To provide a standard operating procedure for management of Rejected Materials in warehouse.
The scope of this SOP is applicable for management of Rejected Materials in warehouse .
Warehouse person: Storage of rejected material in rejected material area
Warehouse supervisor: Checking of the documents regarding rejected materials
Warehouse head: Overall responsibility to ensure compliance to the procedure
Head QA: Approval of rejection and disposal of rejected material
5.1 Source of rejected material would be any of the following:
i. Damaged material during material receipt
ii. Discrepancy noted during receipt of material
iii. Material rejection during testing
iv. Material rejected because of the quality event during manufacturing
v. Material is expired
vi. Material no longer required to be used in the facility
vii. Product return and recall
5.2 Procedure for rejection handling when the material is rejected during testing:
5.2.1 During testing, if the material gets rejected, the QC analyst shall generate a rejected material certificate of analysis (CoA) and rejection labels according to number of containers.
5.2.2 On rejecting the material in the system, material stock shall be automatically transferred from quarantine/ under test status to blocked/ rejected status in material management software.
5.2.3 QA person shall affix the rejection label on rejected material containers.
5.2.4 Once the QA person affixes the rejected material label, warehouse personnel shall transfer the material to the rejection area and make the necessary entry in the rejected material logbook.
5.2.5 If Raw material or Packaging material gets rejected, the information shall be shared with the procurement department for financial transactions.
5.2.6 Raw material can be returned to the material manufacturer or destroyed at factory premises depending on commercial agreements.
5.2.7 Printed packaging material cannot be returned to the material manufacturer. It must be destroyed at factory premises. Except for printed packaging material, it can be destroyed at factory premises or returned to material manufacturers depending on commercial agreements.
5.3 Procedure for the handling of rejection during material receipt:
5.3.1 If the material is found damaged/ unacceptable as per material receipt procedure during receipt, the warehouse person will record the observation in the observation sheet and intimate it to the Quality Assurance (QA) department through intimation form. Based on the verification, the QA person shall affix the rejection label on the containers, which will not be in the condition to accept for use.
5.3.2 Warehouse personnel shall transfer the rejected materials to the rejected material room.
5.3.3. If material is rejected during receipt of material, record the rejection into the outright rejection form. The material can be returned to the material to the material supplier or destroyed at factory premises.
5.4 Procedure for the handling of rejection during manufacturing or packing operations (online rejection):
5.4.1 While the manufacturing or packaging process is in the progress, various instances where material rejection could happen. For example, defective packaging material observed during operation, the material is not performing as intended, machine setting rejection, material spillage, etc.
5.4.2 In the above cases, the user department shall initiate the online rejection form and get it approved by the department head and QA. Then, QA will affix the rejection label on materials or material containers.
5.4.3 User department will submit the material to the warehouse and the online rejection form to store in the rejected material area. However, in case of spillage of raw material, it needs not to transfer to the rejection area. It shall be recorded in respective batch records, and material shall be destroyed as per material destruction procedure by the manufacturing department.
5.4.4 For material returned to the warehouse, material movement transactions to be done in the material management software.
5.4.5 The material can be returned to the material to the material supplier or destroyed at factory premises.
5.5 Procedure for management of expired material:
5.5.1 In case material is expired, warehouse personnel shall affix the expired material label or stamp [as procedure defined by an organization] over the available label on the container.
5.5.2 Warehouse personnel shall transfer the material to the rejection area. Record the details in the rejection logbook.
5.5.3 Initiate the destruction report and, after approval of the destruction report, destroy the material.
5.6 Procedure for the destruction of rejected, expired, or unusable material:
5.6.1 Warehouse person shall fill the material destruction requisition form and get it approved from the operational head and quality assurance head.
5.6.2 After approval of the destruction requisition note, warehouse personnel initiates the material destruction process.
5.6.3 Printed aluminum foil, PVC, PCV-PVdC film shall be destroyed in such a way that it will not be in the form of usability. For example, the material can be destroyed using an industrial crusher machine or using drill machine.
5.6.4 Labels, cartons, leaflets, or any other packaging material shall be destroyed using a shredding machine or destroyed manually. Material can be defaced using ink in such a way that it cannot be reused.
5.6.5 Raw material and product can be destroyed as per approved procedure by the organization. Various options are available, such as transfer material to the effluent treatment plant, send to a shared effluent treatment plant (commercially provided service), incinerators, or send to the approved agency that performs destruction activity.
The rejected material shall be stored with the storage condition applicable for specific materials. This is to facilitate material return to the manufacturer if need. If the storage condition is not maintained, the material will no longer remain usable if the material manufacturer wants to reprocess the material or use it for any other purpose.
Appropriate safety precautions shall be used while handling rejected material and destruction of material. Personal protective equipment shall be used, and Material Safety Data Sheet shall be available for reference in case of any accidental exposure or to prevent any hazard.