Incident Handling and Investigation Procedure – EHS

Standard Operating Procedure (SOP) for Handling, Investigation, Classification and Reporting of Incident by Environmental,  Health and Safety (EHS) department in pharmaceuticals.

Incident Investigation, Classification and Reporting (EHS)

1.0   PURPOSE:

    • To laydown a procedure to describe the incident, its classification, the requirement of investigation and its reporting procedure by Environment, Health and Safety Department (EHS).
    • The main objective is to provide a safe, accident free work place where employees feel free to report all incident by EHS in order to help identify root causes and eliminate the possibility for a recurrence.

2.0   SCOPE:

    • This procedure is applicable all types of incident occurring and handling by the EHS department.
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3.0   RESPONSIBILITY – INCIDENT (EHS):

    • User Department:

    • The department personnel shall immediately verbal information given the department in-charge or head as well as EHS about the incident.
    • User Department In-charge / Department Head:

    • After hearing the incident, user department in-charge or Department HOD should perform the following:
      • Immediately visit the incident site
      • Gather preliminary information
      • Inform to EHS and Unit Head regarding incident.
      • Prepare a team along with EHS for investigation purposes of incident.
      • Fill the FIR (First Information Report) or it also known as Initial Incident Report (Form A) within the working shift of at the maximum within 24 hours of the incident happening      
    • EHS In-charge / Designee. :

    • After getting information about incident EHS In-Charge or Design. should perform the following:
    • Immediately visit the incident site.
    • Inform to the Unit Head / higher level of management about the incident.
    • Gather preliminary information
    • Ensure Immediate Corrective Action to be taken
    • Ensure First Aiders / Fire Fighters reached the site for emergency help
    • Continue the Investigation along with the user department in-charge or Department head and other team members.
    • Record the same in Final investigation Report (Form B) and Accident report (Form C)

4.0   PROCEDURE FOR HANDLING INCIDENT (EHS):

    • The department personnel shall immediately verbal information given the department in-charge / HOD as well as EHS about the incident.
    • After hearing the incident, user department in-charge / HOD / EHS should perform the following:

      • Immediately visit the incident site
      • Gather preliminary information
      • Immediate Corrective Action to be taken
      • Awaiting help from First Aiders / Fire Fighters
      • Inform to EHS and Unit Head.
      • Prepare a team along with EHS for investigation purposes
    • Fill the FIR (First Information Report) or it also known as Initial Incident Report (Form A) within the working shift of at the maximum within 24 hours of the incident happening.
    • If the incident will be caused any injury, the injured person shall be attended first and necessary treatment should be given.
    • Care and precautions should be taken to prevent the injury from becoming worse.

    • The first aider/area in-charge available at the time shall be analyse and decide whether the injured needs to be taken to the nearest hospital for further treatment.
    • If the Incident has potential to cause further damage to other people, environment and property, shift/area in-charge or department head should stop the production activities, raise an emergency alarm and evacuate people form the location.
    • When an incident happened, it needs to be investigated to arrive at the root cause of the situation so that appropriate further actions can be taken to prevent its reoccurrence.
    • The investigation team shall be determine the facts and identify the key factors and root causes.

    • The key factors will be divided into 5 categories Machine, System Material, Environment and Human. Focus of the team should be to identify the root cause of the incident.
    • Incidents which shall be leads to injuries will be classified based on the mode of treatment given to the person.
    • The investigation team shall consist of people from different departments relevant to the incident.
    • Key Factors leading to the incident should be identified.

    • For Major Fire or Spillage, Medical treatment, Lost Time and Reportable Lost Time Incidents.
    • If there is an injury, the inputs of the injured person should also be part of the investigation.
    • Final investigation report (Form B) along with CAPA shall be submitted to the department head, EHS head and Plant head within 10 working days of the incident.
    • The CAPA shall be addressed the key factors identified.
    • For Accidents, Form C should be completed along with Form B.
    • The CAPA will be reviewed during the monthly safety meetings.
    • The Section Head or HOD where the incident has occurred will be responsible for the timely and effective closure of the CAPA.
    • Once all the CAPA, for a particular incident are closed and verified, EHS person will close the incident report with the approval of Plant Head.

