6 Non-Conformances You Can Avoid During Your Next Audit

 

No one prepares for an Audit with failure as an objectives. Yet you often walk away with non conformance from minor to major. What happened? Did you miss something that now seems obvious?

Here Is Our List Of 6 Non-Conformances You Can Avoid During Your Next Audit

Not understanding customer requirements

6 common non conformances and how to avoid them alliance calibration.jpeg

A common problem is not listening to the customer and have the requirements in writing. Don't assume that previous work will meet new work. Specifications and tolerances may have changed.Make sure you thoroughly review the Purchase Order and the specifications are exactly what you discussed with the customer. Many companies use templates for purchase orders and legacy boiler plate language often is not scrubbed with revisions.

Requirements not stated by the customer, but necessary.

6 common non conformances alliance calibration.jpegThere are certain inherent requirements when providing a product/service. When producing a part, do you have the master standards necessary to meet the requirements. Have you discussed the standards used with the customer for a particular project? Do the standards require calibration? Will the calibration schedule cause interruption to the manufacturing process? Do you have the proper data based criteria to extend a calibration cycle for production?

Understanding measurement capabilities

You have probably heard of the 10:1 rule or the 4:1rule in measurement and calibration. If these are new to you check out this article in Quality Progress and What you need to know about Z540.3 and calibration. Do you have the measurement capability to perform proper measurement? This may not have happened to you, but we have seen overkill with measurement and test equipment and some real problems with calibration. One example that comes to mind is a calibration performed where all items failed to meet specifications. They were using the 10:1 rule and purchased measurement and test equipment "10x better" than required. Their solution was to truncate the results so the instruments would "pass". Bad idea. Auditor hated it. Major non conformance. This could have been avoided if they had discussed measurement requirements with their customer instead of assuming the 10:1 rule was the best approach.

Forgetting about measurement uncertainty

What is measurement uncertainty?

Measurement uncertainty is way to quantify the “Grey area” that surrounds a measurement. A 1 inch measurement with an uncertainty of ± 0.1 inch means that the “true” value could be as small as 0.9 inch or as large as 1.1 inch, but is most likely very close to 1 inch. You must take measurement uncertainty into account when meeting customer specifications. For a detailed measurement uncertainty alliance calibration.jpegexplanation you may want to read FAQ's: Measurement Uncertainty.

Equally important is understanding measurement uncertainty in calibration. You send measurement & test equipment in for calibration. If you don't understand the implications of measurement uncertainty, how can you have confidence in your measurement results? Check out this article Measurement Uncertainty: Calibration uncertainty for dummies from Beamex.

 

 

Not communicating requirements to external providers

terms and condition audit non conformance alliance calibration.jpegBoth IATF 16949 Section 7 and ISO 9001 Section 9 have clear requirements when communicating with external providers, specifically calibration. It is a common misconception that your calibration provider knows exactly how you use your measurement & test equipment. If you do not clearly communicate what points across what range you want calibrated, this could easily become a non conformance during an audit. Specialty standards such as CQI-9 are very explicit about drawing conclusions for measurements beyond or below calibration points. They don't allow it. Clearly communicate calibration points on your purchase order to your calibration provider. This is a non conformance that is easy to avoid.

Failure to review calibration certificate/report

While using an ISO 17025 accredited calibration company is best practice, it does not stop there. It is the obligation of  the end user of calibration to review calibration reports/certificate to determine suitability for use. This is often overlooked and a common cause of non conformance in an audit. Review your calibration reports and have a documented process of review. This simple step can make your next audit easier.

We have provided a FREE Calibration Audit Checklist to help you prepare for your next audit.

Download The Calibration Audit Checklist

Phil Wiseman

Phil Wiseman

Phil Wiseman is Chief Marketing Officer at Alliance Calibration. He earned a B.S. in Chemical Physics from Centre College. Phil is an ASQ Certified Quality Auditor and ASQ Certified Manager of Quality/Organizational Excellence.

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