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Hoddesdon Environmental Risk

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Risk Assessment Title Pharmaron UK Hoddesdon's Environmental Site Risk and Opportunities Register
Location Hoddesdon Site
Initial assessment team and date
Associated documents SOP Environmental Management System Hoddesdon
SOP Hoddesdon Change Control Process
FRM
SPT RA-Hoddesdon Environmental Aspects and Impacts
EXT
Other
Purpose of this assessment To effectively assess the risks and opportunities from Interested Parties relevant to the site's
Environmental Management System

Definitions Interested Parties relevant to the EMS - Person or organisation can affect or be affected by
or perceive themselves to be affected by a decision or activity. These may be internal or
external.
Environmental conditions: climate, air quality, water quality, land use, existing
contamination, natural resource availability and biodiversity, that can affect the organisations
purpose, or be affected by it's environmental aspects

External Issues : external cultural, social, political, legal, regulatory, financial, technological,
economic, natural and competitive circumstances, whether international, national, regional or
local.

Internal Issues : internal characteristics or conditions of the organisation, such as its

activities, products and services, strategic direction, culture and capabilities (ie. people,
knowledge, processes, systems)

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The purpose of this tab is to record changes made to this risk assessment following review.
Any supporting information can be placed onto additional tabs.

Version 1 New Document

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Assumptions made prior to and during the risk assessment

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SWOT and STEEPLE analyses has identified all Interested Parties relevant to the EMS for the business and its context.
###
Context of the business is understood
###
Definitions are understood
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Following each review and/or change, a new version of the register is published and publicised via the site brief .

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Criteria - Risk
Likelihood Score Severity Score
Improbable - extremely unlikely 1 Negligible 1
Remote – but conceivable 2 Marginal 5
Occasional – even chance of occurring 5 Serious 15
Probable – no surprise 10 Critical 30
Highly probable - to be expected 20 Catastrophic 50

RISK = Probable Likelihood X Severity of Outcome

Severity
1 5 15 30 50
Likelihood 1 1 5 15 30 50
2 2 10 30 60 100
5 5 25 75 150 250
10 10 50 150 300 500
20 20 100 300 600 1000
LOW MEDIUM HIGH

Priority Action
1 1-20 Risk is as low as reasonably practicable
2 21 – 50 No immediate action – keep under review
3 51-100 Action within next year - Keep under review
4 101-150 Action within 3 months
5 151 – 201 Action within next month
6 201-300 Action within a week
7 > 300 Immediate action - Risk cannot be tolerated

Note: The scoring can sit between numbers if the hazard does not meet the criteria.

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STEEPLE Analysis

Social Technology Economic Environment Political Legal Ethical

Education Rate of technology obsolesce(up grades) Exchange rate Threats from natural causes Government changes EPR 2016 bribery, all levels
Income Mobile technology Economic growth Waste recycling International trade regulations Employment laws IP
Attitudes IT changes Inflation rates Sustainable energy sources Union Health and safety laws Reputation
Demographic (age) Alternative technology Government funding Site infrastructure Government policy on research funding IP Business ethics
Mobile work force Data security international trade Gaseous discharges Exit from EU Data Security Customer confidentiality
Site location Raw material - sole supplier Company change API emissions Protestors
Public opinion TD process to protect raw material supply Utilities costs CFC Emissions
Raw material costs Releases to water
Challenge with type of work available. 1/3 Fixed overhead costs for site Transfer of waste
pharma is biological molecules.

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SWOT Analysis

Helpful to achieving objectives Harmful to achieving objectives

Strengths Weaknesses
Hoddesdon Site Internal Origin

Highly experienced, skilled staff High running costs

Respected heritage and reputation Raw material costs and supply
Strong relationship with customers Variability of order demand
Well presented refurbished facility Technological changes/advancements
Location of facility Loss of experienced staff
Responsiveness to enquiries Loss of knowledge and technical expertise
High levels of customer satisfaction Training burden
Succession Planning Discharge limits
Supportive Management Different legislation across the world
Technical expertise Facility maintenance costs
EHS activities Controlled temperature storage monitoring
Back catalogue of work Data management
Investment opportunities from wider Company Uneven flow of work affecting waste disposal levels
Limited number of experienced staff

