GLOBALGAP Smallholder QMS Set-up

Guide
How to establish a QMS in your group

Division Economic Development and Employment
Division Agriculture, Fisheries and Food



























Published by

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Picture Credits:
Goert Nieuwland - otolia.de
Iarald 1ostheim - otolia.de
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Kate Shepard - otolia.de

GLOBALGAP Smallholder QMS Set-up Guide
How to establish a QMS in your group
Based on: GLOBALGAP IFA Ver. 3.0-2 QMS Checklist_Mar08, English version

Table of content
1 Introduction 1
1.1 Challenge and chance for smallholders 1
1.2 What is a QMS? 1
1.3 QMS manual 2
1.4 QMS representative 2
1.5 Group types 3
2 Setting up a QMS 5
2.1. Legal status 8
2.2. Producer register 8
2.3. Management structure 14
2.4. QMS manual 22
Site management
Planting material
Soil management and fertilizer use
Irrigation
Plant protection products
Harvesting
Produce handling
Workers health, safety and welfare
Waste and pollution management
Environmental conservation
2.5. Document control 45
2.6. Traceability system 48
2.7. Complaint handling 51
2.8. Contract 51
2.9. Internal inspections and audit 54
2.10. Sanctions 59









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1 Introduction
1.1 Challenge and chance for smallholders
As the retailers and consumers are becoming more and more aware of the food safety,
environmental and social issues to be addressed in the agricultural production, the
world market today is increasingly demanding the compliance of public and private
standards. GLOBALGAP has become one of the most recognized international
standards, and is required as a minimum market-entry requirement by a considerable
number of biggest retailers. In this global trend, smallholders who are not certified, are
often marginalized and left out of the supply chain.
However, this trend can also present a chance for smallholders to participate
in the global market on the equal ground at the same time. Smallholders, when
organized and certified as a group, can be recognized by international retailers as a
certified supplier and can export their produce to the global market.
In order for smallholder groups to be certified according to GLOBALGAP, each
group has to establish its own Quality Management System (QMS) to manage its
production. QMS is one of the crucial requirements for GLOBALGAP group
certification, yet is a very difficult theme for smallholders to handle. Therefore, this
GLOBALGAP QMS Set-up Guide intends to explain what is QMS in easy words and
to assist the smallholder groups to establish QMS of their group step-by-step in a very
simple and practical manner.
1.2 What is a Quality Management System (QMS)?
Quality Management System is a set of rules that the group and its members have to
abide by. When many farmers get together as a group, each person should not be
doing his/her own thing without any control. When the members want to sell their
produce together as a group, all their products should be managed in the same way.
When the production of the members is managed under a certain control,
GLOBALGAP allows those farmers to be certified as a group. This is called
GLOBALGAP certification Option 2. Under this option, not all the members need to be
inspected by an external inspector. Only the square root of the total number (for
example, square root of 25 members would be 5) will be inspected by an internal
inspector from a certification body. This number could be increased based on the risk,
Smallholder QMS Set-up Guide

