Gs1 GTC Training Manual v21 Print Version

GS1 GTC Training
Student Manual - V 2.1

Traceability GS1 GTC – Student Manual
August 2010, Version 2.1 All contents copyright © GS1 2010 Page 2 of 151
GS1 GTC aims at

helping companies
implementing
traceability according
to best practices and
GS1 global standards
GS1 GTC Training
Document Change History
Author Date Review Actions
Mark Van Eeghem 13/11/2008 V2 Creation
Juan Pablo Vial 02/06/2010 Version 2 New Version
Juan Pablo Vial 24/08/2010 Version 2.1 Modifications based on

GA outcomes
Acknowledgements
The faculty which launched this training initiative consisted of:
Glenda Connoll GS1 South Africa

Janice Kite GS1 Global Office
Sabine Klaeser GS1 Germany
Ana-Paula Maniero GS1 Brazil
Slobodan Romac GS1 Croatia
Mike Sadiwnyk GS1 Canada
Juan-Pablo Vial GS1 Global Office
(Course Director)
The GTC Core Group:
Nicholas Fergusson GS1 Global Office

Jean-Marc D’Hooghe GS1 Global Office
Nora Kaci GS1 Global Office
Melanie Kudela GS1 Global Office
Diane Taillard GS1 Global Office
Juan-Pablo Vial GS1 Global Office
(Project Manager)
Special thanks to:
Peter Zaepfel Kraft

Cristian Barcan BASF
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Disclaimer
Whilst every effort has been made to ensure that the guidelines to use the GS1 standards contained in
this document are correct, GS1 and any other party involved in the creation of this document HEREBY
STATE that this document is provided without warranty, either expressed or implied, of accuracy or
fitness for purpose, AND HEREBY DISCLAIM any liability, direct or indirect, for damages or loss
relating to the use of this document. This document may be modified, subject to developments in
technology, changes to the standards, or new legal requirements. Several products and Organisation
names mentioned herein may be trademarks and/or registered trademarks of their respective
companies.
Copyright Notice and Terms of Use

This publication is protected by international copyright law and is subject to the following terms of use:
You are allowed to translate, copy and reproduce the GS1 GTC Training Manual provided you use this
document in its entirety and do not alter or modify it in any way, you acknowledge GS1 as the
copyright owner and include the below copyright notice in any copy that you make. It is highly
recommended that you attend GS1 GTC training for a better understanding of this document.
GS1 GTC Training Manual. © Copyright GS1, 2010. All Rights reserved.
Table of Contents
1. Introduction ...................................................................................................... 11
1.1. Training Objectives and Goals ............................................................................11
1.2. Prior Knowledge Required ...................................................................................12
1.3. Target Audience....................................................................................................12
2. Training Regulation ......................................................................................... 13
3. Training Manual Structure ............................................................................... 14
4. Information about the training ........................................................................ 15
4.1. Instructions to the participants............................................................................15
4.2. Evaluation Method ................................................................................................15
4.3. Continuous Evaluation .........................................................................................15
4.4. Final Evaluation ....................................................................................................15
4.5. Diplomas and Certificates ....................................................................................16
4.6. To Remember ........................................................................................................16
5. Training Agenda ............................................................................................... 17
6. What is the GS1 Global Traceability (GS1 GTC) Programme? ..................... 21
6.1. GTC Program Vision, Mission and Objectives ....................................................22
6.1.1. Vision ...............................................................................................................22
6.1.2. Mission ............................................................................................................22
6.1.3. Objectives ........................................................................................................22
6.2. Who can use the GS1 GTC Programme? ............................................................22
6.3. Major benefits of the GS1 GTC Programme ........................................................23
7. How does the GS1 GTC Programme work? ................................................... 24
7.1. GS1 GTC Programme roles ..................................................................................24
7.1.1. Auditor: ............................................................................................................24
7.1.2. GTC Trainer: ....................................................................................................24
7.1.3. GTC Auditing Organisation: .............................................................................24
7.1.4. Certification Body: ............................................................................................25
7.1.5. Accreditation Body: ..........................................................................................25
7.2. GS1 GTC Implementation Path ............................................................................27
7.2.1. GS1 GTC Assessments and GS1 GTC Auditors in practice .............................29
7.2.2. How can a company obtain a GS1 GTC Global Seal or Certificate? ................29
7.2.3. The role of GS1 Member Organisations (GS1 MOs) ........................................30
7.3. The GS1 GTC Programme Material ......................................................................31
7.3.1. What documentation, in what languages is currently available? .......................32
7.4. How is the GS1 GTC Programme maintained? ...................................................33
8. Requirements for becoming a GS1 accredited GTC Auditor ....................... 34
8.1. Reasons for obtaining GS1 GTC Auditor accreditation .....................................34
8.2. How to become an accredited GS1 GTC Auditor ...............................................34
8.2.1. Step 1 ..............................................................................................................35
8.2.2. Step 2 ..............................................................................................................35
8.2.3. Step 3 ..............................................................................................................36
9. How to get involved? ....................................................................................... 38
10. Introduction .................................................................................................... 40
11. Terms and Definitions related to ISO 19011 ................................................ 41
12. The Principles of Auditing ............................................................................. 43

13. Managing an Audit Programme .................................................................... 45
14. Audit Activities ............................................................................................... 48
14.1. Initiating the Audit ..............................................................................................48
14.2. Conduct Document Review ................................................................................49
14.3. Preparing the On-Site Audit Activities ..............................................................49
14.4. Conducting On-Site Audit Activities..................................................................50
14.5. Preparing, approving & distributing the Audit Report .....................................50
14.6. Completing the Audit ..........................................................................................51
14.7. Conducting Audit follow up ...............................................................................51
15. Competence and Evaluation of Auditors ..................................................... 52
15.1. Personal Attributes .............................................................................................52
15.2. Knowledge and skills .........................................................................................53
15.3. Useful tips to remember .....................................................................................53
16. Certification and Registry of Organisations and Auditors ......................... 56
16.1. Certification Process for Organisations............................................................56
16.1.1. Initial audit and certification ............................................................................56
16.2. Certification for Auditors....................................................................................58
16.2.1. International Registers ...................................................................................58
16.2.2. Schema for Auditor Certification .....................................................................58
17. The GS1 GTC Checklist ................................................................................. 60
17.1. How was it developed? ......................................................................................60
17.2. Structure..............................................................................................................61
17.3. Regulations References .....................................................................................62
17.4. Standard References ..........................................................................................62
17.5. Compliance Levels .............................................................................................63
17.6. Control Points Usage Guide ..............................................................................65
17.7. GTC and its compliance with the GS1 Global Traceability Standard ..............68
17.8. Relationship with other Traceability & Best Manufacture Practices (BMP)
Standards ........................................................................................................................69
18. Introduction .................................................................................................... 72
19. The Initial Meeting .......................................................................................... 73
19.1. The Audit Team ...................................................................................................74
19.1.1. Appointing the Audit Team .............................................................................74
19.1.2. Audit Team Functions and Responsibilities ....................................................74
19.1.3. Good Practices in Meetings ...........................................................................75
19.2. Establishing initial contact with the auditee .....................................................76
19.3. Defining Audit Objectives and Scope................................................................76
19.3.1. Objective Definition ........................................................................................76
19.3.2. Scope Definition .............................................................................................77
19.4. Determining the feasibility of the audit .............................................................78
19.5. Selecting the audit team .....................................................................................79
19.6. Conducting document review ............................................................................80
20. The Audit Program ......................................................................................... 81
20.1. Assigning work to the audit team ......................................................................82
20.2. Preparing work documents ................................................................................82
20.3. Completing the Audit Plan Form .......................................................................84
20.3.1. Company Information Section ........................................................................84
20.3.2. Audit Team Information ..................................................................................85
20.3.3. Audit Information ............................................................................................85

20.3.4. Audit Activities................................................................................................87
20.3.5. Audit Program ................................................................................................88
21. On-Site audit................................................................................................... 91
21.1. The Opening Meeting .........................................................................................91
21.1.1. Communication during the Audit ....................................................................92
21.1.2. Roles and responsibilities of guides and observers ........................................93
21.1.3. Control of the Audit ........................................................................................93
21.2. Collecting and verifying information .................................................................95
21.2.1. Observation of activities .................................................................................96
21.2.2. Review of documents .....................................................................................96
21.2.3. Interviews .......................................................................................................97
21.3. Generating Audit findings ..................................................................................99
21.3.1. How to write Nonconformities (NC)? ............................................................100
21.3.2. When declaring an Observation? .................................................................102
21.4. Filling the GS1 GTC Assessment Checklist ....................................................103
21.4.1. Terms in the GS1 GTC Assessment Checklist .............................................103
21.4.2. When checking the Fulfills field ....................................................................104
21.4.3. Defining a Not Applicable .............................................................................105
21.4.4. Writing an Observation.................................................................................106
21.4.5. Writing a Nonconformity? .............................................................................106
21.4.6. Checking the Control Points .........................................................................108
21.5. Preparing Audit Conclusions ...........................................................................109
21.6. Conducting the Closing Meeting .....................................................................110
22. Preparing, approving & distributing the Audit Report .............................. 111
22.1. The Nonconformities Report ............................................................................111
22.1.1. Nonconformity Information Section ..............................................................111
22.1.2. Corrective Action Information Section ..........................................................112
22.1.3. Corrective Action Inspection Section ............................................................114
22.2. The Audit Report ...............................................................................................115
22.2.1. Company Information Section ......................................................................115
22.2.2. Audit Team Information ................................................................................116
22.2.3. Audit Information ..........................................................................................117
22.2.4. Summary Table Section ...............................................................................118
22.2.5. Nonconformities against the standards Section ............................................119
22.2.6. Traceability Implementation Degree Section ................................................120
22.2.7. Report Distribution Section...........................................................................122
22.3. The Conformance Report .................................................................................123
22.4. Completing the Audit: Presenting the Assessment Report ...........................125
Appendix 1: References ....................................................................................... 127
Appendix 2: Additional Information .................................................................... 129
Appendix 3: IAF Members.................................................................................... 131
Appendix 4: Audit Plan Example ......................................................................... 134
Appendix 5: Nonconformity Report Example .................................................... 138
Appendix 6: Audit Report Example ..................................................................... 139
Appendix 7: Conformance Report Example ....................................................... 143
Appendix 8: Common Rules for On-Site Audit .................................................. 144
Appendix 9: Opening Meeting Checklist ............................................................ 145
Appendix 10: Closing Meeting Checklist............................................................ 146

Appendix 11: IRCA Code of Conduct.................................................................. 147
Appendix 12: Audit Log Form ............................................................................. 148
Module 1: Introduction to the GTC Training

This module will cover the following topics:
 Introduction
 Training Objectives and Goals
 Prior Knowledge Required
 Target Audience
 Training Regulation
 Training Manual Structure
 Information about the training

 Instructions to the participants
 Evaluation Method
 Continuous Evaluation
 Final Evaluation
 Diplomas and Certificates
 To Remember
 Training Agenda
1. Introduction
You will be attending a training activity provided by GS1 Global Office Training & Education.
This training was compiled by international experts so you can acquire the required
knowledge and skills needed to be applied and as a result, becoming a valuable contributor
to your organisation.
The GS1 GTC Training was developed after the Pilot Phase of the GS1 GTC Programme so
it includes all the experiences, observations, comments and contribution gained from those
experiences.
Accreditation as GTC Auditors:
Participants who satisfactorily pass the training will be ready to

apply for the GTC Auditor accreditation.
Rules for GTC Auditor accreditation are given in Module 2:Module
1: The GS1 GTC Programme
1.1. Training Objectives and Goals

The objective of the training is to:
 Provide all the skills necessary to operate as a GTC auditor in assessing companies with
the aim of improving their traceability.
 Give an essential perspective to GS1 professionals responsible for the planning and
implementation of traceability assessments under the GS1 GTC Programme.
 Teach how a professional auditor structures, plans, and executes an effective

traceability audit, then evaluates and communicates the audit findings.
At the end of this course participants will be able to:
1. Understand the principles of auditing

2. Prepare and advise organization before a GTC assessment
3. Prepare for, carry out, report and follow up on GTC assessments and demonstrating
skills to
 Effectively plan and prepare
 Achieve objective evidence, through interviews, observation, sampling and notes
taking.
 Analyze and interpret the information to determine conformity with requirements
4. Effectively assess organizations preparedness against major traceability regulations and
commercial traceability requirements
5. Contribute to implementing the GS1 Global Traceability Standard
6. Contribute to the development and improvement of an organization’s traceability system
Participants will need to demonstrate an acceptable understanding of all these areas to

satisfactorily complete the training.
1.2. Prior Knowledge Required

A prerequisite to this training is the GS1 GTS Training course.
The objective of the GTS training is to provide an understanding of traceability in supply
chains and of the GS1 Global Traceability Standard and Traceability solution. It provides
sufficient knowledge to gain confidence and be able to promote the GS1 Traceability
Solution in any market and to provide high level advice on how to implement a traceability
system.
Also, it is required that participants must read in advance the following documents in order to
have enough knowledge to follow the training. Knowledge of these documents will be
evaluated during the sessions.
 GS1 GTC Operations Manual
 GS1 GTC Control Points & Compliance Criteria (GS1 GTC Checklist)
1.3. Target Audience

Attendance is open to GS1 Member Organisations staff, local collaboration partners and/or
solution providers responsible for auditing or identifying traceability opportunities and
providing high level traceability technical advice.
2. Training Regulation
Participants will be involved in a training activity provided by GS1 Global Office Training &
Education.
This training was elaborated by international experts for you to acquire the knowledge and
skills needed to be applied therefore bringing a valuable contribution to your organisation.
The training material provided during the training is property of GS1. You are allowed to
translate, copy and reproduce the GS1 GTC Training Manual provided you use this
document in its entirety and do not alter or modify it in any way, you acknowledge GS1 as
the copyright owner and include the below copyright notice in any copy that you make.
In order to assure the quality of the service, participants will have the opportunity to evaluate
the training when completed.
Student Regulation
1. The participant must establish whether he/she fulfills the pre-requirements established
by GS1 Global Office Training & Education, in every course, which is needed to achieve
the activity objectives.
2. The participant will successfully pass the training if his/her attendance is 100% and
his/her final score is equal or higher to 70%.
3. If the participant fails the final evaluation, the participant will have to do the GTC training
again. For this, the participant is required to directly contact GS1 Global Office Training
& Education.
4. Diplomas and attendance certificates will be delivered to participants by mail within 90
days of completing the activity.
5. It is mandatory that participants keep an ethic behavior at all times and avoid
misbehaviors such as copying in the final evaluation, don’t give back the final evaluation
to the trainer or any other considered by the trainer as a transgression to the
transparency and normal performance of the training.
6. If the participant has an observation related to the training activity, he/she should
communicate that observation to:
 The trainer
 The training satisfaction evaluation
 The GS1 Global Office Training & Education contact
3. Training Manual Structure
The Training Manual is comprised of 5 modules:
MODULE 1: Introduction to the GTC training. This Module introduces the participant to
the GTC Training and presents its objectives, pre-requisites, regulation,
manual structure and training program.
MODULE 2: The GS1 GTC Programme. Overview of the GS1 Global Traceability
Programme Operation’s Manual. Presents how the GS1 GTC Programme
works and how organisations can be involved and start offering the service.
MODULE 3: Auditing under ISO 19011. Presents an overview of the ISO 19011
standard. Contents include Terms and Definitions related to ISO 19011, The
principles of auditing, managing an audit program, the audit activities and
competence and evaluation of Auditors.
MODULE 4: The GS1 GTC audit criteria and materials. Presents the GS1 GTC
Checklist, how it was developed, the structure of the document, regulations
and standard references, compliance levels, Control Points usage guide. Also
shows the GS1 GTC Audit materials
MODULE 5: The GS1 GTC audit activities: Presents how mapping GTC to business
processes of an organisation. Establish how to perform the Audit activities
and fill the Audit forms using the GS1 GTC materials.
4. Information about the training

4.1. Instructions to the participants
At the beginning of the training all the participants will be asked to introduce themselves. The
introduction should include information about their job function within the organisation they
are working, their knowledge about Traceability, GS1 GTS and Quality Standards and what
they expect at the end of the training.
4.2. Evaluation Method

The participants will be evaluated based on:
 A continuous evaluation of their participation during the training
 The scores achieved in every evaluation during the training
 The scores obtained in the final evaluation.
To successfully pass, the training participants need to have at least
 60% in the final evaluation
 70% in the final score
4.3. Continuous Evaluation

During the training, participants will be evaluated at all times, including role playing activities
and exercises. Participants must show an acceptable performance in all the learning
activities to successfully end the training.
The fulfillment of the training schedule by the participants will be evaluated positively. A poor
fulfillment will lead to a failure in completing the training objectives. There will be no
exceptions to extend the breaks in order to attend external business activities.
Participants will have to pay attention during the whole training. Not doing it will be reflected
in the continuous evaluation and in the final evaluation.
4.4. Final Evaluation

The Final Evaluation will be a written test with a duration of 2 hours. Participants will only
have access to their Training Manual and to the GS1 GTC Checklist.
4.5. Diplomas and Certificates

Participants who pass the training successfully, will receive a diploma to that effect. This
diploma will allow the participants to apply for the GTC Auditor accreditation.
Participants who don’t pass the training will receive an attendance certificate.
Diplomas and attendance certificates will be delivered to participants by mail within 90 days
after finishing the activity.
4.6. To Remember
The use of mobile phones, pagers and notebooks are not allowed during the training unless
express authorization from the trainer.
5. Training Agenda
DAY 1
08:45 Registration
09:00 Welcome, Introduction, Training Outline

Objectives, instructions, workshops, team work, continuous evaluation,
evaluation criteria, participants introduction
09:30 WORKSHOP 1: Warm Up!

09:45 WORKSHOP 1: Feedback
10:00 THE GS1 GTC PROGRAMME

What is the GS1 Global Traceability Programme?
How the GS1 GTC Programme Works
Requirement for becoming a GS1 accredited GTC Auditor
How to Get Involved
11:15 Coffee Break
11:30 AUDITING UNDER ISO 19011

Introduction, Terms and Definitions
Principles of Auditing
Managing an Audit Programme
Audit Activities
Competence and Evaluation of Auditors
Certification and Registry of Organisations and Auditors
13:00 – 14:00 Lunch
14:00 WORKSHOP 2: Audit Principles

15:00 THE GS1 GTC AUDIT CRITERIA

The GS1 GTC Checklist
16:00 Coffee Break
16:15 WORKSHOP 3: Knowing the GS1 GTC Checklist

17:15 WORKSHOP 4: Find the Control Point

18:30 End of day 1
DAY 2
09:00 Summary
09:30 THE GS1 GTC AUDIT ACTIVITIES (part 1)

The Initial Meeting
The Audit Team
Establishing initial contact with the auditee
Defining Audit Objectives and Scope
Determining the feasibility of the audit
Selecting the audit team
Conducting document review
The Audit Program
Assigning work to the audit team
Preparing work documents
Filling the Audit Plan Form
11:15 Coffee Break
11:30 WORKSHOP 5: Planning the Audit (Role-playing Game):

Audit preparation, fulfilling the audit plan.
13:00 – 14:00 Lunch

On-Site Audit
The Opening Meeting
Collecting and verifying information
Generating Audit findings
Filling the GS1 GTC Assessment Checklist
Preparing Audit Conclusions
Conducting the Closing Meeting
16:00 Coffee Break
16:15 WORKSHOP 6: Writing Observations & Nonconformities

16:50 WORKSHOP 7: Performing the On-Site Audit (Role-playing Game):

On-site Audit, fulfilling the assessment checklist.
18:30 End of day 2
DAY 3
09:00 Summary

Preparing, Approving & Distributing the Audit Report
The Nonconformities Report
The Audit Report
The Conformance Report
Completing the Audit: Presenting the Audit Report
10:30 WORKSHOP 8: Preparing the Audit Report
11:15 Coffee Break
11:30 WORKSHOP 9: Presenting the Audit Report (Role-playing Game):

Performing the closing meeting
13:00 – 14:00 Lunch
14:00 Course Summary and Feedback
14:30 – 16:30 FINAL EVALUATION
16:30 End of the training
Note:
All the times are estimated and only for orientation.
Module 2: The GS1 GTC Programme

This module will be dealing with the following topics:
 What is the GS1 Global Traceability (GS1 GTC) Programme?

 GTC Program Vision, Mission and Objectives
 Who can use the GS1 GTC Programme?
 Major benefits of the GS1 GTC Programme
 How does the GS1 GTC Programme work?

 GS1 GTC Programme roles
 GS1 GTC Implementation Path
 The GS1 GTC Programme Material
 How is the GS1 GTC Programme maintained?
 Requirements for becoming a GS1 accredited GTC Auditor

 Reasons for obtaining GS1 GTC Auditor accreditation
 How to become an accredited GS1 GTC Auditor
 How to get involved?
6. What is the GS1 Global Traceability (GS1 GTC)

Programme?
The GS1 Global Traceability Programme (GS1 GTC Programme) supports the
implementation of traceability across the supply chain both locally and globally.
The GS1 GTC Programme enables organisations to:
 have their readiness for introducing a GS1 based traceability system assessed
 have their current system evaluated and audited in compliance with customers’
requirements, regulations, best practices and global standards.
The Initial focus is to provide the food industry with a common and understandable toolset
enabling the testing and implementation of a standardized traceability language using the
GS1 Global Traceability Standard. Sharing traceability information between trading partners
across the extended supply chain will be simpler, more accurate and with improved
efficiency.
The Case for the GS1 GTC Programme:
 Demand in most markets to improve food safety is growing

 Traceability for specific areas (e.g. beef) is compulsory in most
countries.
 GTS and GTC are based on user requirements.
 GTC complements other food programs (e.g. GlobalGAP) since
GTC addresses the inter-company information exchange
 The Global Traceability Standard (GTS) forms a basis for
companies to improve their efficiencies and quality controls
 The GS1 GTC Programme complements GTS with a concrete
service for implementation and enables companies to
demonstrate correct implementation of the standard.
 Some countries – mainly in Latin America - are already
implementing local GTC programs.
6.1. GTC Program Vision, Mission and Objectives
6.1.1. Vision
GS1 standards are a fundamental element of Traceability Systems across the supply chain.
GS1 standards are widely implemented by manufacturers, retailers, third party logistics
providers, carriers and solution providers enabling full supply chain traceability.
6.1.2. Mission
The GTC Program supports all stakeholders in improving their supply chains in an optimal
way to implement full supply chain traceability and with meeting both regulatory and
business requirements.
The GTC program’s primary goal is to support implementation of

Full Supply Chain Traceability based on GS1 standards and
services.
6.1.3. Objectives
The main objectives of the GS1 GTC Programme can be summarized as follows:
 Support organizations with the implementation of GS1 Global Traceability Standard.

