Safety, Health and Environmental

Merck & Co. Inc.

Safety, Health and Environmental

Plan

Global Engineering Services (GES) PROJECTS

SEUS REGION

Durham, NC - Cleveland, TN

Elkton, VA - Charlotte, NC

Wilson, NC - Miami Lakes, FL

Memphis, TN

(Revision 12 - 04Nov 14)

Prepared by: / Fred Hammonds
(SEUS Region Safety Manager)
Name / Signature / Date
Reviewed by: / Chris Dummermuth
(GES Safety Director)
Name / Signature / Date
Reviewed by: / Ed Wittig
(SEUS Regional Director)
Name / Signature / Date

1.0Introduction

1.1Scope
1.2Project Safety Objectives
1.2.1Compliance with Statutory Regulations
1.2.2Conformance to Merck Standards and Safety Program Requirements
1.2.3Statistical Safety Performance
1.3Responsibilities
2.0Planning
2.1Legal Requirements
2.1.1Federal and State Requirements
2.2Job Safety Analysis Program
2.3Construction Requirements
2.3.1Qualification of Contractors

Statistical Limits
Past Performance Evaluation
Safety Program and Organization
Contractor Pre-mobilization (Bid Selection Process)
Contractors in Construction Phase

3.0Implementation and Operation
3.1Responsibility and Authority to Act
3.1.1Merck Personnel

Project Manager
Procurement Representative
Project Engineers
Merck Construction Safety Manager
Contractor Personnel

Main Contractor
Contractors/Subcontractors
Competency and Training
Contractor/subcontractor Safety Professional’s Qualifications
Operator Qualifications
Minimum Contractor Training requirements
Monthly Training
Communication
Meeting Communication
Document Control
Project Safety Record Management
Monthly Reports
Material Safety Data Sheets (MSDS)
Operational Control
Alcoholic Beverages and Drugs
Asbestos
Barricades
Cable Management
Compressed Gas Cylinders
Drinking Water
Eating
Emergency Response Plan (ERP)
Equipment Use and Inspection
Fire Prevention
Hazardous Work Permits and Practices
Hearing Protection
Housekeeping
Lighting
Manual Handling Practices
Medical Management
Personal Identification
Personal Protective Equipment (PPE)
Removal of Material, Exit Passes
Vehicle and Road Safety
Cell Phones
Safety Observation Report (SOR)
Prohibited Equipment and Practices
Environmental Planning
Environmental Considerations

4.0Checking and Corrective Action
4.1Monitoring Work Environment
4.1.1Inspections
4.1.2Project Completion
4.2Reporting and Correcting Deficiencies
4.2.1Accidents
4.2.2Incident Trending
4.2.3Global Engineering Services/ Accident Recording Procedure 7.3
4.2.4Discipline and Dismissal
4.3OHS Auditing
4.4Contractor/subcontractor Incentives
5.0Acknowledgement Signature
6.0Reference Documents
ATTACHMENTS
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1.0Introduction

Construction work provides unique environmental and safety challenges. This procedure applies to all areas of any GES/SEUS Region Project Sites and describes the safety requirements that must be adhered to by all contractors/subcontractors and their employees in order to reduce the safety and security risks associated with construction.

1.1Scope

This document is created to outline the minimum safety and environmental standards for all activities carried out during design, construction and commissioning of the Project facility. This document applies to Contractors contracted directly to Merck (referred to as the Main Contractors), their subcontractors, vendors, and visitors that work in any area of the Merck facility. Within this document, when referring to everyone collectively on site, the term “all personnel” will be used. When referring to the Subcontractors and Vendors collectively the term “Subcontractors” will be used.

1.2Project Safety Objectives

1.2.1Compliance with Statutory Regulations

All personnel will be managed to ensure full compliance with all statutory and local regulations, codes and standards. The goal of ALL GES Projects is to achieve a record of zero accidents and/or regulatory notices, or similar actions by government enforcement agencies.

1.2.2Conformance to Merck Standards and Safety Program Requirements

All personnel will be managed to ensure conformance with Merck Safety Program Requirements. Minimum requirements are outlined in this document.

