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articles:classifying_nonconformities [2022/07/20 09:27] – [Classifying Minor & Major Nonconformities] rrandallarticles:classifying_nonconformities [2023/05/16 09:13] (current) – [Definitions...] rrandall
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-====== Classifying Minor & Major Nonconformities ======+====== How Certification Bodies Classify Minor & Major Nonconformities ====== 
 +{{keywords>How Certification Bodies Classify Minor and Major Nonconformities}} 
 +===== Why should you care? =====
  
-Before we can classify a nonconformity as a minor or major, we must have a clear understanding of their definitions.+When undergoing an ISO 9001 or AS91xx audit by a Certification Body (CB), if the auditor incorrectly classifies a "minor" nonconformity as a "major", this typically requires the auditor to return on-site to (1) verify the effectiveness of the corrective action and (2) confirm a return to compliance. This means, in addition to the day rate charged by the CB, your company would have the added Travel & Living expenses of the auditor.
  
-Nonconformity classifications are defined in ISO/IEC 17021-1 for both ISO 9001 & AS9100 audits. AS9101 expands these definitions for AS9100 series audits. However, IMO, AS9101 merely clarifies the vague definitions contained in ISO/IEC 17021-1.+Similarly, if an auditor incorrectly classifies an "Opportunity for Improvement" (OFI) as a "minor" nonconformity, this would require you to initiate a corrective action... and the CB to verify and close the nonconformity (typically performed during the following site visit). While less expensive than a major non-conformity, each incorrectly classified "minor" nonconformity results in unnecessary administrative costs. 
  
-Due to the ambiguous/vague nature of many "requirements" contained in ISO 9001 & AS9100, the auditor must be able to justify each nonconformity (which the auditee may appeal to the CB). Due to the auditor's bias toward a particular interpretation of the standard, far too many auditors "//imagine//" nonconformities where none exist. It is recommended to always refer to the applicable definitions document when interpreting a standard. "//Notes//", whether in the terms and definitions section of a standard or in a vocabulary and definitions document, are NOT requirements.+If your company is certified to one of the AS91xx standards, minor nonconformances must be included in the [[articles:ocap|OCAP]] risk calculation... which could result in additional time added to your audits.
  
-===== Minor Nonconformities =====+You should be aware of the below "official" definitions and challenge the auditors to explain their justification for classifying a: 
 +  * nonconformity as a "Major" instead of a "Minor", and/or 
 +  * "Minor" nonconformity rather than an "Opportunity for Improvement" (OFI)
  
-<blockquote>ISO/IEC 17021-1 clause 3.13, Minor nonconformity \\ +Where you disagree over the classification, you should "[[articles:how_to_appeal_nonconformance|appeal]]" the nonconformity based on its classification (i.e., requesting the CB to reclassify the nonconformity). 
 + 
 +===== Definitions... ===== 
 +{{ :articles:dictionary-1619740_1920.jpg?direct&300|Source: https://pixabay.com/photos/dictionary-reference-book-learning-1619740/}} 
 +Before classifying a nonconformity as a minor or major, the auditor must have a clear understanding of their definitions. 
 + 
 +Nonconformity classifications are defined in [[https://www.iso.org/standard/61651.html|ISO/IEC 17021-1]] for both ISO 9001 & AS9100 audits. AS9101 expands these definitions for AS9100 series audits. However, IMO, AS9101 merely clarifies the vague definitions contained in ISO/IEC 17021-1. 
 + 
 +Due to the ambiguous/vague nature of many "requirements" contained in ISO 9001 & AS9100, the auditor must be able to justify each nonconformity (which the auditee may [[articles:how_to_appeal_nonconformance|appeal]] to the CB). Due to the auditor's bias toward a particular interpretation of the standard, far too many auditors "//imagine//" nonconformities where none exist. It is recommended to always refer to the applicable definitions document when interpreting a standard. "//Notes//", whether in the terms and definitions section of a standard or in a vocabulary and definitions document, are NOT requirements. 
 + 
 +ISO 9001 & AS9100, "Introduction, 0.1 General" (last sentence in section) states: 
 +<blockquote>Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.</blockquote> 
 +==== Minor Nonconformities ==== 
 + 
 +<blockquote>[[https://www.iso.org/obp/ui#iso:std:iso-iec:17021:-1:ed-1:v1:en:term:3.13|ISO/IEC 17021-1 clause 3.13, Minor nonconformity]] \\ 
 nonconformity that does not affect the capability of the management system to achieve the intended results.</blockquote> nonconformity that does not affect the capability of the management system to achieve the intended results.</blockquote>
  
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 In other words, a nonconformity that is NOT likely to result in the delivery of a nonconforming product or service. Examples of minor nonconformities may include: administrative errors in non-deliverable records or procedures, a lapse in following a procedure that did not impact the deliverable product or service, etc. In other words, a nonconformity that is NOT likely to result in the delivery of a nonconforming product or service. Examples of minor nonconformities may include: administrative errors in non-deliverable records or procedures, a lapse in following a procedure that did not impact the deliverable product or service, etc.
  
-===== Major Nonconformities =====+==== Major Nonconformities ====
  
-<blockquote>ISO/IEC 17021-1 clause 3.12, Major nonconformity \\ +<blockquote>[[https://www.iso.org/obp/ui#iso:std:iso-iec:17021:-1:ed-1:v1:en:term:3.12|ISO/IEC 17021-1 clause 3.12, Major nonconformity]] \\ 
 nonconformity that affects the capability of the management system to achieve the intended results. \\  nonconformity that affects the capability of the management system to achieve the intended results. \\ 
  
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 As you can see, the threshold for a Major Nonconformance is actually quite low. Consequently, many CBs ask their auditors to provide justification for identifying minor nonconformities that //could// be interpreted as major nonconformities. This justification should identify any factors mitigating the nonconformity from a major to a minor. As you can see, the threshold for a Major Nonconformance is actually quite low. Consequently, many CBs ask their auditors to provide justification for identifying minor nonconformities that //could// be interpreted as major nonconformities. This justification should identify any factors mitigating the nonconformity from a major to a minor.
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