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Creating Your
Corporate Vision for
Food Safety Compliance
SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES
Our mission is to provide global food businesses with
cutting-edge software products and expert advice
that support you in the management of food safety,
quality and compliance.
We provide you with solutions that exceed your
expectations and are a pleasure to use. These
solutions help your operations staff complete work
faster and better while giving management the
oversight and control that they need.
Food safety, quality and
compliance software for the
forward thinking food company
CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCESAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES
All rights reserved. Published by Safefood 360, Inc. 2015
For more of our professional food safety whitepapers,
presentations, tools and blogs please visit
safefood360.com
Table of Contents
1. 	 Setting the Stage			 6
	
2. 	Challenges				13
	
3.	 Three Areas Where Change	 20
	 Is Happening
4.	 The Five Elements of		 24
	 Your New Vision
5.	 How to Realize Your Vision		 38
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Setting the Stage
What is a Corporate Vision for Food Safety
Compliance and Why Does It Matter?
A corporate vision for food safety compliance is a defined
and documented strategy for mapping out the business’s
objectives for meeting its compliance obligations now and
in the future. It is focused on future-proofing the business’s
need to meet a dynamic compliance framework, maintain
a high level of consumer protection and support business
development objectives.
The Corporate Food Business
The corporate food business may be characterized as a
food enterprise that maintains operations and markets
spanning a number of geographical borders. It is typically
multi-site in nature with a corporate structure which may
include group, business unit and local site operations.
General
Food safety hazards and their management remain an on-
going preoccupation for most food businesses. Food safety
is driven by numerous commercial, legal and regulatory
demands. Often the true nature of food safety hazards and
their associated risks do not become apparent until there
is a specific event. These events may range from a minor
consumer complaint to the more serious market recall in
full public and regulatory glare.
Today, food businesses manage these risks through various
systems of compliance which are developed against spe-
cific standards and internal business needs. These systems
are verified through a framework of internal and external
audits or certification programs, and the expectation is that
they are sufficient to keep the business on the right side of
their compliance and business objectives.
However, the scope and nature of food safety compliance
has been changing dramatically over recent decades. The
changes have taken place on many fronts and have led to
an increased compliance burden.
Globalization
Key among these changes has been the globalization of the
food industry. This has seen the emergence of many large
food businesses operating across numerous geographical
borders and regions. These companies are multi-site in
nature with some form of central organization and man-
agement compliance needs and oversight.
Today, food businesses
manage risks through
various systems of
compliance which are
developed against
specific standards and
internal business needs.
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The challenges of globalization are significant. How does
a global business maintain a system of compliance which
now needs to achieve the following:
•	 Meet legal and regulatory compliance demands across
various national and international legal frameworks
•	 Maintain certification across numerous sites
•	 Meet the specific technical requirements of different
customers
•	 Manage variation in the quality of compliance systems in
local sites due to resource and cultural differences
•	 Maintain the oversight of local operations and system
creep (process of local sites deviating from standard
procedures in an incremental fashion)
•	 Keep track of the shifting legal, social and political
events at a local level
Supply Chain Management
Another significant impact of globalization has been the
increasing complexity of the food supply chain. While direct
relationships between producers and suppliers have steadi-
ly diminished, the demands to obtain more information and
data from stakeholders in the chain have increased dramat-
ically. Obtaining, reviewing, assessing and keeping this data
current has become an almost impossible task for even
well-resourced food companies.
Global Expansion of Third Party Certification
The recent explosion of third-party certification for food
businesses poses additional challenges. GFSI certification
in particular is now considered to be a pre-requisite to any
serious market activity. The benefits are clear. However,
many companies retain the feeling that certification is now
a business overhead and are seeking to derive more value
from the process. For large multi-site companies, local sites
may maintain certification to different GFSI standards, cre-
ating a barrier to business group needs.
GFSI certification
in particular is now
considered to be a pre-
requisite to any serious
market activity.
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Changing Regulatory Environment
Traditionally, legal and regulatory control of the food indus-
try operated at a level far below commercial and certifica-
tion standards. However, this is changing. Recent develop-
ments in the legal frameworks in the USA, Canada, China
and India point to the greater intervention of national and
international agencies in how the food industry maintains
compliance. The simple assumption that legal requirements
will be easily obtained once a GFSI certification is in place
is no longer valid. In terms of market recalls and adverse
business impacts, the regulatory agencies are now the
main players.
Commercial Compliance
The dominance of the many retailers has found expression
in many aspects of the food supply chain. Not least is the
role of retailer technical standards, which can be a pre-req-
uisite for doing business with them. These technical stan-
dards are typically process and product focused and pre-
scriptive in terms of requirements. Meeting them increases
both the operational and compliance costs.
Size and Complexity of Food Businesses
The nature and character of food businesses are changing.
Consolidation of the industry globally is a continuing trend.
The trend is towards fewer, but larger, and more global
businesses.
Multi-site, multi-national companies with developing busi-
ness unit and group structures create the conditions for
significant business and food safety risks. It is not uncom-
mon for senior executives to lose sleep over the unknown
level of control in a small remote plant recently acquired
and absorbed into the group. The potential impact of the
weakest link in a global business can be significant. Man-
agement of this risk presents a key challenge.
Traditionally, legal
and regulatory control
of the food industry
operated at a level far
below commercial and
certification standards.
Cost of Compliance
Another major change in the food industry is the increasing
realization of senior executives that the cost of food safety
compliance is significant.
Historically it was perceived as a relative cost when com-
pared against other business functions such as operations,
logistics and administration. However, as businesses have
matured and successfully adopted lean practices and IT
in these functions, food safety compliance has occupied a
more absolute position in terms of impact on costs, losses
and business risk. From the CEO down to middle man-
agement, there is a growing awareness that not only can
significant savings be made in the area of compliance but
there is value in being smarter about how compliance is
managed.
Perspective
Based on our experience in the food industry, food safety
compliance systems in most food businesses haven’t yet
been fully built to cope with these emerging challenges.
The role of food safety compliance in most companies re-
mains under-invested compared to other business func-
tions.
Due to compliance becoming more important from a cus-
tomer’s perspective, compliance now plays a much larger
role than ever before. FSMA in the United States has been a
driver of new types of regulations, and events like the 2013
Horsegate have caused the introduction of a whole new
wave of rules. The regulations have evolved from the early
days of CODEX to being the highly sophisticated, and com-
plex, international standards of today. In this environment
new types of compliance risks become evident.
Food businesses should formulate a corporate vision for
food safety compliance which reflects the objective chang-
es in the legal, regulatory and commercial environment and
which is future proofed for whatever may come along in the
coming decades.
Another major change in
the food industry is the
increasing realization
of senior executives
that the cost of food
safety compliance is
significant.
Food businesses should
formulate a corporate
vision for food safety
compliance that is
future proofed for
whatever may come in
the coming decades.
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Challenges
Change Management
Change management can be a thorn in the side of many
great initiatives. Effective change management requires
both transformational leadership and strong teamwork
across the organization. Corporate food businesses must
overcome many hurdles to keep pace with an expanding
volume of regulatory requirements while balancing impacts
on people, processes, and technology.
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In our work with food businesses, we have witnessed first-
hand the challenges posed by the expanding scope of com-
pliance. In the following chapters we will highlight some of
these challenges.
Absence of a Vision
Most senior executives in a corporate food business know
there are significant gains to be found by improving how
compliance is managed and controlled in their organization.
However, it can be difficult to see where one should start
and how it fits into the broader development strategy of
the company.
This absence of a vision is due to a number of reasons that
are covered in this paper. However, food safety compliance
is a relatively new function compared to traditional compli-
ance disciplines, e.g., financial or corporate. For this reason,
the best approach to formulating a food safety compliance
vision is only now starting to emerge. Nonetheless, the ab-
sence of an established vision holds companies back from
achieving the gains they seek.
Lacking Integration of FSM in Core
Management Team
Technical teams and managers often feel rejected by the
core business processes and decisions. Food safety compli-
ance as a business objective is often the subject of second-
ary meetings and generalized operational budgets. Costs
savings and efficiencies relating to compliance usually do
not form a core or specific requirement when investing in
ICT or Lean programs. The effect can be to frustrate the
technical compliance team in seeking improvements in their
roles and benefits to the business as a whole.
Non-standardization
One of the most significant risks and destroyers of time and
resources is non-standardization. By non-standardization
we mean the completion of the same tasks by business
units in a different manner.
The absence of a clear
vision holds companies
back from achieving the
gains they seek.
Food safety compliance
as a business objective
is often the subject of
secondary meetings and
generalized operational
budgets.
Variation in how key processes, such as CAPA manage-
ment, are conducted from site to site can result in failure of
some sites to correctly estimate risks. Other sites, on the
other hand, may be expending valuable resources on low
priority issues. From a business group perspective, it can
result in poor and varying visibility on compliance status
and can frustrate efforts to address issues.
Non-standardization can also lead to significant waste
in human and financial resources. People spend time on
activities and workflows that add little value. Even the mere
activity of having to figure out how a local site is conduct-
ing some processes can be enormously wasteful.
The vast majority of systems and processes used for food
safety compliance are repetitive, particularly in the areas of
management processes, HACCP and general controls. They
lend themselves well to standardization.
Poor Quality of System Design
In any organization, poorly designed systems and work-
flows for the management of compliance can lead to
inefficiencies, waste and failure to maintain compliance
standards. Poor design often emerges out of a reaction to
specific arising compliance needs and the efforts of the
company to meet these needs quickly — the quick fix. Over
time, these systems become embedded in the company
and create a “hidden plant” with waste and poor compli-
ance outcomes. In larger enterprises, this effect is more
pronounced as it is magnified across greater and more
complex structures, business units and plants.
Variation in Legal and Commercial Standards
Corporate food businesses by their nature tend to oper-
ate globally both in terms of manufacturing and markets.
Globally spread operations often lead to a situation where
the business as a whole needs to deal with different legal
standards. Legislation relating to risk assessment, hazards,
commodities, composition, origin, ingredients and labeling
can differ remarkably from one country to another.
One of the most
significant risks and
destroyers of time is
non-standardization,
which is the situation
where business units,
sites, departments
and functions
conduct similar or
identical activities,
tasks, processes and
workflows differently.
Poorly designed
systems and workflows
lead to inefficiencies,
waste and failure to
maintain compliance
standards.
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This places large demands on the company in terms of
knowledge and resources to operate and trade legally.
Similarly, a customer such as the large retailers can often
operate on their own set of technical standards. For food
businesses, servicing a number of these retailers while
meeting the requirements can be a daunting task.
Variation in Third Party Certification
Food businesses who operate plants in different locations
across the globe often find that each site has its preferred
third-party standard they wish to be certified against. Even
when they all operate under GFSI, there can be variation in
the specific scheme and protocol used to maintain certifi-
cation.
