I think it should go like this:
1) Hazards that fall into a low severity risk, are considered generally
acceptable and will not require further analysis.
2) The one with the medium severity should be looked over and find the problem and mitigate it.
3) Hazards that fall into a high severity risk, are generally unacceptable. If
hazards at these level cannot be further mitigated to the point of
falling into an acceptance zone (low or medium), a formal risk/ benefit analysis
shall be performed and documented.
I believe the following is what should be followed:
1) Low Severity Hazards: Should be mitigated but it can also be considered trivial or negligible, however it it is a common problem then it should be considered looked into because it could be considered a faulty design.
2) Intermediate Severity Hazards: Can be considered conditional and a company can take a risk on overlooking it, if it plans to take the risk and purchase a good insurance as a backup. However, in general a company should strive to mitigate it and conduct a risk analysis and be reviewed.
3) High Severity Hazards: Should be prevented entirely, medical devices with this type of hazard would not be approved because it would go against all engineering ethics.
Low Severity Hazards is considered a risk passable condition where it can be accepted, depending that it is not high occurencem, this is where a risk analysis must be considered to ensure that it does not pass the acceptable threshold.
In general, I agree with the above comments that state that lower risks can mostly reasonably be managed by using the strategies acceptance and/ or mitigation. This makes sense because if it is relatively low risk, the consumer most likely will not experience any ill effects and excessive mitigation attempts could cause excessive funds to be spent with little reward.This is in contrast to hazards that fall into high severity of risk which can mostly reasonably be managed by using the strategies transference and/ or avoidance. This makes sense because transferring a high severity of risk will pass responsibility off to a third party. This is always preferable in higher risk situations for liability reasons.
However, I would like to add that sometimes acceptance of higher severity of risk products can (but very rarely) fall under the acceptance/ mitigation categories as well. This can primarily be seen in the strong chemotherapy drugs used to treat cancer. Standing alone, these potent platinum drugs can easily kill a human being, however, doctors bet on the gamble that the cancer cells die before the patient is killed. This is an example of acceptance of risk because there is currently no better way to treat a guaranteed fatal condition.
For low severity I would rely on accepting the risk. Accepting the risk occurs when the price to pay for managing a type of risk is accepted due to the risk involved not adequate enough to warrant the added cost it will take to avoid that risk. This would be a good strategy to implement if it involves a very small risk.
Risk control involves avoiding the risk entirely or mitigation the risk. I prefer mitigation for high severity. This is achieved by lowering the probability of magnitude loss. Most of the time many risks cannot be avoided but most of the risks may be mitigated through the use of control. Even though mitigated risks may be minimized by control they can still be expensive.
Avoidance can be a safe bet as many manufactures can avoid manufacturing particular products to avoid legal risks.
Risk acceptance does not reduce any effects but can be used as a strategy. This is a wise option when the cost of risk management outweighs the cost of the risk itself.
When dealing with low severity risks it can be deemed worthy to accept the risk. By using the strategy of risk acceptance you can anticipate or adjust for greater profit margins and this should cover for the risks. Because the risks taken in this case are minor, the adjustments needed will also be non-consequential. However, if the severity of the risk is high, the strategy, transfer of risk, should be implemented. By anticipating for severe risks, the company can buy insurance on the product. This will ensure that if their product causes heavy financial burden on the company, they will be compensated. Risk mitigation does not do much to reduce the severity of the risk. If the risks are consequential, trying to limit its negative effect will only do so much. Rather at times if the risk is so great, no form of mitigation will do any good.
For high severity risk, I would use avoidance. I want to get rid of the high severity risk. The best way to do this is by avoidance because mitigation just lowers the risk of it happening, acceptance is just accepting it and transference still lets it happen. Avoidance and getting rid of the problem is the best solution when you know the consequence is high severity if it happens. For low severity risk, I would just lower the risk of it happening with mitigation. I don't think I would ever just accept a risk. At the bare minimum I would mitigate the risk. I don't like to give a problem to someone else so transference is also not really an option for me.
I think acceptance doesn't reduce the risk level out of these four and I would never use it. Again, at the bare minimum, I would at least mitigate the risk.
I believe risks should be handled differently depending on how critical the part of the device the risk is associated with. the most critical parts will likely be handled with acceptance or transference regardless of the risk level, unless the risk is too high, in which case the device probably too risky to make in the first place. for less critical parts of a device, mitigation or avoidance can be utilized as these components are less likely to be essential to the devices main function and can therefore be changed or omitted.
