Risk Assessment

INVENTORY OF WORK ACTIVITIES

Workplace: Sampling Room Date: 4 Feb. 14

No.
Process / Location Work Activities

1 Sampling Personnel Airlock Personnel protection / HSE

2 Sampling Material Airlock Use of electrical equipment

Use of laboratory heating equipment
3 Sampling laminar air flow cabin Use of mechanical equipment
Use of compressed gas cylinders
Use of fume hood
Use of API materials
Use of hazardous chemicals
Use and disposal of sharp object
Environmental aspects

GMP aspects / cross contamination

Disposal of waste sample / waste chemicals

Use of laminar flow cabin/ clean bench
Cleaning effort
Material flow
Environmental condition control
Personnel flow/organizational
Space requirements airlocks
Air flow & Airborne transfer.
Microbial control
Risk Assessment Risk

ACTIVITY- BASED RISK ASSESSMENT FORM

Workplace: Sampling Room
Eng. B. Rostampour (Validation &qualification Expert)
Eng. H.P. Benam (Validation &qualification Expert)
Sampling Personnel Airlock
Dr. Mostafavi (VS for quality and compliance)
Conducted by: (Name/ Signature / Date)
Process / Location: Sampling Material Airlock

Sampling laminar air flow

Approved by Faulty in- Eng. Mollazade Last Review Date: 4 Feb. 14 Next Review Date:
Charge (warehouse):
(Name/ Signature / Date) 4 Feb. 2016

Personnel protection / HSE

1. Hazard Identification 2. Risk Evaluation 3. Risk Control

1a. 1b. 1c. 1d. 2a. 2b. 2c. 2d. 3a. 3b.
Possible Existing Risk Severity Likeli- Risk Additional Action Officer,
No. Work Activity Hazard Accident / III Health & Control hood Level Designation
*S Risk Control
Persons-at- Risk (if any) *L *R=LxS (Follow-up date)
Check all electrical
Electrical shock equipment used must
bear the Safety Mark
Electrocution Conduct risk
assessment
Use of electrical equipment

All lab & warehouse staff

Burns caused by the prior usage
passage of heavy
Electrical hazard

currents through the Plugs that are cracked Follow the

body or by direct or broken must not be safe work
1 contact with an used. 5 2 10 procedure
electrically heated
surface Fire and The cable must be in Adequate
Explosion caused by good condition and training by a
electrical sparks, short free from breaks in the competent
circuits or overload insulation. person is
heating, old wiring in required
the presence of Cables run across the
flammable material floor must be covered
with cable protectors
Risk Assessment Risk
1. Hazard Identification 2. Risk Evaluation 3. Risk Control

1a. 1b. 1c. 1d. 2a. 2b. 2c. 2d. 3a. 3b.
Possible Existing Risk Severity Likeli- Risk Additional Action Officer,
No. Work Activity Hazard Accident / III Health & Control hood Level Designation
*S Risk Control
Persons-at- Risk (if any) *L *R=LxS (Follow-up date)
All heating devices
must be kept well
away from flammable
material
Use of laboratory heating equipment

Conduct risk
Ovens should not be assessment
Burns from hot

All lab & warehouse staff

used to dry any prior usage
surfaces, liquids,
chemical sample that
Thermal hazard

vapors or flames
has even moderate Follow the
volatility safe work
Ignition or explosion
2 3 2 6 procedure
Scalding from hot Ovens should not be
used to dry plastic Adequate
steam
ware training by a
competent
Fire and explosion
The state of the person is
heating element should required
be checked before
use.

Heating can only be

All the machinery must Conduct risk
provide with safe guard assessment

All lab & warehouse staff

or safety gear prior usage
Body Injury such as
Use of hands being trap in Do not wear long Follow the
Physical
3 mechanical between the moving or sleeve shirt, sleeve 5 2 10 safe work
hazard must be fold up to the procedure
equipment rotating machinery
part arm
Adequate
Switch off the main training by a
power point before competent
taking or putting person is
Risk Assessment Risk
1. Hazard Identification 2. Risk Evaluation 3. Risk Control