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variation of products and geographical location of the farms, but would still be lower
than the total number. Therefore, this helps smallholders to bring down the cost of
certification significantly.
The groups QMS has to ensure that all the members are complying with the
GLOBALGAP standard, and that there is a mechanism within the group to monitor it
and control it. When this is achieved, GLOBALGAP allows that only the square root of
members are inspected, instead of all the members of the group, because the sample
of inspected farms can well represent the situation of all the farms in the group.
1.3 The QMS manual
QMS should not be just an idea in someones mind. It has to be written into a
document, so that everyone can read it and understand. This would be the document
that inspectors will verify as well. This document is called QMS Manual. It contains all
the rules that the group and its members have to abide by, and should explain how the
members should conduct a certain activity, how the group would monitor it, record it,
and ensure that it meets the GLOBALGAP criteria.
This Set-up Guide was developed in the framework of a GTZ-project on smallholder
certification according to the GLOBALGAP certification program. A draft of this generic
guide was tested in different countries (Ghana, Kenya, Macedonia and Thailand),
modified and adopted to the local conditions and finally revised.
1.4 The QMS representative
The group needs to designate one person to be responsible for the QMS of the group.
The person is called QMS Representative of the group. The person will be in charge
of developing QMS, writing the manual, implementing it, and revising it every year. This
is a lot of work, so the person has to be really committed to do this job. There are
different possibilities for a group to have a QMS Representative. The following are
some possible cases:
Someone competent in the group volunteers to be a QMS Representative, and the
group approves.
The group nominates someone competent and asks him/her to assume the role
either as a volunteer or with payment.
There is no one competent or willing in the group, so group hires an external
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person to assume the role with payment.
There is a risk involved in the third case. When an external consultant is hired to
manage the QMS, the charge may be too high for the group, or the consultant may
move to a different place. The sustainability of the work is at stake.
When a group cannot find an appropriate person to manage the QMS or
cannot afford the cost of sustaining it, GLOBALGAP Option 2 may not be a feasible
option for the group. GLOBALGAP Option 2 does not mean that the groups can be
easily certified. For the groups which cannot develop and sustain QMS, Option 2 is
even more difficult than individual certification. Option 2 is only possible when the
group is united, committed and determined.
1.5 Group types
There are two types of groups at large. One is an association of farmers or a farmers
cooperative, whereby smallholders organize themselves and manage the group by
themselves. The other is an outgrower scheme of a company, whereby an exporter or
a production company organizes smallholders and manage them as a group. Both
types can opt for GLOBALGAP Option 2 certifications, and there are advantages and
disadvantages for both types.
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Type 1
Farmers cooperative / association
Type 2
Outgrower scheme of a company
Advantage
The group owns the certificate.
Once certified, the group can use
the certificate to sell the produce
to whomever it wants.
Members can take decisions in a
democratic way.
Disadvantage
The group has to manage itself
the QMS financially and
technically.
Advantage
Manager of the company
responsible for the outgrower
scheme can set up a QMS for the
group and maintain it.
Company could support the
farmers financially and technically.
Disadvantage
Farmers have no option but to
sell the produce to the company
(but farmers may consider it as
an advantage of having a
guaranteed market).
Decision making power lies more
in the company rather than the
farmers themselves.
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2 Setting up a QMS
This chapter is structured in the following way.
This section shows GLOBALGAP requirements extracted from GLOBALGAP IFA Ver. 3.0-2
QMS Checklist_Mar08, English Version. This is the official GLOBALGAP document that is
used to audit a groups QMS. Each requirement is called a Control Point. Please note that in
this QMS Set-up Guide, the control points are sometimes re-categorized in order to make
facilitate understanding. Therefore, if you notice that certain control points have been skipped,
they will appear later in the chapter.
Example
QM 8 . 1 Does the group have a system for effectively managing customer complaints?
This section explains step-by-step how to establish the relevant part of QMS.
Example
1. Think of all types of complaints the group has ever received and the group can
possibly receive. Ask the following questions:
From whom could the group receive complaints?
What are the possible problems that caused/ will cause the complaint?
How should the group solve the problems?
How should the group document the complaint?
How can the group ensure that the same problem would not happen again?

