The Case File Library

One publicly documented quality failure, dissected for lessons — a new case file every day. Recalls, groundings, outbreaks: what actually failed, and which discipline would have caught it.

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·July 6, 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·July 6, 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·July 6, 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·July 6, 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·July 6, 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·July 6, 2026·7 min readRead case →
737 MAX MCAS: how delegated authority certified a single-point failure
Aerospace

737 MAX MCAS: how delegated authority certified a single-point failure

How delegated authority allowed Boeing to self-certify a single-sensor flight control system—and what happens when quiet engineering compromises scale into tragedy.

Case file #3·July 6, 2026·6 min readRead case →
GM ignition switch: how a silent redesign bypassed quality and cost 124 lives
Automotive

GM ignition switch: how a silent redesign bypassed quality and cost 124 lives

A silent 2006 redesign of GM's ignition switch kept the same part number, leaving engineering records pointing at a nonexistent part and contributing to 124 deaths and a $900M settlement.

Case file #2·July 6, 2026·6 min readRead case →
Takata: how suppressed test data became the largest recall in history
Automotive

Takata: how suppressed test data became the largest recall in history

The Takata airbag recall exposed a hard truth: most quality catastrophes stem from known risks that governance systems failed to halt.

Case file #1·July 6, 2026·5 min readRead case →