Opportunities Threats
Collaborative work with customers Competitors
Loyal customers Pricing
External Origin

Linking sales with capabilities on other sites Specialist market

Exhibiting at industry events Cost of materials
Hosting industry events Shipping
Promotion by publishing work Data security
Links with university chemistry departments Technological changes/advancements
Funding from government Alternative technologies
Part of a bigger company Customer budget restrictions
Chemical Industry Association (CIA), promotional body Cost of utilities
Technological changes and advancements EHS licences
Strategic acquisitions made by Company Financing
Expansion of other areas of site Exchange rates
Customer EHS Audits Customer demands
High degree of risk, pricing based on estimates
Resource stretched supporting other sites
Change of client perception following Company change
Equipment wear and tear
Customer EHS Audits
Regulatory Inspections

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Risk Analysis

Groups at risk: A = Customers, B = Staff, C = Facility/ Equipment, D = Process, E = Technology, F = Suppliers G= Environment, H = Stakeholders/Regulators, I = Business
LOW = GREEN MEDIUM = YELLOW HIGH = RED
Ref Risk Identified Source Potential Harm Groups L1 S1 R1 Existing Controls L2 S2 R2 Additional Actions/Controls Required L3 S3 R3 Action Responsibility
at Risk Priority

R1 Failure of EMS Internal and Maintain compliance A, H, I 20 50 1000 20 50 1000 Permit compliance document (line by 1 30 30 2 Top Management
could result in external against Permit line review) ensures that resources
Permit breaches conditions and limits are adequate and
and regulatory equipment/processes are in place
non-compliance. Staff awareness of the permit limits
and importance of remaining
compliant maintained through training
against SOPs, RPS training, EHS
committee meetings, etc
Management lines and accountability.

Good communication - site

meetings/production meetings.
Controlled documentation in place.
Effectiveness of processes is audited
and change is controlled.
Management review.
Internal EHS inspection programme

R2 Management of Internal Business H, I 20 50 1000 Optimising operational efficiency by 5 30 150 Monitoring costs and continual 1 30 30 3 Top Management
costs and profitability, budget eliminating unnecessary costs/waste improvement of processes.
overheads compliance

R3 Fulfilment of Internal and Failure of EMS I, G, H 20 50 1000 20 50 1000 Terms of licences understood. 1 30 30 3 EHS Manager
licensing details External could breach
licensing rights
Control and monitoring of processes
that could impact on our adherence to
licence conditions
Management review,
Internal EHS monitoring programme.
External audits by agencies and
customers
Maintain open dialogue with agencies.
R4 Protection of Internal and IP, Customers, Staff A, B, 10 50 500 2 50 100 Data security committee. 2 50 100 3 QA Department
Company owned External D, E, Competitive pay and conditions for staff IT Department
IP, customer base H, I
and staff, custody Investment in appropriate
of customer data software/hardware to reduce risk.

Competitive pay and conditions for

staff
Data encryption.
USB ports control.
Management review.
Internal EHS inspection programme

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R5 Failure of aspects Internal and Flow of A, B,C, 20 50 1000 Defined responsibilities for processes. 2 50 100 Defined responsibilities for processes. 1 50 50 2 Top Management
of the EMS could External information/samples D, F, I Management lines and accountability.
bring about a between processes.
failure between Failure of Good communication - site
processes communication meetings/production meetings.
(Effective could delay or Controlled documentation in place.
communication prevent product Processes are understood by staff and
between realisation , responsibilities are well defined
departments challenge the site Effectiveness of processes is audited
(interface between permit limits, place and change is controlled.
BD/Quotations/Pla staff in danger of Management review.
nning. receiving exposure Internal EHS inspection programme
Production/QC/Shi to radiochemicals or
pping. EHS & chemicals
Waste ))

R6 Failure by external External Fulfilment of A, D, I, 10 30 300 Supplier approval and review process. 2 30 60 Internal EHS inspection programme 1 30 30 1 EHS Manager
suppliers could be contract. C, B Investigation of non conformances.
detrimental to us Availability of Records that support equipment
fulfilling our products/services conformity are formally accepted by the
environmental and Company (stamped - sign and date by
regulatory Facilities)
responsibilities