    • Hard Copies of the Investigation reports of incident and other supporting documents shall be maintained by the EHS department.
    • Incident analysis shall be done by the EHS department and shared with the Plant head, department heads, EHS head and safety committee members.
    • The results of these analyses should be used as inputs for the EHS objectives and programs.
    • All the incidents shall be numbered in sequence as XXX-YY,
    • Where XXX is serial no. e.g. 001,002 so on.
    • YY stands for year. e.g. 21 for the year of 2021.e.g. 001-13

5.0   ABBREVIATIONS:

    • EHS : Environment, Health &  Safety
    • FIR : First Information Report
    • FAI : First Aid Incident
    • LTI : Lost Time Incident
    • MTI : Medical Treatment Incident
    • PPE’S : Personal Protective Equipment’s
    • R’LTI : Reportable Lost Time Incident

6.0   DEFINITION – (EHS INCIDENT):

    • What is Incident:
    • An incident is a sequence of events or conditions that could result in an accident, injury, occupational illness, and / or property damage.
    • In other words any unplanned events or series of events which cause, bodily injuries, fire, damage to environment, equipment and property.
    • Incidents are not welcome situations.
    • Accident:

    • A workplace incident which has caused bodily injuries to human beings, damage to environment, equipment and property.
    • Near Miss:

    • It is also known as Learning Incident.
    • Near misses are the event other than dangerous occurrences, which have potential to become an incident and require action to prevent occurrences. (E.g. Slip / trip / fall, sparking / smoke, minor overflow / leaks, failure of the valve etc.
    • Near misses describes incidents where no property was damage and no personal injury sustained, but where given a slight shift in time or position, damage and / or injury easily could have occurred.
    • First Aid Incident (FAI):

    • A workplace incident which cause minor injury like cuts, scratches, burns etc. to the person and are treated immediately by trained first aiders.
    • After the first aid treatment, the person will resume back to work.
    • Fire Incidents:

    • An unplanned combustion which leads to heat, smoke and flames is called as fire incidents.
    • Environmental Incidents:

    • Any incidents that have potential adverse impacts on environment are classified as environmental incidents.
    • A major spillage or leakage of toxic and hazardous chemicals from the primary equipment (E.g. pipes, valves, tanks) to air, ground or water.
    • Vehicle Incidents:

    • These are the incidents related to incidents involving vehicles within the operating locations or employee travelling on company business.
    • Fatal Incident:

    • Any incident which results in death. This includes all cases involving employees / contractors / visitors.
    • Dangerous Occurrences:

    • The following incidents whether or not they are attended by personal injury or disablement shall be dangerous occurrences. e.g.
      • Bursting of steam plant under pressure,
      • Collapse or failure of lifting appliances or overturn of crane,
      • Fire, explosion, explosion of pressure vessels,
      • Escape of molten metal, hot liquor or gas,
      • Collapse or subsidence of a structure.
    • Prosecution Notification:

    • Notifications from regulatory authority regarding prosecution or fine on account of any infringements to safety or environmental laws and regulations.
    • Occupational Illness:
    • A diseases or illness caused by repeated or prolonged exposure to a workplace hazard as well as acute & chronic illness or diseases caused by inhalation, ingestion, absorption or direct contact.
    • Medical Treatment Incident (MTI):
    • A workplace incident which cause injury and requires treatment by an off site medical professional or physician. Once the treatment is completed, the person will come back to work on same day or next day.
    • Lost Time Incident (LTI):

    • A workplace incident which cause minor injury and prevents the person from joining back his duty next day.
    • Reportable Lost Time Incident (R’LTI):

    • A workplace incident or any dangerous occurrence which cause injury and prevents the person from joining back his duty for more than 48 hrs.
    • Such incidents are known as Reportable Lost Time Incident (L’LTI)
    • Man Days Lost:
    • Man days lost of days the injured person is away from duty due to the work place incident.
    • This includes Saturday / Sunday, Public holidays and official off day of the person.
    • The incident day is not consider in man days lost.
    • Accident Free Days:
    • Total number of continuous days without any first aid, medical treatment, lost time incidents and reportable lost time incidents.
    • Hazard:
    • Any source or situation at the work place with the potential to cause bodily injury or ill-health.
    • Hazard can be physical, chemical, environmental, ergonomics or biological.

