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Auditing Fitness of Purpose for Monitoring and Measuring Equipment

Rich Shippy

Starting to get Involved
#1
Anyone with experience of what the auditors are looking for here? It needs to be "documented information". We have equipment manuals that specify precision voltage sources as an example, but other than that we get equipment capable of taking the measurements like torque equipment.
 

dubrizo

Involved In Discussions
#2
Potential Internal Audit queries:

1. How is M&M equipment being protected from damage?

2. How is M&M equipment identified?

3. How do you ensure your M&M equipment is calibrated?

Does your organization identify preventative maintenance activities that are recommended by the OEM? I.E. CMM requires replacement air filter every 6 months and replacement ball bearings every two years. Are these activities being done, and if so, there should be documented information of these activities.
 

howste

Thaumaturge
Super Moderator
#3
Anyone with experience of what the auditors are looking for here? It needs to be "documented information". We have equipment manuals that specify precision voltage sources as an example, but other than that we get equipment capable of taking the measurements like torque equipment.
You could create a record of evaluation for each measurement specified for receiving, in-process, and final inspection, etc. but that would become an overwhelming task rather quickly.

I would say that you could handle this in a much more general way. For example, a machine shop may measure a lot of similar types of features with general measuring equipment, such as steel rulers, calipers, and micrometers. Each piece of equipment has different capabilities and would not be suitable for the measurement of all features. You could create a document based on accepted principles or studies that states a ruler can be used to measure features with tolerances of ±X of above. 6" calipers (with a display resolution of .0005") can be used to measure features with tolerances of ±Y or above. 8" calipers (with a display resolution of .001") can be used to measure features with tolerances of ±YY or above. Micrometers can be used to measure features with tolerances of ±Z or above.

This would get a lot of the general measurements out of the way in one document. For more specialized features and equipment you may need individual records of the decisions made, and may need to do R&R studies to demonstrate suitability.
 

yodon

Staff member
Super Moderator
#4
It's a matter of tying your specs to the equipment. If you have a timing requirement to meet something within milliseconds, a manual stopwatch won't do. What are you trying to measure, to what degree of accuracy, and is the equipment used capable of measuring to that accuracy.
 
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