to see the whole view in a single page. However the head department uses relies on FMEA to analyze the risks. So, I think each methods has different aspects to handle, it depends on who is going to deal with methods.
I would say FMEA is the most effective method to identify the risks. It clearly shows the risks and the impact of risks on the project where you can come across solutions to overcome that. Many companies use FMEA in various stages of the projects to identify the risks associated with it. The fishbone diagram also provides the risk analysis in a single glance as everything is present in one place. This helps to track down the variations, defects, or failures. It helps in analyzing the root cause of the failures. Both the FMEA and fishbone diagrams are the most important risk management tools used by any of the companies in various projects.
I have not personally participated in the FMEA process, but normally in my company that works on the biologics FMEA process happens under upper management supervision. However, the process of FMEA starts with my team getting together in a group and assessing the risks of the project of interest. Then categorize the level of risk and explore options to mitigate the risks taken or explore alternate ways to avoid that risk completely if possible, then those data get delivered to upper management to start the FMEA process.
When performing the Risk Assessment of a new medical device, I think all three tools serve a purpose and can potentially identify risks that the other do not. I also believe that each tool can be used in different stages. For instance, one can brainstorm, use diagrams, questionnaire, etc. at the initial stages of the project; kind of just throwing ideas. Diagrams and questionnaire seem to be more of a team task when you can have input from multiple people, therefore identifying more risks that one person can. Lastly and also agreeing with @mg482, the DFMEA is a more concrete tool that identifies more technical risks and therefore is done by people who have more experience and have perhaps dealt with risk management in the past. Although, it can be done by all members of the team, each tool can be more useful in group or single individual scenarios.
