HARMONISATION TRAINING

2018

FSSC 22000 (V4.1)

Introduction

• Harmonisation Conference in Amsterdam 10-11 Oct 18

• President attended for TQCSI
• clarified that 5 audits per year are pro-rata for new auditors
• Portal still a problem – hope to be fully operational by 2019.
Over 18,000 Certificates Worldwide
Current Status
18000 Certificates
110 Certification Bodies

40 Accreditation Bodies

1500 Auditors

154 Countries
New Scopes
Communication

• Translations:
• Spanish
• Chinese
• Japanese
• Scope Flyers:
• Transport & Storage
• Retail
• Food Manufacturing.
Why FSSC Scheme Version 5?

• publication of ISO 22000:2018

• IAF ID on new ISO 22000 transition process
• IAF Decision for 3 year transition period after publication
• enable integrated management system audits for FSSC-Quality
option
• clarification of requirements in Version 4.1
• compliance with GFSI Benchmarking Requirements Version 7.2
• compliance with EA1/22 requirements.
FSSC Scheme V5 - Objective

Notes:
• until V5 publication, everything is “business-as-usual”
• SMEs may need help in HLS implementation
• CBs support in auditing HLS requirements (see ISO 19011:2018).
FSSC Scheme V5 – Project Scope

In scope Out of scope

FSSC Scheme documentation: FSMA Supplement &

• Part 0 to Part 5 including all Addendum.
• Annexes
• Guidelines
• Checklists & templates
• FSSC-Quality
• Portal changes
• Training of internal personnel
FSSC Scheme V5 - Timing

• publication in May 2019.

 ISO 22000 Food Upgrade

• development of new ISO 22000 Handbook

• revision of ISO/TS 22002-x series
• ISO/TS 22002-5, Transport & Storage - planned publication Oct 19
• ISO 22003:2013 being reviewed – expected publication Jun 20.
GFSI Benchmarking
FSSC Scheme v4.1 successfully benchmarked against GFSI v7.1
• C – Food Manufacturing
• D – Animal Feed Production (new)
• G – Transport & Storage Services (new)
• I – Food and Feed Packaging and Materials
• K – Production of (Bio)Chemicals

Version 5 to be submitted in 2019 against GFSI v7.2 & new scopes

• GFSI Knowledge exam for:
• qualified new auditors starting from 1 Jul 19
• approved auditors no later than 1 Jul 22
• submit new scopes for Catering (E) & Retail (F).
Our Approach in Japan

• Yukawa is local representative Japan since June 2018

• Japan 2nd largest in FSSC 22000 (1284 certificates)
• membership of GFSI Local Group since July 2018
• communication with JACB and CBs on future activities of SSC
• communication with industry, institutes & authorities,

Goichiro Yukawa -
• gyukawa@fssc22000.com
• +81-90-6506-1573.
Major Opportunities in Japan

• revision of Food Sanitation Law: HACCP obligatory by Jun 20

• increasing demand on GFSI recognized FSMS certification from
retailors and major food processors
• some local governments also ask food industries to get certification,
including HACCP
• large number of food companies not yet on GFSI recognized
certification level.
GFSI Benchmarked Schemes
Allergen Management
 Allergen Recalls

Top 5 causes for allergen recalls:

1. wrong package or label
2. terminology
3. failure to carry forward information from an ingredient to final
label
4. cross-contact
5. ingredient mislabelled from supplier.
Basics of Allergen Management
Environment Monitoring

FSSC 22000 V5 Draft Definition:

The evaluation of the effectiveness of all controls on preventing

contamination from the factory environment. It shall include as a
minimum the evaluation of microbiological and allergen controls
present.

Note: It is not only an evaluation of cleaning/sanitation procedure(s)

itself but also of other programs including but not limited to personnel
practices, sanitary design, operational methods and supplier control.
Environmental Monitoring
Environmental Swabbing

Sample before starting up the line gives the best information

about the effectiveness of cleaning/sanitation controls.
Testing for Pathogens

When there is a risk of pathogens, test for the pathogen(s) itself,

indicator organisms, ATP (TPC) or a combination of the above,
depending on the HACCP/OPRP Plan.
Positive Results

When a positive result is found, first perform a risk

assessment on where the pathogen was found.
 Nonconformities in Audit Reports
Area
Change Management
Clauses indicated as ”not applicable”
Outsourced Services
The PRP section on Purchased Material and
Service states “special attention is paid to
purchasing raw milk of high quality”.
Missing data
Executive summary
Issue
Not reporting on V4.1 changes
No justification provided
Service providers reported
Audit category is food packaging (I)
Portal sections not completed
Copy/paste of all summary sections from
checklists
 Audit Criteria
Actual examples of poorly reported audit criteria

None

Assessed policies, procedures and requirements.

