BUSINESS CONTINUITY

THROUGH EHS COMPLIANCE

At Indian Pharmaceutical Association seminar.

January 31, 2014.
By: Madan Joshi, Life Science Consulting Pvt. Ltd.
A CONVAL group of company

Madan Joshi:
Have worked with Pfizer Ltd.- an
American MNC for about 20 years.
Total experience of more than 30 years
Have been responsible for rolling out
EHS Program in compliance with
International and Local Regulatory
guidelines.
Was Managing Director of a Diversified
Business Unit of Pfizer Ltd.
Worked as EHS Leader Asia Pacific for
an American Company

 CHALLENGE:
FOR ME:

The presentation is immediately after

lunch
As it is EHS is an odd one out in this
seminar, though included in Metrics
EHS IS INTRINSICALLY A DRY SUBJECT
In any organization, EHS leader has
tougher time getting colleagues for
meeting compared to QA

Agenda:
EHS and Business Value
Environment
Health
Safety
General approach to EHS

Metrics can be organised into various

operational/ financial categories.

Productivity
People
Safety [OSHA]
Assets
Quality
Total productive maintenance

BUSINESS VALUE:
Business value refers to the
tangible and intangible assets
and qualities that determine
organizations health, attract
investors and drive decision
making for all work activities.

TANGIBLE VALUES
Cash flow, increased revenue,
increased productivity, decreased
cost, faster response to market,
operational efficiency.
INTANGIBLE VALUES
Include technical expertise,
companys reputation, employee
morale, innovation, compliance
risk etc.
Intangible values majorly support

INTANGIBLE VALUES
Many qualities of safety &
environmental programs are in
intangible category.
EHS is as critical as financial
performance irrespective of cost or
profits.
Readiness / ability to produce is
critical
Fire Brigades readiness is critically
significant

Environment, Health & Safety ( EHS)

professionals must transform EHS into a
Business Value and demonstrate EHS
performance in the context of
organizations business objective

EHS Activity

Business Value
Objective

Measure Of
Performance

Business Value
Result

Training

Reduce
compliance risk
cost containment

Incident rate
Employees
Completed

% incident rate
change/time
% courses
completed

Program
Development

Reduce
compliance risk
cost containment

Injuries per # of
work hours

% change in lost
work days/ DART

Personal
Protective
Equipment

Reduce
compliance risk
cost containment

% of employees
wearing PPE
during incident

Cost comparison
of injury with and
without PPE

Barriers to EHS as a business value

In general, safety professionals:

Have major focus on technical aspects of EHS
Do not integrate the safety program into Organizations
business initiatives
Lack key adaptive type technical skills such as evaluating
effectiveness of safety program

CONCERN
EHS has become an
administrative function rather
than technical
In many companies, EHS is
responsibility of H.R.
Safety of people & property
is so critical to Business
continuity", which is not well
demonstrated

CONCERN

(continued)

There are no warning letters

483s for compromised EHS
performance
But the consequences can be
fatal
Companies may replace the
colleague ASAP, but that does

SHIFT IN STATUS
Now a days, in few enlightened
companies value of EHS program is
measured / accounted, using
process improvement tools
Simple techniques like Balanced
scorecard can be structured to
enable users demonstrate
relationship between EHS &
Business Value

BUSINESS
VALUE

PROFIT

PRODUCTIO

RISK

REPUTATION

CONTROL COST

Training

Waste Reduction

TIME TO
MARKET

EHS Function

Environmental
Permit Compliance
Studies, Audits,
Reports

Safety compliance

Remediation

Energy Efficiency

Safety Committee

Security

Pollution
Prevention
Record Keeping

SHIFT IN STATUS
( continued)

Recent Industrial accidents like

explosion of Boiler / reactors,
electrical fires etc. Show how
tangible values are not more
significant than safety, OR
reputation of the organization
SO
Safety performance can play a
major role in shaping
organizations competitive edge

 Safety performance, EHS

compliance and Robust
employee hygiene program are
critical to companys reputation &
Business continuity

Which intervention can ensure this?

Employee training
Enforcement of EHS policies & procedures
Meaningful safety Management program
Better equipment/ workplace
Better health/ Industrial hygiene program
Total safety culture.

Organizational Culture Model

Strong
Tribal

Operational
Excellence

Chaotic

Bureaucratic

People

Weak

Weak

Systems

Strong

Organizational Culture Model

Strong
Tribal

Operational
Excellence

Chaotic

Bureaucratic
Bureaucratic

People

Weak

Weak

Systems

Strong

CHALLENGE:
Employees undergo Training
Training creates Understanding
Understanding synthesizes Information
Information becomes Knowledge
Does the knowledge become Wisdom?

