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I have been consulting with a medical device manufacturer over the past few months.  Their devices are currently manufactured in Silicon Valley, even though they buy parts and sub-assemblies from all over the world, including China.  The products are regulated by the US FDA, serialized and very carefully quality-controlled.

These devices are used to diagnose disease, and are considered precision instruments.  Parts are engineered with very close measurement tolerances.  There is little or no margin for error.  Parts vendors are qualified and then they are asked to produce samples which must pass inspection before an order is placed.

So it was with some surprise that a shipment of machined parts from a qualified Chinese vendor arrived with defects.  The holes drilled into the metal were too big for the screws that hold the part in place.  The entire shipment was rejected and sent back to the vendor with the expectation that new parts would be created and the old parts would be scrapped.  There was some flexibility in the production schedule, so this rejected lot wouldn’t impact deliveries to customers.

The Purchasing Department worked with the vendor to get the situation remedied.  The Purchasing Manager here in Silicon Valley (a Mandarin speaker) called the vendor in Dongguan to discuss the new schedule for replacement parts and emphasize the precision requirements.

When the replacement shipment arrived today (just after the start of Chinese New Year), the Manufacturing Engineers were anxious to get the parts to the production line.  When QA inspected the parts though, they were quite shocked.  The vendor, in a rush to get the parts shipped before the plant shut down for the New Year, had simply injected super glue into the screw holes and installed the screws!  I saw these parts and the super glue was quite visible.

Needless to say, the entire lot was once again rejected.

The periods before the US Christmas holidays as well as the period before Chinese New Years are times for concern over the quality of production.  When Chinese factories are in a rush to meet production schedules or to close for holidays, quality often suffers.  Mattel toys, you may recall, were finished with lead paint, primarily because it dries faster and the subcontractor needed to meet a demanding customer schedule for Christmas.

If you are doing business in China, be mindful the calendar and watch for defects around the holidays.

 

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One Comment

  1. Eeeeuuuwwww! I think you are VERY understanding of the quality control issues, Rosemary….
    It makes sense, the reasons you give for such carelessness(the holiday calendar), but what happened to the allegedly strong Asian pride-in-workmanship? Hmmmm…


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