Professional Documents
Culture Documents
SOP-CACH-ENG-00017
2 Purpose
This document describes the permit to work (PTW) system used within the PEI M&Q facilities
and specifically:
o The function of the permits & certificates making up the system.
o The responsibilities of persons who write permits – the Issuing Authority.
o The qualifications and responsibilities of those that carry out work under a permit.
o To provide a procedure to qualify and or approve contractors for hire within PEI facilities.
o To ensure that approved contractors are adequately informed of hazards that may be
encountered while working at any of the PEI sites, and to specify the HSE, Security, and
Quality requirements.
The PTW system will NOT normally be used to control the routine activities of Technical
Operations, Quality, Supply Chain, Quality Control Wetlab and normal engineering operations as
other formal measures such as Quality Risk Assessments, Standard Operating Procedures
(SOP’s) and other policies will be in place to establish safe operations.
3 Scope
This procedure applies to all Elanco personnel and external contractors working at PEI facilities.
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4 Responsibilities
It is the responsibility of the Line or Area Manager/Production Leader to ensure that all work is
performed in a safe manner and that they authorize Permit to Work permits in their areas or
work performed on equipment /utilities that may affect production processes.
It is the responsibility of the equipment owner to ensure equipment is safely taken out of
service when required for required maintenance/repairs to be completed.
All managers, permit issuers, and facilities associates shall be trained in this procedure.
It is the responsibility of the Elanco / CBRE contractor’s supervisor or designate to review this
SOP with all contractors, prior to the start of work on any project.
Contractors are expected to conduct all work in compliance with this SOP.
Contractors are also responsible for providing their own fire watch for all hot work permits.
It is the responsibility of the Elanco / CBRE contractor supervisor to ensure all related training
for contractors is completed.
It is the responsibility of Elanco Engineering and CBRE to maintain an up to date list of approved
contractors based on the Maintenance/Facilities Managers’ demonstration the contractor has
satisfied all components of this SOP.
It is the responsibility of the CBRE Facilities Technician or Manager to ensure the Production
Manager / Supervisor is aware of any contractor working in their area. Work that may affect the
production process or the employees working within or around the production workspace.
It is the responsibility of all site personnel and contractors involved in the work to be performed
to assess the risks and mitigate the risk to a manageable level prior to initiating work.
5 Procedures
5.1.1 The general procedure to be followed in using the permit to work system is defined in the
Permit to Work Flowchart 1(Appendix 1)
5.1.2 The use of permits to work to establish a safe system of work should always be considered
when any of the following applies:
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Work that is non-routine or unfamiliar or not covered by any other formal procedure or
safe system of work.
Work that has potentially significant risk such as working at height, modifications to
electrical systems, construction/demolition, confined space work etc.
Work that has the potential for hazardous interaction with routine operations or other
maintenance/construction activity.
5.1.3 All work involving third party contractors on the PEI site will require a permit to work.
5.1.4 The permit to work system will normally be used for any of the following tasks/activities:
Hot Work – To control fire risks and to control & document isolation of automatic fire
detection equipment
Confined Space Entry - Any work requiring entry into a confined space as defined as
an enclosed or partially enclosed space
(a) not designed or intended for human occupancy;
(b) with restricted access or exit; and
(c) that is or may become hazardous to a person entering it because of its design,
construction, location, atmosphere or the materials or substances in it or other conditions,
and includes any bin, tank, tanker, tunnel, silo, sewer, vault, chamber, pipeline, pit, vessel,
vat and flue.
Excavation – Any excavation using mechanical equipment. Any work involving entry into
excavations at a depth of 1.21 meters (4 feet) or more.
Working at Height – Any work by a third party contractor requiring access to roofs, use of
access equipment including scaffolding, towers, Mobile Elevated Work Platforms (MEWPS).
Risks that a worker could be exposed to include but not limited to:
o Falling from a height of more than 1.8 meters (6 feet);
o Falling into operating machinery;
o Falling into water or another liquid;
o Falling into or onto a hazardous substance or object;
o Falling though an opening in a work surface.
Electrical - Isolation of electrical systems to allow a third party to work on them safely. Live
functional testing of any electrical system by a third party.
Lock Out Tag Out – Any work by a third party contractor requiring energy sources to be
isolated from the equipment prior to work being performed.
Lifting operations – Operations requiring the lifting objects by use of mechanical systems.