R7 Environmental Internal and Minimise A, B, 20 50 1000 Compliance with NRW permits. 2 50 100 Management review, Internal EHS 1 30 30 1 EHS Manager
management External environmental G, I Pessimistic approach to ensure stringent monitoring programme. Constructive
impact for local control dialogue with agencies
community.
Changes to
interpretation of the
permit conditions by
agencies

R8 Retention of Internal Business capability. A, B, 20 50 1000 Succession planning. 2 50 100 Management review of skills of 1 30 30 1 Top Management
specialist skills Time taken to train, C, D, Staff training - multiskilling in small teams workers
and knowledge gain experience. H, I to ensure suitable knowledge and cover
at all times.

Recruitment/succession planning.

R9 Maintaining of External Harm from pricing A, H, I 10 50 500 Discussions and service review of 5 50 250 Support for staff to attend symposiums 2 50 100 3 Top Management
efficient and cost increases, changes suppliers and other industry events
effective systems in service provision, Awareness of market pricing Membership of industry committees
that ensure efficiency of Keeping abreast of technology Secure and appropriate waste routes
compliance processes Regular duty of care and service and contractors
suitability audits

R10 Risk to staff, data, External and IP, customer A, B, 5 50 250 Site security. 2 50 100 Management review. 2 50 100 3 Top Management
equipment, site Internal confidentiality, D, E, Internal EHS inspection programme
specialist skills and H, I Staff training. ICT security committee
techniques
Business values and Code of conduct

R11 Risk to business External Pricing, lead-times A, H, I 10 50 500 Skills and specialist nature of work. 5 30 150 Business Development support 2 50 100 3 Top Management
from competitors
Competitive pricing.

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R12 Technological Internal and Specialist E, B, 20 30 600 Planning and budgeting. 10 15 150 Management review. 5 15 75 3 Top Management
Changes / External equipment, A, C, I Internal EHS inspection programme
Advancements technologies, IT Staff training Change control process
software and New staff bring their
hardware knowledge/experiences and new ideas
R13 Changes following External Potential for A, B, 10 50 500 Risk is currently unknown, any impact
UK decision to uncertainty with C, D, will affect our UK based competitors too
leave EU. Risk to trading rules and E, F,
trade links, regulations. G, H, I
inflation and
exchange rates,
European funding.
UK government
changes

R14 Couriers used to External Fulfilment of A, G, 20 50 1000 Technical Agreement sets out 5 50 250 Shipping documentation produced on 2 50 100 2 QA Department
ship products to contract to deliver H, I expectations with Courier. site.
the customer product as agreed, Shipping checks conducted at
both in terms of time handover to Courier.
and conditions to Internal QA inspection programme
preserve product On site DGSA

R15 Site Internal Specialist site and A, C, 20 50 1000 Maintenance schedule for quality and 5 50 250 CAPEX plan and review. 2 50 100 2 QA Department
equipment, wear H, I safety critical equipment. Prioritisation of work needed. EHS Manager
and tear Failure to Maintenance contracts with approved Internal QA inspection programme
adequately maintain service providers. Training of staff
the facility could
result in equipment
breakdowns which
in turn could
compromise our
ability to meet the
EMS requirements

R16 Site - interaction Internal Lack of knowledge A, H, I 20 50 1000 BD and Technical meetings with new 5 50 250 Systems and structure for the new Top Management
with wider on how we may Pharmaron sites. Outcome will help company across all sites is needed
Company support new assess any gaps we may have
Company
acquisitions
.Potential for
uncertainty when
quoting to
customers, could
lead to delays with
providing customers
with information

R17 Environment External Potential for the A, H, I 20 50 1000 Maintain compliance against EPR 2016 1 50 50
Agency breaching of the site Permit conditions and limits
permit due to lack of Dedicated EHS Manager to audit the
understanding about disposal of waste and discharges from
the permit site
conditions

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R18 Health and Safety External Potential for being A, H, I 20 50 1000 Dedicated EHS Manager to ensure to 1 50 50
Executive non-compliant ensure compliance health and safety
against Health and legislation
Safety Regulations EHS committee meetings to highlight any
trends and potential problems
Occupational hygiene monitoring to
ensure staff exposures the API and
chemicals is minimised

