PowerPoint Presentation

BUSINESS CONTINUITY THROUGH EHS COMPLIANCEAt Indian Pharmaceutical Association seminar.January 31, 2014.By: Madan Joshi, Life Science Consulting Pvt. Ltd. A CONVAL group of company

1Madan 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

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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 SUBJECTIn any organization, EHS leader has tougher time getting colleagues for meeting compared to QA

3Agenda:

EHS and Business Value

Environment

Health

Safety

General approach to EHS

4Metrics can be organised into various operational/ financial categories. ProductivityPeopleSafety [OSHA]AssetsQualityTotal productive maintenance

5BUSINESS 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.

6TANGIBLE VALUES

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

7INTANGIBLE VALUESMany 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 criticalFire Brigades readiness is critically significant

8 Environment, Health & Safety ( EHS) professionals must transform EHS into a Business Value and demonstrate EHS performance in the context of organizations business objective

EHS ActivityBusiness Value Objective Measure Of PerformanceBusiness Value ResultTrainingReduce compliance risk cost containmentIncident rate

Employees Completed % incident rate change/time% courses completed

Program DevelopmentReduce compliance risk cost containment

Injuries per # of work hours% change in lost work days/ DARTPersonal Protective EquipmentReduce compliance risk cost containment

% of employees wearing PPE during incidentCost comparison of injury with and without PPE

10Barriers 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

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

12CONCERN (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

13SHIFT IN STATUS

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

14BUSINESS VALUE

EHS Function

PROFITPRODUCTIORISKREPUTATIONCONTROL COST TIME TO MARKETTraining

Waste Reduction

Environmental Permit Compliance

Studies, Audits, Reports

Safety compliance

Remediation

Energy Efficiency

Safety Committee

Security

Pollution Prevention

Record Keeping

15SHIFT 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 SOSafety performance can play a major role in shaping organizations competitive edge and reputation

16Safety performance, EHS compliance and Robust employee hygiene program are critical to companys reputation & Business continuity

17Which 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.

18PeopleSystemsTribalChaoticOperational ExcellenceBureaucraticStrongWeakStrongOrganizational Culture Model

Weak

PeopleSystemsTribalChaoticOperational ExcellenceBureaucraticStrongWeakStrongOrganizational Culture Model

WeakBureaucratic

CHALLENGE:Employees undergo Training

Training creates Understanding

Understanding synthesizes Information

Information becomes Knowledge

Does the knowledge become Wisdom?

ENVIRONMENT, HEALTH & SAFETY

22ENVIRONMENTAn Invisible Threat.

23ENVIRONMENTHave concerned colleagues trained in regulatory requirementsHave focussed, meaningful program for Waste ReductionRecycle, Reuse & ReduceHave serious energy conservation program

24ENVIRONMENT (continued)Comply with all regulatory guidelines with logical & organizational understandingHave- Ozone Depleting Compounds (ODC) Management system with everyones involvementInspire & Encourage innovative approach to managing operationsTraining & Education play key role

25LEGAL REGISTRYSpend good effort on preparing & monitoring legal registryHave a structured system in place for getting regular updates Applicability of various regulations must be discussed & decided with user departments

26HEALTHRobust medical surveillance program

Robust industrial hygiene program

27HEALTH ( continued)Meaningful program is the keyUse medical test results to design menu in the cafeteria Make fitness Management integral to operationsHave specific medial tests performed for special/specific operationsDevelop a Sickness Management Tool similar to Accident Management ToolMake a Business Case

28HEALTH - 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?

29Occupational Hygiene

GMP & IH / OHGMP protects product from people

&Industrial hygiene protects people from product

31OCCUPATIONAL HYGIENEThe 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.

32Occupational 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.

33OCCUPATIONAL 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.'

34Under 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.

35OCCUPATIONAL HYGIENEMethodology:Qualitative Exposure Assessment- ( QLEA)Quantitative Exposure Assessment- ( QNEA)

Formulate the remediation program for Improvements.

36Qualitative Exposure AssessmentQLEA includes:

Comprehensive walk through survey of the facility

2. Interviews of employees and supervisors

3. Review of MSDS

4. Review of control measures provided.

37Qualitative Exposure Assessment Health Risk Ranking / Total Risk Number is calculated based on:

The Operation / Task involvedThe time Duration and Number of employees involvedThe Physical Agent involved in the processSpecific hazard associated with the agentHazard Ranking for Air Born Risk and Skin Contact Risk.Risk of Inhalation.Hazard for Skin ContactControl Ranking for Skin Contact

38Qualitative 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 sifterDetailed Monitoring Plan can be Prepared

39Qualitative Exposure Assessment (contd.)The Risk is Categorized :Low : 1- 100Medium: 101- 200High : 201-300Very High: More than 300

40Quantitative Exposure AssessmentFor 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

41Occupational 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)Anoccupational exposure limitis an upper limit on the acceptableconcentrationof a hazardous substance in workplaceairfor 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.

