The Case File Library

Publicly documented quality failures, dissected for lessons — case file by case file. Recalls, groundings, outbreaks: what actually failed, and which discipline would have caught it.

Vioxx: how ignored risk signals became a $4.85B quality failure
Medical & Pharma

Vioxx: how ignored risk signals became a $4.85B quality failure

A blockbuster drug, a foreseeable risk, and an organization that kept running: Vioxx as a $4.85B lesson in what happens when quality signals are ignored.

Case file #15·July 11, 2026·6 min readRead case →
PCA salmonella: how 'test until it passes' became a 28-year federal sentence
Food & Beverage

PCA salmonella: how 'test until it passes' became a 28-year federal sentence

In quality, the first test result is the real one. Every test after that is a negotiation with reality — and the more you negotiate, the more you are telling yourself something you do not want to…

Case file #14·July 10, 2026·5 min readRead case →
Intel Pentium FDIV: how the response, not the defect, cost $475 million
Software & Systems

Intel Pentium FDIV: how the response, not the defect, cost $475 million

Intel's correct frequency estimate for the Pentium FDIV bug became a $475 million liability — not because the math was wrong, but because trust doesn't reduce to a single number.

Case file #13·July 9, 2026·5 min readRead case →
Firestone: how ignored warranty data became 271 deaths
Automotive

Firestone: how ignored warranty data became 271 deaths

Firestone ignored warranty spikes for years before tread separations killed 271 people. A case study in what happens when field returns are a finance footnote, not a safety signal.

Case file #12·July 8, 2026·5 min readRead case →
Deepwater Horizon: when defence-in-depth becomes defence-in-name
Energy & Process

Deepwater Horizon: when defence-in-depth becomes defence-in-name

Every barrier meant to prevent Deepwater Horizon was present—each quietly hollowed out. When nobody verifies the load, defence-in-depth becomes just a checklist.

Case file #11·July 7, 2026·7 min readRead case →
Tylenol: how a $100M recall against advice set the crisis gold standard
Medical & Pharma

Tylenol: how a $100M recall against advice set the crisis gold standard

When cyanide-laced Tylenol killed seven in 1982, J&J pulled 31M bottles nationwide against FBI and FDA advice—a $100M bet that rewrote crisis response and saved the brand.

Case file #10·July 6, 2026·5 min readRead case →
Philips Respironics: how known foam risk became a 5.5M-device recall
Medical & Pharma

Philips Respironics: how known foam risk became a 5.5M-device recall

One of the largest medical-device recalls on record: 5.5M Philips CPAP and ventilator units pulled after foam degradation risks went unaddressed—costing billions.

Case file #9·June 25, 2026·6 min readRead case →
Samsung Note 7: how schedule pressure defeated dual-sourcing strategy
Consumer Products

Samsung Note 7: how schedule pressure defeated dual-sourcing strategy

Samsung's Note 7 crisis shows how launch pressure undermines even dual-sourcing: two suppliers, two different failure modes, one $5.3 billion root cause.

Case file #8·June 11, 2026·6 min readRead case →
Therac-25: what removing a hardware interlock costs in human lives
Software & Systems

Therac-25: what removing a hardware interlock costs in human lives

When AECL replaced physical safety interlocks with software checks in the Therac-25, three patients died from radiation overdoses—and the risk register was never updated.

Case file #7·May 26, 2026·5 min readRead case →
Challenger: how a known seal defect became an acceptable flight risk
Aerospace

Challenger: how a known seal defect became an acceptable flight risk

How NASA's normalization of a known O-ring defect turned a preventable failure into the Challenger disaster.

Case file #6·May 7, 2026·5 min readRead case →
Volkswagen dieselgate: how software deception became a €30B quality failure
Automotive

Volkswagen dieselgate: how software deception became a €30B quality failure

Volkswagen shipped defeat-device software in roughly 11 million diesel vehicles — compliant on the test stand, up to 40x over NOx limits on the road. The €30B lesson: a quality system whose gates can be deceived eventually will be.

Case file #5·April 17, 2026·6 min readRead case →
Toyota unintended acceleration: when growth outran the andon cord
Automotive

Toyota unintended acceleration: when growth outran the andon cord

Toyota's 9-million-vehicle recall crisis exposed what happens when quality infrastructure scales slower than production volume, silencing critical field signals.

Case file #4·March 26, 2026·7 min readRead case →