Follow
1. Head of Quality shall prepare the final market complaint response report (Annexure –III) for products manufactured at site.
2. The market complaint investigation report should be exhaustive, reveal complete facts of investigation, identify the causes clearly in the best possible manner, may contain corrective action plan by the QA Manager for preventing recurrence of such complaints and also indicate actions already taken if any to prevent recurrence.
3. The report should be concluded as to whether the complaint is substantiated or non-substantiated. The complaint register must be completed with a brief report of the complaint investigation. The Head of Quality must sign off the complaint report and forwarded to complainant. Copies shall be distributed to concerned department and Plant Head.
4. All records of complaints, reports, corrective and preventive actions taken to resolve the quality problems, responses to the complaints, redressal, complaint register / log etc. shall be maintained by the QA Manager.
5. Review the complaint, if physical checking of control sample or dockets and a first response/reply is sent to Marketing department within 15 days after receipt of complaint.
6. Detailed response report after thorough investigation include complete analysis of control sample (and/or complaint sample) shall be sent.
7. If a microbiology analysis is required, inform to concern accordingly, regarding time required for analysis and tentative date of secondary reply.
8. The closure of complaints along with redressal should be completed within one month period after the receipt of the complaints. Any delays shall be justified.
9. In case of complaints received from marketing department the Marketing Manager shall attach his note to response report and forward to the complainant. Copy of the same note may also be sent to Head of Quality.
10. In case of complaint received directly at site, the Head of Quality or the QA Manager shall directly write to complainant and copy to marketing department.
