In the world of quality management systems (QMS), the nature of the relationship between risk management and preventive actions is often confused and misunderstood. Indeed, some believe that a thorough risk assessment process replaces the need for preventive action.

In fact, risk management and preventive action are sequential, complementary elements that are essential to the QMS. The effectiveness of any preventive action depends on the extent to which the action addresses the root causes identified by the risk assessment. Therefore, the success of the risk assessment process depends on the extent to which it identifies root cause issues. When all root cause issues have been identified, it is possible to examine the proposed preventive actions to determine if all elements of risk have been satisfactorily addressed.

Risk assessment of changes to a QMS

All of the elements described in an ISO 9001-compliant QMS can benefit from a risk assessment evaluation. Let’s examine some of these elements from the risk management perspective.

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