Gs1 Gtc Training Manual v21 Print Version

8/2/2019 Gs1 Gtc Training Manual v21 Print Version

1/151

GS1 GTC TrainingStudent Manual - V 2.1


2/151

Traceability GS1 GTC Student Manual

August 2010, Version 2.1 All contents copyright GS1 2010 Page 2 of 151


3/151



GS1 GTC aims at

helping companies

implementing

traceability according

to best practices and

GS1 global standards


4/151



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 onGA outcomes

Acknowledgements

The faculty which launched this training initiative consisted of:

Glenda Connoll GS1 South AfricaJanice Kite GS1 Global OfficeSabine Klaeser GS1 GermanyAna-Paula Maniero GS1 Brazil

Slobodan Romac GS1 CroatiaMike Sadiwnyk GS1 CanadaJuan-Pablo Vial GS1 Global Office

(Course Director)

The GTC Core Group:

Nicholas Fergusson GS1 Global OfficeJean-Marc DHooghe GS1 Global OfficeNora Kaci GS1 Global OfficeMelanie Kudela GS1 Global OfficeDiane Taillard GS1 Global OfficeJuan-Pablo Vial GS1 Global Office

(Project Manager)Special thanks to:

Peter Zaepfel KraftCristian Barcan BASF


5/151



Document ConventionsThroughout this document, you will find textboxes using icons. The explanation of the icons is below.

Useful information often summarized. Hints and tips.

Important information

Do not do this

Disclaimer

Whilst every effort has been made to ensure that the guidelines to use the GS1 standards contained inthis document are correct, GS1 and any other party involved in the creation of this document HEREBYSTATE that this document is provided without warranty, either expressed or implied, of accuracy orfitness for purpose, AND HEREBY DISCLAIM any liability, direct or indirect, for damages or lossrelating to the use of this document. This document may be modified, subject to developments intechnology, changes to the standards, or new legal requirements. Several products and Organisationnames mentioned herein may be trademarks and/or registered trademarks of their respectivecompanies.

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 thisdocument in its entirety and do not alter or modify it in any way, you acknowledge GS1 as thecopyright owner and include the below copyright notice in any copy that you make. It is highlyrecommended that you attend GS1 GTC training for a better understanding of this document.

GS1 GTC Training Manual. Copyright GS1, 2010. All Rights reserved.


6/151



Table of Contents1. Introduction ...................................................................................................... 11

1.1. Training Objectives and Goals ............................................................................111.2. Prior Knowledge Required ...................................................................................121.3. Target Audience ....................................................................................................12

2. Training Regulation ......................................................................................... 133. Training Manual Structure ............................................................................... 144. Information about the training ........................................................................ 15

4.1. Instructions to the participants............................................................................154.2. Evaluation Method ................................................................................................154.3. Continuous Evaluation .........................................................................................154.4. Final Evaluation ....................................................................................................154.5. Diplomas and Certificates ....................................................................................164.6. To Remember ........................................................................................................16

5. Training Agenda ............................................................................................... 176. What is the GS1 Global Traceability (GS1 GTC) Programme? ..................... 21

6.1. GTC Program Vision, Mission and Objectives ....................................................226.1.1. Vision ...............................................................................................................226.1.2. Mission ............................................................................................................226.1.3. Objectives ........................................................................................................22

6.2. Who can use the GS1 GTC Programme? ............................................................226.3. Major benefits of the GS1 GTC Programme ........................................................23

7. How does the GS1 GTC Programme work? ................................................... 247.1. GS1 GTC Programme roles ..................................................................................247.1.1. Auditor: ............................................................................................................247.1.2. GTC Trainer: ....................................................................................................247.1.3. GTC Auditing Organisation: .............................................................................247.1.4. Certification Body: ............................................................................................257.1.5. Accreditation Body: ..........................................................................................25

7.2. GS1 GTC Implementation Path ............................................................................277.2.1. GS1 GTC Assessments and GS1 GTC Auditors in practice .............................297.2.2. How can a company obtain a GS1 GTC Global Seal or Certificate? ................297.2.3. The role of GS1 Member Organisations (GS1 MOs) ........................................30

7.3. The GS1 GTC Programme Material ......................................................................317.3.1. What documentation, in what languages is currently available? .......................327.4. How is the GS1 GTC Programme maintained? ...................................................33

8. Requirements for becoming a GS1 accredited GTC Auditor ....................... 348.1. Reasons for obtaining GS1 GTC Auditor accreditation .....................................348.2. How to become an accredited GS1 GTC Auditor ...............................................34

8.2.1. Step 1 ..............................................................................................................358.2.2. Step 2 ..............................................................................................................358.2.3. Step 3 ..............................................................................................................36

9. How to get involved? ....................................................................................... 3810. Introduction .................................................................................................... 4011. Terms and Definitions related to ISO 19011 ................................................ 41


7/151



12. The Principles of Auditing ............................................................................. 4313. Managing an Audit Programme .................................................................... 4514. Audit Activities ............................................................................................... 48

14.1.

