This document describes a case study on implementing change control for a Brookfield viscometer that was experiencing frequent spindle speed changes without human handling. This was affecting manufacturing processes and resulting in misleading viscosity readings. A change control process was initiated to address calibration intervals and validation procedures for the viscometer. Documentation was created justifying the need for the change and submitted to the quality assurance team for review and approval. Once approved, the change was implemented.

1. CASE STUDY ON
CHANGE CONTROL

2. INTRODUCTION
• Change refers to any modification in equipment,
manufacturing materials, facilities, utilities, design,
formulations, processes, packaging/labeling, computer
systems, and all associated documentation.
• Change control is a systematic approach to managing all
changes made to a product or system.

3. Here's a simple process I've followed to ensure changes are
properly managed.
1.Change Initiation
2.Change Request Approved
3.Proposed Change
4.Request Evaluation by other departments
5.Change Implementation
6.Change Review

4. About the.......
• The Brookfield Viscometer measures fluid viscosity at given
shear rates.
• Viscosity is a measure of a fluid’s resistance to flow.
• It is to drive a spindle ( which is immersed in the test fluid )
through a calibrated spring.
• Then the viscosity reading are being noted.

5. Case study
• The Brookfield viscometer spindle speed is changing
frequently with out human handling.
• Which due this the process of manufacturing is effected is
identified.
• Which due to this the readings that are being calculated are
mislead the flow properties of the manufacturing process.

6. • As the current manufacturing process is fully automated.
• Which the team finds that with out proper viscosity one can
find serious issues related improper filling and improper
picking of medication from the product after packaging.

7. Change control initiation
• For this change control being implemented.
• Which that the change control team make changes regarding
the change in the calibration intervals and also verify for the
validation .
• Beacuse even after the validation next day ,the instrument may
show wrong results.

8. • As for this the change is being documented.
• And the importance of the change is being justified by the
respective team where they want to change control.
• As long as the document regarding the change control is made
then finally it submitted to the QA team.

9. • Finally the QA team will verify change control documents.
• The comes to assessment of the document and if they found
that it is necessary to make change control.
• Then they give approval for the change after testing and if they
found necessary then the change is being implemented.

10. Thank you