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| articles:human_factors [2021/12/23 19:20] – [Are nonconformities resulting from Human Factors "Common Cause" or "Special (Assignable) Cause" Variations?] rrandall | articles:human_factors [2023/03/09 15:46] (current) – [Are nonconformities resulting from Human Factors "Common Cause" or "Special (Assignable) Cause" Variations?] rrandall | ||
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| + | ====== Human Factors ====== | ||
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| + | While not specifically mentioned in ISO 9001:2015 (other than a awkwardly written " | ||
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| + | 10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall: \\ | ||
| + | b. evaluate the need for action to eliminate the cause(s) of the nonconformity, | ||
| + | 2. determining the causes of the nonconformity, | ||
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| + | However, ISO 9001 does require: | ||
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| + | Controlled conditions shall include, as applicable: \\ | ||
| + | g. the implementation of actions to prevent __human error__; | ||
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| + | ===== What are Human Factors? ===== | ||
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| + | I find that AS 9100 clients (and many AS 9100 auditors) have difficulty understanding “human factors”. And I typically mention the availability of the FAA “Dirty Dozen” Human Factors. You can download this 2-page PDF from: | ||
| + | [[https:// | ||
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| + | ^ The FAA “12 Common Causes of Human Factors Errors” publication includes: | ||
| + | | 1. Lack of Communication | ||
| + | | 2. Complacency | ||
| + | | 3. Lack of Knowledge | ||
| + | | 4. Distractions | ||
| + | | 5. Lack of Teamwork | ||
| + | | 6. Fatigue | ||
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| + | Since human factors are mentioned in AS 9100, sec. 10.2, many assume that it is required to eliminate root causes associated with human factors. In the vast majority of cases, this is not true. I recommend reading the AMT (FAA " | ||
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| + | The AMT Handbook: Chapter 14, Human Factors, can be downloaded from: | ||
| + | [[https:// | ||
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| + | There is also a quadrant tool (similar to a SWOT) for determining the " | ||
| + | {{ : | ||
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| + | <WRAP center round tip 80%> | ||
| + | An excellent source of news and information about Aviation-related Human Factors is the " | ||
| + | </ | ||
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| + | ===== Are nonconformities resulting from Human Factors " | ||
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| + | The answer depends on whether an assignable cause can be identified. In the majority of cases, an assignable cause does not exist. In this case, the nonconformity should be evaluated to determine whether the current risk controls are within an acceptable risk tolerance (established by the company). If not, then there may be additional risk controls that can be put into place to mitigate the risk to an acceptable risk tolerance. | ||
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| + | However, if there is an assignable cause... then it may be possible to implement "error proofing" | ||
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| + | " | ||
| + | [[https:// | ||
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| + | <WRAP center round important 80%> | ||
| + | MANY of the "Poke Yoka" examples provided by " | ||
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| + | Be sure to distinguish between "Risk Mitigation" | ||
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| + | ^ Action | ||
| + | | Fuse box lock-out procedures so that power cannot be turned on before an electrical repair is complete and all personnel are out of harm's way. | Risk Mitigation (making it difficult for workers to unknowingly re-introduce electrical power) | ||
| + | | Guide pins to guarantee proper alignment. | ||
| + | | Color-coding of components that otherwise look similar. | ||
| + | | Bins of parts that are electronically connected to the bill of materials through a barcode scanner, so that only the proper bin door opens for a given product. | ||
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| + | One of the most common failed attempts at error proofing we see appears in documents, e-mails & text messages. Of course, I'm speaking of the auto-spell correction. These have resulted in some hilarious memes. These are much better described as "risk mitigation" | ||
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