R19 Health and Safety External Potential for being A, H, I 20 50 1000 Maintain compliance with ADR2017 and 1 50 50
Executive non-compliant CDG2009 when transporting fproducts
against CDG2009 and waste
when transporting On-site DGSA to ensure compliance
materias
R20 Home Office External Potential for non A, H, I 20 50 1000 Maintain compliance with the sites drug 1 50 50
compliance with the precursor and controlled drug licenses
Misuse of Drugs Act Staff with key roles in the controlled drug
1971and Misuse of process based on site and ensure
Drugs regulations compliance though the control and
2001 documented use of substances and
regular auditing and annual returns
Chemical database and planning teams
highlight any new substances

R21 The Department External Potential for non A, H, I 20 50 1000 Maintain compliance with the Chemical 1 50 50 Consider a chemical database Top Management
for Business, compliance with Weapons Convention by having a highlights which highlights any new
energy and CWC responsible member of staff on site who substances which have compliance
industrial strategy maintains records, carries out audits and conditions and/or restrictions
(BEIS) completes the annual returns annual
returns

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Opportunity Analysis
Interested Groups: A = Customers, B = Staff, C = Facility/ Equipment, D = Process, E = Technology, F = Suppliers G= Environment, H =
Stakeholders/Regulators,
Opportunity I =Opportunity
Business Risk Source Potential Opportunity Interested Existing Controls to Additional Responsibility
Ref Groups manage opportunity Actions/Controls
Required
O1 Customers Early discussion External Potential for repeat A, I, H Quotations, BD and Promotional
with customers to business, operations literature, exhibiting
ensure their recommendations to interaction and at consortium
requirements are others. feedback events to ensure
met and the Protects Company's that we provide a
chmicals used and reputation service rather than
waste created is Minimises make a product
minimised discharges and
reduces costs
Allows for more
projects to be
carried out with
current Permit limits

O2 Potential Reaching new External Potential to grow the A, I, H Promote our as O1 Business
Customers customers business, increase capabilities, Development
market share advertising,
publishing work,
attending industry
events

O3 Employees Company's Internal Loyalty, flexibility as B, I, H Provision of a Top management Top

biggest asset: business develops working environment supportive of Management
professional, and conditions innovation,
highly skilled and which supports the investment in
motivated staff. facilitation of training, rewards
customer
requirements.
Competitive rates of
pay and conditions

O4 Potential Ensuring business External Competitive terms B, I, H Succession Links with STEM, Top
employees continuity. and conditions of planning, local school and Management
Specialist skills employment requirement to universities.
employ best skilled Opportunities for
candidates promotion at
available, career graduate fairs
progression.
Competitive rates of
pay and conditions

O5 Technological Enable to compete External More competitive in A, B, E, Sharing knowledge Attending industry Top
Changes and in marketplace. marketplace. H, I across Pharmaron events and Management
Advancement Further A more sites seminars
improvements in environmentally (Chemistry, IT,
environmental sound and less risky EHS, Quality).
performance and place for customers CAPEX reviews
reduction of costs, to send their
liabilities and business
business risks Further enhance our
offering to our
customers

O6 Site - Expansion of Internal Ensuring best A, B, D, Informing clients of Company wide Top
interaction capability. practice and E, H, I acquisition, linking meetings of Senior Management
with wider Business common approach our known brand Management.
Company development use to environmental with Pharmaron. BD and Technical
of CRM to exploit management Managing customer meetings with other
opportunities. Strategic concerns with Sites to assess any
Potential for acquisitions by change and with gaps we may have.
investment from Company environmental Clear lines of
the wider management communication,
Company reporting lines and
responsibilities
across the UK sites

O7 Stakeholders Allow for greater External External funding A, B, C Contacts with Top
investment to from Government, Government and Management
enable Research and RDEC
development. Development
Opportunity to (RDEC) grants
advertise business
and its capabilities

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O8 Site More production Internal Expansion of A, B, F, Scope of this Top
capacity to allow production capability E, G, H, I opportunity has yet Management
growth and to be fully defined.
development of Controls will be
the site detailed
documented plan of
project . CAPEX
funding