1.2.3Statistical Safety Performance

All personnel will be managed to eliminate the potential for serious and recordable injuries. Overall safety statistics are targeted to achieve or improve upon the previous year’s safety record. Refer to the Merck Global Engineering ServicesProject Engineer for the current year’s statistics.

1.3Responsibilities

Contractors working on GES Projects are accountable for safety performance and are responsible for implementing the Project Safety requirements as outlined in this document. The performance of each organization will be measured against the metrics identified in section 1.2.3 and performance against the plan.

Contractors are required to provide a commitment statement recognizing that the particular contractors or vendor will implement the Safety, Health and Environmental Plan (SHE) requirements associated with this plan.

2.0 Planning

2.1Legal Requirements

2.1.1Federal and State Legal Requirements

At a minimum, all Contractors are expected to fully comply with applicable OSHA Standards, both Constructions, 1926, and General Industry, 1910, while working on the project site.

A method of handling OSHA inspectors must be determined and a procedure developed with reference to GES program Standard 7.2 (Guidelines for Handling OSHA Inspections), this will be lead by the Merck project team. Contractors will be expected to adhere to the requirements.

2.2Construction Hazard Analysis (CHA)

A Construction Hazard Analysis (CHA) is a review of the work method of a particular task in order to identify and mitigate all potential hazards. This is conducted during the planning stage of a particular work task.

The CHA program is administered by the Merck Construction Safety Manager. Each CHA is prepared by individual contractors/subcontractors and submitted for review to the Main Contractor. Guidelines for administering this program are to be kept with each contractor. Merck involvement in this program is primarily for review and comment of CHA content only. Work cannot proceed in the field if it is not associated with a completed CHA (Refer to GESPractice 7.9: Project Hazard Analysis and Job Safety Analysis).

2.3Construction Requirements

2.3.1Qualification of Contractors

Prior to being allowed to bid on a job, a contractor must qualify based on guidelines established by Merck & Co., Inc. With regard to safety, these guidelines require documentation of a contractor’s historical safety performance and a detailed review of a contractor’s written safety program and safety management practices. Key areas for qualification of contractors are explained below.

a.Statistical Limits

Subcontractors must provide detailed statistical information from their OSHA 300 logs for the most recent three years, as well as their Worker’s Compensation Insurance Experience Modification Rates (EMRs). Small subcontractors (less than 10 employees) who may not have a detailed statistical history such as the OSHA 300 log may provide historical data in some other form.

It is recognized that there may be some variability in the recording of OSHA related injuries by contractors. As such, the Experience Modification Rate (EMR) will be given more weight with regard to statistical qualification. A contractor with an EMR below 1.00 will be allowed to bid on Merck jobs. If the contractor’s EMR is above 1.00, but below 1.25, bidding is allowed on Merck projects provided that the OSHA Recordable Incidence Rate and OSHA Lost Work Day Case Rate are below 125% of the national averages, and that both the EMR and OSHA rates show an improving trend over the last three years.

A subcontractor not meeting the statistical limits or in cases where no statistical limits can be calculated, may submit a written action plan as to how their organization plans to maintain a high level of safety performance. That plan must be reviewed and approved by the Merck Project Team.

Past Performance Evaluation

Safety Performance Evaluations from any previous Merck & Co., Inc. projects are taken into prime consideration. A contractor with injury incidence rates at or below the national averages will be considered to have had acceptable safety performance unless otherwise noted by the Merck representative. A contractor with a previously unsatisfactory safety performance may submit an improvement plan to the Merck Construction Safety Manager and the Procurement Representative.

Safety Program and Organization

Each contractor must submit a copy of their safety program. The program will be reviewed by the Merck Construction Safety Manager to determine the emphasis the contractor places on safety. The program should address all topics as identified in this document with an emphasis on management commitment and safety philosophy. An evaluation of the written program is part of the selection criteria and any changes in the program, subsequent to evaluation shall be submitted to Merck & Co., Inc. for review and concurrence prior to implementation.

