Master Black Belts and Black Belts can bring about changes in design, but cannot guarantee the success of the changes. Each unique process can be affected adversely – or otherwise – due to the changes brought about, and team leaders can predict them when they design the product or process.

A design risk assessment is imperative before implementing the change in any product or process.

What Is Design Risk Assessment?

Design Risk Assessment is determining the risk potential of a changed design. It becomes even more significant when an entirely new process is developed. Even the sub-processes of the design should be assessed to ensure that the change is successful.

Even a small defect can be disastrous on the outcome of the new design. An assessment of the design from conceptualizing to the actual designing phase has to be done. This involves simulation tests of the different designs and sub-processes of the project. If a design is implemented without conducting the assessments, problems may surface in the implementation. This can have a bad effect on other related processes and designs. It can even make the process design redundant and affect the overall project finances and the efforts made on the product and process design.

Design risks are not limited to any one sector; manufacturing as well as service sector projects need to carry out timely assessments. A systematic and meticulous examination also captures system level hazards. The risk is not limited to non-conformity to the voice of the customer and CTQ factor.

Tools for Design Risk Assessment

One of the most common tools used for assessment is the Preliminary Hazard Analysis (PHA), which is used for qualitative assessment of risks. It allows the Six Sigma team to identify the risk so that it is avoided by making small changes in the design. However, the utility of this tool is limited, as the risks arising in the implementation stages may not be predicted.

Another useful tool is the Design Failure Mode and Effects Analysis (DFMEA) tool; it is used for measuring the criticality of factors that affect the CTQ and CTC. The FMEA tool can also be utilized for undertaking Design Risk Assessment.

Documentation Is Necessary

The results of such Design Risk Assessment tools are documented and stored for reference in the future. Additional input from the employees, managers, Six Sigma professionals and the data collected are assessed to effect any changes in the proposed design. The changes in the design, if well documented, will be useful in the control or verify phases.

Thus, Design Risk Assessment is useful in maintaining the reliability of the planned designs. With a timely understanding of the risks, the right changes can be made at the right time. Project implementation without assessment will surely lead to failure of the project to achieve its goal on implementation. It should be made an integral step in the design phase.

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