CASE STUDY ON CHANGE CONTROL

A CASE STUDY ON CHANGE CONTROL ON BROOKFIELD VISCOMETER

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 B rookfield 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