Impact of Compliance Failures
Food safety failures are an inherent part of production and
distribution of food products. Our goal is the reduction in
the number of failures and the mitigation of their severity.
With greater regulations, standards of compliance, and
investment in food safety control, there remain significant
levels of product failures in the marketplace that affect
consumers. The impact of these failures can be traumatic
financially, to the company, and personally, to the employ-
ees concerned.
Management of an Increasingly Complex
Supply Chain
Recent food safety issues in the market and the resultant
regulatory and commercial reaction has led to a dramatic
increase in the burden to manage supply chain compliance.
Much of this compliance burden centers on the collection,
analysis, and assessment of supply chain data including
specifications, risk assessments, certification, audits, CAPA
and others. It is a major undertaking and for large corporate
food businesses it is almost a dedicated department in its
own right. The issue is compounded by the increasing com-
plexity of the supply chain which makes sourcing primary
data difficult and provides ample opportunity for food fraud
and deception.
Food safety failures
are an inherent part
of production and
distribution of food
products. The real goal
is the reduction in the
number of failures.
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Many food businesses now report major pressure to both
implement and maintain systems for Supplier Quality Man-
agement (SQM), and the sector is crying out for workable
solutions.
Lack of Oversight on Compliance Levels
Across the Group
Many technical managers experience a sense of helpless-
ness regarding the true state of compliance across a large
corporate business with multiple sites. Short of always
getting on a plane and spending days traveling to put their
feet on the sites in question, there is always a nagging
sense that little can be done except react to issues as they
arise. This reactionary approach is not sustainable, par-
ticularly where the business is expanding and compliance
changes are rapid. The lack of real-time oversight and con-
trol are major sources of business risk, personal stress and
costs in maintaining standards of compliance.
“Creep” in Local Systems and Processes
Creep is the slow and incremental change in key processes
and systems that can take place in local plants unknown to
the business unit or group. Individually these changes do
not amount to much but over time the cumulative effect
can be significant and pose a risk to the business and prod-
uct safety.
The process is facilitated by use of open platforms for
document and procedure control, workflows and reporting
(paper, Excel, Word, etc.). Changes can be made by local
managers without any recourse to the business group and
may not be detected until a scheduled internal or external
audit, if at all. The ultimate effect of creep is a lack of con-
trol. It can also undo the efforts to put in a standard system
across the group and hide underlying risks emerging over
time.
Creep is the slow and
incremental change
in key processes and
systems that can
take place in local
plants unknown to the
business unit or group.
The lack of real-time
oversight and control
are major sources of
business risk, personal
stress and costs in
maintaining standards
of compliance.
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Three Areas Where
Change Is Happening
The danger of not taking action
The constantly changing legal and compliance food safety
framework creates challenges.
Corporate food businesses that fail or are slow to react to
this changing environment face significant risks:
•	 Inability to stay on top of mounting compliance
requirements
•	 Rising costs of product failures and non-conformances
which for many companies can be catastrophic
•	 Significant failures of the products in the market damage
business and brand values and the overall performance
of the company
Consider the business impact of:
•	 Public recalls and withdrawals
•	 Increased operational costs and waste in processes
•	 The increasing legal compliance burden on the industry
as a whole as a result of political and consumer reaction
to food safety issues
Given the scope and dynamic nature of today’s food safety
and compliance framework and its clear impact on corpo-
rate food businesses, incremental or reactionary adjust-
ments will not provide a sustainable business model. A new
vision and approach is required which integrates the core
business activities and functions with food safety and its
management.
A new vision and
approach is required
which integrates the
core business activities
and functions with
food safety and its
management.
Corporate food
businesses that fail or
are slow to react to this
changing environment
face significant risks.
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Area of Change in
Food Safety Management
Current State Emerging State
Approach to Food Safety
Management
•	 Key compliance processes, such as auditing, CAPA,
recall, SQM, monitoring and document control are
different from site to site.
•	 Compliance level against industry regulations
differs from site to site even if each site follows the
same certification.
•	 Compliance is heavily reactive which means that
new processes are introduced together with new
regulations.
•	 Reporting and KPIs differ from site to site making
group-wide overview of compliance status nearly
impossible.
•	 Food safety processes are starting to be integrated to single platform as opposed to
being managed in a number of fragmented systems.
•	 Key processes are being group led as opposed to being defined at site level.
•	 Benchmarking and performance management is starting to be possible due to better
application of ICT solutions.
•	 More and more companies are moving away from following multiple certifications and
are adopting one of the GFSI standards.
•	 Business groups are now in the position to offer real support and not just oversight due
to better application of ICT solutions.
Food Safety Management Team •	 Senior compliance roles are disconnected from
business decision making.
•	 Compliance teams are typically overburdened with
tasks and lack resources to deal with the volume
of work.
•	 Communication technologies are improving the way food safety compliance teams can
now interact and audit systems from even remote locations.
•	 Food safety talent is moving freely from site to site. Talent is being developed by
investment in education and professional events participation.
Scope of
Food Safety Management
•	 Food safety compliance is often like a separate
business within the larger group and food safety
risks are not usually taken into account as part of
wider business risk assessments.
•	 Food safety systems are disconnected from
each other, which leads to double work in some
areas while in other areas critical tasks are falling
between the cracks.
•	 While more industry regulations are putting pressure on food safety compliance
organizations to grow, there is also a countering trend of compliance processes being
better managed and concentrated.
Areas of Food Safety Management Undergoing Change
Area of Change in
Food Safety Management
Current State Emerging State
Approach to Food Safety
Management
•	 Key compliance processes, such as auditing, CAPA,
recall, SQM, monitoring and document control are
different from site to site.
•	 Compliance level against industry regulations
differs from site to site even if each site follows the
same certification.
•	 Compliance is heavily reactive which means that
new processes are introduced together with new
regulations.
•	 Reporting and KPIs differ from site to site making
group-wide overview of compliance status nearly
impossible.
•	 Food safety processes are starting to be integrated into a single platform as opposed to
being managed in a number of fragmented systems.
•	 Key processes are being group led as opposed to being defined at a site level.
•	 Benchmarking and performance management is starting to be possible due to better
application of ICT solutions.
•	 More and more companies are moving away from following multiple certifications and
are adopting one of the GFSI standards.
•	 Business groups are now in the position to offer real support, and not just oversight, due
to better application of ICT solutions.
Food Safety Management Team •	 Senior compliance roles are disconnected from
business decision making.
•	 Compliance teams are typically overly burdened
with tasks and with not enough resources to deal
with the volume of work.
•	 Communication technologies are improving the way food safety compliance teams can
now interact and audit systems can be accessed from remote locations.
•	 Food safety talent is moving freely from site to site. Talent is being developed by
investment in education and professional events participation.
Scope of
Food Safety Management
•	 Food safety compliance is often like a separate
business within the larger group and food safety
risks are not usually taken into account as part of
wider business risk assessments.
•	 Food safety systems are disconnected from
each other, which leads to double work in some
areas while in other areas critical tasks are falling
between the crack.
•	 While more industry regulations are putting pressure on food safety compliance
organizations to grow, there is also a countering trend of compliance processes being
better managed and concentrated.
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The Five Elements of
Your New Vision
Following the changes in general approach, team and
scope of food safety, it is now time to start developing your
vision and build a roadmap for realizing it. We recommend
food businesses use the following five tried and tested ap-
proaches as the starting point for developing their corpo-
rate vision.
1. Integration
2. Analysis
3. Standardization
4. Streamlining
5. Improvement
Integrate food safety
management with core
management.
Analysis of legal and
commercial framework
Standardize systems and
processes across group
Streamline and simplify
systems and processes
Build on your success by
seeking and implementing
ongoing improvements in
compliance management
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Approach What is it? Benefits
1. Integration
Integrate food safety
management with core
management
•	 Integration of food safety compliance functions
into the broader business management to
address gaps in risk coverage emerging from
different hazards, products, channels, commercial,
legal and regulatory sources.
•	 Introduce new thinking to decision
making and avoid costly surprises later.
•	 Better utilize the compliance expertise
and knowledge that has previously
remained tacit in your organization.
2. Analysis
Analysis of legal and
commercial framework
•	 Clear and ongoing understanding of the
compliance demands of your business necessary
to support sustainable development and business
objectives.
•	 Provides a clear definition of business,
legal, customer, food safety and
stakeholder requirements.
•	 Sustainable business development.
3. Standardization
Standardize systems and
processes across group
•	 Standardizing compliance processes and systems
across the business group, unit and site level.
•	 Group-wide reporting and analysis
become possible with standardized
processes.
•	 Improves learning from site to site and
allows people to move within the group.
4. Streamlining
Streamline and simplify
systems and processes
•	 Over time, compliance processes have a tendency
to become more complex and time-consuming.
Streamlining means that your team adopts a new
mindset where processes are made leaner, which
will benefit your organization tremendously in the
long run.
•	 Allows your teams focus their efforts on
value-adding work.
•	 Improves employee motivation.
5. Improvement
Build on your success by
seeking and implementing
ongoing improvements in
compliance management
•	 As the regulatory environment keeps on changing
your food safety compliance organization must
keep momentum by promoting continuous
improvement.
•	 Continuous incremental improvement
keeps you continuously ahead in the
regulatory environment.
Five Approaches
Approach What is it? Benefits
1. Integration
Integrate food safety
management with core
management
•	 Integration of food safety compliance functions
into the broader business management to
address gaps in risk coverage emerging from
different hazards, products, channels, commercial,
legal and regulatory sources.
•	 Introduce new thinking to decision
making and avoid costly surprises later.
•	 Better utilize the compliance expertise
and knowledge that has previously
remained tacit in your organization.
2. Analysis
Analysis of legal and
commercial framework
•	 Clear and ongoing understanding of the
compliance demands of your business necessary
to support sustainable development and business
objectives.
•	 Provides a clear definition of business,
legal, customer, food safety and
stakeholder requirements.
•	 Sustainable business development.
3. Standardization
Standardize systems and
processes across group
•	 Standardizing compliance process and systems
across the business group, unit and site level.
•	 Group-wide reporting and analysis
become possible with standardized
processes.
•	 Improves learning from site to site and
allows people to move within the group.
4. Streamlining
Streamline and simplify
systems and processes
•	 Over time, compliance processes have a tendency
to become more complex and time-consuming.
Streamlining means that your team adopts a new
mindset where processes are made leaner, which
will benefit your organization tremendously in the
long run.
•	 Allows your teams focus their efforts on
value-adding work.
•	 Improves employee motivation.
5. Improvement
Build on your success by
seeking and implementing
ongoing improvements in
compliance management
•	 As the regulatory environment keeps on changing
your food safety compliance organization must
keep momentum going by promoting continuous
improvement.
•	 Continuous incremental improvement
keeps you continuously ahead in the
regulatory environment.
