Standard Operating Procedure For Complaint Handling And Corrective Action

by Pharmadocx Consultants

PURPOSE:     Analysis on complaints , handling them properly and take corrective


SCOPE: This procedure applies to all product complaints. No matter how trivial some may appear.


                           Factory Manager


1) Identify the complaint received. They will be of 4 following categories.                 

a). Delayed delivery                                       

b). Short supply

c). Packing complaints

d). Product quality complaints

2) For category ‘a’ identify, the cause and ask the dispatcher to act in time to comply the delivery schedule.

3) For short supply, check the stocks and if found short, dispatch the balance quantity.

4) For packing complaint identify the belt or person(s) responsible. Increase the frequency of in process checks and if found that the fault is due to personal error, replace those particular workmen/supervisors involved. Replace the packs with the good ones.

5) For product complaint do the following steps:

a). Visually inspect the product into the complaints side by side

b). Analyse the Control Samples.

c). If sold units show deviation in quality with the control sample, find the reason, which may be:

i)    Improper storing

ii)   Improper handling

iii)  Deterioration during use/storage

d). In third case withdraw the batch from the market and replace them with fresh stock.

e). In first/second case educate the whole seller/customer to store and handle the product properly.

6) Record the corrective action                                                      

Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

   (Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

11 June 2023

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