Change Control System

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

Implementation

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

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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.

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Requirements Before Making Changes

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

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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

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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

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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 Assurance8

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 Records11

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.13

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/ implementation15

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 Status18

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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