 Provide a tool to test the traceability implementation level and deliver guidance to solve
any gaps
 Provide organisations with a standardised procedure to implement and test the GS1
GTS locally and globally
 Support organisations with the correct implementation of the GS1 System
 Allow organisations to identify other GS1 standards that can help improve their business
 Help organisations to fulfill multiple traceability requirements from customers, regulators
and industry
 Play an active role with local and global food associations and regulators to increase
GS1 awareness, especially in the context of Food Safety
6.2. Who can use the GS1 GTC Programme?

Essentially any stakeholder that handles goods in the supply chain: e.g. producers,
manufacturers, processors, logistics service providers, transporters/carriers, retailers,
wholesalers, importers/exporters, storage/deposit providers and container/packaging
manufacturers in the food supply chain.
Also companies providing implementation services related to traceability: e.g. consultants,
solution providers, third party logistic providers (3PLs) and others can use the GS1 GTC
Programme.
6.3. Major benefits of the GS1 GTC Programme

The benefits can be extended to all supply chain partners, including end users or customers,
suppliers and GS1 MOs, and to international trade. In general it will:
1. Facilitate GTS adoption, i.e. the adoption of global traceability standard and best
practices worldwide
2. Ensure the right implementation of full supply chain traceability
3. Ensure continuous conformance to the GS1 System and consistency with best practices
related to supply chain efficiency
4. Have a technology independent solution for traceability
5. Offer a common global solution
6. Provide the possibility to :
 Measure the Minimum Traceability capability of each actor in the chain
 Receive traceability reference and recognition by an international indepe ndent

party
 Address the main international traceability regulations, standards and

commercial requirements.
 Enable any organization to establish its actual traceability level and to be

benchmarked against agreed supply chain minimum requirements and best
practices for traceability.
 Allows organisations to obtain guidance on complying with major international

traceability regulations as well as traceability requirements established by the
key quality standards used in the Food industry.
A global programme for traceability, based on global standards, will improve Global
Traceability and facilitate the flow of information across the supply chain.
7. How does the GS1 GTC Programme work?

The GS1 GTC Programme is a set of documents and procedures that were designed to
complement the GS1 Global Traceability Standard, presenting an implementation model in
order to provide GS1 recognition to Organisations that satisfactorily comply with the
requirements of the GTS through independent assessments.
The GS1 GTC Programme is governed by the GS1 GTC Operation Manual. This document
contains the minimum rules, the process and the compliance criteria for each actor involved
in the GS1 GTC Programme. The following are the actor of the Programme:
■ Auditor
■ GTC Trainer
■ GTC Auditing Organisation
■ Certification Body
■ Accreditation Body
7.1. GS1 GTC Programme roles

The actors and requirements of the Programme are the following:
7.1.1. Auditor:
Auditors are the persons performing GS1 GTC Assessments. The requirements for being
GS1 GTC accredited auditor are defined in the Subsection 8: Requirements for becoming
a GS1 accredited GTC Auditor. Only those Auditors that are accredited by GS1 may
perform GS1 recognized assessments under the GTC Programme.
GS1 GTC Auditors can work for GS1 Member Organisations (GS1 MO), solution providers,
consultants or certification bodies.
7.1.2. GTC Trainer:

GTC Trainers are the persons qualified by GS1 to train GTC Auditors. Only trainings
performed by GTC Trainers allow Auditors to be candidates for auditor accreditation.
GTC Trainers are auditors with the required experience, performing GS1 GTC Assessments.
The rules for GTC Trainer are under the responsibility of GS1 Global Office (GS1 GO).
7.1.3. GTC Auditing Organisation:

A GTC Auditing Organisation is an organization performing assessments within the context
of GTC. This organization must comply with the following criteria, before it can be
recognized as such:
 The organization has a licensing agreement with GS1 GO
 The organization must have at least one accredited GTC Auditor
 The organization must appoint a GTC contact
7.1.4. Certification Body:

It is the organization granting certification. A CB has a licensing agreement with GS1 Global
Office (GS1 GO). Any organisation can be candidate for being accredited as a Certification
Body, by a neutral third party (Accreditation Body), under the criteria ISO 17021 “Conformity
assessment -- Requirements for bodies providing audit and certification of management
systems”.
7.1.5. Accreditation Body:

The Accreditation Body accredits Certification Bodies by ensuring they adhere to quality and
test procedures according to the criteria of ISO 17021 “Conformity assessment --
Requirements for bodies providing audit and certification of management systems”.
The accreditation body is a neutral third party. Normally an IAF registrar.
After an organisation is accredited GS1 GO will continue the process to finally approve the
organisation as an accredited Certification Body in the GS1 GTC Programme.
ISO 17021 “Conformity assessment -- Requirements for bodies

providing audit and certification of management systems”:
Contains principles and requirements for the competence,
consistency and impartiality of the audit and certification of
management systems of all types (e.g. quality management systems
or environmental management systems) and for bodies providing
these activities. Certification bodies operating to this International
Standard need not offer all types of management system
certification.
Certification of management systems is a third-party conformity
assessment activity. Bodies performing this activity are therefore
third-party certification bodies.
The International Accreditation Forum, Inc. (IAF):

is the world association of Conformity Assessment Accreditation
Bodies and other bodies interested in conformity assessment in the
fields of management systems, products, services, personnel and
other similar programmes of conformity assessment.
Its primary function is to develop a single worldwide program of
conformity assessment which reduces risk for business and its
customers by assuring them that accredited certificates may be
relied upon.
Accreditation assures users of the competence and impartiality of the
body accredited. IAF members accredit certification or registration
bodies that issue certificates attesting that an organisation's
management, products or personnel comply with a specified
standard (called conformity assessment).
The following table summarizes the Role/Functions for every actor and their minimum requirements:
Actor/Organisation Role / Function Requirements
Auditor Person performing GS1 GTC GS1 GTC accredited, including

Assessments GS1 GTC training.
Can work for
 GS1 Member Organisation
(GS1 MO),
 solution provider, consultant
or
 certification body
GTC Trainer Person who trains and accredit Qualified by GS1 GO
GS1 GTC Auditors
GTC Auditing Organization performing GS1 GTC Must have at least one accredited
Organisation assessments. Has licensing GTC Auditor
agreement with GS1 Global Office Must have signed the licensing
(GS1 GO). agreement
Certification Body Organization performing GS1 GTC GS1 GTC accredited by GS1
(CB) assessments and certification. Has through neutral third party.
licensing agreement with GS1 An auditor shall never be involved
Global Office (GS1 GO). Meets in implementing in the same
ISO 17021 criteria. company.
Accreditation Accredits Certification Bodies by GS1 GO manages:
Body ensuring they adhere to quality and  Neutral third parties
test procedures and criteria as  IAF accreditation bodies
defined in ISO 17021.
7.2. GS1 GTC Implementation Path

The GS1 GTC Programme defines an Implementation Path, which involves three steps:
1. Implement: Consultancy service aimed at helping a company implement the Global

Traceability Standard (GTS). The service can be provided when implementing a
Traceability System for the first time or to support bridging the gaps identified during an
Assessment.
2. Assessment: Audit performed on a company, using the GS1 GTC Control Points &
Compliance Criteria (GTC Checklist). The assessment must be performed by an
accredited GTC Auditor according to ISO 19011 “Guidelines for quality and/or
environmental management systems auditing”. The Assessment can be used as a
diagnosis to identify gaps at the beginning of a traceability implementation. At the end of
1
the Assessment, the audited company receives an Audit Report informing on the audit
findings.
3. Report: Recognition granted to a company that proved compliance to the GS1 GTC
Checklist after being assessed. At the end of the Assessment, the audited company
2
receives a Conformance Report delivered by the Auditing Organisation, summarising
the result against the compliance criteria (defined in GS1 GTC checklist).
GS1 GTC Reports & Certificates:

3
The GS1 GTC Assessment Report as well as certificates are
governed by a sublicense agreement that covers: usage, branding,
publication as well as roles and responsibilities thereof.
1
The Audit Report is explained in Module 5: Subsection 22.2 “The Audit Report”
2
The Conformance Report is explained in Module 5: Subsection 22.3 “The Conformance Report”
3
The Assessment Report is explained in section 22.4 Completing the Audit: Presenting the
Assessment Report
The following picture shows the GTC Implementation Path:
ISO 19011 “Guidelines for quality and/or environmental

management systems auditing”:
Provides guidance on the principles of auditing, managing audit
programmes, conducting quality management system audits and
environmental management system audits, as well as guidance on
the competence of quality and environmental management system
auditors.
It is applicable to all organizations needing to conduct internal or
external audits of quality and/or environmental management systems
or to manage an audit programme.
Module 3: Auditing under ISO 19011 explains how to perform GTC
Assessments under this standard.
The GS1 focus is:

 Increasing awareness for the global traceability standard and to
demonstrate its benefits through implementations throughout
the Supply Chain (both upstream and downstream) on a global
level.
 Promote the GS1 GTC Assessment which is not a certification
but fulfils the goals of supporting the implementation.
7.2.1. GS1 GTC Assessments and GS1 GTC Auditors in practice

The GS1 GTC Programme works through systematic
traceability assessments using an audit schema. The
audit schema is based on ISO 19011 “Guidelines for
quality and/or environmental management systems
auditing”. The details on how to perform an audit
following the rules of this standard are explained in
Module 3: Auditing under ISO 19011.
The assessments are carried out by accredited GS1 GTC
auditors. The accredited auditor performs the traceability
assessment at the organisation’s facilities, using audit
criteria called “the GS1 GTC Control Points & Compliance Criteria (GS1 GTC Checklist)”.
The result of this assessment is a complete report detailing the traceability level and
identifying the traceability gaps that the organisation should correct. The complete activity
takes between one and three weeks on average for a medium sized company including an
on-site audit at the organisation’s facilities.
7.2.2. How can a company obtain a GS1 GTC Global Seal or Certificate?
The GS1 GTC Programme provides the possibility of certification; however this is contingent
on local market demand. What this means is that if a Certification Body or key stakeholders
in global supply chains wants to put in place a Certification scheme based on the GS1 GTC
Programme and GS1 standards, the GS1 GTC Programme has this option and the company
should contact the local GS1 Member Organisation or the GS1 GTC Programme contacts
(see list of contacts).
Key certification principles of the GS1 GTC Programme
1. Certification must be performed by different bodies than standards development and

accreditation.
2. Certification Bodies need to be independent, impartial and accredited according to ISO
17021.
3. GS1 Member Organisations can be Certification Bodies.
4. Assessments/Consultancy need to be carried out by different individuals
5. Any Organization meeting the accreditation criteria can become a Certification Body
6. Accreditation needs to be carried out by an impartial 3rd party
Currently the focus is on increasing awareness for the global traceability standard and to
demonstrate its benefits through implementations throughout the Supply Chain - both
upstream and downstream - on a global level.
Note:
The GS1 GTC Audit Report is not a certification but fulfils the
goals of supporting the implementation.
7.2.3. The role of GS1 Member Organisations (GS1 MOs)

When a GS1 MOs has at least one accredited GS1 GTC Auditor as well as having appointed
a GS1 GTC contact, they are in a position to start providing several services in their local
markets such as:
 Supporting organizations with the implementation of the GS1 Global Traceability

Standard.
 Performing GS1 GTC Assessments
 Providing training for third party auditors
 Providing internal auditor trainings for organisations
 Promoting the GS1 GTC Programme
 Playing an active role with local food associations and regulators to increase GS1
awareness, especially in the context of Food Safety
 Informing organisations about the process for the maintenance of the standards and
inviting them to join the Traceability Business Requirement Group (BRG)
If GS1 MOs decide to participate as Certification Bodies, they have to create a separate
department to deal with certification. The certification staff cannot take part in GS1
standardisation activities nor implementation activities.
GS1 MOs cannot have exclusivity on their market to perform certification. MOs will compete
with other certification bodies who meet the same criteria.
7.3. The GS1 GTC Programme Material

The GS1 GTC Programme material is a tool- kit of documents
and templates to standardize the way Auditors offer the audit
service to companies around the world.
It is mandatory that all Accredited Auditors use this kit when
applying the GTC Programme. Thereby those audits will be
recognized globally by GS1.
The instructions on how to use the documents included in the
kit when performing an audit is explained in detail in the
Module 5: The GS1 GTC Audit Activities.
The GS1 GTC Programme considers a set of documents

developed to complement the GS1 Global Traceability Standard (GTS). Included within the
Programme documentation are the following:
a. GS1 Global Traceability Standard (GTS)

GS1 standard that presents the minimum business requirements (BR) and business
rules (BRU) for a traceability system for each actor of the chain (internal traceability
as well as between different parties such as between a customer and a supplier)
a. GS1 GTC Operation Manual
Provides the instructions and rules for the parties involved (Auditor, GTC Trainer,
Certification Body and Audit Body)
b. GS1 GTC Control Points & Compliance Criteria:
The GS1 GTC Checklist. Contains all the Control Points and their Compliance
Criteria that an Organisation requires to assess its Traceability system
c. GS1 GTC Audit Material
Contains the documents required to carry out a GS1 GTC Audit on a Traceability
Management System of an Organisation. The following documents are included:
- Audit Plan: Indicates the necessary information required in order to carry out a
GS1 GTC Audit such as Organisational information, audit team, objectives and
scope of the audit as well as the dates of the meetings planned.
- GS1 GTC Assessment Checklist: Contains all the Control Points of the GS1
GTC Control Points & Compliance Criteria and is used by the Auditor to perform
the Assessment.
- Non-Compliance Report: This report is utilized to present items of non-
compliances detected and recorded and the follow up actions required.
- Audit Report: This report is utilized to present the findings of a GS1 GTC
Assessment carried out on an Organisation’s Traceability Management System.
d. GS1 GTC Training Manual
Document aimed to support the GS1 GTC Training. Is a fundamental part of the
training kit and provides guidance on how to perform a GS1 GTC Assessment by
accredited GTC Auditors.
Kit of documents
 GS1 Global Traceability Standard (GTS)
 GS1 GTC Control Points & Compliance Criteria
 GS1 GTC Operation Manual
 GS1 GTC Audit Material
o Audit Plan
o GS1 GTC Assessment Checklist
o Nonconformity Report
o Audit Report
 GS1 GTC Training Manual
The following table shows the latest version of documents and forms considered in the GTC
Programme. It is extremely important to always be aligned with the latest version of every document
and use the translation for the local market language when it exists. If this is not the case, the
English version should be used until an authorized version in the desired language has been
developed.
Document English Version
GS1 Global Traceability Standard Issue 1, Version 1.2.2
GS1 GTC Operation Manual Issue 1
GS1 GTC Control Points & Compliance Criteria Issue 3, June 2010
Audit Plan Issue 1
GS1 GTC Assessment Checklist Issue 1, April 2010
Nonconformity Report Issue 1
Audit Report Issue 1
GS1 GTC Training Manual Version 2.1
7.3.1. What documentation, in what languages is currently available?

The latest version of the documentation and supporting material included in the Programme
is available as of March 2010 at www.gs1.org. Initially documentation is in English only,
becoming available in other languages dependant on market. It is foreseen that a French
and Spanish version will be available in the near future.
7.4. How is the GS1 GTC Programme maintained?

GS1 GTS and the GS1 GTC Checklist are maintained by the Traceability Business
Requirement Group (BRG) according to the normal GSMP process.
The actual way to operate the GS1 GTC Assessments, GS1 GTC Auditor and Certification
Body accreditations is maintained by an internal team composed of GS1 Global Office staff
and representatives from GS1 MOs. It is ultimately validated through the GS1 decision
processes involving the GS1 Advisory Council and the GS1 Leadership Team.
Traceability Business Requirement Group (BRG):

It is a GSMP group that defines the specifications and structures of
traceability involved in supply chain processes. It aims to be the
global, foundational standard for traceability in ANY industry sector
8. Requirements for becoming a GS1 accredited

GTC Auditor
Any person fulfilling the GS1 GTC requirements for
Auditors can be a GS1 GTC Auditor.
GS1 GTC Auditors must have a proven knowledge
and understanding on the concept of traceability
and how the different GS1 solutions interact along
the supply chain and how they improve the
traceability information sharing.
8.1. Reasons for obtaining GS1 GTC Auditor accreditation

Only GS1 GTC Auditors are entitled to perform GS1 GTC Assessments recognized globally
by GS1. The GS1 GTC Auditor accreditation is a guarantee for the company being
assessed, that the auditor has the required knowledge, experience and skills needed in
performing the GS1 GTC Assessment, in terms of Traceability, GS1 System and supply
chain experience.
Auditors will have demonstrated their knowledge and understanding of the concept of
traceability and how the different GS1 solutions interact along the supply chain and how they
improve the traceability information sharing.
Accredited GTC Auditors will have:
 a good understanding of the auditing principles under ISO standards and effectively
prepare for, carry out, report and follow up on GTC Assessments.
 an ability to effectively assess an organizations readiness against key traceability
regulations as well as related commercial requirements.
 participated in improving the implementation of the GS1 Global Traceability Standard in
any organisation.
8.2. How to become an accredited GS1 GTC Auditor

There are 3 main steps for becoming and accredited GS1 GTC Auditor.
1. Step 1: Proven theoretical knowledge of GTS and GTC

2. Step 2: Demonstrated capability to carry out an assessment
3. Step 3: Fulfilled administrative / legal requirements
Candidates having successfully passed all 3 steps will be awarded a certificate indicating
that they are “Accredited GS1 GTC Auditors”.
8.2.1. Step 1
Goal: Ensure the candidate can demonstrate sufficient knowledge of the GS1 Global
Traceability Standard (GTS) and GS1 Global Traceability Programme (GTC).
To successfully pass this step, the candidate must have taken the GTS and GTC
training courses and have passed the written test at the end of the GTC training
4
course .
Training will be offered on a regular basis in different geographic locations. The training
includes the two compulsory modules: GS1 Global Traceability Standard (GTS) and GS1
GTC.
The two trainings modules take five full days and provide all the necessary knowledge
required for a GS1 GTC Auditor. It gives an essential perspective to individuals responsible
for the planning and implementation of Traceability Audits through the GS1 GTC Programme
as well as teaching all the basic requirements included in the GS1 Global Traceability
Standard. Furthermore it establishes how a professional auditor structures, plans, and
executes an effective audit, to subsequently evaluate and communicate the audit findings.
Participants who pass the training will receive a diploma stating that the training was
successfully approved. This diploma will allow the participants to apply for the next steps
for accreditation.
See http://learn.gs1.org/ for the calendar of the GTS and GTC training courses
8.2.2. Step 2
Goal: Ensure the candidate can demonstrate his/her capability of carrying out a GS1 GTC
assessment.
To successfully pass this step, the candidate must fulfill AT LEAST ONE of the
conditions below:
a) Be ISO 19011 certified
b) Send 2 assessment reports from different companies that are positively evaluated by a
faculty of GTC Auditors.
The template for the assessment reports can be downloaded from
http://www.gs1.org/traceability/gtc.
Completed assessment reports have to be returned to GTCauditors@gs1.org
c) Achieved a minimum 10 hours of assessment in companies under the guidance of a
GTC auditor.
The template to report the hours (Audit Log) used in these assessments can be
downloaded from http://www.gs1.org/traceability/gtc.
Audit Log reports have to be returned to GTCauditors@gs1.org
The candidate will be notified within 10 working days of his/her successful completion of
STEP 2.
4
The combined GTS / GTC training course delivered in 2008 and 2009 (Bangkok, Bogota, Brussels,
Santiago, Springfield and Dublin) are also accepted to fulfill this step.
Note: Assessments not accepted:

 Assessments of the same traceability system that are
repeated more frequently than once every 12 months
 Assessments of less than one day (6 hours of on-site
audit activity exclusive of breaks) duration.
 Assessments performed before successful completion
of the formal training requirement.
8.2.3. Step 3
Goal: Ensure the candidate complies with all the GS1 GTC Programme administrative and
legal requirements.
To successfully pass this step, the candidate must fulfill ALL of the conditions below:
 Have a post secondary school diploma (minimum 3 years).
 Have a minimum of 5 years of professional experience.
 Have working language skills in the corresponding native/working language including the
locally used specialist terminology.
 Agree to be re-accredited every 2

nd
year by successfully completing a refresher web-
based training module.
 Agree for his/her contact details to be published in the GTC registry.
 Agree to provide timely and accurate reports on assessments using the GS1 GTC
Auditor material and forms.
 Agree to maintain up-to-date files of all quality policies, procedures, work instructions
and documentation issued by GS1.
 Agree to keep abreast of developments, issues and legislative changes pertaining to the
scope in which assessments are carried out.
 Agree to be independent and impartial i.e.:

 Auditors are not permitted to take final certification decisions regarding their own
assessments (note: this means the certification body has to endorse the
responsibility).
 Auditors are not permitted to carry out any activities which may affect their
independence or impartiality, and specifically shall not carry out consultancy or
training activities for the organizations they assess. Training is not considered
consultancy, provided that, where the course relates to management systems or
auditing, it is confined to the provision of generic information that is freely
available in the public domain i.e. the trainer cannot provide company-specific
solutions.
 Auditors must strictly observe the organization’s and the Certification Body’s
procedures to maintain the confidentiality of information and records.
The candidate is therefore invited to send to GTCauditors@gs1.org:
 An electronic version of his/her post secondary school diploma
 The latest version of his/her Curriculum Vitae (resume) in English
 The list wherein the candidate agrees with the above-mentioned conditions. This list can
be downloaded from http://www.gs1.org/traceability/gtc.
The candidate will be notified within 20 working days of his/her successful completion of
STEP 3.
9. How to get involved?

