by 1.0 OBJECTIVE
To describe the procedure for generation and handling of incident report.
2.0 SCOPE
This SOP is applicable for the generation and handling of incident report arising out of any untoward incident for the unseen or unexpected unusually occurring activity which has already taken place and may not necessarily fall under the category of process deviation, Change Control Procedure, Corrective and Preventive Action Report.
3.0 RESPONSIBILITY
Individual staff of department shall be responsible for:
Raising incident report in accordance with this SOP and taking up necessary actions.
Head – Quality Assurance (QA) shall be responsible for:
Ensuring that the procedures defined in this SOP are adhered to.
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDURE
Any member of the staff, finding the unseen or unexpected deviation in any of the functional areas can raise the deviation after obtaining the format from QA.
Examples of incident report include spillage of material / chemical, breakage of glassware during analysis, electric short circuit, overlapping of reading from the system print out like autoclave or other equipments.
QA personnel shall assign the incident report number as follows while issuing the format:
The number shall comprise nine (09) characters. For example, IR/XX/YYY. Where “IR” stands for incident report, “/” is a separator, “XX” represents the last two digits of the current year in which the deviation is raised and “YYY” is serial number of the deviations starting from 001. F
For instance, the first incident report number for the year 2019 shall be IR/19/001.
QA personnel shall log in the report number in the log book of incident report.
After obtaining the format, the detail is filled up and is being acknowledged by QA personnel.
Subsequently, this is being forwarded to the concerned Head of Department (HOD) and or Section-In-Charge (SIC) for investigation and conclusion.
Upon completion of the investigation, immediate corrective and preventive action shall be taken up and if required, help from other department shall be taken.
The duly filled report shall be forwarded to Head – QA for the evaluation and final disposition.
His shall then be verified by QA personnel for closure of the particular incident report.
After the closure of the incident report, the original copy shall be maintained with QA and a photocopy of the same shall be maintained with the concerned Batch Processing Control Record (BPCR), if related to a batch/product or the concerned relevant document.
QA personnel shall update the log book of the incident reports accordingly.
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8.0 ATTACHMENT
| Sr. No. | Annexure No | Title | Format No. |
| 1 | NA | NA | NA |
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