2. Design a complaint form based on the above consideration.
GLOBALGAP Requirement
What to do
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Where relevant, this section shows some examples of how it can be written in a QMS manual.
Please keep in mind that those examples are shown just to give you some ideas. Policies or
forms of another group may not be suitable or sufficient for your group. Your group needs to
create its own QMS that is most adequate for the situation of the group and its surrounding
environment.
Example
The following is an example of a simple policy on complaint handling.
The following page is an example of a complaint form.
Examples
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2.1 Legal status
The first step for a group towards certification is to become legally registered.
QM 2 ADMINISTRATION AND STRUCTURE
QM 2 . 1 Legality
QM 2 . 1 . 1
Is there documentation, which clearly demonstrates that the applicant producer group
is or belongs to a legal entity?
QM 2 . 1 . 2
Have the legal entity been granted the legal right to carry out agricultural production
and/or trading, and be able to legally contract with and represent the group
members?
QM 2 . 1 . 3
Does this legal entity have a direct responsibility over the production, handling and
ownership of the products, thus it is responsible for the compliance with the
GLOBALGAP standard and General Regulations within the GLOBALGAP producer
group?
Register your group officially with a governmental institution. The legal status could be farmers
association, cooperative, company or any other. The auditor would ask an official document that
shows the groups legal status. Legal registration process often takes a long time, so if the
group is not registered yet, it is better to start now. And please do not forget: your group needs
to have the legal right to produce or to trade agricultural products!
2.2 Producer register
You need to collect data of the producers to register the group with GLOBALGAP.

QM 2 . 4 Producer Register
QM 2 . 4 . 1
Is there a register maintained of all GLOBALGAP member producers, and of all the
applicable sites used for production in accordance with the GLOBALGAP standard?
QM 2 . 4 . 3 Does the register contain the name of each producer?
QM 2 . 4 . 4 Does the register contain the name of the contact person?
QM 2 . 4 . 5
Does the register contain the full address (physical and postal) of every producer
member?
GLOBALGAP Requirement
What to do
GLOBALGAP Requirement
Smallholder QMS Set-up Guide

