STANDARD OPERATING PROCEDURE QUALITY EVENT OR INCIDENT REPORTING

STANDARD OPERATING PROCEDURE

SUBJECT:                      QUALITY EVENT OR INCIDENT REPORTING

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

1.0       OBJECTIVE:

            To define procedures and responsibility for reporting Quality related events and incidents.

            To investigate the root cause for the reported event/incident to prepare & implement  

            CAPA.

2.0       POLICY:  

            This procedure is applicable to the reporting of investigation and disposition of unplanned or     

            uncontrolled incidents either directly or indirectly associated with manufacturing /Packing /or

            Analytical operations.

3.0       PROCEDURE:

3.1       Definitions:

3.1.1    Quality Event: is defined as a quality system failure that can lead to major loss and risk to consumer if release to market.

3.1.2    Quality Alerts: (Reporting for P&G only) Quality Alerts is defined as a quality system failure that was caught early in the system prevented as a major loss & Quality failure that result in loss of productivity.

Example: Wrong coding, supplier failure, wrong data filling or documentation not proper, process not followed.

Elegant only have to fill alert form report immediately and furnish to P&G (QA), next steps are taken by P&G (QA) according to P&G requirements.

3.1        Report all Internal Quality Events / Quality Incidents (related to site) as per Annexure # 1       

within 24 hours of non-compliance finding. Classify the event or alert as Major/Minor based on the situation and area of occurance.

3.2        Report all Supplier Quality Events / Quality Incidents as per Annexure # 2 within 24 hours of       

      non- compliance finding.

3.3          Principal Company Materials Planner shall circulate Supplier Quality Events / Quality Incidents   to the relevant suppliers within 24 hours of Quality Events / Quality Incidents raised by site and shall follow-up with the supplier for root cause analysis and CAPA and closure of the CAPA as per agreed timeline. Shall communicate RCA and CAPA with closure status to the Site QA for record and reference of any repeat non-compliance.

3.4         Principal Company QA shall register both Site Quality Events and Suppliers Quality Events in      

GQIS within 24 hours of Quality Incident circulation by Site QA shall follow-up with supplier for RCA and CAPA shall submit 48 hrs, 30 days and 90 days QI Report to Site QA for records and reference of any repeat non-compliance.

3.6       Quality Events / Incident owner department head shall complete the root cause analysis using

                  appropriate quality tools (e.g. Fishbone Analysis, WHY-WHY Analysis – Annexure # 3) and  

 determine CAPA with the timeline and responsibilities within 3 working days of the Quality Events / Quality Incidents receipt.

3.7        Quality Events / Incident owner shall share the Root Cause and CAPA with all concerned   

                  employees and provide the training to employees to prevent recurrence of the non-compliance.

3.8        Quality Events / Incident owner shall analyze and make all preventive action plans as a part of

      relevant SOPs.

3.9        Executive QA shall track the completion of all Quality Events / Quality Incidents for action  

             plan completion and circulate  the status to P&G QA & Site Leader and action plan owners on  

             monthly basis.

3.10ABBREVIATIONS:      

Standard Operating Procedures (SOP)                                                                         

      Quality Assurance (QA)

Quality Incident (QI)

Root Cause Analysis (RCA)

Corrective and Preventive Action Plan (CAPA)

Global Quality Information System (GQIS)

4.0         FREQUENCY: As and when Quality Events / Quality Incidents occur.

5.0       RESPONSIBILITIES:

5.1       Site QA: Shall raise Internal Quality Events / Incidents as per Annexure # 1.

5.2       Internal Quality Events / Incident Owner Department Head: Shall perform Root Cause Analysis  

            and determine CAPA for reported Quality Events / QI and submit to QA for Tracking.

      Shall ensure completion of all CAPA as per given timeline. Shall communicate closure of the   

      action plans and shall submit action plan completion evidence (as applicable) to QA. Shall

      evaluate action plan effectiveness.

5.3        Executive QA: Shall track the completion of all CAPA and circulate the status to leadership    

       team on monthly basis. Shall assess the effectiveness of action plans based on repeat non- 

       compliance.

5.4     General Manager: Shall ensure the classification of non-compliance reported as Quality Events    

      /Incidents is appropriate. Circulate all Quality Incidents to Principal Company QA. Circulate    

      Supplier Quality Events and Quality Incidents to Principal Company Material Planner.

5.5         Principal Company QA Manager: Shall report all Quality Incidents in GQIS and provide      

48 hrs, 30 days and 90 days report to Site QA for record purpose.

6.0       REVIEW GUIDE:  Quality Events / Quality Incidents File.

7.0        ANNEXURE:   1.Quality event/ incident format.

2. Suppliers Quality Event / Incident.

3. Why-why analysis report.

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	√
General	x	x
Maintenance	x	√