Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment
(CRA)
Chem. Cristina CIAMA, EHS Manager,
Mihail GEORGESCU, Safety Inspector
S.C EUROPHARM S.A Brașov
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
• Issue
► Many of the Active Pharmaceutical Ingredients (API) used in the pharmaceutical production industry have the potential of causing occupational illness (e.g. skin rash, dermatitis, asthma, etc).
► Using the right tools and process to assess the chemical risk at workplace
• Problem
► Employees working in pharmaceutical industry are exposed to pharmaceutical substances causing risk to their health. The ways of exposure to the chemical substance are various as skin, respiratory, ingestion, eye.
► The company set up Key Performance Indicators (KPI) on occupational health injuries and illnesses to monitor the performance on employees’ health and safety
► 3 potential allergies at skin level have been reported
• Solution► Investigation
Following the reporting, an investigation committee has been set-up in order to find out the root cause of incidents
Tools used during investigation:• ROOT CAUSE ANALYSIS (RCA)• FISH BONE ANALYSIS • GEMBA tour
► Root Cause
Chemical Risk Assessment undertook is addressing few aspects and does not take into consideration the risk of employees’ exposure to chemical substances
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk
assessment (CRA)
►Project Steps Step 1 Establish the target
• Improvement of Chemical Risk Assessment
Step 2 Set-up the project team• with members from all relevant departments
Step 3 Identify the best solutions • Introduce information about ways of exposure: inhalation/ingestion and skin contact• Introduce a risk quantification • Introduce types of chemical contact • Introduce R phrases• Link between risk assessment and occupational monitoring• Involvement of operators in chemical risk assessment process
Step 4 Implement the new WOW• Training of the employees on CRA methodology• Training on chemical effects• Deployment of new CRA
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk
assessment (CRA)
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk
assessment (CRA)
CHEMICAL RISK ASSESSMENT METHODOLOGY
• Occupational Health Category
•Occupational Hazard Categories (OHCs) is in-house GSK ranking tool for practical assessment of the health hazards of substances.
•An Occupational Hazard Category (OHC) is defined as a grouping which classifies compounds based on health hazards.
•The specific hazards of materials within an OHC may not be comparable, but to avoid ill-health following exposure, all materials in an OHC require control to the same degree. In the GSK OHC system the least hazardous materials are classified as OHC 1; the most hazardous as OHC 5.
5. OHC 5 - < 1mcg/m3 ( 8HrTWA)
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk
assessment (CRA)
Consequence
Likelihood
OHC11
OHC 22
OHC 33
OHC 44
OHC 55
RARE< 20
11 2 3 4 5
IMPROBABLE<50
22 4 6 8 10
POSIBLE<100
33 6 9 12 15
PROBABLE<150
44 8 12 16 20
ALMOST CERTAIN>= 150
55 10 15 20 25
Quantification method: take into consideration the way of exposure: inhalation/ingestion and skin contact
Assessment of exposure through inhalation/ingestion
Quantification: Likelihood x Consequence
CHEMICAL RISK ASSESSMENT METHODOLOGY
Score Dustiness Duration Quantity Frecquency
1Capsules, coated tabletts,
suspension, rasinMax 15 min
<1 kg sau <1 l
1 time per shift
2Peletts,
uncoated tablettsBeetween 15-30 min
< 10 kg sau <10 l
Min 2 times per shift
3 granulesBeetween 3
0-60 min
<50 kg sau
<50 l
Min 3 times per shift
4 powderBeetween 1-2 hours
<75 kg sau<75 l
Min 4times per shift
5 Micronized powderBeetween 2-4 hours
