Risk Assessment

Risk assessment is the practice of identifying risks and determining their consequences should a risk occur. Risk assessment looks at the possible risks, the likelihood of their occurrence, and the tolerance for these risks. The results of risk assessment can be quantitative or qualitative, and it has become essential to have efficient tools and approaches for risk assessment in light of strict regulatory requirements.  

To be more precise, risk assessment is the practice of identifying and analyzing potential events that could negatively affect people, property, or the environment. It also makes judgments "on the tolerability of the risk on the basis of a risk analysis" while considering influencing factors.  

Where can risk assessment fit in? 

The processes listed below can be used to assess risks and determine the extent to which preventive measures or solutions can be implemented. The use of assessment at this stage will help to make the process less complicated and less expensive to implement. The essence of this activity is to examine the risks that might arise in a given scenario and develop an action plan, which might range from avoiding the risk to accepting it or attempting to mitigate it. 

Here are a few processes where risk assessment could be helpful: 

• Quality Management System Planning: Where are the risks in your processes? What risks arise when making changes to the processes? What resources are required to address the risks?  

• Planning of Product/Service Realization: When are we planning to deliver the produced goods? Have we identified the potential risk points in our process? Do we have any strategies for dealing with potential issues?  

• Review of Requirements for Product/Service: Are there any chances that we will be able to comply with the specifications of the product or the service? Is there any innovative product that exceeds our capabilities or knowledge? Is there a modern technology that we are going to adopt to comply with the requirements that we have in achieving our targets?  

• Design: Which fields in design are risky regarding compliance with the requirements? What risks are involved in changing the design? How are we sure that we will be able to fight non-compliance with product or service specifications?  

• Purchasing: What are the risks of introducing a new supplier into our chain? What needs to be done to resolve any issue that might arise when the supplier is commissioned for the first time?  

• Control of Product and Service Provision: Do we have control over the most risky parts of our product development process? If we've established a set of post-sale processes, have we engineered them to cover the areas identified by the risk assessment that could go wrong? 

• Measurement, Analysis and Improvement: Are we sure that we focus on measurement and analysis of the most risky parts of the processes instead of opting for parts of the process that are easier to measure? Are we targeting improvements in the riskiest areas of the processes?  

• Internal Audit: Are the more risky processes being audited more frequently? Are the risks being accounted for during the audit? When we received a report on non-compliance, were we able to spot a risk our assessment did not show us? 

• Non-Conforming Product: When making a decision about how to manage non-compliant product, do you consider the risks related to that decision? This is often true when we accept a product, but do we also consider the risks associated with its rework? 

• Corrective Action/Preventive Action: Preventive Action is a way to reduce the risks because, in this case, we have identified the risk and decided to implement some measures. However, do we consider the risks associated with implementing planned corrective or preventive measures to avoid them?