When a product fails sometimes the reason for the failure is obvious. Other times the true root cause of the problem can be complicated. Whatever the case may be, it is important to perform a thorough failure analysis.
In order to conduct a root cause analysis, it is important to understand the design process itself. The design of a product requires the development of design specifications. In addition, determining the product's manufacturing specifications is important as well.
A few of the choices that have to be made include:
- How the product will be used in the market place
- The materials used in the product itself
- To fabricate or procure key components
- Where to manufacture the product
- The lifetime of the product
These choices just scratch the surface and indicate a lot of thought has to go into the design process. A product can fail any number of ways, but those failures are typically grouped into a design defect, manufacturing defect, or a failure to warn (labeling issue). Certainly, these categories apply to litigation, but they also apply the determination of the root cause. For example, any number of questions come to mind that relate to design or manufacturing defects.
- Was the right material selected?
- Did the manufacturer use the right material?
- Was the product structurally strong enough to handle the loads it experienced?
- Did the manufacturing process create a defect in the part?
- Do the procured parts meet the design and procurement specifications?
- Should the quality control process have caught the bad component?
- Was the part used in the manner intended? Or was it used in an unexpected way?
No matter the cause or failure mechanism, the engineering team at Envista has the experience to make that determination.
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