1.0 Purpose
1.1 To establish a documented procedure for inspection of compliance of safety SOPs in the operation area and to take corrective/preventive actions for compliance.
2.0 Scope
2.1 This SOP is applicable for all operating areas of Factory complex of “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Safety Inspection Team
3.2 Head of QA is responsible for regulatory compliance and approval of this SOP.
4.0 Abbreviations and Definitions
4.1 Safety : The condition of being safe, free from danger, risk or injury.
4.2 Inspection : Inspection is a systematic and wherever possible, independent examination to determine whether activities and related results confirm to planned arrangements.
4.3 MSDS : Material Safety Data Sheet
4.4 PPE : Personal Protective Equipment
4.5 HVAC : Heating, Ventilation, and Air Conditioning
4.6 ETP : Effluent Treatment Plant
5.0 Materials and Equipment
5.1 Personal Protective Equipment
6.0 Precaution / Health and Safety Considerations
6.1 Not Appreciable
7.0 Procedure
7.1 Internal safety inspection shall be conducted by internal safety inspection team of the plant comprising member from Administration Department; Engineering Department and QA Department.
7.2 The facility shall be inspected twice in a year.
7.3 During safety inspection, a specific safety inspection checklist format as per Annexure-I shall be followed.
7.4 Inspection team shall cover all areas (both inside and outside) in the facility. Observations shall be recorded in the internal safety inspection checklist format.( Annexure-I)
7.5 After completing the inspection, inspection team shall analyze the observations and recommend corrective/preventive action.
7.6 Inspection report shall be sent to All Departmental Head for taking necessary action.
7.7 Recommendation and action plan shall be circulated by concerned Plant/Head of QA to all department heads before the due date of the next inspection.
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 Annexure –I : INTERNAL SAFETY INSPECTION CHECKLIST
10.0 Revision History
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
01 |
New |
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11.0 Training
11.1 Head of Quality Assurance or his nominee is responsible to conduct a training session on this SOP.
Annexure-I
INTERNAL
SAFETY INSPECTION CHECKLIST |
Area: Audited on : Audit Ref:
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Sl. No. |
Check
points |
Yes |
No |
Observations |
Recommendation
for corrective/Preventive Action |
Responsibility / Action Plan
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Target |
Fire Safety |
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01. |
Are fire exits
clearly marked and easily identifiable? |
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02. |
Are fire exits free
from obstruction? |
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03. |
Are there multiple entrances
and exits to the area? |
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04. |
Are Emergency
telephone Numbers clearly displayed? |
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05. |
Are fire
extinguishers available and suitable to the type of fires that may occur
(e.g. carbon dioxide for electrical fires) |
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06. |
Are flammable
materials properly stored? |
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07. |
Fire/Emergency alarm
systems operational; fire exit signs lit. |
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08. |
Fire evacuation plan
is posted |
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09. |
Worker know the plan
(ask a worker) |
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Electrical Safety |
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10. |
Extension cords are secured
& in good condition. |
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11. |
Clear access to
electrical panels & no combustible material stored around. |
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12. |
Is a carbon dioxide
fire extinguisher placed adjacent to switch board? |
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Storage & Handling of Hazardous
Substances |
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13. |
Are MSDSs for each
substance is available & accessible? |
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14. |
Is the plant/facility
provided with adequate PPE? |
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15. |
Are all hazardous
substances are properly labeled, stored and disposed off? |
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16. |
Are all chemicals safely stored? |
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17. |
Are all areas in
which hazardous substance are used or stored well ventilated? |
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18. |
Are there easy to
read warning signs in hazardous areas? |
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19. |
Are the amounts the
solvent used and stored kept to minimum? |
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20. |
Are all gas cylinders suitably stored? |
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21. |
Is a flammable/ corrosive/
poisonous liquid cabinet installed? |
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22. |
Is training provided
for safe use & Storage of Hazardous Substances? (ask worker) |
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Use of Personal Protective Equipment
(PPE) |
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23. |
Is appropriate PPE available? |
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24. |
Is PPE worn in designated areas? (observe) |
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25. |
Is regular maintenance of PPE? |
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26. |
Is training provided
on the correct use and maintenance of PPE? (ask worker) |
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First Aid |
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27. |
Is/Are First Aid Box
(s) available and contains required medicine? |
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28. |
Are First Aid Box (s)
placed in proper place? |
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29. |
Are the contents of
the First Aid Box check monthly? |
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30. |
Employees know how to
get first aid when needed. (ask worker) |
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31. |
Are first aid cabinet
clearly labeled? |
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Lighting
in Areas |
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32. |
Are all the areas adequately
lit? |
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33. |
Is there an emergency
lighting system that is adequately maintained? |
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34. |
Are light fitting in
good repair and clean? |
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Storage
Areas |
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35. |
Are storage areas
easily accessible? |
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36. |
Are the shelves in
good condition? |
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37. |
Is there adequate
lighting? |
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38. |
Is there adequate
ventilation? |
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39. |
Are shelves free from
dust and rubbish? |
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40. |
Are floor clear of
rubbish? |
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41. |
