Deviations Management: From Root Cause to Resolution

Managing deviations and investigations efficiently is critical to ensuring product quality, compliance with regulations, and continuous improvement. 

An effective quality management system (QMS) must include procedures to identify, document, segregate, evaluate, and disposition production and post-production issues. 

You need to report and document the deviation as soon as it is identified. This includes collecting all relevant data, such as the time and date of the event, and maintaining a record of the personnel involved and any environmental factors that may have contributed to the deviation. 

It also requires that you check previous deviations for repeat events.

  • How do you consistently categorize deviations upon identification? 
  • And, can a deviation categorization be modified prior to closure?

Deviations are of two types: planned deviations and unplanned deviations.

Planned Deviations:

Any deviation from a standard procedure selected intentionally for a short period to avoid undesirable situation without affecting the safety and quality of the product or procedure.

Unplanned Deviations:

Unplanned deviations are the accidental nonconformance observed after or during the implementation of an activity. 

Based on the criticality deviations are three types: major, minor, and critical.

Critical deviation:

The deviation will have a notable impact on the critical attributes of the product.

Major Deviation:

The deviation will or may have a notable impact on critical attributes of the product.

Minor Deviation:

The deviation will not have any direct impact on the quality of the product.

Deviation management follows a closed-loop process. 

When performing investigations, you must be sure to characterize the failure correctly, describe the circumstances in which the problem occurred, and answer the following questions:

  • What is the problem?
  • When and how did it happen?
  • Where did it happen?
  • Who was involved?
  • What is its significance (risk)?
  • Is there an impact on the product or material quality and/or can it impact the regulatory filing?
  • Is there a data integrity risk?
  • Is there a significant process omission or significant modification to a process step or a deliberate attempt by an employee to deviate from procedure or good manufacturing practices (GMPs) and potentially impact product quality, end user and patient safety, or data integrity?

Performing a root cause analysis (RCA) in manufacturing to understand how to correct the problem as well as preventing future occurrences (CAPA) is key to properly managing deviations.

In a fast-paced business environment, the ability to push through deviations and ensure just in time lot release is essential for success. 

It is also critical to know how to approach a backlog of unresolved deviations which can leave an organization subject to high compliance risk.

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Resource Person: BARBARA PIROLA

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