STANDARD OPERATING PROCEDURE

SOP No.: Title Revision No.:Project co-

QC 016 CUSTOMER COMPLAINT HANDLING 0 financed
by Asean
Date Issued Department Effective Date
14 Nov 2005 QUALITY CONTROL 1 January 2006
Prepared by : Approved by : Page: 1 of 6
Quality Control Manager General Manager

1.0 Purpose

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

complaints.

2.0 Scope

This SOP applies to all finished products complaints received from

customers and other external parties.

3.0 Responsibility

3.1 It is responsibility of all ABC’s employees who receive a complaint to

relay all pertinent information to the Quality Control Manager.

3.2 Quality Control is responsible for conducting the investigation of

complaint.

3.3 The Quality Control Manager is responsible for any follow-up

required, and forward a completed “Monthly Complaint Summary
Report’ to the Plant Manager.

4.0 Procedure

4.1 Receipt and Processing of Complaints

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.

All complaints received will be recorded on the Customer Complaint

Form (Exhibit 1) and processed according to this SOP.

4.2 The written records are kept for at least one (1) year after the
expiration date of the product, or one (1) year after the date the
complaint was received, whichever is longer.

4.3 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.
4.4 In the absence of the Quality Control Manager the following
designated alternates, in order is responsible to receive any
GMP ASEAN GUIDELINE
 STANDARD OPERATING PROCEDURE

SOP No.: Title Revision No.:Project co-

QC 016 CUSTOMER COMPLAINT HANDLING 0 financed
by Asean
Date Issued Department Effective Date
14 Nov 2005 QUALITY CONTROL 1 January 2006
Prepared by : Approved by : Page: 2 of 6
Quality Control Manager General Manager

complaint calls:
 Production Manager
 Administrative Manager

4.5 All written and oral complaints regarding a cosmetic product are
received, evaluated, investigated and responded to as quickly as
possible.

4.6 The designated individual receiving the complaint will initiate the
Customer Complaint Form (Exhibit 1) and will obtain all
informationd pertinent to the complaint. The written record of each
complaint shall contain:
 The completed Customer Complaint Form
 Correspondences (letter / fax / e-mail)
 Investigation Report

4.7 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,

4.7.1 Examine the batch record for the lot in question, with
particular interest directed towards those portions of the
manufacturing procedure that would impact on the reported
deficiency.

4.7.2 Interview those personnel who were directly involved in the

manufacture of the product/lot.

4.7.3 Examine several batch records for the same product/potency

which were manufactured before and after the lot in question to
determine if there were similar deficiencies noted.

4.7.4 Examine the Complaint File to determine if there have been

complaints of a similar nature for the product.

4.7.5 Examine retain samples of the product lot to determine,

upon visual examination, if there appears to be a problem with the
product.

4.7.6 As appropriate to the nature of the complaint, perform all

testing of the retain sample to determine if the product/lot
GMP ASEAN GUIDELINE
 STANDARD OPERATING PROCEDURE

SOP No.: Title Revision No.:Project co-

QC 016 CUSTOMER COMPLAINT HANDLING 0 financed
by Asean
Date Issued Department Effective Date
14 Nov 2005 QUALITY CONTROL 1 January 2006
Prepared by : Approved by : Page: 3 of 6
Quality Control Manager General Manager

specifications are within acceptable ranges.

4.7.7 As appropriate, discuss the nature of the complaint directly

with the complainant.

4.7.8 Once the complaint is confirmed with a defective product, it

is necessary to consider a recall. Recall shall be undertaking in
according with SOP Recalled Product.

4.8 Summarize the results of the investigation, and record details of

disposition of the complaint in the Customer Complaint Form,
together with all other pertinent documentation.

4.9 Periodically, review the Complaint File and identify complaint trends
which may signal a basic product problem.

4.10 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:
 Complaint No.
 Identity of Complainant
 Nature of Complaint
 Product name
 Lot No.
 Quantity involved
 Status/Summary of Investigation
 Final Disposition
 Document Ref. # (for responding of the product
complaint in writing)

4.11 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 which may be occurring with
particular products or product lots.

4.12 Report any serious complaint with allegedly or potentially

serious “medical” (therapeutic and/or toxicological)
implications to the General Manager and Marketing
Manager immediately after receipt.

GMP ASEAN GUIDELINE

 STANDARD OPERATING PROCEDURE

SOP No.: Title Revision No.:Project co-

QC 016 CUSTOMER COMPLAINT HANDLING 0 financed
by Asean
Date Issued Department Effective Date
14 Nov 2005 QUALITY CONTROL 1 January 2006
Prepared by : Approved by : Page: 4 of 6
Quality Control Manager General Manager

Exhibit 1
CUSTOMER COMPLAINT FORM
Complaint No : Date received :

Company/Name and Address :

Phone No : Fax No

Mode of Transmission of Complaint

 Telephone  Letter Other

Individual Making Complaint : Individual Receiving Complaint :

Name : Name :
Title: Title:
Product Name:
Quantity Involved:
Batch No #:
Invoice No #:

Nature of Complaint:
 Quality  Quantity
 Packaging  Shipment Delayed
 Labeling  Others
Description :

Is material being returned for evaluation ?  Yes  No

Cosmetic Defect Report:  Has/Has not been filed _____________
 Will be filed __________________
Investigation :

Performed by : Title : Date :

Disposition :

Reviewed by :
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Date:
 STANDARD OPERATING PROCEDURE

SOP No.: Title Revision No.:Project co-

QC 016 CUSTOMER COMPLAINT HANDLING 0 financed
by Asean
Date Issued Department Effective Date
14 Nov 2005 QUALITY CONTROL 1 January 2006
Prepared by : Approved by : Page: 5 of 6
Quality Control Manager General Manager

Exhibit 2
COMPLAINT SUMMARY REPORT
Complaint No. Date Product Batch No. Complaint Nature of
Name Complaint

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 STANDARD OPERATING PROCEDURE

SOP No.: Title Revision No.:Project co-

QC 016 CUSTOMER COMPLAINT HANDLING 0 financed
by Asean
Date Issued Department Effective Date
14 Nov 2005 QUALITY CONTROL 1 January 2006
Prepared by : Approved by : Page: 6 of 6
Quality Control Manager General Manager

Summarized by : QC Manager Acknowledge by : Production Manager

Date : Date :

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