ENVIRONMENT, HEALTH
& SAFETY

ENVIRONMENT

An Invisible Threat.

ENVIRONMENT
Have concerned colleagues
trained in regulatory
requirements
Have focussed, meaningful
program for Waste Reduction
Recycle, Reuse & Reduce
Have serious energy
conservation program

ENVIRONMENT

(continued)

Comply with all regulatory

guidelines with logical &
organizational understanding
Have- Ozone Depleting
Compounds (ODC)
Management system with
everyones involvement
Inspire & Encourage innovative
approach to managing

LEGAL REGISTRY
Spend good effort on preparing
& monitoring legal registry
Have a structured system in
place for getting regular
updates
Applicability of various
regulations must be discussed
& decided with user
departments

HEALTH

Robust medical surveillance

program
Robust industrial hygiene
program

HEALTH

( continued)

Meaningful program is the key

Use medical test results to design
menu in the cafeteria
Make fitness Management integral
to operations
Have specific medial tests
performed for special/specific
operations
Develop a Sickness Management
Tool similar to Accident

HEALTH - CONCERNS:
Is ergonomic assessment part of
operational monitoring?
Are function specific tests
performed?
Is Occupational Health Centre
well equipped?
Is the Ambulance included in
periodic audit program?
Is Medical Record Management
governed as per your policy?

 Occupational Hygiene

GMP & IH / OH

GMP protects product from

people
&
Industrial hygiene protects
people from product

OCCUPATIONAL HYGIENE
The practice of identifying hazardous
agents- chemical, physical and
biological; in the workplace that could
cause disease or discomfort, evaluating
the extent of the risk due to exposure
to these hazardous agents, and the
control of those risks to prevent illhealth in the long or short term.

Occupational Hygiene ?
Industrial Hygiene.?
For USA it is Industrial Hygiene
For Rest of the World it is- Occupational
Hygiene
Considering the scope- Occupational Hygiene
is more appropriate
Various offices, shops, house hold businesses
can also
have similar sensitivity.

OCCUPATIONAL HYGIENE
'Occupational Hygiene is the discipline of
anticipating, recognizing, evaluating and
controlling health hazards in the working
environment with the objective of protecting
health and well-being of the colleagues and
safeguarding the community at large.'

Under the Occupational Health and

Safety Act, occupational illness is
defined as a condition that results
from exposure in a workplace to a
physical, chemical or biological
agent to the extent that the normal
physiological mechanisms are
affected and the health of the
worker is impaired.

OCCUPATIONAL HYGIENE
Methodology:

Qualitative Exposure

Assessment( QLEA)
Quantitative Exposure
Assessment- ( QNEA)
Formulate the remediation
program for Improvements.

Qualitative Exposure
Assessment
QLEA includes:

1. Comprehensive walk through survey of the

facility
2. Interviews of employees and supervisors
3. Review of MSDS
4. Review of control measures provided.

Qualitative Exposure
Assessment
1. Health Risk Ranking / Total Risk Number is
calculated based on:
.
.
.
.
.
.
.
.

The Operation / Task involved

The time Duration and Number of employees
involved
The Physical Agent involved in the process
Specific hazard associated with the agent
Hazard Ranking for Air Born Risk and Skin
Contact Risk.
Risk of Inhalation.
Hazard for Skin Contact
Control Ranking for Skin Contact

Qualitative Exposure
Assessment
(contd.)

3 Specific Observations about the operations

need to be
captured and studied.
4 Recommendations can be prepared
5 Pictures can be used more effectively to
explain the concern to colleagues :

Isolator
Ventilated Balance
Ventilated sleeve and sifter

Detailed Monitoring Plan can be Prepared

Qualitative Exposure
Assessment
(contd.)

2.
.
.
.
.