7.0   ANNEXURES – INCIDENT – EHS:

Annexure 1 : Initial Incident Report (Form – A)

(TO BE FILLED BY SHIFT / AREA IN-CHARGE)

           

                                                                                               Incident No.  ________________

Date & Time of Incident:
Department / Location:
Shift

1st           2nd             3rd             General           OT    Holiday

Nature of Incidents

Near Miss         Accident        Fire            Environment        Dangerous Occurrence

Category of affected employee

Employee  Contractor    Vendor / Supplier   Visitor  Material or equipment

 

Title:
Immediate cause of Incident:
Immediate Corrective Action Taken:
Any Recommended Preventive Action:
Date of Report: 

Issued By Name:

Sign. & Date

Note – Title – (Brief Description of Incident i.e. brief summary of what actually happened, names of chemical or material and quantity involved and status of the person involved)

Annexure 2 : Final Investigation Report (Form – B)

                                                                                               Incident No. ________________

Date & Time of Incident:
Department / Location:
Shift

1st           2nd             3rd             General           OT    Holiday

Nature of Incidents

Near Miss         Accident        Fire            Environment        Dangerous Occurrence

Category of affected employee

Employee  Contractor    Vendor / Supplier   Visitor  Material or equipment 

 

Date & Time of Investigation:
 Top of Form

Type of Accident: First Aid Incident Medical Treatment Incident

Lost Time Incident Reportable Lost Time Incident

Fatality

Bottom of Form

Top of Form

Bottom of Form 

If Environment Incident:

Name of Chemical or Material Involved: ___________

Quantity: ____________(liters or kg)

Top of Form

Medium Affected:

Air                                               Water                                              Ground Bottom of Form

If Fire Incident:

Source of Fuel: Source of Ignition: Source of Oxygen: 

Key factors:

Top of Form

Machine           System         Environment              Material            Human Bottom of Form Bottom of Form

 

Key Learning’s of the Incident: 
Corrective And Preventive Actions:

 

Sr. No. Details of the Action Key factor Responsibility Target Date
         
         

 

Details of Investigation Team:
 

Sr. No. Name of the Member Department Role/Designation

 

Shift/Area In-charge HOD EHS
Date:____________

Name:___________

Sign: ____________

Date:____________

Name:___________

Sign: ____________

Date:____________

Name:___________

Sign: ____________

 

Report Closure (Plant Head): All the CAPA have been effectively closed and verified.
Date:____________

Name:___________

Sign: ____________

Annexure 3 : Accident Report (Form – C)

                                                                                               Incident No.  ________________

1.      DETAILS OF INJURED PERSON

Name:
Employee Code:
Designation:
Date of Birth: (MM/DD/YY)
Age:
Gender Top of Form

Male Female

Bottom of Form

 

Employment Status:

 

Top of Form

Employee Contractor Vendor/Supplier Visitor Bottom of Form

Period in current job/role:

 

2.      DETAILS OF ACCIDENT

Date and Time of Accident:
Location of Accident:
Date of return back to work:
Total No. of Lost Work days:

 

3.    DETAILS OF INJURY

Nature of Injury(e.g. cut, burn etc):
Part/s of body affected:
Diagnosis and Treatment given:

 

4.      DETAILS OF WITNESS

Sr. No. Name of the Witness Role/Designation Signature

 

Annexure 4 : Direct and Underlying Causes

EHS INCIDENT FLOW CHART

 

 

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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