SOP Title: Incident Reporting and Investigation
- Objective
To lay down the procedure for Incident Reporting related to the Product Quality in the Site.
- Scope:
This procedure is applicable to any incident, evidence notified in the Manufacturing Area, QC Laboratory, Warehouse and Storage Area, Critical Utilities and other Product/Material related activities in the Site.
- Responsibility:
Officer/Executive Concerned Department: To report the incident to Supervisor/HOD of department, fill Incident Report Form and follow the procedure.
QA Officer/Executive: To verify incident, issue incident report form, documentation of incident and follow the procedure.
Head Concerned Department: To review and report the incident to QA Department, analyse, investigate, review the CAPA and implementation.
Head QA: To review, analyse incident report, investigate, recommend and implement CAPA
- Accountability:
Head QA/Concerned Department
- Procedure:
5.1 Definitions:
Incident: A discrepancy in implementation of GMP or failure of systems in day-to-day operation. Any event that can affect product quality directly or indirectly or not but that is against GMP
Critical Incident: An incident that is likely to affect the quality, safety and efficacy of the product.
Major Incident: An incident that may result in the production of a drug product not meeting the standards.
Minor Incident: An incident that may not significantly affect the quality of product and/or system.
Note: Incidents vary in nature and severity, hence proper identification and elimination of root cause needs to be done by adequate procedure.
5.2 Procedure:
| 5.2.1 | General Approach to file Incident Report | ||||
In following circumstances incident shall be filed but not limited to:
|
|||||
| 5.2.1.1 | Production Department Incidents:
|
||||
| 5.2.1.2 | Quality Control Laboratory Incidents:
|
||||
| 5.2.1.3 | Warehouse Department Incidents:
|
||||
| 5.2.1.4 | Engineering Department Incidents:
|
||||
| 5.2.2 | Reporting of Incident | |||||||||
| 5.2.2.1 | Any incident taking place in the Site shall be reported and further proceeded as per “Flow Chart for Incident Reporting”. | |||||||||
| 5.2.2.2 | Report to Senior Personnel/Supervisor or Section Head immediately when incident occur. The supervisor shall perform initial investigation to find out cause of incident. | |||||||||
| 5.2.2.3 | Incident shall be reported in the “Incident Report Form” as per format and shall be notified to QA Department. | |||||||||
| 5.2.2.4 | The Incident Report Form shall be reviewed and send to QA Department for further action. | |||||||||
| 5.2.2.5 | The “Incident Report Log” shall be maintained as per format (having the details like Incident Report No., Department, Date, Description of Incident, Type of Incident Minor/Major/Critical, Closing Date, Closing Remark and Sign of QA.) | |||||||||
| 5.2.2.6 | Incident Report number shall be allotted to each incident as mentioned below:
IDRQAYYNNN where, IDR denotes Incident Report QA denotes Quality Assurance Department YY denotes last two digit of the current year and NNN denotes three digit serial number as (001, 002, 003….). For example Incident Report Number for first incident of year 2024 shall be assigned as IDRQAD24001. |
|||||||||
| 5.2.2.7 | Incident investigation shall be done as soon as possible after the incident. | |||||||||
| 5.2.3 | Immediate Action to be taken: | |||||||||
| 5.2.3.1 | If the incident was very recent, secure the scene of the incident to ensure and preserve any evidence that may contribute to the investigation. |
|
||||||||
| 5.2.3.2 | Identify the potential sources of information, such as the injured person, witnesses and any physical evidence. | |||||||||
| 5.2.3.3 | If the incident occurs in product/material/related activities /equipment /operation stop the same and segregate the material/product with proper identification. | |||||||||
| 5.2.3.4 | Gather the facts about the incident. | |||||||||
| 5.2.4 | Evaluation and Analysis of Incident: | |||||||||
| 5.2.4.1 | Evaluation and analyses of the incident shall be done depending on the nature and severity; it shall be classified as minor, major or critical. | |||||||||
| 5.2.4.2 | Review the following necessary information during evaluation and analysis of incident:
