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articles:those_who_fail_to_plan [2020/04/27 22:01] – rrandall | articles:those_who_fail_to_plan [2021/09/29 17:44] (current) – rrandall | ||
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- | As a Quality Management System (QMS) auditor and consultant, I’ve visited many companies during my career… including several Fortune 500 companies. And I've observed that MANY of the nonconformities identified, whether internally or from external QMS auditors, have similar root causes. | + | As a Quality Management System (QMS) auditor and consultant, I’ve visited many companies during my career… including several Fortune 500 companies. And I've observed that MANY of the nonconformities identified, whether internally or from external QMS auditors, have similar root causes. |
- | ^ Category | + | When Root Cause Analysis (RCA) is reduced to simply identifying the proper “Drop-Down List” selection, it becomes obvious that the difference between "// |
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+ | One of the best and most effective tools for performing a structured RCA is the Ishikawa Fishbone chart (shown below). Fishbone charts typically categorize problems through the 6 Ms (Manpower, Materials, Measurements, | ||
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+ | And Fishbone charts are commonly used as a structured approach to identifying " | ||
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+ | Had a series of PFMEAs (Process Failure Mode and Effects Analysis) been completed during the planning stage, virtually all of the "root causes" | ||
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+ | Very few of the companies I've visited have ever performed any PFMEAs as part of their planning. IF they had, then the costs associated with their product returns, customer complaints, and performing individual Root Cause Analysis (RCAs) and Corrective Actions would have been dramatically reduced. This is especially true when "// | ||
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+ | Below are some common examples of " | ||
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+ | ^ Category | ||
| Personnel | | Personnel | ||
| ::: | Training not updated to stay aligned with process changes (e.g., new equipment) | | ::: | Training not updated to stay aligned with process changes (e.g., new equipment) | ||
| ::: | Instructor Knowledge / Competence (Lack of a "Train the Trainer" | | ::: | Instructor Knowledge / Competence (Lack of a "Train the Trainer" | ||
| ::: | Trainee Comprehension / Understanding (Lack of, or inadequate testing) | | ::: | Trainee Comprehension / Understanding (Lack of, or inadequate testing) | ||
- | | ::: | Trainee Competence (Ineffective | + | | ::: | Trainee Competence (Ineffective demonstration of competence) |
| ::: | Requirements not communicated (due to ineffective communication between functions & Personnel) | | ::: | Requirements not communicated (due to ineffective communication between functions & Personnel) | ||
| Materials | Incorrect material received - due to incorrect specifications communicated to the supplier | | Materials | Incorrect material received - due to incorrect specifications communicated to the supplier | ||
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| ::: | Foreign Object Debris / Damage (FOD) | | | ::: | Foreign Object Debris / Damage (FOD) | | ||
- | While many " | + | So why isn't your company performing PFMEAs... or equivalent risk assessments? |
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- | Because, IF a series of PFMEAs (Process Failure Mode and Effects Analysis) had been completed during the planning stage, virtually all of the above "root causes" | + | |
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- | Very few of the companies I've visited have ever performed any PFMEAs as part of their planning. IF they had, then the costs associated with their product returns, customer complaints, and performing individual Root Cause Analysis (RCAs) and Corrective Actions would have been dramatically reduced. | + | |
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- | So why isn't your company performing PFMEAs? | + | |