SOP Title: Emergency Power Failure
- Objective
To lay down procedure for actions to be taken in case of emergency power failure during critical operations at the site
- Scope:
This procedure is applicable to Production and Quality Control area
- Responsibility:
Production Associate: To inform the incident to senior and follow the procedure
QA Associate: To verify, inform the incident to senior and follow the procedure
Engineering Associate: To verify, review, identify the cause of incident and take necessary actions
QC Associate: To inform the incident to senior and follow the procedure
- Accountability:
Head QA/All head of departments
- Procedure:
5.1 Definitions:
Emergency Power: Electricity temporarily produced and supplied by a standby power generator when the conventional electric power supply fails or is interrupted.
Emergency Power Failure: Failure of standby power generator to supply electric power which in turn causes the equipment to shut down.
5.2 Procedure
| 5.2.1 | Actions to be taken during manufacturing of product (dispensing, granulation, compression ,blending, capsule filling, Packing etc) in Production Department in case of emergency power failure | |
| 5.2.1.1 | Switch off the mains of machine and record the time of processing/activity or operation. | |
| 5.2.1.2 | Remove or unload the material in proper manner in clean poly bag/container, tie/cover, label, segregate etc as applicable. | |
| 5.2.1.3 | Inform immediate supervisor/department head. | |
| 5.2.1.4 | Fill the ‘Complaint Note’ and submit to Engineering Department. | |
| 5.2.1.5 | Fill the ‘Incident Report Form’ and submit to Quality Assurance Department. | |
| 5.2.1.6 | Start further process/activity only after decision made through incident assessment. | |
| 5.2.1.7 | After resumption of the power, check temperature, relative humidity and pressure differential of the area as per BMR/BPR. | |
| 5.2.1.8 | Switch ON the main, check the equipment for correct operation, process parameter, product parameters etc. | |
| 5.2.1.9 | Start further activity/operation/process for remaining time period to continue the process. | |
| 5.2.1.10 | Record the details in the respective BMR/BPR and Equipment Log. | |
| 5.2.2 | Actions to be taken during testing operation of products (chemical, instrumental, microbiological etc) in Quality Control Department in case of emergency power failure | |
| 5.2.2.1 | Sophisticated equipment/instruments shall be provided with untripped power supply in the Quality Control laboratory. | |
| 5.2.2.2 | For others switch off the mains of equipment/instrument and record the time of operation/activity in case of emergency power failure. | |
| 5.2.2.3 | Inform immediate Supervisor/Department Head. | |
| 5.2.2.4 | Fill the ‘Complaint Note’ and submit to Engineering department. | |
| 5.2.2.5 | Fill the ‘Incident Report Form’ and submit to Quality Assurance Department. | |
| 5.2.2.6 | Start further testing operation/activity only after decision made through incident assessment based on impact on testing parameters. | |
| 5.2.2.7 | After resumption of the power, check temperature, relative humidity and pressure differential of the area as applicable | |
| 5.2.2.8 | Switch ON the main, check the equipment/instrument for correct operation, parameter etc. | |
| 5.2.2.9 | Stabilise the solution for sample and continue the operation as per procedure. | |
| 5.2.2.10 | Record the details in the respective worksheet and Instrument Log | |
| 5.2.3 | General Points: | |
| 5.2.3.1 | An immediate decision shall be taken on the basis of impact assessment regarding further processing/activity of product to reduce risk to the product quality during emergency power failure. | |
| 5.2.3.2 | Alternate equipment/processing step may be considered if applicable, through deviation when there is no significant impact product quality attributes. | |
| 5.2.3.3 | Incident report should address comprehensive evaluation, analysis, investigation, action plan and implementation with necessary recommendation to prevent such incident in future. | |
| 5.2.3.4 | Specific assistance in investigation of root cause and corrective actions related to technical/mechanical or functional error or failure of standby power generator by external engineer or expert may be considered suitable as suggested by Engineering Head, if applicable. | |
| 5.2.3.5 | A copy of incident report shall be attached to the respective product BMR/BPR after completion or closing of incident. | |
| 5.2.3.6 | If the incident emergency power failure found frequent as a result of inefficient system/service for emergency power supply and/or modification or replacement of system is required, it should be brought to the notice of management for implementation of new efficient system. | |
- Abbreviation:
| Abbreviation | Expansion |
| QAP | Quality Assurance Procedure |
| HVAC | Heating Ventilation and Air Conditioning |
| BMR | Batch Manufacturing Record |
| BPR | Batch Packing Record |
| QAD | Quality Assurance Department |
| SOP | Standard Operating Procedure |
*Note – Ready to use SOP available in “DOWNLOAD” Section.