Contact the following persons in order to find out more about this Programme, including how
to become an Accredited GS1 GTC Auditor, how to implement and test your traceability
system using the GS1 Global Traceability Standard and how to become actively involved in
the development and implementation of global standards.
If you are interested in becoming an accredited GS1 GTC Auditor

Jean-Marc D'Hooghe
jeanmarc.dhooghe@gs1.org
If you need more information about certification of organisations

Nicholas Fergusson
nicholas.fergusson@gs1.org
If you want to participate in the Traceability Business Requirement

Group (Traceability BRG)
Melanie Kudela
melanie.kudela@gs1.org
If you need more information about the GS1 GTC Programme in

general
Juan Pablo Vial
juanpablo.vial@gs1.org
Module 3: Auditing under ISO 19011

This module deals with the following topics:
 Introduction
 Terms and Definitions related to ISO 19011
 The Principles of Auditing
 Managing an Audit Programme
 Audit Activities
 Initiating the Audit
 Conduct Document Review
 Preparing the On-Site Audit Activities
 Conducting On-Site Audit Activities
 Preparing, approving & distributing the Audit Report
 Completing the Audit
 Conducting Audit follow up
 Competence and Evaluation of Auditors

 Personal Attributes
 Knowledge and skills
 Useful tips to remember
 Certification and Registry of Organisations and Auditors

 Certification Process for Organisations
 Certification for Auditors
10. Introduction
GS1 has chosen the ISO 19011 standard as the basis for performing the audits in the
context of the GS1 GTC Programme.
The ISO 19011 is an international standard which provides guidance on the management of
audit programs and on how to conduct internal and external audits.
Amongst other things, it is used as the basis for auditing quality related standards, such as:
 HACCP
 ISO 22000
 IFS
 BRC
 SQF
 GlobalGap
GS1 has decided not to re-invent the wheel, which is why we are using a standard for
auditing management systems in our Audit Programme for Traceability Systems.
ISO 19011 provides guidance on:
 the principles of auditing

 managing audit programs
 conducting quality management system audits and environmental management system
audits
 competence of quality and environmental management system auditors.
The application scope of the ISO 19011 standard is for all organisations needing to conduct
internal or external audits of quality and/or environmental management systems or who have
to manage an audit program.
11. Terms and Definitions related to ISO 19011

Below is a list of the most frequently used terms and their definitions, which you should know
by the end of this course. These terms are key to understanding auditing according to GTC.
Audit
Systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which the audit criteria are fulfilled
Different types of audit, by party

st
1 party Audit: Or Internal Audits are those where an organization
carries out audits on itself.
nd
2 party Audit: Commonly known as Supplier Audits because they are
used where an organization has to assure itself of the ability of a potential
or existing supplier or sub-contractor to meet the requirements.
rd
3 party Audit: Or External Audit are those performed by an independent
organization (3rd party) over a supplier to certify it. This can be done
asked by a group of customers
Audit Criteria:
Set of policies, procedures or requirements
Audit Evidence:
Records, statements of fact or other information, which are relevant to the audit criteria and
are verifiable
Audit Findings:
Results of the evaluation of the collected Audit Evidence against Audit Criteria
Audit Conclusion:
Outcome of an Audit, provided by the Audit Team after consideration of the audit objectives
and all Audit Findings
Audit Client:
Organization or person requesting an Audit
Auditee:
Organization being audited
Auditor:
Person with the competence to conduct an audit
Audit Team:
one or more auditors conducting an audit, supported if needed by technical experts
Technical Expert:
Person who provides specific knowledge or expertise to the audit team
Audit Programme:
Set of one or more audits planned for a specific time frame and directed towards a specific
purpose
Audit Plan:
Description of the activities and arrangements for an audit
Audit Scope:
Extent and boundaries of an audit
Competence:
Demonstrated personal attributes and demonstrated ability to apply knowledge and skills
12. The Principles of Auditing

The principles of auditing we discuss here are related to the auditors, i.e. yourself. If and
when you observe the following 5 principles, you will ensure that the audits you perform are
effective and reliable.
Ethical Conduct
Behaving in an ethical way is the foundation of a professional attitude for an auditor. Key
characteristics of ethical behavior are trust, confidentiality and integrity. By displaying
these behaviors, you show that the essence of auditing is respected when you perform
audits.
Fair Presentation
What is meant by this? It means that as an auditor you have the obligation to report truthfully
and accurately on what you audit. It is very important that you ensure that your audit
findings, audit conclusions and audit reports reflect the reality you have discovered through
your audit activities.
Due Professional Care

This is a fairly generic statement, but on the other hand, it just refers to the application of
diligence and judgment in auditing. When you audit, you are expected to exercise care in
accordance with the importance of the task you perform and the confidence placed in you by
the audit client.
Independence
When performing an audit, you should always remember that you as an auditor being
independent is the ground-rule for the impartiality of the audit and that is the only way to
guarantee that the audit conclusions are going to be objective. By being independent, we
mean that you should not in any way be involved or related to the activity you audit. This is
not enough, however, you should also refrain from having a bias towards the auditee, nor
should you be in a position of conflict of interest. A conflict of interest could exist where you
provided consultancy on implementation of a traceability system to the same company you
are auditing now.
Evidence-based Approach
This approach is also described as the rational method for reaching reliable and reproducible
audit conclusions in a systematic audit process. It goes without saying that the conclusions
you make are based on evidence. This evidence should be verifiable, as it should be based
on the samples of the information available.
Some practical examples of desired Auditor Behavior
 Prepare the Audit. Know the process in advance
 Dress according to the situation. Don't go dressed elegant to a

plant
 Be aware of quality requirements, for ex. use apron, a head cap

and a nose cap if you go to a food plant or to a hospital
 Do not be rude or intimidate the people.
 Do not make comparisons, nor should you have preconceived

ideas. Don't say things like this: “the other company does this in
this way”. It could be direct competition.
 Do not get involved in discussions with the auditee
 Always look for evidence and say “show me”
13. Managing an Audit Programme

An audit program may include one or more audits, depending upon the size, nature and
complexity of the organisation to be audited. These audits may have a variety of objectives
and may also include joint or combined audits.
Those assigned the responsibility for managing the audit program should:
 establish, implement, monitor, review and improve the audit program, and
 identify the necessary resources and ensure they are provided.
When establishing an audit program, other quality management tools can be very helpful.
One of the tools is the Continuous Improvement Cycle (Also called the Deming-cycle, or
PDCA-cycle). Continuous improvement is actually one of the underlying goals of audits.
Conformance is tested, and where necessary, improvements should be made to improve the
conformance.
The figure below shows the Continuous Improvement cycle in the light of conformance
testing:
In the Plan Phase policies and procedures are defined.

In the Do-Phase the company executes its activities.
In the Check-Phase the company does an assessment of its activities by auditing them.
Continuous monitoring of exceptions and ad-hoc or planned verifications provide data
samples of how well the company is doing. Another source of information may be customer
feedback, this might be through complaints or praise.
In the Act-Phase a company takes action based on the data it has received, after analyzing
what can be done to improve the situation. Typical actions in this phase include corrections
and management review.
At this point, the cycle starts all over again, with changed policies and procedures.
The integration of the process flow for the management of an audit program with the PDCA-
Cycle looks like the diagram below.
In the process flow, everything starts with the reception of authority to execute an audit
program. From there, we enter the Planning phase.
Establishing an audit program contains a number of distinct sub-steps. The first and most
important step is to define the objectives of the audit program and its scope. Scope creep is
one of the most common reasons for program failure (80%).
Once the objectives and the scope have been established, the different responsibilities
within the program need to be identified. What are the different roles that will be played in
the process?
The next step consists of matching the roles to resources: Who will be executing what role?
Please note that it is possible to have one individual having multiple roles, everything
depends on the size of the organisation and the availability of resources… It does remain
necessary, however, to remain vigilant and to avoid conflicts of interest. E.g. an auditor
cannot be responsible for controlling himself.
The last part of the planning phase consists of establishing the policies and procedures that
will be used during the audit program. It is important that these policies and procedures are
recorded for reference purposes: what is not written does not exist…
When everything has been planned and documented satisfactorily, it is time to move on to
the Do-Phase. This phase consists of Implementing the Audit Programme.
First of all, the audits within the program need to be scheduled. You depend on the
availability of the auditee as well as of the auditors here. In building the audit teams, you
depend on a side process, where you Evaluate the Competence of the Auditors.
The competence, even more than the availability of the auditors determines who is the right
person for the job at hand. Competence should not be strictly understood as competence at
auditing, but also competence at the standards against which will be audited. Additional
factors may be knowledge of the industry or vertical in which will be audited, whether the
auditor has more experience in a service than a production industry etc.
Once you have found the right auditors for the job and the audit teams have been selected,
the real work starts: Audit Activities. It is important to direct the audit activities and to
maintain records of all the work that has been done.
The Checking Phase is the next big process step. It is all about monitoring and reviewing
the audit program. Please note that there is a crucial difference between monitoring and
reviewing. Monitoring is an activity, which should be executed all through the audit program
and not just at the end of it. The review of the program typically is done at the end, but may
also be done somewhere during the program if there is evidence or data which requires the
program to be changed.
In both cases, hard data provides the input for the identification of needs for corrective and
preventive actions. Basically, you answer the questions “what went wrong?” and “why?” This
becomes the driver for identifying opportunities for improvement.
The identification of the corrective and preventive actions are to

improve the management of the audit program, this is not about the
recommendations you make for improving the processes of the
auditee!
The last phase of the process flow for the management of an audit program is the Act-
Phase. Here you improve the audit program to work away any identified flaws or problems
in the process.
14. Audit Activities

In this topic, we take an overview of the different audit activities. This corresponds to the box
Audit Activities in the process flow of the previous topic. A closer look of these activities and
how should be performed into the GS1 GTC Programme are presented in the Module 5: The
GS1 GTC Audit Activities.
The figure below shows the flow of the different steps that need to be taken.
14.1. Initiating the Audit

The first activity is the initiation of the audit. Those assigned the responsibility for managing
the audit program should appoint the audit team leader for the specific audit. The main tasks
to address in this activity are shown in the following figure;
Initiating the Audit

• Appointing the audit team leader
• Defining audit objectives, scope and criteria
• Determining the feasibility of the audit
• Selecting the audit team
• Establishing initial contact with the auditee
14.2. Conduct Document Review

The second step is to conduct a document review. Here you review relevant management
system documents, including records, and determine their adequacy with respect to the
audit criteria.
Prior to the on-site audit activities, the auditee’s documentation should be reviewed to
determine the conformity of the system, as documented, with the audit criteria. The
documentation may include relevant management system documents and records, and,
where available, previous audit reports.
Initiating the Audit
Reviewing relevant management system documents, including

records, and determining their adequacy with respect to audit
criteria
Prepare the on-site Audit Activities
14.3. Preparing the On-Site Audit Activities

Once the relevant documentation has been reviewed, you can proceed to the next step
which is the actual preparation for the on-site activities.
Preparing for the on-site audit activities

• Preparing the audit plan
• Assigning work to the audit team
• Preparing work documents
Conducting on-site Audit Activities
14.4. Conducting On-Site Audit Activities

Only now does the “real work” of auditing onsite begin. The goal of this activity is to perform
the On-site audit according to the Audit Plan prepared in the previous activity. The tasks are:
Prepare the on-site Audit Activities
Conducting on-site audit activities

• Conducting opening meeting
• Communication during the audit
• Roles and responsibilities of guides and observers
• Collecting and verifying information
• Generating audit findings
• Preparing audit conclusions
• Conducting close meeting
Preparing, approving & distributing the Audit Report
14.5. Preparing, approving & distributing the Audit Report

After completing the On-Site Audit, all the Audit findings must be included in the Audit
Report. The audit report should provide a complete, accurate, concise and clear record of
the audit.
The audit report must be approved and then distributed to recipients designated by the audit
client.
The audit report is the property of the audit client. The audit team members and all report
recipients should respect and maintain the confidentiality of the report
Conduct on-site Audit Activities
Preparing, approving and distributing the audit report

• Preparing the audit report
• Approving and distributing the audit report
Completing the Audit
14.6. Completing the Audit

The audit is completed when all activities described in the audit plan have been carried out
and the approved audit report has been distributed.
Documents pertaining to the audit should be retained or destroyed by agreement between
the participating parties and in accordance with audit program procedures and applicable
statutory, regulatory and contractual requirements.
Preparing, approving & distributing the Audit Report
Completing the audit
Conducting Audit follow up
14.7. Conducting Audit follow up

The conclusions of the audit may indicate the need for corrective, preventive or improvement
actions, as applicable. Such actions are usually decided and undertaken by the auditee
within an agreed timeframe and are not considered to be part of the audit. The auditee
should keep the audit client informed of the status of these actions.
The completion and effectiveness of corrective action should be verified. This verification
may be part of a subsequent audit.
The audit programme may specify follow-up by members of the audit team, which adds
value by using their expertise. In such cases, care should be taken to maintain
independence in subsequent audit activities
15. Competence and Evaluation of Auditors

Here you will learn what to expect from an auditor. You will also learn what professional and
personal characteristics an auditor should have.
Confidence and reliance on the audit process depend on the competence of those
conducting the audit. This competence is based on the demonstration of personal attributes
and on the auditor’s ability to apply the knowledge and skills acquired through general
education, general work experience, auditor training and audit experience.
The competence of auditors required by GS1 can be summarized in the figure below.
15.1. Personal Attributes

Auditors should possess personal attributes to enable them to act in accordance with the
principles of auditing:
An auditor should be:
 ethical, i.e. fair, truthful, sincere, honest and discreet;
 open-minded, i.e. willing to consider alternative ideas or points of view;
 diplomatic, i.e. tactful in dealing with people
 observant, i.e. actively aware of physical surroundings and activities;
 perceptive, i.e. instinctively aware of and able to understand situations;
 versatile, i.e. adjusts readily to different situations;
 tenacious, i.e. persistent, focused on achieving objectives;
 decisive, i.e. reaches timely conclusions based on logical reasoning and analysis;
 self-reliant, i.e. acts and functions independently while interacting effectively with others.
15.2. Knowledge and skills

There is generic knowledge and skills any auditor of production and traceability management
systems should have. They are listed below.
 Audit principles, procedures and techniques
 Management system and reference documents
 Organizational Situations
 Applicable laws, regulations and other requirements relevant to the discipline:
An audit team leader should be able:
 to plan the audit and make effective use of resources during the audit,
 to represent the audit team in communications with the audit client and auditee,
 to organize and direct audit team members,
 to provide direction and guidance to auditors-in-training,
 to lead the audit team to reach the audit conclusions,
 to prevent and resolve conflicts,
 to prepare and complete the audit report.
15.3. Useful tips to remember
What to do if an auditee objects to what you have to say?

The most important thing is to remain calm and to listen actively to what the auditee is
saying. Wait until he has finished speaking before replying. Stay objective and try to find the
underlying cause for the objection/disagreement. When you reply to the auditee, make sure
you are clear and concise.
Key elements of good auditor behavior during the audit development

For the development of the audits, the auditor
 Will always have to base himself on the Audit Criteria
 Will have to do an initial visit to the facilities
 Must always search for objective evidence
 Must report always to the auditee
 Must immediately report any Nonconformity found
Key elements of good auditor behavior during interviews

When looking for information, the auditor should only ask one question at a time, and when
he gets a reply, he should verify the answer with a “show me“.
There are some additional basic considerations, the auditor should be aware of, such as
dress code and an attitude of showing respect towards the auditee.
The auditor should also be prepared to deal with particular situations, e.g. reception of
spontaneous information, being shown internal conflicts of the organization, or being
confronted with employees concealing information.
Minimum requirements for good auditor behavior

There is a saying that “a failure to plan is planning to fail”. This is certainly true for auditors:
be very well prepared to execute the audit.
Try to avoid unpleasant surprises for the auditee at all cost. This also means that you need
to communicate any NC to the auditee.
As an auditor you will be confronted with people who are nervous enough as it is. Any
confrontational behavior on your behalf should be avoided at all cost. This includes avoiding
personal attacks on individuals.
You should actually take this behavior one step further in the positive direction. Your actions
and behavior should stimulate and motivate the staff of the audited area.
Also be aware that you will need to be persuasive in certain instances, e.g. in getting
information, or in order to make the auditee understand why something is a NC.
Key elements of good auditor behavior when conducting the audit

As an auditor, you have to set the pace, this includes getting information swiftly, but at the
same time you have to take into consideration the capacity and personality of the auditee.
One of the key attributes of an auditor, is having an open mind coupled to a strong belief in
the mission he has. Being open-minded also includes that you leave behind any
preconceived ideas about the organization or its processes. Nothing is more dangerous than
to compare one organization to another. For all you know, you might be divulging information
about the business processes of a direct competitor, and that is something you cannot
afford.
Avoid getting involved in (endless) discussions with the auditee.
Do not make things personal, this means you cannot –e.g.- relate people to Nonconformities
Key elements of good auditor behavior when informing about audit results
When informing the auditee or the audit client about the audit results, you have to present
the information in an impersonal, clear and direct way. This does not mean, however, that
you don’t have to explain what you say. There are two elements you certainly need to
explain. The first is that you have taken samples for your audit, as it is impossible to look at
all the data of all times. The second one is even more important than the first one. You have
to explain that positive as well as negative aspects were observed, but that the negative
ones will be communicated to improve the system.
Being fair as an auditor, means that you also have to give the auditee the benefit of the
doubt where necessary: you have to assume the best, not the worst.
Main reasons for problems caused by the auditor

As mentioned before, preparation is key. If audits fail, most of the time it is because they
were not well prepared. Taking shortcuts in the preparation phase can cost you dearly.
Shortcuts may include inexistent or ill-defined objectives, and a scope which is either too
wide or narrow.
Main reasons for problems caused by the auditee

Again, preparation is key. Make sure you have commitment from the auditee that the right
people will be available at the agreed date, time and place. It can happen that auditees try to
stall audits by delaying appointments or schedules. Another problem, which is often
observed, is that the staff, responsible for certain process steps or areas is not available.
There is no point in doing an audit without the auditee’s staff being present.
In other cases the auditee’s staff provides you with longwinded explanations that lead
nowhere. Be firm and try to stop unproductive behavior. (See also key elements of good
auditor behavior when conducting interviews).
A last kind of problematic behavior you might encounter is when you are intimidated as
auditor by an auditee or their staff. It is key to stay calm at all times, but it is advisable to call
a meeting with your own organization and the audit client to see whether this can be
stopped. If the client does not cooperate, your organization might have to stop the audit.
16. Certification and Registry of Organisations and

Auditors
There are strict rules and regulations over the third-party audits intended for certification.
This type of audits is supervised by accreditation bodies
In the UK, the national accreditation body is “The United Kingdom Accreditation Service”
(UKAS) that directly reports to the Department for Business, Enterprise and Regulatory
Reform. In USA, RAB does a similar role, as well as in Japan is the JAB. In Spain this role is
carried out by ENAC (Entidad Nacional de Acreditación).
The most important function in a national accreditation body is to “accredit” organisations
(certification bodies) to “certify” or “register” other organisations against the National and
International Standard. This way, UKAS accredits companies such as SGS, BSI, Lloyds so
they can grant certifications to companies that fulfill the standard used for the audit.
The standard used to accredit certification bodies is ISO 17021 “Conformity assessment --
Requirements for bodies providing audit and certification of management systems”.
16.1. Certification Process for Organisations

ISO 17021 defines that an audit programme must be established to grant certification. The
audit programme shall include:
 a two-stage initial audit,
 surveillance audits in the first and second years, and
 a recertification audit in the third year prior to expiration of certification.
The three-year certification cycle begins with the certification or recertification decision.
16.1.1. Initial audit and certification

The initial certification audit of a management system shall be conducted in two stages:
stage 1 and stage 2.
16.1.1.1.Stage 1 audit
The stage 1 audit shall be performed
a) to audit the client's management system documentation;
b) to evaluate the client's location and site-specific conditions and to undertake discussions
with the client's personnel to determine the preparedness for the stage 2 audit;
c) to review the client's status and understanding regarding requirements of the standard,
in particular with respect to the identification of key performance or significant aspects,
processes, objectives and operation of the management system;
d) to collect necessary information regarding the scope of the management system,
processes and location(s) of the client, and related statutory and regulatory aspects and
compliance (e.g. quality, environmental, legal aspects of the client's operation,
associated risks, etc.);
e) to review the allocation of resources for stage 2 audit and agree with the client on the
details of the stage 2 audit;
f) to provide a focus for planning the stage 2 audit by gaining a sufficient understanding of
the client's management system and site operations in the context of possible significant
aspects;
g) to evaluate if the internal audits and management review are being planned and
performed, and that the level of implementation of the management system
substantiates that the client is ready for the stage 2 audit.
For most management systems, it is recommended that at least part of the stage 1 audit be
carried out at the client's premises in order to achieve the objectives stated above.
16.1.1.2.Stage 2 audit
The purpose of the stage 2 audit is to evaluate the implementation, including effectiveness,
of the client's management system. The stage 2 audit shall take place at the site(s) of the
client. It shall include at least the following:
a) information and evidence about conformity to all requirements of the applicable
management system standard or other normative document;
b) performance monitoring, measuring, reporting and reviewing against key performance
objectives and targets (consistent with the expectations in the applicable management
system standard or other normative document);
c) the client's management system and performance as regards legal compliance;
d) operational control of the client's processes;
e) internal auditing and management review
f) management responsibility for the client's policies;
g) links between the normative requirements, policy, performance objectives and targets
(consistent with the expectations in the applicable management system standard or
other normative document), any applicable legal requirements, responsibilities,
competence of personnel, operations, procedures, performance data and internal audit
findings and conclusions
16.1.1.3.Initial certification audit conclusions

The audit team shall analyse all information and audit evidence gathered during the stage 1
and stage 2 audits to review the audit findings and agree on the audit conclusions.
16.1.1.4.Surveillance audit
Surveillance audits are on-site audits, but are not necessarily full system audits, and shall be
planned together with the other surveillance activities so that the certification body can
maintain confidence that the certified management system continues to fulfill requirements
between recertification audits. The surveillance audit programme shall include, at least
a) internal audits and management review,
b) a review of actions taken on nonconformities identified during the previous audit,
treatment of complaints,
c) effectiveness of the management system with regard to achieving the certified client's
objectives,
d) progress of planned activities aimed at continual improvement,
e) continuing operational control,
f) review of any changes, and
g) use of marks and/or any other reference to certification.
Surveillance audits shall be conducted at least once a year. The date of the first surveillance
audit following initial certification shall not be more than 12 months from the last day of the
stage 2 audit.
16.2. Certification for Auditors

In order to assure independency of the certification process, the organisation that certify
auditors must be separated form the one certifying organisations.
16.2.1. International Registers

Examples are:
 IRCA: International Register of Certificated Auditors
 RABQSA: Registrar Accreditation Board and Quality Society of Australasia. Design,

develop, and deliver personnel and training certification services relevant to any industry
 IPC (former IATCA): International Personnel Certification Association. Restricted to

those personnel certification bodies who are accredited to the new standard for
personnel certification bodies, ISO 17024. IPC uses IRCA Auditor Certification
Programme.
16.2.2. Schema for Auditor Certification

The schema used by IRCA establishes four types of Auditors:
a) Provisional auditor: Designed for: entry level/trainee auditors seeking a career in

auditing and experienced auditors taking a break from auditing or moving into
management. Recognizes: personal attributes, education, professional and technical
competencies
b) Auditor: Designed for: audit team members. Recognizes: auditor competence and
contribution as an effective member of an audit team
c) Lead auditor: Designed for: audit team leaders who typically work for certification
bodies or perform supplier audits for large organizations. Recognizes: competence at
managing audits and leading teams
d) Principal auditor: Designed for: experienced auditors who operate on their own (i.e. as
a team of one, performing sole audits). This grade is an alternative to the lead auditor
grade. Recognizes: experience and competence of two categories of auditors:
 consultancy background: competence in implementing management systems and

performing all aspects of the audit process
 lead auditor background: competence in audit management and team leadership
The IRCA register system is described in detail in its website: http://www.irca.org. The IRCA
code of conduct for Auditors can be found in the Appendix 11: IRCA Code of Conduct.
Module 4: The GS1 GTC Audit Criteria

 The GS1 GTC Checklist

 How was it developed?
 Structure
 Regulations References
 Standard References
 Compliance Levels
 Control Points Usage Guide
 GTC and its compliance with the GS1 Global Traceability Standard
 Relationship with other Traceability & Best Manufacture Practices (BMP) Standards
17. The GS1 GTC Checklist

The GS1 GTC Checklist sets out audit criteria to test
traceability. It defines essential elements for the
development of best-practices for the global production and
distribution of trade items acceptable to the industry
Worldwide.
The GS1 GTC Control Points and Compliance Criteria (GS1
GTC Checklist) has been designed in order to implement
and review the Traceability Systems in manufacturing
Organisations, producers/handlers and providers of product
supplies and services to the supply chain.
A producer/manufacturer/handler is defined as any
Organisation that produces, synthesizes, prepares, treats,
modifies, packs or manipulates products including product
supplies, packaging material and raw material. This also
includes supplements.
A provider is defined as any Organisation that supplies any type of material that comes into
direct contact with manufactured or processed products.
A service provider is defined as any Organisation that provides services, which come into
direct contact with manufactured or processed products.
In accordance with the aforementioned definitions, any of the following Organisations qualify
for the application of the audit presented in this document:
 Producers
 Manufacturers
 Processors
 Supply Producers
 Third Party Logistics Providers
 Logistic Providers
 Transporters and carriers
 Retailers
 Wholesalers
 Importers and Exporters
 Storage and Deposits providers
 Container and Packaging Manufacturers
17.1. How was it developed?

