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| | ====== How Certification Bodies Classify Minor & Major Nonconformities ====== |
| | {{keywords>How Certification Bodies Classify Minor and Major Nonconformities}} |
| | ===== Why should you care? ===== |
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| | 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. |
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| | 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. |
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| | 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. |
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| | 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) |
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| | 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). |
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| | ===== 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. |
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| | 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. |
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| | 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. |
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| | 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 ==== |
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| | <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> |
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| | And |
| | <blockquote>AS9101F, sec. 3.4 Minor Nonconformity \\ |
| | The requirements of ISO/IEC 17021-1 clause 3.13 apply. \\ |
| | In addition a minor nonconformity can be a single system failure or lapse in conformity to meet a 9100-series standard requirement, customer QMS requirement, or documented information defined by the organization.</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. |
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| | ==== Major Nonconformities ==== |
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| | <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. \\ |
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| | //Note 1 to entry: Nonconformities could be classified as major in the following circumstances: \\ |
| | • if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements; \\ |
| | • a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus |
| | constitute a major nonconformity.//</blockquote> |
| | |
| | And |
| | <blockquote>AS9101F, sec. 3.3 Major Nonconformity \\ |
| | The requirements of ISO/IEC 17021-1 clause 3.12 apply. \\ |
| | In addition, a major nonconformity can be one or more of the following situations: \\ |
| | • a nonconformity where the effect is judged to be detrimental to the integrity of the product or service; \\ |
| | • the absence of or total breakdown of a system to meet a 9100-series standard requirement, a customer QMS requirement, or documented information defined by the organization; \\ |
| | • any nonconformity that can result in the probable delivery of nonconforming product or service; and \\ |
| | • a condition that can result in the failure or reduce the usability of the product or service and its intended purpose.</blockquote> |
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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. |
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