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5.1.5 A permit to work is issued based on a defined scope of work. During the execution of the
work should the scope change, then work should stop until a new permit to work is issued
based on the revised scope of work.
5.2.1 Will be used in all other areas where the nature of the operations and work task requires
more detailed assessment of the risks.
5.2.3 May be used to authorize work on their own or in conjunction with other relevant Technical
Permits in Table 1.
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Technical Permit Title & SOP Reference Definition/When used Links to Other Permits Issuing Authority
Veeva # and Title
“Confined Space Entry “Confined Space Initial (b) with restricted access or exit; and trained tech ops associates). Engineering staff or
Permit” Risk Assessment (c) that is or may become hazardous to a Lock Out/Tag Out of energy systems in consultation with
Worksheet” person entering it because of its design, may also be required where the HSE
construction, location, atmosphere or the confined space normally contains or is Confined Space Entry
SOP-CACH-HSE-00027 materials or substances in it or other connected to a source of electricity, Permits may only be
“Lock Out/Tag Out conditions, and includes any bin, tank, tanker, gases, vapors, liquids, or free flowing issued by competent
Procedure” tunnel, silo, sewer, vault, chamber, pipeline, solids that require isolation. associates who have
pit, vessel, vat and flue. Equipment Specific Instructions (ESI) are completed a
When is a Confined Space Entry Permit required for which work requires the Confined Spaces
Required? isolation to be in place for equipment Training course in
All access to any confined space as defined being fed with multiple energy systems successfactors
above within the PEI site, irrespective of Issued in conjunction with one or more
duration, will require the issue of a Confined Permits To Work.
Space Entry permit.
Fire Suppression/Alarm SOP-CACH-HSE-00027 Work which will produce smoke (integrity May be issued as a standalone permit or Fire
Temporary Impairment “Lock Out/Tag Out testing of HEPA filters), dust, steam that may as a Permit To Work when other permits Suppression/Alarm
Permit Procedure” trigger fire detection equipment or work on are required. Temporary
the sprinkler or fire detection systems Impairment Permits
themselves will require the temporary may only be issued
impairment of the building fire panel alarm by competent
FRM-CACH-ENG-00024 system. associates who have
“Fire Suppression/ Alarm been trained
Temporary Impairment The temporary impairment permit is required
Permit” when one of the above mentioned situations
is presented by a contractor or Elanco
employee.
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Technical Permit Title & SOP Reference Definition/When used Links to Other Permits Issuing Authority
Veeva # and Title
Fire Suppression/Alarm The Alarm Reporting Station (Alliance Security)
Temporary Impairment must be notified prior to any work being
Permit(continued) performed with the account number (inside
panel) and the timeframe the fire alarm is
required to be in “test”.
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Technical Permit Title & SOP Reference Definition/When used Links to Other Permits Issuing Authority
Veeva # and Title
Lifting Permit SOP-CACH-HSE-00027 To be used when there is equipment being Issued in conjunction with one or more To be issued by a
“Lock Out/Tag Out lifted by means of a hoist, boom truck or crane Permits To Work. competent member
FRM-CACH-ENG-00027 Procedure” as it Lock Out/Tag Out of energy systems of the CBRE /
“Lifting Permit” pertains to potential may also be required where the Engineering staff
hazards in the vicinity confined space normally contains or is
of the lift operation connected to a source of electricity,
gases, vapors, liquids, or free flowing
solids that require isolation.
Equipment Specific Instructions (ESI) are
required for which work requires the
isolation to be in place for equipment
being fed with multiple energy systems
Excavation Permit SOP-CACH-HSE-00027 To be issued when there is any excavation at a May be issued as a standalone permit or To be issued by a
“Lock Out/Tag Out depth 4 ft or beyond or where known as a Permit To Work when other permits competent member
FRM-CACH-ENG-00026 Procedure” as it potential hazards have been identified and a are required such as confined space of the CBRE /
“Excavation Permit” pertains to the plan for mitigation is needed. permit or lift permit. Engineering staff
potential hazards in
the vicinity of the
excavation activity
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5.3.1 Permits to Work should only be issued by competent persons, appointed by senior
management within each function on site, who have completed a site Permit to Work
training.
5.3.2 Each functional department using the permit to work will maintain an up-to-date list of
appointed issuing authorities; the lists should be displayed at a key location(s) across the
site.
