QUICK START GUIDE

for FSSC 22000

Implementation
www.22000-tools.com

Copyright © 2018 Vinca, LLC.

CONTENTS
WHAT IS FSSC 22000?

BENEFITS OF FSSC 22000

IMPLEMENTING FSSC 22000 AND

PREPARING FOR CERTIFICATION

ASSIGN YOUR PEOPLE RESOURCES

Food Safety Team Leader
IMPLEMENTATION: STEP-BY-STEP
Food Safety Team Leader is Trained on Re-
quirements of FSSC 22000
Food Safety Team Leader and Management
Prepare Project Plan
Identify Steering Team
Conduct the Gap Analysis
Identify Task Teams
Train Task Team Members
Train Food Safety Team
Complete Detailed Project Plan & Timeline
Document Processes
Review and Approve Documentation
Identify Internal Auditors
Conduct Internal Audits
Management Review Meetings
Run Your System

CERTIFICATION AUDIT

APPENDIX

THE PROJECT PLAN

 FSSC 22000 PROJECT PLAN

THE GAP ANALYSIS

THE FSSC 22000 STEERING TEAM

THE TASK TEAM MEETINGS

SAMPLE TIMELINE

CONVENIENT ONLINE TRAINING

COMPLETE TRAINING PACKAGE FOR THE

FSSC 22000 FOOD SAFETY TEAM LEADER

CONVENIENT ONLINE TRAINING

COMPLETE TRAINING PACKAGE FOR

THE FSSC 22000, FOOD SAFETY TEAM &
INTERNAL AUDITORS

OUR CUSTOMERS SAY...

Food processors, WHAT IS FSSC 22000?
and food
packaging FSSC 22000 is a Food Safety Management System (FSMS)
manufacturers, Certification Scheme.
and others in
the industry are The FSSC 22000 System was designed to provide companies in the
becoming certified food industry with an ISO-based food safety management system
to meet customer certification that is recognized by the Global Food Safety Initiative
demands and to (GFSI). Recognition by GFSI provides worldwide recognition and
stay competitive in acceptance by food manufacturers and retailers. FSSC 22000
the marketplace. defines requirements for integrated processes that work together
to control and minimize food safety hazards.

Once a facility implements processes that address all the

requirements of FSSC 22000, they can be certified to FSSC 22000.
The certification program is managed by the Foundation for Food
Safety Certification.

The FSSC 22000 system uses a management systems approach

to food safety, using ISO 22000 for the management system
requirements and ISO Technical Standards (for prerequisite
program requirements). The food safety management system
integrates nicely with other management systems such as ISO
9001 and ISO 14001.

FSSC 22000 Prerequisite Program Requirements (PRP)

Prerequisite programs are programs and practices put in place to
address the role the production environment plays in producing
safe food products.

FSSC 22000 requires that the organization establishes PRP

programs to control the likelihood of introducing contamination
through the work environment. There are different PRP
requirements depending on your industry:

ISO/TS 22002-1: Food Processing

ISO/TS 22002-3: Farming
ISO/TS 22002-4 Food Packaging Manufacturing
FSSC 22000 REQUIREMENTS

The certification scheme and requirements are defined in three

documents:
Becoming certified • FSSC 22000: Part 2 Requirements for organizations
can help you stay that require certification This document is available for
competitive and download at no charge at www.fssc22000.com
qualified to work • ISO 22000:2005: Food safety management systems -
with your current Requirements for any organization in the food chain This
customers as well document is available for purchase and download at www.
as to gain access to iso.ch or Techstreet.com
new ones. Requirements for Prerequisite Programs
The document you use for prerequisite programs will depend on
your scope.

