Resource Library/Process Control and Measurement/Out-of-Tolerance Impact Assessment
Out-of-Tolerance Impact Assessment
When a calibration comes back out of tolerance: record the event, trace every lot the instrument measured since it was last known good, judge each reading against its limits with the error, decide, tell the customer where needed, and close with the evidence.
- Excel
- fillable PDF
- Worked example
- Your logo on it
- Aegis Insights
Page 1 of the PDF. Every resource includes a fully worked example.
The problem it solves
An out-of-tolerance calibration result is not a calibration problem; it is a product problem. Every part the instrument accepted since it was last known good is in question until the records show otherwise, and an auditor will ask which parts, how you judged them and who decided. Most shops answer with a line on the certificate saying 'no impact'. This workbook walks the assessment from the event to the lots, judges each lot's recorded readings against its limits with the instrument's error and its direction, separates what is cleared from what is in question, and shows when the assessment can close.
Who uses it
Quality managers and quality engineers; calibration coordinators who receive certificates.
When
The day a certificate shows an as-found result out of tolerance, or a gauge is found damaged, dropped or failing its interim check. Review the OOT log monthly.
Free to use, change and copy, in your own organization or with your clients; add your own logo, keep the Aegis credit. Part of: Calibration Control Kit. Clause references: 7.1.5.2 (with 8.7, 8.7.1 and 8.2.1) (numbers only; use your own licensed copy of the standard).
A management aid, not certification or a registrar audit. Using it does not by itself show conformity to AS9100D or any other standard.
How to put it to work
Chapters of our free guides that use this tool.
- The kit and how the tools connectThe Calibration Control Kit Handbook, chapter 2
- The calibration control workflowThe Calibration Control Kit Handbook, chapter 3
- Who does whatThe Calibration Control Kit Handbook, chapter 4
- When a calibration fails: the impact assessment (E02)The Calibration Control Kit Handbook, chapter 9
- Records that hold upThe Calibration Control Kit Handbook, chapter 13
- The weekly and monthly rhythmThe Calibration Control Kit Handbook, chapter 14
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These tools help you run the work by hand. When you want the whole picture of your quality system from the records you already keep, that's what the AeroAssure Audit Defense Pack and the IA9100 Transition Gap Analysis do.