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Clause 8.7: Corrective actions

Root cause, proportionate action and the effectiveness review, and why a nonconformity cannot close without one.

Screen: Corrective actions Clause 8.7 Updated

What the clause asks for

When a nonconformity occurs, clause 8.7.1 requires the laboratory to:

  • react to it, taking action to control and correct it and dealing with the consequences,
  • evaluate the need for action to eliminate its causes so that it does not recur or occur elsewhere, by reviewing and analysing the nonconformity, determining its causes, and determining whether similar nonconformities exist or could occur,
  • implement any action needed,
  • review the effectiveness of any corrective action taken,
  • update risks and opportunities determined during planning, if necessary,
  • make changes to the management system, if necessary.

Corrective actions are appropriate to the effects of the nonconformity (8.7.2). Records are kept of the nature of the nonconformity, its cause and subsequent actions, and the results of any corrective action (8.7.3).

What assessors sample

Assessors read a handful of closed corrective actions and look for three things: a cause that goes beyond “human error”, an action that addresses that cause, and an effectiveness review carried out after enough time has passed to show a result. Common findings:

  • Root cause recorded as a restatement of the problem.
  • Corrective action identical to the immediate correction.
  • Closure on the day the action was completed, with no effectiveness check.
  • Due dates passed with no record of extension.

Where this lives in AccreditBook

Corrective actions sit inside the nonconformity they address.

Requirement Field in AccreditBook
Correction and consequences Nonconformity: immediate action, work affected
Cause analysis Corrective action: root cause
Action to eliminate the cause Action, owner, due on, completed on
Effectiveness review Effectiveness check due on, effectiveness check on, result (effective, not effective, pending)
Records (8.7.3) All of the above plus the Activity tab

The due list tracks both the action’s due date and the effectiveness check date. A nonconformity cannot be closed until at least one action is completed and recorded as effective; if a check shows the action was not effective, the record returns to action in progress.

See Corrective actions, Nonconformities and Clause 7.10.

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