SOP for Failure Investigation .
Standard Operating Procedure (SOP)
1. Purpose
To outline the procedure for investigating failures in processes, systems, products, or equipment to determine root causes, implement corrective actions, and prevent recurrence.
2. Scope
This SOP applies to all failures related to [products, processes, equipment, systems] within [Organization/Facility Name]. It covers the steps from the initial failure report to the resolution and preventive actions.
3. Responsibilities
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Failure Investigation Team: Conduct the investigation, identify root causes, and document findings.
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Quality Assurance (QA): Ensure proper documentation, compliance, and approval of corrective actions.
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Department Managers: Ensure that failure investigations are initiated when needed and that resources are provided.
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Technicians/Operators: Assist in failure identification, root cause determination, and troubleshooting.
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Corrective Action Coordinator: Track corrective and preventive actions (CAPA) until completion and effectiveness.
4. Definitions
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Failure: An event or condition where a product, process, system, or equipment does not meet specified requirements.
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Root Cause: The underlying reason for the failure, identified through investigation.
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Corrective Action: Actions taken to address the immediate cause of the failure.
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Preventive Action: Measures implemented to prevent recurrence of the failure.
5. Procedure
5.1 Failure Detection and Reporting
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Step 1: Detection
Failure can be detected through regular inspections, tests, audits, customer complaints, or internal reports. -
Step 2: Immediate Notification
As soon as a failure is detected, it should be reported to the relevant department (e.g., Quality, Production, Engineering) through a formal Failure Report Form. -
Step 3: Logging the Failure
The failure is logged into the system, including key details:-
Description of the failure
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Product, process, or equipment involved
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Date and time of detection
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Initial observations or symptoms
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5.2 Investigation Initiation
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Step 1: Assign Investigation Team
An investigation team is assigned, including experts from relevant departments (e.g., QA, Engineering, Production). The team should be led by a qualified investigation lead. -
Step 2: Define Scope and Objectives
The investigation scope must be clearly defined, including:-
The specific failure being investigated
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The systems, processes, or equipment impacted
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The goals (e.g., root cause identification, corrective action)
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5.3 Root Cause Analysis
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Step 1: Data Collection
Gather all relevant data, including:-
Operating conditions during failure
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Maintenance and service history
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Product or process specifications
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Inspection and test results
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Any environmental factors (e.g., temperature, humidity)
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Step 2: Failure Assessment
Evaluate the failure using appropriate analysis techniques:-
5 Whys Analysis: Ask “why” repeatedly to identify the root cause.
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Fishbone Diagram (Ishikawa): Use this tool to categorize potential causes (e.g., people, processes, equipment, materials).
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FMEA (Failure Mode and Effects Analysis): Assess failure modes and their consequences.
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Step 3: Hypothesis Testing
Test hypotheses or theories about potential causes by conducting additional tests, experiments, or simulations, if applicable.
5.4 Corrective Action and Resolution
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Step 1: Corrective Action Proposal
Once the root cause is identified, propose corrective actions to address the failure. These may include:-
Equipment repair or replacement
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Process adjustments
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Training or procedure updates
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Environmental or material changes
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Step 2: Corrective Action Implementation
Implement the corrective actions, ensuring proper resources are allocated for resolution. -
Step 3: Verification and Validation
Verify the effectiveness of the corrective actions through re-testing, re-inspections, or performance reviews to ensure the failure is resolved.
5.5 Preventive Action
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Step 1: Preventive Action Proposal
Based on the findings, propose preventive actions to reduce the likelihood of recurrence. These might include:-
Updated procedures or work instructions
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Enhanced monitoring systems or controls
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Long-term equipment upgrades
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Step 2: Preventive Action Implementation
Implement preventive measures and communicate any changes to affected departments. -
Step 3: Monitor Effectiveness
Monitor the effectiveness of both corrective and preventive actions over time to ensure that the failure does not recur.
5.6 Documentation and Reporting
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Document the entire investigation process, including:
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Investigation team members
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Root cause analysis results
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Corrective and preventive actions
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Implementation dates and completion status
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Verification and validation outcomes
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Prepare an Investigation Report detailing:
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Summary of the failure event
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Analysis methodology used
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Root cause findings
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Actions taken (corrective and preventive)
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Recommendations for future improvements
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Distribute the report to relevant stakeholders for approval.
6. Documentation and Record Keeping
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Failure Report Form
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Root Cause Analysis Reports
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Investigation Reports
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Corrective and Preventive Action Logs
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Verification and Validation Records
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Failure Tracking System Logs
7. Monitoring and Review
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Review completed failure investigations regularly to ensure CAPA effectiveness.
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Track the number and frequency of failures to identify potential systemic issues.
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Conduct periodic audits of failure investigation procedures to assess adherence to the SOP.
8. References
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ISO 9001 Quality Management System
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Corrective and Preventive Action (CAPA) Guidelines
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Root Cause Analysis Best Practices
9. Annexures
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Annex 1: Failure Report Template
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Annex 2: Root Cause Analysis Tools (e.g., Fishbone Diagram, 5 Whys Template)
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Annex 3: Corrective and Preventive Action Tracking Form.
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