1.0 OBJECTIVE:
The objective of this SOP is:
1.1 To describe a procedure for allowing transfer of Finished Goods under “Quarantined status” to our godown.
2.0 RESPONSIBILITY:
2.1 The Head – Warehouse shall be:
2.1.1 Responsible for raising the request for Quarantined Release.
2.2 Quality Assurance Officer shall be:
2.2.1 Responsible for verification and reconciliation of batch.
2.3 The Packaging – Executive shall be:
2.3.1 Responsible for quantity and completion of records.
2.4 The Head – Quality Control shall be:
2.4.1 Responsible for Quality Control Status and verification.
2.5 The Head – Quality Assurance shall be:
2.5.1 Responsible for Batch Manufacturing Record audit and recommendation.
3.0 ACCOUNTABILITY:
Head – Quality Assurance
4.0 PROCEDURE:
4.1 QUARANTINED RELEASE SHALL BE GIVEN STRICTLY IN EXIGENCY ONLY AND NOT ROUTINELY UNDER THE FOLLOWING CONDITIONS
4.1.1 In case of marketing exigencies, in order to reduce the lead-time and facilitate the transfer of the batch to the Depot by the time this is cleared by Quality Control for sale.
4.1.2 UNDER NO CIRCUMSTANCES DEPOT MANAGER SHALL RELEASE THE BATCH FOR SALE.
4.1.3 Depot Manager shall release the batch for sale only after receiving the written clearance from Head – Quality Assurance.
4.1.4 Head Warehouse to intimate the request for “Quarantined release” in format No
4.1.5 The request form duly filled by Head – Warehouse and Packaging Officer shall be given to Quality Assurance Officer after filling the details in the format. Quality Assurance Officer will verify the details and after signing of Head – Production the same shall be forwarded to Head – Quality Control.
4.1.6 Head – Quality Control will give his comments and probable date of release of the batch and forward the same to Head – Quality Assurance for Batch Manufacturing Record audit and recommendation for Quarantined Release.
4.1.7 After Review, Head – Quality Assurance shall give the final approval for the proposed “Quarantined release”.
4.1.8 Head – Warehouse shall forward this duly approved form to sales depot along with the consignment.
4.1.9 The Depot Manager shall acknowledge the Quarantined status of the consignment and after signing, shall immediately return the copy duly signed by fax (for expeditious action to avoid delays in paper movement) to Head – Warehouse.
4.1.10 Upon final clearance by Quality Control, the Head – Quality Control shall inform to Head – Quality Assurance then Head – QA shall communicate to Head – Warehouse
4.1.11 After release and confirmation from Head – QA, Head – Warehouse shall communicate to respective Depot by immediate fax for the release of goods for sale.
5.0 REASON FOR REVISION:
New SOP.
6.0 TRAINING:
Trainer — Head – Quality Assurance
Trainee — All departmental heads
Period — One day
7.0 DISTRIBUTION:
Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Head of Department – Warehouse
Certified Copy No.3 : Head – Plant Operations
Certified Copy No. 4 : President – Technical Operations.
Original Copy : Head – QUALITY ASSURANCE
8.0 ANNEXURE:
Annexure – 1 : Format for Quarantine Release Form
9.0 REFERENCE:
In-house.
QUARANTINED RELEASE
(To be filled in by Head – Warehouse)
Product : _______________ Depot Name : ______________
- No. : _______________ Mfg. Date : _______________
Exp. Date : _______________ Dispatch Date : ____________
Reason: _______________________________________________________________________________
| Pack
Style |
Quantity
Packed |
Verification of Qty. by Officer – QA | Comments of Head – QC & probable date of release | Head – Quality Assurance
Comments. |
__________ _______________ ____________
Officer – QA Head – Warehouse Head – QC
Approved for Quarantined Release:
_________________ _____________________
Head – Plant Operation Head – Quality Assurance
(To be filled by Depot Manager)*
We confirm the receipt of ____________ qty. of ________________ on ______________ under “QUARANTINED STATUS” and shall not release the goods for sale until final released written communication is received from Head – Warehouse, Amaliya Daman.