SOP For handling of customer complaint is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This procedure is established to provide guidelines for proper response to the complaint of the customer, promptly and effectively.

SCOPE

This procedure is applicable to Quality Control / Quality Assurance Department.

RESPONSIBILTY

Production Manager

Quality Control Manager 

Quality Assurance Officer

ACCOUNTABILITY

Manager Quality Assurance 

DESCRIPTION

Complaint:

A complaint is any expression of dissatisfaction with a product or service marketed.

Customer

Customer is a person or institution making the complaint.

Complainant 

A person or organization making a complaint. 

Critical Complaint 

A complaint that strongly indicates the purity, identity, safety or efficacy of a product may have been compromised and has the potential to cause a life threatening or serious health situation.

Serious Complaint 

A complaint that indicates the purity, identity, safety or efficacy of a product may have been compromised but does not present as a life threatening or serious health risk. 

Standard Complaint 

A complaint that is neither critical nor serious.

Justified Complaint

A complaint where the investigation has shown the complaint to be valid and that it occurred under company control.

Non-Justified Complaint

A complaint where the investigation has shown no valid reason for the complaint.

CUSTOMER COMPLAINTS

Product Complaints are divided into:  

Product Quality Complaints/Non Medical Product Complaints:-

Those dealing with some physical, chemical, microbiological or other alleged deterioration of the product or its possible failure to meet specifications. It includes:

Scorched Particles Viscosity 

Lumps         Appearance 

Color         Broken tablets / Empty strips/ vials 

Odor         Package integrity 

Taste         Infiltration/counterfeit

Reconstitution                                  Foreign matter

Medical Product Complaints:-

Those dealing with an alleged overdose, adverse experience or lack of expected activity of the product. Example includes: 

Diarrhea

Nausea 

Vomiting 

Spitting up

Constipation

Anaphylactic reactions of the product

Lack of expected activity 

Death 

Serious body reaction to drug (significant increase / decrease in vitals i.e. blood pressure, respiration, heart rate)

Policy and Service Complaints:

Those dealing with 

a) Company Policy:

Advertising, returns, etc.

b) Service:

Slow delivery, incorrect item or quantity shipped, etc.

A time limit of NMT 30 days is required for completion of product complaint reviews and finding.

The Quality Assurance Department will maintain Complaint File which includes Serial No, Date, Reference, Product Name, Batch No., Nature of Complaint, and Investigated By, Findings, Feed Back and remarks.

Records must be retained for one year after the expiry date of the product or one year after the date that the complaint was received, whichever is longer.

PROCEDURE

After receiving any complaint from the customer following steps are to be taken:

QAM will receive the complaint sample with info. Letter,  

Check the sample physically and record following data:

Date and reference of complaint 

Nature of complaint with product name (strength) and batch no.

QAM will forward the complaint sample, if required, to QCM for arranging the chemical analysis.

QC analyst/microbiologist will perform the chemical analysis/microbiological report of provided sample as directed and report to QCM.

After analysis, QCM will prepare the test report on the basis of analytical results and forward it to QAM. 

QAM will review the Batch Manufacturing Record, initial test results and retain samples and discuss the results with the Plant Manager.

The Plant Manager will take the decision keeping in view the test report of the complainant sample in the presence of QAM and QCM.

Report prepared by QAM will be sent to the complainant agency and copies to all the concerned (e.g. RM, ZSM, SD etc.)