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Nonconforming outputs (NCR)

Nonconforming outputs and CAPA in Keel

The Nonconforming outputs register is Keel Quality’s answer to ISO 9001 Clause 8.7: identify and control outputs that don’t conform, so nonconforming product is never used or delivered unintentionally. Each entry is a nonconformity report (NCR).

Log an NCR

Section titled “Log an NCR”

In Nonconforming outputs, log a nonconformity with a title, an optional NCR code, the affected product / part / lot, and a quantity. Record where it was detected (internal inspection, incoming inspection, in-process, final inspection, customer return, supplier, audit, or other) and a severity: minor, major, or critical.

Contain and disposition

Section titled “Contain and disposition”

An NCR moves through Open → Contained → Dispositioned → Closed. Capture a quarantine location while it’s held, then record the Clause 8.7 disposition once it’s decided:

  • Use as-is (concession)
  • Rework
  • Repair
  • Scrap
  • Return to supplier
  • Regrade / downgrade
  • Segregate / quarantine

Note the approving authority (for example the MRB or Quality Manager) and the justification for the decision. When the disposition is rework or repair, tick Conformity re-verified once the output has been checked again, which is what Clause 8.7 requires after any rework.

Raise a CAPA for root-cause

Section titled “Raise a CAPA for root-cause”

When an NCR points to a systemic cause, use Raise a CAPA (root-cause) on the record. This opens a linked nonconformity for the corrective-action loop, and the NCR then shows CAPA raised so the containment record and the root-cause work stay connected.

Next steps

Section titled “Next steps”