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articles:how_iso_perpetuates_flawed_concepts [2023/04/19 20:13] – [Perpetuatuation of "flawed" Concepts] rrandall | articles:how_iso_perpetuates_flawed_concepts [2023/05/17 10:01] – [Perpetuatuation of "flawed" Concepts] rrandall |
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I've never seen a single instance of a "Quality Policy", or lack thereof, have any impact on the QMS at all. | I've never seen a single instance of a "Quality Policy", or lack thereof, have any impact on the QMS at all. |
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Consequently, to the educated Quality Professional, ISO 9001 is a living philosophical battleground. In some cases (particularly with AS 9100) the standard even contains contradictory requirements. While ISO 9001 (and all of the QMS standards using it as a base) promotes the concept of continuous improvement, it also mandates the institutionalization of flawed concepts that perpetuate the status quo. Worse, QMS certification to these standards promotes mediocrity and creates a //constraint// hindering innovative improvements. | Consequently, to the educated Quality Professional, ISO 9001 is a living philosophical battleground. And the AS 9100 standard even contains contradictory requirements. |
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<box 80% round blue|**AS9100 Contradictory Requirements**> | <box 80% round blue|**AS9100 Contradictory Requirements**> |
When using ANY sampling plan, an AQL (or equivalent) must first be determined. The AQL (defined in [[https://www.iso.org/standard/1141.html|ISO 2859-1:1999]]) represents the maximum percentage of defective units, beyond which a batch is rejected. For example, an "AQL of 1.5%” means “//The company is willing to ACCEPT that there will be no more than 1.5% defective items in the entire order quantity, on average over several production runs//”. Companies usually establish different AQLs for critical, major, and minor defects. \\ | When using ANY sampling plan, an AQL (or equivalent) must first be determined. The AQL (defined in [[https://www.iso.org/standard/1141.html|ISO 2859-1:1999]]) represents the maximum percentage of defective units, beyond which a batch is rejected. For example, an "AQL of 1.5%” means “//The company is willing to ACCEPT that there will be no more than 1.5% defective items in the entire order quantity, on average over several production runs//”. Companies usually establish different AQLs for critical, major, and minor defects. \\ |
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Now, the contradiction is contained in AS9100 is sec. 8.7.1: \\ | The contradiction is contained in AS9100 is sec. 8.7.1: \\ |
"//The organization’s nonconformity control process shall be maintained as documented information including the provisions for: \\ | "//The organization’s nonconformity control process shall be maintained as documented information including the provisions for: \\ |
− defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts (see 10.2).//" \\ | − defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts (see 10.2).//" \\ |
Obviously, if the company must define "corrective actions for nonconforming products and services detected after delivery", then it makes no sense to allow the establishment of ANY sampling plan (including c=0 plans) BECAUSE that sampling plan allows for an ACCEPTABLE number of defects to be shipped! \\ | Obviously, if the company must define "corrective actions for nonconforming products and services detected after delivery", then it makes no sense to allow the establishment of ANY sampling plan (including c=0 plans) BECAUSE that sampling plan allows for an ACCEPTABLE number of defects to be shipped! \\ |
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Even more interesting, AS9101F, sec. 3.3 defines a "Major Nonconformity as: \\ | Even if we adopt a more lax interpretation of the above requirement, AS9101F, sec. 3.3 defines a "Major Nonconformity as: \\ |
//• any nonconformity that can result in the probable delivery of nonconforming product or service;// \\ | //• any nonconformity that can result in the probable delivery of nonconforming product or service;// \\ |
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Consequently, using a sampling plan (compliant with AS9100, 8.5.1C,2) can result in a Major Nonconformity!!! | Consequently, using a sampling plan (compliant with AS9100, 8.5.1C,2) can result in a Major Nonconformity being issued by the Certification Body!!! |
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