fssc

FSSC 22000 is a Food Safety Management System (FSMS) The system defines requirements for integrated processes that work together to control and minimize food safety hazards. The FSSC System was designed to provide companies in the food industry with an ISO based FSMS certification that is recognized by the Global Food Safety Initiative (GFSI). Recognition by GFSI provides worldwide recognition and acceptance by food manufacturers and retailers.

Introduction to FSSC 22000

Head of Regional Quality Management [email protected]

Food Safety System Certification

FSSC 22000 is a Food Safety Management System (FSMS) The system defines requirements for integrated processes that work together to control and minimize food safety hazards. The FSSC System was designed to provide companies in the food industry with an ISO based FSMS certification that is recognized by the Global Food Safety Initiative (GFSI). Recognition by GFSI provides worldwide recognition and acceptance by food manufacturers and retailers. The FSSC 22000 system uses a management systems approach to food safety, using ISO 22000 for the management system requirements and ISO Technical Standards or Publicly Available Specifications (PAS) for prerequisite program requirements. The food safety management system integrates nicely with other management systems such as ISO 9001 and ISO 14001. The certification audit and surveillance audits also take a management systems approach, with a process based audit instead of a checklist based audit. The audits determine if your FSMS meets the requirements of the standard, if it does your organization is recommended for certification. If it does not you will need to make improvements to the system before achieving certification. There is no score or grade from the audit.

FSSC 22000 Certification The certification scheme and requirements are defined in three documents:

1. FSSC 22000: Part 1 Requirements for organizations that require certification.

2. ISO 22000:2005: Food safety management systems - Requirements for any organization in the food chain.

3. 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. Food Packaging Manufacturers use the PAS 223 - Prerequisite programs and design requirements for food safety in the manufacture and provision of food packaging. Manufacturers or Providers of Animal Food, Feed or Ingredients use the PAS 222 - Prerequisite programs for the manufacture of food and feed for animals.

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Initial Certification to FSSC 22000 Once you have built and implemented the system in your organization your certification body will perform a Stage 1 Audit. This audit is conducted on site, and is an evaluation of the food safety management system you have designed to determine if it meets the requirements of the standard, and your organizations readiness to move on to a Stage 2 Audit. The Stage 2 Audit is also an onsite audit. The Stage 2 Audit focuses on compliance to the system you have designed and compliance to the standard. The Stage 2 Audit is longer, giving the auditors time to review records, observe processes and practices and talk to employees throughout the organization about their food safety responsibilities. During the certification audit the Auditor will examine your System to determine:

If the system has been implemented effectively.

If there is evidence of Management Commitment to the maintenance and improvement of the system.

If activities comply with regulatory, customer and FSSC 22000 requirements.

If the audit identifies areas of the system that do not comply with the standard, you will need to correct nonconformance's 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.

Findings are categorized as: Minor Nonconformity, must have correction action plans in place within 30 days and will be verified at the next audit of your system (see surveillance audits below).

This is a nonconformance to the documented system or to the standard that does not cause an immediate food safety risk or indicate ineffective implementation of a system element.

Major Nonconformity, must be corrected and verified by an onsite follow up by the auditor from your certification body.

A Major Nonconformity is issued when there is a situation that could lead to an immediate food safety risk or if there is a complete failure of one of the FSMS processes, for example multiple minor nonconformities identified within one process.

The FSSC Food Safety Team Leader: Qualifications and Responsibilities

Each company must designate a Food Safety Team Leader. This person will manage and lead the food safety team, and is responsible for making sure that the team members are qualified and trained. The team leader is also responsible for ensuring that the FSMS is fully implemented, meets the requirements of the standard, and is updated and maintained. Management must consider what this encompasses, and designate a person with the qualifications to handle these responsibilities effectively. Identify this person early in the project, so that they can lead the design and implementation of the system.




Training for the Food Safety Team Leader To be prepared to manage the responsibilities listed above, the Food Safety Team Leader must have a thorough understanding of the requirements of the standard and of HACCP.

FSSC 22000 series: A. Introduction to FSSC 22000:

This course clearly explains the FSSC 22000 requirements and defines the processes that must be in place in your company to comply with these management systems requirements.

B. FSSC 22000 Prerequisite Programs

This course explains the requirements for the Prerequisite Programs (PRPs) for your industry segment (Food Packaging Manufacturers or Food Processors). The program will help the Food Safety Team Leader understand how your facility can best comply with the requirements.

C. The Gap Analysis Checklists and Tutorial The Food Safety Team Leader will learn how to start the project with a Gap Analysis Audit. The Gap Analysis will assist the Team Leader in comparing the current processes to the requirements of the standard and creating an effective project plan.

D. Plan, Implement and Document an FSSC System This FSSC 22000 Program will provide the Food Safety Team Leader with the instruction, templates, planning tools and knowledge that they need to effectively implement FSSC 22000 to prepare for certification. They will be provided with instructions to lead the implementation of the food safety management system.

E. Internal Auditor Training

This course is designed to train Internal Auditors and provide them with the knowledge and skills needed in order to audit a company's food safety management system with confidence.

Steps to FSSC 22000 Certification

In this section we outline our recommended steps to follow to prepare your organization for FSSC Certification. In the next few sections we will take a look at each step in more detail and provide guidance and resources for completing the steps.

