NEBOSH International General Certificate in Occupational Health and Safety

NEBOSH International General Certificate
in Occupational Health and Safety
UNIT IGC3: HEALTH AND SAFETY PRACTICAL

APPLICATION
Student Name: Faisal Aziz
Student Number: 00216199
Date of Submission: January 08, 2014

APPENDIX 1
IGC3 – The Health and Safety Practical Application
Candidate and course provider declarations:
For completion by the candidate:
I declare that the work submitted for this practical application assessment ie. the completed observation sheets
and the report to management, is my own work. I recognise that contravention of this statement constitutes
malpractice and may result in my being subject to the penalties set out in the NEBOSH Malpractice policy.
Name (Print) Faisal Aziz
Signature
Date January 03, 2014
For completion by a course provider representative (e.g. internal practical assessor):
I declare that the work marked is identical to that received from the candidate. I recognise that contravention of
this statement constitutes malpractice and may result in my being subject to the penalties set out in the NEBOSH
Malpractice policy.
Name (Print)
Signature
Date
For completion by the course provider’s internal practical assessor:
I declare that I have marked this work and am both qualified and approved by NEBOSH to do so. I recognise that
contravention of this statement constitutes malpractice and may result in my being subject to the penalties set out
in the NEBOSH Malpractice policy.
Name (Print)
Signature
Date
NB: This declaration must be completed in full, submitted and retained with the
candidate’s script. If this declaration is not submitted the candidate’s result may
be declared void.
APPENDIX 3
INTERNATIONAL GENERAL
CERTIFICATE Assessor’s marking sheet (2011 specification)
IGC3 – THE HEALTH AND

SAFETY PRACTICAL APPLICATION
Date of practical application 03-01-2014 Name of assessor

Course provider Course provider
number
548 name
Shields Ltd.
Student number 00216199 Student name Faisal Aziz
NEBOSH
Maximum
Assessor’s moderated
marks
Criteria marks awarded marks
available
(if different)
1 Completion of observation sheets
1.1 Range and number of hazards/good practice 15
Identification of suitable control measures and

1.2 timescales 15
2 Report - Introduction and Executive Summary
Introduction providing an overview of the chosen

2.1 area 5
2.2 Executive summary 5
3 Report - Main findings of the inspection
Quality of interpretation of findings and clear

3.1 references to strengths and weaknesses 15
Identification of possible breaches of international

3.2 standards 5
3.3 Persuasiveness / conciseness / technical content 10
4 Report - Conclusions and Recommendations
Clear and concise conclusions which are clearly

4.1 related to report findings and are effective in 15
convincing management to take action
Recommendations which present realistic actions to

4.2 improve health and safety in the chosen area 15
TOTAL MARKS 100

Outcome: PASS (60% or more) REFER (less than 60%)
Date assessed / /
Assessor’s signature
Date received by course provider / /
Date received by NEBOSH

(if applicable) / /
Assessor’s additional comments on the practical application:
ASSESSED BY (name in block letters)
The mark sheet must be retained by the Course Provider and sent to NEBOSH only if requested.
NEBOSH USE ONLY
NEBOSH Moderator’s comments:

APPENDIX 4
CERTIFICATE Candidate’s observation
(2011 specification) sheet

Sheet number 01 of 12
Student name Faisal Aziz Student number 00216199
Place inspected Getz Pharma (Pvt.) Ltd. Date of inspection 03 / 01/ 14
Observations Control measures Timescale

Hazards and consequences Immediate and longer-term actions
1) Risk of respiratory illness due to I- Provide PPE such as Full face RPE 1 day
presence of Dichloromethane (as recommended in Safety Data
(solvent) fume during pre- Sheet of Dichloromethane) along and
weighing for batch preparation display safety signs.
in the dispensing area- likely to M- Conduct detailed risk assessment 2 weeks
cause throat infection, coughing of dispensing activity consulting
and chest pain leading to Safety Data Sheet and identify
sickness leaves. controls considering “hierarchy of
controls”.
L- Isolate weighing area by providing 3 months
glass cabin within the dispensing area
and install explosion proofed LEV for
effective removal of solvent fumes.
L- Develop SOP for safe dispensing 1 month
of solvents and provide information,
instructions and training to relevant
workers.
L- Monitor effectiveness in safety On-going
inspections.
2) Risk of chemical splash on faceI- Prohibit the dispensing activity 1 hour
of worker during the transfer of
immediately until PPE such as face
solvents from large drums to shield is provided.
plastic bags using plastic mugs
M- Provide plastic hand pump and 4 days
as a part of batch preparation in
pipe arrangement to eliminate the risk
dispensing area- likely to cause
of chemical splashes while
serious eye infection,
transferring through mugs.
inflammation or disability
L- Install emergency shower and eye 2 months
(blindness). wash station at easily accessible
location near dispensing area.
L- Provide training on effective use
of emergency shower and eye wash.
L- Monitor effectiveness in safety
inspections.
Note: I = Immediate Action, M = Mid-term Actions, L = Long-term Actions.
APPENDIX 4

