PROCEDURE FOR HANDLING OF REJECTED/EXPIRED MATERIALS

• OBJECTIVE:

• To lay down the procedure for handling of Rejected/Expired material in warehouse.

• SCOPE:

This SOP is applicable for the active material dispensing in the Isolator in the warehouse department at {Company Name} {Location}.

• RESPONSIBILITY:
• WH Executive/Designee – is responsible for ensuring compliance with the SOP.
• QC Executive/Designee- shall be responsible to affix Rejected Label on the rejected material.
• Head Warehouse – is responsible for compliance of the SOP.
• ACCOUNTABILITY:

  QA Head shall be Accountable for implementation of SOP.

• PROCEDURE:
• The Process/Material Non-Conformance whichever applicable, shall be initiated by concerned responsible personnel in the following scenarios but not limited:
• Material Received Report (MRR) Rejections – shall be initiated by Warehouse In-Charge/Analytical assurance Executive.
• On-line Rejections – shall be initiated by the Production In-Charge /Manufacturing Assurance In-Charge and/or Warehouse.
• Expired materials – shall be initiated by the Warehouse.
• Obsolete materials– shall be initiated by the Warehouse.
• All the Obsolete/Non-moving materials shall be labelled with the “REJECTED” label in RED colour on the material by QA department.
• Damaged materials during receipt shall be handled as per SOP.
  • MRR REJECTIONS:
    • “R E J E C T E D” label in RED colour shall be provided on all containers/boxes of rejected material by QC department.
    • All the rejected materials shall be segregated Lot No. Wise and stored separately in “Rejected materials” storage area under lock & key.
    • The material details shall be entered in the “Rejected Material Stock Register”.
    • The Process/Material Non-Conformance shall be initiated by the Analytical Assurance Executive/Warehouse In-charge for the Material received rejections as per SOP.
    • PNC/MNC shall be reviewed and approved by QA In-Charge.
    • QA In-Charge shall select the concerned Warehouse In-Charge as the CAPA Owner for carrying out the disposition of the rejected material.
    • On receiving the disposal instructions from purchase, Warehouse personnel shall start the disposal procedure of the material (i.e., sending back to the supplier/destroying the material by handing over to safety & health department or physical destruction (packing materials) as the case may be and the stores personnel shall update the rejected material stock register).
    • CAPA Owner shall select the concerned persons as CAPA team members for disposal of the rejected material.
    • The CAPA Owner shall fill the details of the disposition in the Remedial Actions. After completion of the Remedial Action steps, the CAPA Owner shall submit the Remedial Actions Header.
    • The final approval of Remedial Action Steps shall be done by CAPA Co-coordinator (QA In-Charge).
    • The destruction record shall be maintained by the safety & health department.
  • ON-LINE REJECTIONS:
    • If any raw material/packing material is found not conforming during production/packing activity PNC/MNC whichever applicable shall be initiated as per SOP by the concerned Production In-Charge / Manufacturing Assurance In-Charge / Executive.
    • The Manufacturing Assurance Executive shall counter sign on the ‘Rejected’ Label.
    • Intimate to the respective Section In-Charge and Manufacturing Assurance In-Charge for further action.
    • The rejected raw/packing material shall be segregated and affix “ONLINE REJECTION” label.
    • Respective Section in-Charge/Manufacturing Assurance In-Charge- shall verify all details like Material Manufacturer, Supplier, Quantity Rejected, MRR No., D.C. No. reason for rejections and mention the details in the MNC.
    • Initiator shall carry out preliminary investigation for the PNC/MNC.
• The initiator shall confirm the quantity of material received in the On-line rejected lot.
• Initiator shall confirm whether the same lot material has been used for Manufacturing/packing in other batches.
• If the On-line rejected lot material has been used in other batches, the control sample of the same shall be verified for any such defects.
  • The preliminary investigation shall be uploaded as an attachment by the respective Section In-Charge to the initiated PNC/MNC, wherever required.
  • PNC/MNC shall be reviewed and approved by QA In-Charge.
  • The Warehouse Head shall intimate purchase department for disposal of the material.
  • QA In-Charge shall select the concerned Warehouse In-Charge as the CAPA Owner for carrying out the disposition of the On-line rejected material.
  • Production shall transfer the material to Warehouse after approval of QA In-Charge/Head QA
  • The Warehouse Head shall intimate purchase department for disposal of the material.
  • On receiving the disposal instructions from Purchase, In-Charge QA shall enter the mode of disposal of the material (i.e., sending back to the supplier/destroying the material as the case may be).
  • CAPA Owner shall start the disposal activity by selecting the concerned persons as CAPA team members for disposal of the On-line rejected material.
  • The material shall be disposed of by the Safety Executive by Shredding of all the On-line rejected cartons/labels/containers and shippers by using scissors into the small pieces.
  • Collect the pieces of shippers, cartons, containers and labels into a poly bag and transfer to scrap yard through trolley for further disposal.
  • The raw material shall be disposed of by the Safety Executive as per SOP.