Initiating the Audit ..............................................................................................48

14.2. Conduct Document Review ................................................................................4914.3. Preparing the On-Site Audit Activities ..............................................................4914.4. Conducting On-Site Audit Activities..................................................................5014.5. Preparing, approving & distributing the Audit Report .....................................5014.6. Completing the Audit ..........................................................................................5114.7. Conducting Audit follow up ...............................................................................51

15. Competence and Evaluation of Auditors ..................................................... 5215.1. Personal Attributes .............................................................................................5215.2. Knowledge and skills .........................................................................................5315.3. Useful tips to remember .....................................................................................53

16. Certification and Registry of Organisations and Auditors ......................... 5616.1. Certification Process for Organisations ............................................................5616.1.1. Initial audit and certification ............................................................................56

16.2. Certification for Auditors....................................................................................5816.2.1. International Registers ...................................................................................5816.2.2. Schema for Auditor Certification .....................................................................58

17. The GS1 GTC Checklist ................................................................................. 6017.1. How was it developed? ......................................................................................6017.2. Structure ..............................................................................................................6117.3. Regulations References .....................................................................................6217.4. Standard References ..........................................................................................6217.5. Compliance Levels .............................................................................................6317.6. Control Points Usage Guide ..............................................................................6517.7. GTC and its compliance with the GS1 Global Traceability Standard ..............6817.8. Relationship with other Traceability & Best Manufacture Practices (BMP)Standards ........................................................................................................................69

18. Introduction .................................................................................................... 7219. The Initial Meeting .......................................................................................... 73

19.1. The Audit Team ...................................................................................................7419.1.1. Appointing the Audit Team .............................................................................7419.1.2. Audit Team Functions and Responsibilities ....................................................7419.1.3. Good Practices in Meetings ...........................................................................75

19.2. Establishing initial contact with the auditee .....................................................7619.3. Defining Audit Objectives and Scope................................................................76

19.3.1. Objective Definition ........................................................................................7619.3.2. Scope Definition .............................................................................................77

19.4. Determining the feasibility of the audit .............................................................7819.5. Selecting the audit team .....................................................................................7919.6. Conducting document review ............................................................................80

20. The Audit Program ......................................................................................... 8120.1. Assigning work to the audit team ......................................................................8220.2. Preparing work documents ................................................................................8220.3. Completing the Audit Plan Form .......................................................................84

20.3.1. Company Information Section ........................................................................8420.3.2. Audit Team Information ..................................................................................85


8/151



20.3.3. Audit Information ............................................................................................8520.3.4. Audit Activities ................................................................................................8720.3.5. Audit Program ................................................................................................88

21. On-Site audit ................................................................................................... 9121.1. The Opening Meeting .........................................................................................9121.1.1. Communication during the Audit ....................................................................92

21.1.2. Roles and responsibilities of guides and observers ........................................9321.1.3. Control of the Audit ........................................................................................93

21.2. Collecting and verifying information .................................................................9521.2.1. Observation of activities .................................................................................9621.2.2. Review of documents .....................................................................................9621.2.3. Interviews .......................................................................................................97

21.3. Generating Audit findings ..................................................................................9921.3.1. How to write Nonconformities (NC)? ............................................................ 10021.3.2. When declaring an Observation? ................................................................. 102

21.4. Filling the GS1 GTC Assessment Checklist .................................................... 10321.4.1. Terms in the GS1 GTC Assessment Checklist ............................................. 10321.4.2. When checking the Fulfills field .................................................................... 10421.4.3. Defining a Not Applicable ............................................................................. 10521.4.4. Writing an Observation ................................................................................. 10621.4.5. Writing a Nonconformity? ............................................................................. 10621.4.6. Checking the Control Points ......................................................................... 108

21.5. Preparing Audit Conclusions ........................................................................... 10921.6. Conducting the Closing Meeting ..................................................................... 110

22. Preparing, approving & distributing the Audit Report .............................. 11122.1. The Nonconformities Report ............................................................................ 111

22.1.1. Nonconformity Information Section .............................................................. 11122.1.2. Corrective Action Information Section .......................................................... 11222.1.3. Corrective Action Inspection Section ............................................................ 114

22.2. The Audit Report ............................................................................................... 11522.2.1. Company Information Section ...................................................................... 11522.2.2. Audit Team Information ................................................................................ 11622.2.3. Audit Information .......................................................................................... 11722.2.4. Summary Table Section ............................................................................... 11822.2.5. Nonconformities against the standards Section ............................................ 11922.2.6. Traceability Implementation Degree Section ................................................ 12022.2.7. Report Distribution Section ........................................................................... 122

22.3. The Conformance Report ................................................................................. 12322.4. Completing the Audit: Presenting the Assessment Report ........................... 125