· Any similar incident history related to equipment, operation, area and activities. · A review of similar causes in the past. · Any potential quality impacts on the product. · Any impact on regulatory commitment. · Impact of incident to any other batches. |
|||||||||
| 5.2.5 | Investigation of Root Cause | |||||||||
| 5.2.5.1 | QA Department shall investigate the root cause of the incident along with Concern Department. | |||||||||
| 5.2.5.2 | During root cause investigation always use words like what, when, where, why, who, how and which for detail investigation and to find out the root cause. | |||||||||
| 5.2.5.3 | The maximum time for investigation and closeout of incident shall be 30 working days from the date of incident filing. | |||||||||
| 5.2.5.4 | If the investigation is extended then justification shall be documented for the same. | |||||||||
| 5.2.5.5 | When the incident happened. Date and time may be crucial. | |||||||||
| 5.2.5.6 | If an employee was involved, or a piece of equipment damaged, be specific about piece of equipment and the extent of damage or injury. | |||||||||
| 5.2.5.7 | Specific details may be critical for investigation like department, product, activity, area etc. | |||||||||
| 5.2.5.8 | What work element was deficient and most directly caused the incident. If there was a specific condition (i.e. lifting, twisting, spills, poor maintenance, falling objects, defective equipment, lack of procedure, poor lighting, human error, lack of training etc.) | |||||||||
| 5.2.5.9 | If the incident is Minor then necessary Remedial Action shall be taken immediately and it shall be authorized by Head QA Department. | |||||||||
| 5.2.5.10 | Summary of the root cause investigation shall be entered on the incident form. A separate sheet may be attached for investigation with reference if required. | |||||||||
| 5.2.6 | Some Examples of these Root Cause Elements are as follows: | |||||||||
|
||||||||||
|
||||||||||
| 5.2.7 | Generally following Checkpoints may be considered during incident investigation but not limited to: | |||||||||
| 5.2.7.1 | Production Department:
|
|||||||||
| 5.2.7.2 | Quality Control Laboratory:
|
|||||||||
| 5.2.7.3 | Warehouse Department:
|
|||||||||
| 5.2.7.4 | Engineering Department:
|
|||||||||
| 5.2.8 | Corrective and Preventive Action (CAPA) | |||||||||
| 5.2.8.1 | Based on the Root Cause Analysis, all tasks required to correct the problem and prevent reoccurrence shall be identified and included in an action plan. | |||||||||
| 5.2.8.2 | Corrective Actions to be taken for the particular incident shall be discussed with related department and mentioned in the “Incident Report Form”. | |||||||||
| 5.2.8.3 | The need for maintenance of machine, retraining, development/ modification of procedure shall be evaluated. | |||||||||
| 5.2.8.4 | Preventive Actions to prevent occurrence of similar potential incident with
respect to other equipment/product/activity shall also be mentioned in the “Incident Report Form” if applicable. |
|||||||||
| 5.2.9 | Review of CAPA | |||||||||
| 5.2.9.1 | Based on nature of incident, Incident Report Form shall be circulated to other departments for impact assessment and review of action plan. | |||||||||
| 5.2.9.2 | The CAPA shall be reviewed by QA, Production, QC, Engineering and Warehouse Department as applicable. Finally the report shall be reviewed by QA Department. | |||||||||
| 5.2.10 | Implementation of CAPA, Follow up and Close out | |||||||||
| 5.2.10.1 | The Concerned Department Head shall be responsible to ensure execution of all tasks and implementation of action plan recommended in Incident Report Form. | |||||||||
| 5.2.10.2 | The actions that were taken shall be documented. | |||||||||
| 5.2.10.3 | The appropriateness and effectiveness of the action taken shall be evaluated and verified by QA Department. | |||||||||
| 5.2.10.4 | Finally the Incident Report shall be reviewed for completeness, implementation of CAPA shall be verified and Incident Report shall be closed out. | |||||||||
| 5.2.10.5 | A photocopy of the incident report form shall be attached to the batch
document (if required) and original shall be retained with QA Department. |
|||||||||
- Abbreviation:
| Abbreviation | Expansion |
| GMP | Good Manufacturing Practices |
| RH | Relative Humidity |
| RM | Raw Material |
| PM | Packing Material |
| RSD | Relative Standard Deviation |
| CAPA | Corrective and Preventive Action |
| HOD | Head of Department |
*Note – Ready to use SOP available in “DOWNLOAD” Section.