The 6M (Man, Machine, Method, Material, Measurement, Mother Nature) Tool Analysis helps in identifying

the root cause of an issue by evaluating all possible contributing factors. Below is the root cause analysis for the
issue:

Problem Statement:

"Reconciliation of approved and rejected labels is not maintained as per the SOP, and the stock was not matching
with the physical stock."

1. Man (People-related factors)

 Lack of awareness or training among employees about proper reconciliation procedures.

 Human errors in data entry, counting, or reconciliation.
 Negligence or non-compliance with SOPs.
 Insufficient manpower for reconciliation tasks, leading to rushed or skipped steps.

2. Machine (Equipment-related factors)

 Label printing machine errors leading to discrepancies in the number of labels printed vs. recorded.
 Barcode scanning errors affecting reconciliation accuracy.
 ERP/system issues causing incorrect stock updates.

3. Method (Process-related factors)

 Ineffective or outdated SOPs leading to confusion in reconciliation procedures.

 Lack of a structured process for tracking approved and rejected labels.
 Absence of a secondary verification step in reconciliation.
 Inconsistent application of SOPs across different shifts or teams.

4. Material (Label and Stock-related factors)

 Defective or duplicate labels leading to mismatches in count.

 Misplacement or loss of labels due to improper handling.
 Unauthorized access to labels, leading to potential mismanagement.
 Stock movement without proper documentation.

5. Measurement (Data & Documentation-related factors)

 Inaccurate recording of issued, approved, and rejected labels.

 Discrepancies in manual vs. system entries.
 Lack of real-time reconciliation reports.
 Poor audit trail or missing documentation.

6. Mother Nature (Environmental factors)

 Storage conditions affecting label integrity, causing misidentification.

 Poor lighting or workspace layout leading to counting errors.
 Unintentional mixing of labels due to workspace clutter.
Conclusion & Recommendations:

1. Training & Awareness: Conduct regular training sessions on SOP adherence and reconciliation processes.
2. Process Improvement: Implement a barcode-based reconciliation system to reduce manual errors.
3. SOP Review & Enforcement: Update SOPs to include real-time reconciliation checkpoints.
4. Technology Integration: Use automated inventory tracking tools to sync physical and system records.
5. Regular Audits: Conduct routine internal audits to identify discrepancies early.
6. Accountability Measures: Assign responsibility for reconciliation tasks with verification steps.

Conclusion:

By implementing both corrective and preventive actions, the reconciliation process will improve, ensuring
compliance with SOPs and eliminating stock mismatches. Would you like a structured implementation timeline for
these actions?

Here's an Ishikawa (Fishbone) Diagram for analyzing the root causes of the issue:

Problem Statement:

"Reconciliation of approved and rejected labels is not maintained as per SOP, leading to stock mismatches."

Fishbone Diagram Structure

1. Man (People-Related Causes)

 Lack of training on reconciliation SOP.

 Negligence or non-compliance with SOP.
 Insufficient manpower for reconciliation tasks.
 Human errors in label counting and documentation.

2. Machine (Equipment-Related Causes)

 ERP/system glitches causing stock mismatches.

 Barcode scanner malfunction leading to incorrect tracking.
 Label printing machine errors (e.g., misprints, duplicates).

3. Method (Process-Related Causes)

 Ineffective SOPs leading to inconsistent reconciliation.

 No structured process for tracking approved/rejected labels.
 Absence of a secondary verification step.
 Lack of a standardized reconciliation report.

4. Material (Label and Stock-Related Causes)

 Misplaced or lost labels due to improper handling.

 Duplicate, defective, or unaccounted-for labels.
 Unauthorized access to label storage.
 Stock movement without proper documentation.
5. Measurement (Data & Documentation Causes)

 Errors in recording issued, approved, and rejected labels.

 Discrepancies between physical and system records.
 Lack of real-time reconciliation updates.
 No proper audit trail for label reconciliation.

6. Mother Nature (Environmental Causes)

 Poor storage conditions leading to label deterioration.