The GS1 GTC Checklist was elaborated with the contribution of more than 20 traceability
experts from more than 10 countries (GS1 and industry). It was reviewed by more than 100
people around the world (GS1 and industry) and Issue 2 was finally approved its by the
Traceability BRG on April 11th 2010.
Development started in GS1 Chile with its local end users. Initially, it was based on GTS,
ISO 22005, international regulations, Traceability requirements in other standards and other
main traceability guides.
Then, the work moved to the GS1 GO Solutions work group with GS1 Member
Organisations and was open to users to develop pilot documentation. Finally it was moved
to GSMP for validation and maintenance involving Users, GS1 Member Organisations and
Solution Providers.
17.2. Structure
The GS1 GTC Checklist is structured in the following way:
 Introduction: Introduces the compliance criteria for the GS1 Global Traceability
Standard (GS1 GTS), the compliance levels of approval or failure and relationship
with other traceability standards, and regulatory references.
 Control Points: Describes the basic points and the considerations the audited
Organisation must comply with in order to approve the Control Points and the
Compliance Criteria of the GS1 GTC Checklist. The Control Points review:
 Identification (how traceable items are identified and coded)
 Procedures (how the traceability is declared and documented)
 Operations (how the traceability works)
 Information (what information is being used and given)
The GS1 GTC checklist
Operations
How traceability works and
how crisis are managed ?
 Terms and Definitions: Presents the standard vocabulary used throughout this
document.
 Appendix: Shows the relation between the GTC Checklist and other standards. This
relation can help organisations to benchmark their traceability system against
traceability requirements present in these standards.
 Bibliography: Comprises a list of all the references and documentation from which
relevant information was obtained for the preparation of this document.
The following figure shows the structure of the Control Points section:
17.3. Regulations References

In the preparation of the GS1 GTC Checklist, the following international regulations were
taken into consideration:
 Regulation (CE) N° 178/2002, “Laying down the general principles and requirements
of food law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety” of the European Parliament and of the Council
of January 28, 2002.
 Public Health Security and Bioterrorism Preparedness and Response Act of 2002,
“To improve the ability of the United States to prevent, prepare for, and respond to
bioterrorism and other public health emergencies”, United States Food and Drug
Administration (FDA), June 12, 2002.
17.4. Standard References

The following referenced traceability and codification standard documents are essential for
the application of the GS1 GTC Checklist:
 GS1 Global Traceability Standard – Business Process and System Requirements for
Full Chain Traceability (GS1 GTS)
 GS1 General Specifications
 ISO 22005:2007, Traceability in feed and food chain – General principles and basic
requirements for system design and implementation.
17.5. Compliance Levels

The GS1 GTC Checklist contains all the Control Points and their Compliance Criteria that an
Organisation must follow in order to successfully complete a Traceability Audit. These
points must all be fulfilled to verify compliance to the GS1 GTS. The document is divided
into 12 sections. It contains a total of 105 Control Points, divided into the following levels:
 Mandatory Musts: There are 28 “Mandatory” Control Points in the GS1 GTC
Checklist (shaded in Red in the document). These Control Points address the most
important Business Requirements present in the GS1 GTS that can not be indicated
as NOT Applicable (N/A) by the Auditor.
Example:
5.6 Are logistic units distributed by the The logistic units distributed by the
Organisation physically identified Organisation must have standard serial
with a global, unique serial number identification on the item or if not
number? possible at least on the asset containing it Mandatory
(GTS: BR6, BRU4) or on an accompanying document. The
corresponding GS1 standard is SSCC.
No N/A.
 Mandatory Conditional Musts: There are 30 “Mandatory Conditional” Control Points

in the GS1 GTC Checklist (shaded in Green in the document). These Control Points
address the most important Business Requirements present in the GS1 GTS that
could be indicated as NOT Applicable (N/A) by the Auditor according to specific
realities or situations detected in every organisation.
Example:
2.1 Are all trade items, distributed by A Master Data record with a GS1
the Organisation, identified with a identification key and a description must
GS1 identification key and a exist for all trade items distributed by the
description in a Master Data record Organisation at all levels of the product Mandatory
for each product hierarchy level hierarchy that need to be traced.The (Conditional)
that needs to be traced? (GTS: corresponding GS1 standard is the GTIN.
BR3, BR7, BRU4, BRU16)
 Optional: There are 10 “Optional” Control Points in the GS1 GTC Checklist (shaded
in yellow in the document). These Control Points address those Business
Requirements present in the GS1 GTS that are under the responsibility of the
supplier of the trade items received by the audited organisation.
Example:
5.13 Are trade items received by the The trade items received by the
Organisation, which needs to be Organisation must have a global, unique
traced, physically identified with a identification number on packaging or if
global, unique identification not possible at least on the asset Minor
number? containing it or on an accompanying
(GTS: BR6, BR7, BRU4) document. The corresponding GS1
standard is the GTIN.
 Recommendations: There are 37 “Recommended” Control Points in the GTC

Checklist (not shaded in the document). These Control Points address Traceabili ty
Requirements of other Standards, Best Manufacturing Practices or International

Traceability Guidelines
Example:
10.8 Does a plan exist for the recall of Documentation exists detailing how
products? affected products are to be recalled. No Recommended
N/A.
Possible responses to every Control Point may include: Compliance (yes); Non-Compliance
(no) or NOT Applicable (N/A). N/A may not be used as a response to those control activities
that state “No N/A” (i.e. “Mandatory Musts”). Only Auditors can indicate if a Control Point can
be a NOT Applicable (N/A).
In order to obtain GS1 compliance to the GS1 Global Traceability Standard (GS1 GTS), the
applicant is required to successfully complete the assessment and fulfill each of the Control
Points as follows:
 Mandatory Musts:
100% compliance of all Mandatory Must Control Points is compulsory.
 Mandatory Conditional Musts:

100% compliance of all applicable Mandatory Conditional Must Control Points is
compulsory.
 Optional
No minimum percentage of compliance is set.
 Recommendations:
All Control Points in the GS1 GTC Checklist must be audited.
17.6. Control Points Usage Guide

The GS1 GTC Checklist contains 105 Control Points and their Compliance Criteria divided
into 12 sections. Every Section of the GS1 GTC Checklist has a different traceability
objective. By following every section it is possible to fully assess any traceability system. The
following table explains in detail what is assessed in every section.
Control
Section Description
Points
Knowledge and documentation of Traceability
1. Objectives 1.1 - 1.5
system
Trade item assignment in Master Data systems for
2. Product Definition 2.1 - 2.5
all trade items received, produced and/ or shipped
Identification of Trading partners in Master Data
3.1 - 3.2
3. Supply Chain Placement systems
3.3 - 3.7 Identification of Locations in Master Data systems
Definition of all produced and received trade items
4.1 - 4.3
in specifications or other similar document
Documented procedures for manufacturing
4. Establishment of 4.4 - 4.8 processes, data alignment and definition of batch/
Procedures lot and/or serial numbers
Documented procedures or tools to enable
4.9 - 4.11 collection, recording and sharing of traceability
information, and responsible parties
Process flow documentation for manufacturing
5.1 - 5.2 processes (from raw materials/ packaging to
finished goods)
Physical identification on all trade item packages
received, produced and/or shipped:
 Global Trade item number (e.g., GTIN/ UPC)
5. Flow of Materials
 Production batch/ lot code (consumer, case,
5.3 - 5.19 pallet)
 Unique serial number (Logistics-pallet level
only)
 Bar code (all levels)
 Shipment identification number (shipment only)
Documented linkage (electronic or paper) of
6.1 - 6.14 traceability information between trade item levels
6. Information Requirements (Le., one up, one down linkage of data)
Documented list of suppliers and/or customers that
6.15 - 6.17
received trade items
Control
Section Description
Points
Identification of detailed traceability information for
all trade items produced, received and/or shipped
to any parties, including the following components:
 Trade item number (e.g., GTIN/ UPC)
 Production batch/ lot code (consumer, case,
pallet)
 Unique serial number (Logistics-pallet or
case level)
6.18 - 6.25
 Shipment identification number (shipment
only)
 Quantity
 Code date (e.g., Sell-By, Pack, Production)
 Recipient (customer, supplier, etc)
 Transporter name
 Transport date/ time
Procedures to provide detailed communications to
6.26 - 6.30 trading partners regarding above information upon
request
Traceability manual and/or documentation which
7.1 - 7.3 describes detailed processes associated with
traceability
Documentation of roles, responsibilities and
7. Documentation
7.4 Organisation structure in place to support all
Requirements
traceability related activities
Ongoing maintenance of traceability
7.5 - 7.7 documentation and traceability records
(transactional)
Traceability team in place with proper knowledge
8. Structure & Responsibilities 8.1 - 8.4
of traceability procedures
Training program and proof of training for those
9. Training 9.1 - 9.3
responsible for traceability activities
Acquisition of traceability information from trading
partners, including the following:
 Trade item number (e.g., GTIN/ UPC)
 Quantity
10.1 - 10.3
 Batch/ lot number
10. Supply Chain  Code date
Coordination  Transport date
 Transporter name
Documentation of team structure, responsibilities
and procedures associated with addressing a
10.4 - 10.9
potential safety hazard crisis, including
communications and contact information
Existence of monitoring and control plan for
11. Monitoring 11.1 - 11.2
reviewing effectiveness of Traceability procedures
Definition of all produced and received trade items
12.1 - 12.2
12. Internal and External in specifications or other similar document
Audits Documentation of corrective action plans to
12.3
address Traceability Nonconformities
17.7. GTC and its compliance with the GS1 Global Traceability
Standard
The GS1 GTC Checklist fulfills the GS1 Global Traceability Standard (GS1 GTS) if the
applicant follows all Mandatory Must, applicable Mandatory Conditional and Optional Control
Points. Also indicated below every Mandatory Must, Mandatory Conditional or Optional
Control Point is the corresponding GTS Business Requirement (BR) and/or the
corresponding GTS Business Rule (BRU), i.e.: (GTS:BR1).
17.8. Relationship with other Traceability & Best Manufacture

Practices (BMP) Standards
The GS1 GTC Programme provides guidance to users on meeting the traceability
requirements required by the highest standards of quality and food safety such as ISO 9001,
ISO 22005, HACCP, BRC, IFS and GLOBALGAP. Food safety and quality standards
define the “what” should be done in terms of traceability (i.e. the objectives). The GS1
GTC Programme helps companies to actually do it: it is about the “how” to do it.
The GS1 GTC Checklist presents cross reference between the Control Points and the
Traceability requirements of the following standards:
 ISO 22005
 ISO 9001
 HACCP (ISO 22000:2005)
 BRC (British Retail Consortium) Global Standard - Food
 IFS (International Featured Standard) - Food
 SQF (Safe Quality Food)
 GlobalGap
The cross reference between the GS1 GTC Checklist and the
standards addressed has been prepared by GS1 and do NOT in any
case imply compliance with the traceability requirements of such
standards. This cross references has not been validated by the
Standard Bodies that own the standards presented in this Appendix
The following table presents a section of the Cross Reference Summary of related standards
covered by every Control Point. In every column is indicated with an “x” when the Control
Point covers a traceability requirement of the standard referenced in the header.
Control Global
Point GTS 22005 HACCP IFS BRC SQF 9001 GAP
1. CHOICE OF OBJECTIVES
1.1 x x
1.2
1.3 x
1.4 x x
1.5 x
2. PRODUCT DEFINITIONS
2.1 x x x x x x
2.2 x
2.3 x x x x x
2.4 x
2.5 x x
34 Control Points cover the ISO 22005 traceability requirements

13 Control Points cover the ISO 9001 traceability requirements
18 Control Points cover the HACCP traceability requirements
21 Control Points cover the BRC traceability requirements
21 Control Points cover the IFS traceability requirements
23 Control Points cover the SQF traceability requirements
6 Control Points cover the GlobalGAP traceability requirements
Module 5: The GS1 GTC Audit Activities

 Introduction
 The Initial Meeting

 The Audit Team
 Establishing initial contact with the auditee
 Defining Audit Objectives and Scope
 Determining the feasibility of the audit
 Selecting the audit team
 Conducting document review
 The Audit Program

 Assigning work to the audit team
 Preparing work documents
 Completing the Audit Plan Form
 On-Site audit
 The Opening Meeting
 Collecting and verifying information
 Generating Audit findings
 Filling out the GS1 GTC Assessment Checklist
 Preparing Audit Conclusions
 Conducting the Closing Meeting
 Preparing, approving & distributing the Audit Report

 The Nonconformities Report
 The Audit Report
 The Conformance Report
 Completing the Audit: Presenting the Assessment Report
18. Introduction
Six Activities should be completed to finalize an Audit process. If agreed with the company,
the Auditor should follow up the correction of every Nonconformity found during the On-Site
Audit according to the solution proposed in the Nonconformity Report template.
The GTC Audit Activities are slightly different from the Audit Activities proposed in ISO
19011, but are totally based on it. This is shown in the figure below; where for every activity
of ISO 19001 a number indicates to what GTC activity it corresponds. This way every ISO
activity is covered by the GTC activities.
19. The Initial Meeting

Where:
Auditor offices
Initial Meeting Average Duration:
1
Define essential elements to prepare the On-site Audit and 1 to 3 hours
Template to fill:
prepare the Audit Plan.
Audit Plan

Reviewing relevant management system documents, including records, and
determining their adequacy with respect to audit criteria
The Initial meeting is the starting point of the whole audit process. During the Initial meeting
the Audit Team Leader should be appointed. The initial meeting may be informal or formal,
but should be made by those assigned responsibility for managing the audit programme or
the audit team leader. The purpose of the initial meeting is to:
1. to establish communication channels with the auditee’s representative,

2. to confirm the authority to conduct the audit,
3. to provide information on the proposed audit leader and audit team composition,
4. to request access to relevant documents, including records,
5. to determine applicable site safety rules,
6. to agree on the attendance of observers and the need for guides for the audit team.
7. to define the audit objective and scope.
8. to define activities, dates and times for the On-site audit
9. to deliver the Audit Material Folder
The feasibility of the audit also should be determined during initial meeting, taking into
consideration such factors as the availability of:
 sufficient and appropriate information for planning the audit,
 adequate cooperation from the auditee, and,
 adequate time and resources.
Where the audit is not feasible, an alternative should be proposed to the audit client, in
consultation with the auditee
It is necessary to be clear with the auditee at this point that the whole Audit process will be
strictly confidential and all the information collected, will be only used internally by the
Auditor. If possible, you should sign an NDA with the company to avoid future problems.
19.1. The Audit Team
19.1.1. Appointing the Audit Team

When the audit has been declared feasible, those assigned the responsibility for managing
the audit program should:
 Establish the audit team for the specific audit
 Appoint the Audit Team Leader who should have the appropriate skills and competence
to reach the audit objectives
When establishing the Audit Team, the Audit Team Leader can include auditors, auditors-in-
training and technical experts, but all must work under the direction and guidance of the
Audit Team Leader. However, if there is only one auditor, the auditor should perform all
applicable duties of an Audit Team Leader.
In deciding the size and composition of the audit team, consideration should be given to the
following:
1. audit objectives, scope, criteria and estimated duration of the audit;

2. whether the audit is a combined or joint audit;
3. the overall competence of the audit team needed to achieve the objectives of the audit;
4. statutory, regulatory, contractual and accreditation/certification requirements, as
applicable;
5. the need to ensure the independence of the audit team from the activities to be audited
and to avoid conflict of interest;
6. the ability of the audit team members to interact effectively with the auditee and to work
together;
7. the language of the audit, and an understanding of the auditee’s particular social and
cultural characteristics;
Both the audit client and the auditee can request the replacement of particular audit team
members on reasonable grounds based on the principles of auditing. Examples of
reasonable grounds include conflict of interest situations (such as an audit team member
having been a former employee of the auditee or having provided consultancy services to
the auditee) and previous unethical behavior.
Such grounds should be communicated to the audit team leader and to those assigned
responsibility for managing the audit programme, who should resolve the issue with the audit
client and auditee before making any decisions on replacing audit team members.
19.1.2. Audit Team Functions and Responsibilities
 Audit Team Leader Responsibilities:

During the audit, the responsibilities of the Audit Team Leader are:
 Take final decisions in every phase of the audit
 Prepare the Audit Plan
 Assign functions to the Audit Team
 Give information to the Team
 Review documentation to assure its adjustment
 Represent the Audit Team in opening and closing meetings
 Report immediately Nonconformities to the auditee when detected

 Report any major obstacle found during the audit
 Sign the Audit Report
 Audit Team Tasks:

The Audit team Leader must assign to every audit team member specific
responsibilities to audit the traceability management processes, functions, locations,
activities and products. These assignations must take into account the necessity of
keeping independency, competence and effectiveness in the resource usage.
 Audit Team Responsibilities:

 The Audit Team members should:
 Review all he relevant information related to the assigned tasks
 Prepare any work document needed to perform their tasks
 Fulfill the audit requirements
 Perform the assigned tasks with efficiency and effectiveness
 Report audit problems and findings to the Audit Team Leader
 Cooperate and support the Audit Team Leader
During the audit, audit team members should:
 Remain inside of the audit scope

 Communicate the audit requirements to the auditee
 Collect objective evidence
 Document Corrective Actions
 Report audit findings to the auditee
 Verify Corrective Actions taken from previous audits
 Preserve and protect all the documents belonging to the auditee
19.1.3. Good Practices in Meetings

In the meetings, auditors should always be respectful, professional and remain calm.
MUST:
 Introduce themselves
 Make sure the agenda is known and understood
 Follow the schedule
 Maintain the Control
 Control and respect the timing
 Avoid discussions
 Listen carefully (not go ahead)
 Maintain the applicable registries
19.2. Establishing initial contact with the auditee

The initial contact for the audit with the auditee may be informal or formal, but should be
made by those assigned responsibility for managing the audit program or the audit team
leader. The purpose of the initial contact is:
1. to establish communication channels with the auditee’s representative,

2. to confirm the authority to conduct the audit,
3. to provide information on the proposed timing and audit team composition,
4. to request access to relevant documents, including records,
5. to determine applicable site safety rules,
6. to make arrangements for the audit, and
7. to agree on the attendance of observers and the need for guides for the audit team.
19.3. Defining Audit Objectives and Scope

Within the overall objectives of an audit program, an audit should be based on documented
objectives and scope.
The audit objectives define what is to be accomplished by the audit and may include the
following:
1. determination of the extent of conformity of the auditee's management system, or parts

of it, with audit criteria;
2. evaluation of the capability of the traceability system to ensure compliance with
statutory, regulatory and contractual requirements;
3. evaluation of the effectiveness of the traceability system in meeting its specified
objectives;
4. identification of areas for potential improvement of the traceability system.
19.3.1. Objective Definition

The audit objective is the most crucial part of a good audit. It describes the extent and
boundaries of the audit, such as physical locations, organizational units, activities and
processes to be audited, as well as the time period covered by the audit. A bad objective
definition is a recipe for a bad audit result.
The audit objectives should be defined by the audit client and ALWAYS should state the
Audit Criteria which will be used for the Audit. Also, it should define all the traceable items
which are going to be audited.
It is of the utmost importance to define the items, which will be considered as traceable
items. These items could be any, (one, a couple or all) in the logistic hierarchy. Ex:
1. Consumer Unit by its lot

2. Pallet by its SSCC
3. Boxes by its SSCC
4. Bags by its lot
5. Returnable objects such plastic boxes by its GRAI
The GS1 GTC Checklist uses three grouping categories for this:
 Trade items: It is necessary to define the trade items to trace. A trade item could be a
consumer unit, a box or even a pallet.
 Ex: if a company receives pallets, doesn’t open the pallets and distributes the
same pallets they received, then the trade item for that company is the pallet.
 It is necessary to be careful with the Batch/Lot definition. A batch/lot in certain
circumstances could be a serialized code. In the same example, the Batch/L ot
for the company’s trade items is the SSCC of every pallet.
 Logistics Units: It is necessary to define the formats for the Logistics Units the company
wants to trace. This could be boxes, bags, pallets, truck loads, containers, etc. Logistics
Units can be trade items as well. Ex: a pallet could be the minimal sale unit a company
delivers. In this case, the pallet is a trade item and a Logistic Unit.
 Shipments: A shipment could be a truck load, a Container or even a Warehouse in a

ship.
19.3.2. Scope Definition

The audit scope describes the extent and boundaries of the audit, such as physical
locations, organizational units, activities and processes to be audited, as well as the time
period covered by the audit.
The audit scope should be defined between the audit client and the audit team leader in
accordance with audit program procedures. Any changes to the audit objectives or, scope
should be agreed to by the same parties.
Example 1: One Physical location with several processes

