If our production plant is running from 10 years and all the qualifications documents of production equipments are lost/misplaced, what we have to do for qualifications of equipments.
Initially raise the deviation for document misplace and then findout the Purchase Order for the Vendor’s details. DQ documents prepared as per vendor’s equipment manual.
After that initiate the requalification from IQ, OQ and PQ.
Raise the incident and need to carryout retrospective validation of equipment as corrective action.Preventive action is that proper archival of documents and training Also performs the scheduled re qualification of equipment.