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With the new edition of the ISO 9001 certification standard's necessities for building an impeccable Quality Management System (QMS), the new idea of risk based thinking has brought to surface with some inarticulate ways to implement this new updated ISO certification needs and requirements. Whereas some organizations were already employing a SWOT analysis (strength, weakness, opportunity, threat) on their organization to assist them to pinpoint or identify risks in all areas. However, this method of analysis is not decisive and provide sufficient data on how to address these risks once they're identified. So, how does one assess the significance of the risk once it is recognized what it is?
When you to know how to addresses the ISO 9001 risks and opportunities, the ISO 9001 QMS standard's necessities will need you to determine risks, plan your reaction to it, integrate it into this ISO certification system and assess its efficacy. In order to make sure the effectiveness of the implemented process or method you need from your risk response, there is one way you may need to do as a part of planning your response: Determine how significant your risk is. In other words, how vital is the risk?
For people who perceive the Failure Modes and Effects Analysis (FMEA) method, you may be accustomed to the actual fact that there are many things to contemplate when deciding what risk is, its severity of incidence, chances of occurrence and chance of detection. The possibility of detection is influenced by the controls you set in your organization, that has not however been discussion to mitigate his severity and recurrence. The severity and likelihood of incidence, however, are the 2 things you may want to think about while assessing the significance of the risks.
It is significant to contemplate how dangerous the potential risks can be (severity), considering the fact that how likely it is that the issues or problems can happen (probability). If a risk could cause a problem that you just suppose can have radical consequences, and also the probability of the risk happening is extremely feasible, then this can be a significant risk that you just will need to do some essential actions or measures regarding this. On the contrary, if you have identified a risk which will cause a minor inconvenience, and isn't likely to happen, then perhaps this can be a risk that you simply can prefer to do nothing to forestall and just react without any complication in order to mitigate the severity and probability of recurrence.
After sorting out or determining the potential risk in ISO 9001 quality management system, what does one do next? You may have to be compelled to expand your consideration about each and every risk. If the risk in your organization is capable of causing more one problem at a time for you, and have a probability of happening is 50-50, then you may have to be compelled to assess what you will do to overcome those risks. To simply put: what controls or plan you should set up in your organization. Keep in mind that you simply may prefer to do nothing if the importance of the risk does not impose adverse threat or action on your organization's overall process. Determining how significant the risk is, or how it will have an effect on your organization, should be the very first thing you would like to do before deciding how you are going to react.
So, what criteria does one use to assess the severity and probability? What assessment criteria you decide on is not as vital as keeping your criteria consistent. You will be able to prefer to assess every component with ranging between low-medium-high or 1 to 5 point scale or whichever ranking method that works best for you. What is vital is that a consistent ranking criterion which will assist you to form consistent decisions regarding what is really important and what is not. This way, you may only control what is vital for you to manage.
While the FMEA method will try to assess all different types of risks by assigning numbers to the severity, likelihood and detection using a 10-point scale. However, this is often not necessary in the ISO 9001 QMS certification. It is adequate for you to work out how significant the risk is and so determine what kind of risk controls are necessary for you to deal with it to a degree wherever the risk threat is at an appropriate level for your organization. So, use your risk significance assessment to avoid going overboard along with your risk controls.