sop for Handling of Incident during operation

1.0 Objective
To lay down a procedure for handling, reporting, investigation and closing of incident during operation.
2.0 Scope
This Standard Operating Procedure is applicable for all Incidents during operation and that can directly/ indirectly

affect the quality of the product to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive of initiator department shall be responsible for
3.1.1 Brief description of the incident shall be written where the incident has occurred.
3.1.2 A personnel who is reporting shall sign with date and forward the report to their department head.
3.2 In charge / head of concern department shall be responsible for the investigation and review of the

report with sign and date and forward the report to QA department.
3.3 In charge / his designee shall be responsible for its investigation, completeness and allocate the Incident

Report number with recording in the log book and submitted to Head-QA for comments.
3.4 Head QA / his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
Incident : It is notification of discrepancies observed during the implementation of cGMP or notification

of failure of system in day to day working. These notifications are other than product non-conformance,

OOS and deviation. These notifications may or may not affect the product quality, safety and efficacy.
SOP : Standard Operating Procedure
CAPA : Corrective and Preventive Action
BPCR : Batch Production & Control Record
QA : Quality Assurance
QC : Quality Control
No. : Number
5.0 Procedure
5.1 Identification of Incident
5.1.1 Personnel of concerned department shall report immediately to responsible officer or concerned

department head must identify incidents.
5.1.2 Following are the examples of incidents, but not limited to
5.1.2.1 Spillage of raw/ packing material.
5.1.2.2 Damage of container carrying raw, bulk, semi finish or finish material.
5.1.2.3 Error notify during the operation, machine handling or automation or sudden

temporary/ permanent break down of machine equipment.
5.1.2.4 Any mishandling observes during the operation, packing, over printing etc.

5.2 Reporting of Incident
5.2.1 Officer / Executive of the concerned department shall initiate Incident Report

as per Annexure-1.
5.2.2 The form shall be clearly filled and no abbreviations shall be used while filling the Incident Report.
5.2.3 Incident Report shall be clearly filled for Date of Incident, Department Name, Product Name and

details as per Annexure-1.
5.2.4 Brief description of the incident shall be written where the incident has occurred.
5.2.5 Immediate action taken (if any) after the incident, the same shall be recorded in the report.
5.2.6 A personnel who is reporting shall sign with date and forward the report to departmental

head for Assessment.
5.3 Assessment by concerned department head and Manager-QA.
5.3.1 The departmental head shall review the report & comment with signature and date and

forward the report to QA department.
5.3.2 The QA department shall check the report for its completeness and allocate the Incident

report number with recording in the logbook and submitted to Manager–QA for comments.
5.3.3 The Incident Report Number shall be allocated as IN/ YY / NNN where:
“IN”– Denotes the Incident
“YY”– Last two digits of Calendar year
“NNN”– Serial number of the Incident form raised in current Calendar Year.
For example: IN /13/001 denotes first Incident Report No. raised in year 2013.
5.4 Investigation Report
5.4.1 On the receipt of Incident Report, Manager-QA shall review the impact on the quality

of product and comment with signature and date.
5.4.2 If Manager-QA shall recommend for investigation, the investigation shall be carried out.
5.4.3 If investigation is not required, departmental Head along with the target date of completion,

signature and date shall mention the details of Corrective and Preventive Action (CAPA) taken.11
5.4.4 QA department shall monitor the compliance of CAPA.
5.4.5 The CAPA shall be duly approved by Plant Head and Authorized by Head-QA.
5.5 Closure of Incident Report
5.5.1 After closing the Incident report, the same shall be submitted to QA department and

documented in Incident Log Book as per Annexure-2.
6.0 Forms and Records
6.1 Incident Report – Annexure-1
6.2 Incident Logbook – Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance, Quality Control, Production,
Warehouse, Engineering.

8.0 History