Change Control System

Process for the Control of Changes to Equipment, Processes,Techniques and Controlled Documentation
Initiation Review & Approval

Implementation

Control Change Why? Verify QUALITY impact before implementation  Ensure procedures are followed  Communication to all concerned  Inform to customers  Updation with regulatory agencies


Control Change Why? Uncontrolled change can have a significant effect on the quality of products or service provided.  A change control system allows review of changes made over time because we have a database listing by department.


Requirements Before Making Changes

DO NOT MAKE CHANGE UNTIL EVERYTHING IS IN PLACE (PLANNING)

Essential Elements in a Change Control System Element Description Unique identification of the change Change Type Description of change including reason and justification Responsibility Quality Assurance Proposer Proposer

Essential Elements in a Change Control System Element Description Responsibility Classification of change Head of Department/ Quality Assurance Impact of change Head of Department Approval/ rejection of proposed change Quality Assurance

Essential Elements in a Change Control System Element Description Responsibility Implementation Head of Department Register of change control requests Review of changes Customer communication Quality Assurance Quality Assurance Quality Assurance
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Essential Elements in a Change Control System (Role of QA) Unique identification of the change Number/ year  Classification Major / Minor  Impact assessment  Inform to customer QA  Inform to customer RA  Final approval by QA

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Essential Elements in a Change Control System  Change description of the proposed change. This is a black and white statement of what you want to change.  Reasons and justification of the proposed change.

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Essential Elements in a Change Control System  Change Type  Equipment  Process  Test Method  Material  Documents  Records
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Essential Elements in a Change Control System

Review process consists of: Classification of the change

Major/ Minor  Measurement of the effectiveness of change  Implementation of changes and cause of delay, if any

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Essential Elements in a Change Control System  MAJOR A major change will fulfil one or more of the following criteria: Has a quality implication  Involves change in testing methodology, test performance specifications etc.  Involves change or implementation of new equipment used in the production.
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Essential Elements in a Change Control System  MINOR A minor change will have no major impact on the quality of the product .Typically minor changes will be procedural changes.  SOP changes  Format /Record changes

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Essential Elements in a Change Control System Impact of change (critical)  Who does the change effect internally/ externally  Who needs to review the change  Circulate change control  Feedback  Identify & compare equipment, materials, processes or documentation requiring change/ implementation
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Essential Elements in a Change Control System Approval/ rejection of the proposed change  Pre-implementation verification Validation requirements Procedures implemented or reviewed Staff have been trained Documents and records are in place External communication Regulatory approval

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Essential Elements in a Change Control System  Implementation verification Formal confirmation of date by proposer when the change was implemented. Confirmation by QA that all relevant procedures/documents are implemented
 Final closure

by QA

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Essential Elements in a Change Control System



Register of change control requests (log) Gives status at a glance Provides data for changes Department Date Proposed Change description Date Implemented Classification Unique number Approval Status
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Essential Elements in a Change Control System

Output (Change control Records)

Original change control documentation is retained in the QA office. Periodical Review of changes: Monthly (Quality Meeting) Annually (Quality Management Review)  Monthly report  Annual report (Quality Management Review)


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THANK YOU

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