This table lists out five different ar-
eas where your organization can start
developing a highly effective corporate
vision for food safety.
Each of these approaches work as a
standalone, but the most benefits are
realized by employing them all in se-
quence.
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Current State Transition State Target State
•	 No clear vision for corporate compliance
•	 Food safety management and compliance lie outside
the core management processes of strategy, finance, HR
and purchasing
•	 Food safety management team members are technical
people with no formal management training or education
•	 	Key decisions, development and budgets are
taken independently of food safety and informally
notified	
•	 Food safety team only involved at management level
during crises or following poor audit outcomes
•	 Food safety representative has informal or no direct line
of communication to senior management
•	 No integration of reporting at senior or enterprise level
•	 No formal system for measuring compliance and not
measured as a cost center
•	 Development of initial
corporate vision for
compliance
•	 Process of integration of
food safety team into key
decisions commences
through formal review
processes
•	 	Commence training of
existing team in key
management skills or
appointment of skilled
manager
•	 Early development of
budgeting processes and
cost centers
•	 Appointment of defined
BG and BU level
management to execute
vision
•	 Fully embedded vision that is documented, with defined KPIs, reviewed and revised
•	 Food safety leaders are a core and integrated part of the general management team
•	 Clear Business Unit and Group organisation structure with defined responsibilities
•	 Key business, strategy, operational and other decisions are taken with food safety
fully part of the process
•	 Food safety managers are trained and experienced in
management skills and communication
•	 Formal budgets and cost centers in place and under
the control of senior technical members
•	 Clear lines of communication to top level executives
•	 Risk and compliance responsibilities are spread across all functions, not just technical
•	 Risk assessment and management is driven by analytics, key risk indicators, and
dynamic risk assessment, monitoring, and testing
•	 Reporting provides actionable information at the enterprise level
1. Integration
Current State Transition State Target State
•	 No clear vision for corporate compliance
•	 Food safety management and compliance lie outside
the core management processes of strategy, finance, HR
and purchasing
•	 Food safety management team members are technical
people with no formal management training or education
•	 	Key decisions, development and budgets are
taken independently of food safety and informally
notified	
•	 Food safety team only involved at management level
during crises or follow poor audit outcomes
•	 Food safety representative has informal or no direct line
of communication to senior management
•	 No integration of reporting at senior or enterprise level
•	 No formal system for measuring compliance and not
measured as a cost centre
•	 Development of initial
corporate vision for
compliance
•	 Process of integration of
food safety team into key
decisions commences
through formal review
processes
•	 	Commence training of
existing team in key
management skills or
appointment of skilled
manager
•	 Early development of
budgeting processes and
cost centres
•	 Appointment of defined
BG and BU level
management to execute
vision
•	 Fully embedded vision that is documented, with defined KPIs, reviewed and revised
•	 Food safety leaders are a core and integrated part of the general management team
•	 Clear Business Unit and Group organization structure with defined responsibilities
•	 Key business, strategy, operational and other decisions are taken with food safety
fully part of the process
•	 Food safety managers are trained and experienced in
management skills and communication
•	 Formal budgets and cost centers in place and under
the control of senior technical members
•	 Clear lines of communication to top level executives
•	 Risk and compliance responsibilities are spread across all functions, not just technical
•	 Risk assessment and management is driven by analytics, key risk indicators, and
dynamic risk assessment, monitoring, and testing
•	 Reporting provides actionable information at the enterprise level
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2. Analysis
Current State Transition State Target State
•	 Poor understanding of legal and commercial
framework
•	 No formal or robust processes for
monitoring, reporting and actioning legal
and commercial changes across the group
•	 Lack of or poor access to legal, technical and
compliance expertise
•	 Increased understanding or limited
access to expert knowledge
•	 Semi-automated systems for
notification of legal and commercial
changes
•	 Automated systems for the monitoring and actioning of legal, regulatory, commercial
and scientific developments in the sector
•	 High-level understanding of legal and commercial framework within internal resources
•	 High-level ability to translate requirements into lean and effective systems of
management and control
•	 Risk Analysis central process to all decisions
Current State Transition State Target State
•	 Poor understanding of legal and commercial
framework
•	 No formal or robust processes for
monitoring, reporting and actioning legal
and commercial changes across the group
•	 Lack of or poor access to legal, technical and
compliance expertise
•	 Increased understanding or limited
access to expert knowledge
•	 Semi-automated systems for
notification of legal and commercial
changes
•	 Automated systems for the monitoring and actioning of legal, regulatory, commercial
and scientific developments in the sector
•	 High-level understanding of legal and commercial framework within internal resources
•	 High-level ability to translate requirements into lean and effective systems of
management and control
•	 Risk Analysis central process to all decisions
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Current State Transition State Target State
•	 	Little or no standardization of compliance
systems or processes across the group
•	 Each local site operating independently in
terms of legal and certification standards
•	 Significant “creep” between sites and within
sites
•	 Little or no oversight of compliance status in
local site
•	 Long lag time between significant events and
notification of same, e.g., product failures
•	 Little or no use of IT or other standardization
tools with high reliance on manual processes
and tools
•	 Changes in system take place at discretion of
local managers with no reporting to central
group
•	 Risk assessment and control is performed in
site “silos”
•	 General or generic hazard identification
•	 Introduction of new ICT and
software solutions for FSM,
SQM and other key process and
workflows
•	 New tools and systems establish
the first phase of standardization
in management processes
workflows, risk assessment,
HACCP, PRPs, etc
•	 Early stages of site alignment
•	 Basis for real-time oversight
developing
•	 Communications practices and
data exchange shifting on-line and
more automated
•	 Risk assessment becoming more
centralized forcing culture change
at both business group and site
level
•	 Local sites use various certification
standards
•	 Utilises ICT and other technical tools to standardize all processes and workflows across
group, unit and site operations
•	 Centralised control from top down with flexibility for local sites based on risk and
businesses cases
•	 Common certification used across group
•	 Each site operates to defined and standardized systems of workflows
•	 Benchmarking of all site activities
•	 Real-time visibility on compliance status at all levels
•	 Real-time notification of significant events
•	 Little or no creep in local systems. Failures are a result of system design and local
variation
•	 Automatic and real-time reporting to business group
•	 Changes controlled at central level – risk defined.
•	 Use of standard risk assessment methods
•	 Specific hazard identification
3. Standardization
Current State Transition State Target State
•	 	Little or no standardization of compliance
systems or processes across the group
•	 Each local site operating independently in
terms of legal and certification standards
•	 Significant “creep” between sites and within
sites
•	 Little or no oversight of compliance status in
local site
•	 Long lag time between significant events and
notification of same, e.g., product failures
•	 Little or no use of IT or other standardization
tools with high reliance on manual processes
and tools
•	 Changes in system take place at discretion of
local managers with no reporting to central
group
•	 Risk assessment and control is performed in
site “silos”
•	 General or generic hazard identification
•	 Introduction of new ICT and
software solutions for FSM,
SQM and other key process and
workflows
•	 New tools and systems establish
the first phase of standardization
in management process
workflows, risk assessment,
HACCP, PRPs, etc
•	 Early stages of site alignment
•	 Basis for real-time oversight
developing
•	 Communications practices and
data exchange shifting on-line and
more automated
•	 Risk assessment becoming more
centralised forcing culture change
at both business group and site
level
•	 Local sites use various certification
standards
•	 Utilizes ICT and other technical tools to standardize all processes and workflows across
group, unit and site operations
•	 Centralized control from top down with flexibility for local sites based on risk and
business case
•	 Common certification used across group
•	 Each site operates to defined and standardized systems of workflows
•	 Benchmarking of all site activities
•	 Real-time visibility on compliance status at all levels
•	 Real-time notification of significant events
•	 Little or no creep in local systems - failures are a result of system design and local
variation
•	 Automatic and real-time reporting to business group
•	 Changes controlled at central level – risk defined
•	 Use of standard risk assessment methods
•	 Specific hazard identification
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Current State Transition State Target State
•	 Systems and processes are complex with
lots of non-value adding workflows and
methods
•	 No assessment of how systems can be
re-designed
•	 High level of manual operation and
systems maintenance
•	 Formal policy of reducing complexity and
non-value adding activities established
•	 Process of reviewing and eliminating
complexity commences
•	 New tools and ICT introduced and at
initial stages of set-up leading to change
in work practices
•	 	Emergence of improvement
opportunities
•	 Systems and processes are as simple as possible but not simpler
•	 “Waste” has been eliminated from all key processes and workflows	
•	 Quality design of systems built in from the start
•	 Virtual elimination of manual processes which repeat
4. Streamlining
Current State Transition State Target State
•	 Systems and process are complex with
lots of non-value adding workflows and
methods
•	 No assessment of how systems can be
re-designed
•	 High level of manual operation and
systems maintenance
•	 Formal policy of reducing complexity and
non-value adding activities established
•	 Process of reviewing and eliminating
complexity commences
•	 New tools and ICT introduced and at
initial stages of set-up leading to change
in work practices
•	 	Emergence of improvement
opportunities
•	 Systems and processes are as simple as possible but not simpler
•	 “Waste” has been eliminated from all key processes and workflows	
•	 Quality design of systems built in from the start
•	 Virtual elimination of manual processes which repeat
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Current State Transition State Target State
•	 Systems and processes have not been
assessed for improvement opportunities
•	 No management of change process in
place
•	 No use of KPIs or reporting
•	 Decisions to improve based on
immediate compliance need and not
sustainability
•	 Poor or no validation of systems
•	 Certification in place because it is
required
•	 Benefits of improvement as a business
process increasing in management
consciousness
•	 New systems and standardization
highlight more improvement
opportunities
•	 Ongoing review and identification of improvement projects based on quality data
generated from systems
•	 Clear management of KPIs
•	 Decisions based on sustainable objectives and not quick-fixes
•	 Real-time oversight, visibility notification and escalation of activities based on risk
assessment
•	 Supplier quality management, management of change and other key improvement
processes are fully integrated into overall FSM
•	 Benchmarking is used in all sites to drive improvement and best practice
•	 Strong validation of systems for hazards and risks
•	 Certification used for improvement
5. Improvement5. Improvement
Current State Transition State Target State
•	 Systems and processes have not been
assessed for improvement opportunities
•	 No management of change process in
place
•	 No use of KPIs or reporting
•	 Decisions to improve based on
immediate compliance need and not
sustainability
•	 Poor or no validation of systems
•	 Certification in place because it is
required
•	 Benefits of improvement as a business
process increasing in management
consciousness
•	 New systems and standardization
highlight more improvement
opportunities
•	 Ongoing review and identification of improvement projects based on quality data
generated from systems
•	 Clear management of KPIs
•	 Decisions based on sustainable objectives and not quick-fixes
•	 Real-time oversight, visibility notification and escalation of activities based on risk
assessment
•	 Supplier quality management, management of change and other key improvement
processes are fully integrated into overall FSM
•	 Benchmarking is used in all sites to drive improvement and best practice
•	 Strong validation of systems for hazards and risks
•	 Certification used for improvement
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How to Realize
Your Vision
Managing Change
A key hurdle to realizing your vision will be the management
of change. A grand vision requires an extensive project
and you need to be equipped with the necessary tools and
knowledge to be successful.
