Method and management system

What is the difference between a nonconformity and a corrective action?

A nonconformity is a requirement not fulfilled. A correction removes the consequence — mopping up the spilled chemical. A corrective action removes the cause so it does not recur — changing the transfer method that led to the spill. Clause 10.1 of the harmonised structure asks for both and requires the effectiveness of the corrective action to be reviewed. An action whose effectiveness was never verified is an open problem that looks closed.

Three different things

TermWhat it addressesExample
NonconformityA requirement not fulfilledEye protection was not used during chemical transfer.
CorrectionRemoving the consequenceGoggles issued, the task stopped.
Corrective actionRemoving the causeThe goggles were kept out of reach; a cabinet is installed at the transfer point.

The steps

  1. React: take control, deal with the consequences.
  2. To prevent recurrence, investigate the cause and check whether similar nonconformities exist elsewhere.
  3. Implement the action needed.
  4. Review the effectiveness of that action.
  5. Change the management system if necessary.

The step most often skipped

The fourth. The action is marked "complete" but whether it worked is never measured. The test is simple: does the same nonconformity appear again? If it does, the action did not close — the record did.

Why "who did it" is the wrong question

A system that ends its root-cause analysis at a person stops learning: the person disciplined does not report the next event. The right question is which condition made the wrong action easy and the right one hard.

Records

The nature of the nonconformity, the actions taken and their results are documented. In Optifora's data layer "nonconformity and corrective action" is a shared document type of the harmonised structure (10.1).

Manage this in Optifora

Optifora is not a single program but a compliance platform assembled from modules. The catalogue states which module is ready today and which is on the roadmap.

See what Optifora is