Commissioning and Qualification Safety Plan
Date: DD MM YYYY Project: XXXXXXXXXXXXXX
Prepared By: GES Project Manager
Signature: / Date:
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Signature of primary author of document.
Approved By: Global Engineering Services Safety
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Approval signature represents document use authorization.
Approved By: CONSTRUCTION MANAGER
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Approved By: Contractor
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Approved By: Site S&E or GSE
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Approved By: Site Management (Operations/Engineering/Administration)
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Revision History
Revision No. / Date / Description
A / MM DD YYYY / Issued for Review
0.0 / MM DD YYYY / Issued for Approval
Table of Contents
1.0 Introduction 5
2.0 Scope 5
3.0 definitions 5
4.0 Roles and Responsibilities 5
5.0 Plan 5
5.1 hierarchy of safety plan 6
5.2 Project Hazard Analysis 6
5.3 Job Safety Analysis 7
5.4 Safety Task Assignment (STA) 8
5.5 Work Permit 9
5.6 Equipment Pre-Energizing Safety CHECKLIST (EESC) 11
5.7 Pre Start-Up Safety & Environmental Review (PSSER) 11
5.8 General Guidelines 11
5.9 System Safety Inspections 12
5.9.1 Equipment Safety Inspections (ESI) 12
5.9.2 Electrical Safety Procedure 12
5.9.3 Additional Checklist 12
5.9.4 Safety Walkdown 13
5.10 Equipment installation end-to-end process 13
6.0 Attachments 14
6.1 Project Hazards Analysis (PHA) and Job Safety Analysis (JSA) 14
6.2 Safety Task Assignment (STA) 14
6.3 Equipment Pre-Energizing Safety Checklist 14
6.4 Pre- Start Up Safety & Environmental Review 14
6.5 equipment safety inspection 15
6.6 Electrical SAFETY PROCEDURE and appendixes (1-6) 15
6.6.1 Procedure 15
6.6.2 Appendixes (1-6) 15
1.0 Introduction
This Plan defines the required safety documentation for commissioning and qualification. The plan addresses the work that occurs between Pre-commissioning and Operational Qualification (OQ) and is an extension of the SHE Plan.
The following guiding documents are available for review and should be consulted when reviewing this plan:
· Project Safety Program
· Project SHE Plan
2.0 Scope
This document applies to all personnel supporting field execution of commissioning and qualification.
3.0 definitions
Refer to GES Practice 7.12 Commissioning & Qualification Safety Program.
4.0 Roles and Responsibilities
Roles and responsibilities are described throughout the specific sections of the Commissioning and Qualification Safety Plan. The following provides a summary of the general roles and responsibilities:
· MODULE/SUITE Team – Are empowered to align commissioning and qualification responsibilities as appropriate within their teams. Within the empowered suite teams, every individual performing field Commissioning and Qualification activities are responsible for the execution of the Safety Plan. The Global Engineering Services team member is traditionally designated to be the point person in the suite for leading and mentoring the team on the safety requirements and procedures.
· Commissioning Engineer - Has startup, commissioning, and turnover responsibilities for a group of systems designated from the project system list.
· Commissioning System Lead – Assigns lead responsibilities for IC and OC of systems to Merck and Construction Manager. Merck will lead all IQ, IOQ, shakedown, and OQ activities. The lead group will typically be responsible to write the JSAs for the work.
· Turnover Manager - Responsibilities include the coordination of all tasks to bring a system/area from substantial completion to turnover to Merck.
5.0 Plan
Commissioning and Qualification (C&Q) work represents a significant change in the types of tasks being executed on a day-to-day basis. As well, the C&Q tasks present unique environmental and safety challenges. This C&Q Safety Plan is created to outline the minimum safety and environmental standards for all activities carried out during the commissioning and qualification of and to establish general roles and responsibilities for these tasks.
A Commissioning and Qualification Safety Orientation is required for all personnel who will be spending any portion of their time supporting the field execution of commissioning and / or qualification. The orientation is intended to define procedures to safety assimilate C&Q activities into ongoing construction activities.
Task specific training, e.g., arc flash training, will be provided to employees as required to execute their work.