Key success factors include:
•	 Management commitment is present to making your
change initiatives stick and carry them over the initial
challenges
•	 A sufficient budget needs to be reserved for change
projects every year
•	 Change is usually met with organizational inertia;
overcome the inertia by involving people from all levels
of the organization early on in the change process
making sure that they feel ownership in the change.
•	 Focus your communication efforts to explaining the
meaning and purpose of change, as opposed to fixating
on mere benefits of change. People will respond to your
change initiative more positively when they understand
the impact of change within the big picture. Instead of
explaining that “this new mock recall process will save
1 hour of your time” you should communicate that “this
improved mock recall process will make sure that if
we ever have to conduct a real recall, you will be in a
better position to pull the product out of the market and
potentially save lives by being better prepared”.
Key success factors
include broad
executive-level
ownership and visible
support for change.
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1. Integration
Integration of food safety management with core manage-
ment. Making food safety compliance an embedded ele-
ment of corporate business activities.
The first step in developing your corporate vision and
strategy is the real integration of the compliance team into
the core business management processes. Integration is
required to ensure that all decisions are made with con-
sideration to the compliance demands of the business and
to avoid compliance failures. Your vision document should
address each of these areas with clear projects to support
their implementation.
Area Actions
Organization The first step is to define the current organizational structure and
responsibilities at the group, unit and site level. Identify where
gaps exist in terms of resources, competencies and assigned
responsibilities.
The objective here is to identify where opportunities exist to
integrate compliance management into the core management
processes.
Group Compliance
Officer
If not already in place, the company should install a person in the
position of Group Compliance Officer. This is a senior position, and
the person should be an experienced individual with competency
in management and communication skills. A robust knowledge of
compliance is also essential. This person will report directly to the
most senior level in the organization.
It will be this role that will facilitate the changing culture of the
organization and delivery of the corporate compliance vision and
strategy.
The role will naturally cover other compliance related functions such
as health, safety and environmental management.
The first step in
developing your
corporate vision and
strategy is the real
integration of the
compliance team into
the core business
management processes.
Area Actions
Responsibilities Clear responsibilities regarding food safety compliance should
be assigned at group, unit and site level. These may be existing
positions with expanded responsibilities or new appointments. In
any event, they should have a clearly assigned responsibility and
authority to affect change at the appropriate level.
Competency &
Training
For successful integration of compliance management into the
core team, it is essential that specific competencies in the areas of
management skills, change management and communication at
senior level are present.
Where gaps exist, training and professional development programs
should be developed and implemented.
Integrate Senior
Group Position
The process of integrating the Group Compliance Offer into the
senior management team, key processes and decisions should
commence. Practically, this means their presence at management
meetings regarding business planning, strategy, budgeting and
capital programs.
Of course, the exact nature of this and extent to which it is needed
will vary from business to business, but in all cases the objective is
to ensure key business, strategic and operational decisions are all
made in the context of compliance needs.
Communication Develop integrated communication and reporting channels covering
business group, business unit and site level compliance risks.
Business unit and site level management as well as operation and
compliance risk functions should team-up to design an integrated
approach that helps to establish risk communication. Business
Group management should lead this effort to provide oversight and
compliance expertise.
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2. Analysis
It is time to conduct an analysis of legal and commercial
frameworks. Clear definition of business, legal, customer,
food safety and stakeholder requirements.
The next step in developing your corporate vision for food
safety compliance is an analysis of the compliance frame-
work that governs your entire food business operations and
markets. The analysis should be conducted by competent
resources and, where required, expertise should be sought.
The scope of this can be endless, so take your time and
take a structured approach. The number of food businesses
which cannot clearly define the scope of their compliance
obligations is surprising.
This process essentially allows you to define the specifica-
tion of compliance that your vision needs to address.
The output of this step should be a clear register of compli-
ance references, including copies of all relevant laws, acts,
and regulations, codes of practices, technical documents
and standards. Also take account of geographical require-
ments for both operations and mar­kets. The final part of
this process is a clear identification of common require-
ments across the compliance frame­work and outliers. This
analysis facilitates the next stage of process - standardiza-
tion.
The next step in
developing your
corporate vision for
food safety compliance
is an analysis of the
compliance framework
that governs your
entire food business
operations and markets.
Area Actions
Identification
of scope of
compliance
framework
Identify all compliance standards relevant to the business:
•	 Regulations
•	 Directives
•	 Acts
•	 Codes of practice
•	 Technical standards
•	 Certification standards
•	 Internal standards
•	 	Commodity standards
•	 Industry standards
•	 Customer specifications
Identification of
geographical scope
of compliance
framework
•	 FDA
•	 EU
•	 WHO / Codex
•	 Other geographic markets and areas
Identification
of common
compliance
requirements and
outliers
Review and assess the requirements from above and identify the
common requirements contained in the various standards. It will
often be the case that significant aspects of these requirements are
identical or can be met by adopting the most stringent standard as
the benchmark.
Similarly, specific requirements that may lie outside the general
requirements of the standards should be identified and included in
the scope of the vision.
Identification of
specific regulatory
aspects required
for local markets
Some local markets may have very specific regulatory protocols
that need to be addressed when conducting business. For
example, the FDA under FSMA has very specific requirements and
administrative protocols for importers.
Development of a
register and library
of compliance
framework
documents
A register of all relevant compliance framework documents should
be developed centrally and indexed by business application,
operation, product, process, market, unit and site. This register,
along with copies of all these documents, should be centrally
controlled.
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3. Standardization
Standardize systems and processes across group.
Once the compliance framework has been defined, you are
ready for the next step - standardization of relevant pro-
cesses and systems. The reasons for this have already been
discussed, but it is this stage where the real benefits of
your vision become realized. When done right the benefits
can be obtained quickly.
In large corporate food businesses there exists various pro-
cesses, systems, procedures, workflows, forms and records
designed to define and record compliance related activities.
They will have been installed to meet legal, certification
and customer requirements. These pro­cedures will exist at
group, unit and site level and will have been developed in
organizational silos over the years in reaction to different
requirements.
Most businesses have undertaken improvement projects
to standardize these systems across the group with lim-
ited success due to the open platforms used and process
creep. The key to this step is identifying which processes
and systems should be standardized and then selecting the
right platform to implement standardization. In most cases,
a software will be used as the platform of choice, which
means that the project needs to clearly define the require-
ments for the software.
It should be noted that the quality or effectiveness of the
process or tool is not the main focus of this step, but rather
the standardization of the process is. Assuming that the
platform has been well designed, improvements to the pro-
cess will be easy to achieve at a later stage.
Once the compliance
framework has been
defined, you are ready
for the next step which
is the standardization of
relevant processes and
systems.
Area Actions
Identify processes
and systems
Identify the key group, unit and plant level processes and systems
to be standardized. This should include:
•	 HACCP and other risk management systems	
•	 Management processes
•	 General PRPs
•	 Operational PRPs
•	 Documents control
•	 Supply Chain Management
Systems and processes that lend themselves well to
standardization include auditing, CAPA, management review, non-
conformance management, recall, deviation, HACCP and document
management workflow.
Standardization
Platform
Specification
Start a project to define the specification of the software platform
required to deliver standardization. This project should be
conducted by a cross-functional team made up of group, unit and
site leaders, users, IT, and change management members. The
specification should be comprehensive and include:
•	 Scope of the application(s) covering HACCP,
Management, PRPs, Monitoring, Documents, SQM
•	 Business structure supports
•	 Enterprise requirements supports
•	 Security
•	 	Workflows
•	 Oversight, notification, alerts, user controls
•	 Support
•	 Scalability
Remember, the platform must be capable of preventing local creep
of processes and provide clear central business group oversight.
Also, refer to the next step in the process, streamlining, as an input
for your platform specification.
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Area Actions
Tender Process Undertake a robust tendering process to select the right product
and service provider(s).
Certification A project to install a standard certification scheme across the group
and all sites. It is crucial that, where possible, all operational units
use a common certification standard to reduce costs and support a
standard process. Options include:
•	 ISO 22000 (Group level)
•	 FSSC 22000 (Unit and Site Level)
•	 Other GFSI standards (Site Level)
Implementation Following selection of the correct platform and service provider, a
project for the management and implementation of the solution
should commence.
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4. Streamlining
Simplify systems and processes.
After your industry-wide analysis and standardization of
processes you will have the right platform in place to start
streamlining your systems. This process of streamlining
needs to start from the most resource intensive processes
so you will have to spend time identifying where most of
the waste is generated.
Note that if the standardization platform selected in the
previous step is robust enough, you will have already
achieved gains in this area and now have the tool that al-
lows for quick implementation of lean principles.
Area Actions
Organizational
capabilities
•	 Give key people access to the data that allows them to identify
wasteful processes.
•	 While you want to remove creep from your key compliance
processes, you need to give your staff the right tools and
authority to make improvements in their work.
Culture •	 It needs to become second nature in your culture to rethink
processes and question the status quo; allow people to speak
their mind and approach management openly.
•	 Embrace open innovation and gather feedback from all levels of
the organization.
•	 Encourage people to become problem solvers, not complainers.
Compliance processes
and organizational
structures now create
the environment to start
using lean principles,
identify waste in
compliance processes,
and start implementing
more value-added
activities.
Area Actions
Process value •	 Improve the value of your compliance processes by estimating
the perceived value, cost and effort of your processes and then
streamlining those with the worst ROI.
•	 Introduce cost tracking as part of your deviation management;
this will help you make the cost of noncompliance more
transparent.
Process efficiency •	 Remove unnecessary steps, approvals, administrative tasks and
decisions from compliance processes.
•	 Identify bottlenecks in your compliance processes; bottlenecks
are typically related to approvals or verifications that rely on a
single person. Find ways to spread the work.
Performance
management
•	 The management of your compliance processes should be based
on relevant and easily monitored KPIs, that you can then use as
part of group wide streamlining projects. Example of such KPIs
include: complaints time to closing out, mock recall duration,
time to approving a document etc.
•	 Make sure your KPIs are part of the wider compliance strategy
and are often communicated to your people.
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5. Improvement
Build on your success by seeking and implementing ongo-
ing improvements in compliance management.
Improvement is the final stage of realizing your vision. The
objective is to embed an approach to improving the various
compliance workflows on a continuous basis.
To keep your systems improving continuously, make sure to
schedule regular reviews with your team that reveal where
you currently are and where you need to undertake new ini-
tiatives. You should also collect feedback from all levels of
your organization.
