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OSHA Red Flags for Safety. For Construction at YOUR Pharmaceutical Facility Tom Moon, MS Safety Manager, Torcon, Inc. The Pharma Industry is Very REGIMENTED. FDA Regulations – 21 CFR 210 and 211 Federal and State Environmental Regs OSHA Safety Standards – 29 CFR 1910
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OSHA Red Flags for Safety For Construction at YOUR Pharmaceutical Facility Tom Moon, MS Safety Manager, Torcon, Inc. 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 company’s internal protocols and SOP’s – Usually MASSIVE NJ ISPE 2009
In this maze of detailed procedures, It’s easy to miss the FOREST for the TREES NJ ISPE 2009
Compartmentalized Thinking Keep SAFETY IN MIND! NJ ISPE 2009
Goals for This Presentation • Make you cognizant of Red Flags For SAFETY in your facility 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 NJ ISPE 2009
About 700 Pharma Facilities have been Inspected by OSHA Since 2000 Inspections occur for three reasons: • Random inspections • Programmed inspections • For critical or at-risk industries NJ ISPE 2009
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 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 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 NJ ISPE 2009
The OSHA Red Flags come in two types • Specific Construction Activities • Failure to do Due Diligence in Safety Procedures during Construction NJ ISPE 2009
Fall Protection NJ ISPE 2009
The Last Lunch Time NJ ISPE 2009
Motor Vehicle Accidents • #1 Cause of Fatalities in ALL Industries • # 3 Cause in Construction 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 NJ ISPE 2009
Crane Lifts NJ ISPE 2009
Crane Lifts NJ ISPE 2009
Tie-In’s to Existing Systems • Lockout/Tagout Program • Coordination of Shutdowns • Pre-job meetings to clarify procedures • Direct communication from construction foremen to owner’s facilities/operations personnel • Incident of The Unopened Email NJ ISPE 2009
Safety Training of Contractors 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 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 NJ ISPE 2009
Spill Reporting and Cleanup • Written procedures for timely reporting and remediation of hazardous material releases – for contractors • Your company’s reputation as a good corporate citizen with government agencies and the public - if you lose it, you can’t get it back The common theme of many of these critical issues is . . . 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 NJ ISPE 2009
Thank You! I hope we’ve helped to expand your mind today! NJ ISPE 2009