Place inspected Getz Pharma (Pvt.) Ltd. Date of inspection 03 / 01 / 14

3) Illumination levels throughout This is appreciated that adequate On-going
the manufacturing area were LUX levels is maintained throughout
satisfactory and adjusted as the manufacturing area without glare,
per ILO lighting requirements. shadow and flickering effect which
may impede safe working practices.
However, it is recommended to
monitor LUX level periodically and
maintain records.
4) Ambient temperature was low I- Immediately contact HVAC team 1 hour
throughout the manufacturing to check and adjust room temperature
facility. Worker and operators to comfort level (up to 260 C).
were observed uncomfortable M- Monitor to ensure that a 1 week
and shivering. Low temperature reasonable temperature is maintained.
can reduce workers performance L- Develop SOP for periodic 1 month
and may affect risk perception- inspection of environmental
likely to cause increased risk of parameters such as temperature and
injury. humidity.
L- Provide training of SOP to 2 months
concern team members.
L- Maintain inspection records. On-going
5) Overreaching of machine I- Prohibit activity until provision of 1 day
operator to feed raw material in safe working platform and ensure job
the hopper of sachet machine rotation.
through manually lifting of M- Undertake manual handling risk 2 weeks
bucket involve repetitive assessment of the job considering
movement, lifting of heavy load T.I.L.E. and identify control
above shoulder height-likely to measures.
cause WRULD, spinal injuries L- Install pneumatic dispensing 4 months
and fatigue. system to eliminate the risk of lifting
weight above shoulder height.
L- Develop SOP for Safe Lifting of 2 months
Weight and provide Information,
Instruction and Training.
APPENDIX 4


6) Risk of short circuit at I- Immediately isolate the power by a 10 mins
Purified Water Plant (PWP) competent person.
where condensate water is M- Change the position of steam 15 days
dripping from faulty steam strap away from the electrical panel
trap installed right above the and replace the faulty trap.
electrical panel- likely to L- Monitor effectiveness in safety 3 months
cause electrocution to round.
whosoever comes in contact L- Discuss the issue during monthly 1 month
which may lead to serious safety committee meeting.
burns or scald or instant death.
7) Compression machine (MG I- Prohibit the activity and isolate the 10 mins
2457) was not properly isolated energy source and communicate the
while performing maintenance hazard to the maintenance supervisor.
activity- could cause crushing of M- Ensure use of Lock out/ tag out 2 weeks
fingers and permanent disability devices while machine maintenance.
by machine punches if machine L- Conduct refresher training of 1 month
start operating un-intendidly maintenance staff on LOTO.
during maintenance. L- Add LOTO procedure in the 2 months
induction training of maintenance
staff.
L- Monitor effectiveness during 3 months
safety inspections
8) Evacuation plans depicting safe Commendable and inspect regularly On-going

means and location of to maintain good practices especially
emergency exit, location of fire after any change/ modification in
extinguisher, location of nearest layout or addition of new machinery.
assembly point and emergency
contact numbers are displayed
all over the facility at prominent
locations.
APPENDIX 4


9) Finished goods were stacked I- Immediately arrange shifting of 1 day
in front of emergency exit. finished goods in front of emergency
This could cause serious exit to the Finished Goods Store
impediment in evacuation (FGS).
from facility in case of any M- Undertake Root Cause Analysis 2 weeks
emergency scenario-likely to to identify immediate and underlying
cause loss of life due to causes and generate Corrective
entrapment. Action & Preventive Action (CAPA).
L- Inspect emergency exits regularly 3 months
during safety rounds and discuss the
concern in EHS Committee meeting.
10) Hygiene conditions of toilets Housekeeping is strictly maintained On-going

and changing room were throughout the facility.
satisfactory and maintain on a Commendable and inspect regularly
regular basis. to main good practices.
11) Fire extinguishers are Commendable and inspect regularly On-going

regularly inspected and to maintain good practices.
serviced. Maintenance tags are
up to date.
12) LEV installed at granulation I- Immediately inspect by HVAC 4 hours

machine not been inspected staff to check required air flow is
for last 2 years as per pasted maintained and update service tag. maintenance
tag- likely to M- Undertake Root Cause Analysis 2 weeks cause ill health
effect such as to identify immediate and underlying
unconsciousness, vertigo (as causes and generate Corrective
acute effect) and in certain Action & Preventive Action (CAPA).
cases immunity to certain L- Conduct refresher training of 3 months
drugs as a result of long-term HVAC staff and monitor
exposure to process dust effectiveness.
(Active Pharmaceutical
Ingredients).
APPENDIX 4


13) Comprehensive EHS Policy I- This is very good practice to 1 day
statement is displayed at display EHS policy for
prominent locations within communication of organizational
manufacturing facility depicts seriousness on EHS. Translate the
the management commitment policy in Urdu to disseminate the
on EHS. However, the policy message to wider range of viewers.
is written in English which is M- Replace the English version with 2 weeks
understandable to most of the translated version at
operators and workers. manufacturing areas.
L- Monitor the effectiveness through 5 months
interviews during safety inspections.
14) The complete facility is a no- This is a very good and healthy N/A smoking
zone as per “no- initiative which reduces the fire risk smoking” policy and
smoking in the facility and promotes health
is banned even in executive working environment.
offices and meeting rooms. If
anyone need to smoke must
go outside the facility which
is a dedicated smoking area.
15) Health screening of cafeteria I- Arrange immediate health 2 days

staff and chefs not been screening of cafeteria staff.
conducted for last 3 years-can M- Redefine the job responsibility if 15 days
lead to proliferation of needed after considering medical
contagious diseases among records and include health
employees surveillance of cafeteria staff in
Health Screening Procedure.
L- Maintain compliance and health
screening records.
APPENDIX 4