For the scope definition it could be considered one physical location with several processes
such as:
1. Company 1: Receiving, Processing, Warehousing and Dispatch. Ex: a manufacturer of

cookies for local market.
2. Company 2: Receiving, Growing, Processing and Dispatch. Ex: a grape grower who sell
boxes with grape after its harvesting and packing.
3. Company 3: Receiving, Warehousing, Dispatch. Ex: a Cold Warehousing which receive
pallets from it customers to save it and dispatch the same pallets to the same
customers.
4. Company 4: Receiving, Growing, Processing, Warehousing, Dispatch and Distribution.
Ex: A Wine exporter who has his own vine and distributes the wine to foreign markets.
The following figure represents the four examples given above for every Company:
1 Receiving Growing Processing Warehousing Dispatch Distribution
Receiving Growing Processing Warehousing Dispatch Distribution

2
3 Receiving Growing Processing Warehousing Dispatch Distribution
Receiving Growing Processing Warehousing Dispatch Distribution

4
In this example, the audit client and the audit team in every company must define a scope
that includes all the processes involved in the company from Receiving till Dispatch or
Distribution whichever is the case.
Example 2: Several Physical Locations with several processes each

For the scope definition it could be considered one company with several physical locations.
Ex: A Wine Exporter where:
1. Location 1: Receiving, Growing and Dispatch: The vine receive agrochemicals, and
dispatch trucks with grape to the winery plant
2. Location 2: Receiving, Processing, Warehousing and Dispatch. The winery plant receive
the trucks with grapes, elaborate the wine and dispatch boxes with bottles of wine to the
Warehousing
3. Location 3: Receiving, Warehousing, Dispatch and Distribution: The Warehousing save
the boxes with wine, and distributes pallets with boxes to foreign markets.
Receiving Growing Dispatch

Loc. 1
Receiving Processing Warehousing Dispatch

Loc. 2
Receiving Warehousing Dispatch Distribution

Loc. 3
In this example, the audit client and the audit team leader could define a scope that includes
all the locations and all the processes involved in every location starting from Receiving in
Location 1 and ending in Distribution in Location 3.
However, the audit client and the audit team leader could define a scope that involves only
Location 2 of this company.
If, for exceptional case, the Organisation decides to exclude

specific traceable items or processing lines from the scope of
the audit, then this shall be clearly noted and included in the
Audit Report and in the Conformance Report.
19.4. Determining the feasibility of the audit

The feasibility of the audit should be determined, taking into consideration factors as the
availability of:
 sufficient and appropriate information for planning the audit,
 adequate cooperation from the auditee, and
 adequate time and resources.
Where the audit is not feasible, an alternative should be proposed to the audit client, in
consultation with the auditee.
19.5. Selecting the audit team

When the audit has been declared feasible, an audit team should be selected, taking into
account the competence needed to achieve the objectives of the audit. If there is only one
auditor, the auditor should perform all applicable duties of an audit team leader.
In deciding the size and composition of the audit team, consideration should be given to the
following:
1. audit objectives, scope and estimated duration of the audit;

2. the overall competence of the audit team needed to achieve the objectives of the audit;
3. statutory, regulatory, contractual and accreditation/certification requirements, as
applicable;
4. the need to ensure the independence of the audit team from the activities to be audited
and to avoid conflict of interest;
5. the ability of the audit team members to interact effectively with the auditee and to work
together;
6. the language of the audit, and an understanding of the auditee’s particular social and
cultural characteristics; these issues may be addressed either by the auditor's own skills
or through the support of a technical expert.
The process of assuring the overall competence of the audit team should include the
following steps:
 identification of the knowledge and skills needed to achieve the objectives of the audit;
 selection of the audit team members such that all of the necessary knowledge and skills
are present in the audit team.
If not fully covered by the auditors in the audit team, the necessary knowledge and skills may
be satisfied by including technical experts. Technical experts should operate under the
direction of an auditor and must be declared as observers in the Audit Plan.
Auditors-in-training may be included in the audit team, but should not audit without direction
or guidance.
Both the audit client and the auditee can request the replacement of particular audit team
members on reasonable grounds based on the principles of auditing. Examples of
reasonable grounds include conflict of interest situations (such as an audit team member
having been a former employee of the auditee or having provided consultancy services to
the auditee) and previous unethical behavior. Such problems should be communicated to
the audit team leader and to those assigned responsibility for managing the audit
programme, who should resolve the issue with the audit client and auditee before making
any decisions on replacing audit team members.
19.6. Conducting document review

It is necessary to review relevant management system documents, including records, and
determining their adequacy with respect to audit criteria.
Prior to the on-site audit activities the auditee’s documentation should be reviewed to
determine the conformity of the system, as documented, with audit criteria. The
documentation may include relevant management system documents and records, and
previous audit reports.
The review should take into account the size, nature and complexity of the organization, and
the objectives and scope of the audit. In some situations, this review may be deferred until
the on-site activities commence, if this is not detrimental to the effectiveness of the conduct
of the audit. In other situations, a preliminary site visit may be conducted to obtain a suitable
overview of available information.
If the documentation is found to be inadequate, the audit team leader should inform the audit
client, those assigned responsibility for managing the audit program, and the auditee. A
decision should be made as to whether the audit should be continued or suspended until
documentation concerns are resolved.
20. The Audit Program

Where:
Auditor offices
Average Duration:
Prepare the Audit Program
2
One week
Prepare and validate the Audit Plan with the auditee. The Template to fill:
Audit Plan
Audit Plan will facilitate scheduling and coordination of
the audit activities. The tasks are:
• Prepare the audit plan

• Assign work to the audit team
• Appoint auditee’s assistants by activity
• Prepare work documents
• Fill the Audit Plan Form
• Validate Audit Plan with auditee
The purpose of the Audit Program is to help companies by providing the necessary
resources to facilitate the developing of the audits.
The audit team leader should prepare an audit plan, based on the Audit Plan template, to
provide the basis for the agreement among the audit client, audit team and the auditee
regarding the conduct of the audit. The plan should facilitate scheduling and coordination of
the audit activities.
The amount of detail provided in the audit plan should reflect the scope and complexity of
the audit. The details may differ, for example, between initial and subsequent audits and also
between internal and external audits. The audit plan should be sufficiently flexible to permit
changes, such as changes in the audit scope, which can become necessary as the On-site
audit activities progress.
The audit plan should cover the following aspects:
1. the audit objectives;

2. the audit criteria and any reference documents;
3. the audit scope, including identification of the organizational and functional units and
processes to be audited;
4. the dates and places where the on-site audit activities are to be conducted;
5. the expected time and duration of on-site audit activities, including meetings with the
auditee’s management and audit team meetings;
6. the roles and responsibilities of the audit team members and accompanying persons;
7. the allocation of appropriate resources to critical areas of the audit.
The audit plan should also cover the following, as appropriate:
8. identification of the auditee’s representative for the audit;

9. the working and reporting language of the audit where this is different from the language
of the auditor and/or the auditee;
10. the audit report topics;
11. logistic arrangements (travel, on-site facilities, etc.);
12. matters related to confidentiality;
13. any audit follow-up actions.
The plan should be reviewed and accepted by the audit client, and be
presented to the auditee, before the on-site audit activities begin.
Any revised audit program should be agreed among the parties concerned before continuing
the audit and objections by the auditee should be resolved between the audit team leader,
the auditee and the audit client.
20.1. Assigning work to the audit team

The audit team leader, in consultation with the audit team, should assign to each team
member responsibility for auditing specific processes, functions, sites, areas or activities.
Such assignments should take into account the need for the independence and competence
of auditors and the effective use of resources, as well as different roles and responsibilities
of auditors, auditors-in-training and technical experts. Changes to the work assignments may
be made as the audit progresses to ensure the achievement of the audit objectives.
20.2. Preparing work documents

The audit team members should review the information relevant to their audit assignments
and prepare work documents as necessary for reference and for recording audit
proceedings. Such work documents may include forms for recording information, such as
supporting evidence, audit findings and records of meetings.
The use of forms should not restrict the extent of audit activities, which can change as a
result of information collected during the audit.
Work documents, including records resulting from their use, should be retained at least until
audit completion.
Documents pertaining to the audit should be retained or destroyed by agreement between
the participating parties and in accordance with audit program procedures and applicable
statutory, regulatory and contractual requirements.
Unless required by law, the audit team and those responsible for managing the audit
program should not disclose the contents of documents, or any other information obtained
during the audit and the audit report, to any other party without the explicit approval of the
audit client and, where appropriate, the approval of the auditee. If disclosure of the contents
of an audit document is required, the audit client and auditee should be informed as soon as
possible.
Those documents involving confidential or proprietary information should be suitably
safeguarded at all times by the audit team members.
Remember, the Auditor must always follow the auditing 6Ps of

success:
 Proper
 Prior
 Preparation
 Prevents
 Poor
 Performing
20.3. Completing the Audit Plan Form

The audit plan template is the planning instrument for the
administration of the audit process. This document when
completed should facilitate scheduling and coordination of
the audit activities. It should be prepared by the audit team
leader and approved by the auditee prior to start the On-
Site audit.
The audit plan should be sufficiently flexible to permit
changes, such as changes in the audit scope, which can
become necessary as the on-site audit activities progress.
The Audit Plan is divided in four big sections:
1. Company Information
2. Audit Team Information
3. Audit Information
4. Audit Activities
5. Audit Program
20.3.1. Company Information Section
Company Information:
 Name: Company Name
 Address: Company full address
 Sector: Indicate the Business sector of the Company
 Contact: Indicate the counterpart assigned by the company for the
Audit
Below you find an example of a filled out Company Information section
COMPANY INFORMATION
Name ACME Ltd.
Address Merrion Road, Dublin 4, Ireland
Sector Retail (food)
Contact Denis O’Neil, IT Manager
20.3.2. Audit Team Information
Audit Team Information:

 Audit Team Leader: name and position
 Audit Team: names and position
 Observers: names and position
Below you find an example of a filled out Audit Team Information section.
AUDIT TEAM INFORMATION

Audit Team Leader Name Juan Pablo Vial, GS1 GTC Project Manager
Audit Team Slobodan Romac, GS1 Croatia
Group 1:
Brendan Kernan, GS1 Ireland
Gary Garnier, GS1 GO
Group 2:
Michal Bily, GS1 Czech Republic
Janice Kite, GS1 GO
Stefan Gathmann, GS1 Ireland

Group 3:
Stephane Pique, GS1 in Europe
Observers John Ryu, GS1 GO
20.3.3. Audit Information
Audit Information:
 Objective: define what is to be accomplished by the audit
 Scope: including identification of the organizational and functional
units and processes to be audited
 Date: date and time of the on-site audit
 Audit Place: Plant or places where the on-site audit is going to
be
 Audit Criteria: and any reference document including version
and date
Below you find two examples of a filled out Audit Team Information section.
Example 1:
AUDIT INFORMATION
Objective Evaluation of the Fulfillment level for the Control Points of the
Checklist “GS1 GTC Control Points & Compliance Criteria” at the
audit location addressing logistic units (pallets) and trade items
(plastic crates or cartons with read meat primals) shipped from the
Supplier Distribution Center and to trade items (red meat) prepared
in the store.
Scope All sections of the GTC Checklist will be applied to the company
processes beginning with the shipping of the logistic units and
trade items from the Supplier Distribution Center, controlled at
receiving area in Acme store, and through in-store processing on to
final sale to consumer.
th
Date May 25 , 2010
Audit Place ACME Store at Merrion Road, Dublin 4, Ireland
Reference GS1 GTC Control Points & Compliance Criteria, Issue 2, Apr10
documents (Audit
Criteria)
The Audit Place can be a different address from the Company Address. Example: a
Warehouse located in another geographical location. Or, it could be only one plant of several
a Company has at the same address. In this case, it should be highlighted “Process plant
located at the Company Address”
Example 2:
AUDIT INFORMATION
Checklist “GS1 GTC Control Points & Compliance Criteria”, Section
5, Control Points 5.2 till 5.19 and Section 6, Control Points 6.2, 6.3,
6.4, 6.5, 6.6, 6.7, 6.9, 6.10, 6.11, 6.12, 6.13, 6.14, 6.18 and 6.19,
applied to the audit location addressing trade items identified as
cases and pallets for received goods, production, and to loading
point for the plant refrigerated warehouse.
Scope All sections of the GTC Checklist will be applied to the processes of
reception of raw materials, ingredients and packaging material;
production, and dispatch of natural chunk and shred cheese until
the loading dock.
th
Date December 11 , 2009
Audit Place ACME New York Plant, New York, USA
Reference GS1 GTC Control Points & Compliance Criteria, Issue 1, Draft 3,
documents (Audit Mar09
Criteria)
In some cases the objective could define only some sections to be applied. This should be
clearly indicated. For example:
“Section 5, Control Points 5.2 till 5.19 and Section 6, Control Points 6.2, 6.3, 6.4, 6.5, 6.6,
6.7, 6.9, 6.10, 6.11, 6.12, 6.13, 6.14, 6.18 and 6.19 of the GTC Checklist will be applied.”
20.3.4. Audit Activities
Audit Activities:
 Description: Overview description of the activities that will be
performed during the On-site Audit and how the Audit Team and
Observers will be organized.
Below you find an example of a filled out Audit Activities section.

AUDIT ACTIVITIES
Description The Audit will apply the Audit Criteria to the company with the
presence and involvement of the observers. The Audit Criteria
contains 105 control points divided into the following 12 different
sections:
1. Objectives definition of the Traceability System implemented

2. Trade and Traceable Items definitions
3. Supply chain placement of the Organization
4. Establishment of procedures for traceability
5. Flow of material and product identification
6. Internal and external information requirements for traceability
7. Documentation requirements and the instructions concerning
their implementation
8. Definition of structure and responsibilities for traceability inside
the Organization
9. Personnel training on traceability
10. Supply chain coordination among trade partners
11. Monitoring of the Traceability System
12. Internal and external audits
The auditors will be divided into three (3) groups. Each group will
be in charge of selected sections of the Audit Criteria.
The Lead Auditor will start the Audit using the first section of the
Audit Criteria. When completed the rest of the groups will continue
asking the questions in order, according to the Audit Plan.
The Company Contact should be able to answer the questions

according to the Audit Criteria
20.3.5. Audit Program
Audit Program:
 Definition of activities,
 Expected time and duration of on-site audit activities, including
meetings with the auditee’s management and audit team meetings
 Names of the participants of the company in every activity.
The Audit Programme should be divided in two parts:
 The first part and the longest one will be planning & preparation.
 The second part will be a visit to the company’s locations (reception, elaboration,
warehousing, dispatch, etc.)
For the planning & preparation it is necessary to have a room with the capacity for all the
people involved. The planning & preparation considers questions, which need to be solved, if
possible, by a person with access to the company’s ERP system, WMS, excel sheets, etc.
There are some Control Points that need to be verified in on site where they occur. For this
reason, plan the visit with the Company Contact in advance. Some of these Control Points
could become apparent during the planning & preparation. This is one of the reasons that
this work should be done before the visit to the locations.
For the visit, it may be necessary to take pictures, which are going to be used as audit
evidence. This should be indicated in this section.
The On-Site Audit normally will take one and a half day. This could be done as well in three
whole mornings. Normally, the last half day is left to do the visit part of the Audit.
Below are some sample filled out sections on “Audit Program”:
AUDIT PROGRAM (Day 1)

Activities Date Time GS1 Company
Responsible participants
Opening Meeting 25.05.2010 8:30 to 9:00 Audit Team Denis O'Neil
Leader
Denis O'Neil presents 25.05.2010 9:00 to 10:00 Audit Team Denis O'Neil
the ACME Traceability Leader
Solution
Checklist application: First Part

Checklist Sections: 25.05.2010 10:00 to 10:40 Slobodan Romac Denis O'Neil
1. Choice of Objectives Robert Conrad
2. Product Definitions
3. Supply Chain
Placement
4. Establishment of 25.05.2010 10:40 to 11:40 Group 1 Denis O'Neil
Procedures James Kant
5. Flow of Material
- Control Points:
5.1 to 5.2
6. Information
Requirements
- Control Points:
6.1, 6.3 to 6.6,
6.8
6. Information 25.05.2010 11:40 to 12:20 Group 2 Denis O'Neil
Requirements James Kant
- Control Points:
6.10, 6.11 to 6.13
and 6.17 to 6.23
7. Documentation 25.05.2010 12:20 to 13:30 Group 3 Denis O'Neil
Requirement Robert Conrad
8. Structure & James Kant
Responsibilities
9. Training
10. Supply Chain
Coordination
11. Monitoring
12. Internal and
External Audits
Comments:
• Checklist application activities should be done in an office or room with capacity for all
the students.
• The room should be equipped with a projector
• It is necessary to count with persons with access to the company’s information systems
such as ERP WMS, Excel sheets and documental repositories.
• It is necessary to count with a quality and logistics responsible

Store Operations Visit: Second Part
1. Traceability exercises 26.05.2010 15:00 to 17:00 All Groups Denis O’Neil
in Section 5: Suzanne Coyle
Flow of Material Robert McMahon
– Control Points: 5.3 Robert Conrad
to 5.19 James Kant
2. Traceability exercises
in Section 6:
Information
Requirements
– Control Points:
6.2, 6.7, 6.9, 6.14,
6.15 and 6.16
Comments:
• Exercises should be done at the facility in order to visit to the on site processes
(receiving, transforming, warehousing and dispatch).
• The questions will be focused on the receiving, warehousing and dispatch processes
• It is necessary to rely on people who know these processes in detail in order to solve
the questions.
• It may be necessary to take pictures during the visit which are going to be used as audit
evidence
Short Closing Meeting 26.05.2010 17:00 to 17:10 Audit Denis O’Neil
Team Suzanne Coyle
Leader Robert McMahon
Comments:
• It is necessary to be clear that the whole Audit process will be strictly confidential
• We hope the company allows us to use this activity for promotional reasons, promoting
activity but not publishing the results.
21. On-Site audit

Where:
Company offices
Average Duration:
Conducting the On-Site audit One day and a half
On-Site audit according to the agreed Audit Plan:
•
•
Conducting opening meeting
Collecting and verifying information
Template to fill:
GS1 GTC Assessment
Checklist 3
• Generating audit findings
• Filling the GS1 GTC Assessment Checklist
• Preparing audit conclusions
• Conducting close meeting
21.1. The Opening Meeting

At the beginning of the On-Site Audit, an opening meeting should be held with the auditee’s
management or, where appropriate, those responsible for the functions or processes to be
audited. The purpose of an opening meeting is:
 to confirm the audit plan,
 to provide a short summary of how the audit activities will be undertaken,
 to confirm communication channels, and
 to provide an opportunity for the auditee to ask questions.
Some practical help for Opening Meetings
In many instances, for example internal audits in a small organization, the

opening meeting may simply consist of communicating that an audit is being
conducted and explaining the nature of the audit.
For other audit situations, the meeting should be formal and records of the
attendance should be kept. The meeting should be chaired by the audit team
leader, and the following items should be considered, as appropriate:
 introduction of the participants, including an outline of their roles;

 confirmation of the audit objectives, scope and criteria
 confirmation of the audit timetable and other relevant arrangements
with the auditee, such as the date and time for the closing meeting,
any interim meetings between the audit team and the auditee's
management, and any late changes;
 methods and procedures to be used to conduct the audit, including
advising the auditee that the audit evidence will only be based on a
sample of the information available and that therefore there is an
element of uncertainty in auditing;
 confirmation of formal communication channels between the audit
team and the auditee;
 confirmation of the language to be used during the audit;
 confirmation that, during the audit, the auditee will be kept informed
of audit progress;
 confirmation that the resources and facilities needed by the audit
team are available;
 confirmation of matters relating to confidentiality;
 confirmation of relevant work safety, emergency and security
procedures for the audit team;
 confirmation of the availability, roles and identities of any guides;
 the method of reporting, including any grading of nonconformities;
 information about conditions under which the audit may be
terminated;
 information about any appeals system on the conduct or conclusions
of the audit.
21.1.1. Communication during the Audit

Depending upon the scope and complexity of the audit, it can be necessary to make formal
arrangements for communication within the audit team and with the auditee during the audit.
The audit team should confer periodically to exchange information, assess audit progress,
and to reassign work between the audit team members as needed.
Where the available audit evidence indicates that the audit objectives are unattainable, the
audit team leader should report the reasons to the audit client and the auditee to determine
appropriate action.
Such action may include reconfirmation or modification of the audit plan, changes to the
audit objectives or audit scope, or termination of the audit.
21.1.2. Roles and responsibilities of guides and observers

Guides and observers may accompany the audit team but are not a part of it. They should
not influence or interfere with the conduct of the audit.
When guides are appointed by the auditee, they should assist the audit team and act on the
request of the audit team leader. Their responsibilities may include the following:
 establishing contacts and timing for interviews;
 arranging visits to specific parts of the site or organization;
 ensuring that rules concerning site safety and security procedures are known and
respected by the audit team members;
 witnessing the audit on behalf of the auditee;
 providing clarification or assisting in collecting information.
21.1.3. Control of the Audit

The Auditor must keep control of the audit at all times.
MUST NOT
 Leave the auditee avoid the subject
 Be influenced or deceived
 Be drowned in information overload
 Allow the auditee to establish the audit pace
 Make comparisons nor have preconceived ideas
 Attack the people
 Get involved in discussions with the auditee
 Relate people to NC
MUST
 Be very well prepared to execute the audit
 Motivate the personnel of the audited area
 Be persuasive
 Ask only one question at a time
 Insist on the answer from the people questioned
 Be a small talker
 Verify the answer with a “show me“
 Impose velocity, considering capacity and personality of the auditee.
 Demonstrate open spirit and confidence in his mission
 Congratulate
The Auditor must be prepared and know the variety of cases that can arise during the audit.
Here are examples of these:
 Aggressive auditees or intimidatory behavior towards the auditor

 Shy auditees
 Absence of people involved
 Missing documents
 Delay on dates or schedules
 Long explanations
 Special cases
 Emotional coercion
 Local and cultural issues
 Samples prepared in advance (always do random sampling)
When facing situations like these, the auditor must act with decision, professionalism and
impartiality, taking into account the objectives and purpose of the audit.
21.2. Collecting and verifying information

During the audit, information relevant to the audit objectives and scope, including information
relating to interfaces between functions, activities and processes should be collected by
appropriate sampling and should be verified. Only information that is verifiable may be
considered audit evidence. Audit evidence should be recorded.
Collecting the information can be done in four ways:
1. INVESTIGATION: through questions-answers and detect, if established dispositions are

being fulfilled
2. OBSERVATION: witnessing the way the personnel of the company work in the activity
that is being audited and compare with what is established in the documentation
applicable to such activity.
3. TRACKING: reconstruction of a process or succession of activities, to make sure of its
conformity or nonconformity against the audit criteria.
4. EXPLORATION: inspection of records to verify its conformity or nonconformity against
the audit criteria
The following figure shows the process to verify information collected:
Sources of Information
Collecting by appropriate sampling and verifying
Audit Evidence
Evaluating against audit criteria
Audit findings
Reviewing
Audit conclusions
The collection of information can also be presented as in the flowchart below.
Obtaining Evidence through
Observation Review
Interviews
of activities of documents
AUDIT FINDINGS
21.2.1. Observation of activities

This is the initial route to be taken, as it allows determining the proportions of any problem
that might exist. This also means in terms of GTC that you can verify on-site whether there
was an effective implementation or not.
The observation of activities also allows identifying the level of implementation or to what
extent measures for improvement/correction have been adopted/developed.
21.2.2. Review of documents

It is of course impossible to verify all documents, so you have to take a sample. It is
important to think of the location where these documents are stored and how you will be able
to access them. If the company being audited has a document management system, this will
help a great deal. At the same time, it is important to have a document management system
yourself in order to store the necessary copies and versions of documents.
Please note that you should also record the requests for documents to the coordinator.
Practically speaking, what information are you looking for?