Food Processors use ISO/TS 22002-1: Prerequisite programs

on food safety - Part 1: Food Manufacturing. Available from
www.iso.ch or Techstreet.com
Food Packaging Manufacturers use the ISO/TS 22002-4 -
Prerequisite programs and design requirements for food safety
in the manufacture and provision of food packaging. Available
from shop.bsigroup.com
Manufacturers or Providers of Animal Food, Feed or
Ingredients use the PAS 222 - Prerequisite programs for the
manufacture of food and feed for animals. Available from shop.
bsigroup.com.
BENEFITS OF FSSC 22000

The top reasons sited by our customers and visitors for

investigating and pursuing certification are:

Managing Risk
First and foremost, building an FSSC 22000 System will provide
your company with effective management of food safety hazards
by creating an environment capable of producing safe product and
a management system to continually manage, monitor, validate
and improve the system.

Maintain Current Customers

Statistics show that approximately 1 out of 4 certified companies
are asking their suppliers to achieve certification. Chances are that
if you have not been asked yet, you will be asked in the near future.
Becoming certified can help you stay competitive and qualified to
work with your current customers as well as to gain access to new
ones.

Increase your market reach

Large retailers and multinational manufacturers or processors
are also demanding certification of their suppliers. Having FSSC
22000 Certification means you are qualified to supply these
organizations or their suppliers, opening up a large market for
your products.

Prepare for upcoming regulatory changes

Countries across the globe are making changes to food safety
regulations, including the United States and its Food Safety
Modernization Act (FSMA). FSSC 22000 prepares your
organization to meet many or most of the FSMA requirements.
IMPLEMENTING FSSC 22000 AND
PREPARING FOR CERTIFICATION
In a nutshell, here is a list of things you will need to do in order to
become certified to FSSC 22000.

Purchase the standard:

◊ ISO 22000:2005 Food safety management systems -
Requirements for any organization in the food chain
International Organization for Standardization
◊ FSSC 22000 Part I (Free download) - Requirements
for organizations that require certification (version 3.2
- 2015)
and ONE of the following:

◊ ISO/TS 22001-1 Prerequisite programmes on food

safety - Part 1: Food manufacturing (if you are a food
manufacturer/processor)
◊ ISO/TS 22001-4 Prerequisite programmes on food
safety - Part 4: Food packaging manufacturing (if you
manufacture packaging for food products
Select a certification body.
Begin implementation:
• Designate and train your FSSC 22000 Food Safety Team
Leader.
• Designate teams to design, document and implement the
required processes and food safety fundamentals.
• Train your internal audit team.
• Run your system, collect records, perform internal audits,
management review and Food Safety Team meetings.
• Make corrections and improvements to your system.
• Schedule and complete your audits.
 ASSIGN YOUR PEOPLE RESOURCES
Use the team FSSC 22000 Food Safety Team Leader
approach for An FSSC 22000 certified company must designate an FSSC 22000
an efficient Food Safety Team Leader. This person will be responsible for
implementation. overseeing the development and implementation of the system, as
well as the maintenance of the FSSC 22000 Program.

Implementation Teams
Our years of experience assisting companies with Management
Systems Implementation have resulted in a very effective method
of implementation using a team approach.

As we explain this method, think about how big your organization

is; for smaller organizations we have used “teams” as small as one
or two people. For larger organizations, teams are typically 5 to 7
people.

We recommend using several teams.

FSSC 22000 Steering Team

Made up of top management and the FSSC 22000 Food Safety
Team Leader to lead the project and accomplish management tasks
during the implementation.

Food Safety Team

As required by the standard to complete HACCP and Prerequisite
requirements, and led by the FSSC 22000 Food Safety Team
Leader.

FSSC 22000 Task Teams

Several Task Teams to design, document and implement the FSSC
22000 Food Safety Management System procedures to complete
your system.

The Task Teams that are set up will each look at the requirements
for their process and procedure. They will be responsible for
comparing the requirements of the standard to the current process
used at your company. They will:

• Design a new process, or modify the current process so the

company will be meeting FSSC 22000 requirements.
• Write a procedure for the new process, and give it to the
FSSC 22000 Steering Team to review.
 • Once the procedure is approved, they will introduce it to
employees, training as needed. The company will then
start using the new process/procedure.

By using the team approach for implementation appropriate

individuals from all parts of the organization are involved in
the project, leading to an effective and efficient Food Safety
Management System.