1a. 1b. 1c. 1d. 2a. 2b. 2c. 2d. 3a. 3b.
Possible Existing Risk Severity Likeli- Risk Additional Action Officer,
No. Work Activity Hazard Accident / III Health &Control hood Level Designation
*S Risk Control
Persons-at- Risk (if any) *L *R=LxS (Follow-up date)
Suitable safety glasses
or face shield, covered
shoes, gloves should
be worn when
relocating or removing
the pressure regulator
and when opening the Conduct risk
Use of compressed gas cylinders

Tipping and Falling of

physical hazardErgonomic &

spindle valve assessment

gas cylinder

All lab & warehouse staff

prior usage
Cylinders shall be
Explosion
transported by suitable Follow the
hand truck for short safe work
Valve leakage
4 distance only 5 2 10 procedure
Fire and explosion
Cylinders shall be Adequate
secured properly training by a
Cold burns
competent
Ensure the person is
Asphyxiation
cylinder main stem required
valve is closed at the
end of the experiment

Ensure the
surrounding working
area is well ventilated
Risk Assessment Risk
1. Hazard Identification 2. Risk Evaluation 3. Risk Control

1a. 1b. 1c. 1d. 2a. 2b. 2c. 2d. 3a. 3b.
Possible Existing Risk Severity Likeli- Risk Additional Action Officer,
No. Work Activity Hazard Accident / III Health & Control hood Level Designation
*S Risk Control
Persons-at- Risk (if any) *L *R=LxS (Follow-up date)
Check flow is on

Check if the fumehood

is clear of any other
hazards or materials Follow the
that may be safe work
Physical hazard

incompatible with the procedure

material that you are
about to use

All lab & warehouse staff

Adequate
training by a
Use of fume hood

Do not block the competent

Exposure to chemicals baffles person is
5 and airborne 3 2 6 required
hazardous substances Avoid blocking or
Chemical hazard

placing large items Periodic

near the baffles fumehood
function
Work in the middle of inspection
the bench
space Annual
maintenance
Avoid sticking your
head into the fume
cupboard

Any accidental spill of

Risk Assessment Risk
1. Hazard Identification 2. Risk Evaluation 3. Risk Control

1a. 1b. 1c. 1d. 2a. 2b. 2c. 2d. 3a. 3b.
Possible Existing Risk Severity Likeli- Risk Additional Action Officer,
No. Work Activity Hazard Accident / III Health & Control hood Level Designation
*S Risk Control
Persons-at- Risk (if any) *L *R=LxS (Follow-up date)
hazardBiological & infectious
Suitable personal Approval must
Protective be
equipment must be sought from
worn Biological
Safety
Use of biological materials

All lab & warehouse staff

Specimen containers Committee
should be correctly
labeled Conduct risk
Risk of infection assessment
6 Biological materials Secondary containers 5 1 5 prior usage
Spillage should be used to
avoid accidental Follow the
leakage or spillage. safe work
Potential health hazard

They should be procedure

regularly
decontaminated Only trained
person or
Specimens should be competent
unpacked in a person is
Risk Assessment Risk
1. Hazard Identification 2. Risk Evaluation 3. Risk Control

1a. 1b. 1c. 1d. 2a. 2b. 2c. 2d. 3a. 3b.
Possible Existing Risk Severity Likeli- Risk Additional Action Officer,
No. Work Activity Hazard Accident / III Health & Control hood Level Designation
*S Risk Control
Persons-at- Risk (if any) *L *R=LxS (Follow-up date)
Read and follow the
SDS

Suitable PPE must be Conduct risk

worn assessment
Use of hazardous chemicals

prior usage
Chemical bottle should

All lab & warehouse staff

Chemical spillage be correctly labeled Follow the
Chemical hazard

safe work
Fire All withdrawl and procedure
7 use of hazardous 5 2 10
Poisoning chemical solvent and Adequate
acid shall be done in training by a
Exposure to solvent the fumehood to avoid competent
and acid vapor direct contact with the person is
vapor required
Secondary containers
should be used to
avoid accidental
leakage or spillage.
They should be
Sharps should be used
as little as possible and
always with the
Cuts
Use and greatest care
disposal of Conduct risk
Needle-stick
sharp object, After use, if not for assessment
(puncture) injuries
include disposal, sharp items prior usage
Physical All lab &
8 hypodermic must always be placed 3 3 9
hazard Injury from needle- warehouse staff
needles, in a Follow the
stick is associated with
syringes with safe position/orientatio safe work
psychological trauma
needles and n so as to avoid procedure
due to the fear of
etc. possible
poison or infection
accidental injury to
others

