People often ask for examples of benefits from implementing ISO 9001-compliant quality management systems (QMS). Such examples are often difficult to provide, at least in terms of immediate results. The reason is that the effects of ISO 9001 and its automotive counterpart ISO/TS 16949 are largely preventive, which means they are most conspicuous through their absence.
An ancient Chinese story about three doctors is highly instructive. Three brothers were doctors. The youngest used heroic methods to cure serious illnesses—much like manufacturing professionals who fix serious production and quality problems. His name was known throughout the realm. The middle brother cured illnesses in their early stages, so his name was not known beyond his village. The eldest brother prevented the diseases. Nobody knew his name.
This also is true of ISO 9001: When it is in place and functioning properly, the organization takes it for granted and it soon becomes unnoticeable.
Tubecon, a South African tubing company, says this explicitly: “When standards are absent, it is soon noticed!” The company also uses the phrase, “Invisible when present, visible when absent,” which was how I found the company on Google. I was trying to find quotes that exemplify “visible when absent,” and Tubecon came up on the first page of the results.
Jim Mroz in his article, “A Riveting Tale of Nonconformances” (Quality Digest, April 1998), that, had the Titanic’s builder and suppliers been ISO 9001-compliant, the ship might have survived its encounter with the iceberg. The wrought-iron rivets that held the hull plates together had up to 9 percent slag vs. the standard 2 percent, which may have aggravated the damage to the ship’s hull. An ISO 9001-compliant quality system would not have allowed nonconforming rivets to reach a customer, and an ISO 9001-compliant purchasing system would have ensured that nonconforming rivets were not accepted.
ISO 9001 did not, of course, exist in 1909, when Titanic’s construction began, although registrar Det Norske Veritas (DNV) was actually founded in 1864. Its mission at the time was to assess the technical condition of Norwegian merchant vessels, and it is still a leading authority in the maritime industry. Had the White Star Line used DNV’s services, few people today would even know the name of the Titanic, much less make movies about the ship. As matters stand, however, far more people know about the Carpathia, the ship that rescued the Titanic’s survivors, than about DNV. This reinforces the lesson of the three Chinese doctors: the one who prevents the trouble remains largely unknown, while the one who saves the patient from a preventable disease becomes famous.
Quality Digest readers are extensively familiar with the poor service of the airline industries, whether through personal experience, news reports, or H. James Harrington’s “Lost in the Service Quality Void,” which appeared in the November 2005 issue of Quality Digest. The latter drew a response from American Airlines’ CEO Gerard Arpey that said, in part, “We carry about a quarter of a million people every day, and, inevitably, there will be mistakes that impact our customers.” A magazine for quality professionals is not the right place to say that mistakes are inevitable, and Arpey’s failure to so much as mention a closed-loop corrective action response for the problems that Harrington reported suggests that American could never satisfy provision 8.5.2 (Corrective Action) of ISO 9001. I have in fact not been able to identify any domestic airline company that is registered to the standard, although several foreign ones are.
Design, process, and service failure mode effects analysis (FMEAs) support provisions 7.3 (Design) and 7.5 (Production and Service) of ISO 9001:2008, and the absence of FMEA is emphatically conspicuous in the airline industry. A year or so after Arpey told Quality Digest’s readers that mistakes are inevitable, his company stranded passengers on a runway for more than eight hours. In the Jan. 6, 2007, issue of The Wall Street Journal, Scott McCartney wrote in his article, “Runway-Bound: A Holiday Flight Becomes Ugly”:
“After hours of sitting on the runway, the toilets on the American Airlines jet were overflowing. There was no water to be found and no food except for a box of pretzel bags. After more than eight hours on the ground, and 12 hours after the plane had left San Francisco, the captain told passengers he was going to an empty gate, even though he didn’t have permission.”
Lack of water and overflowing toilets are direct menaces to human health and safety, which qualifies this situation for a severity rating of 9 on the FMEA’s standard 1 to 10 scale. (A plane crash would qualify for a 10.) Northwest had similarly stranded passengers several years earlier, but it’s obvious that American did not react to Northwest’s experience with a corrective and preventive action (CAPA) process. Subsequent identical incidents, meanwhile, show that American’s and Northwest’s domestic competitors took no corrective or preventive action either.
The absence of ISO 9001-compliant quality systems is therefore very conspicuous in this industry, and the development of online conferencing technology will hopefully provide businesses with a way to dispense with the airlines’ so-called services.
The United States spends about $2.5 trillion annually on health care. In a December 2005 article for Quality Digest, “Taking the QMS Cure,” I wrote that 30 to 60 percent of that is wasted on the costs of poor quality. The Journal of the American Medical Association (JAMA) conservatively puts the costs at 20 percent. This includes the cost of malpractice, and fatal medical mistakes such as the attachment of a feeding tube to an intravenous line; see “U.S. Inaction Lets Look-Alike Tubes Kill Patients,” by Gardiner Harris (The New York Times, Aug. 20, 2010). An FMEA would assign a severity of 10 to an event of this nature, which should prompt an immediate CAPA process. It apparently did not prompt one because patients have actually been killed in this manner, although Nestlé recently introduced an error-proofed SpikeRight system that makes it impossible to attach enteric food containers to an IV line. An ongoing litany of serious and fatal medical mistakes is yet another example of ISO 9001 being most conspicuous when it’s absent.
“Invisible when present, conspicuous when absent” is therefore the best way to explain the benefits of ISO 9001 to gain buy-in from management, the workforce, and other organizational stakeholders.