Area Actions
Teams •	 Establish project teams to examine processes for improvement
and waste elimination.
•	 	Assign responsibilities for continuous improvement.
Standardization of
root causes
•	 Generate a standard list of root causes from Business Group
down. This list can then be used at all levels of your organization
to support quality reporting and guide improvement initiatives.
Analysis and
reporting
•	 Standardize the reporting of non-conformances and put extra
focus on the categorization and analysis of root causes.
•	 Establish regular and ongoing management review processes
with standard inputs and outputs.
Projects •	 Clear identification of projects.
•	 Undertake projects with clear metrics to achieve continuous
improvement.
•	 Utilize specific improvement tools in your reporting. This should
include the use of statistical tools.
53
CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCESAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES
Available Modules
•	 Document Control
•	 HACCP
•	 Hazard Database
•	 Complaints
•	 CAPA
•	 Non-conformance
•	 Management review
•	 Auditing
•	 Recall
•	 Quality Management
•	 Calibration
•	 Cleaning
•	 Pest Control
•	 Employee Training
•	 Microbiological Control
•	 Traceability Testing
•	 Medical Screening
•	 Contamination Control
•	 Code of Practice
•	 Monitoring
•	 Receiving Inspections
•	 Batching
•	 Supplier Control
•	 Supplier Portal
•	 Employees
•	 Suppliers
•	 Product
•	 Materials
•	 Alerts
•	 Reports & Analytics
Document Control
Upload, approve and review all your
central documents. Keep track of
versions and be notified of changes.
HACCP
Build and maintain all your HACCP
plans. Benefit from advanced risk
assessment models and decision
trees.
Management
Paper free management processes
with automatic reporting.
PRPs
Document and manage your daily
operations and enjoy the benefits of
automatic scheduling and alerts.
Monitoring
Monitor any parameters in your
system including CCPs, oPRPs and
material quality.
Supplier Management
Approve, risk assess and review
suppliers. Conduct audits, collect
documents, and let your suppliers
complete self-assessments.
Utilities
All the necessary tools ranging from
alerts to reporting.
SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES
How can Safefood 360°
help you realize your
vision?
SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES

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Creating Your Corporate Vision for Food Safety Management

  • 1. Creating Your Corporate Vision for Food Safety Compliance SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES
  • 2. Our mission is to provide global food businesses with cutting-edge software products and expert advice that support you in the management of food safety, quality and compliance. We provide you with solutions that exceed your expectations and are a pleasure to use. These solutions help your operations staff complete work faster and better while giving management the oversight and control that they need. Food safety, quality and compliance software for the forward thinking food company
  • 3. CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCESAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES All rights reserved. Published by Safefood 360, Inc. 2015 For more of our professional food safety whitepapers, presentations, tools and blogs please visit safefood360.com Table of Contents 1. Setting the Stage 6 2. Challenges 13 3. Three Areas Where Change 20 Is Happening 4. The Five Elements of 24 Your New Vision 5. How to Realize Your Vision 38
  • 4. 9 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 8 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Setting the Stage What is a Corporate Vision for Food Safety Compliance and Why Does It Matter? A corporate vision for food safety compliance is a defined and documented strategy for mapping out the business’s objectives for meeting its compliance obligations now and in the future. It is focused on future-proofing the business’s need to meet a dynamic compliance framework, maintain a high level of consumer protection and support business development objectives. The Corporate Food Business The corporate food business may be characterized as a food enterprise that maintains operations and markets spanning a number of geographical borders. It is typically multi-site in nature with a corporate structure which may include group, business unit and local site operations. General Food safety hazards and their management remain an on- going preoccupation for most food businesses. Food safety is driven by numerous commercial, legal and regulatory demands. Often the true nature of food safety hazards and their associated risks do not become apparent until there is a specific event. These events may range from a minor consumer complaint to the more serious market recall in full public and regulatory glare. Today, food businesses manage these risks through various systems of compliance which are developed against spe- cific standards and internal business needs. These systems are verified through a framework of internal and external audits or certification programs, and the expectation is that they are sufficient to keep the business on the right side of their compliance and business objectives. However, the scope and nature of food safety compliance has been changing dramatically over recent decades. The changes have taken place on many fronts and have led to an increased compliance burden. Globalization Key among these changes has been the globalization of the food industry. This has seen the emergence of many large food businesses operating across numerous geographical borders and regions. These companies are multi-site in nature with some form of central organization and man- agement compliance needs and oversight. Today, food businesses manage risks through various systems of compliance which are developed against specific standards and internal business needs.
  • 5. 11 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 10 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES The challenges of globalization are significant. How does a global business maintain a system of compliance which now needs to achieve the following: • Meet legal and regulatory compliance demands across various national and international legal frameworks • Maintain certification across numerous sites • Meet the specific technical requirements of different customers • Manage variation in the quality of compliance systems in local sites due to resource and cultural differences • Maintain the oversight of local operations and system creep (process of local sites deviating from standard procedures in an incremental fashion) • Keep track of the shifting legal, social and political events at a local level Supply Chain Management Another significant impact of globalization has been the increasing complexity of the food supply chain. While direct relationships between producers and suppliers have steadi- ly diminished, the demands to obtain more information and data from stakeholders in the chain have increased dramat- ically. Obtaining, reviewing, assessing and keeping this data current has become an almost impossible task for even well-resourced food companies. Global Expansion of Third Party Certification The recent explosion of third-party certification for food businesses poses additional challenges. GFSI certification in particular is now considered to be a pre-requisite to any serious market activity. The benefits are clear. However, many companies retain the feeling that certification is now a business overhead and are seeking to derive more value from the process. For large multi-site companies, local sites may maintain certification to different GFSI standards, cre- ating a barrier to business group needs. GFSI certification in particular is now considered to be a pre- requisite to any serious market activity.
  • 6. 13 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 12 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Changing Regulatory Environment Traditionally, legal and regulatory control of the food indus- try operated at a level far below commercial and certifica- tion standards. However, this is changing. Recent develop- ments in the legal frameworks in the USA, Canada, China and India point to the greater intervention of national and international agencies in how the food industry maintains compliance. The simple assumption that legal requirements will be easily obtained once a GFSI certification is in place is no longer valid. In terms of market recalls and adverse business impacts, the regulatory agencies are now the main players. Commercial Compliance The dominance of the many retailers has found expression in many aspects of the food supply chain. Not least is the role of retailer technical standards, which can be a pre-req- uisite for doing business with them. These technical stan- dards are typically process and product focused and pre- scriptive in terms of requirements. Meeting them increases both the operational and compliance costs. Size and Complexity of Food Businesses The nature and character of food businesses are changing. Consolidation of the industry globally is a continuing trend. The trend is towards fewer, but larger, and more global businesses. Multi-site, multi-national companies with developing busi- ness unit and group structures create the conditions for significant business and food safety risks. It is not uncom- mon for senior executives to lose sleep over the unknown level of control in a small remote plant recently acquired and absorbed into the group. The potential impact of the weakest link in a global business can be significant. Man- agement of this risk presents a key challenge. Traditionally, legal and regulatory control of the food industry operated at a level far below commercial and certification standards. Cost of Compliance Another major change in the food industry is the increasing realization of senior executives that the cost of food safety compliance is significant. Historically it was perceived as a relative cost when com- pared against other business functions such as operations, logistics and administration. However, as businesses have matured and successfully adopted lean practices and IT in these functions, food safety compliance has occupied a more absolute position in terms of impact on costs, losses and business risk. From the CEO down to middle man- agement, there is a growing awareness that not only can significant savings be made in the area of compliance but there is value in being smarter about how compliance is managed. Perspective Based on our experience in the food industry, food safety compliance systems in most food businesses haven’t yet been fully built to cope with these emerging challenges. The role of food safety compliance in most companies re- mains under-invested compared to other business func- tions. Due to compliance becoming more important from a cus- tomer’s perspective, compliance now plays a much larger role than ever before. FSMA in the United States has been a driver of new types of regulations, and events like the 2013 Horsegate have caused the introduction of a whole new wave of rules. The regulations have evolved from the early days of CODEX to being the highly sophisticated, and com- plex, international standards of today. In this environment new types of compliance risks become evident. Food businesses should formulate a corporate vision for food safety compliance which reflects the objective chang- es in the legal, regulatory and commercial environment and which is future proofed for whatever may come along in the coming decades. Another major change in the food industry is the increasing realization of senior executives that the cost of food safety compliance is significant. Food businesses should formulate a corporate vision for food safety compliance that is future proofed for whatever may come in the coming decades.
  • 7. 15 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 14 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Challenges Change Management Change management can be a thorn in the side of many great initiatives. Effective change management requires both transformational leadership and strong teamwork across the organization. Corporate food businesses must overcome many hurdles to keep pace with an expanding volume of regulatory requirements while balancing impacts on people, processes, and technology.
  • 8. 17 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 16 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES In our work with food businesses, we have witnessed first- hand the challenges posed by the expanding scope of com- pliance. In the following chapters we will highlight some of these challenges. Absence of a Vision Most senior executives in a corporate food business know there are significant gains to be found by improving how compliance is managed and controlled in their organization. However, it can be difficult to see where one should start and how it fits into the broader development strategy of the company. This absence of a vision is due to a number of reasons that are covered in this paper. However, food safety compliance is a relatively new function compared to traditional compli- ance disciplines, e.g., financial or corporate. For this reason, the best approach to formulating a food safety compliance vision is only now starting to emerge. Nonetheless, the ab- sence of an established vision holds companies back from achieving the gains they seek. Lacking Integration of FSM in Core Management Team Technical teams and managers often feel rejected by the core business processes and decisions. Food safety compli- ance as a business objective is often the subject of second- ary meetings and generalized operational budgets. Costs savings and efficiencies relating to compliance usually do not form a core or specific requirement when investing in ICT or Lean programs. The effect can be to frustrate the technical compliance team in seeking improvements in their roles and benefits to the business as a whole. Non-standardization One of the most significant risks and destroyers of time and resources is non-standardization. By non-standardization we mean the completion of the same tasks by business units in a different manner. The absence of a clear vision holds companies back from achieving the gains they seek. Food safety compliance as a business objective is often the subject of secondary meetings and generalized operational budgets. Variation in how key processes, such as CAPA manage- ment, are conducted from site to site can result in failure of some sites to correctly estimate risks. Other sites, on the other hand, may be expending valuable resources on low priority issues. From a business group perspective, it can result in poor and varying visibility on compliance status and can frustrate efforts to address issues. Non-standardization can also lead to significant waste in human and financial resources. People spend time on activities and workflows that add little value. Even the mere activity of having to figure out how a local site is conduct- ing some processes can be enormously wasteful. The vast majority of systems and processes used for food safety compliance are repetitive, particularly in the areas of management processes, HACCP and general controls. They lend themselves well to standardization. Poor Quality of System Design In any organization, poorly designed systems and work- flows for the management of compliance can lead to inefficiencies, waste and failure to maintain compliance standards. Poor design often emerges out of a reaction to specific arising compliance needs and the efforts of the company to meet these needs quickly — the quick fix. Over time, these systems become embedded in the company and create a “hidden plant” with waste and poor compli- ance outcomes. In larger enterprises, this effect is more pronounced as it is magnified across greater and more complex structures, business units and plants. Variation in Legal and Commercial Standards Corporate food businesses by their nature tend to oper- ate globally both in terms of manufacturing and markets. Globally spread operations often lead to a situation where the business as a whole needs to deal with different legal standards. Legislation relating to risk assessment, hazards, commodities, composition, origin, ingredients and labeling can differ remarkably from one country to another. One of the most significant risks and destroyers of time is non-standardization, which is the situation where business units, sites, departments and functions conduct similar or identical activities, tasks, processes and workflows differently. Poorly designed systems and workflows lead to inefficiencies, waste and failure to maintain compliance standards.
