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--- articles:those_who_fail_to_plan [2020/04/30 23:03] – rrandall
+++ articles:those_who_fail_to_plan [2021/09/29 17:44] (current) – rrandall
@@ Line 5: / Line 5: @@
 {{ :articles:those_who_fail_to_plan.png?nolink |}}
-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 to create Pareto charts for analysis! For example:
+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 in a misguided effort to assist management in creating Pareto charts to identify the "significant few" from the "trivial many" root causes.
-^  Category  ^  Root Cause  ^
+When Root Cause Analysis (RCA) is reduced to simply identifying the proper “Drop-Down List” selection, it becomes obvious that the difference between "//common cause variation//" and "//special cause variation//" is not understood. This indicates a fundamentally flawed QMS!
+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, Machines, Methods & Mother Nature) that originated with Lean Manufacturing and the Toyota Production System.
+{{ :articles:1920px-cause_and_effect_diagram_for_defect-transparent.png?nolink&700 | Ishikawa Fishbone Chart }}
+And Fishbone charts are commonly used as a structured approach to identifying "Failure Modes" in a FMEA (Failure Mode and Effects Analysis).
+Had a series of PFMEAs (Process Failure Mode and Effects Analysis) been completed during the planning stage, virtually all of the "root causes" (//special cause variations//) would have been eliminated before they were realized. And where issues are identified that contribute to process "//common cause variation//" (that can only be eliminated through changing the process), the PFMEA will be helpful in identifying actions to "mitigate" the likelihood of occurrence and/or the severity of its impact.
+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  "//common cause//" variations have been misidentified as "//special cause//" variations... leading to completely ineffective corrective actions.
+Below are some common examples of "Failure Modes" categorized within the 6 Ms:
+^  Category  ^  Failure Mode  ^
 | Personnel  | Training Content (e.g., incomplete, confusing/cryptic, obsolete)  |
 | :::       | Training not updated to stay aligned with process changes (e.g., new equipment)  |
 | :::       | Instructor Knowledge / Competence (Lack of a "Train the Trainer" program) |
 | :::       | Trainee Comprehension / Understanding (Lack of, or inadequate testing)  |
-| :::       | Trainee Competence (Ineffective of demonstration of competence)  |
+| :::       | Trainee Competence (Ineffective demonstration of competence)  |
 | :::       | Requirements not communicated (due to ineffective communication between functions & Personnel)  |
 | Materials | Incorrect material received - due to incorrect specifications communicated to the supplier  |
@@ Line 38: / Line 53: @@
 | :::       | Foreign Object Debris / Damage (FOD)  |
-While many "Corrective Action" software companies create their own categories, I chose the above categories because they reflect the 6 Ms (Manpower, Materials, Measurements, Machines, Methods & Mother Nature) that originated with Lean Manufacturing and the Toyota Production System. These same categories typically appear in Ishikawa Fishbone charts (shown below). And Fishbone charts are commonly used as a structured approach to identifying "Failure Modes" in a FMEA (Failure Mode and Effects Analysis).
+So why isn't your company performing PFMEAs... or equivalent risk assessments?
-{{ :articles:1920px-cause_and_effect_diagram_for_defect_xxx.svg.png?nolink&700 | Ishikawa Fishbone Chart }}
-If your company is creating Pareto charts to analyze and differentiate the "significant few" from the "trivial many" root causes... you have a fundamentally flawed QMS!
-Had a series of PFMEAs (Process Failure Mode and Effects Analysis) been completed during the planning stage, virtually all of the above "root causes" would have been eliminated before they were realized.
-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.
-So why isn't your company performing PFMEAs?