5.4.1 The Permit to Work Board is situated next to the fire alarm systems for all buildings and will
be used to control contractors primarily working for Engineering.
5.4.2 The Permit to Work Board provides a single point at which live/current permits are
displayed to aid the management of the Permit to Work System.
5.4.3 It provides a point of reference for Engineering when issuing permits to check on the status
of other work on site and the potential for hazardous interference between the different
works under permit.
5.4.4 All permits issued by Engineering are to be detailed and displayed on the permit to work
board as described in – Flowchart 2 (Appendix 2) Permit Board Management.
5.4.5 The permits must be closed out by a competent person and filed with the HSE for a period
of at least two years.
5.5 Contractors:
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A contract is drawn up between Elanco or CBRE and the contractor which specifies their
respective responsibilities and communication processes relating to the outsourced
activities.
This a written contract (e.g. Agreement) between Elanco or CBRE (contract giver) and
each contractor (contract acceptor) covering the business and quality aspects of
outsourced activities, the products and/or services and operations to which they are
related and any technical arrangement made in connection with it. This may be in the
form of a Non-disclosure Agreement (NDA) or Confidentiality Agreement (CDA).
Technical aspects of the contract are drawn up by competent persons suitably
knowledgeable in related outsourced activities and GxP requirements.
The contract describes clearly who is responsible for each step of the outsourced
activity, e.g. knowledge management, technology transfer, supply chain,
subcontracting, quality and purchasing of materials, testing specifications and releasing
materials, undertaking production and quality controls (including in-process controls,
sampling and analysis, Pharmacovigilance).
The contract includes the appropriate approved Adverse Events reporting language and
an agreed reconciliation process (including source data verification) between Elanco
and the contractor to ensure that all Adverse Events have been identified by the
contractor and that all Adverse Events have been forwarded to Elanco, if applicable.
In the case of contract analysis, the contract states whether or not the contractor must
take samples at the premises of the manufacturer if applicable.
The contract permits Elanco to audit the outsourced activities of the Contract Acceptor
or its mutually agreed subcontractors.
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For entry to any controlled areas all contractors will be required to read and be trained
on SOP-CACH-GEN-00028 for non-sterile gowning, SOP-CACH-GEN-00010 for clothing
required for entrance into the aquarium areas.
All contractors and their employees must maintain the appropriate qualifications to
perform work at Elanco Aqua Business sites.
Any GMP equipment that requires maintenance, repairs, or modifications is to be taken
out of service as per SOP-CACH-QA-00457. The equipment owner will sign the Permit to
Work releasing the equipment as safe and ready for work to be completed.
The supporting documentation of these qualifications may be requested at the
discretion of the responsible Manager
All required work documentation must be properly maintained.
The scope of this documentation will be laid out prior to the starting of any project.
Contractors shall ensure no contamination of adjoining areas from dust and debris, etc.
created during the project.
Contractors and their employees shall ensure clean-up of the affected areas prior to
completion of each work day, and at the completion of the project.
All visitors to any of the Elanco PEI sites are required to follow sign in and sign out
procedures to ensure their whereabouts are known in the event of an emergency
situation. See SOP-CACH-GEN-00001
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Prior to bringing a chemical on site, check to see if the SDS (Canadian version) is on
Comply Plus Web. If the SDS is not there, obtain a Canadian SDS for the chemical and
complete the Program Intent Submission Form (FRM-CACH-HSE-00002) for
authorization to bring the chemical onto the site.
Any chemical hazards will be communicated and outlined to the contractors to ensure
hazards are identified and if they are contractor supplied that a current Safety Data
Sheet has been made available to Elanco.
All PEI Facilities are equipped with fire extinguishers. All facilities (with the exception of
the Victoria facility) are fitted with sprinklers.
Contractors should have certified equipment when performing processes that require
the use of back up fire extinguishers.
Elanco can and will provide equipment in the event the contractor cannot.
Approved Contractors will provide ALL required PPE for completion of the activities
required.
In the event respiratory protection is required HSE will assess the equipment and the
contractors fit testing procedures with the expectation that the contractors are fit
tested prior to reporting to work on site.
All electrical safety procedures will follow the CSA Workplace Electrical Safety
Standards (CSA Z462-15)
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The contractor is responsible to supply and sufficiently stock a first aid kit for their
personnel.