  • 9. 19 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 18 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES This places large demands on the company in terms of knowledge and resources to operate and trade legally. Similarly, a customer such as the large retailers can often operate on their own set of technical standards. For food businesses, servicing a number of these retailers while meeting the requirements can be a daunting task. Variation in Third Party Certification Food businesses who operate plants in different locations across the globe often find that each site has its preferred third-party standard they wish to be certified against. Even when they all operate under GFSI, there can be variation in the specific scheme and protocol used to maintain certifi- cation. Impact of Compliance Failures Food safety failures are an inherent part of production and distribution of food products. Our goal is the reduction in the number of failures and the mitigation of their severity. With greater regulations, standards of compliance, and investment in food safety control, there remain significant levels of product failures in the marketplace that affect consumers. The impact of these failures can be traumatic financially, to the company, and personally, to the employ- ees concerned. Management of an Increasingly Complex Supply Chain Recent food safety issues in the market and the resultant regulatory and commercial reaction has led to a dramatic increase in the burden to manage supply chain compliance. Much of this compliance burden centers on the collection, analysis, and assessment of supply chain data including specifications, risk assessments, certification, audits, CAPA and others. It is a major undertaking and for large corporate food businesses it is almost a dedicated department in its own right. The issue is compounded by the increasing com- plexity of the supply chain which makes sourcing primary data difficult and provides ample opportunity for food fraud and deception. Food safety failures are an inherent part of production and distribution of food products. The real goal is the reduction in the number of failures.
  • 10. 21 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 20 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Many food businesses now report major pressure to both implement and maintain systems for Supplier Quality Man- agement (SQM), and the sector is crying out for workable solutions. Lack of Oversight on Compliance Levels Across the Group Many technical managers experience a sense of helpless- ness regarding the true state of compliance across a large corporate business with multiple sites. Short of always getting on a plane and spending days traveling to put their feet on the sites in question, there is always a nagging sense that little can be done except react to issues as they arise. This reactionary approach is not sustainable, par- ticularly where the business is expanding and compliance changes are rapid. The lack of real-time oversight and con- trol are major sources of business risk, personal stress and costs in maintaining standards of compliance. “Creep” in Local Systems and Processes Creep is the slow and incremental change in key processes and systems that can take place in local plants unknown to the business unit or group. Individually these changes do not amount to much but over time the cumulative effect can be significant and pose a risk to the business and prod- uct safety. The process is facilitated by use of open platforms for document and procedure control, workflows and reporting (paper, Excel, Word, etc.). Changes can be made by local managers without any recourse to the business group and may not be detected until a scheduled internal or external audit, if at all. The ultimate effect of creep is a lack of con- trol. It can also undo the efforts to put in a standard system across the group and hide underlying risks emerging over time. Creep is the slow and incremental change in key processes and systems that can take place in local plants unknown to the business unit or group. The lack of real-time oversight and control are major sources of business risk, personal stress and costs in maintaining standards of compliance.
  • 11. 23 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 22 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Three Areas Where Change Is Happening The danger of not taking action The constantly changing legal and compliance food safety framework creates challenges. Corporate food businesses that fail or are slow to react to this changing environment face significant risks: • Inability to stay on top of mounting compliance requirements • Rising costs of product failures and non-conformances which for many companies can be catastrophic • Significant failures of the products in the market damage business and brand values and the overall performance of the company Consider the business impact of: • Public recalls and withdrawals • Increased operational costs and waste in processes • The increasing legal compliance burden on the industry as a whole as a result of political and consumer reaction to food safety issues Given the scope and dynamic nature of today’s food safety and compliance framework and its clear impact on corpo- rate food businesses, incremental or reactionary adjust- ments will not provide a sustainable business model. A new vision and approach is required which integrates the core business activities and functions with food safety and its management. A new vision and approach is required which integrates the core business activities and functions with food safety and its management. Corporate food businesses that fail or are slow to react to this changing environment face significant risks.
  • 12. 25 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 24 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Area of Change in Food Safety Management Current State Emerging State Approach to Food Safety Management • Key compliance processes, such as auditing, CAPA, recall, SQM, monitoring and document control are different from site to site. • Compliance level against industry regulations differs from site to site even if each site follows the same certification. • Compliance is heavily reactive which means that new processes are introduced together with new regulations. • Reporting and KPIs differ from site to site making group-wide overview of compliance status nearly impossible. • Food safety processes are starting to be integrated to single platform as opposed to being managed in a number of fragmented systems. • Key processes are being group led as opposed to being defined at site level. • Benchmarking and performance management is starting to be possible due to better application of ICT solutions. • More and more companies are moving away from following multiple certifications and are adopting one of the GFSI standards. • Business groups are now in the position to offer real support and not just oversight due to better application of ICT solutions. Food Safety Management Team • Senior compliance roles are disconnected from business decision making. • Compliance teams are typically overburdened with tasks and lack resources to deal with the volume of work. • Communication technologies are improving the way food safety compliance teams can now interact and audit systems from even remote locations. • Food safety talent is moving freely from site to site. Talent is being developed by investment in education and professional events participation. Scope of Food Safety Management • Food safety compliance is often like a separate business within the larger group and food safety risks are not usually taken into account as part of wider business risk assessments. • Food safety systems are disconnected from each other, which leads to double work in some areas while in other areas critical tasks are falling between the cracks. • While more industry regulations are putting pressure on food safety compliance organizations to grow, there is also a countering trend of compliance processes being better managed and concentrated. Areas of Food Safety Management Undergoing Change Area of Change in Food Safety Management Current State Emerging State Approach to Food Safety Management • Key compliance processes, such as auditing, CAPA, recall, SQM, monitoring and document control are different from site to site. • Compliance level against industry regulations differs from site to site even if each site follows the same certification. • Compliance is heavily reactive which means that new processes are introduced together with new regulations. • Reporting and KPIs differ from site to site making group-wide overview of compliance status nearly impossible. • Food safety processes are starting to be integrated into a single platform as opposed to being managed in a number of fragmented systems. • Key processes are being group led as opposed to being defined at a site level. • Benchmarking and performance management is starting to be possible due to better application of ICT solutions. • More and more companies are moving away from following multiple certifications and are adopting one of the GFSI standards. • Business groups are now in the position to offer real support, and not just oversight, due to better application of ICT solutions. Food Safety Management Team • Senior compliance roles are disconnected from business decision making. • Compliance teams are typically overly burdened with tasks and with not enough resources to deal with the volume of work. • Communication technologies are improving the way food safety compliance teams can now interact and audit systems can be accessed from remote locations. • Food safety talent is moving freely from site to site. Talent is being developed by investment in education and professional events participation. Scope of Food Safety Management • Food safety compliance is often like a separate business within the larger group and food safety risks are not usually taken into account as part of wider business risk assessments. • Food safety systems are disconnected from each other, which leads to double work in some areas while in other areas critical tasks are falling between the crack. • While more industry regulations are putting pressure on food safety compliance organizations to grow, there is also a countering trend of compliance processes being better managed and concentrated.
  • 13. 27 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 26 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES The Five Elements of Your New Vision Following the changes in general approach, team and scope of food safety, it is now time to start developing your vision and build a roadmap for realizing it. We recommend food businesses use the following five tried and tested ap- proaches as the starting point for developing their corpo- rate vision. 1. Integration 2. Analysis 3. Standardization 4. Streamlining 5. Improvement Integrate food safety management with core management. Analysis of legal and commercial framework Standardize systems and processes across group Streamline and simplify systems and processes Build on your success by seeking and implementing ongoing improvements in compliance management 27 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE
  • 14. 29 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 28 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Approach What is it? Benefits 1. Integration Integrate food safety management with core management • Integration of food safety compliance functions into the broader business management to address gaps in risk coverage emerging from different hazards, products, channels, commercial, legal and regulatory sources. • Introduce new thinking to decision making and avoid costly surprises later. • Better utilize the compliance expertise and knowledge that has previously remained tacit in your organization. 2. Analysis Analysis of legal and commercial framework • Clear and ongoing understanding of the compliance demands of your business necessary to support sustainable development and business objectives. • Provides a clear definition of business, legal, customer, food safety and stakeholder requirements. • Sustainable business development. 3. Standardization Standardize systems and processes across group • Standardizing compliance processes and systems across the business group, unit and site level. • Group-wide reporting and analysis become possible with standardized processes. • Improves learning from site to site and allows people to move within the group. 4. Streamlining Streamline and simplify systems and processes • Over time, compliance processes have a tendency to become more complex and time-consuming. Streamlining means that your team adopts a new mindset where processes are made leaner, which will benefit your organization tremendously in the long run. • Allows your teams focus their efforts on value-adding work. • Improves employee motivation. 5. Improvement Build on your success by seeking and implementing ongoing improvements in compliance management • As the regulatory environment keeps on changing your food safety compliance organization must keep momentum by promoting continuous improvement. • Continuous incremental improvement keeps you continuously ahead in the regulatory environment. Five Approaches Approach What is it? Benefits 1. Integration Integrate food safety management with core management • Integration of food safety compliance functions into the broader business management to address gaps in risk coverage emerging from different hazards, products, channels, commercial, legal and regulatory sources. • Introduce new thinking to decision making and avoid costly surprises later. • Better utilize the compliance expertise and knowledge that has previously remained tacit in your organization. 2. Analysis Analysis of legal and commercial framework • Clear and ongoing understanding of the compliance demands of your business necessary to support sustainable development and business objectives. • Provides a clear definition of business, legal, customer, food safety and stakeholder requirements. • Sustainable business development. 3. Standardization Standardize systems and processes across group • Standardizing compliance process and systems across the business group, unit and site level. • Group-wide reporting and analysis become possible with standardized processes. • Improves learning from site to site and allows people to move within the group. 4. Streamlining Streamline and simplify systems and processes • Over time, compliance processes have a tendency to become more complex and time-consuming. Streamlining means that your team adopts a new mindset where processes are made leaner, which will benefit your organization tremendously in the long run. • Allows your teams focus their efforts on value-adding work. • Improves employee motivation. 5. Improvement Build on your success by seeking and implementing ongoing improvements in compliance management • As the regulatory environment keeps on changing your food safety compliance organization must keep momentum going by promoting continuous improvement. • Continuous incremental improvement keeps you continuously ahead in the regulatory environment. This table lists out five different ar- eas where your organization can start developing a highly effective corporate vision for food safety. Each of these approaches work as a standalone, but the most benefits are realized by employing them all in se- quence.
