The title ‘Design Risk Assessment in Six Sigma’ beckons to be likened with Poka Yoke or ‘Mistake Proofing’. But without going deeper into the comparison part of it, what we can say is that both of these don’t have any similarities whatsoever, even though Poka Yoke appears to be the next logical step of Design risk Assessment in Six Sigma.

So What Is Design Risk Assessment In Six Sigma?

As the name suggests, design risk analysis is the procedure to determine potential risks in designs and design processes. In Six Sigma, the assessment for design risks is not a ritual that is done at the end but it is an inherent step in the design process itself.  It begins from the point of conceptualizing designs where the evaluation exercise continues throughout the designing till the prototype is tested.

The design assessment for potential risks involves design simulation testing at steps including testing the detailed design and sub-assemblies (subroutines for software, etc) with a view to completely eliminate possible risks and cut down the shocks of design failures. For once, the design risk assessment in Six Sigma goes beyond the CTQ technique providing the design process the much needed broader evaluation.

Ensuring Reliability Of Design

The need for reliability of design can’t be overemphasized. The potential hazards of a faulty design extend beyond VOC and ROI parameters. Design risks can’t be overlooked even for service offerings even though manufacturing needs to take extra care of this aspect.

What ensures a systematic and rigorous scrutiny in the dependability of the design also allows capturing system-level hazards.

Design Risk Assessment Methodologies And Tools

PHA, ‘Preliminary Hazard Analysis’ is a qualitative assessment of hazards, constituents of the associated functional system and event successions that could potentially result in avoidable consequences. The study includes possible incidents and possible remedial actions. But significantly, this is a qualitative study whose efficacy is applicable only for initial studies.

DFMEA, an implementation methodology, serves as a quantified appraisal of the criticality of internal failures of CTQ & CTC together with performance components. The typical FMEA form may be used also for design assessments and transfers of know-how.

On the performance front, meeting customer expectations infers using CTC's, design parameters which assist meet all of the requirements. It also takes care of the manufacturability requirements. One might think of calling this CTQ.

The Need For Documentation

Results of risk analysis tests needs to be documented and then updated as the product or service moves in its cycle onto production phase, based on real time failure statistics, which serves as true risk-management and feedback document on design for future reference.

The most interesting application of the concept can be found in Bank of America’s assessment for credit products’ inherent risks which ultimately helped eliminate potential fraud elements.

There are multiple instances where FMEA has served as main mast in design and failure evaluation.