TRAINING ON DEVIATION HANDLING

Engr. Tahir Iqbal

Manager QC
2023
 Introduction

• Welcome to the training on "Deviation Handling." This training is designed to

equip you with the necessary skills to effectively manage and address deviations
in our processes. Proper deviation handling is crucial for maintaining product
quality and regulatory compliance.
 What is a Deviation?

• Definition: A deviation is any departure from established procedures,

specifications, or expected results.
• Example: A deviation occurs when a batch of product fails to meet the specified
quality standards during manufacturing.
 Importance of Deviation Handling

• Deviations can impact product quality, safety, and regulatory compliance.

• Example: A deviation in the laboratory testing process can lead to inaccurate
results, potentially affecting product safety and efficac
 Types of Deviations
• Manufacturing Deviation: Deviation that occurs during the production process.
• Example: A deviation in the mixing procedure results in incorrect proportions of
ingredients.
• Laboratory Deviation: Deviation related to analytical testing or calibration.
• Example: A deviation in the calibration of testing equipment leads to inaccurate
measurements.
• Equipment Deviation: Deviation associated with equipment malfunction or failure.
• Example: A deviation occurs when a critical machine breaks down during production.
 Deviation Reporting Process

• Timely and accurate reporting of deviations is essential.

• Example: An operator notices an abnormality during the manufacturing
process and immediately reports it to the quality department.
 Root Cause Analysis

• Conducting root cause analysis helps identify the underlying reasons for
deviations.
• Example: A deviation in the packaging process is traced back to inadequate
training of the packaging team
 Corrective and Preventive Actions (CAPA)

• Implementing CAPA helps address deviations and prevent recurrence.

• Example: After identifying the root cause, the packaging team receives
additional training to prevent similar deviations in the future.
 Deviation Tracking and Documentation

• Proper documentation ensures compliance and provides an audit trail.

• Example: All deviation reports, investigations, and CAPA activities are
recorded and maintained in a centralized system.
 Case Studies and Examples

• Case Study 1: A deviation in the manufacturing process results in a batch of

defective products. Through thorough investigation and CAPA
implementation, the process is optimized, preventing further deviations.
• Case Study 2: An equipment deviation leads to production downtime. By
conducting root cause analysis, the maintenance team identifies the issue and
implements preventive maintenance procedures to prevent future
breakdowns.
 Training Exercise

• Participants engage in a hands-on training exercise simulating deviation

handling scenarios.
• Example: Teams are presented with a laboratory deviation and must
collaborate to perform a root cause analysis and develop an effective CAPA
plan.
 Best Practices

• Promptly report deviations and communicate them to relevant stakeholders.

• Conduct thorough root cause analysis and implement robust CAPA.
• Ensure proper documentation and tracking of all deviation-related activities.
 Q&A Session

• Open the floor for questions and answers to address any queries or concerns
regarding deviation handling.
• Encourage participants to seek clarification and share their experiences.
 Conclusion

• Proper deviation handling is vital for maintaining product quality and

compliance.
• Your commitment to effective deviation management ensures the success of
our operations.
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 Thank You

• Thank participants for their active engagement in the training.

• For any further inquiries or support, feel free to reach out to us.