Follow
Objective: To provide guidelines to record, check, evaluate and summarize the incidence.
Scope: This procedure is applicable for handling of incidence during manufacturing activities of exhibit, validation and commercial batches at (Company Name).
Responsibility:
1. Operator / supervisor shall be responsible to report the incidence.
2. Head of department shall be responsible to review /check the incidence.
3. QA shall be responsible to evaluate and summarize the incidence.
Accountability: Concerned Department Heads.
Precautions: NA
Procedure:
1. Definition of Incidence: Incidence means the resultant of undue, unwanted, uncontrolled abnormal activities or actions happened during the course of working.
2. Any unexpected happenings during the course of working which may have impact on product/ process shall be recorded to ensure that incidence handled safely to ensure that the operation is under control.
3. Incidence need to be recorded, checked, investigated, evaluated and concluded to ensure that there is no impact of such incidents on strength, quality, efficacy and purity of the product.
4. Unexpected events encountered during product manufacturing activities are classified as incidences. e.g.: spillage of material, power failure, breaking of m/c parts in running condition, accident to operator, intermediate processing of less quantity than standard, nonadherance to specified process parameter.
5. Take immediate and appropriate action to over come the incidence.
6. Report to superior and request for suitable action.
7. Superior shall observe the incidence and initiate action.
8. Supervisor or operator shall record the incidence in Annexure – I and forward to Department Head for their action.
9. Department Head shall put his remarks/ comments on report and forward it to QA Department.
10. QA shall assign serial number to incidence report in logbook (Annexure – II) as follow:
e.g. INC/09/001
Where,
‘INC’ Incidence Report
‘09’ represents the last two digits of the year 2009
“001’ represents for serial number of the incidence report, which starts from 001 for the calendar year.
11. QA Head shall evaluate the incidence and may instruct for investigation.
12. On the basis of investigation QA Head shall instruct for corrective and preventive action, if the incidence requires immediate action, QA head shall instruct accordingly.
13. QA Head shall approve the corrective & preventive action.
14. The necessary training shall be imparted to the concerned to avoid unwanted incidence in future.
15. If the incidence shall trigger any process or procedure deviation then a deviation report shall be raised as per the SOP for ‘Deviation Control’ (SOP No.: QA008) and when applicable the impact or risk in terms of quality to be identified.
