Chapter 42: Questions About Nonconformance Identification and CAR Triggers

What exactly counts as a nonconformance that requires a formal CAR?

A nonconformance is any failure to meet a specified requirement—your documented procedure, customer specification, regulatory requirement, or ISO 9001 standard itself. Not all nonconformances require a formal CAR, though.

ISO 9001 clause 8.5.2 distinguishes between nonconforming product (physical output) and nonconforming processes (system failures). If a scrap item is caught during in-process inspection and destroyed the same day, you may log it as a defect trend but not open a CAR. However, if that scrap points to a systemic breakdown—an operator wasn't trained, a calibration lapsed, or a supplier sent bad material three times—then you initiate a CAR to fix the root cause.

The key: does correcting this one instance prevent recurrence? If not, you need a CAR. If yes, document the immediate action and monitor the trend.

How many CARs is too many? Are we failing if we have dozens open?

No. The number of open CARs is not a sign of failure; it's a sign of a mature system that catches problems. A manufacturer with one CAR open annually is either hiding nonconformances or operating in a perfect world—neither is realistic.

A better metric is the CAR close-out rate and the time-to-close. If you're opening CARs faster than you're closing them, and CARs routinely stay open beyond 90 days without documented reason, that's a signal.

Canadian automotive suppliers under IATF 16949 typically carry 15–40 active CARs depending on volume and complexity. The audit question is not "how many?" but "are you systematically addressing them?" and "are your root causes addressing the actual problem or just the symptom?"

Does every customer complaint have to become a formal CAR?

Not automatically. Clause 8.2.1 (customer satisfaction monitoring) requires you to track and analyze customer feedback. A complaint is data, not a CAR trigger.

If a customer reports late delivery once, you may adjust scheduling without opening a CAR. If three customers report the same issue in a quarter, or if one complaint reveals a design flaw affecting thousands of units, then yes—you open a CAR and investigate root cause.

The rule of thumb: one complaint = review and document the response; repeated complaint pattern or safety/regulatory implication = CAR. Document your decision rule in your nonconformance procedure so auditors see consistent judgment, not arbitrary choices.

What's the difference between a nonconformity and a nonconformance in ISO 9001?

Good catch—we use both terms, and they mean the same thing. ISO 9001 technically uses "nonconformity" (clause 8.5.2), but Canadian manufacturers and auditors often use "nonconformance" interchangeably. Stick with whatever term your procedure uses, but be consistent. Internally, the standard is referring to any failure to meet a requirement, whether it's product, process, or system.