It is true that the changes are effected by experienced Six Sigma professionals such as Black Belts and Master Black Belts, but this does not guarantee the success of such alterations because each business process is unique and is affected by numerous variable factors that are hard to define. This is why it becomes necessary to conduct a design risk assessment prior to actual implementations to assess whether a suggested change or alteration will produce the desired results or not. Why To Conduct A Design Risk Assessment? Conducting a design risk assessment becomes all the more necessary when a completely new business process is being designed and developed for manufacturing a product or for rendering a service. For ensuring the success of a proposed design, it is also necessary to conduct the assessments for all the various sub-parts of the design, no matter how small or irrelevant they might look. This is important because even a seemingly small flaw in the proposed design can have a disastrous affect on the outcome. If a design is implemented without conducting the assessments, chances are high that problems will start surfacing during the implementation process. This can seriously affect the existing efficiency and can even lead to redundancies that can adversely affect the finances of the organization. For achieving desired and timely results, it is thus important to conduct a design risk assessment prior to the actual implementations. Tools And Methodologies Utilized For Design Risk Assessments One of the most commonly utilized tools is PHA (Preliminary Hazard Analysis), which helps in quantitative assessment of potential risks. It allows Six Sigma professionals to point out the potential risks that can be avoided just by making small changes in the existing design. This tool however has limited use, as it cannot be used for predicting risks that can emerge during the implementation stages. DFMEA (Design Failure Mode and Effects Analysis) is a popular design risk assessment methodology that is used for measuring the criticality of factors affecting the CTQ (critical to quality) and CTC (critical to customers). The standard FMEA (Failure Mode and Effects Analysis) can also be utilized for conducting design risk assessments. Data or results generated through design risk assessment tools and methodologies are then documented and stored for future referrals. They are utilized in combination with inputs provided by employees, senior managers, and Six Sigma professionals for effecting changes in the proposed design. Thus, we see that design risk assessments help in maintaining the integrity of proposed designs by allowing organizations to make the right alterations at the right time. Implementing Six Sigma projects without conducting design risk assessments will be like betting top dollar on a lame horse.
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