 Cluttered workspace causing misplacement of labels.
 Poor lighting affecting manual reconciliation accuracy.

Visual Representation:

Since I can't directly draw the diagram, here’s how you can structure it:

pgsql
CopyEdit
┌─────────── Man ────────────┐
│ - Lack of training │
│ - Human error │
│ - Insufficient manpower │
│ - Negligence │
├───────────────────────────┤
│ Machine │
│ - ERP glitches │
│ - Scanner malfunction │
Problem: │ - Label printing errors │
"Reconciliation ├───────────────────────────┤
not maintained │ Method │
as per SOP" │ - Ineffective SOPs │
│ - No verification step │
│ - No reconciliation logs │
├───────────────────────────┤
│ Material │
│ - Misplaced labels │
│ - Defective labels │
│ - Unauthorized access │
├───────────────────────────┤
│ Measurement │
│ - Recording errors │
│ - No audit trail │
│ - System discrepancies │
├───────────────────────────┤
│ Mother Nature │
│ - Poor storage │
│ - Cluttered workspace │
│ - Poor lighting │
└───────────────────────────┘

Would you like me to generate a graphical version of the Ishikawa diagram?

Model Report: Root Cause Analysis & CAPA for Label Reconciliation Issue

1. Title: Root Cause Analysis (RCA) and Corrective & Preventive Actions (CAPA) for Label Reconciliation Non-
Compliance
2. Objective: To investigate the root causes of discrepancies in the reconciliation of approved and rejected labels
and implement corrective and preventive actions to ensure compliance with SOP and eliminate stock mismatches.

3. Problem Statement: The reconciliation of approved and rejected labels is not maintained as per the SOP,
leading to mismatches between system records and physical stock.

4. Root Cause Analysis (RCA) - 6M Methodology

A. Man (People-Related Causes):

 Lack of awareness/training regarding SOP compliance.

 Human errors in label counting and documentation.
 Insufficient manpower for reconciliation tasks.
 Negligence or non-adherence to reconciliation procedures.

B. Machine (Equipment-Related Causes):

 ERP/system glitches leading to incorrect stock records.

 Barcode scanner errors affecting tracking accuracy.
 Label printing machine producing duplicates or misprints.

C. Method (Process-Related Causes):

 Ineffective or outdated SOPs for label reconciliation.

 Lack of structured process for tracking approved/rejected labels.
 No secondary verification step for reconciliation.
 Inconsistent implementation of SOP across shifts or teams.

D. Material (Label and Stock-Related Causes):

 Defective, misplaced, or duplicate labels leading to stock mismatches.

 Unauthorized access to label storage leading to mismanagement.
 Movement of stock without proper documentation.

E. Measurement (Data & Documentation-Related Causes):

 Inaccurate manual data entry leading to discrepancies.

 Discrepancies between system records and physical counts.
 Lack of real-time reconciliation updates and audit trails.

F. Mother Nature (Environmental Causes):

 Poor storage conditions affecting label integrity.

 Cluttered workspace leading to misplacement of labels.
 Poor lighting and ergonomic conditions impacting counting accuracy.

5. Corrective and Preventive Actions (CAPA)

A. Corrective Actions (Immediate Fixes):

1. Stock Reconciliation Audit: Conduct an immediate audit of labels and correct discrepancies.
2. Manual Data Verification: Cross-check past records and correct any errors found.
3. Temporary Label Control Measures: Restrict access to labels to authorized personnel only.
4. Immediate Training: Conduct refresher training sessions on SOP adherence.
5. System Record Updates: Update system records to reflect actual stock and introduce a double-check
process.

