Checklist for Audit in Engineering/ Maintenance : Pharmaceutical Guidelines

Checklist for Audit in Engineering/ Maintenance


Audit checklist for the engineering and maintenance department.
1. Are internal quality audits carried out?
  • Last audit date
  • Compliance status
  • Any pending Issues (May attach separate sheet if required)
2. Is there an organogram for the dept?
3. Are no. of personnel adequate?
4. Is the department manual available for reference?
5. Is responsibility of the personnel available?
6. Are all SOP’s w.r.t. procedures are correct & followed?
7. Are revision status/ date mentioned in all the documents?
8. Is any obsolete document found floating in the dept?
9. Are proper breakdown entries made in history card?
10. Are Boiler, D.G. set, M.S.E.B, Log books maintained?

11. Is the list of equipments available?
12. Are the preventive maintenance schedule & plan available?
13. Is the list of critical spares available?
14. Is proper indent given for required material with proper authorization?
15. What is the identification mark for cleaned & un-cleaned filters?
16. Are all service lines well defined by displaying coded/ color details?
17. Is buffer stock of filter kept with proper identification?
18. Whether all filters with proper identification mark?
19. Whether all calibration carried out by third parties have traceability to national standards?
20. Is the ETP tank labeled properly?
21. Are preventive maintenance schedule done as per schedule?
22. Is the IQ, PQ, OQ done for new equipment?
23. Is the breakdown records maintained?
24. Are levels of underground water, sufficient diesel, boiler & D.G. set tanks inspected regularly?
25. Are there checks on Humidity & Temperature controller?
26. Are calibration tags available on each equipment?
27. Are procedures along with frequencies available for calibration?
28. Whether temp. & pressure gauges used are calibrated as per frequency?
29. What is the procedure for ‘Out of Calibration’ equipment?
30. Is proper status label for critical spares?
31. Is proper status label of filters clean?
32. Are calibration status is available on calibrated equipments?
33. Is any non-conforming product / utility identified properly?
34. Are records maintained if documented procedure changes due to corrective/ preventive action?
35. Whether proper authorisation is taken for any deviation?

36. is work permit taken for critical activities?
37. Are critical spares stored properly?
38. Whether safety wears are used during maintenance work?
39. Are all records (controlled copies) of SOP’s kept / displayed in proper locations?
40. Is there a retention period for each of these documents?
41. Are all operators & workers trained?
42. Are records of training properly maintained?
43. Is employee assessed after training?
44. Is retraining given if required?
45. Is there a training calendar?

View Video Tutorials





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


Click Here

No comments: Read Comment Policy ▼

Post a Comment


Follow Pharmaguideline


CURRENT JOBS

Show All ❭❭Jobs by PharmaJobs

WRITE A POWERFUL CV

Click Here



ADVERTISE HERE


GET APP FOR NEWS UPDATES

Scan to Download

Android App
Android App

Recent Posts