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articles:those_who_fail_to_plan [2020/05/12 11:29] – 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. This is so common that some “Corrective Action” software databases include a selection of “typical” root causes in “Drop-Down List” - presumably to allow management | + | 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. This is so common that some “Corrective Action” software databases include a selection of “typical” root causes in a “Drop-Down List” - presumably |
- | While many " | + | When Root Cause Analysis (RCA) is reduced to simply identifying |
- | {{ : | + | One of the best and most effective tools for performing a structured RCA is the Ishikawa Fishbone |
- | If your company is creating Pareto charts to analyze and differentiate the " | + | {{ : |
- | Had a series of PFMEAs | + | And Fishbone charts are commonly used as a structured approach to identifying " |
- | 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. | ||
- | Below are some common examples | + | Had a series |
- | ^ Category | + | 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 "// |
+ | |||
+ | Below are some common examples of " | ||
+ | |||
+ | ^ 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) | | ||
- | So why isn't your company performing PFMEAs? | + | So why isn't your company performing PFMEAs... or equivalent risk assessments? |