Client policies, procedures and requirements of clients

Required

ISO22000:2005; relevant PRP standard; FSSC 22000 V4.1

Regulatory requirements (where applicable)

Clients’ FSMS
 Audit Objectives
Actual examples of poorly reported audit objectives

Confirm any special attention areas

All objectives met

a) to confirm the readiness of the organization for a complete system audit.

b) to collect the relevant information for effectively planning of complete system 2) audit.

Required

Meet clause 9.2.1.2 of ISO/IEC 17021-1:2015

Be relevant to the type of audit being performed

 Executive Summaries
Actual examples of poorly written summaries
The company maintains a well-functioning and effective Food Safety Management System.
Senior management promotes and supports continuous improvement of the management
system

Listed the four minor nonconformities

Statement on the conformity and the effectiveness of the management system, and
confirmation that the audit objectives have been fulfilled

Focused only on QMS and quality issues, no reference to Food Safety is mentioned.
1 minor raised against 8.3 Management of the systematic monitoring and measurement

No findings
A copy and paste of the General Description of the Organization
 Proposed Guidelines
Area Requirements Guidelines

Vulnerability 1) The organization shall have a documented and
assessment implemented vulnerability assessment procedure
in place that:
a) identifies potential vulnerabilities,
b) develops control measures, and
c) prioritizes them against the identified
vulnerabilities.
2) To identify the vulnerabilities, the organization shall
assess the susceptibility of its products to potential
food fraud acts.
Reference procedure that addresses this requirement.
Detail which system was used (i.e. SSAFE, VACCP
etc.).
Detail team involved with conducting the
vulnerability assessment.
Detail the training the team has received on food
fraud prevention.
List the primary potential food fraud risks (i.e.
substitution of olive oil)
Detail training and communication strategy for
employees.
Statement on effectiveness of implementation of
Food Fraud Vulnerability Assessment.

Control measures The organization shall put in place appropriate control Detail how the control measures reduce or eliminate
measures to reduce or eliminate the identified the identified vulnerabilities.
vulnerabilities.

Plan 1) All policies, procedures and records are included Confirm if all products are covered by the FFVA.
in a food fraud prevention plan supported by the Detail any relevant legislation and the organization's
organization’s Food Safety Management System conformance to it. If there is no legislative
for all its products. requirements then note this fact.
2) The plan shall comply with applicable
legislation.
 Proposed Guidelines
Area Requirements
Product Labelling The organization shall ensure that
the finished product is labelled
according to the applicable food
regulations in the country of
intended sale.
Guidelines
Document which product labels
were reviewed. Document
relevant legislation and whether
the samples meet requirements.
Indicate whether allergens are
addressed appropriately.
Examples of Audit Report Users

• certified client
• senior management
• QAM/FSM
• internal auditors
• CBs
• certification decision process
• auditor preparation for next audit
• ABs
• Scheme Owner
• customers
• Regulatory inspectors.
Uses and Requirements

• provides client detailed information on the conformance and

performance of their FSMS
• provides CBs with the necessary information on which to base a
certification decision
• required by:
• ISO/IEC 17021-1:2015 cl 9.4.8
• ISO/TS 22003:2013 cl 9.1.7
• GFSI V7.2 Part II cl 2.6
• FSSC 22000 Part IV cl 8.
Audit Reports

Audit reports require a recommendation from audit team,

reasons for deviations from audit plan, conclusion on the
appropriateness of the certification scope and audit criteria.
Certificates

Certificate is automatically published on the FSSC 22000

Website Public List.
Other FSSC Issues

• FSSC witness assessors may not be part of the audit team and do
not count towards audit duration
• FSSC auditors required to conduct 5 FSSC audits each calendar
year
• both checklists (FSSC 22000 Checklist and PRP Checklist) are
required to be completed for each audit (separate checklists for
Stage 1 and Stage 2 Audits)
• however, not all clauses need to be assessed during Stage 1
Audits (record ‘to be assessed at Stage 2 Audit’ on the checklist)
• minor nonconformities to be addressed within 3 months after the
audit. auditors to verify evidence of corrective action.
Other FSSC Issues cont.

Audit Report field ‘Summary of Additional Requirements’ to

discuss all additional requirements as per FSSC 22000 Scheme
Part II Requirements for Certification:
• Management of Services
• Product Labelling
• Food Defence
• Food Fraud
• FSSC 22000 Logo Use
• Management of Allergens
• Environmental Monitoring.
Next?

Only auditors and respective ROs who have not attended

this training must now prove their competence by reviewing
the PowerPoint Presentation and conduct the exam on-line
at TQCSI-Training through the home page of
www.tqcsi.com before the end of the month.
Any Questions?

www.tqcsi.com