Appendix 1: References ....................................................................................... 127Appendix 2: Additional Information .................................................................... 129Appendix 3: IAF Members.................................................................................... 131Appendix 4: Audit Plan Example ......................................................................... 134Appendix 5: Nonconformity Report Example .................................................... 138Appendix 6: Audit Report Example ..................................................................... 139Appendix 7: Conformance Report Example ....................................................... 143Appendix 8: Common Rules for On-Site Audit .................................................. 144Appendix 9: Opening Meeting Checklist ............................................................ 145


9/151



Appendix 10: Closing Meeting Checklist ............................................................ 146Appendix 11: IRCA Code of Conduct.................................................................. 147Appendix 12: Audit Log Form ............................................................................. 148


10/151



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


11/151



1. IntroductionYou 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 requiredknowledge and skills needed to be applied and as a result, becoming a valuable contributorto your organisation.

The GS1 GTC Training was developed after the Pilot Phase of the GS1 GTC Programme soit includes all the experiences, observations, comments and contribution gained from thoseexperiences.

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 withthe aim of improving their traceability.

Give an essential perspective to GS1 professionals responsible for the planning andimplementation of traceability assessments under the GS1 GTC Programme.

Teach how a professional auditor structures, plans, and executes an effectivetraceability 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 demonstratingskills to

Effectively plan and prepare

Achieve objective evidence, through interviews, observation, sampling and notestaking.

Analyze and interpret the information to determine conformity with requirements

4. Effectively assess organizations preparedness against major traceability regulations andcommercial traceability requirements

5. Contribute to implementing the GS1 Global Traceability Standard

6. Contribute to the development and improvement of an organizations traceability system

Accreditation as GTC Auditors:

Participants who satisfactorily pass the training will be ready toapply for the GTC Auditor accreditation.

Rules for GTC Auditor accreditation are given in Module 2:Module1: The GS1 GTC Programme


12/151


13/151



2. Training RegulationParticipants 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 andskills 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 totranslate, copy and reproduce the GS1 GTC Training Manual provided you use thisdocument in its entirety and do not alter or modify it in any way, you acknowledge GS1 asthe 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 evaluatethe training when completed.

Student Regulation

1. The participant must establish whether he/she fulfills the pre-requirements establishedby GS1 Global Office Training & Education, in every course, which is needed to achievethe activity objectives.

2. The participant will successfully pass the training if his/her attendance is 100% andhis/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 trainingagain. 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 90days of completing the activity.

5. It is mandatory that participants keep an ethic behavior at all times and avoidmisbehaviors such as copying in the final evaluation, dont give back the final evaluationto the trainer or any other considered by the trainer as a transgression to thetransparency and normal performance of the training.

6. If the participant has an observation related to the training activity, he/she shouldcommunicate that observation to:

The trainer

The training satisfaction evaluation

The GS1 Global Office Training & Education contact


14/151



3. Training Manual Structure

The Training Manual is comprised of 5 modules:

MODULE 1: Introduction to the GTC training. This Module introduces the participant tothe 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 TraceabilityProgramme Operations Manual. Presents how the GS1 GTC Programmeworks and how organisations can be involved and start offering the service.

MODULE 3: Auditing under ISO 19011. Presents an overview of the ISO 19011standard. Contents include Terms and Definitions related to ISO 19011, Theprinciples of auditing, managing an audit program, the audit activities andcompetence and evaluation of Auditors.

MODULE 4: The GS1 GTC audit criteria and materials. Presents the GS1 GTCChecklist, how it was developed, the structure of the document, regulationsand standard references, compliance levels, Control Points usage guide. Alsoshows the GS1 GTC Audit materials

MODULE 5: The GS1 GTC audit activities: Presents how mapping GTC to businessprocesses of an organisation. Establish how to perform the Audit activitiesand fill the Audit forms using the GS1 GTC materials.


15/151



4. Information about the training

4.1. Instructions to the participantsAt the beginning of the training all the participants will be asked to introduce themselves. Theintroduction should include information about their job function within the organisation theyare working, their knowledge about Traceability, GS1 GTS and Quality Standards and whatthey 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 activitiesand exercises. Participants must show an acceptable performance in all the learningactivities to successfully end the training.

The fulfillment of the training schedule by the participants will be evaluated positively. A poorfulfillment will lead to a failure in completing the training objectives. There will be noexceptions 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 reflectedin 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 onlyhave access to their Training Manual and to the GS1 GTC Checklist.


16/151



4.5. Diplomas and Certificates

Participants who pass the training successfully, will receive a diploma to that effect. Thisdiploma will allow the participants to apply for the GTC Auditor accreditation.

Participants who dont pass the training will receive an attendance certificate.

Diplomas and attendance certificates will be delivered to participants by mail within 90 daysafter finishing the activity.