First take a look at this overview of the project steps: 1. The Food Safety Team Leader completes training on the “Introduction to FSSC

22000” and “FSSC 22000 Prerequisite Programs”. 2. The Team Leader works with the management team to prepare the project plan.

This is detailed in the next section of the quick start guide. 3. Management identifies the “FSSC Steering Team”. 4. The Food Safety Team Leader takes the “The Gap Analysis Checklists and Tutorial”

training.




5. 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: a. Document Control b. Records c. Management Responsibility d. Communication e. Emergency Preparedness f. Competence Awareness and Training g. Infrastructure h. Work Environment i. Corrections and Corrective Action j. Control of Nonconforming Product k. Recall or Withdrawal l. Prerequisite Programs m. Preliminary Steps for Hazard Analysis n. Food Safety Team o. Hazard Analysis p. HACCP q. Verification r. Traceability s. Control of Monitoring and Measuring t. Internal Audits

6. The FSSC Steering Team assigns team members to each task team, and a team leader for the each team. Some of the processes may be assigned to the steering team or Food Safety team. See the example table for our recommendations.

7. Identify training requirements for those assigned to the task teams. “Introduction to FSSC 22000” is our recommended training for those team members.

8. 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.

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

10. The task teams meet as scheduled to complete the changes to and implementation and documentation of the new processes.

11. The FSSC Steering team reviews and approves all the procedures and documentation developed by the task teams.

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

13. Start the internal audits when the FSSC Management System processes are completed.

14. Hold management review meetings, conduct internal audits and complete corrective actions. Follow the new FSSC Procedures that the task teams developed, maintain records and make improvements. Run your system for approximately 3 months then have your desk audit and certification audit.




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 in Appendix A. Lets look at how to prepare the plan. A. First, identify your project goals. Answer the questions:

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 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.

B. Identify responsibilities for the project.

1. Identify the Food Safety Team Leader. The Food Safety Team Leader should act as project manager for the implementation project.

2. Identify who makes up Senior Management. 3. Identify the FSSC Steering Team. As you saw in the steps in the previous section,

the FSSC Steering Team plays a key role in managing the project. The Food Safety Team Leader should be the team leader, and senior management should make up the rest of the team.

C. Start to fill in the timeline for the project. 1. Schedule training for the Food Safety Team Leader. 2. Schedule the Gap Analysis. Remember that the Food Safety 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 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 Certification is, and why it is important to the organization.

7. Document your target completion date and target dates for your certification audits.




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 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 “The Gap Analysis Checklists and Tutorial” session to learn how to plan and conduct the gap, what to do with your results.

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, Where you identify requirements that are not yet being

complied with, document a task on the list. a) The packages provide both an overall project task list, and individual

team task lists. If you have purchased a 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 Steering Team

Once the Gap Analysis has been completed, start your FSSC Steering team meetings. During the first team meeting discuss the responsibilities of the FSSC 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 FSSC Steering Team meeting: 1. Review the list of steps to implementation. 2. Review the responsibilities of the FSSC Steering Team (these responsibilities will

not all be completed in the first meeting, but should be reviewed to clarify the purpose of the team.)

a. Identify task teams and members. b. Identify training requirements for task team members, Food Safety

Team members and employees. c. Meet regularly to monitor the project timeline and task team activities

and provide resources as needed to meet project goals.




d. Choose a certification body, and schedule the certification audit. e. Review procedures and other documentation created by the task teams. f. Review and customize the Management Responsibility procedure.

Complete tasks assigned to management. g. Assign internal auditors and create an audit schedule. h. Resolve issues as they arise. i. Identify task teams, team leaders and members. Assign timelines for

each 3. 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 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 FSSC 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 FSSC Management

System 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 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 SQF Code 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 FSSC Steering team for review. Once the procedure is approved, the team will be responsible for seeing that it is effectively implemented.




FSSC Project Plan

Project Goals:

Start Date: Target Date for Completion: Responsibilities: Food Safety Team Leader: Senior Management: FSSC Steering Team: Timetable:

Step Start Date Completion Target

The Food Safety Team Leader completes online training

Conduct Gap Analysis

FSSC Steering Team Meetings

Training for Task Team Members

Task Team Meetings

Announce the Project to all Employees

System Complete

Stage 1 Audit

Stage 2 Audit (Certification Audit)

Certificate in Hand (Allow 4-6 weeks after the Certification Audit)




Appendix A

Example Task list with task team timelines assigned.

Tasks Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Assign processes to teams for implementation

X

Document Control X X X Records X X X Management Responsibility X X X X Communication X X Emergency Preparedness X X Competence, Awareness and Training

X X X X

Infrastructure X X Work Environment X X Corrections and Corrective Action

X X X

Control of Nonconforming Product

X X

Recall or Withdrawal X X Prerequisite Programs X X X X Preliminary Steps for Hazard Analysis

X X

Food Safety Team X X X X X X X X X X Hazard Analysis X X HACCP X X X Verification X X Traceability X X Control of Monitoring and Measuring

X X X

Train the Audit Team X X X X X X Conduct Employee Training X Start Internal Audits and Management Review

X

Stage 1 Audit X CERTIFICATION AUDIT X


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