5.1 hierarchy of safety plan
The following is an example of a hierarchy applied to a particular project safety planning activities:
5.2 Project Hazard Analysis
A Project Hazard Analysis (PHA) is a master list identifying all known tasks for a particular activity (e.g., Commissioning and Qualification). A PHA was completed for the commissioning and qualification activities and matches the requirements previously established in the approved project System List. Each item on the PHA list will correlate to a single JSA, although the module/skid/suite teams will have the flexibility to combine / reference multiple tasks into single JSAs (e.g., a single JSA can apply to the execution of OC, OQ, and Shakedown for two autoclaves, i.e., 6 tasks in a single JSA). The PHA will be submitted to the Site Safety Team for review and archiving.
Refer to Attachment 6.1 for PHA form.
5.3 Job Safety Analysis
A Job Safety Analysis (JSA) involves a review of the work method of a particular task in order to identify and mitigate all potential hazards. The JSA is conducted during the planning stage of a particular work task. The JSA identifies hazards associated with specific work tasks identified in the PHA list and provides protective measures to prevent injury or incident associated with those work tasks.
The JSAs identified in the PHA includes the execution of static and dynamic test plans for the systems identified on the project systems list. The JSAs will be written and executed by the suite teams. The applicable suite team is listed in the first column on the JSA.
The following roles apply to JSAs: (Not limited to these examples)
Activity / Suite JSAsConstruction Manager
Lead Activities / Contractor Lead Activities / Merck
Lead Activities
Automation / Primary Author / Name / Name / Name
Electrical / Name / Name / Name
Facility / Name / Name / Name
HVAC / Name / Name / Name
Process Units / Name / Name / Name
Process Units / Name / Name / Name
Process Units / Name / Name / Name
Mechanical (Non GMP) Utility / Name / Name / Name
Qualified Utility / Name / Name / Name
Portable Equipment / Name / Name / Name
Suite JSA Safety Review / Name / Name / Name
Merck Safety Reviews As Necessary
The leads noted in the table above will be responsible for assuring that the JSA is written although the Module/Skid/Suite Teams may assign the writing of the JSA to other team members as appropriate. JSAs will be reviewed by the safety manager of the Commissioning System Lead in all cases. The safety manager shall recommend if any Merck Safe Work Permits, Shutdown Work releases, or other additional project safety forms are needed. The safety manager will also make the determination if the Merck site safety manager needs to review and / or approve the JSA.
Refer to Attachment 6.1 for JSA form.
5.4 Safety Task Assignment (STA)
A Safety Task Assignment (STA) is used to provide each employee performing a task associated with a Job Safety Analysis (JSA) the means and methods for performing the work safely. The Construction Manager integrates the requirements of the STA into their JSA. All STA requirements apply to the related JSA. The STA or JSA is completed daily and takes into account both the work being executed and the environment and surroundings that the work is being performed. The STA and JSA is reviewed and signed by each worker performing a task prior to start of work. The following roles apply to STAs and JSA's:
Activity / STAs / JSAConstruction Manager
Lead Activities / Contractor Lead Activities / Merck
Lead Activities
Automation / Primary Author / Name / Name / Name
Electrical / Name / Name / Name
Facility / Name / Name / Name
HVAC / Name / Name / Name
Process Units / Name / Name / Name
Process Units / Name / Name / Name
Process Units / Name / Name / Name
Mechanical (Non GMP) Utility / Name / Name / Name
Qualified Utility / Name / Name / Name
Portable Equipment / Name / Name / Name
STA/JSA Reviewed by: / Name / Name / Name
Field Audits by Merck Safety
As noted above, STAs and JSAs shall be reviewed by the Safety Manager of the Commissioning System Lead. The Safety Manager may indicate her/his review is no longer necessary going forward once a history of satisfied completion of STAs and JSAs by the lead is established. The site safety professionals will also have the responsibility to routinely audit STAs and JSAs in the field.
The original STA and JSA with signatures by each individual participating in the task should be posted in the field in the location of the task. Following work for the day, the STA and JSA should be collected and turned into site safety who will archive the STA and JSA.
Refer to Attachment 6.2 for STA form.
