STANDARD OPERATING PROCEDURE HANDLING OF MARKET COMPLAINTS

STANDARD OPERATING PROCEDURE

SUBJECT:                      HANDLING OF MARKET COMPLAINTS

DEPARTMENT            : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To define a system to utilize consumer complaints on marketed products as a source of information concerning the design and perceived performance of product for development and improvement.

2.0       POLICY:

A complaint handling system is essential to record and address consumer complaints regarding a product failure to meet its specifications or performance thus assuring the consumer a product of superior quality and value.

3.0  PROCEDURE:

3.1       Market Complaint shall be received as per the procedure mentioned below and handled:

3.2       After receiving any of the complaint the QA Manager of Principal Company shall forward it to     

       the site QA manager through mail communication or written communication.

3.3       If the complaint is received directly at site address, then the Production Manager/site QA  

       Manager shall forward the complaint document and sample if any to the principal company QA   

       Manager / Site Leader.

3.4        Principal Company QA Manager / site Leader shall review the complaint and take appropriate

       action.

3.5        By acknowledging the complaint, site QA Manger shall log on the complaint in register. The

Information logged in complaint register are: Name/Address of complainant, Date of receiving at  site Q.A, Date of receiving by QA Manger (Principal Company), Description of complaint,   

      Sample availability.

3.6       QA Manager shall look for the Batch No. and study the nature of complaint along with      

       concerned site management team.

3.7        QA Manager will seek information on complaint sample, its scanned image, detail of defect if     

       not received along with the complaint, from the appropriate resource.

           

3.8       Check the sample visually for quantity returned, appearance and for other visual abnormalities

like color and odor. Check the genuineness of the complaint sample in comparison with the control sample with respect to label, carton, coding details, product appearance etc and assess if the complaint sample is manufactured at site.  

3.9       If any visual abnormality is found, cross check the retention samples.

310      After visual check categorize the complaints as Critical, Major, and Minor.

3.10.1   Critical Complaint: Product related i.e. which gives potential impact to the consumer on usage.

3.10.2   Major Complaint: Packing related i.e. which may lead to the potential impact to consumer on    

                                             usage.

3.10.3   Minor Complaint: Anything which is related to Secondary, Tertiary packing which will not   

                                             impact the consumer on usage.

3.10Initially analyze the complaint samples (if any) as per the nature of the complaint. Store the

complaint sample the complaint is investigated and responded. In case of P&G store the received complaint sample for a period of one year from the day of receipt as this is a requirement in their GB

3.12     If complaint sample is not received then test and check the retention sample depending on the    

nature of complaint. verify batch records and stability data of that batch to find any discrepancies / deviations and include the details in investigation report.

3.13     Check batches produced before and after the complaint batch Plant to evaluate whether they   

       are affected similarly. Check in detail of those batches which are manufactured using same       

       starting materials, equipment and processing conditions.

3.14     If the complaint is related to operation it shall be forwarded to Production Manager to identify

the root cause and the same has to be returned to site QA Manager. For root-cause analysis tools like WHY-WHY Analysis & Fish Bone Analysis may be used.

3.15     If the retention sample complies, report the findings to QA representative of Principal  

Company.

3.16     Verification for investigation includes - operating procedure review, batch process, process

      parameters violation, training status of personnel involved in making, packing and analyzing  

       the  batch, equipment condition, storage condition and transport condition etc.

3.17     The investigation shall be done by verifying batch record, in-process record, FG Audit Record,

       downtime/ maintenance/calibration records, finished product analytical data, shift operations

       records.

3.18     Based on root cause analysis site QA Manager shall prepare report for each customer complaint and the CAPA taken shall be documented in “Customer Complaint Investigation Detail”

           ( Annexure # 1)

3.19     “Customer Complaint Investigation Detail” (Reference format: Annexure # 1) shall be

 forwarded to Q.A Manager (Principal Company)

3.20     If the complaint is critical in nature, the same shall be informed to the principal company

      for taking decision regarding withdrawal of particular Batch No / Lot No.

3.21     The complaints investigation details shall be recorded. The necessary CAPA (Corrective Action Preventive Action) taken shall be recorded in “Complaint Investigation Detail”. Each Complaint shall be assigned a unique number in chronology.

3.22     For all the customer complaints complete details shall be recorded and all the individual

complaints will be addressed separately, even through the nature of complaint is similar to

previous one.

3.23.    Where the complaint reveals process control problems, the production Manager shall ensure the

implementation of systemic action. These preventive action steps shall be documented in Complaints file.

3.24     Review of complaints:

The complaints received shall be reviewed monthly. The QA Manager shall review the complaint   records for CAPA implementation on the complaints

            received every six months.

3.25     Reporting:

            The consolidated report of analysis, investigation shall be sent to QA Manager (Principal

            Company) by Site QA Manager within 5 working days from the date of receipt of the

            complaint sample.

3.25.1  In case the product complaint requires Lab Analysis the results of the analysis along with the final report shall be published within 5 working days from the date of the receipt.

3.25.2  Report shall be shared with the Plant Manager, Director, Principal Company & other concerned personnel with complete action plan.

4.0       FREQUENCY: As and when required.

                                                                                   

5.0       RESPONSIBILITIES:

5.1       QA Manger (Principal Company): QA Manager (Principal Company) shall receive all    

             product-related complaints and forward to site QA Manager. However after completion of action        

             by site QA on complaint and also forward the action plan to the relevant department once                    

             received the action plan from site QA.

5.2        QA Manager (Site): QA Manager after receiving complaint shall register the complaints in a   

      designated logbook and lead the investigation, record the findings, prepare the summary and    

      then forward to site QA contact of principal company. QA Manager (Site) shall track the action   

      plan till completion. QA Manager (Site) shall ensure compliance with this procedure.

5.3        QA Executive:  QA executive in coordination shall analyze the complaint sample and

                    provide data as required. Production Manager: Production manager shall analyze the root

                    cause & provide support in the implementation of CAPA.

5.4       Production manager shall provide support from site management to analyze the root cause &    

      implement CAPA.

6.0       REVIEW GUIDE: Market complaint records.

7.0       ANNEXURE: 1. Market/customer complaint investigation detail.

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	√
Warehouse	x	x
General	x	x
Maintenance	x	x