16) Risk of spinal injuries from I- Ensure that at least 2 persons 1 day
manual lifting of 200 L barrels undertake the lifting activity instead
of solvents (IPA/ of single person and provide
Dichloromethane) from supervision. Ensure use of steel toed
ground to pallets located at safety shoes while manual handling.
Solvent room- likely to cause M- Undertake manual handling risk 15 days
back pains, spinal injuries and assessment considering “T.I.L.E” to
WRULD and foot injuries in see whether mechanical lifting aid
case of fall on foot. can be used.
L- Provide barrel truck for lifting of 1 month
containers from floor level to pallet
height.
L- Provide training on safe lifting 2 month
techniques and display instructions
for safe use of barrel trucks.
L- Review performance and On-going
effectiveness during safety rounds.
17) Risk of skin, eye and throat I- Provide PPE such as face mask and 1 day
irritation due to presence of goggles and restrict long working in solvent fume
and inadequate solvent room.
ventilation in the solvent room. M- Review Safety Data Sheets (SDS) 15 days
and identify the ventilation
requirements for solvents.
L- Install explosion proof LEV for 2 months
effective removal of any buildup
fumes from the solvent room.
inspections.
APPENDIX 4


18) Incompatible chemicals such I- Immediately remove container 1 day
as IPA, Dichloromethane, and from solvent stores and stack each
Methyl Ethyl Ketone etc. are chemical separately with the safe
stacked together without any distance. Reduce over stocking of
segregation which might cause dangerous solvents.
serious risk of fire and M- Undertake detailed risk 2 weeks
explosion in case of accidental assessment and consult MSDS for
spill over and mixing of reference.
incompatible chemicals- likely L- Design chemical segregation as 1 months
to cause serious injuries, per MSDS.
fatality and loss of property. L- Provide dedicated Secondary 1 month
containment trays (SS) for
containment of accidental spills for
each solvent type. (Avoid stacking
incompatible chemical within same
containment).
L- Develop SOP for safe storage, 1 month
transfer and handling of hazardous
chemicals.
L- Provide Information, Instruction Bi-annually
and Trainings.
L- Provide HazChem spill kits for 1 months
spill handling.
19) Adequate ground and earthing This arrangement is very effective to On-going
mechanism is provided with discharge buildup of static electricity
each solvent barrel. due to the movement of solvent
during barrel handling. Inspect
regularly to maintain good practice.
APPENDIX 4


20) Risk of slipping from ramp at I- Place caution sign (Slipping 30 mins
the entrance of solvent room Hazard!) at prominent location near
which is slippery-likely to cause ramp.
fracture and broken bones. M- Provide skid resistant, steel toed 15 days
safety shoes with ankle protection.
L- Provide slip resistant epoxy 1 month
coating at ramp and monitor
effectiveness.
21) Risk of trip due to absence of I- Prohibit working in solvent room 1 day
lighting arrangement in solvent after sunset.
room especially in low lighting M- Modify daily material pick list to 2 weeks
conditions which can cause avoid movement in solvent room
major injuries such as fracture after dark
and broken bones. L- Provide explosion proof lighting 1 month
arrangement in the solvent room.
22) Risk of contact injuries e.g. I- Immediately place safety guard to 30 mins
entanglement, drawing-in, its position.
abrasion from the rotary part of M- Identify the root cause to identify 15 days
Lathe machine installed at immediate and underlying causes of
workshop, because safety guard by-passing the safety guard and
is removed from the machine initiate CAPA.
and did not place back. L- Install inter-locking mechanism 1 months
with the fixed guard to ensure
machine would not operate without
guard.
L- Develop SOP for periodic 1 month
inspection of safety guards and
provide training.
L- Daily inspect safety guards before Daily
and after finish of the day shift.
APPENDIX 4


23) Presence of Volatile cleaning I- Remove flammable container from 5 mins
agent near welding plant the area.
which can cause fire and cause M- Develop work instruction for safe 2 weeks
serious burns and scald to storage, handling and use of
nearby workers and damage to engineering chemicals considering
equipment. SDS.
L- Develop safe storage of 3 months
engineering chemicals with provision
of secondary containment and local
ventilation.
24) Several informative posters on Safety signs and posters are good N/A manual
handling, noise and means of communicating hazard to
correct use of tools displayed at the workers which are associated with
prominent location with their day to day activity and remind
workshop them about the safe working practice.
25) Risk of electrocution due to I- Remove it from use immediately. 15 mins

damaged wielding lead which M- Replace lead and inspect the 3 days
may cause skin burn/ scald or equipment.
even fatality to anyone who L- Develop Safe System of Work 1 month
touches it. (SSW) and provide Information,
Instructions and Trainings.
26) Risk of work related hearing I- Provide ear defenders and display 2 days loss
due to high noise in the safety sign.
workshop due to operation on M- Place physical barrier between 15 days
grinder, sander and other operator and machine.
equipment- can cause tinnitus L- Ensure frequent work breaks 1 month
or hearing impairment. during high noise in the workshop.
Provide instructions and training.
L- Noise assessments are made every Annually
year and available in the workshop.
APPENDIX 4