4.6. To Remember

The use of mobile phones, pagers and notebooks are not allowed during the training unlessexpress authorization from the trainer.


17/151



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 ProgrammeAudit 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 Checklist16:45 WORKSHOP 3: Feedback

17:15 WORKSHOP 4: Find the Control Point17:45 WORKSHOP 4: Feedback

18:30 End of day 1


18/151



DAY 2

09:00 Summary

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

The Initial Meeting

The Audit TeamEstablishing initial contact with the auditeeDefining Audit Objectives and ScopeDetermining the feasibility of the auditSelecting the audit teamConducting document reviewThe Audit Program

Assigning work to the audit team

Preparing work documentsFilling 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 MeetingCollecting and verifying informationGenerating Audit findingsFilling the GS1 GTC Assessment ChecklistPreparing Audit ConclusionsConducting the Closing Meeting

16:00 Coffee Break

16:15 WORKSHOP 6: Writing Observations & Nonconformities16:35 WORKSHOP 6: Feedback

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


19/151



DAY 3

09:00 Summary


Preparing, Approving & Distributing the Audit Report

The Nonconformities ReportThe Audit ReportThe Conformance ReportCompleting 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.


20/151



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?


21/151



6. What is the GS1 Global Traceability (GS1 GTC)

Programme?The GS1 Global Traceability Programme (GS1 GTC Programme) supports theimplementation 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 customersrequirements, regulations, best practices and global standards.

The Initial focus is to provide the food industry with a common and understandable toolsetenabling the testing and implementation of a standardized traceability language using theGS1 Global Traceability Standard. Sharing traceability information between trading partnersacross the extended supply chain will be simpler, more accurate and with improvedefficiency.

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 mostcountries.

GTS and GTC are based on user requirements.

GTC complements other food programs (e.g. GlobalGAP) sinceGTC addresses the inter-company information exchange

The Global Traceability Standard (GTS) forms a basis forcompanies to improve their efficiencies and quality controls

The GS1 GTC Programme complements GTS with a concreteservice for implementation and enables companies todemonstrate correct implementation of the standard.

Some countries mainly in Latin America - are alreadyimplementing local GTC programs.


22/151



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 logisticsproviders, 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 optimalway to implement full supply chain traceability and with meeting both regulatory andbusiness requirements.

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 solveany gaps

Provide organisations with a standardised procedure to implement and test the GS1GTS 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, regulatorsand industry

Play an active role with local and global food associations and regulators to increaseGS1 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/packagingmanufacturers 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 GTCProgramme.

The GTC programs primary goal is to support implementation ofFull Supply Chain Traceability based on GS1 standards andservices.


23/151



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 bestpractices worldwide

2. Ensure the right implementation of full supply chain traceability

3. Ensure continuous conformance to the GS1 System and consistency with best practicesrelated 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 independentparty

Address the main international traceability regulations, standards andcommercial requirements.

Enable any organization to establish its actual traceability level and to bebenchmarked against agreed supply chain minimum requirements and bestpractices for traceability.

Allows organisations to obtain guidance on complying with major internationaltraceability regulations as well as traceability requirements established by thekey quality standards used in the Food industry.

A global programme for traceability, based on global standards, will improve GlobalTraceability and facilitate the flow of information across the supply chain.


24/151



7. How does the GS1 GTC Programme work?

The GS1 GTC Programme is a set of documents and procedures that were designed tocomplement the GS1 Global Traceability Standard, presenting an implementation model inorder to provide GS1 recognition to Organisations that satisfactorily comply with therequirements of the GTS through independent assessments.

The GS1 GTC Programme is governed by the GS1 GTC Operation Manual. This documentcontains the minimum rules, the process and the compliance criteria for each actor involvedin 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 Subsection8: Requirements for becominga GS1 accredited GTC Auditor. Only those Auditors that are accredited by GS1 mayperform 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 trainingsperformed 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 contextof GTC. This organization must comply with the following criteria, before it can berecognized 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


25/151



7.1.4. Certification Body:

It is the organization granting certification. A CB has a licensing agreement with GS1 GlobalOffice (GS1 GO). Any organisation can be candidate for being accredited as a CertificationBody, by a neutral third party (Accreditation Body), under the criteria ISO 17021 Conformity

assessment -- Requirements for bodies providing audit and certification of managementsystems.

7.1.5. Accreditation Body:

The Accreditation Body accredits Certification Bodies by ensuring they adhere to quality andtest 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 theorganisation as an accredited Certification Body in the GS1 GTC Programme.

ISO 17021 Conformity assessment -- Requirements for bodiesproviding audit and certification of management systems:

Contains principles and requirements for the competence,consistency and impartiality of the audit and certification ofmanagement systems of all types (e.g. quality management systemsor environmental management systems) and for bodies providingthese activities. Certification bodies operating to this InternationalStandard need not offer all types of management systemcertification.

