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)

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


assessment (CRA)


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)


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


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


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



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


3 granules Beetween 30-60 min<50 kg or

<50 l


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


6Micronized

powder Over 4 hourst or m3


• 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


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



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



Small surface of body skin exposed to dust


4Beetweeen 1-

2 hoursMedium surface of body skin

exposed to dustMin 4 times per shift

5Beetweeen 2-

4 hoursLarge surface of body skin


6 Over 4 hoursLarge surface of body skin


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


Medium quantity of material particles

spalshed



Small surface of body skin exposed to dust


4Beetweeen 1-2 hours

Medium surface of body skin exposed to dust


5Beetweeen 2-4 hours

Large surface of body skin exposed to dust


6Over 4 hours


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


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!



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


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.


C. Culegere de date


Limite de expunere profesionala a locului de

munca


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


PPE este eficient?

Protectia este suficienta?


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?


( care se vor trece in planul de actiuni)

1.

2.

3.

4.

5.

6.

7.

8.

E Evaluarea expunerii prin contact cu pielea



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?


( care se vor trece in planul de actiuni )

1.

2.

3.

4.

5.

6.

7.

8.

CRA Template


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


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



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)

improvement of personal protective equipment (ppe) as a result of chemical risk assessment (cra)

Documents

risk quantification

risk of employees exposure

practical assessment

types of chemical contact

employees health

cra methodologytraining

ways of exposure

occupational health