SOP for incident management | Incident management standard operating procedure |
- Incident Management SOP covers below points:
- Incident definition
- Incidents are categorized as
- Quality Impacting Incidents
- Quality Non-Impacting Incidents
- Examples of incidents
- Handling of incidents
- Format for Incident Form
- Format Incident Control Register
1.0 OBJECTIVE :
- This SOP defines the procedure for reporting, investigating and disposition of any incidents.
2.0 SCOPE :
- This SOP is applicable for investigating and detailing the sequence of events needed for handling of incidents occurred inadvertently in any department.
3.0 RESPONSIBILITY :
- It is the responsibility of respective department Officer / Executive to raise the incident report.
- It is the responsibility of respective department head to carry out the preliminary investigation and to suggest corrective action and preventive action.
4.0 ACCOUNTABILITY:
- Respective Department Head and Quality Assurance Head
5.0 PROCEDURE :
5.1 Incidence is defined as something non cGMP(current Good manufacturing practices) have occurred all of sudden which may or may not have impact on product Quality.
5.2 An incident can happen any time which shall be recorded, investigated and closed with suitable preventive action plan.
5.3 Incidents are categorized as :
- Quality Impacting Incidents:
- Quality Impacting Incidents are unplanned events / errors that occur during the execution of an activity in any departments which may have impact on the quality, purity and strength of the drug material / product.
- Quality Non-Impacting Incidents:
- Quality Non-Impacting Incidents are unplanned events / errors that occur during the execution of an activity in any departments which have no impact on the quality, purity and strength of the drug material / product.
5.4 Following are the examples of incidents may happen but not limited to;
- Unexpected major machine breakdown.
- Unexpected deviation from environmental conditions.
- Unexpected damage to the facility.
- Unexpected power failure and no immediate backup support from electric generator which could cause a major product quality, quantity, safety and commercial issues.
- Spillage of material during batch processing which could affect product yield and commercials.
- Human accidents during development, manufacturing, packing, engineering, analytical work etc.
- Commercial losses due to intentional/unintentional error and negligence.
- Indiscipline behavior from staff/workers inside the facility which can give impact on product quality, quantity and resulting into a major commercial loss.
5.5 On occurrence/ noticing of incident the employee shall immediately inform, verbally or telephonically to the concerned supervisor /shift-in-charge, who shall decide whether to continue the process or stop the process.
5.6 Supervisor /Shift-in-charge shall inform the concerned head of department or his/her designee.
5.7 Incident shall be immediately reported by the concerned department Head to quality assurance head or his/her designee and shall request for issuance of “Incident Form”.
5.8 As per verbal request from any departmental head or his/her designee, chemist and above of Quality Assurance department will issue blank working copy of incident form by allocating incident report number and will also get acknowledgement from requesting department on format issue register.
5.9 The incident request department shall enter the detail in Incident Form.
5.10 Each incident shall be assigned unique number as per below format.
- INC/00/000 Where,
- INC : Incident
- 00 : Year in which incident occurred
- 000: Serial number of Report
5.11 Quality Assurance head or his/her Designee on receipt of an incident form filled and signed from respective department, looking at seriousness of the incident shall plan/check an immediate action, if necessary by taking support from other departments or Director and then enter the incident details into the “Incident Register” as per Incident Control Register (Annexure-02).
5.12 On the basis of the brief description of the incident the Quality Assurance head or his/her Designee decide the category of the incident (Quality Impacting Incident / Quality Non- Impacting Incident) .
5.13 Preliminary investigation of the incident is done by respective department head to find out the root cause for the incident and the same is written in the Preliminary Investigation (root cause for incident) column with sign, date and name.
5.14 Department Head has to choose the correct option from Section III of Incident form. If he / she choose the others option, then he / she has to specify the details of the events or errors.
5.15 Based on the identified error, the Corrective Action and Preventive Action (CAPA) is suggested by Department Head (Section IV of Incident form) and the job is assigned to responsible person of department with the Name and Designation is written in Responsible Staff Column and the date of completion is written in target date to be completed column.
5.16 Department Head then forward the Incident Report to Quality Assurance head or his/her Designee for Evaluation and Recommendation (Section V of Incident form).
5.17 Quality Assurance head or his/her Designee evaluate the Incident Report and provide the recommendations, if any, and return back the Incident Report to respective department.
5.18 The above information is checked by department Head and if found ok, submit the Incident Report to Quality Assurance head or his/her Designee for recommendation and closure.
5.19 Quality Assurance head or his/her Designee shall make sure that all the Corrective Action and Preventive action are completely carried out as per suggestions given by department Head and Quality Assurance Head.
5.20 If the verification found satisfactory, Quality Assurance head or his/her Designee fills the respective compliance details in the Compliance of the Recommendations column and carry out the Closure of the incident (Section VI of Incident form).
5.21 After performing detailed investigation and impact of the incident, Quality Assurance head or his/her Designee shall prepare a report on incident with final conclusion and state the remarks.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| Q.A. | Quality Assurance |
| INC | Incident |
| cGMP | current Good Manufacturing Practices |
| CAPA | Corrective Action and Preventive Action |
7.0 ANNEXURES:
| Annexure No. | Title |
| 01 | Format for Incident Form |
| 02 | Format Incident Control Register |
8.0 SOP REFERENCES
- GMP Guidelines
END OF THE SOP
ANNEXURES :
Annex. No. 01 Format for Incident Form
Annex. No. 02 Format Incident Control Register
