Tires, toys, and drugs

Once again China is being blamed for causing injury or death of Americans (and, in the latest case, others as well).

This time the culprit is "a contaminated blood thinner from China has been found in drug supplies in 11 countries, and federal officials said Monday [21 Apr 2008] they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the USA." Source: ProMED (

http://www.promedmail.org/), based on a New York Times' report (http://www.nytimes.com/2008/04/22/health/policy/22fda.html?ei=5070&en=325163ee977445d3&ex=1209528000&emc=eta1&pagewanted=all).

This blog entry is not so much against the apparent inadequacy of the Chinese government's inspection system as it is the equal inadequacy of U.S., and other, manufacturers to carefully inspect their vendors' products.

In the "olde days," when I was a young reporter in Titusville FL, I bought a Pentax H3v 35mm camera. Except it wasn't "exactly" a Pentax from Japan. It was a Honeywell Pentax. Honeywell was the U.S. distributor for the then well established product.

Why "Honeywell Pentax?" Because Honeywell quality assurance (QA) people inspected the incoming product. How thoroughly? I don't know. I suspect a random inspection based on the vendor's history. As an aside, I never had a problem with the H3v and gave it to a friend who gave it to a son-in-law (who probably gave it to my friend's grandchild). For all I know, the all-mechanical, no-features camera still is being used someplace in Florida.

Later I worked for a company that made valves, primarily for warships, everything from submersibles to nuclear-powered carriers. Leslie Controls had a number of vendors making all manner of parts, including O-rings. (You remember O-rings from the space shuttle disaster. That was not a Leslie O-ring.)

Leslie QA inspectors performed random sample testing on each O-ring shipment, as well as on all other vendors' products. How random depended on the vendor's history with Leslie. A new vendor might be subjected to a 50% inspection, 100% if the part was particularly critical. Granted it was non-destructive testing on all but perhaps a minimal quantity.

Bottom line: Honeywell sampled incoming product before putting its name on the product; Leslie likewise inspected all the components that went into its valve - and then inspected the valve as a unit. Leslie's customer then did its own random sample of the product - including the documentation, which is where I came into the picture.

If we lack the ability to control foreign manufacture, we must - there is no option - develop the capability to at least randomly sample incoming product and we must implement and enforce inspections of all products, including the innocuous such as toys and baby bottles, to pick two products at random.

Sampling won't solve all the problems, but it can greatly reduce our risk.

Sampling the end product is the end manufacturer's responsibility; it must begin by inspecting the component parts, regardless of their point of origin - China or Chinatown, Warsaw Poland or Warsaw Indiana.

John Glenn, MBCI, SRP Enterprise Risk Management/Business Continuity http://JohnGlennMBCI.com Planner @ JohnGlennMBCI.com