A timely topic to bring to your students when discussing quality (Ch.6) is
an embarrassing and expensive problem currently facing Johnson & Johnson. It’s a tale that has been making news for months now, but just ended with the US government taking over 3 Tylenol plants a few days ago (New York Times,March 10,2011). This follows a blizzard of drug recalls and an FDA criminal investigation into safety issues at the factories. The government also indicted two execs, the VP-Quality and the VP-Operations, for failing to comply with manufacturing standards.
The scathing report on 20 manufacturing violations and criminal investigation follows eight recalls of Tylenol, Benadryl, and Motrin that have been ongoing since 2009. J & J was warned over a year ago about the unsanitary and unsafe practices in the plants (one in Puerto Rico and two in Penn.), but the company was slow to fix them. Now, all drugs recalled must be destroyed, a “consent decree” allows independent experts to control the plants until safer manufacturing processes are in place, and one of the Penn. plants will remain closed until the FDA stamps its approval. Fines will also be levied at $15,000 per day up to $10 million annually until the FDA clears the company.
Production is expected to be hurt while the corrective actions take place. But as Philip Crosby wrote in his 1979 classic, Quality is Free, “What costs money are all the actions that involve not doing it right the first time”.
Discussion questions:
1. What happened in Tylenol’s 1982 famous recall?
2. What did Crosby mean when he wrote “quality is free”?
3. What is the role of OM in this dilemma?