ISO 9000 Non Conformance Repo

Using the audit information below complete the enclosed Non-Conformance Report

.On February 5, 2021, you, as the auditor, conducted an ISO 9001:2015 process audit of the ABC Machine Shop production process.

In the production area you identified a single caliper, asset number ID #2345, whose label indicated that its calibration had expired. You randomly selected an additional 12 calipers which were all found to be within their calibration dates (IDs 2467, 2756, 3874, 6789, 3409, 3498, 1254, 7684, 3247, 8765, 3456, 1139).

You concluded that their measuring and monitoring controls were ineffective. You initiated a Non-Conformance Report (NCR) against ISO 9001:2015 clause 8.5.1c. Since you found only one caliper with an expired calibration date you classified the non-conformance as minor.

ABC Machine Shop responded to their section of the Non-Conformance Report:

They attributed the cause to human factors. The technician who is using this caliper to accept product, left work abruptly due to illness two days before the caliper’s calibration expired.

They determined that Caliper ID 2345 was used at that time to accept the following two machined parts (P/N 34678, S/N 3 and P/N 34678, S/N 4). As a good practice these parts were re-measured and the new measured values were the same as before.

The next day it was verified that the caliper was in calibration. A new sticker was affixed to the caliper.

On April 3, 2021, a member of Quality, John J., was assigned the task of daily monitoring of the production floor to ensure that there are no measuring instruments with expired calibration dates.

On April 4, 2021, ABC Machine Shop conducted a meeting with all production workers who use measuring devices to raise their awareness about devices coming due for calibration and why it is important to their business operations and the Quality Management System.

On April 6, 2021, John J. verified that both corrective actions mentioned above were implemented.

John J. had maintained a record of all his production floor checks. Over the last 3 months there has not been an incidence of another measuring device with an overdue calibration label. On July 3, 2021 the auditor used the 3 months of error-free data as a means to substantiate that the corrective actions which were put in place are effective in preventing a recurrence.

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