Linking design reviews with FMEA to quickly mitigate the risk of change…design review based on failure modes

Deming was once quoted saying: “Hard work and best efforts will not by themselves dig us out of the pit.” “The New Economics” 1994 — Ch. 2 — The Heavy Losses —, page 23. It is equally true that hard work and best efforts will not always identify and mitigate the risks of product and process change. We must work together and create a company culture focused on engineering knowledge. The challenge for most companies is the divided responsibility for change (organizational silos) and lack of coordination. Examples abound: assembly processes are changed frequently (and for many reasons) and the manufacturing organization may or may not consider the product risk of those changes; purchasing decides to change a supplier to reduce cost but does not consider the product or process risk while making those decisions; and design makes a change and does not consider the impact to manufacturing, either internally or at the supplier. You can probably think of many other examples but they all add risk that must be mitigated to ensure the product meets customer expectations. Toyota is well known for Quality and Reliability of their products but even better known for their ability to address all risks associated with change. Toyota recognized they must identify the strength of engineering processes and eliminate the waste of redundant meetings (i.e., Technical Design Reviews and Design Failure Modes and Effects Analysis). They recognized the intended results of both were to identify and mitigate the risk of change based on engineering knowledge. Therefore, they linked them together to develop Design Review Based on Failure Modes (DRBFM). Design Review Based on Failure Modes (DRBFM) is a deep analysis process that focuses on engineering changes once a baseline design has been established. A key component of the DRBFM process is the emphasis on development of an organizational culture that is focused on meeting functional requirements and customer expectations. Supporting the engineer, both within and at all levels of the supply chain, is the foundation of the DRBFM methodology. DRBFM is an analytical process used to address design and process changes throughout the product development process, including running changes at launch and postproduction (up to product retirement). The basis of the process is the front-loading of the engineering efforts to clearly define the impact of change and eliminate the need for extended engineering activity due to decoupled and sequential processes. The DRBFM process is inclusive of all systems engineering activities that impact quality/reliability/durability (QRD), service, cost and delivery. The process links the analysis of the impacts to design, validation, service, and manufacturing (including suppliers). Since DRBFM is focused on change, the process fits either directly into the product development cycle, or within the change management process. Most manufacturers have well-defined systems engineering product development processes. DRBFM can add value to the product development process. There are multiple opportunities during the design cycle where DRBFM can be an essential tool and create a culture of focus and efficiency in product development processes, especially in the following scenarios: creation of a new design; use of a similar design for a new application; the modification of a current design; and changes to a design due to product failures. DRBFM is applied during change management when the entire enterprise is involved in business decisions. Companies with formal change management systems can include DRBFM to support or reject a proposed change as part of a technical change review process. DRBFM lends structure to a technical review because it occurs before resources are brought together for a change review board or change committee (change approver). It allows the engineer (change owner) and the engineering manager (change leader) to dig for hidden problems before a change review board makes a decision about implementing the change. Since the DRBFM scope is defined by change points, the change owner and change leader can be highly productive in a short amount of time.