2020

EXPERT ANSWERS

This month’s question:

Is the number of external audit findings a good key performance indicator (KPI) to use to track improvement for a quality management system (QMS)?

Our response:

There are many ways to answer this question because it depends on the standard and the auditors involved.

If it is an AS9100 external audit, the answer would be no—there is too much subjectivity in the audit requirements and the individual auditors’ interpretations of those requirements. As such, the results would not be consistent from audit to audit.

The answer also would depend on who the auditors represent. A customer team would probably be the most varied in background and training.

The results, therefore, would be inconsistent from audit to audit.

If the external auditors are from a third party, such as a registrar, the audit results should be an accurate measurement of the QMS and thus consistent.

Regarding whether audit findings are a good KPI, I am unconvinced that the measurement of something as negative as an audit finding should be used to demonstrate a positive trait such as improvement.

The determination can be based on the previous history of external audit findings.

If the average number of external audit findings over the past several years has yielded only a few findings—for example, fewer than five—it is illogical to use the number of external findings as a KPI because the findings don’t prove or disprove anything substantial.

All in all, the number of external audit findings is not an objectively good KPI.

This response was written by Bernie Carpenter, lead auditor, Carpenter Services Group, Inc., Costa Mesa, CA.

This month’s second question:

We are in the process of getting our new lab ISO 17025 certified. Currently, the lab is part of a parent organization. It has been requested that the lab have its own name with the ability to charge fees, however. Is that possible without establishing the lab as its own company (for example, a limited liability company or division)? Ifthe lab charges fees, would it be considered a third-party lab in relation to the parent company, with its own departments (such as HR, administration and IT) separate from the parent company?

Our response:

The ISO/IEC 17025 accreditation (not certification) process allows for a captive lab under a parent organization to be accredited.

ISO/IEC 17025:2005 clause 4.1.4 states:

"If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.

"Note 1—Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory’s compliance with the requirements of this International Standard.

"Note 2—If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities."1

There is no requirement that the lab have its own name and the ability to charge fees. It is up to the lab to organize in a way that it sees fit, provided potential conflicts with the parent organization are identified.

Nor is there a requirement that the lab have its own IT, HR or other departments—as long as those arrangements with the parent organization are identified and any potential conflicts of interest are resolved in favor of the accrediting body.


Reference

  1. International Organization for Standardization and International Electrotechnical Commission, ISO/IEC 17025:2005—General requirements for the competence of testing and calibration laboratories.

This question and answer was adapted from a post from ASQ’s "Ask the Experts" blog. Visit https://tinyurl.com/mfqjyvt for more details. The response was written by Dilip A. Shah, president, E = mc3 Solutions, Medina, OH.


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