<100 kg sau
<100 lMin 5 times per shift
6Micronized powder
Over 4 hourst sau
m3Min 6 times per shift
Calculation of Likelihood: Dustiness x Duration x Quantity x Frequency
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
Score Dustiness Duration Quantity Frecquency
1
Capsules, coated tabletts,
suspension, rasin
Max 15 min<1 kg or
<1 l1 time per shift
2Peletts,
uncoated tablettsBeetween 15-30
min
< 10 kg or
<10 l
Min 2 times per shift
3 granules Beetween 30-60 min<50 kg or
<50 l
Min 3 times per shift
4 powder Beetween 1-2 hours<75 kg or
<75 lMin 4times per
shift
5 fine powderBeetween 2-4 hours
<100 kg or
<100 l
Min 5 times per shift
6Micronized
powder Over 4 hourst or m3
Min 6 times per shift
• Task: Dispensing/Weighting of Amoxicillin
• Transfer of bulk powder by vacuum
• Frequency: once per day• Duration: 15-30 min• No of operators: 1
Probability inhalation:
4 x 2 x 2 x 1 = 16
Example of quantification for inhalation risks
Example of quantification for inhalation risks:
Consequence
Likelihood
OHC11
OHC 22
OHC 33
OHC 44
OHC 55
RARE< 20
11 2 3 4 5
IMPROBABLE<50
22 4 6 8 10
POSIBLE<100
33 6 9 12 15
PROBABLE<150
44 8 12 16 20
ALMOST CERTAIN
>= 1505
5 10 15 20 25
Likelihood inhalation:
4 x 2 x 2 x 1 = 16
Score under 20 means RARE
Consequence: is OHC 3 that means Score 3
Result: risks of inhalation for this task is in green area, that should be kept under control
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
Assessment of exposure through skin contact :
Consequence
Likelihood
OHC11
OHC 22
OHC 33
OHC 44
OHC 55
RARE< 51
1 2 3 4 5
IMPROBABLE<15
22 4 6 8 10
POSIBLE<25
33 6 9 12 15
PROBABLE<35
44 8 12 16 20
ALMOST CERTAIN
>=505
5 10 15 20 25
Quantification: Likelihood x Consequence
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
CHEMICAL RISK ASSESSMENT METHODOLOGY
Assessment of exposure through skin contact
Scor Duration Quantity Frequency
1 Max 15 minSmall quantity of material
particles spalshed1 time per shift
2Beetweeen 15-30 min
Medium quantity of material particles spalshed
Min 2 times per shift
3Beetweeen 30-60 min
Small surface of body skin exposed to dust
Min 3 times per shift
4Beetweeen 1-
2 hoursMedium surface of body skin
exposed to dustMin 4 times per shift
5Beetweeen 2-
4 hoursLarge surface of body skin
exposed to dustMin 5 times per shift
6 Over 4 hoursLarge surface of body skin
exposed to dustMin 6 times per shift
Example of quantification for skin contact risks: • Task: Dispensing/Weighting of Amoxicillin; Transfer of bulk powder by vacuum
pump. Frequency: once per day. Duration: 15-30 min. No of operators: 1
Score Duration Quantity Frequency
1 Max 15 minSmall quantity of material particles
spalshed1 time per shift
2Beetweeen 15-30 min
Medium quantity of material particles
spalshed
Min 2 times per shift
3Beetweeen 30-60 min
Small surface of body skin exposed to dust
Min 3 times per shift
4Beetweeen 1-2 hours
Medium surface of body skin exposed to dust
Min 4 times per shift
5Beetweeen 2-4 hours
Large surface of body skin exposed to dust
Min 5 times per shift
6Over 4 hours
Min 6 times per shift
Probability skin contact: 2 x 2 x 1 = 4
Consequence
Likelihood
OHC11
OHC 22
OHC 33
OHC 44
OHC 55
RARE< 51
1 2 3 4 5
IMPROBABLE<15
22 4 6 8 10
POSIBLE<25
33 6 9 12 15
PROBABLE<35
44 8 12 16 20
ALMOST
CERTAIN >=505
5 10 15 20 25
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
Severity is OHC 3 that means Score 3
Result: risks of skin contact for this task is in green area, that should be kept under control
Notice: Scoring
• If the CRA identifies nonconformities that affect the operator’s health, the scoring could be increased even the calculation is showing a lower score!
