1. NJ ISPE 2009 OSHA Red Flags for Safety For Construction at YOUR Pharmaceutical Facility Tom Moon, MS Safety Manager, Torcon, Inc.

2. NJ ISPE 2009 The Pharma Industry is Very REGIMENTED FDA Regulations – 21 CFR 210 and 211 Federal and State Environmental Regs OSHA Safety Standards – 29 CFR 1910 Your companys internal protocols and SOPs – Usually MASSIVE

3. NJ ISPE 2009 In this maze of detailed procedures, Its easy to miss the FOREST for the TREES

4. NJ ISPE 2009 Compartmentalized Thinking Keep SAFETY IN MIND!

5. NJ ISPE 2009 Goals for This Presentation Make you cognizant of Red Flags For SAFETY in your facility

6. NJ ISPE 2009 Ignoring these Red Flags can cost your company... Cause injuries to people you work with Cost people their lives or careers Cause shutdowns, wasted or adulterated product OSHA Violations and fines Bad Publicity for your organization

7. NJ ISPE 2009 About 700 Pharma Facilities have been Inspected by OSHA Since 2000 Inspections occur for three reasons: 1. Random inspections 2. Programmed inspections For critical or at-risk industries

8. NJ ISPE 2009 3. OSHA Inspections can be generated from your operations by... Serious employee injuries or fatalities Complaint of a serious hazard from an employee or member of the public Referral from DEP, Local Government agency, or interest group

9. NJ ISPE 2009 Pharma has a lot of hazards For FY 2008, of the top 20 most cited types of OSHA Violations... 18 of the top 20 violations can occur in a pharmaceutical research lab or manufacturing plant Laboratories Manufacturing Lines Maintenance Facilities Vehicles

10. NJ ISPE 2009 Construction is hazardous, too Of the top ten most cited violations by OSHA in FY 2008: Five of the top ten occur in Both CONSTRUCTION and PHARMACEUTICAL OPERATIONS

11. NJ ISPE 2009 The OSHA Red Flags come in two types Specific Construction Activities Failure to do Due Diligence in Safety Procedures during Construction

12. NJ ISPE 2009 Fall Protection

13. NJ ISPE 2009 The Last Lunch Time

14. NJ ISPE 2009 Motor Vehicle Accidents #1 Cause of Fatalities in ALL Industries # 3 Cause in Construction

15. NJ ISPE 2009 Preventing Vehicle Accidents Pharma Company in 5 years cut vehicle accident costs in half with: Extensive training of newer drivers (most crashes during first 5 years driving) Graduated warnings/disciplinary actions for minor infractions Periodic retraining of drivers, esp. following any minor incident

16. NJ ISPE 2009 Crane Lifts

17. NJ ISPE 2009 Crane Lifts

18. NJ ISPE 2009 Tie-Ins to Existing Systems Lockout/Tagout Program Coordination of Shutdowns Pre-job meetings to clarify procedures Direct communication from construction foremen to owners facilities/operations personnel Incident of The Unopened Email

19. NJ ISPE 2009 Safety Training of Contractors

20. NJ ISPE 2009 Exposure of Plant Employees to Construction Hazards Notify your employees of construction in their areas Barricade and place clear signage around hazardous construction activities Discipline employees that ignore barricades

21. NJ ISPE 2009 Process Safety Management: Integrate Construction Activities into Your Existing PSM Program OSHA Concern: Are contractors doing the work qualified to work on systems? Include the general contactor in your design review and subsequent Haz/Ops reviews Keep your construction contractors in the loop of your PSM activities and info

22. NJ ISPE 2009 Spill Reporting and Cleanup Written procedures for timely reporting and remediation of hazardous material releases – for contractors Your companys reputation as a good corporate citizen with government agencies and the public - if you lose it, you cant get it back The common theme of many of these critical issues is...

23. NJ ISPE 2009 Communication between Facility Owners and Contractors Is the key to safety coordination of dangerous construction activities Keeps your workers safe Helps prevent injuries and major incidents that come across as RED FLAGS to OSHA

24. NJ ISPE 2009 Thank You! I hope weve helped to expand your mind today!