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Former Member
Aug 05, 2010 at 08:41 AM

Validation of Equipment - Pharma Industry Scenario

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Subject : Validation of Equipment after Corrective Maintenance by QC in a Pharma Industry

Steps :

1. Equipment Breakdown reported by Production

2. Maintenance Person attend the Breakdown through Breakdown order

3. Maintenance person hand over the Equipment to Prod for check/dry run

4. Production person raise a Validation Request to Quality department.

5. Quality person will validate the Equipment, Same like Calibration.....They will check all the parameters, Room Temperature,humidity & also the parts replaced by maintenance (LIKE LIKE PARTS & LIKE DISLIKE PARTS ....which means the same specif & Make parts replaced or different spare parts replaced) etc.... with reference to the Maintenance order details. After completion of this activity. He will revert back to Production, Production will finally give approval to close the Maintenance order.

Issues : Here there is a Gap between Maintenance order & Calibration order.........how to link these two orders and also quality person should have the details of maintenance order in calibration order. how to link

My suggestion :

1. Create a sub-order as calibration order for this Breakdown order & do the Activity , in that case.... cost will be settled to Maintenance Main order, i want to settle the calibration order cost to Quality dept. to acheive this, Whetther i have to give their cost centre in settlement rule rite ?

Is ther any way to acheive this scenario.............

Regards

Prakash.B