CHEMICAL RISK ASSESSMENT METHODOLOGY
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
GlaxoSmithKline Europharm Brasov Evaluare de risc chimic pentru substante chimice COD : ERC-…..-000.
Rezumatul evaluarii/ privire de ansamblu:
Cladire Departament Arie/Echipament
Proces: Activitate:
Concluzii Risk Semnificativ(cel mai mare): Risk Nesemnificativ(cel mai mic):
Rezumatul riscurilor
1.
Plan de actiuni cu activitati rezultate
Activitati rezultate Responsabil Prioritate1 Termen pentru implementare
estimativ Data finalizarii
1.
2.
CRA Template
1Prioritate: scazuta, medie, inalta
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
CRA Template
A. Descrierea Procesului/Activitatii
Scurta descriere a Procesului/Activitatii/ a sarcinilor angajatului, consisa si cu suficiente informatii care sa ajute la o evaluare eficienta
Conditiile mediului de lucru
Numar lucratori din acest sector
Responsabil loc de munca- Manager Supervizor/
Frecventa/Durata operatiei pe parcursul unui schimb
Frecventa:
Durata:
B. Masuri organizatorice
Aici vor fi luate in considerare toate substantele periculoase, alte materii prime sau amestecuri (produsi intermediari), si substante de curatire
Substanta chimica
periculoasa este clar
semnalizata?
Informatiile de securitate
(MSDS) sunt actuale si
disponibile?
Informatiile de securitate
(MSDS) sunt accesibile la
locul de munca
angajatiilor?
Este inregistrata substanta in baza de date cu substante periculoase?
Angajatul a fost instruit in manipularea substantei
sau amestecului?
Substanta sau mixtura
DA NU
Forma
fizica(solid, lichid, gaz)
DA NU DA NU DA NU DA NU
Masuri de imbunatatire necesare
( care se vor trece in planul de actiuni)
1.
2.
3.
4.
5.
6.
7.
8.
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
C. Culegere de date
Aici vor fi luate in considerare toate substantele periculoase, alte materii prime sau amestecuri (produsi intermediari), si substante de curatire
Limite de expunere profesionala a locului de
munca
Substanta sau mixtura
OEL
[µg/ m3]
OHC [1-5]
Peri-oada de referin-
ta1
Simbol risc
Fraze R
Masuri de protectie existente
din proiectarea constructiei
PPE sau alte masuri de protectie
Risc Explozie
(Categorie)
Risc Reproductiv
Vezi Informatii in MSDS
De exemplu la R R46 60, 61, 62, 63, 64
Cancerigen
Vezi Informatii in MSDS
Cauze de expunere posibile/ observatii (mod de lucru, echipament)
1.
2.
3.
4.
5.
6.
7.
8.
CRA Template
If in section C Reproductive Risks will be identified through R Phrases, we should proceed to specific Risk Assessment and eliminate/reduce exposure using Hierarchy Controls Method
If in section C Carcinogen Risks will be identified through R Phrases, we should proceed to eliminate/reduce exposure using Hierarchy Controls Method
D. Evaluarea expunerii prin inhalare/inghitire/ingerare
Aici vor fi luate in considerare toate substantele periculoase, alte materii prime sau amestecuri (produsi intermediari), si substante de curatire
PPE este eficient?
Protectia este suficienta?
Substanta sau mixtura
Grad de prafuire
Scazut:
Peleti sau ceara
Mediu:
Praf/ Pulbere
Inalt:
Pulbere fina
Dozare/ cantitate
manipulata
Mica:
g sau ml
Medie:
kg sau l
Mare:
t sau m3
Dur
ata
Fre
cventa
Rezultat P
robabili
ate
ECM
A - E
Tip
Filt
ru
Niv
el/gra
d
pro
tectie A
PF
Im
bra
cam
inte
de
pro
tectie
Ochela
ri d
e
pro
tectie
Caracteristicile tehnice ale instalatiilor de protectie sunt cunoscute (numarul de schimburi de aer)?
Instalatiile tehnice de protectie functioneaza bine (corect)?
