SOP FOR HANDLING OF ON-LINE REJECTIONS
PURPOSE: To lay down the procedure for On-line rejected materials.
SCOPE: This SOP is applicable to all Raw and packing materials.
RESPONSIBILITY
Production officer or Executive shall be responsible to initiate online rejection note
QA personnel shall issue online rejection note.
IPQA personnel shall verify online rejection note.
QA head/ designee shall approve the SOP.
ACCOUNTABILITY: The accountability of implementation and compliance of the SOP is of Head of Quality Assurance.
PROCEDURE:
On-line rejections include:
Raw Materials: In raw materials non-conformances such as black particles, fibres, discoloration, obnoxious odour, lumps formation, foreign materials etc. are observed.
Packing materials: Printed aluminum foil: printing clarity, sealing property.
- PVC/PVDC : sealing property
- Cartons/ labels/ leaflets : printing, gumming, closing of flap
- PP caps/ measuring cups
- Bottles
- Vials
- Pumps & Actuator:
- Shippers: gumming, closing of shippers etc.
Non-conformances observed during any stage of manufacturing process and packing process shall be addressed through on-line rejection note.
The quality assurance assigns a tracking number to the on-line rejection. The tracking numbers to the assigned sequentially based on the order in which the OLRN are approved as mentioned below,
OLRN No. – OLRN/XX-001
Where, OLRN – Stands for On-line Rejection Note
XX – Stands for the last two digit of the Year in which OLRN is raised i.e. 21 stands for 2021,
001 – Stands for the continuous serial number for the OLRN .
The On-Line Rejection Note log will be maintained by Quality Assurance Department.
The On-line rejected material is kept in tray or polybag with proper labeling. After the batch completion the on-line rejection shall be reconciled in BPR. The on-line rejected bottles were sorted as per BPR checklist parameters.
On-line rejection note is initiated by the department Executive with brief description for rejection (attach specimen wherever possible) and forward to Department Head for signature.
The singed note is forwarded to In-Process Quality Assurance person for verification.
On-line rejection note shall forward to Quality Control department for their comment for Consignment details e.g. Quantity received, supplier name, and GRN/invoice number.
On-line rejection note shall also be forwarded to account department for their comment and attachment of online generated software debit note.
Quality Assurance head shall decide corrective action and preventive action to be taken.
Scan copy of on-line rejection note shall be forwarded to purchase (H.O.), warehouse and commercial in case of loan license products only.
Concern department shall draw additional material through additional material indent.
Concern department officer/executive shall affix the on-line rejection label as describe in Labelling Procedure of Production Department to on-line rejected material/Product.
On-line rejected material shall be destroyed in production area except Printed aluminum foils and PVC as per SOP Foils and shall be sent back to rejected material room.
In case supplier wants to verify the reason for rejected material, time period for the visit shall not be more than 10 days. If party does not visit in that period, material shall be destroyed.
The material destruction report reference shall be recorded in every online rejection and for destruction and material destroyed as per SOP.
The Online rejection closing period should not be more than 1 month and can be extended with proper justification and approval from QA when required as per SOP.