When a Certified Quality Process Falls Short
Having a "certificate" does not guarantee the end product or service is fit-for-purpose. In order to ensure the quality of a deliverable you must qualify the vendor and oversee the product or service development.
Due to delays in the manufacturing process, a critical component for a new floating facility could not be delivered in time for delivery of the facility to the equipment owner. Therefore, the OEM offered to deliver the completed assembly once the facility was stationed on location just in time for operations to start. Pressed for time, the equipment owner and their client agreed to mobilize the facility incomplete to location and await delivery.
Given the OEM is one of the major suppliers in the industry, has a certified quality management system, and the end product would be delivered with all the necessary certification of compliance, neither the OEM nor the client considered introducing monitor and hold points during the last stages of product development.
Once the facility was on location, the OEM delivered the critical component as promised, along with all the required certification of compliance with industry and regulatory requirements. Both the equipment owner and their client were looking forward to a smooth startup on-time... However, this was not the case. Despite the product complied with all the necessary requirements and was developed under a certified quality management system, the component could not be placed in operation. Why? Because the weld areas on the pad eyes were too thick, preventing the alignment of the clevis connections required for the pins to be inserted. Thus, the critical component was found unfit for purpose, and being a forged custom product, the operation suffered millions of dollars in non-productive time as remedial actions were implemented until a new assembly could be procured.
Industry standards and regulatory requirements define the minimum operating baseline. A quality management system is supposed to establish operational goals and facilitates meeting those goals. If the goal and the quality process are focused solely on compliance with the bare minimum, there will be instances when operational requirements are unmet.
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