How to Prepare for Audit USFDA/EU/ other regularity audit for Engineering / validation prospect

We regularly facing audits and struggling in providing compliance if any issue observed in Internal or External audit. 

So we have prepared the check list for Engineering compliance. This check List will be Very helpful of Preparation of Audit.

Engineering Maintenance / Validation / CSV  

1. Check Calibration Schedule availability, schedule should be updated and complies with current Date and at least for last 3 Year.

2. Check Calibration Master List availability. List should be maintain for at least for last 3 Year with all related change controls availability.

3. Technical Agreement should be available for all outside Calibration Vendors / Agencies.

4. Vendor Audit Document Should be available (At Least 2 Previous Audit).

5. Training Record should be available for all persons who is engaged in performing the calibration from external / outside agency.

6. If calibration procedures / SOP from external calibration agency / vendor used, than Calibration Procedures / SOP shall be reviewed / approved by by Engineering Team or QA team.

7. All SOP'S with respect to practice should be updated, accurate and followed.

8. All Master Instrument Traceability / Calibration Certificate should be available.

9. All Master Instrument Calibration Status tag should be available.

10. All Manufacturing Instrument Calibration status tag should be available.

12. Calibration carried out by external agency should be traceable to NABL / International standard. 

13. Calibration frequencies for respective instruments shall be available in respective procedures

14. Calibration Procedure Should be Available for Out Side Calibration vendors.

15. Instrument Critically Assessment with procedure should be available for all instrument.

16. Change Control Record should be available for Add/Remove/Modification of instruments.

17. Deviation log / list should be available for all out of calibration or other deviations.

18. Calibration Lab Temperature and RH log should be available.

19. Calibration record archival / retention procedure should be available.

20. Calibration Certificate issuing (UNCONTROLLED) procedure should be available.

21. Off site instrument calibration log should be available.  

22. Calibration maintenance work request with user acceptance should be maintained / available.

23. List for faulty/Not in use instruments should be available.

24. Department organogram should be available.

25. Department manual should be available for reference.

26. Job responsibility personal shall be available.

27. Next revision date and document status should be mentioned in all document.

28. Breakdown list should be available.

29. Utility systems i.e. Boiler, D.G. set,water system and other utility log book should be maintained and available.

30. List of equipment should be available with criticality.

31. All equipment preventive maintenance schedule and plan should be available.

32. Critical spares list should be available.

33. Record for Preventive Maintenance performed as per schedule / frequency shall be available.

34. Qualification documents i.e. URS, DQ, IQ, OQ, PQ available new equipment and re-qualification documents shall be available for old equipment as per respective procedure.

35. PM Status tag should be available and updated.

36. Status tag should be affixed and available for AHU filters cleaning.

37. Spare consumption / tracking should be available proper authorization / documentation.

38. Identification mark / proper segregation should be Available in Cleaned and Uncleaned filter.

39. All service line well defined by displaying coded / color detail.

40. All filter with Proper identification Mark.

41. Break down record should be maintained / readily available.

42. All Corrective / Preventive action should be effective / implemented.

43. Deviations shall be logged and investigated for all related non-conformance.

44.  Spares stored properly / maintained with tracking .

45. Proper safety procedures available and followed during maintenance work.

46.  Employee Training Record should be available / ensure no overdue training's.

47. Departmental training calendar should be available.

48. Boiler Inspection Record should be available.

49. House keeping record maintained / available.

50. If Calibration Performed in SAP module and Any Other Software, it should be qualified and respective procedure should be available.

51. Validation plan for Computer System Validation  should be available.

52. All Computerization System Categorization (GxP Critical or Non Critical ) should be available.

53. Risk based Computer System Validation approach procedure should be available.

54. User management log and procedure should be available.

55. All manufacturing computerized system list should be available.

56. If Validation Activity performed by external agency / Vendor, Technical / Quality agreement, training record, vendor Assessment, vendor Audit and procedures from external vendor / agencies should be available. 

57. Computerized System inventory list should be available.

58.  All Computerized System GAP Assessment as per (21CFR Part 11 and Annex. EU-11) should be available.

59. Digital Clock and Manufacturing Clock List and Verification check list with Approve Procedure Should be Available.

60. Computerized system back up and retrieval (Restoration) log and procedure should be available. 

61. Vendor / OEM MOC certificate with composition of each elements i.e. SS 316L / Hallar / others composition should be readily available for inspection.