Are material neatly
& safely piled? |
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42. |
Are storage shelves
overloaded or beyond their rated capacity? |
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43. |
Are large & heavy
objects stored in lower shelves? |
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44. |
Are there ladders or
stools to get to materials on higher shelves? |
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45. |
Pallets are good
condition. |
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Ventilation/Air Conditioning |
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46. |
Are the ventilation
systems satisfactory? |
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47. |
Are air conditioning
filters cleaned regularly? |
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48. |
Are exhaust system
work properly? |
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Laboratory
Safety |
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49. |
Are employees trained
in laboratory safety procedures? |
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50. |
Are safety procedures
available in warning and enforced at all times? |
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51. |
Are disposable
procedures for waste products satisfactory? |
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52. |
Is consummation of
food and drink banned in the laboratory? |
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53. |
Noise levels
appropriate, signs indicating hearing protection required where noise levels
are high. |
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54. |
Are emergency easy
wash & safety showers workable in lab? |
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55. |
Emergency eyewash
& safety shower stations fully accessible. |
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Machines
and Tools |
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56. |
Are all operators
trained to use machines? |
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57. |
Are machines
adequately guarded to prevent accidental contact? |
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58. |
Is the ON/OFF switch
clearly marked and close to the operator’s work station? |
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59. |
Is there adequate
work space? |
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60. |
Are records kept of maintenance on machinery? |
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61. |
Are tools properly maintained? |
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62. |
Equipment
safety instruction known to operator? |
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63. |
Caution sign marked |
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64. |
Defective tools are
tagged & removed from service |
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65. |
Manufacturer’s
manuals available for all tools & machine. |
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Fire
Fighting Equipment |
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66. |
Are fire
extinguishers available? |
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67. |
Are fire
extinguishers placed in dedicated place? |
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68. |
Having fire
extinguishers validity? |
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69. |
Are water and buckets
kept in appropriate place and easily accessible? |
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70. |
Is the firefighting
equipment is usable condition and properly checked? |
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71. |
Are the workers
allowed to handle the equipment? |
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Housekeeping |
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72. |
Are walls, ledges,
and windows, bulb clean and free from dust-deposition? |
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73. |
Is there a schedule
for floor cleaning? |
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74. |
Has man power been
assigned for this work? |
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75. |
Are sufficient areas
and containers allotted for raw material, goods in-process and finished
products? |
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76. |
Are stair kept clear
and not used for storage? |
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77. |
Is material properly
piled / stacked in areas? |
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78. |
Doors are not
blocked. |
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79. |
Routes, signs &
door clearly marked; exit signs easy to see; outside entrances is clearly
lit. |
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SOP |
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80. |
Safety SOP in place |
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81. |
Safety instruction
know to every body |
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82. |
Individual know what
to do during emergency? |
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Utility |
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83. |
Leakage: as there is any leakage in- |
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(a) Water line and
valves |
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(b) Compressed air
line and valves |
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(c) Natural gas line
and valves |
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84. |
Are exhaust system
work properly? |
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85. |
Temperature and
Humidity within range? |
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86. |
Waste segregated and
deposited in proper place? |
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87. |
Waste transferred to
proper place |
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88. |
ETP function properly |
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Hygiene
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89. |
Washrooms &
kitchen are clean. |
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90. |
Washing facility
available (soap, tissue etc.) |
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91. |
Are the chemicals
provided adequately for cleaning? |
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92. |
Are measures in place
to prevent the spread of disease? |
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General
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93. |
Floors: Clean, dry,
free from debris, clutter & trip hazards? |
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94. |
Furniture/ Office
equipment secure from tipping, appropriate for work being done. |
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95. |
Are office
accessories stored appropriately? |
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96. |
Are materials stacked
on desks? |
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Security
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97. |
Emergency numbers for
internal & external contacts are easily available? |
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98. |
Visitor/contractor
rules are in place |
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99. |
Safety measures are
in place for anyone working alone (ask worker) |
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100. |
Training on workplace
violence & harassment (ask worker). |
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