27) First aid box is available at This is commendable and no action is On-going
accessible location within required except monitoring the
workshop with adequate content of the first-aid box to ensure
number of items maintained as that it is maintained up-to-date.
per expiry dates.
28) Risk of eye sight loss/ blindness I- Stop activity immediately. 10 mins
due to UV radiation being M- Provide wielding shield and 3 days
emitted from wielding activity display safety sign near wielding
at workshop and wielder not plant.
using wielding shield. L- Develop Safe System of Work 2 months
(SSW) and provide Information,
Instructions and Trainings.
29) Risk of fire due to presence of I- Immediately clear the waste from 1 day
open electrical distribution the area.
box and loose wiring at scrap M- Fix cover over cables and re-route 1 week
yard and waste (readily them away from scrap yard.
flammable) is overload that it L- Decrease waste removal frequency 1 month
touches the electrical wiring- from 3 days to once a day.
likely to cause serious fire L- Inspect compliance during safety On-going
hazard in the area that may rounds.
lead to loss of life and damage
to property.
30) Diesel was dripping from the I- Immediately place containment to 1 month
valve of fuel tank of diesel collect dripping diesel.
generator-likely to cause land M- Replace the damaged valve. 7 days.
contamination M- Remove the contaminated soil 2 days
cover and replace with fresh soil.
L- Daily inspection by the On-going
maintenance staff.
APPENDIX 4


31) Risk of work related hearing I- Immediate provide ear defender to 1 day
impairment due to high noise operators and display safety signs.
level (>90 dBA) at technical M- Conduct detailed noise 5 days
area where operator is sitting assessment of the technical area
more than 10 hours daily whether Isolation can be provided for
without wearing ear defender- workers.
likely to cause loss of hearing L- Develop acoustic heaven (glass 3 months
or impairment. cabin) to isolate the operator from
harmful effect of noise.
L- Train operator for harmful effect 1 months
of noise and its impact on hearing
loss and safe use of ear defender
inspections and provide refresher
session if necessary.
32) Risk of fall from height due to I- Stop the activity and barricade the On-going
missing boiler platform and use area.
of dilapidated ladder for M- Raise PTW for work at height and 3 days
maintaining the flue duct provide stable MEP for maintenance
located at the top of boiler- job.
likely to cause major injuries or L- Install a fix steel fabricated plat 4 months
fatality form with boiler for safe access to the
flue duct.
L- Information, Instruction and 1 month
Training of boiler operator.
33) Service lines such as Natural Color coding and tagging of service N/A Gas
line, Steam, Condensate, lines will eliminate confusion of Raw Water,
Purified Water, Hot maintenance staff and eliminate the Water are color
coded for risk involve in wrong identification of
effective identification service line. Continue the good
practice.
APPENDIX 4