  • The disposition of the material shall be witnessed by the Respective Section In-Charge and Manufacturing Assurance In-Charge.
  • The SAFETY & HEALTH DEPARTMENT Executive shall fill in the material disposal details in the destruction record form.
  • All the concerned persons who witnessed the disposal shall sign on the destruction record.
  • After completion of the Remedial Action steps, the CAPA Owner shall submit the Remedial Actions Header.
  • The final approval of Remedial Action Steps shall be done by CAPA Co-coordinator (QA In-Charge).
  • The destruction record shall be maintained by the SAFETY & HEALTH DEPARTMENT.
  • Entries shall be made in the Rejected Materials Stock Record after disposal.
  • HANDLING OF THE EXPIRED MATERIALS:
    • Warehouse personnel shall identify the Expired material. The expired materials shall be labelled by QA department with the “EXPIRED” label in RED color on the material.
    • All the expired materials shall be labelled by QA department with the “EXPIRED” label in RED color on the material.
    • All expired materials shall be segregated by Lot Number wise and stored separately in rejected material storage area.
    • MNC shall be raised for the expired material.
    • The quantities shall be checked and material details shall be entered in the Expired Material Stock Record.
    • Disposal Record for Expired materials shall be raised and same shall be intimated to Planning department for disposal instructions.
    • On receiving the disposal instruction from planning/Purchase department, warehouse personnel shall start the disposal procedure by handing over to SAFETY & HEALTH DEPARTMENT or physical destruction as the case may be and the warehouse personnel shall update the expired material stock register.
    • MNC shall be reviewed and approved by QA In-Charge.
    • QA In-Charge shall select the concerned Warehouse In-Charge as the CAPA Owner for carrying out the Disposition of the Expired material.
    • CAPA Owner shall select the concerned persons as CAPA Team members for disposal of the Expired material.
    • The material shall be disposed of by the SAFETY & HEALTH DEPARTMENT Executive as per SOP.
    • The CAPA Owner shall fill in the details of the disposition in the Remedial Action. After completion of the Remedial Action steps; the CAPA Owner shall submit the Remedial Actions Header.
    • The final approval of remedial Action Steps shall be done by CAPA Co-Ordinator (QA In-Charge).
    • The physical destruction record shall be maintained by the SAFETY & HEALTH DEPARTMENT.
    • Warehouse personnel shall maintain the Disposal Record for Expired Materials.
  • NON-MOVING MATERIAL:
    • Disposal Record for non-moving materials shall be raised as per format-V.
    • Based on the destruction note all Non-moving material shall be segregated by Lot no wise and stored separately in the rejected material storage area
    • The quantities shall be checked and material details shall be entered in the Rejected Materials Stock Register.
    • QA shall fill in the “REJECTED” labels and affix the labels.
    • After completion of commercial formalities, the non-moving materials shall be destroyed by SAFETY & HEALTH DEPARTMENT executive in presence of Section In-Charge.
    • The Safety executive shall fill the material disposal details in the destruction record form.
    • All the concerned persons who witnessed the disposal shall sign on the destruction record.
    • The destruction record shall be maintained by the SAFETY & HEALTH DEPARTMENT.
    • Entries shall be made in the Rejected material stock record after disposal.
  • OBSOLETE MATERIALS:
    • Disposal Record for obsolete materials shall be raised as per format-V.
    • On receiving the approval for the disposal record for obsolete materials Warehouse personnel shall initiate MNC as per SOP.
    • Based on the destruction note all obsolete material shall be segregated by Lot no wise and stored separately in the rejected material storage area.
    • The quantities shall be checked and material details shall be entered in the Rejected Material Stock Register.
    • QA shall fill in the “REJECTED” labels and affix the labels.
    • QA personnel shall be forward the issue details report after approval of the initiated PNC / MNC by in charge QA and/or Head QA to the Warehouse department for destruction of the obsolete materials as per SOP.
    • The material shall be destroyed by the Safety executive in presence of Section In-Charge.
    • The Safety & Health department executive shall fill in the material disposal details in the destruction record form.
    • All the concerned persons who witnessed the disposal shall sign on the destruction record.
    • The destruction record shall be maintained by the Safety & Health department.
    • Entries shall be made in the Rejected material stock record after disposal.
  • STORAGE OF MRR REJECTIONS/ON-LINE REJECTIONS/EXPIRED MATERIALS/NON-MOVING MATERIAL/OBSOLETE MATERIALS/DAMAGED/SPILLED MATERIAL DURING MATERIAL HANDLING:
    • MRR Rejections/On-Line Rejections/Non-Moving Material/Obsolete Materials/Damaged/ Spilled Material during Material Handling of raw materials and packaging materials shall be stored in Rejected material storage area.
    • Expired materials of raw materials and packaging materials shall be stored in the Rejected material storage area.
    • Expired/Obsolete/Non-Moving/Damaged/Spilled Material during Material Handling shall be disposed off.
• REFERENCES:

