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.

Theranos: how bypassing APQP and validation built a $9bn fraud
Medical & Pharma

Theranos: how bypassing APQP and validation built a $9bn fraud

A quality professional examines how Theranos scaled process bypass and ignored validation to a $9bn valuation—putting real patients at risk.

Case file #36·August 1, 2026·5 min readRead case →
De Havilland Comet: how a window shape dictated aerospace fatigue testing
Aerospace

De Havilland Comet: how a window shape dictated aerospace fatigue testing

The gap between "strong enough on paper" and "strong enough after the three-thousandth pressurisation cycle" is the gap that killed fifty-six people. I think about this every time a junior engineer…

Case file #35·July 31, 2026·6 min readRead case →
Ariane 5: how unvalidated software reuse doomed a maiden flight in 40 seconds
Aerospace

Ariane 5: how unvalidated software reuse doomed a maiden flight in 40 seconds

Ariane 5's maiden flight self-destructed in 40 seconds due to inherited Ariane 4 software that couldn't handle higher velocities—a $500M lesson in unvalidated code reuse.

Case file #34·July 30, 2026·5 min readRead case →
Mars Climate Orbiter: how a missing interface requirement cost $327m
Aerospace

Mars Climate Orbiter: how a missing interface requirement cost $327m

Two good teams, two solid systems, one assumption nobody wrote down — the interface failure pattern behind the $327M Mars Climate Orbiter loss.

Case file #33·July 29, 2026·5 min readRead case →
Ford Pinto: when a cost-benefit calculation overrules PFMEA
Automotive

Ford Pinto: when a cost-benefit calculation overrules PFMEA

I have been in the room where the spreadsheet says ship and the PFMEA says stop. The Pinto is what happens when the spreadsheet wins – when a cost-benefit calculation is allowed to override the…

Case file #32·July 28, 2026·5 min readRead case →
Guidant: how a known short-circuit became the first device-maker crime
Medical & Pharma

Guidant: how a known short-circuit became the first device-maker crime

Guidant fixed a deadly defibrillator flaw on the production line but stayed silent about flawed units already implanted—becoming the first device maker criminally convicted.

Case file #31·July 27, 2026·6 min readRead case →
Alaska 1282: How undocumented rework led to an in-flight blowout
Aerospace

Alaska 1282: How undocumented rework led to an in-flight blowout

Four missing bolts and zero production records: how undocumented rework on a 737 MAX 9 door plug led to a sudden in-flight blowout at 16,000 feet.

Case file #30·July 26, 2026·6 min readRead case →
Maggi 2015: when a legal defense failed quality containment
Food & Beverage

Maggi 2015: when a legal defense failed quality containment

When a contamination crisis hit Maggi noodles in India, legal defense trumped operational containment—and ~38,000 tonnes of product were destroyed in a recall that erased 80% market share.

Case file #29·July 25, 2026·6 min readRead case →
DePuy ASR: how post-market surveillance failure became a $4B recall
Medical & Pharma

DePuy ASR: how post-market surveillance failure became a $4B recall

Here is an uncomfortable observation from someone who has spent two decades chasing defects across automotive and aerospace: most quality catastrophes don't fail because no one saw the signal. They…

Case file #28·July 24, 2026·6 min readRead case →
Columbia: how normalised deviance turned foam shedding into catastrophe
Aerospace

Columbia: how normalised deviance turned foam shedding into catastrophe

When a recurring defect becomes 'normal,' the cost can be catastrophic. Columbia shows what normalised deviance costs at Mach 24.

Case file #27·July 23, 2026·7 min readRead case →
Denso: how material drift in fuel pumps stalled millions of cars
Automotive

Denso: how material drift in fuel pumps stalled millions of cars

Polymer impellers in Denso fuel pumps absorbed hydrocarbons and swelled beyond running clearances, causing sudden stalling in 6M+ vehicles—a failure mode missed by validation.

Case file #26·July 22, 2026·6 min readRead case →
Lululemon Luon: when the specification itself is the defect
Consumer Products

Lululemon Luon: when the specification itself is the defect

Here is an uncomfortable observation. The most expensive quality failures are rarely the ones where the process broke. They are the ones where the process worked exactly as designed — against a…

Case file #25·July 21, 2026·6 min readRead case →