Learn how a professional medical devices distributor follows GDPMD guidelines for dealing with customer complaints. View the step-by-step procedure for recording and resolving incidents.

Dealing With Customer Complaints: Standard Operating Procedure

As a responsible Medical Devices Distributor, maintaining the highest quality standards is our priority. Dealing with customer complaints effectively is not just about resolving issues; it is about ensuring patient safety and regulatory compliance within the supply chain.

This guide outlines the official Standard Operating Procedure (SOP) for handling both written and oral complaints regarding the medical devices we distribute.

1. Purpose and Scope

The purpose of this procedure is to define a standardized method for dealing with customer complaints. This ensures that every issue is recorded, investigated, and resolved promptly.

This SOP applies to all medical products distributed by the Medical Devices Distributor and governs how the team handles feedback from the moment it is received until the final resolution.

2. Roles and Responsibilities

To ensure accountability when dealing with customer complaints, specific roles have been assigned to the team:

Role	Responsibilities
Sales Supervisor	Responsible for receiving the initial feedback and immediately reporting the complaint to the Warehouse Incharge.
Incharge Warehouse	Ownership of the complaint lifecycle. Responsible for handling, following up, and taking corrective actions as per regulatory requirements.

3. Operational Procedure: Step-by-Step Guide

The process for dealing with customer complaints allows for timely communication between the complainant (the customer) and the receiver (the Medical Devices Distributor).

Step 1: Immediate Recording and Reporting

Sales personnel receiving information regarding a product defect must forward this information immediately to the Warehouse Incharge.
This must be done using the Medical Device Complaint / Incident Form.
The form must be duly filled and signed by the complainant to ensure authenticity.

Step 2: Required Information for Investigation

Effective dealing with customer complaints requires accurate data. When filling out the Incident Form, the following minimum information is mandatory:

Contact Details: Name, address, telephone number, and email of the complainant.
Product Details: Name of the product and Batch Number.
Incident Details: Complaint Number, Date of Complaint, and the specific reason for the complaint.
Evidence: Availability of the sample or photographic evidence of the defect.

Note on Oral Complaints: Complaints communicated verbally must be followed by written confirmation. The relevant sample and batch number must be sent to the Medical Devices Distributor for verification.

Step 3: Investigation and Reply

Once the data is gathered, the designated personnel will obtain source information immediately.

If a reply to the customer is considered appropriate, it shall be accompanied by an official Investigation Report received from the Product Manufacturer or Principal.
Time is of the essence. Every person involved in the process must ensure that the time between receiving the complaint and replying to the customer is kept to a strict minimum.

Step 4: Quarantine and Storage

Proper inventory management is crucial when dealing with customer complaints.

All affected stock (Complaint Stocks) must be physically segregated.
These items must be placed in a separate area clearly labeled "Complaint Stocks" with the respective complaint number attached.

4. Regulatory Reference

This procedure for dealing with customer complaints is strictly aligned with international quality standards, specifically:

Guidelines on Good Distribution Practices for Medical Devices (GDPMD)

Need to file a complaint?

Please download and fill out the Medical Device Complaint / Incident Form attached below and submit it to your Sales Supervisor.

MEDICAL DEVICE COMPLAINT/INCIDENT FORM This form is to be used by medical device user from government or private institutions to complaint of medical device safety and performance issue under Medical Device Rule 2017. This complaint must be completed and submitted to the SNR Enterprises and copy to Medical Device and Medical Cosmetic (MDMC)
Complainant	▯ Government ▯ Private
Institution	▯ Hospital ▯ Clinics ▯ Others:
A. Device Particulars
Device name
Brand name
Description of medical device (as appeared on label) name
Intended use (as appeared on label)
Batch/ Lot/ Serial no.			Expiry date
B. Establishment Particulars
Name of manufacturer (ifloenl device) / Name of nuthorized representative (if imported device)
Manufacturer's / Authorized Representative's address
Contact perxon
Job title
Telephone no.
Email
Name of distributor
Distributor's address
Contact person name
Job title
Telephone no.
Email
C. Complaint Information
Description of complaint incident
History of complaint incident
la there any injury happened?	▯ YES ▯ NO
If Yes, what is the category of incident?	▯ Serious public health threat ▯ Death ▯ Serious injury ▯ Non- Serious injury
All complaints shall be reported to the establishment. Does the establishment alerted on this?	▯ YES ▯ NO
D. Complainant Information
Name
Position/ Occupation		Department/ Unit
Address
Telephone no		Fax no.
Email