This document provides a standardized method for classifying the root causes of issues according to the "Six M's": Man, Machine, Method, Material, Measurement, and Mother Nature. It outlines major and minor cause categories for each of the Six M's. For example, under "Man" the major cause category is "Personnel Related" and minor categories include "Training Related" and "Procedure was not Followed." The goal is to standardize root cause reporting.

1. Root Cause Classification
Standardizing the reporting method

2. Prepared by: Tarek Elneil
telneil@msn.com

3. The Process Six “M”
Manufacturing Categories
• Man
• Machine
• Method
• Measurement
• Material
• Mother Nature

4. Man
Major Causes Category Minor Causes Category Causes Subcategory
Personnel Related
Training Related Inadequate Training
Lack of Required Skills
Lack of Knowledge
Inadequate GMP Training
Inadvertent Error Inadvertent Error
Procedure was not Followed Verbal Instruction
Lack of Instruction Lack of Instruction

5. Machin
Major Causes Category Minor Causes Category Causes Subcategory
Equipment Related Problem Line Clearance Was not Performed
Set Up Wrong Setting
Preventive Maintenance PM Failure
Equipment Control Equipment Identification Problem

6. Material
Major Causes Category Minor Causes Category Causes Subcategory
Material Related Problem Supplier Related Supplier Change Control Failure
Supplier Process Control Failure
Storage Related Inadequate Environment Control
Lack of Storage Procedure
No Expiration Date
Expired Material
Material Identification Misidentified Material
Wrong Labeling
Purchasing Related Wrong Shipment/ Order
Unapproved Supplier
Inadequate Purchase Control
Material Control Inventory Control Problem
Lack of Quarantine

7. Method
Major Causes Category Minor Causes Category Causes Subcategory
Procedure Design Control Related Design Input
Design Output
Design Verification
Design Validation
Design Transfer
Risk Assessment New Risk Identified
Inadequate Risk Assessment
Validation Related Test Method Validation
Process Validation
Procedure Related Procedure was not Clear
Contradicting Instruction
Lack of Procedure
Inadequate Procedure
Change Control Inadequate Change Control
Change Control was not followed
Missing Change Control

8. Measurements
Major Causes Category Minor Causes Category Causes Subcategory
Testing and Inspections Specification Related Missed Specification
Lack of Receiving Inspection
Calibration Related Out of Calibration Instrument
Wrong Calibration Method
Vendor Calibration Issue
Measurements Variation Gage R&R (Repeatability and Reproducibility) Failure
Measuring Method Variation
Sampling Issue Inadequate Sampling Plan
Sampling Related Problem

9. Mother Nature
Major Causes Category Minor Causes Category Causes Subcategory
Environmental Environmental Control Inadequate Environmental Control
System Failure
Environment Control Equipment Failure
Preventive Maintenance Failure

10. Inconclusive Results
Major Causes Category Minor Causes Category Causes Subcategory
Inconclusive Insufficient Information No Objective Evidence was provided
Root Cause couldn’t be determined
No Conclusion can be reached
Problem was not found Reported failure could not duplicated