Date post: | 13-Jul-2015 |
Category: |
Documents |
Upload: | purushothaman-subramanian |
View: | 84 times |
Download: | 2 times |
of 20
Change Control System
1
Process for the Control of Changes to Equipment, Processes,Techniques and Controlled DocumentationInitiation Review & Approval
Implementation
2
Control Change Why? Verify QUALITY impact before implementation Ensure procedures are followed Communication to all concerned Inform to customers Updation with regulatory agencies
3
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.
4
Requirements Before Making Changes
DO NOT MAKE CHANGE UNTIL EVERYTHING IS IN PLACE (PLANNING)
5
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
6
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
7
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
9
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.
10
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
12
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
14
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
16
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
17
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)
19
THANK YOU
20