I agree with aaq2 in respect to mitigation being the best strategy for countering high severity risk. I do not agree with the fact that risk acceptance is wise option based off cost of acceptance being less than the cost of mitigation. Perhaps in the short term the cost of mitigation may be greater compared to risk acceptance, however in the medical device industry a high failure rate for a product can leave a stigma on a company and in the long run the avoidance strategy will cost potential new customers, as quality of the product won't be seen as comparable or better than others on the market.
To deal with the high severity of risk would be to assess the potential outcomes that could arise. If at all possible, I would prefer to avoid the risk. This can be established through protocols that aim to move around the risk completely. It is also worth mentioning that the severity may be high however if the occurrence is low then there is no need to accept the risk. I would propose to put methods in place to mitigate the issue if it were to arise in a case. An occurrence of risk adds a big factor when considering which plan of action is best suitable. Through risk management planning, the risks whether they are of high/low severity can be dealt with. Acceptance may not reduce the risk level out of the options listed above unless there is a plan in place to deal with the potential issues. Risk level shouldn't reduce. I believe that comes through the design protocols in place.
I take avoidance for the high severity and transference for the low severity. Prevention is always better than cure. So avoidance should be taken into consideration first. Every step should be keenly surveillanced and specific measures should be taken. It's all upto thinking out of the basket. However, some critical issues should be solved with proper analysis. Transference is the one we should taken as the lower severity thing. Acceptance is the one which does not reduce the risk level.
I dont think I would give any option low severity because in risk management everything is equally important. You can not have less acceptance while moderate high mitigation. But I would definitely give highest severity to transference. DUring anytime in the business, if there are any an earthly accidents, or non--earthly accidents or someone sued the company, insurance should always be there to cover the damage while company can just take the back seat, plan to get back in the game.
From low severity and for high severity of risk:-
1) Accept The Risk:- This is a good strategy to use for very small risks – risks that won’t have much of an impact on your project if they happen and could be easily dealt with if or when they arise. It could take a lot of time to put together an alternative risk management strategy or take action to deal with the risk, so it’s often a better use of your resources to do nothing for small risks.
2)Avoid The Risk:- You can also change your plans completely to avoid the risk. avoid risk This is a good strategy for when a risk has a potentially large impact on your project.
3) Transfer The Risk:- Transference is a risk management strategy that isn’t used very often and tends to be more common in projects where there are several parties. Essentially, you transfer the impact and management of the risk to someone else.
4) Mitigate The Risk :- Mitigating against a risk is probably the most commonly mitigation of risk used risk management technique. It’s also the easiest to understand and the easiest to implement. What mitigation means is that you limit the impact of a risk, so that if it does occur, the problem it creates is smaller and easier to fix.
5) Exploit The Risk:- Acceptance, avoidance, transference and mitigation are great to use when the risk has a negative impact on the project. But what if the risk has a positive impact? For example, the risk that the new washing machines are so popular that we don’t have enough Sales staff to do the demonstrations? That’s a positive risk – something that would have a benefit to the project and the company if it happened. In those cases, we want to maximize the chance that the risk happens, not stop it from happening or transfer the benefit to someone else! Exploitation is the risk management strategy to use in these situations. Look for ways to make the risk happen or for ways to increase the impact if it does.
I think that avoidance is of the lowest severity simply because the problem is not his, however depending on the drawback to that product function it can be a difficult decision to make. I think that the highest severity would be acceptance because if you would assume the same risk as you did the as you did with avoidance then depending on the product the decision can be just as difficult. However, the if something is dangerous enough to remove it is far more dangerous to ignore. I think that acceptance do not reduce the risk level.
One aspect of low severity risk that people need to understand is that no matter what it is going to occur. You try your hardest to avoid these situations with sampling an strong quality establishment but it is never going to be a 100% perfect situation. A product that is failing at a very low rate and is not damaging or hurting patients does not mean that the product needs to be altered or corrected. Those that occur with a high severity are the ones that are going to need the huge actions such as a recall. The companies that do not recall and allow other products from the same lot fail are the companies that wait too long to try fix the issue. A low severity risk that occurs rarely is not something that has to even truly warrant a response. A high severity issue needs a strong and fast response.
High severity means that the risk occurrence is frequent and is significant and is unacceptable because it has the potential to harm the patient using the device in some way. If the device does hard someone the company would most likely get sued and be responsible for paying more money out to the patient then they probably would have used to remove or fix the risk before putting the device out to market. Transference (the redirection to a substitute-typically hanging the risk off to a third party) or avoidance (not doing anything) would be used for a high severity risk Low severity means that the risk occurrence is intermediate to low and is not significant and is generally acceptable. Mitigation (the action of reducing the severity, seriousness, or painfulness of something) would be used for low severity risks.