FSSC 22000 Steering Team

We use one Team to lead the project, and call this the FSSC 22000
Steering Team. The function of the team is very important.

This team will meet on a regular basis during the project to

complete management tasks, monitor progress of the project,
resolve questions from the other teams, allocate the resources
needed for the implementation and coordinate the design of the
new Food Safety Management System (FSMS).

The FSSC 22000 Steering Team will be made up of top

management representing each of the areas of your company. For
example, include:

• a production manager
• a quality manager
• an administrative manager
• an engineering manager and
• an executive manager
This will give the team the knowledge and authority it needs to
make decisions and devote resources to the project.

The FSSC 22000 Food Safety Team Leader and/or project manager
for the implementation project should lead this team. The team
leader will schedule meetings, prepare agendas, and collect
information to bring to the meetings.

IMPLEMENTATION: STEP-BY-STEP

The steps outlined here are recommended steps based on our

experience implementing management system. Adapt them
as needed for your organization. The training programs and
documents we have referenced are all available on our website:
www.22000-tools.com. They are available individually and in our
Complete Training Package or Premium Training and Templates
Package.

Food Safety Team Leader is Trained on Requirements

of FSSC 22000
The Team leader should understand the FSSC 22000
Requirements for both the System Elements (Module 2) and the
applicable Food Safety Fundamentals (the Module that applies to
your type of business).

Team Leader and Management Prepare Project Plan

The Team Leader works with the Management Team to prepare
the project plan. This is detailed in the next section of this Quick
Start Guide.

Identify Steering Team

Management identifies the “FSSC 22000 Steering Team”. See the
example FSSC 22000 Steering Team first team meeting agenda
and information in the FSSC 22000 Steering Team section

Conduct the Gap Analysis

The FSSC 22000 Food Safety Team Leader takes the “Conducting
the Gap Analysis” training, downloads the checklists from
the training and plans and leads the Gap Analysis Audit. The
Gap Analysis is much like an Internal Audit. It compares the
system you have in place to the FSSC 22000 requirements. The
requirements that you don’t yet meet need to be addressed. The
Gap will identify those areas.

Identify Task Teams

Based on the Gap Analysis results, the FSSC Steering Team
identifies the Task Teams needed to address changes or
implementation of processes for each of the FSSC Management
System Processes. For example:

Document Control
Records
Management Responsibility
Communication
Emergency Preparedness
Competence Awareness and Training
 Infrastructure
Work Environment
Corrections and Corrective Action
Control of Nonconforming Product
Recall or Withdrawal
Prerequisite Programs
Preliminary Steps for Hazard Analysis
Food Safety Team
Hazard Analysis
HACCP
Verification
Traceability
Control of Monitoring and Measuring
Internal Audits
Train Task Team Members
Identify training requirements for those assigned to the Task
Teams. “Introduction to FSSC 22000” is our recommended
training for those team members.

Train Food Safety Team

Identify training requirements for the Food Safety Team.
“Introduction to FSSC 22000” and “FSSC 22000 Prerequisite
Programs” is our recommended training for the Food Safety Team
members.

Complete Detailed Project Plan & Timeline

The FSSC 22000 Steering Team completes the Gantt chart or the
project plan provided in the Complete Training Package with the
projected dates and timelines for the task team activities.

Document Processes
The Task Teams meet as scheduled to complete the changes to and
implementation and documentation of the new processes. Use
the document templates, forms and implementation plans from
the FSSC 22000 Template and Implementation Tools Package or
Complete Training Package.
Review and Approve Documentation
The FSSC 22000 Steering Team reviews and approves all the
procedures and documentation developed by the task teams.

Identify Internal Auditors

The FSSC 22000 Steering Team identifies individuals to be
Internal Auditors, and prepares an initial internal audit schedule.
The individuals complete “Internal Auditor Training”.

Conduct Internal Audits

Start the internal audits when the FSSC 22000 processes are
completed.

Management Review Meetings

Hold management review meetings, conduct internal audits
and complete corrective actions. Follow the new FSSC 22000
Procedures that the task teams developed, maintain records and
make improvements.

