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Deviation

In the chemical industry, a deviation is any departure from approved procedures or regulations, categorized into planned, unplanned, and critical deviations. The Change Control Process for managing deviations includes steps such as identification, risk assessment, documentation, investigation, corrective actions, approval, implementation, and closure. Proper management of deviations is essential for ensuring product quality, safety, and regulatory compliance.

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6 views

Deviation

In the chemical industry, a deviation is any departure from approved procedures or regulations, categorized into planned, unplanned, and critical deviations. The Change Control Process for managing deviations includes steps such as identification, risk assessment, documentation, investigation, corrective actions, approval, implementation, and closure. Proper management of deviations is essential for ensuring product quality, safety, and regulatory compliance.

Uploaded by

ramkarn7989
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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What is a Deviation?

In the chemical industry, a deviation refers to any departure from approved procedures, specifications,
or regulatory requirements. This can occur in production, quality control, safety, or environmental
compliance. Deviations are categorized as:

1. Planned Deviation – A temporary, pre-approved change from standard procedures.

2. Unplanned Deviation – An unexpected departure that occurs during operations and needs
investigation.

3. Critical Deviation – A deviation that significantly affects product quality, safety, or regulatory
compliance.

Change Control Process for Managing Deviations

To ensure deviations are properly managed and controlled, companies follow a Change Control Process,
which includes the following steps:

1. Identification of Deviation

 Any employee can report a deviation when they notice a discrepancy.

 Example: A batch process temperature exceeds the standard operating limit due to equipment
malfunction.

2. Categorization & Risk Assessment

 Assess the impact of the deviation on safety, product quality, and regulatory compliance.

 Example: A solvent purity deviation is detected in raw materials—evaluate whether it affects


product stability.

3. Documentation

 Record the details in a Deviation Report, including:

o Date, time, location

o Description of deviation

o Possible root cause

o Immediate actions taken

4. Investigation & Root Cause Analysis (RCA)

 Use techniques like 5-Why Analysis or Fishbone Diagram to find the root cause.

 Example: If a filter failure caused contamination, investigate whether it was due to improper
maintenance, supplier defect, or operator error.

5. Corrective and Preventive Actions (CAPA)


 Corrective Action: Immediate fix to resolve the current issue.

o Example: Replace the faulty filter.

 Preventive Action: Long-term fix to prevent recurrence.

o Example: Implement a stricter filter maintenance schedule.

6. Approval Process (Change Control Board - CCB)

 The deviation and proposed actions must be approved by the Quality Assurance (QA) and
Regulatory Team before implementation.

 Example: If a substitute raw material is used due to a supplier issue, the regulatory team must
confirm compliance with standards.

7. Implementation & Monitoring

 Implement the approved changes and monitor the effectiveness of the corrective action.

 Example: If a new exhaust system is installed to improve ventilation, airflow must be monitored
for compliance.

8. Closure & Documentation

 Once the deviation is resolved and effectiveness verified, the report is closed.

 Example: If an operator training deficiency caused the deviation, ensure training records are
updated.

Example of Change Control in Chemical Industry

Scenario: A chemical company uses Solvent X in production, but due to a supplier issue, they need to
temporarily switch to Solvent Y.

1. Deviation Identification – Supplier informs they cannot deliver Solvent X on time.

2. Risk Assessment – Evaluate whether Solvent Y is chemically and functionally equivalent.

3. Documentation – Deviation Report is created, stating reasons for substitution.

4. Investigation – Lab testing confirms Solvent Y does not affect product quality.

5. Approval – Quality and regulatory teams approve the temporary change.

6. Implementation – Solvent Y is used for the batch, and additional monitoring is conducted.

7. Verification & Closure – After confirming no issues, the deviation report is closed.

Key Takeaways
✔ Deviations should be documented and justified properly
✔ Risk assessment ensures product quality and safety
✔ Approval from QA & regulatory team is mandatory before changes
✔ CAPA helps prevent future deviations

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