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 organization’s
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, company’s
reputation, employee morale,
innovation, compliance risk etc.
• Intangible values majorly support
tangible value network.
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 Brigade’s readiness is critically
significant
Environment, Health & Safety ( EHS)
professionals must transform EHS into a
Business Value and demonstrate EHS
performance in the context of
organization’s 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 Organization’s
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 not
happen in family
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 organization’s competitive
edge and reputation
• “Safety performance”, “EHS
compliance” and “Robust
employee hygiene program” are
critical to company’s 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 everyone’s involvement
• Inspire & Encourage innovative
approach to managing operations
• Training & Education play key role
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 Management Tool”
• Make a “Business Case”
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 agentschemical, 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
and sifter
Ventilated Balance
Ventilated sleeve
•
Detailed Monitoring Plan can be Prepared
Qualitative Exposure
Assessment
(contd.)
2.
•
•
•
•
The Risk is Categorized :
Low :
1- 100
Medium: 101- 200
High :
201-300
Very High: 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 “way forward”
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, company’s
reputation, employee morale,
innovation, compliance risk etc.
• Intangible values majorly support
tangible value network.
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 first-aid (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, company’s
reputation, employee morale,
innovation, compliance risk etc.
• Intangible values majorly support
tangible value network.
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