Follow
In case of machine breakdown, raise a repair request or share a mail as appropriate to either engineering department or service provider. A duplicate copy of the request / mail shall be retained in QC.
Label the machine with a ‘Under Maintenance’ label and make appropriate entries in the respective log books.
Document the repair / maintenance activities performed by engineer / service provider either with a service report or a copy of the acknowledged work order.
Replacement of spares for repairing the breakdown shall be documented as per change control SOP No. QA005.
Manager QC in consultation with Head Quality or designee shall identify the need of performing re-qualification, depending on the break down maintenance performed.
Copy of repair requests, maintenance records and report of any re-qualification performed shall be maintained for each equipment / instrument in QC.