5.5 Work Permit
The Merck Safe Work Permit is used to document and communicate any service, maintenance, construction, or installation activity involving specific work activity with increased risk such as (but not limited to) roof access, hot work, confined space entry, line breaking, excavation, road closure, crane operations, and work on energized equipment. The following provisions of the permit are generally judged to apply to Commissioning and Qualification:
· Confined Space Entry - Before entering confined areas such as stills, tanks, vessels, manholes, pits, etc., personnel shall be required to procure a Confined Space Entry Permit and training on this task.
· Hot Work Permits - Hot work permits are required where flame/ spark may be produced.
· Line Breaking - Before opening or closing any valves or switches not included in the execution of the OC or before disconnecting / breaking into any piping or electrical systems (including via flanges or other unions), personnel shall secure approval from the Safety Manager via a Line Breaking Permit.
· Roof Access Permit - Before going onto the roof of any site building, a Roof Access Permit must be obtained. Use of this permit is required post construction completion, upon turnover.
The list of permits above is not comprehensive to all potentially required permits. The project engineer must consult with Site S&E to confirm all required permits for the C&Q activities. As well, the permit originator/owner must be trained (documented training) in the permits to be issued.
The following roles apply to Permits:
Construction Manager Lead Activities / Contractor Lead Activities / Merck
Lead Activities
Automation / Primary Author / Name / Name / Name
Electrical / Name / Name / Name
Facility / Name / Name / Name
HVAC / Name / Name / Name
Process Units / Name / Name / Name
Process Units / Name / Name / Name
Process Units / Name / Name / Name
Mechanical (Non GMP) Utility / Name / Name / Name
Qualified Utility / Name / Name / Name
Portable Equipment / Name / Name / Name
Review / Initiator - As indicated above
Owner(CONSTRUCTION MANAGER Lead)-Mrk GES Suite Member
Owner(Merck Lead)-Other Merck Suite Member
(initiator and approver must be different people)
Merck Safety
As noted above, Merck Safe Work Permits shall be initiated by the individual performing or leading the work task (construction of commissioning) and approved by the applicable Owner and Safety Manager. In cases where the Merck CE Suite Member is initiating the permit, another member of the suite team must sign the permit as the owner. The initiator and owner cannot be the same person. The permit will also be used for a Merck member associated with the task to authorize work to occur in the field. The approved form ensures that the Merck Suite Team is knowledgeable of work to be done on Mechanically Complete systems.
The permit will be used with Merck approval in one of two cases:
· Where systems are noted as being “Merck Lead” on the system list, the permit will be used when the system has achieved Documented Construction Completion and work is being performed that is not included on the punchlist included in the MC notice.
· Work is being performed after the OC has been initiated on the system.
The original permit with signatures by each individual participating or approving the task should be posted in the field in the location of the task. Following work for the day, the permit should be collected and turned into site safety who will archive the permit.
5.6 Equipment Pre-Energizing Safety CHECKLIST (EESC)
An Equipment Pre-Energizing Safety Checklist (EESC) has been developed to verify that safety critical tasks are completed prior to start of dynamic commissioning and qualification activities, i.e., OC, IOQ, Shakedown, and OQ. Signatures by the initiator, safety, and the commissioning manager from the lead group are required prior to starting the field execution of dynamic testing.
Refer to Attachment 6.3 for EESC form.
5.7 Pre Start-Up Safety & Environmental Review (PSSER)
A Pre Start-Up Safety & Environmental Review (PSSER) is part of an overall management system to ensure new or modified equipment/processes/facilities are ready for safe startup. The PSSER, in it’s simplest form is a final check prior to initiating the use of new/modified equipment/processes/facilities to confirm that:
· The equipment/process/facility has been constructed by the Construction Management Team as intended by the Design Team.
· Safe work practices, operating procedures, maintenance procedures, and emergency response procedures are adequate and in place.
· All action items from process hazard analysis for the activity(s) have been resolved.
· Training for employees is complete.
PSSER is typically accomplished by verifying that all hazards identified during design and construction are adequately addressed and that the equipment/process/facilities have been constructed in a manner that is consistent with design intent and operating parameters.