Organizations plan its processes and their interactions when they use the process approach. ISO9001:2015 Quality Management systems-Requirements states “The process approach involves the systematic definitions and management of processes, and their interactions, so as to achieve the intended results….and can be achieved using the PDCA cycle with an overall focus on risk-based thinking aimed at…..and preventing undesirable results.”
To conform to this International standard, “an organization needs to plan and implement actions to address risks and opportunities,….establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.”
Although there is no requirement (stated in this Standard) for formal methods for risk management or a documented risk management process, Organizations can and should decide whether or not to develop a more extensive risk management methodology than is required by this International Standard.
One such methodology or technique of risk-based analysis is the potential Failure Mode and Effects Analysis (FMEA). This technique was first used in the aerospace industry in the mid-1960s because the effect of a failure is too severe and costly to bear as human lives are at stake. Later, this technique was also used in the automotive industry.
Studies have shown that using the FMEA as a disciplined technique to identify and eliminate potential concerns is as important as ever, especially when the consequence of a failure is severe and catastrophic in nature. To be effective in using this technique, a team of knowledgeable individuals should be assembled (those with expertise in various functions) to take on this responsibility to prevent problems. One of the most important factors for the successful implementation of a FMEA program is timeliness, i.e. it is meant to be a “before-the-event” action, not an “after-the-fact” exercise.