1.0 PURPOSE
To lay down the procedure for handling of market complaints.
2.0 SCOPE
2.1 This SOP applicable in Quality Assurance, Quality Control, Marketing and Production departments
3.0 RESPONSIBILITY
3.1 Manger- Quality Control
3.2 Manager-Marketing
4.0 ACCOUNTABILITY
4.1 Manager - QA & RA
5.0 PROCEDURE
5.1 Any communication, written or verbal, received regarding the quality, packing directly from any traders or product manufacturer and marketing staff or any other such complaints shall be considered as a Market Complaint.
5.2 On receipt of the complaint, Quality Assurance Manager shall document the following details, in the complaint file as per Annexure I.
5.3 Initial acknowledge to the complainant with in 24hours, after register the complaints.
5.4 Quality Assurance Manager shall investigate the complaint with the help of Production Manager.
5.5 In case complaint is regarding the product quality Quality Assurance Manager shall carry out detailed investigation, check the control samples of the same batch and analyse the same. Necessary help from R&D may be taken, in case if stability is under question.
5.6 Investigation shall be extended to other batches, which may affected by the reason of complainant.
5.7 Batch Production and control Record and related documents shall be checked thoroughly by Quality Assurance Manager and Production Manager to check for any deviations or abnormalities reported or recorded during the manufacturing of the subjected batch.
5.8 A written reply shall then be sent to the complainant, Head-Production and Head-Corporate Quality Assurance about the findings and any necessary actions to be taken. The investigation report shall be sent within 30 days of receiving the complaint.
5.9 The decision of product recall shall be taken after consultation with Head-Corporate Quality Assurance and Director.
5.10 All the documents related to the market complaints shall be retained at least one year beyond the expiration date of the product or one year after the, date of receipt of the complaint whichever is longer.
5.11 Complaint records shall be reviewed annually.
5.12 Refer flow chart for handling of market complaint procedure as per Appendix I.
5.13 Closing of Market complaint:
Market complaint shall be closed as follows
5.13.1 If satisfactory response obtained from complainant against
5.13.2 If the material is recalled.
5.13.3 If no response obtained from complainant after 90 days from the date of written reply.
END OF DOCUMENT
Market complaints, quality assurance, production departments
