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Complaints and recall handling

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COMPLAINTS AND RECALLS HANDLING. PRESENTED BY, HUSNA KANWAL QURESHI. M.Pharm, 1st yr, 2 nd sem. UNDER THE GUIDANCE OF Dr. T. MAMATHA M.Pharm, Ph.D. QUALITY ASSURANCE.
COMPLAINT HANDLING ,[object Object],[object Object],[object Object]
NEED FOR COMPLAINT HANDLING SYSTEM ,[object Object],[object Object],[object Object],[object Object]
SOP on complaint handling ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
PRODUCT NAME COMPLAINT CATEGORY Batch no. Mfg.date expiry date Packaging/ product quality/ medical. Packaging details: Name / address of the complainant: Complaint reported through: Complainant sample enclosed: yes / no Quality of sample enclosed: Investigation report Total quantity involved PCR received by On: Investigation done by: Action taken Conclusion: Confirmed/not confirmed PCR no: PCR approved by: recommended corrective actions
Product complaint data sheet ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Steps in handling of complaints ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Receiving complaints ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
customer Company's contact person QA complaint officer Make a complaint through toll free no., E-mails, P.O. Box ,[object Object],[object Object]
Technical investigation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Laboratory analysis phase ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
CORRECTIVE ACTIONS AND FEEDBACK TO CUSTOMERS ,[object Object],[object Object],[object Object],Contd …
[object Object],[object Object]
MONTHLY REPORTS AND TREND ANALYSIS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Documentation final product complaint report ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
Customer complaint record book Report no. Date received Product name Received by Product lot no. Date investigation started Date investigation ended
RECALL HANDLING ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SOP on recall ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NAME ALTERNATE PERSON BUSINESS PHONE AFTER HOURS PHONE RESPONSIBILITIES DURING RECALL Chief Executive Officer Production Manager ,[object Object],[object Object],[object Object],[object Object],[object Object],Quality Assurance Manager Production Manager ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
PRODUCT RECALL CHART Contd ….
References ,[object Object],[object Object],[object Object],[object Object],[object Object]
References ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Complaints and recall handling

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Complaints and recall handling

  • 1. COMPLAINTS AND RECALLS HANDLING. PRESENTED BY, HUSNA KANWAL QURESHI. M.Pharm, 1st yr, 2 nd sem. UNDER THE GUIDANCE OF Dr. T. MAMATHA M.Pharm, Ph.D. QUALITY ASSURANCE.
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  • 7. PRODUCT NAME COMPLAINT CATEGORY Batch no. Mfg.date expiry date Packaging/ product quality/ medical. Packaging details: Name / address of the complainant: Complaint reported through: Complainant sample enclosed: yes / no Quality of sample enclosed: Investigation report Total quantity involved PCR received by On: Investigation done by: Action taken Conclusion: Confirmed/not confirmed PCR no: PCR approved by: recommended corrective actions
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  • 29. Customer complaint record book Report no. Date received Product name Received by Product lot no. Date investigation started Date investigation ended
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  • 46. PRODUCT RECALL CHART Contd ….
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