The Risk is
Low :
Medium:
High :
Very High:

Categorized :
1- 100
101- 200
201-300
More than 300

Quantitative Exposure Assessment

For Chemicals, Noise, Heat, Vibrations, Bio
aerosols etc.
NIOSH/OSHA recommended sampling and
analytical methods must be used.
Calibrated equipment must be used
Samples- should be analyzed by an
accredited laboratory
Elaborate report along with the test results
must be prepared & studied to identify the

Occupational Hygiene -

( continued)

Results must be shared with concerned

colleagues through a structured colleague
communication program
Results must be discussed with the Medical
practitioner if needed
Engineering controls must be installed
Personal Protective Equipment ( PPE) must be
used as the last resort / in emergency

Occupational Exposure Level ( OEL)

An occupational exposure limit is an upper limit on the
acceptable concentration of a hazardous substance in
workplace air for a particular material or class of materials.
Occupational Exposure Limit values (OELs) are set by
competent national authorities or other relevant national
institutions as limits for concentrations of hazardous
compounds in workplace air.
Represent an important tool for risk assessment and
management and valuable information for occupational safety
and health activities concerning hazardous substances.

OCCUPATIONAL EXPOSURE BAND(OEB)

OEB 1:

More than 1000 micrograms/ Meter cube

OEB 2:

More than 100 micrograms/ meter cube

OEB 3:

10 to 100 micrograms / meter cube

OEB 4:

1 TO 10 micrograms/ meter cube

OEB 5 :

Less than 1 microgram / meter cube

SAFETY:

 Chhattisgarh Govt. Reported 106

people were killed in Industrial
accidents in 13 months
State witnessed 167 accidents in 12-13
Last year 157/99 killed

Major benefits of workplace safety

Improved Productivity
Cost reduction
Employee retention
Employee morale

Terminology
Process hazard
A physical situation with potential to cause
harm to people, property or the environment
Risk (acute)
probability x consequences of an undesired
event occurring

Safety Hazards
Accidents usually take place by the combination of unsafe
condition & carelessness.
Most of industrial accidents are due to:
Faulty inspection
Inability of employee
Poor discipline
Lack of concentration
Unsafe practice
Mental & physical problems of the job holder
Faulty equipment or improper working condition
Improper training regarding the safety aspects

Incident Pyramid:
1

Serious/ Disabling/ Fatalities

10

Medical Aid Case

30

Property Loss/ 1st Aid

Treatment

600

Near Misses
Unsafe Behaviors/ Conditions

10,000

A proactive approach focuses on

these categories

They thought they were safe

Good companies can
be lulled into a false
sense of security by their
performance in personal
safety and health
They may not realize
how vulnerable they are
to a major accident until
it happens
Subsequent investigations
typically show that there
were multiple causes, and
many of these were
known long before the
event

Static Electricity Controls- solvent

transfer procedure:
Provide copper cable with crocodile clip at both ends
and bond container and metal drum. Scratch
painted surface.
Use metal funnel . The end of it is touching
the drum wall

Ground drum with copper wire connected to metal strip

which is connected to earth pit

Critical Safety Programs:

Robust PPE management program

Work permit program
Electrical safety program
Ladder safety program
Construction safety program
Contractor's safety program
Process safety
Chemicals at work place program
Effective Waste Management Program
Internal auditing program
Emergency preparedness & Response program

Critical Safety Programs:

Robust PPE management program

Work permit program
Electrical safety program
Ladder safety program
Construction safety program
Contractor's safety program
Process safety

Chemicals at work place program

Effective Waste Management Program
Internal auditing program
Emergency preparedness & Response program

 CHEMICALS AT WORKPLACE

Material Safety Data Sheet [MSDS]

Do you have a good MSDS program?
Do you have inventory of all the chemicals at
the facility?
Does everyone at site understand how to read
MSDS & use the same?
Are chemicals arranged in accordance with
the requirements of Incompatible, Reactive,
Flammable, peroxide forming chemicals etc?
Are specific Antidotes available at site as
part of MSM program?
Are all colleagues including the Research
associates trained to handle MSDS in
structured manner?

Safe Chemical Handling Procedures

Use smallest volume possible
Carryout a small scale experiment to identify if heat is
liberated, or gases are produced or an unusually vigorous
reaction occurs
Use dilute reagents if possible
Know the reactivity
Provide temperature, pressure and cooling water controls
Addition of bromine in acrylonitrile exploded a 5L
flask in absence of continuous cooling

57

Safe Chemical Handling Procedures

Provide controls to warn against failure of critical
parameters such as cooling water flow and agitation
Ensure agitation if needed
During drop wise addition of PBr3 in 3phenylpropanol,
stirrer stopped; dense tribromide accumulated below
alcohol and exploded during manual shaking
Provide properly designed pressure relieving devices
Protect glassware with metal mesh screens if likely to
explode
Provide barriers and restrict entry while handling
potentially hazardous reactions
58