2.3.2Contractor Pre-mobilization

In order to ensure full contractor compliance with all general or special GES Project Safety Regulations, the following procedures should be followed.

a. Bid Selection Process

The Procurement Representative will include this document with all instructions to bidders for all construction contracts. In addition to this document, “Safety Health and Environmental Plan” a copy of the “Program Requirements for Contractor Substance Abuse Control” will be distributed.
Prior to the start of any major construction projects, the Project Engineers will arrange a meeting for contractor representatives. At this meeting, specific safety and work practices will be reviewed. Appropriate representatives from both Safety Management and Global Capital Procurement will attend this meeting along with representatives of any known subcontractors. Procedures should be established by the Merck Construction Safety Manager to ensure that any contractors coming on the job subsequently will receive the same instructions as are issued at the original meeting.
During this meeting, the last page of this document must be signed by an authorized representative of the Contractor and also by the Project Engineers. This signed document shall be maintained as part of the project file, with a copy routed to the Merck Construction Safety Manager.
As part of the bid selection the Contractor must include their Company’s Safety Management System. This System must be approved before the contractor can begin work on site.
All contract personnel entering the plant for the first time, or who have not been on site in the previous 6 months, are required to have passed a Pre-employment/Pre-Access alcohol and drug test within the immediately preceding 30 days, and receive a safety orientation outlining all guidelines and/or rules to be followed, as well as an orientation to current Good Manufacturing Practices (cGMPs). The orientation to cGMPs is to be conducted following the site Orientation. Re-orientation will be required for all contract employees every 12 months.

2.3.3Contractors in Construction Phase

Throughout the construction phase, the Contractor is expected to execute both the Project SHE plan and their company’s Safety Management System submitted during the qualification process. The company’s Safety Management System should include, but not be limited to, the minimum requirements of this plan.

2.3.4C&Q Phase of Projects

Each project needs to develop/modifiy their current C&Q Safety Plan prior to starting activities. (See current attached C&Q Safety Plan per GES practice 7.12)

3.0 Implementation and Operation

3.1 Responsibility and Authority to Act

3.1.1Merck Personnel

The establishment and enforcement of approved safety practices is the responsibility of the Merck Project Manager through designated management staff.

Enforcement and corrective action with contractor personnel will normally be carried out through the Project Safety Manager or the Merck Project Engineers incharge of the work.

a.Merck Project Manager: this positionis ultimately responsible for enforcing adherence to proper safety practices by outside contractors’ employees on site and as such can authorize periodic inspections to ensure the Merck Project Engineers are properly administering safety procedures. They are also responsible for providing both non-resident personnel and visitors with orientation instructions at the beginning of each new project. The Project Manager will have the right, and the responsibility, to observe and stop work until any/all safety violation(s) are corrected.

b.Merck Procurement Representative: this position is responsible to ensure that this document is included in all bidders and construction contracts. The Procurement Representative represents Global Capital Procurement in the field.

c.Merck Project Engineers: shall be familiar with site safety rules and procedures, and is responsible for:

Being the “Owner’s authorized field representative” and chief liaison agent in the field with the contractors.
To support the Merck Project Manager on all Safety issues.
Ensuring contractor compliance with the project safety plan.
Auditing the job site periodically to ensure compliance with governmental, corporate, and site safety rules and regulations and document findings.
Ensuring ongoing safety training by the main contractor for their employees and sub-contractors.
Participating with contractor personnel in the joint investigation of all recordable injuries, fires, near misses, or other incidents as appropriate, and documenting the incident in the project file.
Has the right, and the responsibility, to observe and stop work until any/all safety violation(s) are corrected.

d.Merck/ProgramConstruction Safety Manager: The Merck Construction Safety Manager is to assist the Merck Project Manager with ensuring compliance to the SHE Plan. The Merck Construction Safety Manager or all staff will have the right, and the responsibility, to observe and stop work until any/all safety violation(s) are corrected. They will also act to correct clear abuse of safety regulations when such abuse impacts upon site safety attitude or performance. Their role is to support the Merck Project Manager on all Safety issues. The direct responsibility for the safety of each contractor employee lies with the main contractor.

e.GES Regional Safety Director. Responsible to the GES Regional Project Manager and the GES Global Safety Manager.

f.GES Construction Safety Manager: Is responsible for the implementation of the GES Safety Program at all Merck GES Sites.

