SOP for Handling of Customer Complaints

Purpose

To provide a system for documentation and timely response to customer complaints.

Scope

This SOP applies to all finished product complaints received from customers and other external parties.

Responsibility

• It is the responsibility of all PharmaInfo employees who receive a complaint to relay all pertinent information to the Quality Control Manager.
• Quality Control is responsible for conducting the investigation of complaints.
• The Quality Control Manager is responsible for any follow-up required and forwards a completed “Monthly Complaint Summary Report’ to the Plant Manager.

Procedure

• Receipt and Processing of Complaints

1. The Quality Control Manager maintains a chronological file of all complaints received from all sources through all channels and all follow-up documentation that is generated as a result of the complaint.
2. All complaints received will be recorded on the Customer Complaint Form (Annexure-1) and processed according to this SOP.

• The written records are kept for at least one (1) year after the product's expiration date, or one (1) year after the date the complaint was received, whichever is longer.
• Any complaint involving the possible failure of a cosmetic product to meet any of its specifications shall be reviewed by Quality Control to determine the need for an investigation.
• In the absence of the Quality Control Manager the following designated alternates, in order is responsible for receiving any complaint calls:

1. Production Manager
2. Administrative Manager

• All written and oral complaints regarding a cosmetic product are received, evaluated, investigated and responded to as quickly as possible.
• The designated individual receiving the complaint will initiate the Customer Complaint Form (Annexure-1) and will obtain all information pertinent to the complaint. 
• The written record of each complaint shall contain:

1. The completed Customer Complaint Form
2. Correspondences (letter/fax/e-mail)
3. Investigation Report

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• Investigate each complaint via referral to and discussion with all concerned departments and records (Production, and QC) arranging for confirmatory laboratory and other checks where indicated. Specifically,

1. Examine the batch record for the lot in question, with particular interest directed toward those portions of the manufacturing procedure that would impact the reported deficiency.
2. Interview personnel who were directly involved in the manufacture of the product/lot.
3. Examine several batch records for the same product/potency that were manufactured before and after the lot in question to determine if there were similar deficiencies noted.
4. Examine the Complaint File to determine if there have been complaints of a similar nature for the product.
5. Examine retained samples of the product lot to determine, upon visual examination, if there appears to be a problem with the product.
6. As appropriate to the nature of the complaint, perform all testing of the retained sample to determine if the product/lot specifications are within acceptable ranges.
7. As appropriate, discuss the nature of the complaint directly with the complainant.
8. Once the complaint is confirmed with a defective product, it is necessary to consider a recall. Recall shall be undertaken in according to SOP Recalled Product.

• Summarize the results of the investigation, and record details of the disposition of the complaint in the Customer Complaint Form, together with all other pertinent documentation.
• Periodically, review the Complaint File and identify complaint trends that may signal a basic product problem.
• On a monthly basis, forward a summary of all complaints received to the General Manager, Production Manager, and Marketing Manager, which includes the following items:

1. Complaint No.
2. Identity of Complainant
3. Nature of Complaint
4. Product name
5. Lot No.
6. Quantity involved
7. Status/Summary of Investigation
8. Final Disposition
9. Document Ref. # (for responding of the product complaint in writing)

• A Complaint Summary Report (Exhibit 2) will be the first page in the Complaint File and will serve both as a Table of Contents and as a means to quickly and easily see trends that may be occurring with particular products or product lots.
• Report any severe complaint with allegedly or potentially serious “medical” (therapeutic and/or toxicological) implications to the General Manager and Marketing Manager immediately after receipt.

Annexure

Annexure-1: Customer Complaint Form

Revision History

Nil

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