34) Risk of inhalation of aerosol I- Restrict entry to the roof where 4 hours
arising from cooling tower due cooling towers are installed without
to the absence of enclosure adequate PPE.
system which may cause M- Assess effectiveness of biocide 15 days
Legionnaire’s disease because dosing though sampling of cooling
possible presence of water and laboratory analysis.
Legionella Bacteria in the re- M- If presence of Legionella was 15 days
circulating water. identified in the report adjust biocide
dosing and re-test.
L- Install louver enclosure around 2 months
cooling tower to restrict dispersion of
contaminated aerosol in the area.
L- Monitor effectiveness through 1 month
ambient air sampling and laboratory
analysis.
APPENDIX 5
INTERNATIONAL
GENERAL CERTIFICATE
(2011 specification) UNIT IGC3 – THE HEALTH AND
SAFETY PRACTICAL APPLICAITON
Student number 00216199
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01 /14
Introduction including overview of area inspected and activities taking place
This report elucidates Health & Safety inspection of the manufacturing area, solvent room, mechanical
workshop and utility area of Getz Pharma (Pvt.) Ltd. (hereinafter referred as GPPL), Site inspection was
conducted on January 03, 2014 from 900 to 1700 hours at GPPL facility located in Korangi Industrial Area
(KIA), Karachi, Sindh, Pakistan.
GPPL is the largest branded generic pharmaceutical company in Pakistan with its head office in Dubai,
UAE. The complete facility of GPPL is expanding over the 4 acre plot which mainly comprises of
manufacturing block, raw material & finished goods warehouses, solvent room, head office buildings,
engineering and utilities. Manufacturing area comprises of Oral Solid Dosages (OSD) such as tablets,
capsules, Sterile and Penicillin production. Main Utilities include Boilers, Air Handling Units (AHUs),
Purified Water Plant (PWP), Reverse Osmosis (RO) Plant, Engineering Warehouse and Mechanical
Workshops. Management provided reasonably good welfare facilities to maintain well being of its
employees, these include gym, emergency health care centre, cafeteria, training halls, auditorium, baby
day care centre, mosque and recreational areas. The other allied facilities include basement car parking,
emergency command centre and scrap yard.
Currently, more than 1,500 people are working in different functional areas such as Plant Operations,
Engineering, Projects, Engineering, EHS, Supply Chain, HR, Admin, IT and Security – making GPPL one
of the largest pharma companies in term of human resources. There are about 600-650 permanent staff
rest are on contract basis; these are mostly workers and supervisors. GPPL operates 300 days a year in
two shifts of 12 hours duration each. Most of the managerial and head office staff observes 9 hour
general shift. Overtime is performed according to production requirements. GPPL produces variety of
“Life Saving Drugs” in hepatalogy, gastroenterology, diabetology, cardiology and infertility and major
brands include Risek, Levofloxacin, Lipiget, Nexum, Ribazole etc.
The leadership of GPPL is highly committed towards maintaining high standards in Quality, Environmental
& Health & Safety and continuously striving for continual improvement and achieving legal compliance.
GPPL is compliant with cGMP standards and has certification in Quality Management System (QMS) ISO
9001, Environmental Management System (EMS) ISO 14001 and striving to achieve OHSAS 18001 by
mid of 2014. Moreover, GPPL is the winner of the “Annual Landscaping Competition” for last three years
and looking forward to receive Golden Award this year.
This report mainly focuses on manufacturing area where various tablets manufacturing & packaging
machines like granulation, dryer, blender, compression, coating packaging and automatic cartoners are
installed for product development; The solvent room located away from main stream manufacturing block,
purpose built for storage of production solvents; The mechanical workshop comprises of lathe machine,
wielding plant, CNC machine, grinder, sander etc.; and the utility area where boiler, chiller, cooling tower,
generator and AHUs are installed. Therefore the inspection excludes the Health & Safety findings
pertaining to administration office, allied and other welfare facilities.
APPENDIX 5
INTERNATIONAL
GENERAL CERTIFICATE
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01 /14
Executive Summary
It was an immense learning experience to conduct Health & Safety inspection at the state-of-the- art
pharmaceutical manufacturing facility operating in the full swing and to observe the complex interaction of
Quality, Environmental, Health & Safety Management Systems from such close. The management of
GPPL is committed towards providing safe work place with all welfare and social facilities, adequate both
in terms of quality and quantity. Few highlights of the welfare facilities provided to all without discretion
are; provision of safe drinking water, state-of-the-art gym, emergency health centre, auditorium, training
halls, baby day care centre, subsidized food and executive dine in facility and recreational area shows
management dedication towards its employees.
Incident/ accident record shows that there have been no serious accident has occurred during last five
year. However, there have been several minor ones. The inspection identified various potential health &
safety risk which pose serious threats to human life, property, plant and equipment. Focusing on these
will not only improve the overall HSE performance of the GPPL and support organizational endeavor to
achieve OHSAS 18001 but also satisfy many international standards and conventions such as the
Guidelines on Occupational Safety and Health Management System (ILO-OSH 2001); the ILO
Occupational Safety and Health Convention (C155) and Recommendation (R164).
The most serious concern is related to incompatible solvents stored at solvent room which are stacked
without adequate segregation. In case of any unfortunate event “Fire & Explosion” might occur this may
cause serious injuries to plant workers, loss of life and damage to property. Other areas of concerns are
illnesses due to presence of chemicals fumes; in adequate handling of hazardous chemicals; manual
lifting of heavy loads; maintenance related health & safety aspects; electric hazards; noise induced
hearing impairment; slipping and tripping hazards.
Risks associated with the aforementioned hazards out-weight the cost in term of resources, time and
money required to rectify these risks. Failure in managing these risks would lead in deterioration in Health
& Safety culture and as a consequence moral and motivation of workforce will be tainted. Repercussion of
dilapidated moral would result in work base illness and injuries, sickness absenteeism, production loss
and other indirect cost to the company. Moreover it is the moral, legal and social responsibility of the
employer to provide safe place or work, safe plant & equipment and safe system of work.
These improvements will cost the company not more than 1-1.5 million PKR, however in case of
negligence the resulting incident will cost organization in millions in term of bad market reputation, loss of
stock value and business. However, adopting these improvement will not only improve Health & Safety
performance of the company but also facilitate the smooth OHSAS 18001 certification. In addition,
positive health and safety culture will be promoted throughout the organization.
APPENDIX 5
INTERNATIONAL
GENERAL CERTIFICATE
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01/ 14
Main findings of the inspection
It was identified during the inspection that the GPPL is striving hard to achieve OHSAS 18001 certification
and some very good practices were observed. The effective maintenance of fire extinguishers and first
boxes, displaying of HSE Policy Statement and maintenance of adequate LUX level throughout working
areas are few examples. However, there are number of HSE risks identified during the inspection which
need serious consideration of the management. Some of the main findings of the inspection are listed
below:
1) Observation # 1 : Risk of Respiratory Illness at Dispensing Area:
Dispensing area serve as the backbone for pharmaceutical manufacturing company. Several raw
materials and chemicals such as Active Pharmaceutical Ingredients (API), Excepients and Solvents are
transferred from the warehouse to the dispensing area as identified in the pick list. Where raw material
batches are developed after weighing as per the recipe and dispensed to production for manufacturing.
It was observed during the inspection that dichloromethane (solvent) was being transferred from the barrel
(200 L) to plastic bags through mugs as a part of dispensing process. Intense fumes of the solvent were
felt in the area and workers in the area are exposed to these fumes almost daily for 12 hours which is
serious concern and generally do not use any protective equipment. Laminar airflow is installed but this is
valid for raw materials dust only. Acute health effects of dichloromethane are eyes and throat irritation,
however long term exposure may lead to chest pain and respiratory illnesses.
Presence of health hazardous fumes in the work place is a clear violation of law. ILO convention C148:
working Environment (Air, Pollution, Noise and Vibration) and (R156); C170: Safety of Chemicals at Work,
(R172) and Sindh Factories Rules, 1975 of Pakistan that provides clear references to control health
hazardous fumes in occupational areas.
It is recommended that management should provide Full face RPE to all workers involve in dispensing
activity as per Material Safety Data Sheet (MSDS) of dichloromethane and no one should be allowed in
the area without RPE and should display mandatory signs (wear respiratory protection) as an immediate
measure. However, providing RPE will not solve the issue completely as hazard (fumes) will remain there.
For controlling the problem holistically it is suggested that a glass cabin with explosion proofed Local
Exhaust Ventilation (LEV) should be installed within dispensing area and weighing of the solvent will be
done under this area. Accordingly, SOP of dispensing will be developed and training of SOP will be
provided to all concern workers and monitor effectiveness.
The cost for the installation of the glass cabin along with the explosion proofed LEV system will be around
PKR 150,000/- only and logistic arrangements for in-house training will not cost more than PKR 5,000/-.
This cost is quite considerable in comparison to the cost to company would bear in term of fines, medical
treatment and loss of business in term of bad market reputation.
APPENDIX 5
INTERNATIONAL
GENERAL CERTIFICATE
2) Observation # 6 : Risk of Electric Shock/ Burns/ Scald or Fatality at Purified Water Plant:
