Recently I was in a discussion with several Quality Managers regarding ISO 9001:2015 and the focus on Risk.
The discussion focused on what tools/techniques people would be using for Risk Assessment, Risk Management and Mitigation. The numbers of tools available is almost limitless and everyone had a good sense of where they were going to focus. There was keen focus on Process and Supplier Management.
What did not come up in the conversation was calibration. So I brought it up.
How are you going to assess your risk from your calibration program, I asked.
What exactly do you mean? Where does calibration introduce risk? We use an accredited Lab.
While I would never discourage anyone from using an ISO 17025 accredited Lab for external calibrations, that alone does NOT mitigate or manage your risk.
As the end user of calibration, be it internal or external, a sticker and a piece of paper do nothing to mitigate your risk if you simply file them away and never look at the data. A proper calibration report/certificate has data that must be reviewed:
- Traceability- physical standards used must have an unbroken chain of traceability through NIST or another NMI(National Metrology Institute) back to the SI Unit.
- Measurement Uncertainty- it is critical to look at this number as part of your risk management program. Don't measure a gage block with a ruler! The end user of calibration must look at the tolerance of the product being manufactured and determine if Measurement & Test Equipment used is suitable. Take the value recorded on your calibration report/certificate and add/subtract the measurement uncertainty. Is that number good enough for your end use?
- Flow through Measurement Uncertainty- What are the contributors to measurement uncertainty through your entire process? Draw a process map. What are the critical measurements? Dimensional? Time? Temperature? Vibration? Rotational? Humidity? etc. These contributors must be accounted for as part of your risk management strategy.
We have prepared a Calibration Audit Checklist that can assist you in evaluating your calibration program from a risk perspective. The download would be too large if we covered everything possible, but you should find it valuable in starting your path looking at calibration from a risk perspective.