Certification of management systems is a third-party conformityassessment activity. Bodies performing this activity are thereforethird-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 thefields of management systems, products, services, personnel andother similar programmes of conformity assessment.

Its primary function is to develop a single worldwide program ofconformity assessment which reduces risk for business and itscustomers by assuring them that accredited certificates may berelied upon.

Accreditation assures users of the competence and impartiality of thebody accredited. IAF members accredit certification or registrationbodies that issue certificates attesting that an organisation'smanagement, products or personnel comply with a specifiedstandard (called conformity assessment).


26/151


27/151



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 GlobalTraceability Standard (GTS). The service can be provided when implementing aTraceability System for the first time or to support bridging the gaps identified during anAssessment.

2. Assessment: Audit performed on a company, using the GS1 GTC Control Points &Compliance Criteria (GTC Checklist). The assessment must be performed by anaccredited GTC Auditor according to ISO 19011 Guidelines for quality and/orenvironmental management systems auditing. The Assessment can be used as adiagnosis to identify gaps at the beginning of a traceability implementation. At the end ofthe Assessment, the audited company receives an Audit Report

1informing on the audit

findings.

3. Report: Recognition granted to a company that proved compliance to the GS1 GTCChecklist after being assessed. At the end of the Assessment, the audited companyreceives a Conformance Report

2delivered by the Auditing Organisation, summarising

the result against the compliance criteria (defined in GS1 GTC checklist).

1The 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 Report3The Assessment Report is explained in section 22.4 Completing the Audit: Presenting the

Assessment Report

GS1 GTC Reports & Certificates:

The GS1 GTC Assessment Report3

as well as certificates aregoverned by a sublicense agreement that covers: usage, branding,publication as well as roles and responsibilities thereof.


28/151


29/151



7.2.1. GS1 GTC Assessments and GS1 GTC Auditors in practice

The GS1 GTC Programme works through systematictraceability assessments using an audit schema. The

audit schema is based on ISO 19011 Guidelines forquality and/or environmental management systemsauditing. The details on how to perform an auditfollowing the rules of this standard are explained inModule 3: Auditing under ISO 19011.

The assessments are carried out by accredited GS1 GTCauditors. The accredited auditor performs the traceabilityassessment at the organisations facilities, using auditcriteria called the GS1 GTC Control Points & Compliance Criteria (GS1 GTC Checklist) .The result of this assessment is a complete report detailing the traceability level andidentifying the traceability gaps that the organisation should correct. The complete activitytakes between one and three weeks on average for a medium sized company including an

on-site audit at the organisations 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 contingenton local market demand. What this means is that if a Certification Body or key stakeholdersin global supply chains wants to put in place a Certification scheme based on the GS1 GTCProgramme and GS1 standards, the GS1 GTC Programme has this option and the companyshould 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 andaccreditation.

2. Certification Bodies need to be independent, impartial and accredited according to ISO17021.

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 todemonstrate its benefits through implementations throughout the Supply Chain - bothupstream and downstream - on a global level.

Note:

The GS1 GTC Audit Report is not a certification but fulfils thegoals of supporting the implementation.


30/151



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 appointeda 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 TraceabilityStandard.

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 GS1awareness, especially in the context of Food Safety

Informing organisations about the process for the maintenance of the standards andinviting them to join the Traceability Business Requirement Group (BRG)

If GS1 MOs decide to participate as Certification Bodies, they have to create a separatedepartment to deal with certification. The certification staff cannot take part in GS1standardisation activities nor implementation activities.

GS1 MOs cannot have exclusivity on their market to perform certification. MOs will competewith other certification bodies who meet the same criteria.


31/151



7.3. The GS1 GTC Programme Material

The GS1 GTC Programme material is a tool- kit of documentsand 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 whenapplying the GTC Programme. Thereby those audits will berecognized globally by GS1.

The instructions on how to use the documents included in thekit when performing an audit is explained in detail in theModule 5: The GS1 GTC Audit Activities.

The GS1 GTC Programme considers a set of documentsdeveloped to complement the GS1 Global Traceability Standard (GTS). Included within theProgramme documentation are the following:

a. GS1 Global Traceability Standard (GTS)

GS1 standard that presents the minimum business requirements (BR) and businessrules (BRU) for a traceability system for each actor of the chain (internal traceabilityas 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 TraceabilityManagement System of an Organisation. The following documents are included:

- Audit Plan: Indicates the necessary information required in order to carry out aGS1 GTC Audit such as Organisational information, audit team, objectives andscope of the audit as well as the dates of the meetings planned.

- GS1 GTC Assessment Checklist: Contains all the Control Points of the GS1GTC Control Points & Compliance Criteria and is used by the Auditor to performthe 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 GTCAssessment carried out on an Organisations Traceability Management System.

d. GS1 GTC Training Manual

Document aimed to support the GS1 GTC Training. Is a fundamental part of thetraining kit and provides guidance on how to perform a GS1 GTC Assessment byaccredited GTC Auditors.