  • 15. 31 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 30 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Current State Transition State Target State • No clear vision for corporate compliance • Food safety management and compliance lie outside the core management processes of strategy, finance, HR and purchasing • Food safety management team members are technical people with no formal management training or education • Key decisions, development and budgets are taken independently of food safety and informally notified • Food safety team only involved at management level during crises or following poor audit outcomes • Food safety representative has informal or no direct line of communication to senior management • No integration of reporting at senior or enterprise level • No formal system for measuring compliance and not measured as a cost center • Development of initial corporate vision for compliance • Process of integration of food safety team into key decisions commences through formal review processes • Commence training of existing team in key management skills or appointment of skilled manager • Early development of budgeting processes and cost centers • Appointment of defined BG and BU level management to execute vision • Fully embedded vision that is documented, with defined KPIs, reviewed and revised • Food safety leaders are a core and integrated part of the general management team • Clear Business Unit and Group organisation structure with defined responsibilities • Key business, strategy, operational and other decisions are taken with food safety fully part of the process • Food safety managers are trained and experienced in management skills and communication • Formal budgets and cost centers in place and under the control of senior technical members • Clear lines of communication to top level executives • Risk and compliance responsibilities are spread across all functions, not just technical • Risk assessment and management is driven by analytics, key risk indicators, and dynamic risk assessment, monitoring, and testing • Reporting provides actionable information at the enterprise level 1. Integration Current State Transition State Target State • No clear vision for corporate compliance • Food safety management and compliance lie outside the core management processes of strategy, finance, HR and purchasing • Food safety management team members are technical people with no formal management training or education • Key decisions, development and budgets are taken independently of food safety and informally notified • Food safety team only involved at management level during crises or follow poor audit outcomes • Food safety representative has informal or no direct line of communication to senior management • No integration of reporting at senior or enterprise level • No formal system for measuring compliance and not measured as a cost centre • Development of initial corporate vision for compliance • Process of integration of food safety team into key decisions commences through formal review processes • Commence training of existing team in key management skills or appointment of skilled manager • Early development of budgeting processes and cost centres • Appointment of defined BG and BU level management to execute vision • Fully embedded vision that is documented, with defined KPIs, reviewed and revised • Food safety leaders are a core and integrated part of the general management team • Clear Business Unit and Group organization structure with defined responsibilities • Key business, strategy, operational and other decisions are taken with food safety fully part of the process • Food safety managers are trained and experienced in management skills and communication • Formal budgets and cost centers in place and under the control of senior technical members • Clear lines of communication to top level executives • Risk and compliance responsibilities are spread across all functions, not just technical • Risk assessment and management is driven by analytics, key risk indicators, and dynamic risk assessment, monitoring, and testing • Reporting provides actionable information at the enterprise level
  • 16. 33 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 32 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES 2. Analysis Current State Transition State Target State • Poor understanding of legal and commercial framework • No formal or robust processes for monitoring, reporting and actioning legal and commercial changes across the group • Lack of or poor access to legal, technical and compliance expertise • Increased understanding or limited access to expert knowledge • Semi-automated systems for notification of legal and commercial changes • Automated systems for the monitoring and actioning of legal, regulatory, commercial and scientific developments in the sector • High-level understanding of legal and commercial framework within internal resources • High-level ability to translate requirements into lean and effective systems of management and control • Risk Analysis central process to all decisions Current State Transition State Target State • Poor understanding of legal and commercial framework • No formal or robust processes for monitoring, reporting and actioning legal and commercial changes across the group • Lack of or poor access to legal, technical and compliance expertise • Increased understanding or limited access to expert knowledge • Semi-automated systems for notification of legal and commercial changes • Automated systems for the monitoring and actioning of legal, regulatory, commercial and scientific developments in the sector • High-level understanding of legal and commercial framework within internal resources • High-level ability to translate requirements into lean and effective systems of management and control • Risk Analysis central process to all decisions
  • 17. 35 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 34 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Current State Transition State Target State • Little or no standardization of compliance systems or processes across the group • Each local site operating independently in terms of legal and certification standards • Significant “creep” between sites and within sites • Little or no oversight of compliance status in local site • Long lag time between significant events and notification of same, e.g., product failures • Little or no use of IT or other standardization tools with high reliance on manual processes and tools • Changes in system take place at discretion of local managers with no reporting to central group • Risk assessment and control is performed in site “silos” • General or generic hazard identification • Introduction of new ICT and software solutions for FSM, SQM and other key process and workflows • New tools and systems establish the first phase of standardization in management processes workflows, risk assessment, HACCP, PRPs, etc • Early stages of site alignment • Basis for real-time oversight developing • Communications practices and data exchange shifting on-line and more automated • Risk assessment becoming more centralized forcing culture change at both business group and site level • Local sites use various certification standards • Utilises ICT and other technical tools to standardize all processes and workflows across group, unit and site operations • Centralised control from top down with flexibility for local sites based on risk and businesses cases • Common certification used across group • Each site operates to defined and standardized systems of workflows • Benchmarking of all site activities • Real-time visibility on compliance status at all levels • Real-time notification of significant events • Little or no creep in local systems. Failures are a result of system design and local variation • Automatic and real-time reporting to business group • Changes controlled at central level – risk defined. • Use of standard risk assessment methods • Specific hazard identification 3. Standardization Current State Transition State Target State • Little or no standardization of compliance systems or processes across the group • Each local site operating independently in terms of legal and certification standards • Significant “creep” between sites and within sites • Little or no oversight of compliance status in local site • Long lag time between significant events and notification of same, e.g., product failures • Little or no use of IT or other standardization tools with high reliance on manual processes and tools • Changes in system take place at discretion of local managers with no reporting to central group • Risk assessment and control is performed in site “silos” • General or generic hazard identification • Introduction of new ICT and software solutions for FSM, SQM and other key process and workflows • New tools and systems establish the first phase of standardization in management process workflows, risk assessment, HACCP, PRPs, etc • Early stages of site alignment • Basis for real-time oversight developing • Communications practices and data exchange shifting on-line and more automated • Risk assessment becoming more centralised forcing culture change at both business group and site level • Local sites use various certification standards • Utilizes ICT and other technical tools to standardize all processes and workflows across group, unit and site operations • Centralized control from top down with flexibility for local sites based on risk and business case • Common certification used across group • Each site operates to defined and standardized systems of workflows • Benchmarking of all site activities • Real-time visibility on compliance status at all levels • Real-time notification of significant events • Little or no creep in local systems - failures are a result of system design and local variation • Automatic and real-time reporting to business group • Changes controlled at central level – risk defined • Use of standard risk assessment methods • Specific hazard identification
  • 18. 37 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 36 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Current State Transition State Target State • Systems and processes are complex with lots of non-value adding workflows and methods • No assessment of how systems can be re-designed • High level of manual operation and systems maintenance • Formal policy of reducing complexity and non-value adding activities established • Process of reviewing and eliminating complexity commences • New tools and ICT introduced and at initial stages of set-up leading to change in work practices • Emergence of improvement opportunities • Systems and processes are as simple as possible but not simpler • “Waste” has been eliminated from all key processes and workflows • Quality design of systems built in from the start • Virtual elimination of manual processes which repeat 4. Streamlining Current State Transition State Target State • Systems and process are complex with lots of non-value adding workflows and methods • No assessment of how systems can be re-designed • High level of manual operation and systems maintenance • Formal policy of reducing complexity and non-value adding activities established • Process of reviewing and eliminating complexity commences • New tools and ICT introduced and at initial stages of set-up leading to change in work practices • Emergence of improvement opportunities • Systems and processes are as simple as possible but not simpler • “Waste” has been eliminated from all key processes and workflows • Quality design of systems built in from the start • Virtual elimination of manual processes which repeat
  • 19. 39 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 38 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Current State Transition State Target State • Systems and processes have not been assessed for improvement opportunities • No management of change process in place • No use of KPIs or reporting • Decisions to improve based on immediate compliance need and not sustainability • Poor or no validation of systems • Certification in place because it is required • Benefits of improvement as a business process increasing in management consciousness • New systems and standardization highlight more improvement opportunities • Ongoing review and identification of improvement projects based on quality data generated from systems • Clear management of KPIs • Decisions based on sustainable objectives and not quick-fixes • Real-time oversight, visibility notification and escalation of activities based on risk assessment • Supplier quality management, management of change and other key improvement processes are fully integrated into overall FSM • Benchmarking is used in all sites to drive improvement and best practice • Strong validation of systems for hazards and risks • Certification used for improvement 5. Improvement5. Improvement Current State Transition State Target State • Systems and processes have not been assessed for improvement opportunities • No management of change process in place • No use of KPIs or reporting • Decisions to improve based on immediate compliance need and not sustainability • Poor or no validation of systems • Certification in place because it is required • Benefits of improvement as a business process increasing in management consciousness • New systems and standardization highlight more improvement opportunities • Ongoing review and identification of improvement projects based on quality data generated from systems • Clear management of KPIs • Decisions based on sustainable objectives and not quick-fixes • Real-time oversight, visibility notification and escalation of activities based on risk assessment • Supplier quality management, management of change and other key improvement processes are fully integrated into overall FSM • Benchmarking is used in all sites to drive improvement and best practice • Strong validation of systems for hazards and risks • Certification used for improvement
  • 20. 41 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 40 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES How to Realize Your Vision Managing Change A key hurdle to realizing your vision will be the management of change. A grand vision requires an extensive project and you need to be equipped with the necessary tools and knowledge to be successful. Key success factors include: • Management commitment is present to making your change initiatives stick and carry them over the initial challenges • A sufficient budget needs to be reserved for change projects every year • Change is usually met with organizational inertia; overcome the inertia by involving people from all levels of the organization early on in the change process making sure that they feel ownership in the change. • Focus your communication efforts to explaining the meaning and purpose of change, as opposed to fixating on mere benefits of change. People will respond to your change initiative more positively when they understand the impact of change within the big picture. Instead of explaining that “this new mock recall process will save 1 hour of your time” you should communicate that “this improved mock recall process will make sure that if we ever have to conduct a real recall, you will be in a better position to pull the product out of the market and potentially save lives by being better prepared”. Key success factors include broad executive-level ownership and visible support for change.
