SOP Title: Handling of Instruments/Equipments Breakdown
- Objective:
To lay down the procedure for Handling of Instruments/Equipments Breakdown.
- Scope:
This SOP is applicable for Procurement and Handling of Instruments/Equipments Breakdown in Quality Control Department.
- Responsibility:
- Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Handling of Instruments/Equipments Breakdown in Quality Control Department as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexures.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department
- Procedure:
| 5.1 | Handling of Instruments/Equipment’s Breakdown: | |
| 5.1.1 | Equipments/Instruments that has been subjected to overloading or mishandling which gives improper results or has been shown to be defective or out of calibration shall be kept out of routine use. | |
| 5.1.2 | When Instrument/Equipment fails to qualify the test for calibration or validation, Quality Control Analyst should be report to the Supervisor and affix the label as “Under Maintenance”. | |
| 5.1.3 | Whenever a breakdown occurs, a complaint note in complaint format shall be sent to the HOD (Engineering) by Supervisor/HOD. | |
| 5.1.4 | If major fault observed in Equipments/Instruments, Supervisor should be consult to HOD of QC and further HOD of Engineering Department. | |
| 5.1.5 | When Engineering Department rectify the problem, the Equipments/ Instruments should be recalibrated or validated for performance. | |
| 5.1.6 | If the Engineering Department declares the critical fault and requirement for outside engineer or parts, than put the label as “Non-Functional Equipment” till the problem is rectified. | |
| 5.1.7 | For each and every activity performed, update the “Instrument/Equipment Usage Log Book” and “Instrument/Equipment History Card” as per SOP “Calibration of Instruments and Equipments”. | |
| 5.1.8 | All repair/service documentation shall be kept with the Instrument/ Equipment history card in order to provide a concise history for each instrument. |
| 5.1.9 | At the conclusion of the repair/service a service report should be completed
by the engineer indicating what work has been undertaken and what work may be required in the future. |
| 5.1.10 | If any spare or part procured for this Equipments/Instruments, it should be recorded with detailed in Instrument/Equipment History Card. |
| 5.1.11 | When Equipments/Instruments ready for use after repairing, it is compulsory to check calibration parameter or validation for performance check or operational qualification tests based on assessment. |
| 5.1.12 | After successful qualification of the tests, Instruments/Equipments shall be release for routin use. |
| 5.1.13 | If any Instrument/ Equipment is not possible to repair, then it shall be retired from the department with proper assessment and impact evaluation by filling change control. |
| 5.1.14 | Retired Instrument/ Equipment shall be send it back to manufacture or hand over to Engineering Department for further disposal. |
- Definitions / Abbreviations:
- Definitions:
- Abbreviations:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
| No. | Number |
| HOD | Head Of Department |
*Note – Ready to use SOP available in “DOWNLOAD” Section.