Medical Device Complaint Handling

SOP for Medical Device Complaint Handling at Medical Devices Distributor. Guidelines for recording incidents, managing complaint stocks, and GDPMD compliance.

1.0 PURPOSE:

This procedure defines the handling of complaints both written and oral.

2.0 SCOPE:

This SOP is applicable to all written and oral complaints regarding medical devices distributed by Aika Ceuticals, Lahore.

3.0 ROLE AND RESPONSIBILITY:

Marketing Officer: Shall report the complaint to Manager Warehouse.

Incharge Warehouse: Shall be responsible for handling complaints, follow up and taking corrective actions as per regulatory requirements.

4.0 OPERATIONAL PROCEDURE:

4.1 The complaint information shall be recorded in such a way as to allow timely and effective communication between complaint and complaint receiver.

4.2 All the marketing personnel who receive information on product complaints shall forward this information as soon as possible through Medical Device Complaint / Incident Form duly filled and signed by the complainant to Incharge Warehouse.

4.3 The complaint on prescribed Medical Device Complaint / Incident Form should have the minimum information listed below:

a) Name, address, telephone number (email address if available) of the complainant.

b) Name of product

c) Batch number

d) Complaint number

e) Date of complaint

f) Complaint reason as reported by complainant

g) Availability of the relevant sample or evidence of the defect (e.g. photo)

h) Alliance Medical personnel shall obtain this information as soon as possible from the originating source.

i) Complaints communicated orally shall require written confirmation, sending of relevant sample and appropriate batch number.

4.4 If a reply to the complainant is considered appropriate, it shall be accompanied with investigation report received from Product Manufacturer / Principal.

4.5 It shall be the responsibility of each person involved in each step to ensure that time limits from receiving the complaint to replying to the complainant are maintained strictly to a minimum level.

4.6 All Complaint Stocks shall be placed on separate area Labeling "Complaint Stocks" with respective complaint number.

5.0 REFERENCE:

Guidelines on Good Distribution Practices for Medical Devices (GDPMD)

PERSONNEL SAFETY CHECKLIST

Sr. #	Description	YES	NO	N/A	Remarks
1.	Passage used for foot is free of clutter, debris and spilled substances.
2.	Employees are equipped with proper safety equipment including hard hats, protective eyewear, earplugs, gloves, masks and footwear.
3.	The warehouse is well-ventilated.
4.	Emergency exits are clearly marked and evacuation maps are posted throughout the warehouse.
5.	First-aid kits, fire extinguishers, eyewash stations and defibrillators are easily accessible and clearly marked.
6.	Stairs are accompanied by hand railings.
7.	A backup power source is in place.
8.	Weight limitations are clearly marked on anything used to carry or store inventory or equipment.
9.	All exits are easily accessible and kept free of objects.
10.	Work areas are properly lightened.
11.	All equipment is regularly inspected and preventive maintenance is performed.
12.	Work schedules are set up to ensure all employees receive adequate breaks and time off between shifts.
13.	Hot, sharp or slippery surfaces are clearly marked as such.
14.	Hazardous materials are properly sealed, stored and labeled.
15.	The overhead sprinkler system is in working order and not obstructed.
16.	Employees are instructed on how to avoid heat stress in hot, humid environments.
17.	The facility has lockout/tagout procedures.
18.	Personnel use proper lifting techniques.
19.	Newly-hired employees receive general ergonomics training and task-specific training.
20.	Loose/unboxed materials that might fall from a pile are properly stacked by blocking