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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.

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business continuity through ehs compliance
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
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
slide3
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
Agenda:
  • EHS and Business Value
  • Environment
  • Health
  • Safety
  • General approach to EHS
metrics can be organised into various operational financial categories
Metrics can be organised into various operational/ financial categories.
  • Productivity
  • People
  • Safety [OSHA]
  • Assets
  • Quality
  • Total productive maintenance
business value
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
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
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
slide9

Environment, Health & Safety ( EHS)

professionals must transform EHS into a

Business Value and demonstrate EHS

performance in the context of organization’s business objective

barriers to ehs as a business value
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
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
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
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
shift in status continued
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
slide17

“Safety performance”, “EHS compliance” and “Robust employee hygiene program” are critical to company’s reputation & “Business continuity”

which intervention can ensure this
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.
slide19

Organizational Culture Model

Strong

Tribal

Operational Excellence

People

Chaotic

Bureaucratic

Weak

Weak

Strong

Systems

slide20

Organizational Culture Model

Strong

Tribal

Operational Excellence

People

Bureaucratic

Chaotic

Bureaucratic

Weak

Weak

Strong

Systems

challenge
CHALLENGE:
  • Employees undergo Training
  • Training creates “ Understanding”
  • Understanding synthesizes “Information”
  • Information becomes “ Knowledge”
  • Does the knowledge become “ Wisdom”?
environment
ENVIRONMENT
  • An Invisible Threat……….
environment1
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
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
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
HEALTH
  • Robust medical surveillance program
  • Robust industrial hygiene program
health continued
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
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?
gmp ih oh
GMP & IH / OH
  • GMP protects product from people

&

  • Industrial hygiene protects people from product
occupational hygiene
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 ill-health in the long or short term.
occupational hygiene industrial hygiene
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 hygiene1
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.\'
slide35

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 hygiene2
OCCUPATIONAL HYGIENE

Methodology:

  • Qualitative Exposure Assessment-

( QLEA)

  • Quantitative Exposure Assessment- ( QNEA)
  • Formulate the remediation program for Improvements.
qualitative exposure assessment
Qualitative Exposure Assessment

QLEA includes:

  • 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 assessment1
Qualitative Exposure Assessment
  • 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
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 contd1
Qualitative Exposure Assessment (contd.)
  • The Risk is Categorized :
  • Low : 1- 100
  • Medium: 101- 200
  • High : 201-300
  • Very High: More than 300
quantitative exposure assessment
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
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
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
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
slide46

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
Major benefits of workplace safety
  • Improved Productivity
  • Cost reduction
  • Employee retention
  • Employee morale
terminology
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
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

they thought they were safe
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
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
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 programs1
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
material safety data sheet msds
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
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
safe chemical handling procedures1
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
safe chemical handling procedures2
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
laboratory accidents
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
laboratory accidents1
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/eohssweb/aiha/accidents/topic.htm
total safety culture
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
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
greatest concern
GREATEST CONCERN
  • There is “483” for unsafe operations!
  • The correspondence can be “fatal”
slide68

Organization can write “CAPA” but families can have permanent loss & constant anxiety (PLACA)

tangible values1
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
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 categories1
Metrics can be organised into various operational/ financial categories.
  • Productivity
  • People
  • Safety [OSHA]
  • Assets
  • Quality
  • Total productive maintenance
number of osha 200 log incidents
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
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
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-to- year 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
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
Incident rate:
  • Number of OSHA 200 log incidents * 200,000/Number of hours worked
lost workday illness injury rate
Lost workday illness/ injury rate
  • Number of OSHA 200 log incidents * 200,000/Number of hours worked
lost day rate
Lost day rate
  • Number of lost workdays* 200,000/Number of hours worked
tangible values2
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 status1
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 joshi1
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
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