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 company’s internal protocols and
SOP’s – Usually MASSIVE

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

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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

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The OSHA Red Flags
come in two types
•Specific Construction Activities
•Failure to do Due Diligence in
Safety Procedures during
Construction

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Fall Protection

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The Last Lunch Time

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Motor Vehicle Accidents
• #1 Cause of Fatalities in ALL Industries
• # 3 Cause in
Construction

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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

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Crane Lifts

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Crane Lifts

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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

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Safety Training of Contractors

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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 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 . . .

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 we’ve helped
to expand your mind today!