 Product Identification
 Controlled documents
 Warehousing
 Record management
 Traceability System knowledge
 Training capacities
Practically speaking, what should you be observing?

 Personnel suitability
 Documentation
 Records (Excel, DBs, ERP, WMS, etc)
 Labels on:
o Products
o Boxes
o Pallets
 Warehouses and Racks
 Flow of activities
21.2.3. Interviews
The most important thing to retain about collection of information through interviews is that
you want to understand.
Indeed, the only thing you want to achieve is understand what people/systems do, how they
do it and why they do it. The questions you ask should be targeted to ensure you
understand how the organisation functions.
As an auditor, you should pay particular attention to the body language of the person you are
talking to. Body language conveys very important clues as to how people feel about the
messages they and you exchange.
The figure below shows the most common facial expressions you’ll encounter.
When interviewing someone, you have to be aware of how you lead the interview. This goes
from the type of questions over your body-language to the actual content of your questions.
It is best practice to work with open questions, asked in an understandable fashion, whilst
remaining non directive and non accusing.
Open, Closed and Alternative Questions:

Open questions
What? When? Where? Why? Who?
Closed questions
The answer to the question can only be “yes” or “no”.
Questions with alternatives
The question you ask already contains a predefined number of
answers, e.g. something is either black, white or grey.
The Golden Rules of Interviewing during an Audit:

Make sure that what you write down during the interview is
enough to enable you to write your findings document or
Nonconformity document afterwards.
Make sure you communicate with the auditee on any
Nonconformity you may have found BEFORE you close the
interview.
21.3. Generating Audit findings

Once the Audit is completed the auditor must review all the findings. It might be necessary to
generate intermediate revisions at the end of each day of the audit.
The review will include:
 A review of the GS1 GTC Assessment Checklist
 A study and comparison of the notes taken by the audit team
 Enumeration of Nonconformities found
 Decisions over Nonconformities and observations
 Write the Corrective Actions in the Nonconformities Report Form.
Audit findings can be classified as:
 Nonconformity
 Observation (Improvement opportunity)
The most important audit findings are nonconformities and their supporting evidence. A
Nonconformity is leveraged when the process or procedures that are being audited are not
performed or complete as it would be.
ISO 9000 define a nonconformity as:

“non-fulfillment of a requirement”
What exactly is a Nonconformity? It is a failure, often caused by a lack of procedures, or else

it is an inconsistency in the implementation of the traceability system being audited.
The failure is against a policy, one of the audit criteria, a procedure or the accepted fault-
tolerance for a parameter.
The evidence that you have to gather to prove your finding of a Nonconformity may consist
of records, documents or the observation of the execution of a procedure (E.g. a procedure
has 9 steps and step 5 is not executed)
Nonconformities can be identified by both internal and external means. By internal and
external is meant: to the organisation. The internal sources contain internal audits,
processes and final inspections or products which are non conforming. The external sources
contain audits, customers, complaints or legal controls.
Practical help on identifying Nonconformities:
Nonconformities are results of:
o Repeated failures in achieving continuous improvement

o Traceability system requirement not met
o Policy requirement not met
o Customer requirement not met
o Legal requirement not met
The process of getting to the Nonconformity report can be depicted as below.
21.3.1. How to write Nonconformities (NC)?

Nonconformities must be recorded only after you have made every attempt possible to
resolve any diverging opinions you have with the auditee with regards to the audit evidence
and/or findings. You have to ensure that you include any unresolved points in your audit
findings.
If during the audit, the auditor identifies a problem that can be effectively solved by the
company before the closing meeting, if the auditor approves the solution given, then the
nonconformity must not be leveraged.
When writing a Nonconformity always include:
 Global vision of the finding (where and under what circumstances)
 Description of the Nonconformity
 Summary of Objective evidence examples
 the requisite. (Use the Compliance Criteria writing)
Some basic rules include:
DO
…Write down clearly the objective evidence found
…Specify the area where the NC was found
…Make sure that the auditee understands and accepts the NC
…Write the NC so it is traceable
…Write in a concise way, associating the objective evidence detected on-site
…Write in a clear way, transparent and without surprises
…Communicate in an exact form the facts (evidence) and why these facts
are a NC (audit criteria)
…Commit the implementation date for the action plan or the date on which
this plan will be generated
DO NOT
…identify guilty ones.
…write NC on the basis of perceptions
…give solutions to avoid the NC.
Examples:
DO report
It was observed that in the delivery process, the trade items distributed by the Company are
not identified with the GTIN and the production lot on the packaging.
DO NOT report
“The company doesn’t identify the trade items”.
DO report
It was observed that no records exist indicating whether the employees have attended the
traceability training programs.
DO NOT report
“The employees of the company have not attended the traceability training courses”.
DO report
“The safety hazard crisis procedure only works by day”
DO NOT report
“The safety hazard crisis procedure only works by day so the company can be seriously
affected in case of an emergency happening during the night”.
21.3.2. When declaring an Observation?

The audit findings can also be “Observations”. These are an added value of the audit. An
Observation must be declared by the auditor when there is an opportunity to improve the
traceability management system.
Observations can be:
 Best practices that could benefit other organization’s areas
 Points that are of concern, but are not enough to be declared as Nonconformities
 Situations that if they are not addressed, can later become a Nonconformity
 Deficiencies to which the auditor has granted the “benefit of the doubt”
Observations must be recorded when the auditor:
 Doesn’t clearly identify the requirement
 Judge that the evidence is not clear
 Is not well prepared
 Hasn’t enough expertise
 Is out of time
 Evaluates the magnitude and impact of the problem and decides under his criteria that
unless the requirement is partially solved, it can still be an observation.
The observations gives the auditor a flexible mechanism to report; however they don’t have
a formal character, can establish the difference between a negative or a positive process.
21.4. Filling the GS1 GTC Assessment Checklist

The GS1 GTC Assessment Checklist is a template used to report the observations and
Nonconformities found during the On-site Audit. It covers the following:
 Control Points: Presents the Control Points as described in the document GS1 GTC
CP&CC.
 Compliance Criteria: Presents the Compliance Criteria for every Control Point as
described in the document GS1 GTC CP&CC.
 Levels: Presents the level of Compliance (MAN for Mandatory, MAN(Cond) for
Mandatory Conditional, OP for Optional or REC for Recommended)
 Fulfillment degree: Field to record if the Control Point is a Conformity or Nonconformity

against any of the standards presented
 Observations: Field to report the Observation or Nonconformity
The GS1 GTC Assessment Checklist should be used by the Auditor to report Conformity
against every Control Pont of the GS1 GTC CP&CC. This document allows the auditor to
record if the Compliance Criteria is met by the audited company and to report Observations
and Nonconformities found.
The GS1 GTC checklist must accompany the Auditor during the whole audit process. All the
notes taken plus the Observations and Nonconformities found should be the basis to write
the Audit Report. This document, once formally completed comprises part of the Audit
Report.
21.4.1. Terms in the GS1 GTC Assessment Checklist

 X: Symbol to note a Nonconformity
 : Symbol to note a Conformity
 L: The Compliance Level
 GS1: Corresponds to GS1 GTS requirement
 22005: Corresponds to ISO 22005 requirement
 HACCP: Corresponds to HACCP traceability requirement
 IFS: Corresponds to IFS traceability requirement
 BRC: Corresponds to BRC traceability requirement
 SQF: Corresponds to SQF traceability requirement
 9001: Corresponds to ISO 9001 traceability requirement
 GGAP: Corresponds to GlobalGAP traceability requirement
 NA: Not Applicable
 CONF: Conformance. Present a checkmark () if the Control Point is a Conformity,
an x (X) if the Control Point is a Nonconformity or and NA if it is Not Applicable.
21.4.2. When checking the Fulfills field

This field is split into several squares. The first eight (8) squares indicate the standard to which
the Control Point belongs. The ninth square is there to inform if the Control Point is Not
Applicable (NA) and the last square indicates the Conformance (CONF) to the Control Point.
GS1 22005 HACCP IFS BRC SQF 9001 GGAP NA CONF

Fulfills 
X X
 All white squares must be fulfilled unless the Control Point is Not Applicable.
 There are some Control Points which can not be NA. These ones are indicated with a
black cell
 The white squares must be fulfilled with a checkmark () if the Control Point is a
Conformity or with an (X) if the Control Point is a Nonconformity
 Grey squares must not be fulfilled
Sometimes the Control Points applie to two (2), three (3) or all the standards in the same way
without any difference. In those cases, the squares are combined, so one checkmark () must
be used in the extended square and it will be valid for all the standards combined in this
square.

Fulfills 
X X
Checking the CONF square:

The CONF square indicates the Conformance (CONF) to the Control Point. It must always
be fulfilled unless the Control Point is Not Applicable. It is the summary of all the others
squares in the row. If all the applicable squares labeled as “GS1”, “22005”, “HACCP” “IFS”,
“BRC”, “SQF”, “9001”, or “GGAP” are marked with a checkmark (), then the “CONF”
square must be marked with a checkmark () as is shown in the following figure:

Fulfills     
If any of the squares labeled as GS1”, “22005”, “HACCP” “IFS”, “BRC”, “SQF”, “9001”, or
“GGAP” is marked with a Nonconformity (X), then the “CONF” square must be marked as a
Nonconformity (X) as is shown in the following figure:

Fulfills 
X X
Example:
Control Point 2.1 says: “Are all trade items, distributed by the Organisation, identified with a
GS1 identification key and a description in a Master Data record for each product hierarchy
level that needs to be traced?” In this case if the company use an Internal identification key for
any of the trade items they distribute, then the Control Point is a Nonconformity against GS1,
but it is a Conformity against ISO 22005, HACCP, IFS, BRC and SQF and should be fulfilled in
the following way:
N° CONTROL POINTS COMPLIANCE CRITERIA L Observations

2.1. Are all trade items, A Master Data record with a
distributed by the GS1 identification key and a
Organisation, description must exist for all
identified with a GS1 trade items distributed by the
identification key and Organisation at all levels of the MAN
a description in a product hierarchy that need to (Cond)
Master Data record be traced.The corresponding
for each product GS1 standard is the GTIN.
hierarchy level that
needs to be traced?
(GTS: BR3, GS1 22005 HACCP IFS BRC SQF 9001 GGAP NA CONF
BR7, BRU4, Fulfills
BRU16) X  X
21.4.3. Defining a Not Applicable

Not Applicable (NA) is a Control Point which is not applicable for an Organisation. Ex: A
company that doesn't export their trade items, then all the Control Points which makes
reference to exporting goods is going to be NA. If a NA applies, then the auditor should mark
the square labeled “NA” with an (X) and additionally record the cause of the NA.

Fulfills
X
 Note that there are some Control Points which cannot be NA. These are indicated with
a black cell.
 All Not Applicable Control Points are excluded from the final scoring
Example:
2.2. Are intermediate A Master Data record with an OBS: The organisation does not
items produced by the identification number and manufacture intermediate items.
Organisation that description must exist for
needs to be traced intermediate items, produced REC
identified with an by the Organisation, that need
identification number to be traced.
and a description in a
Master Data record?
Fulfills
X
21.4.4. Writing an Observation

Observations shall be reported in the “Observations” field by applying the following rules:
 Write in a concise way, the Observation details after the beginning of the sentence
“OBS:”
 Associate the evidence detected on-site objectively
 Specify the area (location / stage) that the observation references
 Observations should only be written up when the Control Point is a Conformity
 Write in a way that is legible and also easily understandable
Example:
5.12. Are trade items The trade items received by the OBS: The raw materials received by
received by the Organisation must be identified the company are identified with a
Organisation, with the production batch / lot or logistic label, adhered to its package,
identified with the Serial Number on the which only indicates the product code,
MAN
production batch / lot packaging or on the asset the supplier and the lot number. These
or Serial Number on containing it, or on an are the unique data the company
the packaging? accompanying document. register when receiving the raw material
GS1 22005M HACCP IFS BRC SQF 9001 GGAP NA CONF

Fulfills
 
21.4.5. Writing a Nonconformity?

Nonconformities shall be reported in the “Observations” field by applying the following rules:
 Write the Nonconformity details in a concise way, after the beginning of the sentence “NC:”
 Associate the evidence detected on-site objectively.
 Write down clearly the objective evidence found (be open and transparent)
 Communicate the facts (evidence) precisely and state why these facts are a
Nonconformities
 Do not identify guilty persons
 Do not write up Nonconformities on the basis of perceptions, only record the facts
 Specify the area (location / process stage) where Nonconformities exist
 Write the Nonconformity so it can be traced
 Nonconformities must not be related to solutions in this document
 Identify objectively all evidence that proves the Nonconformity. Ex: a document, a label, a
record in DB, a record in the ERP, a photograph, etc.
 Write in a way that is legible and also easily understandable
Example 1:
5.4. Are trade items The trade items distributed by NC: The items received by the
distributed by the the Organisation must carry a Company don’t have a GS1 standard
Organisation carrying GS1 Data Carrier attached to Data Carrier on packaging from the
a GS1 Data Carrier? the packaging or on the asset supplier. Every item (bag, box or tank)
containing it or on an is locally identified with a label by the
accompanying document. company when received. A picture was
The corresponding GS1 taken as evidence (P5150131.jpg)
standards are:
 For trade item crossing the MAN
point of sale (consumer (Cond)
unit): EAN-13, EAN-8,
UPC-A, UPC-E, GS1
DataBar, GS1 DataMatrix,
EPC tag
 For trade item not crossing
the point of sale (grouping
of trade items): EAN-13,
ITF-14, GS1-128, GS1
DataMatrix, EPC tag
(GTS: BR7,
BR11) Fulfills
X  X
Example 2:
2.1. Are all trade items, A Master Data record with a NC: The items distributed by the
distributed by the GS1 identification key and a Company don’t have a GS1 standard
Organisation, description must exist for all Identification Number on packaging
identified with a GS1 trade items distributed by the from the supplier. Every trade item
identification key and Organisation at all levels of the (bag, box or tank) is locally identified
MAN
a description in a product hierarchy that need to (Cond)
with a label by the company.
Master Data record be traced.The corresponding Only internal identification is required in
for each product GS1 standard is the GTIN. ISO 22005, HACCP, IFS, BRC and
hierarchy level that SQF
needs to be traced? A picture was taken as evidence
(P5150135.jpg).
(GTS: BR7,
BR11) Fulfills
X  X
21.4.6. Checking the Control Points

It is extremely important for the auditor to always confirm every answer with a “show me”.
Every affirmative answer to a Control Point must be endorsed by objective evidence. Ex: a
document, a label, a record in some DB, a record in the ERP, a photograph, etc.
Best Practice when checking the Control Points:
 Search always for objective evidence

 Report immediately any Nonconformity found
 Point to the evidence when writing a Conformance or a
Nonconformance
 Do not link individuals to a NC
 Write in the Checklist in a way you can understand later
 Ask only one question at a time
 If you can not solve a question, leave it for later when you have
the adequate person from the company to solve it
21.5. Preparing Audit Conclusions

The audit team should meet prior to the closing meeting in order to review the audit findings,
and any other appropriate information collected during the audit. The review should be
carried out by matching the findings with the audit objectives. During the same meeting, the
audit team should also agree on the audit conclusions, taking into account the uncertainty
inherent to the audit process. The team should prepare recommendations, if specified by the
audit objectives, and discuss the audit follow-up, if included in the audit plan.
Audit conclusions can address issues such as the extent to which the management system
is conform to the audit criteria, the effective implementation, maintenance and improvement
of the management system, and the capability of the management review process to ensure
the continuing suitability, adequacy, effectiveness and improvement of the management
system.
If specified by the audit objectives, audit conclusions can lead to

recommendations for improvements, business relationships,
certification/registration or future auditing activities.
21.6. Conducting the Closing Meeting

A closing meeting, chaired by the audit team leader, should be held to present the audit
findings and conclusions in such a manner that they are understood and acknowledged by
the auditee, and to agree, if appropriate, on the timeframe for the auditee to present the
audit report. Participants in the closing meeting should include the auditee, and may also
include the audit client and other parties. If necessary, the audit team leader should advise
the auditee of situations encountered during the audit that may decrease the reliance that
can be placed on the audit conclusions.
In many instances, for example internal audits in a small organization, the closing meeting
may consist of just communicating the audit findings and conclusions. For other audit
situations, the meeting should be formal and minutes, including records of attendance,
should be kept.
Any diverging opinions regarding the audit findings and/or conclusions between the audit
team and the auditee should be discussed and if possible resolved. If not resolved, all
opinions should be recorded.
Some practical help for Closing Meetings
The following list contains some typical elements that should be covered in a
closing meeting:
 Distribute attendance list

 Present audit objectives, scope and criteria used including
modifications and exclusions
 A summary of the good things observed over the activity
 Explain the Nonconformities found
 Inform observations declared
 Explain the Nonconformities Report
 Explain the Audit Report
 Obtain the signature of the Assessment Checklist
 Commit a date to present the Audit Report
 Obtain the attendance list
 Thanks to the client
 Congratulate if appropriate
22. Preparing, approving & distributing the Audit

Report
Where:
Auditor offices
Average Duration:
One or two weeks
Preparing, approving and Template to fill:
•
•
distributing the audit report
Preparing the Nonconformities report
Preparing the audit report Audit Report
456
GS1 GTC Assessment
Checklist
Nonconformities Report
Conformance Report
• Approving and distributing the audit report
This topic is split into 3 main parts: the first being the preparation of the nonconformities
report, the second being the preparation of the audit report and the third being the approval
and distribution of the audit report.
22.1. The Nonconformities Report

The conclusions of the audit may indicate the need for
corrective, preventive or improvement actions, as
applicable. Such actions are usually decided and
undertaken by the auditee within an agreed timeframe
and; The auditee should keep the audit client informed of
the status of these actions.
The completion and effectiveness of corrective action over
Nonconformities found should be verified. This verification
may be part of a subsequent audit.
The audit program may specify follow-up by members of
the audit team, which adds value by using their expertise.
In such cases, care should be taken to maintain
independence in subsequent audit activities.
The Nonconformities report Form is a document to inform
the Nonconformities found during the audit. It covers the
following 3 sections:
1. Nonconformity Information
2. Corrective Action Information
3. Corrective Action Inspection
22.1.1. Nonconformity Information Section
Nonconformity Information:
 CP N°: Number of the Control Point number with Nonconformity
 Nonconformity Description: Description of the Nonconformity
 Date: Date when the Nonconformity was detected
 Audit Criteria: Audit Criteria version used for the audit

 Auditor Name % Signature: Name of the Auditor reporting the
Nonconformity
 Responsible Name & Signature: Name of the Company
responsible accepting the Nonconformity
Below you find an example of a filled out Nonconformity Information section
NONCONFORMITY INFORMATION
CP N° NONCONFORMITY DESCRIPTION DATE
4.4 It doesn’t exist a documented procedure in the Company 25/05/2010
which describes in detail the Master Data alignment
procedure with the trading partners. AUDIT CRITERIA
GS1 Global Traceability

Conformance Control Points
& Compliance Criteria, Issue
1, Apr 10
Auditor Name & Slobodan Romac, Responsible Name & Peter Folk,
Signature GS1 Croatia Signature ACME
22.1.2. Corrective Action Information Section
Corrective Action Information:

 Origin investigation: Cause of Nonconformity
 Corrective Action to Implement: Action declared by the company
which once implemented will solve the Nonconformity
 Implementation Responsible Name & Signature: Name of the
Company responsible of implementing the Corrective Action
 Implementation date: Date committed by the company to
implement the Corrective Action
As part of the Audit Activities the Auditor must report the cause of the Nonconformity in the
Origin investigation field. The Corrective Action or Preventive Action should be declared by
the Company responsible after the Conclusion of the Audit. This Action should be reviewed
in a subsequent audit.
 Corrective Action
Are steps that are taken to remove the causes of an existing Nonconformity or
undesirable situation.
The corrective action process is designed to prevent the recurrence of
Nonconformities or undesirable situations. It tries to make sure that existing
Nonconformities and situations don’t happen again.
It tries to prevent recurrence by eliminating causes. Corrective actions address

actual problems. Because of this, the corrective action process can be thought of as a
problem solving process.
 Preventive Action:
Are steps that are taken to remove the causes of potential Nonconformities or potential
situations that are undesirable.
The preventive action process is designed to prevent the occurrence of Nonconformities
or situations that do not yet exist. It tries to prevent occurrence by eliminating causes.
While corrective actions prevent recurrence, preventive actions prevent occurrence.
Both types of actions are intended to prevent Nonconformities.
Preventive actions address potential problems, ones that haven't yet occurred. In
general, the preventive action process can be thought of as a risk analysis process.
Below is an example of a filled out Nonconformity Information section
CORRECTIVE ACTION INFORMATION

Origin The Company never documented the procedure they have at an
investigation operative level. It is not included in any of the Companies Quality
(Cause of the Procedures.
Nonconformity)
Corrective Action It was developed a formal procedure to align Master Data, including
to implement products, parties and locations, with trading partners fully based on
the procedure template given by GS1. This procedure was included
in the Quality Procedure PP-101-08 as a regular directive that every
trading partner should implement in order to start doing business
with the Company.
Implementation Peter Folk, Implementation 01/07/2010

responsible name ACME date
& signature
22.1.3. Corrective Action Inspection Section
Corrective Action Inspection Information:

 Accepted: Response given by the Auditor accepting or denying the
Corrective Action
 Observations: Observation Filed to report the acceptance or denial
of the Corrective Action
 Auditor Name & Signature: Name of the Auditor reporting the
Nonconformity
 Inspection date: Date of the inspection of the implemented
Corrective Action
If in a previous audit where Nonconformities were detected, the Auditor must review all the
Nonconformities Reports and analyze if the Corrective Actions or Preventive Actions
declared were effectively solved by the Company.
Below is an example of a filled out Inspection Information section
CORRECTIVE ACTION INSPECTION

ACCEPTED Only if the answer is NO, write the new NONCONFORMITY
YES NO

OBSERVATONS The Company initiated a program with their trading partners to

fully implement the new procedure. Till date 50% of the trading
partners have their Master Data aligned with the Company’s
Master Data.
Auditor Name & Slobodan Romac, Inspection Date 08/08/2010

Signature GS1 Croatia
22.2. The Audit Report

The audit team leader should be responsible for the
preparation and contents of the audit report. The audit report
should provide a complete, accurate, concise and clear record
of the audit. To prepare the audit report, the audit team leader
should use the Audit Report Form. Once the Audit Report has
been approved by the auditee, a formal presentation should be
done with the Audit Client. After this presentation the audit is
completed.
Documents pertaining to the audit should be retained or
destroyed as per agreement between the participating parties
and in accordance with audit program procedures and
applicable statutory, regulatory and contractual requirements.
Unless required by law, the audit team and those responsible
for managing the audit program should not disclose the
contents of documents, any other information obtained during
the audit, or the audit report, to any other party without the explicit approval of the audit client
and, where appropriate, the approval of the auditee. If disclosure of the contents of an audit
document is required, the audit client and auditee should be informed as soon as possible.
The audit report Form is a document to inform the audit conclusions. It cover the following 3
sections:
1. Company Information
2. Audit Team Information
3. Audit Information:
22.2.1. Company Information Section
Company Information:
 Name: Company Name
 Address: Company full address
 Sector: Indicate the Business sector of the Company
 Contact: Indicate the counterpart assigned by the company for the
Audit
Below is an example of a filled out Company Information section
COMPANY INFORMATION
Name ACME Ltd.
Address Deans Grange, Dublin
22.2.2. Audit Team Information
Audit Team Information:

 Audit Team Leader: name and position
 Audit Team: names and position
 Observers: names and position
Below is an example of a filled out Audit Team Information section.