Sharps object must be

Risk Assessment Risk
Risk Assessment
GMP aspects / cross contamination
1. Hazard Identification 2. Risk Evaluation 3. Risk Control

1a. 1b. 1c. 1d. 2a. 2b. 2c. 2d. 3a. 3b.
Risk Assessment Possible Existing Risk Severity Likeli- Risk Additional Action Officer,
No. Work Activity Hazard Accident / III Health & Control hood Level Designation
*S Risk Control
Persons-at- Risk (if any) *L *R=LxS (Follow-up date)
Ventilate the affected
Disposal of waste sample / waste chemicals

area

Chemical, biological & infectious hazard

Eliminate any sources
of ignition if flammable

All lab & warehouse staff

Containers should be Conduct risk
Spillage of chemical
correctly labeled assessment
waste
prior usage
1 
Explosion due to Secondary containers 5 2 10
Likelihoo
should be used to Follow the
incompatible of d:5–
avoid safe work
chemical frequent; 4
accidental leakage procedure
–
or spillage. They moderate,
should be regularly 3–
decontaminated occasional
,2–
Separate waste remote, 1
storage
Suitablebottles
PPE must be – unlikely.
worn
Follow the
safe work
Use of laminar flow hood/ clean bench

Disinfects the surfaces

inside the hood before procedure
and after used

All lab & warehouse staff

Adequate
training by a
Biological hazard

To be used by one
person at a time to competent
Exposure to chemicals avoid interfere person is
2 and airborne with the airflow 3 2 6 required
hazardous substances
Work in the middle of Periodic
the bench laminar hood
space function
inspection
Never store anything in
a laminar flow hood Annual
maintenance
Lower the hood to
safety marking to
rt
Risk Assessment
Severity : 1 – negligible, 2 – marginal, 3 – serious, 4 – very serious, 5 – critical
 Risk Level : 1 – 5 Low, 6 – 10 medium, 11 – 15 warning, 16 and above is considered HIG
ADE (Acceptable Daily Exposure) is the daily dose of a substance, below which no adverse effects are anticipated by any route, even if exposure
occurs for a lifetime.
Number is derived from information on the toxicity of the product to the patient. It is based on regulatory information such as NDAs and is used in
occupational toxicology to set Occupational Exposure Limits (OEL).
mg
The use of ADE as a basis of risk assessment is a scientific approach.
ADE( mg/day)=
NOAEL
kg
day ( )
∗BW

UFc∗MF
 NOAEL= No observed adverse effect level Rule of thumb for calculation:
: BW = Body weight ADE ≤10 OEL
UFc = Uncertainty
Severity Potential Factor
Patient Exposure
MF = Modifying Failure Exposure Result
Value (mg) Factor
10 -1
Above [LD50x70 kg][10 ] Critical, may cause serious injury
7 Above the ADE Major, may cause an adverse event
Patient exposure is below the adverse effect dose, but with
5 Lower than ADE
a low safety margin
3 Lower than ADE/3 Patient exposure is below the adverse effect dose
Patient exposure is significantly below the adverse effect
1 Lower than ADE/10
limit

Occurrence Evaluated Occurrence

Detection
Value
Detection Method Batch Based Event General Manufacturing Event
Value
10 One or more times per batch One or more times per day
10 Not detected by current methods
7 One or more times per 50 batches One or more times per month
7 Not inspected, but can be identified during manufacturing
5 One or more times per 600 batches More than once a year
5 Inspection of statistical sampling
3 Once in >600 batches Once every one to five years
3 100% inspection (manual)
1 --- Once in greater than five years
1 Obvious, monitored and alarmed automatically, or two consecutive manual inspections

Process Risk Value=Severity∗Occurrence∗Detection

Severity = A measure of the possible consequences of the failure Based on evaluation of Contamination in the next batch.
Occurrence = The likelihood that the failure event will happen Base on MDR, Breakdown maintenance, annual product review, complaints, change
controls and internal audits.