Safe Chemical Handling Procedures

Know incompatibility of chemicals
Never mix incompatible chemicals unless extremely
essential and adequate hazard control measures are
provided
Do not pour chemical in an empty bottle of different
chemical
Segregate waste of incompatible chemicals and ensure that
incompatible chemicals are not allowed to come in contact
with each other
Display list of incompatible chemicals conspicuously in
laboratories
59

Laboratory Accidents
A case where in, waste was accidentally
mixed at university laboratory resulting into
fire and explosion
Methylene chloride was added without
knowing incompatibility, student saw brown
smoke, capped the bottle and left
Hood and about 2000 sq feet of laboratory
area caught fire
Broken glasses of bottles hit about 10
meters radius and caused injuries

60

Laboratory Accidents
Waste bottle exploded when nitric
acid was poured in a waste bottle
that was rinsed with ethanol
A 4 L bottle of flammable liquid
broke inside fume hood. Hot plate
ignited the vapor. Other bottles in
the area broke.
Over 100 gallons of ethers, acetone
and mixed waste bottles were in the
area.
More incidents at
http://www2.umdnj.edu/eohsswe
b/aiha/accidents/topic.htm
61

 Approach to EHS

Total Safety culture!

Detect a hazard program
Have Sincere focus on EHS policy
Well executed Near Miss accident
program
Track the first aid program
Display minutes of Safety committee
meetings
Institute meaningful safety award scheme

FOR EFFECTIVE IMPLEMENTATION OF EHS

PROGRAM:
Have EHS included in induction program
Have EHS as a function reporting to higher
decision making authorities
Include EHS in objectives /KRAs
Have a meaningful EHS organization- beyond
statutory requirement

 THANKS FOR PATIENT AUDIENCE !

Questions?

GREATEST CONCERN
There is 483 for unsafe operations!
The correspondence can be fatal

 Organization can write CAPA but families can

have permanent loss & constant anxiety
(PLACA)

TANGIBLE VALUES
Cash flow, increased revenue,
increased productivity, decreased
cost, faster time to respond d to
market, operational efficiency.
INTANGIBLE VALUES
Include technical expertise,
companys reputation, employee
morale, innovation, compliance
risk etc.
Intangible values majorly support

Do You Need to Conduct Exposure

Assessment For This Scenario?

Skip exposure assessment and place exposure

controls first when exposure is obvious!

Metrics can be organised into various

operational/ financial categories.

Productivity
People
Safety [OSHA]
Assets
Quality
Total productive maintenance

Number of OSHA 200 log incidents:

Any injury or illness requiring more than firstaid (e.g prescription drugs, stitches, light duty,
lost time). Year to year comparisons should be
made through comparable time period . ( first
4 months of 2000 vs. first 4 months of 1999)

Number of OSHA lost workday

incidents:
Any injury or illness resulting in light-duty or lost time.
Year-to-year comparisons should be made through a
comparable time period. (e.g. first 4 months of 2000 vs.
first 4 months of 1999)

Number of lost workdays

When an employee is unable to perform his normal job,
whether it is due to light-duty or being off work, year-toyear comparisons should be made through comparable
time period (e.g. first 4 months of 2000 vs. first 4 months
of 1999)

Number of days off work

The employee is unable to return to work in any capacity,
year-to- year comparisons should be made through
comparable time period (e.g. first 4 months of 2000 vs.
first 4 months of 1999)

Incident rate:
Number of OSHA 200 log incidents * 200,000/Number of
hours worked

Lost workday illness/ injury rate

Number of OSHA 200 log incidents * 200,000/Number of
hours worked

Lost day rate

Number of lost workdays* 200,000/Number of hours
worked

TANGIBLE VALUES
Cash flow, increased revenue,
increased productivity, decreased
cost, faster time to respond d to
market, operational efficiency.
INTANGIBLE VALUES
Include technical expertise,
companys reputation, employee
morale, innovation, compliance
risk etc.
Intangible values majorly support

SHIFT IN STATUS
Now a days, value of EHS program
is measured / accounted, using
process improvement tools
Simple techniques like Balanced
scorecard can be structured to
enable users demonstrate
relationship between EHS &
Business Value

Madan Joshi:
Have worked with Pfizer Ltd.- an
American MNC for about 20 years.
Total experience of more than 30 years
Have been responsible for rolling out
EHS Program in compliance with
International and Local Regulatory
guidelines.
Was Managing Director of a Diversified
Business Unit of Pfizer Ltd.- an American
MNC

Wyeth