I'm looking to determine the meaning of the term "Calibration Criticality Number".

My company is looking to reduce calibration costs and want to assign a criticality number to all of our gages. This is supposed to aid in determining if an investigation should be done if a measuring instrument goes out of tolerance.

The corporate directive did not define the term. We are a US subsiderary of an Europeon owned company so translation of the term may be an issue. I'm way down the food chain and don't have a direct contact to clarify the question myself.

From the description you gave this sounds like an internal phrase which describes a ranking system assigned to your instruments which ranks instruments by how critical they are (how big of an effect on product quality they can produce)...

I would try and consult with your corporate staff to clarify or perhaps with other plants in your system.

This may be what you are looking for: GAMP Good Practice Guide: Calibration Management (http://www.ispe.org/page.ww?section=Training&name=Practical+Approach+to+Calibration) from the pharmaceutical industry.


"...a structured approach to instrument criticality assessment."
"A pragmatic approach to calibration, based on a criticality assessment, will ensure effectiveness and regulatory compliance as cost effectively as possible."

We had a similar issue with rejection of M&TE. The requirement is to notify owner/users of M&TE with out of tolerance conditions are significant. Critical or significant are similar terms. We utilize a "Calibration Requirements Checklist" that identifies the calibration points and tolerances. We identify the M&TE design/manufacturers tolerance, the product tolerance (where the M&TE is used) and the Significant Tolerance (which is directly related to the product). The general rule is that the Significant Tolerance should not exceed 25% of the total product tolerance. We require the product/process engineers to identify the significant tolerances prior to calibration. This has effectively reduced rejection notifications by over 75%. This checklist is approved by the Product Engineer, Quality Engineer and Standards Lab Supervisor and is considered the controlling document. It has eliminated the need for gage drawing changes and assisted with the traceability to product.

Hope this helps.

May I have a sample of the "Calibration Requirements Checklist"? THanks.

It's kind of a simple "no frills" form.

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