Group 1:
Group 2:
Janice Kite, GS1 GO

Group 3:
22.2.3. Audit Information
Audit Information:
 Objective: define what is to be accomplished by the audit
 Scope: including identification of the organizational and functional
units and processes to be audited
 Date: date and time of the on-site audit
 Audit Place: Plant or places where the on-site audit is going to
be held
 Audit Criteria: and any reference document including version
and date
Below is an example of a filled out Audit Information section.
AUDIT INFORMATION
Checklist “GS1 GTC Control Points & Compliance Criteria” at
the audit location addressing logistic units (pallets) and trade
items (plastic crates or cartons with read meat primals) shipped
from the Supplier Distribution Center and to trade items (red
meat) prepared in the store.
Scope All sections of the GTC Checklist will be applied to the

company processes beginning with the shipping of the logistic
units and trade items from the Supplier Distribution Center,
controlled at receiving area in Acme store, and through in-store
processing on to final sale to consumer.
Control Points Audited The 105 Control Points of the Checklist were audited.

th
Date May 25 , 2010
Reference documents GS1 GTC Control Points & Compliance Criteria, Issue 2, Apr10
(Audit Criteria)
Mandatory : 2
Number of
Mandatory (Conditional) : 3
Nonconformities
Optional : 3
Recommended : 8
Audit Place, Audit Date, Audit Criteria, Objective and Scope must be the same as declared
in the Audit Plan.
In the raw “Number of Nonconformities”, the auditor must declare all the Mandatory,
Mandatory (Conditional), Optional and Recommended Nonconformities.
22.2.4. Summary Table Section

To prepare the Summary table, the auditor should consider the following descriptions:
 Total: inform the total number of Control Points of the Audit Criteria in every level of
obligations. The sum of the four levels must be the total of CP in the Audit Criteria.
 N/A: Are the Not Applicable Control Points found in every level of obligations (Mandatory
Control Points can no be N/A)
 Max: Are the number of “applicable “Control Points audited, this is the Total CP minus the
N/A Control Points.
 Obtained: are the total CP in conformity found in every level
 %: Is the percentage of conformity. This is calculated dividing the CP in conformity by the
applicable CP (Obtained/Máx).
 Approved: Should be informed yes when the percentage in every level is equal or greater
than the Compliance Criteria.
An example of a filled out Summary table is below:
Obligations Total N/A Max. Obtained % Approved
Mandatory 28 28 26 93 No
Mandatory (Cond) 30 11 19 16 84 No
Optional 10 1 9 3 22 Yes
Recommended 37 8 29 21 72 Yes
Total 105 20 85 66 NO
Compliance Level:
 Mandatory Musts:
 Mandatory Conditional Musts:
compulsory.
 Optional
 Recommendations:
22.2.5. Nonconformities against the standards Section

To prepare the Nonconformities against the standards table, the auditor should inform all the
Nonconformities found in every CP ticketed in the standard column of the GS1 GTC
Assessment Checklist.
An example of a filled out Nonconformities against the standards table is below:
Standard Mandatory Mandatory Optional Recom.

(Conditional)
GS1 GTS 2 1 3 1
ISO 22005 0 2 0
HACCP 0 1 0
IFS 0 1 0
BRC 0 1 0
SQF 0 1 0
ISO 9001 0 0 0
GlobalGAP 0 0 0
22.2.6. Traceability Implementation Degree Section

The Traceability Implementation Degree can address issues such as:
 the extent of conformity of the management system with the audit criteria,
 the effective implementation, maintenance and improvement of the management system
 the capability of the management review process to ensure the continuing suitability,
adequacy, effectiveness and improvement of the management system.
Only if specified by the audit objectives, can audit conclusions lead to recommendations
regarding improvements, business relationships, certification/registration or future auditing
activities.
An example of a filled out Traceability implementation degree table is below:
Traceability ACME traceability is supported by a software based IT solution to

Implementation manage traceability for the sale of red meat products. This solution is
Degree fully operational and staff demonstrated their skill at using the system.
It was proved that all trade items received are identified on the
packaging and batch/lot numbers are also present. GS1 standard
identifiers; GTIN-13 and batch no. Identification and traceability data
are captured using the GS1 Standards for ID and bar codes.
It was also evident that all logistic units (plastic or coated-cardboard
boxes) are identified with an internal identification (6 numbers). All
“Primals”, contained in the logistic unit, are also identified. There was
no evidence of any products missing labels.
It was confirmed that all trade items on sale to customers are identified
with GS1 standard identifiers; GTIN and batch Number. Consumer
products, both prepack and serve-over are identified with a trace
number, thereby facilitating a trace should there be an issue with a
product. It was also possible to identify using the “Food Trace”
application if there was any product, received from a particular farm
where an incident had occurred. However, it was not possible to trace
to the actual consumer.
Documented procedures exist; these are controlled, independently
audited and reapproved twice per year. These are mainly contained
within the HACCP manuals. However, these procedures do not fully
address the requirements of the GTS.
GS1 Standards are used, but are not fully deployed to all possible
control points as defined by the GTS. This creates an information gap
in the data that should be retained by the company to execute full
traceability solution in compliance with the GTS.
Traceability information is displayed to customers at the “red meat
serve over” counter – “The Whiteboard”.
In summary, the general understanding and application of broad
traceability standards and country regulations is good at ACME.
Regarding GS1 GTS, there are three (3) major Nonconformities that
should be addressed:
 (CP 4.4) ACME should have a documented procedure to align

master data with their suppliers
 (CP 6.12) ACME should relate by documentation each batch and

Traceability lot of trade items received (Primals) with the logistic units involved.
Implementation As presently structured, batch and lot numbers are not recorded at
Degree goods inwards and logistical units are not identified. It is
recommended that this be reviewed for future development
(Continued)
 (CP 6.18) ACME should have a registry that documents whether a
batch and lot of a primal is still in the warehouse or was processed
and sent to butchery or counter for sale. ACME does not have an
in-store stock control system and therefore, they are not able to
record whether a batch/lot of a trade item is still in the warehouse.
Regarding ISO 22005, the organization must solve two (2) Control
Points.
 (CP 4.7) A documented procedure which describes in detail the

definition for the production batch and lot numbers for each trade
item.
 (CP 6.1) A document indentifying for each production batch / lot or

Serial Number of a trade item, all processes, reprocessing if
applicable, transformation dates and sell by dates if applicable.
Also is recommended to relate this document with a traceability
flow diagram of the information linking the processes within the
company which may be used to perform traceability requests
Regarding HACCP, BRC, IFS and SQF, the organization must solve
one (1) Control Point

applicable, transformation dates and sell by dates if applicable.
Also is recommended to relate this document with a traceability
flow diagram of the information linking the processes within the
company which may be used to perform traceability requests.
All the Control Points regarding ISO 9001 and GlobalGAP were
fulfilled satisfactorily.
ACME does not pass the audit because does not fulfill the 100% of the
required Major Control Points. It only fulfills 93% of Mandatory and
84% of Mandatory (Conditional). This means that two (2) Mandatory
Control Points and three (3) Mandatory (Conditional) Control Points
are due to solve to approve the audit.
22.2.7. Report Distribution Section

The audit report should be dated, reviewed and approved in accordance with audit program
procedures. The approved audit report should then be distributed to recipients designated by
the audit client.
The audit report is the property of the audit client. The audit team members and all report
recipients should respect and maintain the confidentiality of the report.
An example of a filled out Report Distribution table is below:
Report distribution Juan Pablo Vial, GS1 GO; John Ryu, GS1 GO; Stefan Gathmann,
GS1 Ireland; Stephane Pique, GS1 in Europe; Brendan Kernan,
GS1 Ireland; Gary Garnier-Guisgand, GS1 GO; Michal Bily, GS1
Czech Republic; Janice Kite, GS1 GO; Slobodan Romac, GS1
Croatia.
Audit Team Juan Pablo Vial, GTC Project Date 15.05.2010

Leader Manager GS1 GO
signature
22.3. The Conformance Report

The Conformance Report is a document where the
Organisation which performed the GTC Assessment informs
the Audit results in a summarized way.
The Conformance Report must be signed by the Auditor Team
Leader and the Organisation to which he works.
It contains the following information:
4. Auditing Organisation Logo
5. Audited Company Name and Address
6. Audit Criteria
7. Audit Scope definition
8. Summary of Results (Summary Table of the Audit Report)
9. Report Number
10. Auditor Number, name and signature
11. Audit Date (first day of the on-site audit)
12. Report Issue Date
13. Auditing Organisation Responsible name and signature
14. Auditing Organisation name and address
The Conformance Report must be given to the audited Company attached to the Audit
Report and is a decision of the audited Company to make it public or not.
The Conformance Report Form is shown on the next page:
Conformance Report
provided to
Company Name
Address
This Audit Report presents the summary of results of the Audit performed by [Auditing Organisation]
according to the GS1 GTC Programme.
Further clarifications regarding the scope of this Report and the applicability of
GS1 GTC requirements may be obtained by consulting the organization
Audited Under
GS1 GTC Control Points & Compliance Criteria,
Issue 1, Apr 2010
Scope of Supply
Scope
Summary of Results
Obligations Total N/A Max. Obtained % Compliance Approved

Mandatory 28 28 100%
Mandatory (Cond) 30 100%
Optional 10 0%
Recommended 37 0%
Total 105
Nomenclature:  Total: Total Number of Control Points
 N/A: Number of Non Applicable Control Points detected
 Max: Maximum Number of Applicable Control Points
 Obtained: Number of Control Points with Conformity
 %: Percentage of Approval
 Approved: Conformance to Compliance Criteria (Yes / No)
 Compliance: Compliance Criteria to approve
Report No.: xxxxxxxxxxxxxxx

Auditor No: xxxxxxxxxxxxxxx
Audit Date: Month, day, Year
Issue Date: Month, day, Year Auditor name
[Auditing Organisation]
[Address], [City], [Country]
Responsible name
The global language of business
22.4. Completing the Audit: Presenting the Assessment Report

The Assessment Report comprises all the material collected and prepared during all the
audit activities. To present and distribute the Assessment Report, organize two folders with
the following material:
 The Audit Plan
 The Nonconformities Report for every Nonconformity found
 The GS1 GTC Assessment Checklist with all the Nonconformities and Observations
detected during the Audit
 The Audit Report
 The Conformance Report
 Copies of the evidence found and pointed out in the GS1 GTC Assessment Checklist
 Other relevant documentation such a legal documentation
One folder is given to the Company. The other folder is kept by the auditing organisation with
all the handwritten material used during the whole process.
Consider the preparation of a PowerPoint presentation with the summary of the Audit Report
and all the Mandatory Nonconformities found.
The audit is then completed when all activities described in the audit plan have been carried
out and the approved audit report has been distributed.
Appendices
 Appendix 1: References
 Appendix 2: Additional Information
 Appendix 3: IAF Members
 Appendix 4: Audit Plan Example
 Appendix 5: Nonconformity Report Example
 Appendix 6: Audit Report Example
 Appendix 7: Conformance Report Example
 Appendix 8: Common Rules for On-Site Audit
 Appendix 9: Opening Meeting Checklist
 Appendix 10: Closing Meeting Checklist
 Appendix 11: IRCA Code of Conduct
 Appendix 12: Audit Log Form
Appendix 1: References
This appendix contains reference material used during the training:
British Retail Consortium (2008)

BRC Global Standard for Food Safety Issue 5: BRC, London, UK.
Food Marketing Institute (2008)

SQF 2000 Code: A HACCP- Based Supplier Assurance Code for the Food Manufacturing and
th
Distributing Industries 6 Edition; FMI, Arlington, Virginia, USA.
Foundation for Food Safety Certification (2010)

FSSC 22000: Certification scheme for food safety systems in compliance with ISO 22000: 2005 and
BSI-PAS 220: 2008; FSSC, Gorinchem, Netherlands.
Global Food Safety Initiative (2007)

GFSI Guidance Document Fifth Edition; CIES-GFSI; Paris, France.
GLOBALG.A.P. (2007)
Control Points and Compliance Criteria Integrated Farm Assurance: Fruit and Vegetables V3.0-2;
GlobalGAP, Köln, Germany.
GS1 (2010)
General Specifications Version 10: GS1, Brussels, Belgium.
GS1 (2010)
Global Traceability Standard Issue 1.2.2: Business Process and System Requirements for Full Supply
Chain Traceability; GS1, Brussels, Belgium.
GS1 (2010)
GTC Control Points and Compliance Criteria Issue 2; GS1, Brussels, Belgium.
International Featured Standards (2007)

International Food Standard: Standard for Auditing Retailer and Wholesaler Branded Food Products
Version 5; IFS, Berlin, Germany.
International Organisation for Standarization (2004)

17021: Conformity assessment – Requirements for bodies providing audit and certification of
management systems; ISO, Geneva, Switzerland.

19011: Guidelines on quality and/or environmental management systems auditing; ISO, Geneva,
Switzerland.

22005: Traceability in the feed and food chain -- General principles and basic requirements for system
design and implementation; ISO, Geneva, Switzerland.

22000: Food safety management systems -- Requirements for any organization in the food chain; ISO,
Geneva, Switzerland.

9001: Quality management systems - Requirements; ISO, Geneva, Switzerland.
International Register of Certificated Auditors

IRCA/500: An Introduction and Overview; IRCA, London, UK.
International Register of Certificated Auditors

IRCA/602: Criteria for Certification as a Quality Management Systems (QMS2000) Auditor; IRCA,
London, UK.
Appendix 2: Additional Information

This chapter focuses on additional sources of information that the authors would like to share with you.
Mention of products here does not imply an endorsement of them by GS1 in any shape or form.
Books
The following books might be of interest to those wishing to depend their understanding. An online
version of this list is maintained at Amazon.
1. The ASQ Auditing Handbook by J. P. Russell (Author)
2. After the Quality Audit: Closing the Loop on the Audit Process by J. P. Russell
3. Fundamentals of Quality Auditing by B. Scott Parsowith
4. The Process Auditing Techniques Guide by J. P. Russell
5. Quality Audits for Improved Performance by Dennis R. Arter
6. Food Identity Preservation and Traceability: Safer Grains by Gregory S. Bennet
7. ISO 9000 In Our Company, Self-Study Course for Personnel by Jack Kanholm
(Author)
Magazines
 Food safety magazine
Software for Auditors

 http://www.muddyboots.com
Organisations providing auditor training

 IRCA – Internation Register of Certified Auditors
 American Society for Quality
 Moody International
 SGS
 Bureau Veritas
 DNV
 TÜVRheinland
Appendix 3: IAF Members

Accreditation Body Members
A2LA: American Association for Laboratory Accreditation
ACCREDIA: Italian Accreditation Body
ANAB: American National Standards Institute - American Society for Quality National Accreditation
Board LLC
ANSI: American National Standards Institute
BoA: Bureau of Accreditation (Vietnam)
BELAC: Belgian Accreditation Structure
BMWFJ: Federal Ministry for Economy, Family and Youth (Austria)
CAI: Czech Accreditation Institute, (Ceský Institut pro Akreditaci, o.p.s.)
CNAS: China National Accreditation Service for Conformity Assessment
COFRAC: Comite Francais d'Accreditation (France)
DA: Directorate of Accreditation (Albania)
DAC: Dubai Accreditation Center (United Arab Emirates)
DANAK: Danish Accreditation
DAkkS: German Accreditation
ECA: Costa Rican Accreditation Entity
EMA: Mexican Accreditation Entity, (Entidad Mexicana de Acreditacion)
ENAC: Entidad Nacional de Acreditacion (Spain)
EGAC: Egyptian Accreditation Council
ESYD: Hellenic Accreditation System S.A. (Greece)
FINAS: Finnish Accreditation Service
HKAS: Hong Kong Accreditation Service
IAS: Iran Accreditation System
INAB: Irish National Accreditation Board
INDECOPI: National Institute for the Defense of Competition and Protection of Intellectual Property
(Peru)
INMETRO: National Institute of Metrology, Standardization and Industrial Quality (Brazil)
INN: Instituto Nacional de Normalizacion (Chile)
IPAC: Portuguese Institute for Accreditation
JAB: Japan Accreditation Board for Conformity Assessment
JAS-ANZ: Joint Accreditation System of Australia and New Zealand
JASC: Japan Accreditation System for Product Certification Bodies of JIS Mark
JIPDEC: Japan Information Processing Development Corporation - Information Management Systems
Promotion Center (JIPDEC IMSPC)
KAB: Korea Accreditation Board
KAN: Accreditiation Body of Indonesia (Komite Akreditasi Nasional)
KAS: Korea Accreditation System

MAURITAS: Mauritias Accreditation Service
NA: Norwegian Accreditation
NABCB: National Accreditation Board for Certification Bodies (India)
NAC: National Accreditation Council of Thailand, The Office of
OAA: Organismo Argentino de Acreditacion (Argentina)
OLAS: Luxembourg Office of Accreditation
ONAC: Colombia National Accreditation Body
PAO: Philippine Accreditation Office
PCA: Polish Centre for Accreditation
PNAC: Pakistan National Accreditation Council
RENAR: Romanian Accreditation Association (Asociatia de Acreditare din Romania)
RvA: Dutch Accreditation Council (Raad Voor Accreditatie)
SA: Slovenska Akreditacija (Slovenia)
SAC: Singapore Accreditation Council
SANAS: South African National Accreditation System
SAS: State Secretariat for Economic Affairs (SECO), Swiss Accreditation Service
SCC: Standards Council of Canada
SNAS: Slovak National Accreditation Service (Slovakia)
Standards Malaysia: Department of Standards Malaysia
SWEDAC: Swedish Board for Accreditation and Conformity Assessment
TAF: Taiwan Accreditation Foundation (Chinese Taipei)
TUNAC: Tunisian Accreditation Council (Conseil National d'Accréditation, CNA)
TURKAK: Turkish Accreditation Agency
UKAS: United Kingdom Accreditation Service
Association Body Members

ALPI: Association of Independent Test Laboratories and Certification Bodies (Associazione Laboratori
di Prova e Organismi di Certificazione Indipendenti)
APEDA: Agricultural and Processed Food Products Export Development Authority
BDI: Bundesverband der Deutschen Industrie e.V. (Federation of German Industries)
CEA: Canadian Electricity Association
CIES: CIES - The Food Business Forum
DTA: Dental Trade Alliance
EFAC: European Federation of Associations of Certification Bodies
EOQ: European Organization for Quality
GLOBALGAP c/o FoodPLUS GmbH
IAAR: Independent Association of Accredited Registrars
IAQG: International Aerospace Quality Group
IFIA: International Federation of Inspection Agencies Limited

IIOC: Independent International Organisation for Certification
IPC: International Personnel Certification Association
IQNet: The International Certification Network IQNet Association
JACB: Japan Association of Management System Certification Bodies
PEFCS: Programme for the Endorsement of Forest Certification Schemes
Special Recognition Regional Groups

EA: European Cooperation for Accreditation
IAAC: Interamerican Accreditation Cooperation
PAC: Pacific Accreditation Cooperation
SADCA: Southern African Development Community in Accreditation
Appendix 4: Audit Plan Example
ORGANISATION INFORMATION
Name ACME Ltd.
Address Merrion Road, Dublin 4, Ireland