  • 21. 43 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 42 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES 1. Integration Integration of food safety management with core manage- ment. Making food safety compliance an embedded ele- ment of corporate business activities. The first step in developing your corporate vision and strategy is the real integration of the compliance team into the core business management processes. Integration is required to ensure that all decisions are made with con- sideration to the compliance demands of the business and to avoid compliance failures. Your vision document should address each of these areas with clear projects to support their implementation. Area Actions Organization The first step is to define the current organizational structure and responsibilities at the group, unit and site level. Identify where gaps exist in terms of resources, competencies and assigned responsibilities. The objective here is to identify where opportunities exist to integrate compliance management into the core management processes. Group Compliance Officer If not already in place, the company should install a person in the position of Group Compliance Officer. This is a senior position, and the person should be an experienced individual with competency in management and communication skills. A robust knowledge of compliance is also essential. This person will report directly to the most senior level in the organization. It will be this role that will facilitate the changing culture of the organization and delivery of the corporate compliance vision and strategy. The role will naturally cover other compliance related functions such as health, safety and environmental management. The first step in developing your corporate vision and strategy is the real integration of the compliance team into the core business management processes. Area Actions Responsibilities Clear responsibilities regarding food safety compliance should be assigned at group, unit and site level. These may be existing positions with expanded responsibilities or new appointments. In any event, they should have a clearly assigned responsibility and authority to affect change at the appropriate level. Competency & Training For successful integration of compliance management into the core team, it is essential that specific competencies in the areas of management skills, change management and communication at senior level are present. Where gaps exist, training and professional development programs should be developed and implemented. Integrate Senior Group Position The process of integrating the Group Compliance Offer into the senior management team, key processes and decisions should commence. Practically, this means their presence at management meetings regarding business planning, strategy, budgeting and capital programs. Of course, the exact nature of this and extent to which it is needed will vary from business to business, but in all cases the objective is to ensure key business, strategic and operational decisions are all made in the context of compliance needs. Communication Develop integrated communication and reporting channels covering business group, business unit and site level compliance risks. Business unit and site level management as well as operation and compliance risk functions should team-up to design an integrated approach that helps to establish risk communication. Business Group management should lead this effort to provide oversight and compliance expertise.
  • 22. 45 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 44 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES 2. Analysis It is time to conduct an analysis of legal and commercial frameworks. Clear definition of business, legal, customer, food safety and stakeholder requirements. The next step in developing your corporate vision for food safety compliance is an analysis of the compliance frame- work that governs your entire food business operations and markets. The analysis should be conducted by competent resources and, where required, expertise should be sought. The scope of this can be endless, so take your time and take a structured approach. The number of food businesses which cannot clearly define the scope of their compliance obligations is surprising. This process essentially allows you to define the specifica- tion of compliance that your vision needs to address. The output of this step should be a clear register of compli- ance references, including copies of all relevant laws, acts, and regulations, codes of practices, technical documents and standards. Also take account of geographical require- ments for both operations and mar­kets. The final part of this process is a clear identification of common require- ments across the compliance frame­work and outliers. This analysis facilitates the next stage of process - standardiza- tion. The next step in developing your corporate vision for food safety compliance is an analysis of the compliance framework that governs your entire food business operations and markets. Area Actions Identification of scope of compliance framework Identify all compliance standards relevant to the business: • Regulations • Directives • Acts • Codes of practice • Technical standards • Certification standards • Internal standards • Commodity standards • Industry standards • Customer specifications Identification of geographical scope of compliance framework • FDA • EU • WHO / Codex • Other geographic markets and areas Identification of common compliance requirements and outliers Review and assess the requirements from above and identify the common requirements contained in the various standards. It will often be the case that significant aspects of these requirements are identical or can be met by adopting the most stringent standard as the benchmark. Similarly, specific requirements that may lie outside the general requirements of the standards should be identified and included in the scope of the vision. Identification of specific regulatory aspects required for local markets Some local markets may have very specific regulatory protocols that need to be addressed when conducting business. For example, the FDA under FSMA has very specific requirements and administrative protocols for importers. Development of a register and library of compliance framework documents A register of all relevant compliance framework documents should be developed centrally and indexed by business application, operation, product, process, market, unit and site. This register, along with copies of all these documents, should be centrally controlled.
  • 23. 47 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 46 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES 3. Standardization Standardize systems and processes across group. Once the compliance framework has been defined, you are ready for the next step - standardization of relevant pro- cesses and systems. The reasons for this have already been discussed, but it is this stage where the real benefits of your vision become realized. When done right the benefits can be obtained quickly. In large corporate food businesses there exists various pro- cesses, systems, procedures, workflows, forms and records designed to define and record compliance related activities. They will have been installed to meet legal, certification and customer requirements. These pro­cedures will exist at group, unit and site level and will have been developed in organizational silos over the years in reaction to different requirements. Most businesses have undertaken improvement projects to standardize these systems across the group with lim- ited success due to the open platforms used and process creep. The key to this step is identifying which processes and systems should be standardized and then selecting the right platform to implement standardization. In most cases, a software will be used as the platform of choice, which means that the project needs to clearly define the require- ments for the software. It should be noted that the quality or effectiveness of the process or tool is not the main focus of this step, but rather the standardization of the process is. Assuming that the platform has been well designed, improvements to the pro- cess will be easy to achieve at a later stage. Once the compliance framework has been defined, you are ready for the next step which is the standardization of relevant processes and systems. Area Actions Identify processes and systems Identify the key group, unit and plant level processes and systems to be standardized. This should include: • HACCP and other risk management systems • Management processes • General PRPs • Operational PRPs • Documents control • Supply Chain Management Systems and processes that lend themselves well to standardization include auditing, CAPA, management review, non- conformance management, recall, deviation, HACCP and document management workflow. Standardization Platform Specification Start a project to define the specification of the software platform required to deliver standardization. This project should be conducted by a cross-functional team made up of group, unit and site leaders, users, IT, and change management members. The specification should be comprehensive and include: • Scope of the application(s) covering HACCP, Management, PRPs, Monitoring, Documents, SQM • Business structure supports • Enterprise requirements supports • Security • Workflows • Oversight, notification, alerts, user controls • Support • Scalability Remember, the platform must be capable of preventing local creep of processes and provide clear central business group oversight. Also, refer to the next step in the process, streamlining, as an input for your platform specification.
  • 24. 49 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 48 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Area Actions Tender Process Undertake a robust tendering process to select the right product and service provider(s). Certification A project to install a standard certification scheme across the group and all sites. It is crucial that, where possible, all operational units use a common certification standard to reduce costs and support a standard process. Options include: • ISO 22000 (Group level) • FSSC 22000 (Unit and Site Level) • Other GFSI standards (Site Level) Implementation Following selection of the correct platform and service provider, a project for the management and implementation of the solution should commence.
  • 25. 51 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 50 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES 4. Streamlining Simplify systems and processes. After your industry-wide analysis and standardization of processes you will have the right platform in place to start streamlining your systems. This process of streamlining needs to start from the most resource intensive processes so you will have to spend time identifying where most of the waste is generated. Note that if the standardization platform selected in the previous step is robust enough, you will have already achieved gains in this area and now have the tool that al- lows for quick implementation of lean principles. Area Actions Organizational capabilities • Give key people access to the data that allows them to identify wasteful processes. • While you want to remove creep from your key compliance processes, you need to give your staff the right tools and authority to make improvements in their work. Culture • It needs to become second nature in your culture to rethink processes and question the status quo; allow people to speak their mind and approach management openly. • Embrace open innovation and gather feedback from all levels of the organization. • Encourage people to become problem solvers, not complainers. Compliance processes and organizational structures now create the environment to start using lean principles, identify waste in compliance processes, and start implementing more value-added activities. Area Actions Process value • Improve the value of your compliance processes by estimating the perceived value, cost and effort of your processes and then streamlining those with the worst ROI. • Introduce cost tracking as part of your deviation management; this will help you make the cost of noncompliance more transparent. Process efficiency • Remove unnecessary steps, approvals, administrative tasks and decisions from compliance processes. • Identify bottlenecks in your compliance processes; bottlenecks are typically related to approvals or verifications that rely on a single person. Find ways to spread the work. Performance management • The management of your compliance processes should be based on relevant and easily monitored KPIs, that you can then use as part of group wide streamlining projects. Example of such KPIs include: complaints time to closing out, mock recall duration, time to approving a document etc. • Make sure your KPIs are part of the wider compliance strategy and are often communicated to your people.
  • 26. 53 CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCE 52 SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES 5. Improvement Build on your success by seeking and implementing ongo- ing improvements in compliance management. Improvement is the final stage of realizing your vision. The objective is to embed an approach to improving the various compliance workflows on a continuous basis. To keep your systems improving continuously, make sure to schedule regular reviews with your team that reveal where you currently are and where you need to undertake new ini- tiatives. You should also collect feedback from all levels of your organization. Area Actions Teams • Establish project teams to examine processes for improvement and waste elimination. • Assign responsibilities for continuous improvement. Standardization of root causes • Generate a standard list of root causes from Business Group down. This list can then be used at all levels of your organization to support quality reporting and guide improvement initiatives. Analysis and reporting • Standardize the reporting of non-conformances and put extra focus on the categorization and analysis of root causes. • Establish regular and ongoing management review processes with standard inputs and outputs. Projects • Clear identification of projects. • Undertake projects with clear metrics to achieve continuous improvement. • Utilize specific improvement tools in your reporting. This should include the use of statistical tools. 53
  • 27. CREATING YOUR CORPORATE VISION FOR FOOD SAFETY COMPLIANCESAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES Available Modules • Document Control • HACCP • Hazard Database • Complaints • CAPA • Non-conformance • Management review • Auditing • Recall • Quality Management • Calibration • Cleaning • Pest Control • Employee Training • Microbiological Control • Traceability Testing • Medical Screening • Contamination Control • Code of Practice • Monitoring • Receiving Inspections • Batching • Supplier Control • Supplier Portal • Employees • Suppliers • Product • Materials • Alerts • Reports & Analytics Document Control Upload, approve and review all your central documents. Keep track of versions and be notified of changes. HACCP Build and maintain all your HACCP plans. Benefit from advanced risk assessment models and decision trees. Management Paper free management processes with automatic reporting. PRPs Document and manage your daily operations and enjoy the benefits of automatic scheduling and alerts. Monitoring Monitor any parameters in your system including CCPs, oPRPs and material quality. Supplier Management Approve, risk assess and review suppliers. Conduct audits, collect documents, and let your suppliers complete self-assessments. Utilities All the necessary tools ranging from alerts to reporting.
  • 28. SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES How can Safefood 360° help you realize your vision?
  • 29. SAFEFOOD 360° PROFESSIONAL WHITEPAPER SERIES