Qualitative and Quantitative Audit Methods

The following is an excerpt from The Complete Guide to the CQA (QA Publishing, LLC) by Steve Baysinger, which is out of print. Complete coverage of Quality Audit techniques may be found in The Handbook for Quality Management (2013, McGraw-Hill) by Paul Keller and Thomas Pyzdek

As a quality auditor you might be asked "how many findings did you discover during the course of the audit?" For some unexplained reason, some people sometimes equate a large number of findings with a "good" audit; never mind the fact that these findings have little, if any, effect upon the system, process or product that was the subject of the audit. The true test of the value of an audit is not in the quantity of findings discovered but their quality, i.e., how significant were they? Did the audit findings adversely affect (or have the potential to affect) product quality, reliability, safety, etc.? If the answer is yes, and the proposed corrective action to the audit-identified discrepancy is sound, you can feel satisfied that you helped to affect change— positive change for improvement. Solid, fact-laden findings, accompanied by helpful, innovative auditor recommendations to help correct those findings, not only help by identifying significant shortfalls within the quality system, process or product but launch the corrective action process even before the audit report is written and distributed!

Objective Evidence

Objective evidence can be defined as information which is based on facts obtained through observation, measurement, test or other means. (ISO/DIS 8402 (1992)) It is qualitative or quantitative information, i.e., records or statements of fact pertaining to the quality of an item or service or to the existence and implementation of a quality system element, which is based on observation, measurement or test and can be verified. (ISO 10011-1 (1990)) Objective evidence can be found in many different forms such as internal audit report findings and observations, test lab reports, measurement and test equipment calibration records, receiving inspections reports, etc. In short, objective evidence will generally be verifiable in the sense of tangible, physical evidence. On occasion, however, there may occur a situation in which a finding or observation is based on verbal testimony provided by the auditee to the auditor. This type of evidence, while acceptable, is not preferable. In the case of verbal testimony, always attempt to corroborate it with physical, objective evi-dence.

There are two basic "types" of objective evidence:

1. Physical objective evidence that can be seen, touched or witnessed by several people simultaneously.

2. Testimony given to you by management as being company policy, procedure, etc.