O9 Regulators Opportunity to External Competitive A, B, F, EHS Manager

influence what is advantage over E, G, H, I
regarded as being business opponents
best practice Reduced regulatory
across the industry interaction and
costs

O10 Customer Opportunity to External Competitive A, B, F, Top

Auditors confirm to advantage over E, G, H, I Management
customers that business opponents
their IP, and Increased amount
projects will not be and value of work
at risk when
Pharmaron carries
out their business

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Interested Parties and Business Context relevant to the EMS

Risks/
Interested Party/ External/ Risks/
Opportunity Needs /Expectations/Details Why
Business Context Internal Opportunity
Ref.

Failure of EMS could result in Permit

R1 Regulatory Interested Party External Maintain compliance against Permit conditions and limits Risk
breaches and regulatory non-compliance.

Management of costs, inventory and overheads to ensure Optimising operational efficiency by

R2 Stakeholders Interested Party Internal Risk
profitability eliminating unnecessary costs/waste

Fulfilment of licensing details

Terms of licences understood.
R3 Regulatory Interested Party External Risk Failure of EMS could breach licensing rights
Control and monitoring of processes that could impact on
our adherence to licence conditions

Protection of Company owned IP, customer

R4 Competitors Interested Party External IP, Staff, other customers Risk
base and staff, custody of customer data

Flow of information/samples between processes. Failure of aspects of the EMS could bring
Failure of communication could delay or prevent product about a failure between processes (Effective
R5 Customers Interested Party Internal realisation , challenge the site permit limits, place staff in Risk communication between departments
danger of receiving exposure to radiochemicals or (interface between BD/Quotations/Planning.
chemicals Production/QC/Shipping. EHS & Waste ))

Failure by external suppliers could be

Fulfilment of contract.
R6 Suppliers Interested Party External Risk detrimental to us fulfilling our environmental
Availability of products/services
and regulatory responsibilities

Minimise environmental impact for local

R7 Local community Interested Party External Environmental management Risk
community
Retention of specialist skills and knowledge
Succession planning.
Staff training - multiskilling in small teams to ensure
Time taken to train, gain experience.
suitable knowledge and cover at all times.
R8 Employees Business Context Internal Risk Demographic of workforce is towards an older
population
Recruitment/succession planning.

Levels of authority - accountability.

Retention of customer base, promote
R9 Customers Business Context External Competitors, pricing, changes in customers Risk
business
Risk to staff, data, equipment, site, physical
R10 Security Business Context Internal IP, customer confidentiality, specialist skills and techniques Risk
security

R11 Competitors Business Context External Pricing, lead-times Risk Risk to business

Technological
R12 Business Context Internal Specialist equipment, IT software and hardware Risk Risk to business
Changes
Changes following UK decision to leave EU. Risk to trade
Potential for uncertainty with trading rules,
R13 Stakeholders Business Context External links, inflation and exchange rates, European funding. UK Risk
regulation. Risk is currently unknown
government changes

Failure by the Courier could be detrimental to

Fulfilment of contract to deliver product as agreed, both in us fulfilling our responsibilities to customers.
R14 Courier Business Context External terms of time, conditions to preserve product and to ensure Risk Product could be compromised.
compliance with the transportation of dangerous goods Potential for breach of regulations prompting
regulatory intervention

Failure to adequately maintain the facility

could result in equipment breakdowns which
R15 Stakeholders Business Context Internal Specialist site and equipment, wear and tear Risk
in turn could compromise our ability to meet
the EMS requirements

Potential for uncertainty when quoting to

Stakeholders Lack of knowledge on how we may support new Company
R16 Business Context Internal Risk customers, could lead to delays with providing
Regulators acquisitions
customers with information