Exista masuratori de pulberi la locul de munca?
Valoare inregistrata
(tracker)
Angajatii se simt
confortabil?
Masuri de imbunatatire necesare
( care se vor trece in planul de actiuni)
1.
2.
3.
4.
5.
6.
7.
8.
E Evaluarea expunerii prin contact cu pielea
Aici vor fi luate in considerare toate substantele periculoase, alte materii prime sau amestecuri (produsi intermediari), si substante de curatire
Substanta sau mixtura
Cantitate:
Mica:Stropi
Mare: acoperirea pe o suprafata mare a mainilor, antebratelor sau altor parti
din corp
Durata activitate
Scurta
< 15 min
Lunga
> 15 min
Fre
cven
ta
Rez
ulta
t pro
babi
litat
e
Ris
c pe
ntru
pie
le
(Fra
ze R
)
Din
ce
mat
eria
l sun
t m
anus
ile?
Tip
ul m
anus
ii, m
ater
ialu
l sa
u gr
osim
ea m
ater
ialu
lui
sunt
sat
isfa
cato
are
?
Mas
urile
de
prim
aju
tor
in c
az d
e co
nsta
ct c
u pi
elea
sun
t cun
oscu
te?
Est
e di
spon
ioil
plan
de
ingr
ijire
al p
ielii
?
Ang
ajat
ul s
e si
mte
co
nfor
tabi
l?
Masuri de imbunatatire necesare
( care se vor trece in planul de actiuni )
1.
2.
3.
4.
5.
6.
7.
8.
CRA Template
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
F. Date referitoare la rezultatele masuratorilor/prelevarilor de pulberi la locul de munca Aici vor fi luate in considerare toate substantele periculoase, produsi si substante de curatire folosite in proces
Rezultatele masuratorilor/prelevarilor2
Material/Substanta Operatie din process/Task Mod de
masurare/prelevare1
Numar masuratori/prelevari
Durata prelevarii
(minute)
Abatere standard
(tracker)
Meanvalue
(tracker)
Valuarea medie
% OEL
G. Cerinte pentru controalele de sanatate ca urmare a rezultatelor masuratorilor la locul de munca (valabile din momentul obtinerii rezultatelor masuratorilor respectiv din momentul evaluarii de risc)
Activitate Necesar (DA/NU) Frecventa Responsabil
Monitorizare de rutina ; urmatoarea masurare in data de:
Controale medicale la medicul companiei(supravegherea medicala):
H. Observatii si testarea masurilor de protectie existente
Tipul masurii de protectie Modul de verificare, este necesara o intretinere
corespunzatoare? Frecventa Inregistrari de date la: Aplicare de catre:
Masuri Tehnice de Control(Engineeing Control):
Vas
Asigurarea climatului ( inst. Climatizare/ ventilare)
Echipament de protectie individual
Echipament de protectie respirator
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
CRA Template
RESULTS
• operators involvement in CRA process
• cross reference with the OH monitoring results
•PPE Improvement
•½ length latex gloves replaced by ¾ length nitril gloves
•Standardize the RPE in production area
•Remove the RPE for the areas where OH monitoring shows results less than OEL
•For the glove selection process, introduction of new criteria as permeation parameters
•Redesign of clothing equipment in order to minimize the skin exposed areas
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
Improvement of Personal Protective Equipment (PPE) as a result of chemical risk assessment (CRA)
BENEFITS
• a structured approach of CRA
• Chemical 5x5 risk quantification system allows quick ranking of the risk and helps on action prioritization
• increase the ownership and understanding at shop floor level of chemical risks
COMMENTS
Health and Safety of the employees is always an important part of GSK, and therefore it is important to find ways to minimise EHS risks and impacts to create and develop a healthy work-place.
This CRA methodology has been recognized as Good Practice in the GSK network
“In addition we aim to continue improving process safety and to move toward an environment where containment rather than respirator is the primary control of chemical exposure” (quote David Pulman, President Global Manufacturing and Supply GSK)
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