It was noted at the Purified Water Plant (PWP) that condensate water is dripping over the main electrical
panel of the PWP from the faulty steam trap which is installed at steam feed line to the plant, located right
above the electrical panel.
This may cause electrocution to the plant operator or whosoever comes in close contact which may lead
to serious burns/ scald or even fatality. It is not safe for the operator or anyone whosoever comes in close
contact with the plant. It is a clear breach of ILO Convention C155: Occupational Safety & Health and
(R164), 1981 which are concerned with Safety and Health of employees at work place and Pakistan
Federal Law, The Electrical Act, 1910 which state the Electrical Safety in the factories. In case of any fatal
incident company need to pay hefty fines to the enforcement agency any there may be a chance that
someone from the management may imprisoned which could directly affect the reputation and business of
the company in both national and international context.
Considering the aforementioned risk it is highly recommended that activity should immediately be restricted and
power source should be isolated and maintenance lead would be informed about the issue. As a precautionary
measure it is suggested to change the location of the steam trap away from the electrical panel. This will cost
company note more than PKR 25,000/- (inclusive of equipment and installation cost).
3) Observation # 16 : Risk of Spinal Injuries from Manual Handling at Solvent Room:
It was observed during the inspection that solvent room workers are manually shifting the solvent barrels
unloaded near solvent room to the pallets placed there. Each barrel contains 200 liters of solvent by
volume and weights more than 250 kg. The task include repetitive movements, lifting of heavy load to the
pallet height, frequent twisting and stooping which could lead to back muscle strain, ligament damage,
disk injury or/ and WRULD to the worker dealing with solvents barrel. The load which worker were dealing
is excessive to the safe load limit as specified in the Pakistan Factories Act, 1934 and it is against the ILO
regulations C155: Occupational Safety & Health Convention, Article (1) & (2) which require to provide safe
working environment to workers at workplaces and to remove health concerns and hazards.
Manual handling and the associated hazards would be controlled considerably by the provision of barrel
truck for barrel shifting. Further, training of workers can be done on safe use of the truck to minimize the
hazard associate with truck. The cost of barrel truck would be around PKR 25,000/- and for arranging
training internally not more than PKR 5,000/- which include cost of logistics.
APPENDIX 5
INTERNATIONAL
GENERAL CERTIFICATE
Main findings of the inspection
4) Observation # 18 : Risk of Fire & Explosion at Solvent Room:
It was observed at the solvent room that incompatible chemicals such as Methyl Ethyl Ketone (MEK),
Isopropyl Alcohol and Dichloromethane are stacked together without any segregation. The chemical
containers are sealed however, accidental mixing of incompatible chemicals in case of container leak
would result in major “Fire and Explosion” as more than 12 barrels, each containing 200 L of solvents are
stored in the solvent room. This could result in loss of life and serious damage to property and equipment.
It is suggested that all chemicals are immediately placed separately on the pallets (dedicated to each type
of solvent). Adequate chemical segregation should be designed by referring Material Safety Data Sheet
and Chemical Compatibility Chart. In addition, dedicate Stainless Steel (SS) containment trays should be
provided to each type of solvent to contain accidental spills. Moreover, spill kits should be made available
to handle the spills and training should be given to the concern workers. More importantly, management
should considered reducing the solvent stock and store as minimum solvent as reasonably possible.
The cost of these initiatives would be PKR 150,000/- only which is far less than anticipated loss to
company in term of fatalities and damage to the property or equipment.
Ref: ILO Convention C170: Safety in the use of Chemicals at Work and R172.
5) Observation # 22 : Risk of Contact Injuries on Lathe Machine at Workshop:
During the visit of the workshop it was observed that the worker was working at the Lathe machine and
the guard was removed. It was identified through interview that the guard was removed during
maintenance and was not placed back to its position. The lathe machine without guard can cause contact
injuries mostly due to drawing-in, entanglement and abrasion which could lead to serious injuries or even
a disability can occur.
The situation is a violation of ILO Occupational Safety & Health Convention (C155), Article 16(1) which
requires ensuring safe workplace and the Factories Act of Pakistan that clearly defines the need of
machine guarding at factories.
In this case it is advisable to immediately place the guard of the machine and report the near miss to
initiate investigation to identify “immediate” and “Underlying” Causes. Moreover, an interlock device can
be connected with the fixed guard which stop machine automatically when the guard will be removed.
Installation of the “Interlocking Device” would cost PKR 10,000/- only which is negligible when compared
with direct and indirect cost factors incurred in case of injury or disability.
6) Observation # 31 : Risk of Work Induced Hearing Impairment at Technical Area:
It was noted that at technical area where AHUs and other noise emitting equipment are installed,
operators and support staff is sitting without any cabin and did not wearing ear defenders for protection
and generally exposed to high noise level (>95 dBA) for 12 hour shift, each day. This would cause work
induced hearing loss or impairment to operator and support staff.
The said issue is directly concern with the ILO convention C148: Working Environment (Air, Pollution,
Noise and Vibration) and Recommendation (R156) which enforce employer to either control noise at
workplace or protect workers from its harmful effects.
It is recommended to provide adequate quality Ear defenders to all available in the area on immediate
basis. A detailed noise assessment can be conducted to identify whether noise can be controlled at
source or at recipient level. Develop isolation (acoustic heaven) to protect workers from harmful effects of
noise. Further, information, instructions and trainings should be conducted to raise awareness among
workers and effectiveness can be monitored in the safety inspections. The cost of development of glass
cabin would be PKR 130,000/- and for training and sign posting PKR 8,000/-.
7) Observation # 34 : Risk of Legionnaire’s Disease from Cooling Towers:
It was identified during the inspection conducted at utility area that the enclosure is not provided to control
spread of aerosol being generated from the showering of water and these aerosol are dispersing with the
wind throughout the area. There is potential that the aerosol may contains Legionella Bacteria that could
cause Legionnaire’s disease to workers present in the nearby areas. This issue particularly addresses in
ILO R97: Protection of Workers’ Health Recommendation and R31: List of Occupational Diseases
Recommendation, 2002.
The health risk associate with Legionella bacteria can be considerably reduced by effective biocide dosing
in the cooling water and providing the louver type enclosure around the cooling tower to prevent spread of
aerosol in the ambient without affecting the efficient working of the cooling tower. The cost of the provision
of the enclosure will be PKR 155,000/- only which easily out-weight the cost to the company in term of
medical/ insurance claims and increased insurance premium.
APPENDIX 5
INTERNATIONAL
GENERAL CERTIFICATE
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01 / 14
Conclusions
It is appreciated that management of GPPL provide high level of welfare facilities and working
environment to maintain the well being of its employees at work place. The endeavor of the company in
achieving the OHSAS 18001 certification was also noticed during the inspection. However, a number of
Health & Safety related issues are identified during the inspection and are listed in the recommendations
section on this report which needs immediate attention of the management.
The fumes of dichloromethane can cause serious health concerns to the worker exposed to them at
dispensing area. Condensate water dripping at main electrical panel of the PW plant can cause electric
shock to whosoever may come in contact. The manual handling was observed by the workers at solvent
room without any handling aid can cause spinal injuries. Contact injuries can occur at lathe machine as
guard was not in place during working at machine. High noise levels at technical floor can cause work
induced hearing impairment as operator and support staff not wearing any ear protection and exposed to
the noise for the 12 hours each day. The potential of Legionnaire’s disease due to possible presence of
Legionella Bacteria in the aerosol of cooling tower. The most significant of all is the fire and explosion risk
at solvent room due to improper chemical segregation which can lead to loss of life, damage to property
and equipment.
Aforementioned issues can cause significant health & safety risk to human life, property and equipment
and therefore required immediate attention of the management. Moreover, these could pose critical
impediment in meeting management vision of achieving OHSAS 18001 certification. In addition, these
findings are the clear breach of both National and International regulations such as the Factories Act of
Pakistan, the main ILO Convention (C155) Occupation Safety & Health, Recommendation (R164) which
could lead to enforcement action against company that could affect the market reputation and morale of
the workers and management alike.
It is recommended to implement the proposed recommendation as per the mentioned timelines to avoid
the worst consequences. It should be noted that most of the recommendation are low in terms of time,
effort and money and out-weight the cost to company in case of injury, ill-health and prosecution.
Implementation of these recommendations would lead to prominent improvement in the Health & Safety at
the GPPL and reduce the risk of injury, ill-heath and enforcement action.
The implementation of the said recommendation has clearly established morale, legal and financial
justification as a result of increased workforce morale which results in an increased productivity and
profitability.
APPENDIX 5
INTERNATIONAL
GENERAL CERTIFICATE
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01 / 14
Recommendations:
Recommendation Likely resource implications Priority Review date

