How to Identify Risk Controls in ISO 9001

Identifying and implementing risk controls could be a vital step in risk-based thinking for the ISO 9001 certification & Quality Management System (QMS). This blog is all about how to identify risk controls and its significance in ISO 9001 QMS. We have the tendency to check the necessity to assess how important risk is before deciding controls. With every risk you have pinpointed, you may have to be compelled to assess the severity of the issue or problem and making sure how likely the risk will happen again. You furthermore may have to combine this with the assessment of how seemingly the problem is to occur and whether or not it's possible to notice the problem. By combining the numbers assigned to those properties you get the risk priority number (RPN) from the Failure Modes and Effects Analysis (FMEA). This will assist you to systematically verify the importance of every risk you have identified for your ISO 9001 Quality Management System.

To make risk-based thinking work for your organization or company, you will need to create your risk controls match your risk significantly.

Six risk controls for a standard management structure

After crucially determining that risks are important, what does one do? You may need to work out what controls to devise in place for every risk. However, how does one do this? The key is to use the risk significance to determine what level of control and management is required. This can be most likely best understood as a standard control structure that uses six ways to manage risks. Below are the six risk methods, explained within the context of the ISO certification for Quality Management System risk assessment:

Retaining risk by the sophisticated decision:

For insignificant risks, generally, the most effective strategy is to simply settle for the risk and proceed. If that issue or risk have a very low probability of happening or if it isn't severe that it will occur again, then choosing to merely react to the problem will be the most effective call that you could ever come up with. This could be the case when a potential avoidance measure is just too time-consuming or expensive to be worth the resources it might take to implement.

Avoiding risk:

For significant risks, you will have to value more highly to take action to hinder the risk from happening, or in other words: modify the possibility of occurrence of those risks. This might be enhancement in the existing process or replacing existing instruments or equipment with much better equipment, or dynamic style of approach to get rid of those parts that are inflicting the risks. The secret is that when the risk control actions are completed, the risk will no longer be existing.

Eliminating the source of risks:

One efficient technique of avoiding the risk is to eliminate the risk source. This could involve implementing modifications to the parts employed in an assembly or removing a process step that's risky and replacing it with one that doesn't have the chance for any kinds of risk.

Sharing the risk:

Typically, you should be able to transfer a risk elsewhere, corresponding to implementing a process carried out by the skilled supplier or professional instead of doing it yourself. One other different way of transferring risk is through having insurance in house that will offer the required additional resources to cope up with the persisting problem or issue if it happens.

Changing the probability of risk consequences:

Setting up administrative training, controls and regular or periodic inspections can effectively and efficiently mitigate the probability of the risk occurrence. This ensures that you will stop the risk from happening, but you are effectively enhancing the possibilities of identifying the risk when it happens. This mitigation typically includes devising contingency plans in the house to take care of the implications of the risk once the issue has occurred. These plans will embrace such things as remodelling product or procedures to modify a process to an orthodox state. If the risk still exists, now you have got actions and plans to cut back the possibility of risk consequences.

Taking the risk to pursue an opportunity:

We have often mentioned about risks in terms of having a negative consequence, but what if taking a risk turns out to be an opportunity for your organization or company? In these kinds of situations, you're assessing the risk in terms of betterment of your organization which in turn you're just maximizing the opportunities and taking action to create it and make it happen. When you accomplish this effectively, you're exploiting the risks so as to get benefitted by actions in the long run of your organization.