Potential for the breaching of the site permit

Maintain compliance against EPR 2016 Permit conditions
R17 Environment Agency Interested Party External Risk due to lack of understanding about the permit
and limits
conditions
Health and Safety
R18 Interested Party External Maintain compliance with Health and safety legislation Risk Potential for being non-compliant
Executive
Health and Safety Maintain compliance with ADR2017 and CDG2009 when Potential for being non-compliant against
R19 Interested Party External Risk
Executive transporting final products and waste materials CDG2009 when transporting materials
Potential for non compliance with the Misuse
Maintain compliance with the sites drug precursor and
R20 Home Office Interested Party External Risk of Drugs Act 1971and Misuse of Drugs
controlled drug licenses
regulations 2001
The Department for
Maintain compliance with the Chemical Weapons
Business, energy
R21 Interested Party External Convention by maintaining records and performing annual Risk Potential for non compliance with CWC
and industrial
returns
strategy (BEIS)
Potential for repeat business, recommendations to others.
Early discussion with customers to ensure
Protects Company's reputation
their requirements are met and the
O1 Customers Interested Party External Minimises discharges and reduces costs Opportunity
radioactivity used and waste created is
Allows for more projects to be carried out with current
minimised
Permit limits
Potential to grow the business, increase
O2 Potential Customers Interested Party External Need to forge links and promote our capabilities Opportunity
market share
Provision of a working environment and conditions which
Company's biggest asset: professional, highly
O3 Employees Interested Party Internal supports the facilitation of customer requirements. Location Opportunity
skilled and motivated staff.
of the facility
succession planning, requirement to employ
O4 Potential employees Interested Party External Competitive terms and conditions of employment Opportunity best skilled candidates available, career
progression

More competitive in marketplace.

Technological
A more environmentally sound and less risky place for Enable to compete in marketplace. Further
O5 Changes and Business Context External Opportunity
customers to send their business enhance our offering to our customers.
Advancement
Further enhance our offering to our customers

Expansion of capability.
Informing clients of acquisition, linking our
Ensuring best practice and common approach to
Site - interaction with known brand with Pharmaron.
O6 Business Context Internal environmental management Opportunity
wider Company Managing customer concerns with change
Strategic acquisitions by Company.
and with environmental management
Potential for investment from the wider Company.

Allow for greater investment to enable

External funding from Government, Research and development.
O7 Stakeholders Business context External Opportunity
Development grants Opportunity to advertise business and its
capabilities

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Stakeholders
Regulators External More production capacity to allow growth and
O8 Business Context Expansion of production capability Opportunity
Customers & Internal development of the site
Staff
Opportunity to influence what is regarded as being best Competitive advantage over business
O9 Regulators Interested Party External practice across the industry Opportunity opponents
Reduced regulatory interaction and costs

Opportunity to confirm to customers that their IP, and Competitive advantage over business
O10 Customer Auditors Interested Party External projects will not be at risk when Pharmaron carries out their Opportunity opponents
business Increased amount and value of work

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Risk Ref. Actions or Recommendations Action owner

R1 Permit compliance document (line by line review) ensures that resources are adequate and equipment/processes are in M Goodwin
place
R1 Good communication - site meetings/production meetings M Goodwin
R1 Controlled documentation in place. QA Dept
R1 Effectiveness of processes is audited and change is controlled. QA Dept
R1, R6, R7 Internal EHS inspection programme
R2 Monitoring costs and continuous improvement of processes Top
Management
R3 Terms of licenses understood M Goodwin
R4, R10 Data and IP security should be considered by the Pharmaron UK ICT security committee IT Dept
QA Dept
R5 Defined responsibilities for processes. Management lines and accountability. Top
Processes are understood by staff and responsibilities are well defined Management
Effectiveness of processes is audited and change is controlled.

R8 Management review of skills of workers Top

Management
R9 Support for staff to attend symposiums and other industry events Top
Membership of industry committees Management
R11 Business Development support to ensure products and services are competitive and targeted Business
Development
R12 Management review of the best practices including technology for the business sector and ensuring improvements and Top
changes are considered in the change control process so that changes are made efficiently, safely and with no negative Management
compliance impacts
R14 The shipping process should be audited on a regular basis to ensure compliance QA
Department
R15 Prioroities for investment such as CAPEX projects should be prioritised to meet the present and future needs of business Top
whilst considering compliance obligations Management
R16 Systems and structure for effective communication and sharing of best practice across all Pharmaron UK sites required Top
Management
R21 Consider a chemical database highlights which highlights any new substances which have compliance conditions and/or
restrictions

Opportunity
Actions or Recommendations Action owner
Ref

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