Every nonconformity gets a response from the process owner on the Audit Nonconformity Response Template (A10), by the due date in the report. Majors and repeats run as corrective actions in the CAPA Command Kit (K01), with its effectiveness worksheet (B08). The program owner reviews each response before accepting it, against the test below.
| The response must ... | Send it back when ... |
|---|---|
| Accept the finding, or show evidence that a fact in it is wrong | It argues the wording without evidence |
| Show correction and containment, with the effect on product | It offers the correction as the corrective action |
| Say where else the same condition was looked for, and what was found | There is no extent of condition |
| Give a root cause that is a condition of the process | The cause restates the finding or stops at a person |
| Give the escape cause: why your own controls didn't catch it | There is no escape cause |
| Plan actions that each name the cause they remove | Retraining is the only action |
| Set the effectiveness criterion before the actions go in | There is no way to tell whether it worked |
Effectiveness is checked twice: once at the end of the window in the response, by someone other than the action owner, and again at the next audit of the process, which lists every earlier finding and what was seen (A11 section 5). A finding that is not holding becomes a repeat in the new report, and the program owner changes the process's ratings and interval on the A06 Process list.
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Clause numbers refer to AS9100D (SAE AS9100 Rev D) unless another document is named. The standards' text is not reproduced here: use your own licensed copy.
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