32/151



The following table shows the latest version of documents and forms considered in the GTCProgramme. It is extremely important to always be aligned with the latest version of every documentand use the translation for the local market language when it exists. If this is not the case, theEnglish version should be used until an authorized version in the desired language has beendeveloped.

7.3.1. What documentation, in what languages is currently available?

The latest version of the documentation and supporting material included in the Programmeis 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 Frenchand Spanish version will be available in the near future.

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

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


33/151



7.4. How is the GS1 GTC Programme maintained?

GS1 GTS and the GS1 GTC Checklist are maintained by the Traceability BusinessRequirement Group (BRG) according to the normal GSMP process.

The actual way to operate the GS1 GTC Assessments, GS1 GTC Auditor and CertificationBody accreditations is maintained by an internal team composed of GS1 Global Office staffand representatives from GS1 MOs. It is ultimately validated through the GS1 decisionprocesses 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 oftraceability involved in supply chain processes. It aims to be theglobal, foundational standard for traceability in ANY industry sector


34/151



8. Requirements for becoming a GS1 accredited

GTC AuditorAny person fulfilling the GS1 GTC requirements forAuditors can be a GS1 GTC Auditor.

GS1 GTC Auditors must have a proven knowledgeand understanding on the concept of traceabilityand how the different GS1 solutions interact alongthe supply chain and how they improve thetraceability information sharing.

8.1. Reasons for obtaining GS1 GTC Auditor accreditation

Only GS1 GTC Auditors are entitled to perform GS1 GTC Assessments recognized globallyby GS1. The GS1 GTC Auditor accreditation is a guarantee for the company beingassessed, that the auditor has the required knowledge, experience and skills needed inperforming the GS1 GTC Assessment, in terms of Traceability, GS1 System and supplychain experience.

Auditors will have demonstrated their knowledge and understanding of the concept oftraceability and how the different GS1 solutions interact along the supply chain and how theyimprove the traceability information sharing.

Accredited GTC Auditors will have:

a good understanding of the auditing principles under ISO standards and effectivelyprepare for, carry out, report and follow up on GTC Assessments.

an ability to effectively assess an organizations readiness against key traceabilityregulations as well as related commercial requirements.

participated in improving the implementation of the GS1 Global Traceability Standard inany 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 indicatingthat they are Accredited GS1 GTCAuditors.


35/151



8.2.1. Step 1

Goal: Ensure the candidate can demonstrate sufficient knowledge of the GS1 GlobalTraceability Standard (GTS) and GS1 Global Traceability Programme (GTC).

To successfully pass this step, the candidate must have taken the GTS and GTCtraining courses and have passed the written test at the end of the GTC trainingcourse

4.

Training will be offered on a regular basis in different geographic locations. The trainingincludes the two compulsory modules: GS1 Global Traceability Standard (GTS) and GS1GTC.

The two trainings modules take five full days and provide all the necessary knowledgerequired for a GS1 GTC Auditor. It gives an essential perspective to individuals responsiblefor the planning and implementation of Traceability Audits through the GS1 GTC Programmeas well as teaching all the basic requirements included in the GS1 Global TraceabilityStandard. 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 wassuccessfully approved. This diploma will allow the participants to apply for the next stepsfor accreditation.

Seehttp://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 GTCassessment.

To successfully pass this step, the candidate must fulfill AT LEAST ONE of theconditions below:

a) Be ISO 19011 certified

b) Send 2 assessment reports from different companies that are positively evaluated by afaculty of GTC Auditors.

The template for the assessment reports can be downloaded fromhttp://www.gs1.org/traceability/gtc.

Completed assessment reports have to be returned [email protected]

c) Achieved a minimum 10 hours of assessment in companies under the guidance of aGTC auditor.

The template to report the hours (Audit Log) used in these assessments can bedownloaded fromhttp://www.gs1.org/traceability/gtc.

Audit Log reports have to be returned [email protected]

The candidate will be notified within 10 working days of his/her successful completion ofSTEP 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.
http://learn.gs1.org/http://learn.gs1.org/http://learn.gs1.org/http://www.gs1.org/traceability/gtchttp://www.gs1.org/traceability/gtcmailto:[email protected]:[email protected]:[email protected]://www.gs1.org/traceability/gtchttp://www.gs1.org/traceability/gtchttp://www.gs1.org/traceability/gtcmailto:[email protected]:[email protected]:[email protected]:[email protected]://www.gs1.org/traceability/gtcmailto:[email protected]://www.gs1.org/traceability/gtchttp://learn.gs1.org/


36/151



8.2.3. Step 3

Goal: Ensure the candidate complies with all the GS1 GTC Programme administrative andlegal 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 thelocally 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 GTCAuditor material and forms.

