Topic:- Change Control, Deviation & Incident Management

 

1. Change Control

Definition: Change control is the process of managing any alterations or modifications to a project, system, or process in a controlled and systematic way. This ensures that any change is reviewed, documented, and approved before being implemented, preventing unintended consequences or disruptions.

2. Deviation

Definition: A deviation refers to a departure from an established standard, process, or procedure. This can occur when something does not meet the specified requirements, whether due to human error, equipment failure, or external factors. It requires investigation and corrective action.

3. Incident

Definition: An incident is an event or occurrence that disrupts normal operations, processes, or systems. A discrepancy in implementation of GMP or failure of systems in day-to-day operation. It typically requires a response to resolve and mitigate the impact.

 

	Change Control	Deviation	Incident
	Change includes any Addition to, Deletion of or Modification	A departure from standard practices or Procedures	A discrepancy in implementation of GMP or failure of systems in day-to-day operation
	Critical, Major, Minor	Planned/Unplanned Critical, Major, Minor	Critical, Major, Minor
	User/concern department should initiate	User/concern department should initiate	User/concern department should initiate
	All supporting and reference documents shall be attached to the form	All supporting and reference documents shall be attached to the form	All supporting and reference documents shall be attached to the form

	Change Control	Deviation	Incident
	Justification shall be provided by initiating department	The supervisor shall perform initial investigation to find out cause	The supervisor shall perform initial investigation to find out cause
	form and supporting document shall be reviewed for its appropriateness by HOD	form and supporting document shall be reviewed for its appropriateness by HOD	form and supporting document shall be reviewed for its appropriateness by HOD
	QA shall done primary evaluation and allot number	QA shall done primary evaluation and allot number	QA shall done primary evaluation and allot number
	form shall be circulated to Concerned Department for impact assessment and comments	form shall be circulated to Concerned Department for impact assessment of CAPA	form shall be circulated to Concerned Department for impact assessment of CAPA

 

	Change Control	Deviation	Incident
	QA shall review all comments to assess any other impact of the change	QA shall review all comments to assess any other impact of the deviation	QA shall review all comments to assess any other impact of the incident
	After complete assessment, change shall be approved or rejected	Deviation shall be authorize by QA	Root cause shall be investigated
	Implementation and follow up shall be done by Initiating and QA department	Implementation and follow up shall be done by Initiating and QA department	Implementation and follow up shall be done by Initiating and QA department
	shall be closed within 30 days from the date of initiation	shall be 30 working days from the date of incident filing	shall be closed within 30 days from the date of initiation

 

Change Control	Deviation	Incident
The appropriateness and effectiveness of the action taken shall be evaluated and verified after implementation	The appropriateness and effectiveness of the action taken shall be evaluated and verified after implementation	The appropriateness and effectiveness of the action taken shall be evaluated and verified after implementation
Final review of the completed deviation report shall be done and comment shall be made with closeout date	Final review of the completed deviation report shall be done and comment shall be made with closeout date	Final review of the completed deviation report shall be done and comment shall be made with closeout date

Disclaimer:-This presentation is solely prepared for training, sharing knowledge and information purpose only  collected from various guidelines and literature. The information presented here is only for reference purpose.

 

 

 

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