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CAPA

An effectiveness check is a measurement

Closing a corrective action records that work was done. Only a defined measure shows whether it worked.

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A technician's hands measure a sampled part with a dial gauge, a row of sampled parts and a paper run chart beside it

Placeholder. This article is placeholder copy written to test layout and tone. It is not published research and makes no factual claims.

Corrective and preventive action (CAPA) closes with an effectiveness check. In many systems that check is a signature confirming the action was completed. This piece describes what a measurable check contains instead.

What to define before closure

A measurable check names the outcome, the observation period and the threshold in advance. It is scheduled when the CAPA is opened, not when it is closed.

Exhibit 1

Illustrative data

In this illustrative CAPA, the effectiveness check takes longer than the action it verifies

Median days in each CAPA stage, one site, one year, days

Note: Values are placeholders chosen to demonstrate the exhibit format. Stages are shown in process order. CAPA is corrective and preventive action.

Source: Illustrative data for layout purposes only; not research findings.

Data table
In this illustrative CAPA, the effectiveness check takes longer than the action it verifies (Median days in each CAPA stage, one site, one year, days)
CategoryValue
Investigation21 d
Action34 d
Effectiveness check58 d
Closure6 d

Reading the result

If the measure stays within its threshold for the full period, the check passes. If it does not, the CAPA is reopened. Both results are evidence.

Flagship report

Control every day

What it takes for a quality system to stay in a state of control between audits.

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