Group 1:
Group 2:
Janice Kite, GS1 GO
Group 3:
AUDIT INFORMATION
Checklist “GS1 GTC Control Points & Compliance Criteria” at the
audit location addressing logistic units (pallets) and trade items
(plastic crates or cartons with read meat primals) shipped from the
Supplier Distribution Center and to trade items (red meat) prepared
in the store
Scope All sections of the GTC Checklist will be applied to the company
processes beginning with the shipping of the logistic units and
trade items from the Supplier Distribution Center, controlled at
receiving area in Acme store, and through in-store processing on to
final sale to consumer.
th
Date May 25 , 2010
Reference documents (Audit GS1 GTC Control Points & Compliance Criteria, Issue 2, Apr10
Criteria)
AUDIT ACTIVITIES
Description The Audit will apply the Audit Criteria to the company with the
presence and involvement of the observers. The Audit Criteria
contains 105 control points divided into the following 12 different
sections:
13. Objectives definition of the Traceability System implemented

14. Trade and Traceable Items definitions
15. Supply chain placement of the Organization
16. Establishment of procedures for traceability
17. Flow of material and product identification
18. Internal and external information requirements for traceability
19. Documentation requirements and the instructions concerning
their implementation
20. Definition of structure and responsibilities for traceability inside
the Organization
21. Personnel training on traceability
22. Supply chain coordination among trade partners
23. Monitoring of the Traceability System
24. Internal and external audits
The auditors will be divided into three (3) groups. Each group will
be in charge of selected sections of the Audit Criteria.
The Lead Auditor will start the Audit using the first section of the
Audit Criteria. When completed the rest of the groups will continue
asking the questions in order, according to the Audit Plan.
The Company Contact should be able to answer the questions

according to the Audit Criteria

Opening Meeting 25.05.2010 8:30 to Audit Team Denis O'Neil
9:00 Leader
Denis O'Neil presents the ACME 25.05.2010 9:00 to Audit Team Denis O'Neil
Traceability Solution 10:00 Leader
Checklist application: First Part

Checklist Sections: 25.05.2010 10:00 to Slobodan Romac Denis O'Neil
1. Choice of Objectives 10:40 Robert Conrad
2. Product Definitions
3. Supply Chain Placement
4. Establishment of Procedures 25.05.2010 10:40 to Group 1 Denis O'Neil
5. Flow of Material 11:40 James Kant
- Control Points:
5.1 to 5.2
6. Information Requirements
- Control Points: 6.1, 6.3 to 6.6,
6.8
6. Information Requirements 25.05.2010 11:40 to Group 2 Denis O'Neil
- Control Points: 6.10, 6.11 to 12:20 James Kant
6.13 and 6.17 to 6.23
7. Documentation Requirement 25.05.2010 12:20 to Group 3 Denis O'Neil

8. Structure & Responsibilities 13:30 Robert Conrad
9. Training James Kant
10. Supply Chain Coordination
11. Monitoring
12. Internal and External Audits
Comments:
• Checklist application activities should be done in an office or room with capacity for all the
students.
• The room should be equipped with a projector
• It is necessary to count with persons with access to the company’s information systems such as
ERP WMS, Excel sheets and documental repositories.
• It is necessary to count with a quality and logistics responsible

Store Operations Visit: Second Part
1. Traceability exercises in Section 5: 26.05.2010 15:00 to All Groups Denis O’Neil
Flow of Material 17:00 Suzanne Coyle
– Control Points: 5.3 to 5.19 Robert McMahon
2. Traceability exercises in Section Robert Conrad
6: James Kant
Information Requirements
– Control Points: 6.2, 6.7, 6.9,
6.14, 6.15 and 6.16
Comments:
• Exercises should be done at the facility in order to visit to the on site processes (receiving,
transforming, warehousing and dispatch).
• The questions will be focused on the receiving, warehousing and dispatch processes
• It is necessary to ensure people who know these processes in detail will be present in order to
resolve any questions.
• It may be necessary to take pictures during the visit which are going to be used as audit evidence
Short Closing Meeting 26.05.2010 17:00 to Audit Team Denis O’Neil

17:10 Leader Suzanne Coyle
Robert McMahon
Comments:
• It is necessary to be clear that the whole Audit process will be strictly confidential
• We hope the company allows us to use this activity for promotional reasons, promoting the activity
but not publishing the results.
Appendix 5: Nonconformity Report Example

NONCONFORMITY INFORMATION
CP N° NONCONFORMITY DESCRIPTION DATE
4.4 It doesn’t exist a documented procedure in the Company which 25/05/2010
describes in detail the Master Data alignment procedure with the
trading partners. AUDIT CRITERIA
GS1 GTC Control Points &
Compliance Criteria, Issue 2,
Apr10
Auditor Name & Slobodan Romac, Responsible Name Peter Folk,

Signature GS1 Croatia & Signature ACME
CORRECTIVE ACTION INFORMATION

Origin investigation The Company never documented the procedure they have at an operative
(Cause of the level. It is not included in any of the Companies Quality Procedures.
Nonconformity)
Corrective Action to It was developed a formal procedure to align Master Data, including
implement products, parties and locations, with trading partners fully based on the
procedure template given by GS1. This procedure was included in the
Quality Procedure PP-101-08 as a regular directive that every trading
partner should implement in order to start doing business with the Company.
Implementation Peter Folk, Implementation 01/07/2010

responsible name & ACME date
signature
CORRECTIVE ACTION INSPECTION

ACCEPTED Only if the answer is NO, write the new NONCONFORMITY
YES NO

OBSERVATONS The Company initiated a program with their trading partners to fully
implement the new procedure. To date 50% of the trading partners have
their Master Data aligned with the Company’s Master Data.
Auditor Name & Slobodan Romac, Inspection Date 08/08/2010

Signature GS1 Croatia
Appendix 6: Audit Report Example
Name ACME Ltd.
Address Deans Grange, Dublin


Group 1:
Group 2:
Janice Kite, GS1 GO
Group 3:
AUDIT INFORMATION
Objective Evaluation of the Fulfillment level for the Control Points of the Checklist “GS1
GTC Control Points & Compliance Criteria” at the audit location addressing
logistic units (pallets) and trade items (plastic crates or cartons with read
meat primals) shipped from the Supplier Distribution Center and to trade
items (red meat) prepared in the store.
Scope All sections of the GTC Checklist will be applied to the company processes
beginning with the shipping of the logistic units and trade items from the
Supplier Distribution Center, controlled at receiving area in Acme store, and
through in-store processing on to final sale to consumer.
Control Points The 105 Control Points of the Checklist were audited.
Audited

th
Audit Date May 25 , 2010
Reference GS1 GTC Control Points & Compliance Criteria, Issue 1, Apr10
documents (Audit
Criteria)
AUDIT INFORMATION (Continued)

Number of Mandatory :2
Nonconformities Mandatory (Conditional) :3
Optional :3
Recommended :8
Summary Table
Obligations Total N/A Max. Obtained % Approved
Mandatory 28 28 26 93 No
Mandatory (Cond) 30 11 19 16 84 No
Optional 10 1 9 3 22 Yes
Recommended 37 8 29 21 72 Yes
Total 105 20 85 66 NO
Nomenclature:
 Total: Total Number of Control Points
 N/A: Number of Non Applicable Control Points detected
 Approved: Compliance Criteria Conformance
Compliance Level:
 Mandatory Musts:
 Mandatory Conditional Musts:
compulsory.
 Optional
 Recommendations:
Nonconformities
against the Standard Mandatory Mandatory Optional Recom.
standards
(Conditional)
GS1 GTS 2 1 3 1
ISO 22005 0 2 0
HACCP 0 1 0
IFS 0 1 0
BRC 0 1 0
SQF 0 1 0
ISO 9001 0 0 0
GlobalGAP 0 0 0

Traceability ACME traceability is supported by a software based IT solution to
Implementation Degree manage traceability for the sale of red meat products. This solution is
fully operational and staff demonstrated their skill at using the system.
It was proved that all trade items received are identified on the
packaging and batch/lot numbers are also present. GS1 standard
identifiers; GTIN-13 and batch no. Identification and traceability data are
captured using the GS1 Standards for ID and bar codes.
It was also evident that all logistic units (plastic or coated-cardboard
boxes) are identified with an internal identification (6 numbers). All
“Primals”, contained in the logistic unit, are also identified. There was no
evidence of any products missing labels.
It was confirmed that all trade items on sale to customers are identified
with GS1 standard identifiers; GTIN and batch Number. Consumer
products, both prepack and serve-over are identified with a trace
number, thereby facilitating a trace should there be an issue with a
product. It was also possible to identify using the “Food Trace”
application if there was any product, received from a particular farm
where an incident had occurred. However, it was not possible to trace
to the actual consumer.
Documented procedures exist; these are controlled, independently
audited and reapproved twice per year. These are mainly contained
within the HACCP manuals. However, these procedures do not fully
address the requirements of the GTS.
GS1 Standards are used, but are not fully deployed to all possible
control points as defined by the GTS. This creates an information gap in
the data that should be retained by the company to execute full
traceability solution in compliance with the GTS.
Traceability information is displayed to customers at the “red meat
serve over” counter – “The Whiteboard”.
In summary, the general understanding and application of broad
traceability standards and country regulations is good at ACME.
Regarding GS1 GTS, there are three (3) major Nonconformities that
should be addressed:
 (CP 4.4) ACME should have a documented procedure to align

master data with their suppliers
 (CP 6.12) ACME should relate by documentation each batch and lot
of trade items received (Primals) with the logistic units involved. As
presently structured, batch and lot numbers are not recorded at
goods inwards and logistical units are not identified. It is
recommended that this be reviewed for future development
 (CP 6.18) ACME should have a registry that documents whether a

batch and lot of a primal is still in the warehouse or was processed
and sent to butchery or counter for sale. ACME does not have an
in-store stock control system and therefore, they are not able to
record whether a batch/lot of a trade item is still in the warehouse.
Regarding ISO 22005, the organization must solve two (2) Control
Points.

Traceability  (CP 4.7) A documented procedure which describes in detail the
Implementation Degree definition for the production batch and lot numbers for each trade
(Continued) item.

applicable, transformation dates and sell by dates if applicable. Also
is recommended to relate this document with a traceability flow
diagram of the information linking the processes within the company
which may be used to perform traceability requests
Regarding HACCP, BRC, IFS and SQF, the organization must solve
one (1) Control Point

applicable, transformation dates and sell by dates if applicable. Also
is recommended to relate this document with a traceability flow
diagram of the information linking the processes within the company
which may be used to perform traceability requests.
All the Control Points regarding ISO 9001 and GlobalGAP were fulfilled
satisfactorily.
ACME does not pass the audit because does not fulfill the 100% of the
required Major Control Points. It only fulfills 93% of Mandatory and 84%
of Mandatory (Conditional). This means that two (2) Mandatory Control
Points and three (3) Mandatory (Conditional) Control Points are due to
solve to approve the audit.
Report distribution Juan Pablo Vial, GS1 GO; John Ryu, GS1 GO; Stefan Gathmann, GS1
Ireland; Stephane Pique, GS1 in Europe; Brendan Kernan, GS1 Ireland;
Gary Garnier-Guisgand, GS1 GO; Michal Bily, GS1 Czech Republic;
Janice Kite, GS1 GO; Slobodan Romac, GS1 Croatia.
Audit Team Leader Juan Pablo Vial, GTC Project Date 15.05.2010
signature Manager GS1 GO
Appendix 7: Conformance Report Example
Conformance Report
provided to
ACME
Deans Grange, Dublin 4, Ireland
This Audit Report presents the summary of results of the Audit performed by [Auditing Organisation] according to
the GS1 GTC Programme.
Further clarifications regarding the scope of this Report and the applicability of
GS1 GTC requirements may be obtained by consulting the organization
Audited Under
GS1 GTC Control Points & Compliance Criteria,
Issue 1, Apr 2010
Scope of Supply
The Audit was applied to the company processes beginning with the shipping of the logistic
units and trade items from the Supplier Distribution Center, controlled at receiving area in
Acme store, and through in-store processing on to final sale to consumer.
Summary of Results
Obligations Total N/A Max. Obtained % Compliance Approved
Mandatory 28 28 26 93 100% No
Mandatory (Cond) 30 11 19 16 84 100% No
Optional 10 1 9 3 22 0% Yes
Recommended 37 8 29 21 72 0% Yes
Total 105 20 85 66 NO
 Total: Total Number of Control Points
Nomenclature:  N/A: Number of Non Applicable Control Points detected
 Approved: Conformance to Compliance Criteria (Yes / No)
 Compliance: Compliance Criteria to approve
Report No.: 539888850798400012

Juan Pablo Vial, Auditor
Auditor No: 70330725
Audit Date: 05, 25, 2010 GS1 Chile
Issue Date: 06, 01, 2010
GS1 Ireland
The Nutley Building,
Jim Bracken, CEO
Merrion Road 2, Dublin 2, Ireland GS1 Ireland
The global language of business
Appendix 8: Common Rules for On-Site Audit
When visiting the facilities, the visitor must abide by the following Rules and Prohibitions so as not to
cause any delays and/or inconveniences on both the audit team and the company. Visitors are
encouraged to do their best to ensure their visit will be according to the Audit Planx|.
Do’s
1. Visitors are allowed to enter the plant only if they are healthy. In case of illness (cold, digestion
problems, or skin diseases) the Lead Auditor and/or the guide must be immediately informed.
2. Always follow the guide and not separate from the group
3. Listen carefully and follow the instructions given by the guide
4. Only auditors are allowed to ask questions to the guide
5. Visitors should observe silence at all times in order to not disrupt the work in the plant. Do not
enter into conversations between visitors.
6. Visitors should enter the plant with the material specified by the Lead Auditor
7. While walking through the production plant visitors must:
a. Be appropriately dressed when entering production zones. This is:
 Wear a coat
 Wear a cap
 Wear a mask if solicited
 Do not wear bracelets, watches, rings, pendants, scarfs, etc.
b. Wear jewelry under the protective clothes
c. Wash hands with antibacterial soap if solicited before entering production zones
d. Use personal protection devices when solicited
e. Be at least 0,5 m away from production lines and machines
f. Be aware of slippery floors due to production processing of water or fat
g. Keep away from transportation paths
h. Be aware of circulating pallet lifters
Dont’s
1. Do not leave the group during the visit
2. Do not enter with or eat food inside the production plant
3. Smoking is prohibited
4. Do not run
5. Avoid touching machines, materials or equipment
6. Avoid taking products
7. Do not take pictures without authorization
8. Do not use mobile phones and in some cases they need to be switched off when entering
certain facilities
The whole On-Site Audit process will remain strictly confidential.

The visitor accepts the Rules and Prohibitions and confirms that he/she has read and understood
them, as well as accepts responsibility for the application of the above mentioned rules.
Appendix 9: Opening Meeting Checklist
An opening meeting can be different according to the type of audit performed. The meeting should be
chaired by the audit team leader, and the following items should be considered, as appropriate:
 Introduction of the Audit Leader and Audit Team including an outline of their roles
 Introduction of other participants in the meeting, including an outline of their roles
 Distribution of the attendance list
 Confirmation of the audit objectives, scope and criteria
 Confirmation of the audit timetable and other relevant arrangements with the auditee, such as:
 the date and time for the closing meeting,
 any interim meetings between the audit team and the auditee's management,
 and any late changes
 Communicate methods and procedures to be used to conduct the audit, including:

 Nonconformity declaration
 Sampling techniques
 element of uncertainty in auditing
 Establish formal communication channels between the audit team and the auditee
 Confirmation that, during the audit, the auditee will be kept informed of audit progress;
 Confirmation that the resources and facilities needed by the audit team are available;
 Confirmation of matters relating to confidentiality
 Confirmation of relevant work safety, emergency and security procedures for the audit team
 Availability, roles and identities of any guides
 Method of reporting, including any grading of nonconformities
 Information about conditions under which the audit may be terminated
 Information about any appeals system on the conduct or conclusions of the audit
 Any questions?
Appendix 10: Closing Meeting Checklist
The closing meeting should also be chaired by the audit team leader, and the following items should
be considered, as appropriate:
 Distribution of the attendance list
 Present audit objectives, scope and criteria used including modifications and exclusions
 A summary of the good things observed over the activity
 Explain the Nonconformities found
 Inform observations declared
 Explain the Nonconformities Report
 Explain the Audit Report
 Obtain the signature of the Assessment Checklist and Reports
 Commit a date to present the Audit Report
 Obtain the attendance list
 Thanks to the client
 Congratulate if appropriate
Appendix 11: IRCA Code of Conduct
It is a condition of certification that you agree to act in accordance with, and be bound by the following
Code of Conduct:
1. To act in a strictly trustworthy and unbiased manner in relation to both the organization to which
you are employed, contracted or otherwise formally engaged (the audit organization) and any
other organization involved in an audit performed by you or by personnel under your direct control.
2. To disclose to your employer any relationships you may have with the organization to be audited
before undertaking any audit function in respect of that organization.
3. Not to accept any inducement, gift, commission, discount or any other profit from the organizations
audited, from their representatives, or from any other interested person nor knowingly allow
personnel for whom you are responsible to do so.
4. Not to disclose the findings, or any part of them, of the audit team for which you are responsible or
of which you are part, or any other information gained in the course of the audit to any third party,
unless authorised in writing by both the auditee and the audit organization to do so.
5. Not to act in any way prejudicial to the reputation or interest of the audit organization.
6. Not to act in any way prejudicial to the reputation, interests or credibility of IRCA.
7. In the event of any alleged breach of this code, to co-operate fully in any formal enquiry
procedure.
Appendix 12: Audit Log Form

This Audit Log Form should be used by the candidates interested in being accredited as a GS1
GTC Auditor.
The Audit Log Form can be used in 2 ways that are:
 To report about an assessment you have performed in a company
 To report the number of hours of assessment in companies you have performed under
the guidance of a GTC auditor
This Audit Log should be returned to the GS1 faculty of GTC auditors at GTCAuditors@gs1.org
Auditor (candidate) Name
Telephone/fax number
E-Mail
Date
Instructions:
Please, complete the following table using Capitol Letters. If you need guidance, please see at the end
of the Form.
Note: THIS FORM IS CONFIDENTIAL WHEN COMPLETE
1. Audit initial date (DD/MM/YYYY)
2. Duration of audit On-site time
3. Contact details of Organisation name

the Organisation
audited (auditee)
Sector
Complete address
Organisation Website
Size of organisation
(i.e. number of people
employed)
Auditee contact name
Signature of the
Auditee contact
Contact position
within the
organization
Contact telephone/fax
number
E-mail address
4. Role in audit
Auditor □ Lead Auditor □ Sole Auditor □
5. Number of people in the Audit Team
6. Audit Criteria
7. Contact details of Company name

the Company that
employed you Complete address
Contact name
Signature
Position within the

organization
Contact telephone/fax
number
E-mail address
8. Contact details of Name

the directing &
guiding Lead Signature
Auditor
GTC Auditor number
Contact
Telephone/fax
number
E-mail address
Auditor (candidate) Date

signature
Guidelines to complete the Form:

Item Field Instruction
1. Date Day, month and year of the first day of the on-site audit. This is
when the opening meeting starts.
2. Duration of audit Total time of the audit in days measured in hours.
On-site time:
Time spent on actual auditing activities, including the opening
and the closing meeting. The Off-site time is not relevant for this
Form.
3. Contact details of the This section must be completed in full in order GS1 can perform
Organisation audited evaluation and verification. Please provide all the information
(auditee) requested.
4. Role in audit Please indicate Auditor or Lead Auditor as appropriate.
Only enter Lead Auditor if you led a team consisting of yourself
and at least one other auditor. Please enter Sole Auditor if you
carried out an audit where you were the only auditor and
performed all phases of the audit.
5. Number of people in Number of active participating auditors (including you) on the
the Team audit team. Observers should be also included
6. Audit criteria Indicate the Audit Criteria and the version used.
7. Contact details of the Inform the company that employed you for the audit. This
company that section must be completed in full in order GS1 can perform
employed you evaluation and verification.
8. Contact details of the The contact details and status of the team leader under whose
directing & guiding direction and guidance you completed the audit.
Lead Auditor This Lead Auditor must be a GTC Accredited Auditor. This
section must be completed in full. If any of this information is not
available we may ask you to supply us with more evidence.
Note: Not accepted Audit Logs

We will not accept:
 Audits of the same traceability system that are repeated more frequently than once
every 12 months
 Audits of duration less than one day (6 hours of on-site audit activity exclusive of
breaks) duration.
 Audits performed before successful completion of the formal training requirement
(GTS + GTC training courses).

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GS1 GTC Training

Student Manual - V 2.1

GS1 GTC aims at

GS1 GTC Training

Document Change History

Author Date Review Actions

Mark Van Eeghem 13/11/2008 V2 Creation

Juan Pablo Vial 02/06/2010 Version 2 New Version

Juan Pablo Vial 24/08/2010 Version 2.1 Modifications based on

Glenda Connoll GS1 South Africa

Nicholas Fergusson GS1 Global Office

Peter Zaepfel Kraft

Useful information often summarized. Hints and tips.

Copyright Notice and Terms of Use

12. The Principles of Auditing ............................................................................. 43

20.3.3. Audit Information ............................................................................................85

Appendix 10: Closing Meeting Checklist............................................................ 146

Module 1: Introduction to the GTC Training

 Training Manual Structure

 Information about the training

Accreditation as GTC Auditors:

Participants who satisfactorily pass the training will be ready to

1.1. Training Objectives and Goals

 Teach how a professional auditor structures, plans, and executes an effective

At the end of this course participants will be able to:

1. Understand the principles of auditing

Participants will need to demonstrate an acceptable understanding of all these areas to

1.2. Prior Knowledge Required

 GS1 GTC Operations Manual

1.3. Target Audience

3. Training Manual Structure

The Training Manual is comprised of 5 modules:

4. Information about the training

4.2. Evaluation Method

 A continuous evaluation of their participation during the training

 The scores achieved in every evaluation during the training

 The scores obtained in the final evaluation.

To successfully pass, the training participants need to have at least

 60% in the final evaluation

 70% in the final score

4.3. Continuous Evaluation

4.4. Final Evaluation

4.5. Diplomas and Certificates

09:00 Welcome, Introduction, Training Outline

09:30 WORKSHOP 1: Warm Up!

10:00 THE GS1 GTC PROGRAMME

11:15 Coffee Break

11:30 AUDITING UNDER ISO 19011

13:00 – 14:00 Lunch

14:00 WORKSHOP 2: Audit Principles

15:00 THE GS1 GTC AUDIT CRITERIA

16:00 Coffee Break

16:15 WORKSHOP 3: Knowing the GS1 GTC Checklist

17:15 WORKSHOP 4: Find the Control Point

18:30 End of day 1

09:30 THE GS1 GTC AUDIT ACTIVITIES (part 1)

11:15 Coffee Break