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

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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!

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Goals for This Presentation

• Make you cognizant of Red Flags

For SAFETY in your facility

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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

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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

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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

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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

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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

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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

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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 . . .

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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

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Thank You! I hope we’ve helped to expand your mind today!