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Man and machine in perfect harmony.

Man and machine in perfect harmony

Six sigma, kaizen, benchmarking and quality function deployment were for another world and another era when Richard Hoover began building guitars and carved-top mandolins in 1972. His ambition was simple – to become a master at all aspects of guitar making.

Over the years, he patiently refined his craftsmanship and knowledge. As his business grew, he translated his skills as an individual builder to a team of craftspeople, each of whom could become an expert in a single specialty. And, as Foo (Quality Progress, Feb 2008) reports, Richard Hoover’s style of allowing his craftspeople to interpret his vision has propelled Santa Cruz Guitar Company to the forefront of modern guitar making.

Each worker, known as a luthier, not only performs his or her own specialty, but also reviews the work of those who have completed earlier stages. The company does use a computer-controlled wood-cutting machine, but Foo argues that this removes barriers to pride of workmanship since it relieves the luthiers of repetitive work and so gives them more time for hand-crafted components.

Pride in workmanship is a fundamental aspect of quality, whether in a small, craft organization such as Santa Cruz or the USA’s third-largest pharmaceutical company, Merck. Simons (Fortune magazine, 18 Feb 2008) describes the legal, scientific and financial breakthroughs that Merck has achieved since 2004, when the company pulled its popular pain medication Vioxx from the market after a study linked it to an increased risk of heart attack and stroke.

Merck’s decision resulted in a flood of lawsuits and a 40 per cent drop in the company’s share price. People also began to question the Food and Drug Administration’s ability to screen for safety, as it had approved the drug for the US market in 1999.

The company initially decided to fight each Vioxx case – and won more than twice as many as it lost. But later the firm announced it would pay €4.85 billion into a fund, and people who claimed they had been hurt by Vioxx could petition for money. The company said the deal was not a class-action settlement, however, and individual cases would be examined before payments from the fund were made.

People would have to provide medical evidence that they suffered heart attacks or strokes, and proof of having taken Vioxx within 14 days of their illness and 30 pills in all. Awards would depend on how long the person had taken the pills and the severity of injury.

By March 2008, more 44,000 of the approximately 47,000 people who registered eligible injuries had submitted some or all of the materials needed for enrolment that could qualify them for a payment. Some 5,000 other claimants had also sought to enrol, but their eligibility had still to be decided. The figures are significant because Merck reserved the right to go back to fighting cases one by one if 85% of claimants did not sign up to the agreement. This would prevent law firms from ‘cherry picking’ their best cases and dumping the rest.

Merck, which has consistently denied allegations that Vioxx killed anyone or that the company knowingly misrepresented the dangers of the drug, now looks as though it has put the worst of its Vioxx difficulties behind it. Its shares have doubled from their low point in November 2004.

Like all the major pharmaceutical companies, Merck faces pressure from generic drug-makers as patents run out on popular drugs. The cholesterol drug Zocor lost patent protection in 2006 and the patent on osteoporosis drug Fosamax expires this year. But Simons points out that Merck recently launched several potential blockbuster products, including the cervical-cancer vaccine Gardasil and the diabetes drug Januvia. The FDA has approved Merck’s HIV treatment Isentress, and is testing an experimental cholesterol drug, Cordaptive.