Not Applicable

• ANNEXURES: 

ANNEXURE NO	TITLE OF ANNEXURE
Annexure-I	Rejected Material Stock Record
Annexure-II	Expired Material Stock Record
Annexure-III	Online Rejection Label
Annexure-IV	Expired Label
Annexure-V	Disposal Record for Expired/Obsolete/Non-Moving Material/ Damaged/Spilled Material during Material Handling

ENCLOSURES: SOP Training Record.

•  DISTRIBUTION:
• Controlled Copy No. 01  :    Head Quality Assurance
• Controlled Copy No. 02  :    Head Warehouse
• Master Copy                    :    Quality Assurance Department

• ABBREVIATIONS:

No.	:	Number
SOP	:	Standard Operating Procedure
CAPA	:	Corrective And Preventive Actions
MRR	:	Material Received Report
PNC	:	Process Non Conformance
MNC	:	Material non conformance
QA	:	Quality Assurance

• REVISION HISTORY:              

CHANGE HISTORY LOG

Revision No.	Details of Changes	Reason for Change	Effective Date
00	New SOP	Not Applicable	To Be Written Manual

Annexure-I
RejectedMaterialStock Record

Annexure-II
Expired Material Stock Record

Annexure-III
Online Rejection Label

Annexure-IV
Expired Label

Annexure-V
Disposal Record for Expired/Obsolete/Non-Moving Material/Damaged/Spilled Material during Material Handling

Frequently Asked Question ?

Question 1: How does a warehouse identify expired materials?

Answer: Warehouse personnel are responsible for identifying expired materials. The QA department labels these materials with a red “EXPIRED” label.

Question 2: What happens to rejected materials after they are identified?

Answer: All rejected materials are:

• Segregated by lot number and stored in a designated “Rejected Materials” area. 
• Labeled with “REJECTED” or “ONLINE REJECTION” by the QA department. 
• Documented in the “Rejected Material Stock Register.”
• Disposed of according to specific procedures depending on the reason for rejection. 

Question 3: Who is responsible for initiating a Process/Material Non-Conformance (PNC/MNC)?

Answer: The responsible personnel initiate a PNC/MNC depending on the scenario:

• MRR Rejections: Initiated by Warehouse In-Charge/Analytical Assurance Executive. 
• On-line Rejections: Initiated by Production In-Charge/Manufacturing Assurance In-Charge or Warehouse. 
• Expired Materials: Initiated by the Warehouse. 
• Obsolete Materials: Initiated by the Warehouse. 

Question 4: What happens to obsolete materials after they are identified?

Answer: Obsolete materials follow a similar process to rejected materials:

• Segregation by lot number and storage in the “Rejected Materials” area. 
• Labeling with “REJECTED” by the QA department. 
• Documentation in the “Rejected Material Stock Register.”
• Destruction by the Safety & Health department after commercial formalities. 
• Record keeping of the destruction process. 

Question 5: How are expired materials disposed of?

Answer: Expired materials can be disposed of in two ways:

• Returned to the supplier: This requires approval from the Purchase department. 
• Destroyed: The Safety & Health department handles the physical destruction, and a record is maintained.