BUSINESS CONTINUITY THROUGH EHS COMPLIANCE

1. 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

2. 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

3. 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

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

5. Metrics can be organised into various operational/ financial categories. • Productivity • People • Safety [OSHA] • Assets • Quality • Total productive maintenance

6. 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.

7. 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.

8. 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

9. Environment, Health & Safety ( EHS) professionals must transform EHS into a Business Value and demonstrate EHS performance in the context of organization’s business objective

11. 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

12. 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

13. 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

14. 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

16. 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

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

18. 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.

19. Organizational Culture Model Strong Tribal Operational Excellence People Chaotic Bureaucratic Weak Weak Strong Systems

20. Organizational Culture Model Strong Tribal Operational Excellence People Bureaucratic Chaotic Bureaucratic Weak Weak Strong Systems

21. CHALLENGE: • Employees undergo Training • Training creates “ Understanding” • Understanding synthesizes “Information” • Information becomes “ Knowledge” • Does the knowledge become “ Wisdom”?

22. ENVIRONMENT, HEALTH & SAFETY

23. ENVIRONMENT • An Invisible Threat……….

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

25. 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

26. 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

27. HEALTH • Robust medical surveillance program • Robust industrial hygiene program

28. 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”

29. 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?

30. Occupational Hygiene

31. GMP & IH / OH • GMP protects product from people & • Industrial hygiene protects people from product

32. 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.

33. 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.

34. 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.'

35. 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.

36. OCCUPATIONAL HYGIENE Methodology: • Qualitative Exposure Assessment- ( QLEA) • Quantitative Exposure Assessment- ( QNEA) • Formulate the remediation program for Improvements.

37. 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.

38. 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

39. 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

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

41. 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”

42. 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

43. 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.

44. 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

45. SAFETY:

46. 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

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

48. 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

49. 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

50. A “proactive” approach focuses on these categories