Isolation (glass cabin) The cost of isolation along with High April 02, 2014
with explosion proofed LEV would be PKR 150,000/-
LEV should be installed and further PKR 5,000/- would
at Dispensing area to incur for arranging in-house
reduce the ill health effect training of workers. The total
of dichloromethane cost of implementation would
fumes. be PKR 155,000/-
Replace and relocate the Total PKR 25,000/- (inclusive High January 20, 2014
steam trap at suitable of equipment and installation
location away from the cost)
electrical panel of the
Purified Water Plant
(PWP).
A barrel truck should be The cost of barrel truck would Medium February 04, 2014
purchased to reduce be PKR 25,000/- and for
manual handling at arranging training for safe use
Solvent Room. would be PKR 5,000/-. The total
cost to the company would be
PKR 30,000/-
Secondary containment The total cost for the provision High February 04, 2014
should be provided for of SS containments and spill kit
effective segregation of would be PKR 150,000/-
incompatible chemicals
and HazChem spill kit for
management of spills.
Interlocking device The device and installation cost High January 30, 2014
should be installed with would be around PKR 10,000/-
safety guard of the Lathe
machine at workshop to
avoid machine operation
w/o guard.
Develop acoustic heaven The cost of development of High April 02, 2014
to isolate the operator and glass cabin would be PKR
support staff at technical 130,000/- and for training and
area from harmful effects sign posting PKR 8,000/-. Total
of noise. cost of implementation would
be PKR 138,000/-
Louver enclosure should The total cost (inclusive of High March 04, 2014
be provided around the material and labor) would be
cooling tower to restrict PKR 155,000/-
the dispersion of water
aerosol that may contain
Legionella Bacteria.