43OCCUPATIONAL 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

44SAFETY:

Chhattisgarh Govt. Reported 106 people were killed in Industrial accidents in 13 monthsState witnessed 167 accidents in 12-13Last year 157/99 killed

46Major benefits of workplace safetyImproved Productivity

Cost reduction

Employee retention

Employee morale

47Terminology Process hazardA 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

A proactive approach focuses on these categories

50They thought they were safeGood companies can be lulled into a false sense of security by their performance in personal safety and healthThey may not realize how vulnerable they are to a major accident until it happensSubsequent 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 pitUse 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 programWork permit programElectrical safety programLadder safety programConstruction safety programContractor's safety programProcess safetyChemicals at work place programEffective Waste Management ProgramInternal auditing programEmergency preparedness & Response program

53Critical Safety Programs:Robust PPE management programWork permit programElectrical safety programLadder safety programConstruction safety programContractor's safety programProcess safetyChemicals at work place programEffective Waste Management ProgramInternal auditing programEmergency preparedness & Response program

54CHEMICALS 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?

56Safe Chemical Handling ProceduresUse smallest volume possibleCarryout a small scale experiment to identify if heat is liberated, or gases are produced or an unusually vigorous reaction occursUse dilute reagents if possibleKnow the reactivityProvide temperature, pressure and cooling water controlsAddition of bromine in acrylonitrile exploded a 5L flask in absence of continuous cooling

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Safe Chemical Handling ProceduresProvide controls to warn against failure of critical parameters such as cooling water flow and agitationEnsure agitation if neededDuring drop wise addition of PBr3 in 3phenylpropanol, stirrer stopped; dense tribromide accumulated below alcohol and exploded during manual shaking Provide properly designed pressure relieving devicesProtect glassware with metal mesh screens if likely to explodeProvide barriers and restrict entry while handling potentially hazardous reactions

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Safe Chemical Handling ProceduresKnow incompatibility of chemicalsNever mix incompatible chemicals unless extremely essential and adequate hazard control measures are providedDo not pour chemical in an empty bottle of different chemicalSegregate waste of incompatible chemicals and ensure that incompatible chemicals are not allowed to come in contact with each otherDisplay list of incompatible chemicals conspicuously in laboratories

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Laboratory AccidentsA case where in, waste was accidentally mixed at university laboratory resulting into fire and explosionMethylene chloride was added without knowing incompatibility, student saw brown smoke, capped the bottle and leftHood and about 2000 sq feet of laboratory area caught fireBroken glasses of bottles hit about 10 meters radius and caused injuries

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Laboratory AccidentsWaste bottle exploded when nitric acid was poured in a waste bottle that was rinsed with ethanolA 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

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Approach to EHS

Total Safety culture!Detect a hazard programHave Sincere focus on EHS policyWell executed Near Miss accident programTrack the first aid programDisplay minutes of Safety committee meetings Institute meaningful safety award scheme

63FOR EFFECTIVE IMPLEMENTATION OF EHS PROGRAM:Have EHS included in induction programHave EHS as a function reporting to higher decision making authoritiesInclude EHS in objectives /KRAsHave a meaningful EHS organization- beyond statutory requirement

64THANKS FOR PATIENT AUDIENCE ! Questions?

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

67Organization can write CAPA but families can have permanent loss & constant anxiety (PLACA)

68TANGIBLE VALUES

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

69Do 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. ProductivityPeopleSafety [OSHA]AssetsQualityTotal productive maintenance

71Number 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)

72Number 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)

73Number of lost workdaysWhen 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)

74Number of days off workThe 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)

75Incident rate:Number of OSHA 200 log incidents * 200,000/Number of hours worked

76Lost workday illness/ injury rateNumber of OSHA 200 log incidents * 200,000/Number of hours worked

77Lost day rateNumber of lost workdays* 200,000/Number of hours worked

78TANGIBLE VALUES

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

79SHIFT IN STATUS

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

80

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

82Wyeth

Serious/Disabling/Fatalities

Medical Aid Case

Property Loss/1st Aid Treatment

Near Misses

Unsafe Behaviors/Conditions
Incident Pyramid:
1
30
10
600
10,000