B. Preventive Actions (Long-Term Solutions):

1. SOP Revision and Enforcement:

o Revise and strengthen SOPs to include stricter reconciliation steps.
o Introduce a checklist-based reconciliation process.
2. Barcode-Based Reconciliation System:
o Implement barcode scanning to track approved/rejected labels in real-time.
o Ensure system-generated stock updates to avoid manual errors.
3. Segregation of Labels:
o Designate separate storage areas for approved, rejected, and pending labels.
o Introduce clear labeling and tagging for identification.
4. ERP/Inventory System Enhancement:
o Integrate auto-reconciliation features to reduce manual dependency.
o Set up alerts for stock mismatches in real-time.
5. Regular Monitoring and Audits:
o Implement a daily reconciliation log to track label usage.
o Conduct weekly/monthly internal audits to ensure compliance.
6. Ongoing Staff Training and Accountability:
o Provide regular training sessions on reconciliation and inventory management.
o Assign responsibility for label reconciliation with a sign-off process.

6. Expected Outcomes:

 Elimination of stock mismatches through accurate reconciliation.

 Improved SOP compliance through staff training and process automation.
 Enhanced accuracy in label tracking using barcode-based reconciliation.
 Reduction in human errors through system integration and automated alerts.
 Strengthened audit trails for accountability and transparency.

7. Implementation Timeline:

Action Responsible Party Timeline

Immediate stock audit Quality & Inventory Team 1 Week

ERP System Updates IT Department 2 Weeks

SOP Revision & Training Quality & HR 4 Weeks

Barcode System Implementation IT & Inventory 8 Weeks

Monthly Internal Audits Compliance Team Ongoing

8. Conclusion:

By implementing the corrective and preventive actions outlined, the organization can effectively mitigate risks
associated with label reconciliation discrepancies. These measures will enhance process efficiency, ensure
regulatory compliance, and maintain accurate stock records.

Prepared by: [Your Name]

Date: [Insert Date]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]

Impact Analysis: Reconciliation of Approved and Rejected Labels Not Maintained as per SOP

Failure to reconcile approved and rejected labels according to SOP, resulting in stock mismatches, can have
significant consequences across various areas:

1. Compliance & Regulatory Impact

 Regulatory Non-Compliance: Deviation from SOPs may lead to non-compliance with Good
Manufacturing Practices (GMP), FDA, ISO, or other regulatory standards.
 Audit Failures: Failure to maintain accurate reconciliation records can result in findings during internal
or external audits, leading to penalties, warnings, or legal actions.
 Quality Violations: Mismatched stock records raise concerns about product integrity, leading to potential
batch recalls or regulatory scrutiny.

2. Product Quality & Safety Impact

 Risk of Incorrect Labeling: Incorrect reconciliation can cause mix-ups in label usage, leading to
mislabeling of products, which is a serious quality defect.
 Potential Product Recalls: If mislabeled products reach the market, it may result in costly recalls,
damaging the company’s reputation.
 Contamination & Cross-Usage Risks: Untracked rejected labels might be reused mistakenly, leading to
safety hazards.

3. Operational Impact

 Production Delays: Unclear label reconciliation can cause confusion, leading to delays in manufacturing,
packaging, and shipping.
 Inventory Discrepancies: System vs. physical stock mismatches can lead to incorrect material planning
and procurement issues.
 Rework & Additional Costs: Extra efforts are required to recheck, recount, and correct discrepancies,
increasing labor costs and operational inefficiencies.
4. Financial Impact

 Loss of Revenue: Incorrect stock reconciliation can lead to product holds, shipment delays, or loss of
customer trust, impacting sales and revenue.
 Increased Operational Costs: Additional audits, investigations, and corrective actions add unexpected
expenses.
 Penalties & Fines: Regulatory violations may lead to monetary fines and increased scrutiny from
governing bodies.

5. Customer Trust & Reputation Impact

 Brand Reputation Damage: Repeated issues with reconciliation and stock mismatches can lead to
customer dissatisfaction and loss of confidence in product reliability.
 Supplier & Client Disruptions: Incorrect label reconciliation affects supply chain partners,
distributors, and end consumers, leading to loss of business opportunities.

Conclusion & Next Steps

To mitigate these risks, immediate corrective and preventive actions (CAPA) should be implemented, including
SOP revisions, staff training, system improvements, and barcode-based reconciliation methods.