For any identified break areas, it will be the responsibility of the contractor to ensure it
is kept clean and uncluttered.
Contractors are responsible for the removal and disposal of any construction related
debris and waste.
Unless written consent is given, use of the Elanco Aqua Business waste receptacles is
not permitted for the waste described above.
As part of the PTW any incidents must be reported to the site HSE and if applicable to
the appropriate authorities as required (Workers Compensation).
5.5.15 Miscellaneous
All other issues not covered in this SOP will be dealt with as described in the PEI
Occupational Health and Safety Act.
6 Additional Instructions
6.1 Safety
6.1.1 Risks:
Any activities where there are potential hazards to the health and safety of personnel or to
the environment will require a risk assessment completed by a competent person in
accordance with the risk assessment guideline. Specific risks include:
o Foot injuries
o Eye injuries
o Hot work risks
o Unauthorized Access to restricted areas
o Fire evacuation event
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6.1.2 Mitigations:
Performance of HSE walkthroughs / inspections by HSE, ISEC, and Biosafety, as well line and
senior management for all facilities establishes a system of consistency for hazard
identification, increases HSE awareness throughout the sites, and demonstrates a
commitment to safety and the goal of zero harm. Mitigations for the above mentioned
risks are:
o All contractors and their employees are to wear safety footwear when they arrive on
site to begin work
o All contractors are required to wear eye protection when performing work on site.
o Hot Work Permits are required for any grinding, soldering, welding, and other high-risk
activities where open flames, or long-term heat gun use is required.
o When on site, all contractors and their employees are required to sign in and out to
ensure their whereabouts are known. Access is discussed with the contractors to
ensure they are aware of any limitations.
o Sweeps are performed during an evacuation to ensure all contractors signed in have
left the building, and the sign in book is used in addition to the roll call list to ensure all
have left the building.
8 Annexes/Related Forms
FRM-CACH-ENG-00010 Permit to Work – General Form
FRM-CACH-PRD-00007 Confined Space Entry Permit
FRM-CACH-HSE-00004 Hot Work Authorization Permit
FRM-CACH-HSE-00005 Incident/Accident/Near Miss Report
FRM-CACH-HSE-00009 Confined Space Initial Risk Assessment Worksheet
FRM-CACH-ENG-00012 Energized Electrical Work Permit
FRM-CACH-ENG-00024 Fire Suppression/Alarm Temporary Impairment Permit
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9 Summary of Changes
Version Section Description of Change(s)
V 02 Sec 9 Summary of Changes table added to end of document to replace reason for change
and to track the whole history of changes through the SOPs life cycle going forward.
V 02 Sec 4/5 Moved Section on Responsibilities ahead of Procedures
V 02 All Updated to Elanco Formatting
V 03 Header Removed version number as Regulus automatically assigns version numbers
V 03 Section 1 Added reference document SOP-CACH-HSE-00213 (PEI Risk Assessment and
Control)
Removed Workers Compensation Act R.S.P.E.I. 1988, Cap. W-7.1 as it refers to a
version of the PEI Occupational Health and Safety Act
V 03 Section 2 Added “Quality” in front of Risk Assessments as the Permit to Work will now include
a risk assessment section
V 03 Section 4 Added the requirement that the Area/Line Manager/Production Leader is required
to authorize work performed in their area or on equipment/utilities that may affect
production processes of responsibility (as per TR 10206904)
Removed the reference to the Site HSE Manual as the all pertinent information to
be in SOPs
Added responsibility to all site personnel and contractors to assess and mitigate the
risk of the work to be performed
V 03 5.4.5 Added the requirement to maintain completed permits for a period of two years
V 03 5.5.2.7 Replaced the need to sign a Certificate of Agreement documenting they have read
and understand the contents of the Site HSE Manual, with the requirement to
complete HSE orientation every 2 years and perform a knowledge assessment
V03 5.5.6.1 Added the for contractors to supply an up to date Safety Data Sheet on chemicals
they are supplying
V 03 5.5.8.2 Added the expectation that contractors have up to date fit testing completed
V 03 5.15.1 Removed “or the Site HSE Handbook” as the procedure needs to include pertinent
information for safe work
V 03 6.1.1 Removed “corporate” as this procedure refers to the site risk assessment procedure
V 04 4.0 Updated Roles and Responsibilities to include CBRE.
V 04 Table 1 Updated Facilities to CBRE.
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