Detection = The ability to detect failure Based on current controls.

( Batches per Year )∗( API per Batch )∗(Process Risk Value)
Risk=
ADE

Risk Level Risk Acceptability

≥491 Unacceptable
Further risk reduction measures are required
350-490
before production commences
96-343 Consider investigating further
 Acceptable, but always look for continuous
32-90
improvement
1-30 Broadly acceptable

Personnel protection / HSE

Risk Assessment Risk Analyse Risk Reduction

Risk
Risk evaluation Risk evaluation Comments
Cause(failure Necessary Actions Reduction
Effect
mode) Probability Detectability Risk actions? implemented Probability Detectability Risk
Severity (S) Severity (S)
(P) (D) (P x S x D) (P) (D) (P x S x D)
Any container is
o Yes/ ý No
cleaned

Air filtered through

o Yes/ ý No
HEPA filters

Isolation of
o Yes/ ý No
production areas

Positive pressure in
o Yes/ ý No
the clean rooms

o Yes/ ý No Oil-free compressor

o Yes/ ý No Air filtration

o Yes/ ý No Change of clothing

Changing rooms
o Yes/ ý No
adequately designed

o Yes/ ý No Training

Area-dedicated (used
o Yes/ ý No exclusively in a
definite area)

Any material is
controlled and when
o Yes/ ý No necessary
cleaned/purified/steril
ized

ý Yes / o No Clean room

classification
according to
 Risk Assessment Risk Analyse Risk Reduction

GMP

In critical
ý Yes / o No cases air is
not recycled

Establishmen
ý Yes / o No t of pressure
gradients

Construction
of
ý Yes / o No
intermediate
air-locks

Use of closed
systems

Dedicated
ý Yes / o No equipment
and objects

Cleaning
ý Yes / o No areas well
designed

ý Yes / o No Training

Adequate
ý Yes / o No
SOPs

Separation of
ý Yes / o No
areas

Adequate
ý Yes / o No
flows

ý Yes / o No Training

GMP aspects / cross contamination

 Risk Assessment Risk Analyse Risk Reduction

Risk
Risk evaluation Risk evaluation Comments
Reduction
Cause(failure Necessary Actions
Effect
mode) actions? implemented
Probability Detectability Risk Probability Detectability Risk
Severity (S) Severity (S)
(P) (D) (P x S x D) (P) (D) (P x S x D)

Entry of dirty Diffusion of Any container is

o Yes/ ý No
containers contamination cleaned

Inappropriate Entry of Air filtered through

o Yes/ ý No
filtration contamination HEPA filters

Isolation of
o Yes/ ý No
production areas
Penetration of Entry of
outside air contamination
Positive pressure in
o Yes/ ý No
the clean rooms

o Yes/ ý No Oil-free compressor

Compressed Entry of
air contamination
o Yes/ ý No Air filtration

o Yes/ ý No Change of clothing

Entry of Changing rooms

Personnel o Yes/ ý No
contamination adequately designed

o Yes/ ý No Training

Area-dedicated (used
Entry of
Equipment o Yes/ ý No exclusively in a
contamination
definite area)

Any material is
controlled and when
Entry of
Materials o Yes/ ý No necessary
contamination
cleaned/purified/steril
ized

Inadequate Particle Clean room

air-filtration diffusion classification
ý Yes / o No
according to
GMP

ý Yes / o No In critical
cases air is
 Risk Assessment Risk Analyse Risk Reduction

not recycled

Establishmen
ý Yes / o No t of pressure
gradients
Flow of air
Construction
from one Particle
of
room to diffusion ý Yes / o No
intermediate
another
air-locks

Use of closed
systems

Dedicated
ý Yes / o No equipment
and objects

Cleaning
Mixture of ý Yes / o No areas well
Equipment
products designed

ý Yes / o No Training

Adequate
ý Yes / o No
SOPs

Separation of
ý Yes / o No
areas
Particle Adequate
Personnel ý Yes / o No
diffusion flows

ý Yes / o No Training