Run Your System

You will run your system, conduct internal audits and hold
management review meetings for about 3 months. Then you will

be ready for your certification audit.

CERTIFICATION AUDIT

Initial Certification to FSSC 22000

Choose an accredited certification body for your organization.
Certification companies are listed on the FSSC 22000 website.
Once you have implemented the system your certification body
will perform a Document Review to determine readiness for your
next step, the on-site Audit.

If the audit identifies areas of the system that do not comply

with the FSSC 22000 Standard requirements, you will need to
correct nonconformances before you will be recommended for
certification. Once those are corrected and verified your company
will be recommended for certification. The system will then be
monitored by your auditor through surveillance audits.

The FSSC 22000 Certification Audit

During the certification audit the FSSC 22000 Auditor will
examine your FSSC 22000 System to determine:

• Whether the system has been implemented effectively

• Whether there is evidence of Management Commitment
to the maintenance and improvement of the system
• Whether activities comply with regulatory, customer and
FSSC 22000 requirements
Findings are categorized as:

Major Nonconformity
A Major nonconformance is a nonconformance to the documented
system or to the FSSC 22000 Code that could cause an immediate
food safety risk or indicate ineffective implementation of a system
element. A Major Nonconformity must be corrected and verified
within 14 days of the finding

Critical Nonconformity
A critical nonconformance consists of a loss of control at a critical
control point, prerequisite program or other process step that
could cause a significant risk and product safety is compromised
or any falsification of records. A critical nonconformity results in a
suspension of certification.
APPENDIX
Use these sample documents as a reference as you implement
your FSSC 22000 system.
THE PROJECT PLAN
It is important to prepare a project plan to help organize and
manage the project. A sample project plan template is provided on
the next page. Lets look at how to prepare the plan.

First, identify your project goals. Answer the ques-

tions:
1. When will you begin your project? Consider the date of
the Gap Analysis as the beginning date.
2. What is your target date for having the FSSC 22000
Certification? You will work backwards from this date
as you prepare your project timeline. Your date should
be reviewed later. This will be your schedule, but as
you perform the gap analysis and develop and the task
list , you can determine whether that date is realistic.
It will depend on the status of your current food safety
management system and the resources available to you as
you complete the system.
Second, identify responsibilities for the project.
1. Identify the Team Leader. The Team Leader should act as
project manager for the implementation project.
2. Identify who makes up Senior Management.
3. Identify the FSSC 22000 Steering Team. As you saw in the
steps in the previous section, the FSSC 22000 Steering
Team plays a key role in managing the project. The Team
Leader should be the team leader, and senior management
should make up the rest of the team.
Third, start to fill in the timeline for the project.
1. Schedule training for the Team Leader.
2. Schedule the Gap Analysis. Remember that the Team
Leader should complete the Gap Analysis Training and
download checklists before the Gap Analysis.
3. Plan anywhere from 2 to 5 days for the Gap Analysis. It
will depend on the size of your company, the number
of auditors and the number and complexity of your
processes.
4. Schedule the FSSC 22000 Steering team meeting to assign
the task team members, and schedule training for the
team members.
5. Schedule training for the task team members.
6. Announce your project to all employees. Plan a meeting or
meetings to make employees aware of the project, what
FSSC 22000 Certification is, and why it is important to
the organization.
7. Document your target completion date and target dates
for your certification audits.
FSSC 22000 PROJECT PLAN
Project Goals
Start Date
Target for completion
Responsibilities
Team Leader
Senior Management
Steering Team

Timetable
Step Start Comple-
Date tion Target
Team Leader completes oneline training
Conduct Gap Analysis
teering Team Meetings
Task Team Members are Trained
Announce Project to All Employees
System Complete
Desk Audit
Certification Audit
Certificate in Hand
THE GAP ANALYSIS
Once you have outline the project timeline, it is time to complete
the Gap Analysis and identify the specific tasks that will need to
be done to build your FSSC 22000 System. The gap analysis will
identify where your current system meets requirements, and
where changes and additions to your system must be designed and
implemented.

