Q: I have been an auditor of ISO/ANSI/ASQ 9001:2008 Quality management systems–Requirements since 1992 and recently began consulting hospitals who seek ISO 9001 certification.
My experience with auditing to ISO 9001 is mostly in the manufacturing sector. When I audited against ISO 9001 clause 7.6 control of monitoring and measuring equipment, I routinely included questions regarding the process for assessing the validity of previous measurement results when equipment did not conform to established limits. I found no real issues with this until lately.
Now, clients say that calibration service providers do not routinely provide “as found” data in the report that’s sent to clients/customers. I have been told that the”‘as found” data only becomes available to the client/customer for an additional charge (and it’s not cheap).
Obviously, organizations cannot comply with the ISO 9001 requirement to perform the aforementioned assessment without this data. Since this has only come to my attention recently, I am wondering about the ethics and legality of withholding specific information in the calibration report – unless an additional fee is paid.
Could you please provide some insight or justification for this business practice?
A: It is always a good idea to evaluate one’s suppliers. This requirement is in ISO 9001 clause 7.4 purchasing. The May 2010 Quality Progress Measure for Measure column, “Supplier Demand,” provides guidance on evaluating and selecting calibration providers accredited to ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories. In addition, the ILAC-P14:12/2010 policy document requires ISO/IEC 17025 accredited laboratories to provide measurement uncertainty data with the measurement results as of December 1, 2011.
The customer should specify their requirements in their purchasing documents for calibration. ISO/IEC 17025 has contract review requirements that accredited laboratories must meet in order to to comply with clause 4.4 of ISO/IEC 17025.
In order for the laboratory to make an out of tolerance decision, it has to measure “as found” data. Even if the laboratory does not report it, it is required to retain it per ISO/IEC 17025 clause 220.127.116.11, second paragraph:
“When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, the laboratory shall record those results and maintain them for possible future reference.”
So, for a start, it is a good idea to use ISO/IEC 17025 accredited calibration providers and specify the customer’s requirements. Some provide “as found – as left” data routinely. Others may charge because they may claim that it takes extra time. But, if a competing laboratory provides it as part of the service, the other laboratories will follow suit or lose market share.
If the ISO/IEC 17025 accredited providers have to make a compliance decision on an item being calibrated, why would they not record the data? Even if it’s not provided, they are required to retain it for future reference in case of an inquiry. Calibration providers (whether accredited or not) that do not provide “as found – as left” data should probably be avoided. One does not know if they provided a legitimate calibration or they “stickered” the calibrated item and produced a generic certificate.
Other laboratories complying with ANSI Z540-1 or ANSI Z540.3 requirements are also required to provide “as found – as left” data. Otherwise, they are not fully complying with Z540 requirements.
The September 2010 Quality Progress Measure for Measure column, “Calibration Evaluation,” discusses evaluating non-accredited calibration providers and what to look for when assessing them.
Dilip A Shah
ASQ CQE, CQA, CCT
President, E = mc3 Solutions
Chair, ASQ Measurement Quality Division (2012-2013)
Secretary and Member of the A2LA Board of Directors (2006-2014)
Open access articles from ASQ:
Improved Gage R&R Measurement Studies, Quality Progress
Many manufacturers are using tools like statistical process control (SPC) and design of experiments (DoE) to monitor and improve product quality and process productivity. However, if the data collected are not accurate and precise, they do not represent the true characteristics of the part or product being measured, even if organizations are using the quality improvement tools correctly. Read more.
A measuring instrument, gage or device failed recalibration, and you have been asked to determine the influence on previously produced products. Where do you start, and what do you do? Read more.
The Prediction Properties of Classical and Inverse Regression for the Simple Linear Calibration Problem, Journal of Quality Technology
In this article, the classical approach to the calibration of measurement systems is examined. This method treats the standards as the regressor and the observed values as the response when calibrating the instrument. Read more.