Handling Market Complaints

1.0 OBJECTIVE

To lay down a procedure for receiving the market complaint and carryout the   investigation, corrective and preventive actions. 

2.0 SCOPE

This procedure is applicable to all the departments present in the XXX Company. 

3.0 RESPONSIBILITY

3.1 Complaint handover: Head-Marketing

3.2 Review of the Complaint: Head-QA, Production and Quality Control

3.3 Closure of the Complaint: Head-QA 

4.0 PROCEDURE

4.1  Any communication, written or verbal, received directly from any customer, retailer, distributor or field staff, regarding the purity, efficacy, labelling defects, or any other such complaint shall be considered as a market complaint. 

4.2  Procedure handling of Customer Complaint

4.2.1 Receipt of Complaint

4.2.1.1  Head-Marketing shall bring Market/customer complaints received by the field staff to the notice of Head-QA. The complaint along with the sample if any shall be forwarded to Head-QA.

4.2.1.2  The Head-QA shall thoroughly review the complaint and if complaint sample is available it will be physically inspected for any signs of the complaint for authenticity of the complaint. If samples are not available then the control samples shall be used for this review. 

4.2.1.3  Register the Complaint after review by Head-QA.  

4.2.1.4  Registration of the Complaint

4.2.1.4.1  On receipt of a product complaint from market QA shall enter the details in complaint register and assigning a registration number as under.

XXXX/M C/XX/000

XXXX indicates Company Name

MC indicates Market complaint

XX indicate last two digits of the year

000 indicates serial number of the complaint (Starts from 000-999) 

4.2.1.4.2 Customer Complaints register consists of Date, Name of the Product, Batch No, Strength, Mfg Date, Expiry Date, Nature of Complaint, Complaint No, Classification of the Complaint, Closure Date, Remarks and Done by as given in Annexure-1.

4.2.1.4.3 After registration of complaint, send acknowledgement letter as given in Annexure-2.

4.2.1.5 Review of the Complaint

4.2.1.5.1 Up on registration of the complaint, Head-QA shall arrange the Meeting with Head-Production and Head-Quality Control and Review and classify the Complaint. 

4.2.1.5.2 The classification of Complaints shall be as follows 

4.2.1.5.2.1 Minor- Such as shortage in packed units or packs, missing of secondary packing components etc. or due to counterfeiting. 

4.2.1.5.2.2 Major and Critical-Such as Low Assay, less volume, not complying with the specifications, discoloration, precipitated formations, turbidity, wrong packing components, wrong overprinting details etc. 

4.2.1.6  Action to be Taken 

4.2.1.6.1 If the nature of complaint is Major and critical then follow the procedure given below, but not limited to – 

4.2.1.6.1.1 QC reports of raw material shall be checked.

4.2.1.6.1.2 The control sample shall be subjected to complete analysis including biological test wherever applicable and evaluate the results.

4.2.1.6.1.3 If the complaint samples are available then the samples are also subjected for complete analysis.

4.2.1.6.1.4 The record or records of the batch shall be checked for correctness and for any deviation during the manufacturing.

4.2.1.6.1.5 If any additional tests are required based on the complaint shall be judged case by case.

4.2.1.6.1.6 After the assessment, if the batch or the batches need a recall it will be initiated as per the Product recall SOP.

4.2.1.6.1.7 Investigate the complaint as per Annexure-3. 

4.2.1.6.2  If the Nature of Complaint is Minor then 

4.2.1.6.2.1  Such complaints are to be investigated by identifying the possible means of occurrence and corrective action to be made. 

4.2.1.6.2.2 Details of the complaint shall be explained to the people to eliminate the reoccurrence of such problems by bringing awareness in the people involved in the process or activity. 

4.3 A detailed report is made by Quality Assurance department and sent to the customer   and copy to the M.D for information. 

4.4 Records on market complaint should be kept for five years from date of manufacturing. 

4.5 Complaint records shall be regularly reviewed for any indication of specific or reoccurring problems that require attention and might justify the recall of         marketed products. 

4.6 Market complaints shall be reviewed during Annual Product Review. 

4.7 Investigation report should be sent with in 45days from the date of receipt of acknowledgement. 

4.8 If the investigation report is not completed within 45 days, prepare interim report, inform the status of the investigation to the customer explaining the reason for extending the time period.

5.0 ABBREVIATIONS

5.1 QA-Quality Assurance

5.2 SOP- Standard Operating Procedure

5.3  MD- Managing Director        

6.0 ANNEXURES

6.1: Annexure -1: Market Complaint Register

6.2 Annexure -2: Acknowledgement Letter For Market Complaints

6.3 Annexure -3: Market Complaint Investigation form