Agree to maintain up-to-date files of all quality policies, procedures, work instructionsand documentation issued by GS1.

Agree to keep abreast of developments, issues and legislative changes pertaining to thescope 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 theresponsibility).

Auditors are not permitted to carry out any activities which may affect theirindependence or impartiality, and specifically shall not carry out consultancy ortraining activities for the organizations they assess. Training is not consideredconsultancy, provided that, where the course relates to management systems orauditing, it is confined to the provision of generic information that is freelyavailable in the public domain i.e. the trainer cannot provide company-specificsolutions.

Auditors must strictly observe the organizations and the Certification Bodysprocedures to maintain the confidentiality of information and records.

Note:Assessments not accepted:

Assessments of the same traceability system that arerepeated more frequently than once every 12 months

Assessments of less than one day (6 hours of on-siteaudit activity exclusive of breaks) duration.

Assessments performed before successful completionof the formal training requirement.


37/151



The candidate is therefore invited to send [email protected]:

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 canbe downloaded fromhttp://www.gs1.org/traceability/gtc.

The candidate will be notified within 20 working days of his/her successful completion ofSTEP 3.
mailto:[email protected]:[email protected]:[email protected]://www.gs1.org/traceability/gtchttp://www.gs1.org/traceability/gtchttp://www.gs1.org/traceability/gtchttp://www.gs1.org/traceability/gtcmailto:[email protected]


38/151



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 traceabilitysystem using the GS1 Global Traceability Standard and how to become actively involved inthe development and implementation of global standards.

If you are interested in becoming an accredited GS1 GTC Auditor

Jean-Marc D'Hooghe

[email protected]

If you need more information about certification of organisations

Nicholas Fergusson

[email protected]

If you want to participate in the Traceability Business Requirement

Group (Traceability BRG)Melanie Kudela

[email protected]

If you need more information about the GS1 GTC Programme ingeneral

Juan Pablo Vial

[email protected]
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]


39/151



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


40/151



10. IntroductionGS1 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 ofaudit 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 forauditing 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 systemaudits

competence of quality and environmental management system auditors.

The application scope of the ISO 19011 standard is for all organisations needing to conductinternal or external audits of quality and/or environmental management systems or who haveto manage an audit program.


41/151



11. Terms and Definitions related to ISO 19011Below 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 andevaluating it objectively to determine the extent to which the audit criteria are fulfilled

Audit Criteria:

Set of policies, procedures or requirements

Audit Evidence:

Records, statements of fact or other information, which are relevant to the audit criteria andare 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

Different types of audit, by party

1st

party Audit: Or Internal Audits are those where an organizationcarries out audits on itself.

2nd

party Audit: Commonly known as Supplier Audits because they areused where an organization has to assure itself of the ability of a potentialor existing supplier or sub-contractor to meet the requirements.

3rd

party Audit: Or External Audit are those performed by an independentorganization (3rd party) over a supplier to certify it. This can be doneasked by a group of customers


42/151



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 specificpurpose

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


43/151



12. The Principles of AuditingThe 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 areeffective and reliable.

Ethical Conduct

Behaving in an ethical way is the foundation of a professional attitude for an auditor. Keycharacteristics of ethical behavior are trust, confidentiality and integrity. By displayingthese behaviors, you show that the essence of auditing is respected when you performaudits.

Fair Presentation

What is meant by this? It means that as an auditor you have the obligation to report truthfullyand accurately on what you audit. It is very important that you ensure that your auditfindings, audit conclusions and audit reports reflect the reality you have discovered throughyour audit activities.

Due Professional Care

This is a fairly generic statement, but on the other hand, it just refers to the application ofdiligence and judgment in auditing. When you audit, you are expected to exercise care inaccordance with the importance of the task you perform and the confidence placed in you bythe audit client.

Independence

When performing an audit, you should always remember that you as an auditor beingindependent is the ground-rule for the impartiality of the audit and that is the only way toguarantee that the audit conclusions are going to be objective. By being independent, wemean that you should not in any way be involved or related to the activity you audit. This isnot enough, however, you should also refrain from having a bias towards the auditee, norshould you be in a position of conflict of interest. A conflict of interest could exist where youprovided consultancy on implementation of a traceability system to the same company youare 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 conclusionsyou make are based on evidence. This evidence should be verifiable, as it should be basedon the samples of the information available.


44/151



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 aplant

Be aware of quality requirements, for ex. use apron, a head capand 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 preconceivedideas. 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


45/151


46/151



In the process flow, everything starts with the reception of authority to execute an auditprogram. From there, we enter the Planning phase.

Establishing an audit program contains a number of distinct sub-steps. The first and mostimportant step is to define the objectives of the audit program and its scope. Scope creep isone of the most common reasons for program failure (80%).