The outcome of the gap analysis will be a task list for your project.
You will assign the tasks to the task teams that you have identified.

1. Complete the “Gap Analysis Checklist & Training” session

to learn how to plan and conduct the gap, what to do with
your results, and download checklists for your audit. Note
that this training is included in the Complete Training
Package.
2. Identify any other auditors that will be involved, and brief
them on the audit plan and techniques.
3. Inform employees that the audit will be taking place,
and the purpose of the audit. You want employees to feel
comfortable answering auditors questions; understanding
the purpose of the audit will help establish their comfort
with the process.
4. Conduct the audit and document findings on the
checklists.
5. Create a task list, or use the list provided in the FSSC
22000 Templates and Implementation Tools or Complete
Training Package. Where ever you identify requirements
that are not yet being complied with, document a task on
the list.
◊ The FSSC 22000 Templates and Implementation
Tools and Complete Training Packages provide both
an overall project task list, and individual team task
lists. If you have purchased the package, simply add
the tasks to the lists provided. Many common tasks
are already on the individual team task lists as well
as information on the process requirements and a
place to assign timelines.
6. Provide the appropriate task list to each task team.
THE FSSC 22000 STEERING TEAM
Once the Gap Analysis has been completed, start your FSSC 22000
Steering team meetings. During the first team meeting discuss
the responsibilities of the Steering team. If there are members that
were not involved in creating the project plan, review the project
plan and list of steps to implementation.

Proposed agenda for the 1st Steering Team meeting:

1. Review the list of steps to implementation.
2. Review the responsibilities of the FSSC 22000 Steering
Team (these responsibilities will not all be completed in the
first meeting, but should be reviewed to clarify the purpose
of the team.)
◊ Identify task teams and members
◊ Identify training requirements for task team
members, Food Safety Team members and employees.
Use the Premium Training and Templates Package to
provide multiple training sessions to train the Team
Leader, FSSC 22000 Team, Internal Auditors and
others.
◊ Meet regularly to monitor the project timeline and
task team activities and provide resources as needed
to meet project goals.
◊ Choose a certification body, and schedule the
certification audit.
◊ Review procedures and other documentation created
by the task teams.
◊ Review and customize the Management
Responsibility procedure. Complete tasks assigned to
management.
◊ Assign internal auditors and create an audit schedule.
◊ Resolve issues as they arise.
3. Identify task teams, team leaders and members. Assign
timelines for each team to meet. See our example table in
Appendix A.
THE TASK TEAM MEETINGS
The team leader is responsible for scheduling the meetings
according to the timeline on the gantt chart. During the first
team meeting discuss the purpose of the FSSC 22000 Steering
Team and Task Teams. Give an introduction to the purpose of the
individual Task Team that is meeting.

Proposed agenda for the fist team meeting:

1. Discuss the responsibilities of the Steering Team and the
Task Teams.
2. Review the list of steps for the implementation project.
3. Provide a copy of the procedure and forms templates for
the process that the team has been assigned.
4. Review the procedure and forms.
5. Provide a copy of the teams task list. Discuss the tasks that
have been assigned.
6. Discuss the proposed timeline that was assigned by the
FSSC 22000 Steering Team for the Task Team, and start to
assign dates and responsibilities for the individual tasks
on the list.
7. Determine the frequency of the team meetings, and
schedule the next meeting. Prepare the next meetings
agenda, and identify action items to be completed before
the next meeting. Assign responsibility for the action
items.
At subsequent meetings you will review action items and progress
and assign new action items as needed to complete the task list.
The team goal is to design and implement a new process that
meets the requirements of the Standard for that system element.
The team will accomplish this by using the document templates
and the information from the gap analysis.

