STANDARD OPERATING PROCEDURE

Department:
Page 1 of 2
Quality Assurance

SOP No.: QA/DC-030 Customer/Market Complains Revision No.:00

Effective Date: Replaces SOP:

01-03-2017

1.0 Purpose:
To describe the procedure for initiating, receiving, resolving and maintaining records of complaints
relating to the quality of the work products, processes and services; and other customer feedback.
Complaints can provide valuable feedback on the effectiveness of the organization and can be used
to improve the quality of products, with the customer in mind.

2.0 Scope:
This procedure appliesfor initiating, receiving, resolving and maintaining records of complaints
relating to the quality of the work products, processes and services; and other customer feedback.

3.0 Responsibilities:
1. Marketing department
2. QA Department
3. Production Department

4.0 Procedure:
Definitions/Acronyms

Complaint: any written, electronic, or oral communication that alleges deficiencies or expression of
dissatisfaction related to processes, products, or services. This includes alleged deficiencies or
expression of dissatisfaction related to the auditing organizations and manufacturers. Complaints
are also objections, errors, or nonconformities involving work quality, or failures to provide service
or other requests of the customer including timeliness.
Correction: Action to eliminate a detected nonconformity.
Corrective Action (CA): Action to eliminate the cause of a detected nonconformity or other
undesirable situation.
Complaint and/or Customer Feedback Form may be initiated and submitted in written
format, electronically, by telephone, or in person.
Complaint forms are identified by three (3) categories:
• Source A – complaints received internally within the Marketing Team
(SPO).
• Source B – complaints received from Marketing to NS Manager
• Source C – complaints received from outside participating Regulatory Authorities.

Receiving Complaints
Document the complaints on the customer Complaint Form.
The Complaint Form must include, at a minimum:
• The name and affiliation of the complainant
• The name of the individual logging the complaint
• The date the complaint was received, and
• The nature of the complaint.

Processing Complaints
Prepared By
Name: Khuram Shahzad
Signature: Date:
Designation: Sr.Manager QA/QC

Reviewed By
Name: Muhammad Naveed Aslam
Signature: Date:
Designation: Plant Manager
Approved By Copy No.
Name:Irfan Mahmood Qazi
Signature: Date:
Designation: Director Technical & Regulatory Affairs
Confidential Information: Not to be reproduced/disclosed without prior written approval
 STANDARD OPERATING PROCEDURE

Department:
Page 2 of 2
Quality Assurance

SOP No.: QA/DC-030 Customer/Market Complains Revision No.:00

Effective Date: Replaces SOP:

01-03-2017

• If the person receiving the complaint identifies that a known correction may be implemented, they
should undertake the correction, complete the Complaint Form and forward to the marketing
department. The marketing will populate the Complaint database with information from the CF and
forward the CF to the PA Administrator for further evaluation.

Closing and Monitoring Complaints

• When the corrective action has been completed, the complaint is closed. The complaint form and
corrective action form is submitted to the Director Marketing electronically.

Determination and Investigation of Adverse Impact/Nonconformity

• The individual assigned to the complaint will assess (risk analysis) the complaint to determine any
adverse impact / hazard associated on the quality of products, processes, and / or services.
• If it is determined that the complaint has an adverse impact, and correction or corrective action
has not been initiated by the complaint recipient, the individual assigned to the complaint may
recommend corrective action, by communicating via e-mail to the PA Administrator using
Nonconformity Report Form.
• If a corrective action is required, the Director Contact, will assign the nonconformity to his
organization. When necessary, the Director Contact, will consult with the relevant Manager to make
this determination. Once a decision is made, the Director Contact, will email the PA Administrator
indicating whether or not the issue was accepted as a Director into the PA system, the email will
contain the target completion date along with the Director Assignee who will be responsible and
proceed with the process as described in the Corrective Action (CA) Procedure.

5.0 Related Documents:

Customer complain Form QAD/FM/13
Customer complain sheet QAD/FM/14

6.0 Distribution
Company-wide

7.0 Annexure
Customer complain Form QAD/FM/13
Customer complain sheet QAD/FM/14

Approved By
Name:Irfan Mahmood Qazi
Signature: Date:
Designation:Director Technical & Regulatory Affairs
Confidential Information: Not to be reproduced/disclosed without prior written approval