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→

EHS Function↓

PROFIT PRODUCTIO RISK REPUTATION CONTROL COST TIME TO MARKET

Training × × × ×

Waste Reduction × × × × ×

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.

People

Systems

Tribal

Chaotic

Operational Excellence

Bureaucratic

Strong

Weak Strong

Organizational Culture Model

Weak

People

Systems

Tribal

Chaotic

Operational Excellence

Bureaucratic

Strong

Weak Strong

Organizational Culture Model

WeakBureaucratic

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 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.?

• 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 HYGIENEMethodology:

• 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 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

Serious/ Disabling/ Fatalities

Medical Aid Case

Property Loss/ 1st AidTreatment

Near Misses

Unsafe Behaviors/ Conditions

Incident Pyramid:

1

30

10

600

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:

Ground drum with copper wire connected to metal strip which is connected to earth pit

Use metal funnel . The end of it is touching the drum wall

Provide copper cable with crocodile clip at both ends and bond container and metal drum. Scratch painted surface.

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/eohssweb/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-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

• 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