Table of Contents
1.0 OBJECTIVE:
1.1 To lay down the Procedure for Handling of online Rejection.
2.0 SCOPE:
2.1 This SOP is applicable for Handling of online rejection of packing and Raw materials in Production department.
3.0 RESPONSIBILITY:
3.1 Officer-PD
3.2 Analyst-QC
3.3 IPQA-person
4.0 ACCOUNTABILITY:
4.1 Head-QA
4.2 Manager-PD
5.0 PROCEDURE:
5.1 Approved Raw / Packing material can be rejected during dispensing, manufacturing and packing operation if any physical defects observed in material.
5.2 For packaging materials, the defects could be visual, dimensional. For Raw materials it could be abnormal colour, lump formation, presence of foreign particles or any abnormal particle size etc.
5.3 If any defect is observed in the Raw material issued for manufacturing operation, immediately stop the further usage of defected material and inform to Quality Assurance Department
5.4 Concern department shall raise the request for the issuance of online rejection note.
5.5 After receiving the request, QA Department shall issue the Rejection Note.
5.6 Concern department shall raise the Online Rejection Note.
5.7 The Officer-Quality Assurance shall ensure the complete removal of such material and return to Warehouse along with On-Line Rejection Note.
5.8 Online rejected material shall be transferred to the Rejected area after affixing the ‘ONLINE REJECTION’ label on the material.
5.9 Head-QA shall investigate the root cause of the rejection and recommends the corrective and preventive action to be taken.
5.10 If the final investigation indicates that no deviation occurred during storage and handling of material, then Head-QA shall inform to the Purchase Department for the decision of disposal on remaining material.
5.11 Disposal of the rejected packing material shall be done as per company policy.
5.12 In case of Rejected Raw material, it shall be returned to the Vendor.
5.13 Online rejection log shall be maintained.
5.14 Online rejection shall be numbered as YYY/XX/ZZZ.
5.15 Where,
5.15.1 “YYY” stands for ORN i.e. rejection note.
5.15.2 / stands for Separator.
5.15.3 “XX” stands for current year i.e. 24 for 2024, and so on.
5.15.4 / stands for Separator.
5.15.5 “ZZZ” stands for serial number i.e. 001, 002 and so on.
5.15.6 First online rejection of year 2024 shall be as XXX/24/001.
6.0 ABBREVIATION:
6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance.
6.3 QC : Quality Control
6.4 PD : Production
6.5 IPQA : In-process Quality Assurance