Follow
1.0 OBJECTIVE
To describe the procedure for handling, storage and disposal of rejected raw and packaging materials.
2.0 SCOPE
This procedure is applicable for all rejected raw and packaging materials at the time of receipt and on line rejections.
3.0 RESPONSIBILITY
3.1 Warehouse officer shall be responsible to follow the laid down procedure.
3.2 Manager, Warehouse shall be responsible for effective implementation of procedure.
3.3 QC shall be responsible to raise the rejection memo and provide rejected labels.
3.4 QA shall be responsible to take the decision for unacceptable on line rejected materials.
4.0 ACCOUNTABILITY
4.1 Manager, Warehouse
5.0 PRECATUIONS
5.1 Ensure approval of Stock Adjustment Memo before destruction.
5.2 While destruction of raw materials, eye protection optics (safety goggles), hand gloves, nose mask should be worn.
5.3 Destruction shall be done in scrap yard in presence of QA personnel.
5.4 Ensure that rejected materials shall be destroyed properly.Record of destruction to be properly maintained.
6.0 PROCEDURE
6.1 Handling and storage of Rejected Raw and Packaging Materials
6.1.1 At the time of receipt, if the material is received in damaged containers, torn bags or otherwise, warehouse officer shall refer the matter to QC through discrepancy report (FWH/002).
6.1.2 After Investigation regarding discrepancy, QC return photocopy of discrepancy report to warehouse with decision/comment by Quality Head, Warehouse officer will make entry in the discrepancy log book and preserve the copy in the separate file. Warehouse personnel handle the discrepancy materials as per QC decision/comment.
6.1.3 If any raw and packaging material gets rejected by QC after analysis, it shall be intimated to Procurement department through photocopy of ‘Raw Material Rejection Memo (FRM No.: FQC/006)/Packaging Material Rejection Memo’ (FRM No.: FQC/007)’ and original copies to be sent to Warehouse.
6.1.4 After analysis QC shall send duly signed copies of Material Receipt Report (FRM No.: FWH/008)/ (FRM No.: FWH/018) along with original copy of Material Rejection Memo (FRM No.: FQC/006) / (FRM No.: FQC/007) and photocopy of discrepancy report (if any) to warehouse and affix ‘Rejected’ label (FRM No.: FQC/003) on each pack / bag / container or drum etc. for material rejected.
6.1.5 Warehouse officer shall update the material stock in “Inventory Management System” (IMS)”.Warehouse officer shall forward second copy of Material Receipt Report to accounts department and third copy to Procurement department along with copy of material rejection memo and photocopy of discrepancy report (if any).Original copy of material receipt report and material rejection memo shall retain for warehouse record.
6.1.6 Rejection of material shall be intimated to Manufacturer/Supplier by Procurement Department after receiving the Rejection Memo.
6.1.7 Warehouse officer shall transfer rejected material to rejected material store under lock and key and make the necessary entries in “Rejected materials record register (FWH/010)”.
6.1.8 Storage rejected materials as one material, one batch, and one pallet system in the “Rejected material store”. In case this storage system cannot be followed due to any particular reason then segregate the materials of different batches/lots using partitions on the pallet to avoid mix up/contaminations.
6.1.9 Warehouse officer shall raise “Stock Adjustment memo”(FWH/022)along with rejection memo of rejected material and routed through department head, Unit head, Factory account in charge, Chief Financial Officer, Chief Operating Officer and finally approved by Managing Director.
6.1.10 Regular monitoring of the rejected material store shall be done up to disposed of the rejected materials. For regular monitoring of rejected materials, send a mail on first week of every month to Purchase & Accounts department with rejected materials list and preserve hard copy of mail in a file for documentation.
6.2 Handling and storage of On line Rejected Raw and Packaging Materials
6.2.1 During dispensing or consumption, if there is any unusual appearance or if the balance material is having short shelf life or if the packaging material is not acceptable due to improper printing, non-uniform color etc. or any other reason which renders the material unacceptable, the same shall be brought to the notice of QA by Production Department through on line material discrepancy note (FQA/059).
6.2.2 Production Department shall raise ‘Failure Investigation Report (FQA/011) and record the failure details after jointly investigate with QA. On investigation of the matter, if required Quality Control shall re-test the material. Manager QA shall submit duly filled failure investigation report to Head of QA for review, decision and close the failure report with signature and date.
6.2.3 Based on the investigation report, if Head of QA is of the opinion that the material is not acceptable, he shall reject the same. Quality Assurance shall issue reject label for the material and send a copy of failure investigation report, online discrepancy note and rejection memo (if any) to production and warehouse department and retain the original copy for record.