3.1.2Contractor Personnel

Main Contractors/CM's: It is the responsibility of the main contractor/CM to comply with the provisions of this SHE Plan and the specific details of any document it references. For the purpose of this document, Main Contractors/CM referr to those companies that have direct contact with Merck and involves supervision of people in the field. The Main Contractors must ensure that all subcontractors comply with the SHE Plan/Safety Management System.

The Main Contractors/CM Safety Plan must indicate the Safety and Environmental Responsibilities of the following staff (at a minimum):

Main Contractor Director
Construction Management
Contractor Project Safety Manager
Construction Supervision
Workers

Contractors/Subcontractors: The term subcontractors represent the following groups.

Merck requires that the Main Contractor/CM, have at least one full time Safety Supervisor on site at all times while work is taking place.
Safety Staff required per worker:
The ratio is one (1) non-craft / non-supervisor Safety Supervisor for every 15 – 50 workers and adding a second Safety Supervisor at 51- 100 and so on, thereafter. We reserve the right to request a safety officer for high risk jobs (i.e. structural steel erection, rigging, excavation, etc…).
It is the CM's responsibility to impose these same standards on their subcontractor's!
Vendors: Vendors who enter the site and are required to use tools to perform their function, must attend the mandatory Orientation and any other training necessary for them to work in a specific area. Vendors who are on site for less than 1 day may perform their task without attending attending orientation but must be escorted at all times. They must however adhere to the current Drug & Alcohol policies requirements.

3.2Competency and Training

Contractors/subcontractors must provide training to the workers and supervisory/ management staff on site to ensure understanding of relevant site rules and procedures, statutory requirements and site-specific instruction. Contractors are required to plan training at least one month in advance. Details of training programs for the upcoming month must be submitted to the Project Safety Manager, with a copy to the Merck Construction Safety Manager and incorporated into the previous months “Main Contractor Monthly Report.”

The Main Contractor is expected to monitor training programs by spot check attendance to ensure satisfactory quality of training is present. Records of training attendance must be kept by the Main Contractor and an assessment made to ensure adequate contractor attendance.

3.2.1Contractor/Subcontractor Safety Professionals Qualifications:

Minimum experience and training for the Contractor Safety Professionals is as follows:

OSHA 500 series crs
First Aid Training
CPR Training
All site required training and cGMP
3-5 yrs field experience (this could be a combination of craft/safety field experience)
Must submit a resume for review and approval by the Regional Safety Director or his designee.

3.2.2Operator Qualifications:

Contractor Safety Professionals must maintain a record of all Operator qualifications of the following:

Crane Operators (must be NCCO certified), Riggers and Signalmen.
Forklift Operator
Boom Lift Operators
Scissor Lift Operators
Scaffold Supervisors and Scaffold erectors
Competent Person Training

3.2.3Minimum Contractor Training requirements are:

Orientation (for every employee (aprox 2-3 hrs)) – This training for the site must be completed prior to commencing work. Main Contractor must keep records of all personnel attending the orientation training. Once this training is complete, the employee will receive a Badge/sticker that must be on their person/displayed on their individual hard hat at all times. Merck will track individuals who have received orientation training.
Area Specific training – This training will occur during orientation and any specific training required will be administered by the Main Contractor.
cGMP training (if required)
Lockout/ Tag Out (if required)
Daily review of the JSAs before work tasks.
Environmental Awareness Training
Tool Box Talks (weekly safety meetings) – These are to be conducted at least once per week for each of the subcontractors working on the project. The Main Contractor will be expected to provide guidance and evaluate the performance of the training. At these meetings, the participant’s names and subject discussed should be documented.
All contractor personnel at a minimum must have completed an OSHA 10 hr crs within the past 5 years.
All contractor Supervision at a minimum must have completed an OSHA 30 hr or equilavant within the past 5 years.

3.2.4 Monthly Training