The concept of validation was first developed for equipment and processes. In 1993 the software for a large radiotherapy device was not designed and tested properly. Several problems resulted in several devices giving doses of radiation higher than intended. Because of that several patients died and several got permanently injured. That is why validation of equipment is required for pharmaceutical industry. Following are the steps followed to do validation of equipment in SAP and how to create link between maintenance order and calibration order.

Validation

Validation of Equipment after Corrective Maintenance by QC in SAP.

  1. When Equipment Breakdown is reported by Production, Maintenance Person gets a break down order. He attends the Breakdown through Breakdown order.
  2. After solving the issue Maintenance person submit the Equipment to Production for check/dry run
  3. Then Production person will raise a Request for Validation to Quality department.
  4. Quality person will validate the Equipment through calibration order. They will check all the parameters, Room Temperature, humidity & also the parts replaced by maintenance etc. according to details mentioned in the Maintenance order.
  5. After completion quality person will revert back to Production, Production gives approval to close the Maintenance order.
  6. To create link in SAP between Maintenance order and Calibration order, you can use suborder concept.

In SAP create a maintenance order PM01 for break down, and then create a calibration order PM05 as sub order (IW36). You can settle the sub order to a different cost center, so that calibration order cost is settled to Quality department.

 

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By Nikhil Joshi. (on behalf of SAP Consulting Team)


Apprisia
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