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NEBOSH International General Certificate

in Occupational Health and Safety

UNIT IGC3: HEALTH AND SAFETY PRACTICAL

Student Name: Faisal Aziz

Student Number: 00216199

Date of Submission: January 08, 2014

IGC3 – The Health and Safety Practical Application

Candidate and course provider declarations:

For completion by the candidate:

Name (Print) Faisal Aziz

Date January 03, 2014

For completion by a course provider representative (e.g. internal practical assessor):

For completion by the course provider’s internal practical assessor:

IGC3 – THE HEALTH AND

Date of practical application 03-01-2014 Name of assessor

Student number 00216199 Student name Faisal Aziz

1 Completion of observation sheets

1.1 Range and number of hazards/good practice 15

Identification of suitable control measures and

2 Report - Introduction and Executive Summary

Introduction providing an overview of the chosen

2.2 Executive summary 5

3 Report - Main findings of the inspection

Quality of interpretation of findings and clear

Identification of possible breaches of international

3.3 Persuasiveness / conciseness / technical content 10

4 Report - Conclusions and Recommendations

Clear and concise conclusions which are clearly

Recommendations which present realistic actions to

TOTAL MARKS 100

Date received by course provider / /

Date received by NEBOSH

Assessor’s additional comments on the practical application:

ASSESSED BY (name in block letters)

NEBOSH USE ONLY

NEBOSH Moderator’s comments:

IGC3 – THE HEALTH AND

Student name Faisal Aziz Student number 00216199

Place inspected Getz Pharma (Pvt.) Ltd. Date of inspection 03 / 01/ 14

Observations Control measures Timescale

IGC3 – THE HEALTH AND

Student name Faisal Aziz Student number 00216199

Place inspected Getz Pharma (Pvt.) Ltd. Date of inspection 03 / 01 / 14

Observations Control measures Timescale

IGC3 – THE HEALTH AND

Student name Faisal Aziz Student number 00216199

Place inspected Getz Pharma (Pvt.) Ltd. Date of inspection 03 / 01/ 14

Observations Control measures Timescale

8) Evacuation plans depicting safe Commendable and inspect regularly On-going

IGC3 – THE HEALTH AND

Student name Faisal Aziz Student number 00216199

Place inspected Getz Pharma (Pvt.) Ltd. Date of inspection 03 / 01/ 14

Observations Control measures Timescale

10) Hygiene conditions of toilets Housekeeping is strictly maintained On-going

11) Fire extinguishers are Commendable and inspect regularly On-going

12) LEV installed at granulation I- Immediately inspect by HVAC 4 hours

IGC3 – THE HEALTH AND

Student name Faisal Aziz Student number 00216199

Place inspected Getz Pharma (Pvt.) Ltd. Date of inspection 03 / 01/ 14

Observations Control measures Timescale

15) Health screening of cafeteria I- Arrange immediate health 2 days

IGC3 – THE HEALTH AND

Student name Faisal Aziz Student number 00216199