Incident Reporting System SOP

 

1.0              OBJECTIVE:

To lay down the procedure for Reporting, Investigation and Closing of Incident system.

2.0              SCOPE:

This SOP is applicable for all incidents, which can affect the Safety, Identity, Strength, Purity and/or Quality of the Product at -------------------------------

3.0              RESPONSIBILITY:

3.1              Each affected department is responsible for initiation of Incident report.

3.2              Concerned Section Head of the Department is responsible for investigation, identifying root cause and placing corrective action & preventive action.

3.3              QA (Quality Assurance Executive / Quality Assurance Head) is responsible for review and approval of the Incident report.

4.0              ACCOUNTABILITY:

4.1              Department Head / Head - Quality Assurance shall be accountable for the compliance of SOP.

5.0              PROCEDURE:

5.1              Definition: An incident can be defined as an unplanned event that occurs in non compliance with the design systems or procedure at any stage of the receipt, storage, manufacturing packing and handling of drug product. Or

Any unexpected event occurred in uncontrolled manner related to procedures, processes, system, equipment and utilities termed as an incident.

5.2              Identification of incident:

5.2.1  While carrying out day-to-day activities, there is a probability of unexpected event occurring. Such unexpected events  may be related to the procedures, processes, systems, equipment and utilities such as (not limited to)  :

§  Nonconformance / failure of cGMP system observed during shop floor inspection or inspection in different departments.

§  Accident in the plant

§  Documentation Error

§  Laboratory Error

§  Human Error

§  Equipment failure / Breakdown / Malfunctioning

§  Power supply failure / interruption

§  Breakdown in support services / utilities etc

§  Entry missing in equipment / instrument log book and any approved document during review.

5.3              An incident report (IR) shall be initiated as a part of the approved system for handling of incident, in order to provide a mechanism for ensuring the recording of the incident, assess the impact on product quality and perform corrective action and preventive action to ensure the product quality as per SOP on CAPA

5.4              Any individual on the job shall inform the concerned department supervisor regarding the occurrence of incident and details of initial observations.

5.5              Reporting of Incident:

5.5.1        An Incident shall be reported to the QA within one working day.

5.5.2        User department shall make request for issuance of incident report Format no: F/QA-012-01 to Quality Assurance department through Format no: F/QA-013-01.

5.5.3        QA department shall maintain the log for all incidents as per Format no: F/QA-012-02 “Logbook for Incident reports”.

5.5.4        The form shall be clearly filled and no abbreviations shall be used while filling the

5.5.5        Incident Report shall be clearly filled for Date of Incident, Department Name, Product Name and details as per Format No.: F/QA-012-01.

5.5.6        Brief description of the incident shall be written where the incident has occurred.

5.5.7        Immediate action taken (if any) after the incident shall be recorded in the report.

5.5.8        Personnel who are reporting shall sign with date and forward the report to departmental head for assessment.

5.5.9        For repetitive three incidents that incident will consider as deviation, that incident shall be converted into deviation & root cause shall be find out through Investigation.

5.6              Assessment of Incident:

5.6.1        Assessment by Departmental Head and Head-QA/his/her designee.

5.6.2        The departmental head shall review the report & comment with signature and date and forward the report to QA department.

5.6.3        The QA department shall check the report for its completeness and allocate the Incident report Number with recording in the Log Book and submit the same to Head –QA for comments.

5.6.4        The Incident Reporting Form shall be numbered as – @@/IR/XXYYY

           Where @@ indicates the name of the Originating department.

           Codes for individual department shall be as follows –

Sr. no.	Department	Code No.
0.1	Quality Assurance	QA
2.0	Quality Control	QC
3.0	Engineering	EG
4.0	Personnel & Administration	PA
5.0	Production	PD
6.0	Ware house (RM/PM)	WH
7.0	Finished Goods	FG

 

 

 

 

 

 

 

IR-Incident Reporting, XX-Year of deviation like 18 for the current year, YYY-Serial Number of the deviation

5.7              Every Incident Form shall be approved/ rejected and closed within a time frame of 7 days after investigation.

5.8              After implementation of corrective action /preventive action as per the incident, QA person verified the result of effectiveness of the result. Impact of incident shall be assessed and compliance ensured with aspect to various recommendations made in the Incident Form. Then only QA Head/designee shall finally close out the incident.

5.9              After closing the Incident report, the same shall be submitted to QA department and documented in Incident Log Book As per Format No. F/QA-012-02.

5.10          If in any case incident not closed within 7 days then give the reason and justification for extension date of incident extension period as per format number F/QA-012-01.

5.11          Review the Incident log book on yearly basis with a goal to look for trends as common problems as per format no.: F/ QA-012-03. Inform to QA Head about review findings.

 

6.0              LIST OF ANNEXURE AND FORMATS:

 

Sr. No.	Title of Format	Format No.
01	Incident Reporting Form	F/ QA-012-01
02	Incident  Reporting Log	F/ QA-012-02
03	Trending of incident	F/ QA-012-03

 

7.0              REFERENCES:

7.1  SOP-QA-001

7.2  F/QA-001-01

7.3  F/QA-013-01

 

 

 

 

 

8.0              REVISION HISTORY:

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

 

9.0              ABBREVIATIONS:

 

Sr. No	Abbreviations	Details
01	SOP	Standard operating procedure
02	CAPA	Corrective action and preventive action
03	STP	Standard Testing Procedure

 

 

END OF DOCUMENT

INCIDENT REPORT NO: ______________                                                       DATE:  ______________

CONVERTED DEVIATION NUMBER: ____________                                            DATE: ______________

(If applicable)

Name of  Material / Product:		B. No. / A. R. No.:
Equipment Involved:		Test:
Date of Incident Observed:		Date of Occurrence:
Incident Reported By:		Department:
Number Of Similar Type Incident Happened In The Last Six Month:

 

BRIEF DESCRIPTION OF INCIDENT / DISCREPANCY:
Name of Originator:	Sign/Date:		Designation:
Investigation Details :                     (Attach investigation report, if required)
Proposing Department (Sign/Date):		Proposing Department Head (Sign/Date):

 

Root Cause:

Corrective action:             Responsible person sign/date:                                                                          DEPT. HEAD (Sign/Date):

Preventive action :             Responsible person sign/date:                                                                          DEPT. HEAD (Sign/Date):

Review by QA Department:             Responsible person sign/date:                                                                           DEPT. HEAD (Sign/Date):

If Preventive action not completed within time, then reason and justification for extension date of the incident (If applicable):                     Requested  By:                                                                                                                   Approved By:                                                                                                                                                                                 Sign/date:                                                                                                                           Sign/date:

Final evaluation of closure of the incident(QA):                     Close out date:       Closure done By:   QA HEAD (Sign/Date):