6.2.4 Production officer shall prepare Material Return Note (FRM No.: FWH/043) and forward the same with duly signed by production officer and QA officer along with rejected material to warehouse.
6.2.5 Warehouse officer shall verify the on line rejected raw and packaging material with respect to online discrepancy note, failure investigation report, rejection memo (if any) and Material Return Note. Warehouse officer shall sign on material return note and forward duplicate copy to production department by retaining original copy for warehouse record.
6.2.6 Production officer shall raise ‘Raw material requisition note (FRM No.:FPM/001)/Packaging material requisition note’ for replacement of material against on line rejected materials. Warehouse officer shall issue material to production against material requisition note.
6.2.7 Warehouse officer shall make the necessary entries in “Rejected materials record register (FWH/010)”and transfer rejected material to rejected material store under lock and key.
6.2.8 Storage rejected materials as one material, one batch, and one pallet system in the “Rejected material store”. In case this storage system cannot be followed due to any particular reason then segregate the materials of different batches/lots using partitions on the pallet to avoid mix up/contaminations.
6.2.9 Warehouse officer shall update the raw material/packaging material stock in “Inventory Management System (IMS)”.Warehouse officer shall raise “Stock Adjustment memo” (FWH/022) along with online discrepancy note, failure investigation report and rejection memo (if any) of on line rejected material and routed through department head, Unit head, Factory account in charge, Chief Financial Officer, Chief Operating Officer and finally approved by Managing Director.
6.2.10 Regular monitoring of the rejected material store shall be done up to disposed of the rejected materials. For regular monitoring of rejected materials, send a mail on first week of every month to Purchase & Accounts department with rejected materials list and preserve hard copy of mail in a file for documentation.
6.3 Disposal of Rejected Raw Materials (Imported)
6.3.1 After receiving approval of stock adjustment memo, Manager, Warehouse shall prepare ‘Destruction Note’ (FRM No.: FQA/034) and get the authorization from Unit Head and Head of Quality.
6.3.2 After authorization of destruction Note, warehouse officer shall destruct rejected materials properly.
6.3.3 Rejected active material will be incinerated and excipients will be buried in the pit within the factory premises. An area in the disposal pit will be dug in such a way that after pouring the excipient into it, at least one feet height over the excipients can be covered with the soil.
6.3.4 Dissolve /pore the excipients in to water in a bucket and then pour in to the disposal pit hole & then cover the hole with soil.
6.3.5 Material destruction should be done in presence of QA officer and warehouse officer shall filed destruction note along with stock adjustment memo and rejection memo.
6.3.6 As there is a local requirement of finalizing the insurance claim and financial assessment of any rejected materials, all rejected materials will be disposed off within 7 working days of finalizing the insurance claim.
6.4 Rejected Raw material returned back to vendor (only in case of locally procured raw materials)
6.4.1 On intimation from Purchase Department for sending the material back to Vendor, Warehouse officer shall prepare relevant documents like Non-Returnable Gate Pass (FRM No.: FWH/025) and Vat documents if applicable.
6.4.2 Ensure that an authorized person signs all documents before the vehicle is allowed to exit.
6.4.3 Warehouse officer shall filed warehouse copy of the Non-Returnable Gate Pass (FRM No.: FWH/025) along with Rejection Memo and Intimation copy received from Procurement Department to send the material returned back to vendor.
6.5 Disposal of Rejected Packaging Materials
6.5.1 After receiving approval of stock adjustment memo, Manager, Warehouse shall prepare ‘Destruction Note’ (FRM No.: FQA/034) and get the authorization from Unit Head and Head of Quality.
6.5.2 After authorization of destruction Note, warehouse officer shall destruct rejected materials properly.
6.5.3 Printed packaging materials like labels, cartons, catch covers, leaflets/inserts ect. shall be destroyed by shredding / burning and foils shall be damaged by drilling holes into the foil roll from one end to another and then transfer the destroyed material to the scrap area.
6.5.4 Material destruction should be done in presence of QA officer and warehouse officer shall filed destruction note along with stock adjustment memo and rejection memo.
6.5.5 Un-printed packaging materials shall be sent back to the supplier as per instruction from Purchase department and printed foils may be sent to the supplier if requested by Purchase Department but before sending they shall be damaged by drilling holes into the foil roll from one end to another.
6.5.6 Warehouse officer shall prepare relevant documents like non-returnable gate pass, invoice (if applicable) and send back the rejected material to the supplier.
6.5.7 Warehouse officer shall filed warehouse copy of the Non-Returnable Gate Pass (FRM No.: FWH/025) along with Rejection Memo and Intimation copy received from Purchase Department to send the material returned back to vendor.
