Risk assessment is a fundamental requirement for Quality Management Systems. Even though ISO 9001 has no regulatory requirement, organizations have a responsibility of identifying risks taking measures upon them, and would do well implementing ISO standards. In the past, risk thinking was based on reaction and correction measures only. Today, risk assessment procedures are built from a proactive perspective. Risk assessment has shown several benefits when integrated with the Quality Management System.
Reduced loss. The modern proactive approach of risk assessment has saved resources in an organization. Identifying risks in the QMS gives an opportunity of resolving them before they happen. Losses range from accidents, poor quality, lawsuits, to going out of business. Losses strain organization’s resources and assets.
Prevention is a key element in risk management. However, it should not be misunderstood or used to replace the risk assessment. Prevention efforts are complementary actions and part of the process. In situations where risk cannot be prevented, it should be accepted and controlled.
Enhanced products and services. The major reason for implementing risk assessment in QMS is to guarantee safety and other compliances. It would prevent ill health and accidents if products or services were substandard. Businesses have better chances of thriving if their commodities were associated with high-quality standards. Products and services are improved through a risk assessment process. In case there were problems or issues, they are resolved. Consumers may not know all the issues of quality, but risk assessment will eliminate challenges compromising quality.
Contingency measure. These action plans are critical in emergency situations. Organizations have found themselves experiencing unforeseen circumstances. They are part of the modern proactive approach of risk assessment. In case an event has occurred, the standard protocol should be followed. Sometimes these protocols are not practical. At this juncture, contingency plans are utilized. It is a brilliant idea to go an extra mile and formulate a ‘Plan B.’
Managing change. Change in an organization is normal; it will always happen. Changes could be in organizational processes, goods or services. When the change affects products or services, a risk assessment is needed. It will evaluate how the change will affect the quality or effectiveness of goods or services. Since change is inevitable, risk assessment helps to mitigate, avoid or accept hazards. Change related polices are not just important in addressing current issues, they are used in the future by avoiding recurrent problems.
Making policies. Organizations conduct risk assessments as a way of meeting legal requirements. The procedure will point out vital area concerning quality. As a step in addressing important matters in the QMS, policies need to be formulated. A risk assessment process will guide in formulating policies. For instance, the analysis will point out areas of improvement. Policies or principles governing QMS will entail improvement of the areas needed. The assessment will also inspire policies of mitigation and prevention.
The risk is a critical aspect that cannot be ignored. Considering its effect, management of risk is mandatory. Quality management systems cannot be effective without a risk assessment. These two processes should work together in delivering consumer expectations and legal requirements. Each organization should evaluate the most appropriate ways of integrating the two. Due to the changes happening in businesses and organizations, risk assessment and QMS processes need to be reviewed. Revisions and updates should be done every time changes happen. The two processes ought to be relevant and updated always.