The new process will be documented in the procedure. The

procedure and any related forms or documents will be given to
the Steering Team for review. Once the procedure is approved,
the team will be responsible for seeing that it is effectively
implemented.
 Sample Timeline

Tasks Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Assign processes to
teams x
Document Control x x x
Management Re-
sponsibility x x x x
Emergency Pre-
paredness x x
Competence,
Awareness and x x x x
Training
Corrections and
Corrective Action x x x
Control of Noncon-
forming Product x x
Recall or With-
drawal x x
Prerequisite Pro-
grams x x
Preliminary Steps -
Hazard Analysis x x
Food Safety Team x x x x x x x x x x x x
Product Character-
istics x x
HACCP Plan x x x
Verification x x x
Traceability x x
Control of Monitor-
ing and Measuring x x x
Internal Audits x x x x x x
Management of
Services x x x
Food Defense x x x
Fraud Prevention x x x
Management of
Allergens x x x
Management of
Purchased Mate- x x x
rials
Train the Audit Team x
Conduct Employee
Training x
Internal Audits and Man-
agement Review x x x x x
Stage 1 Audit x
CERTIFICATION AUDIT x
CONVENIENT ONLINE TRAINING
COMPLETE TRAINING PACKAGE FOR THE FOOD
SAFETY TEAM LEADER
If you are interested in a quick start and a fast track to your FSSC
22000 Certification, use our Complete Training Package to quickly
work you through each step of your implementation. Our tools
and training help you create a system that is effective, efficient
and tailored to your organization.

The package includes all of our documents, tools and detailed

how-to instructions that will guide your Practitioner through each
step of your project. Create a system that is effective, efficient and
tailored to your organization.

The training series includes the following 5 courses to cover each

step of your project:

Introduction to FSSC 22000

This FSSC 22000 online training course is perfect for
introducing FSSC 22000 and its requirements to the FSSC
22000 Food Safety Team Leader, top management and
employees!

FSSC 22000 Prerequisite Programs

This course explains the requirements of the relevant PRP
document ISO/TS 22002-1 for food processors, or ISO/TS
22002-4 for food packaging manufacturers..

The Gap Analysis Checklists and Tutorial

Includes checklists for the System Elements and Food Safety
Fundamentals along with a Gap Analysis Tutorial. Use your
Gap Analysis to help make your detailed plan.

FSSC 22000 Templates and Implementation Tools

Documents include our: Manual, Procedures, Prerequisite
Programs, Forms, Checklists, Implementation plans and more.

Internal Auditing
Gain the qualifications and skills you need in order to audit
your company’s FSSC 22000 system effectively and with
confidence. Includes an online, interactive practice audit.

These courses are also available individually.

CONVENIENT ONLINE TRAINING
PREMIUM TRAINING PACKAGE FOR THE TEAM LEADER,
FOOD SAFETY TEAM & INTERNAL AUDITORS
If you are interested in a quick start and a fast track to your FSSC
22000 Certification, and want to train your team and your
Leader, use our Premium Training Package to quickly work you
through each step of your implementation. Our tools and training
help you create a system that is effective, efficient and tailored to
your organization.

The package includes all of our documents, tools and detailed

how-to instructions that will guide your Team Leader through
each step of your project. Create a system that is effective, efficient
and tailored to your organization.

The training series includes the following 5 courses to cover each

step of your project:

Introduction to FSSC 22000 (6 seats)

This FSSC 22000 online training course is perfect for
introducing FSSC 22000 and its requirements to the FSSC
22000 Food Safety Team Leader, top management and
employees!

FSSC 22000 Prerequisite Programs (6 seats)

This course explains the requirements of the relevant PRP
document ISO/TS 22002-1 for food processors, or ISO/TS
22002-4 for food packaging manufacturers..

The Gap Analysis Checklists and Tutorial (1 seat)

Includes checklists for the System Elements and Food Safety
Fundamentals along with a Gap Analysis Tutorial. Use your
Gap Analysis to help make your detailed plan.

FSSC 22000 Templates and Implementation Tools (1 seat)

Documents include our: Manual, Procedures, Prerequisite
Programs, Forms, Checklists, Implementation plans and more.

Internal Auditing (3 seats)

Gain the qualifications and skills you need in order to audit
your company’s FSSC 22000 system effectively and with
confidence. Includes an online, interactive practice audit.

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