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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
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
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
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
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