| Machine Break Down |
1.0 OBJECTIVE: 1.1 To lay down a procedure to avoid cross contamination during the machine break down. 2.0 SCOPE: 2.1 This procedure is applicable for the machine break down. 3.0 RESPONSIBILITY: 3.1 Trained Technician/maintenance supervisor shall be responsible for the machine maintenance as per the procedure mentioned in this SOP. 3.2 Production / Supervisor shall be responsible for implementation of the procedure as per this SOP. 3.3 Head-Production shall be responsible for implementation of this procedure. To read this SOP Click here SOP for Decartooning And Cleaning Of Tubes/Pouch From Corrugated Box. 4.0 PROCEDURE: 4.1 Remove all the material (bulk, semi finished, finished and PM) of the stage. 4.2 Store the material properly in the respective area with proper labeling. 4.3 Inform the engineering department through Maintenance work order as per the XXX. 4.4 Display “UNDER MAINTENACE” status label on the machine and handover the machine to engineering department. 4.5 Remove “UNDER MAINTENANCE” status from machine after completion of maintenance work. 4.6 Check the machine for the job attended by engineering department, investigate the cause of break down and plan action to avoid reoccurrence. 4.7 Clean the machine as per standard operating procedure of respective machine. 4.8 Based on nature of break down plan the revalidation /re-qualification /re-calibration of the machine. 4.9 Check the cleaning and area properly before starting of operation, visually checks the cleaning of area and equipment/machine with ‘CLEANED’ label duly filled and signed by production department. Inform IPQA for the verification of cleaning of area and equipment/machine. After clearance by IPQA person, remove the cleaned label and attach in batch record (BMR). Also mention the status of the area on sign board outside the door. 5.0 ABBREVIATIONS 5.1 SOP : Standard Operating Procedure 5.2 PM : Packing Material 5.3 BMR : Batch Manufacturing Record 5.4 IPQA : In process Quality Assurance 5.5 CC No. : Change control number |