Once the objectives and the scope have been established, the different responsibilitieswithin the program need to be identified. What are the different roles that will be played inthe 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, everythingdepends on the size of the organisation and the availability of resources It does remainnecessary, however, to remain vigilant and to avoid conflicts of interest. E.g. an auditorcannot be responsible for controlling himself.

The last part of the planning phase consists of establishing the policies and procedures thatwill be used during the audit program. It is important that these policies and procedures arerecorded for reference purposes: what is not written does not exist

When everything has been planned and documented satisfactorily, it is time to move on tothe 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 theavailability of the auditee as well as of the auditors here. In building the audit teams, youdepend on a side process, where you Evaluatethe Competence of the Auditors.

The competence, even more than the availability of the auditors determines who is the rightperson for the job at hand. Competence should not be strictly understood as competence atauditing, but also competence at the standards against which will be audited. Additionalfactors may be knowledge of the industry or vertical in which will be audited, whether theauditor 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 tomaintain records of all the work that has been done.


47/151



The Checking Phaseis the next big process step. It is all about monitoring and reviewingthe audit program. Please note that there is a crucial difference between monitoring andreviewing. Monitoring is an activity, which should be executed all through the audit programand not just at the end of it. The review of the program typically is done at the end, but mayalso 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 andpreventive actions. Basically, you answer the questions what went wrong? and why? Thisbecomes the driver for identifying opportunities for improvement.

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 problemsin the process.

The identification of the corrective and preventive actions are toimprove the management of the audit program, this is not about therecommendations you make for improving the processes of theauditee!


48/151




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

Conducting document review

14. Audit ActivitiesIn 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 andhow should be performed into the GS1 GTC Programme are presented in the Module 5: TheGS1 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 managingthe audit program should appoint the audit team leader for the specific audit. The main tasksto address in this activity are shown in the following figure;


49/151




Reviewing relevant management system documents, including

records, and determining their adequacy with respect to auditcriteria


Prepare the on-site Audit 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

14.2. Conduct Document Review

The second step is to conduct a document review. Here youreview relevant managementsystem documents, including records, and determine their adequacy with respect to the

audit criteria.

Prior to the on-site audit activities, the auditees documentation should be reviewed todetermine the conformity of the system, as documented, with the audit criteria. Thedocumentation may include relevant management system documents and records, and,where available, previous audit reports.

14.3. Preparing the On-Site Audit ActivitiesOnce the relevant documentation has been reviewed, you can proceed to the next stepwhich is the actual preparation for the on-site activities.


50/151



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

Prepare the on-site Audit Activities


Preparing, approving and distributing the audit report

Preparing the audit report

Approving and distributing the audit report

Conduct on-site Audit Activities

Completing the Audit

14.4. Conducting On-Site Audit Activities

Only now does the real work of auditing onsite begin. The goal of this activity is to performthe On-site audit according to the Audit Plan prepared in the previous activity. The tasks are:

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 ofthe audit.

The audit report must be approved and then distributed to recipients designated by the auditclient.

The audit report is the property of the audit client. The audit team members and all reportrecipients should respect and maintain the confidentiality of the report


51/151



Completing the audit


Conducting Audit follow up

14.6. Completing the Audit

The audit is completed when all activities described in the audit plan have been carried outand the approved audit report has been distributed.

Documents pertaining to the audit should be retained or destroyed by agreement betweenthe participating parties and in accordance with audit program procedures and applicablestatutory, regulatory and contractual requirements.

14.7. Conducting Audit follow up

The conclusions of the audit may indicate the need for corrective, preventive or improvementactions, as applicable. Such actions are usually decided and undertaken by the auditeewithin an agreed timeframe and are not considered to be part of the audit. The auditeeshould keep the audit client informed of the status of these actions.

The completion and effectiveness of corrective action should be verified. This verificationmay be part of a subsequent audit.

The audit programme may specify follow-up by members of the audit team, which addsvalue by using their expertise. In such cases, care should be taken to maintainindependence in subsequent audit activities


52/151



15. Competence and Evaluation of AuditorsHere 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 thoseconducting the audit. This competence is based on the demonstration of personal attributesand on the auditors ability to apply the knowledge and skills acquired through generaleducation, 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 theprinciples 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.


53/151



15.2. Knowledge and skills

There is generic knowledge and skills any auditor of production and traceability managementsystems 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 issaying. Wait until he has finished speaking before replying. Stay objective and try to find theunderlying cause for the objection/disagreement. When you reply to the auditee, make sureyou 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.


54/151



There are some additional basic considerations, the auditor should be aware of, such asdress code and an attitude of showing respect towards the auditee.

The auditor should also be prepared to deal with particular situations, e.g. reception ofspontaneous information, being shown internal conflicts of the organization, or beingconfronted 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 needto communicate any NC to the auditee.

As an auditor you will be confronted with people who are nervous enough as it is. Anyconfrontational behavior on your behalf should be avoided at all cost. This includes avoidingpersonal attacks on individuals.

You should actually take this be