Ehs Chechklist

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Global Pharmaceuticals Pvt. Ltd.

SOR 17054 Effective Date Review date Revision 00


01-04-2020 31-03-2022
Internal Audit Checklist Page 1 of 5

Department ENVIRONMENTAL, Section


HEALTH AND SAFETY
Auditee Name Sign
25/05/2021 Target Date for
Audit Date
Completion
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Participant (Auditor)
Name Designation Signature/ Date

Lead Auditor

Note: During Inspection CAPA will be raised where system needs improvement / amendments.
Global Pharmaceuticals Pvt. Ltd.
SOR 17054 Effective Date Review date Revision 00
01-04-2020 31-03-2022
Internal Audit Checklist Page 2 of 5

(Tick the relevant)


Observations
Yes No Comments

No. Environmental, Health and Safety (EHS)


A) HOUSE KEEPING
1. Is the area properly cleaned and dusted?
Do the house keeping personnel collect the waste material with nylon
2. broom/brush and put them in dustbin covered with additional poly bag
inside?
3. Are waste bins cleaned and closed?
Does the floors, walls windows, ceilings, doors, tables, cabinets, racks
4.
etc properly cleaned and sanitized?
Are the tube lights, electrical switches/panels cleaned and free from
5.
dust?
Do the house keeping personnel clean the floor by mopping with the s
B)
disinfectant solution?
C) EQUIPMENT
Are written operating procedures available for equipment/instruments
6.
with respect to EHS to perform respective operation?
Are written records for maintenance of all equipment/instruments and
7.
their parts available and maintained?
8. Are all equipment suitable in their size / capacity?
Are the equipment properly designed and installed for intended
9.
purpose?
Are all parts of equipment/instruments clearly identified with easily
10.
visible markings?
Are clean instruments and tools used for the maintenance of
11.
equipment?
12. Is the facility equipped with safety instruments like fire hydrants?
13. Is the facility equipped with safety instruments like water sprinkles?
14. Is the facility equipped with safety instruments like smoke detectors?
Is there any emergency alarm system available and operational at
15.
different points in facility?
16. Is the fire hydrant system working properly?
Are the fire extinguishers filled, calibrated and maintained
17.
periodically?
D) CALIBRATION
16. Are all equipment/instruments internally calibrated (where req)?
Global Pharmaceuticals Pvt. Ltd.
SOR 17054 Effective Date Review date Revision 00
01-04-2020 31-03-2022
Internal Audit Checklist Page 3 of 5

(Tick the relevant)


Observations
Yes No Comments
17. Are all equipment/instruments externally calibrated?
Is there any proper program/schedule available and implemented for
18.
calibration?
19. Are all the equipment/instruments calibrated in the operational range?
1. Are calibration tags available on all equipment?

PERSONNEL
E) Is sufficient number of personnel available in EHS department to
fulfill all responsibilities?

18. Does all responsible staff have their specific duties recorded in
written job descriptions?
19. Are all personnel aware about their job responsibilities and GMP
principles?
20. Do all the personnel undergo health examination prior to and during
employment?
21. Are all personnel trained in the practices of personal hygiene?
22. Have the employees undergone training in the following areas on
yearly basis?
 Job responsibilities
 Good manufacturing practices
 Standard operating procedures
 Equipment/instruments
 Health and safety programs etc
23. Are health, environment and safety trainings documented in a readily
retrievable manner that states the name of the employee, the type of
training, the date of the training, and the name of the trainer and the
signature of the trainer and participant?
24. Are the employees about the knowledgeable about their job functions/
operations they are performing?
25. Is there any written procedure available for proper gowning for
personnel?
Global Pharmaceuticals Pvt. Ltd.
SOR 17054 Effective Date Review date Revision 00
01-04-2020 31-03-2022
Internal Audit Checklist Page 4 of 5

(Tick the relevant)


Observations
Yes No Comments
F) DOCUMENTATION
26. Is the documentation meticulously maintained as per rules and kept up
to date?
27. Is the record of written job descriptions of all the personnel available
and maintained?
28. Is the record of written procedures for each activity performed
available and maintained?
29. Does EHS department impart sufficient trainings to employees?
30. Is the training record available and maintained?
31. Is there an organogram for the departments?
32. Does the department have mechanical drawings and maintenance Ha
manual of all equipment/instruments?
33. Does the drawing show position of extinguishers and hydrants point
available in the area?
34. Is preventive maintenance done as per schedule and record thereof
kept?
35. Are safety procedures implemented and updated?
36. Are all emergency evacuation & safety plans displayed properly at
relevant locations?
37. Are Environmental Monitoring reports available and as per EPA rules?
38. Is the list of fire extinguishers available with area codes/numbers?
39. Is the list of equipment/machines available?
40. Is the list of critical spares available?
41. Is the record maintained, if documented procedure changes due to
CAPA?
G) General Considerations
i) Are all smoke alarms are working properly?
42. Is the fire hydrant system working properly?
43. Are pictorial demonstration for emergency evacuation & safety
displayed properly at relevant points/location?
44. Are all Emergency lights working properly?
45. Are the exits and escape routes properly working, easy to identify, and
accessible?
46. Does the company monitor and maintain incident / accident data etc to
create awareness and develop future improvement plans?
Global Pharmaceuticals Pvt. Ltd.
SOR 17054 Effective Date Review date Revision 00
01-04-2020 31-03-2022
Internal Audit Checklist Page 5 of 5

(Tick the relevant)


Observations
Yes No Comments
47. Is the measurements of sounds level of safety alarms system carried
out regularly?
48. Does EHS department impart sufficient training to employees for
probable hazards/dangers?
49. Is the emission for boiler stack being monitored and record thereof
kept?
50. Is the list of staff having proficiency in firefighting available and being
displayed?
51. Is the ON-SITE and OFF-SITE emergency plan ready?
52. Is the list of important/emeergency telephone numbers displayed on
security gate?
53. Are necessary steps taken to eliminate fire hazards?
54. Is the proper training given and documented for the channel of
communication, runners, rescuers, incident controller etc for their role
in event of emergency??

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