THE KEY TO ASSURING A SAFE PRODUCT

 

Dr. E. F. "Bud" Gookins

 

 

Posted with Permission from the Author



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Management of many companies view product liability prevention as just another quality fad, or engineering initiative, designed to add more unnecessary people to the company and generate more paperwork. Indeed, it is understandable that no company's executive management should increase their indirect labor force, or add more work functions, if it is not necessary. But to mandate a decision without fully recognizing the risk that might be involved could expose the organization to financial destruction.

A recent survey by Strategic Quality Consulting, a quality management consultation firm located in Cleveland, showed that only 28 manufacturers out of 89 ( 32%) had a basic PFMEA (Process Failure Mode and Effect Analysis) as the extent of their product liability prevention initiative. And only 9 of the 89 ( 10%) had a formal product liability prevention activity. All nine companies having a full-fledged system were auto or aerospace manufacturers. These statistics are alarming considering today's exposure to the product liability risk of a potential product malfunction and the resultant litigation process. Incidentally, 

But the question then becomes: "How much is needed beyond the basic Process FMEA in order to qualify as having an acceptable product safety initiative?" 

Products can be hazardous because of intrinsic properties, manufacturing defects or design defects.

With respect to intrinsic properties, I suggest that no product is completely safe. A product may be made with virtually all the characteristic inhibitors to maximize safety features, and still exhibit hazardously destructive properties. Many consumer products have caused injuries because of their intrinsic hazardous properties; not because they were inadequately made from a process or design standpoint, and not because they had failed, but because of the application for potential harm. We can cite as examples a misused nail gun, a pocketknife, or a power tool that was misused. These examples illustrate misuse or abuse of the product.

These three defect factors (intrinsic, manufacturing, or design)  all can contribute to potential failure of application, which may cause unsafe conditions to the user of the product or result in limiting the life of the product's usability. Therefore, it is critical that all three of these defect factors be addressed and well documented prior to the release of the product to the end user. Essentially the key to assuring a safe product, and not having to go to court to defend against a product failure is to be cognizant of the conditions and environment in which the product might be exposed and to eliminate the possibility of potentially harmful situations.

The salient factors to be cognizant of are:

  • Always be aware of foreseeable and unforeseeable harmful events and eliminate those events.
  • Always be aware of reasonable and unreasonable harmful situations and eliminate those conditions.
  • Always be aware of abuse and misuse by the user and eliminate those conditions.

A formalized product safety initiative is an investment that no organization can just simply ignore today if they want to reduce or eliminate the possibility of being exposed to product litigation.

"Be a safe manufacturer by manufacturing a safe product."

About the Author

Dr. Bud Gookins is President and Managing Partner of Strategic Quality Consulting, a quality systems and management consulting company. He has held top executive positions in small and medium sized manufacturing companies, led Corporate Quality for Fortune 100 companies and serves on the board of several companies. Bud holds numerous certifications and is an internationally acclaimed, award-winning expert and author in areas of quality systems, quality control and product liability.

 

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