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    For Construction at Your Pharmaceutical Facility Training by Torcon, Inc. For Construction at Your Pharmaceutical Facility Training by Torcon, Inc. Presentation Transcript

    • NJ ISPE 2009 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: 1. Random inspections 2. Programmed inspections  For critical or at-risk industries
    • 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
    • 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!