Nonconformance and CAPA: two decisions, not one form

A nonconformance record controls a specific failed item or process result: what is affected, what is held and how it is disposed. CAPA investigates the cause, assigns corrective action and checks whether the fix worked.

Buğra Gündüz

Co-Founder & CEO of Bourne · Published

Two parts fail a bore check. Quality holds those parts, and perhaps others from the same setup, before the next operation. That is a nonconformance decision. The team then investigates why the bore moved out of tolerance and how to prevent another failure. That may become CAPA.

Combining both into one status called “resolved” hides what quality actually decided.

Control the affected material first

Record the measured result, specification limit, work order, lot or serial numbers, station and time. Identify what is already separated, what remains in WIP, and whether finished stock needs a check. Put the hold where the next shift and next operation can see it.

Quality then decides disposition under the manufacturer’s rules: rework, repair, use as is, scrap, or another approved route. The disposition should name the authority, affected quantity and follow-up inspection. The material stays on hold until the authorized owner approves that decision.

Investigate recurrence separately

Not every isolated defect needs a full CAPA. The site’s escalation rules should consider severity, recurrence, customer impact and process risk. When CAPA opens, preserve the link to the original failed result and containment record.

The investigation should test causes against evidence. If the suspected cause is a tool-offset change, check when it changed, which units passed through that setup, and whether the gauge was in calibration. Assign the action to someone who can change the process, then define how quality will verify it.

After the action is complete, check whether it worked. If the action was to revise a setting, look at later runs and confirm the characteristic stayed within limits. Close the case when the required follow-up results are available and quality has reviewed them.

The American Society for Quality describes CAPA as work to address causes of nonconformities. The immediate hold and disposition still need their own visible decision.

Explore nonconformance management and CAPA management.

Buğra Gündüz

Buğra Gündüz is the co-founder and CEO of Bourne and co-founder of HockeyStack. He built HockeyStack into an eight-figure AI business. At Bourne, he works with entrepreneurs and established companies to create AI products and services.