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QM 2 . 4 . 6 Contact data (telephone number and e-mail and/or fax number)
QM 2 . 4 . 7
Doe the register contain any other ID (VAT Number, ILN, UAID, etc) if required for
the country of production?
QM 2 . 4 . 8 Does the register contain the product registered by each producer member?
QM 2 . 4 . 9
Does the register contain information on the growing/production area and/or quantity
for each registered product?
QM 2 . 4 . 10
Does the register contain information on the Certification Body(ies) if a producer
makes use of more than 1 CB (according to General Regulations PART I; 4.4.1.vi
and 4.4.2.vi) ?
QM 2 . 4 . 11 Does the register contain the Internal audit date for every producer member?
QM 2 . 4 . 12
Does the register log the current GLOBALGAP status (according to the statuses as
indicated in Annex II.1) of every producer member?
QM 2 . 4 . 13
Are those producers of the legal entity who do not apply for GLOBALGAP
certification listed separately?
QM 1 . 5 Is the entire crop registered for certification?
QM 2 . 1 . 4
Will the legal entity enter into a contractual relationship with GLOBALGAP through
the signature of the GLOBALGAP Sub-License and Certification Agreement with a
GLOBALGAP approved CB, and becomes the sole holder of the GLOBALGAP
certificate?
QM 2 . 4 . 2
Are all these member producers in the producer register, registered individually on
the GLOBALGAP database according to the requirements of the General
Regulations PART I; 4.8?
1. Convoke the members and explain what GLOBALGAP is, and see who are willing to
implement it and opt for certification. It is not necessary that all the members go for
certification. It can be just 10 out of 100 members.
2. Once the members are identified, get the following data of each of them.
Name of the farm
Name of the contact person
Address
Tel., fax and e-mail, if available
Product (you have to register the entire crop. You cannot register one variety and not
register the other variety.)
Production area (e.g. 2 acres)
Production quantity (e.g. 1000t)
If a producer is already GLOBALGAP certified individually or with another group, get the
following data in addition.
Certification Body (CB) used
Last inspection date
Inspection result (certified, warning, suspension or cancellation)
3. For those who are not going to join the certification, it is not necessary to collect all the
above data, but create a separate list of their names.
What to do
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4. Once the producer register is completed, you can register the group with GLOBALGAP. The
registration is conducted through a CB. In order to find a suitable CB for your group, you can
follow the following steps.
Go to the GLOBALGAP website (www.GLOBALGAP.org), click Services, and then
click Certification Body. When you choose a region, a country and a scope, the list of
approved CBs will appear on the screen.
Contact several CBs in your country or in the region to request quotations. Inspection
fees vary significantly from a CB to CB. Some CBs charge per day, and some CBs
charge per group. Compare the quotations closely.
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5. Once you decide on a CB, you can register the group with GLOBALGAP. You would need
to submit the following data to the CB together with the producer register:
Name of the group
Contact person
Address
Tel, fax and/ or e-mail
Product (the entire crop, not a variety)
Total production area
Whether the crop is covered or non-covered (covered: green house etc.)
Whether this year would be the first harvest or further harvest
Option (e.g. Option 2)
Whether produce handling is included or not. If the group handles the packhouse or
subcontracts it, produce handling is included.
6. As the registration proceeds, the following things will happen:
The CB will give the registration number to the group.
CB and the groups representative will sign the Sub-License and Certification
Agreement. Some CBs will send it as an e-mail attachment or by fax in advance.
Some CBs bring it on the day of inspection.
GLOBALGAP will input all the data of the group its member on the GLOBALGAP
database. Then GLOBALGAP will give the GLOBALGAP Client Number (GGN) to the
group. This number is the identification code of the group in the GLOBALGAP
database system.
GLOBALGAP will charge the registration fee. CBs normally add it to the inspection fee,
so you can check the amount of registration fee from the quotation.
The following are examples of a producer register form and a group membership application
form. The group membership application form is used to assess a potential member, when a
new person applies to become a member of the group.
Examples
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2.3 Management structure
It is crucial that a group has a team of competent people who can manage and run the system.
There are many control points related to this issue, as you can see below, but do not be
overwhelmed. The section, What to do will try to explain them in easy words.
QM 3 MANAGEMENT AND ORGANISATION
QM 3 . 1 Structure
QM 3 . 1 . 1
Does the producer group have a management structure and sufficient suitably
trained resources to effectively ensure that the registered producers meet the
requirements of GLOBALGAP on their production locations?
QM 3 . 1 . 2 Is the organizational structure of the group documented?
QM 3 . 1 . 3
Does this include information about the GLOBALGAP management representative -
person or department responsible for managing the implementation of
GLOBALGAP in the group?
QM 3 . 1 . 4
Does this include the name(s) of the Internal inspector(s) person(s) responsible
for the internal inspections of each producer member of the group annually;
complying with the GLOBALGAP requirements set for an internal group inspector
(Appendix III.1)?
QM 3 . 1 . 5
Does this include the name(s) of the Internal auditor(s) person(s) responsible for
the internal audit of the Quality Management System, complying with the
GLOBALGAP requirements set for an internal group auditor (Appendix III.2)?
QM 9 INTERNAL AUDITS AND INSPECTIONS
QM 9 . 1 . 2
Do(es) the internal auditor(s), complying with the GLOBALGAP requirements set
for an internal group auditor (Appendix III.2), do the internal audit of the QMS?
QM 9 . 1 . 4
Are the internal auditors suitably trained and independent of the area being
audited?
QM 9 . 1 . 5
Does the CB evaluate the competence of the internal auditor during the external
audit by checking compliance with Appendix III.2?
QM 9 . 2 . 2
Are internal inspectors, complying with the GLOBALGAP requirements set for an
internal group inspector (Appendix III.1) responsible for carrying out the farm
inspections?
QM 3 MANAGEMENT AND ORGANISATION
QM 3 . 1 . 6
Does this include information about the Agricultural or livestock technical
person/department person(s) responsible for technical advice to the group?
QM 3 . 1 . 7
Does this include information about the Quality Systems Management (QMS)
person/department person(s) responsible for managing the QMS?
QM 3 . 2 Responsibility and Duties
QM 3 . 2 . 1
Are the duties and responsibilities of all personnel involved with the compliance of
GLOBALGAP requirements documented, and is an individual who holds a position
of sufficient seniority and resources to serve as the overall responsible person
nominated for maintenance of the GLOBALGAP certification (see 1.2.1.i)?
QM 4 COMPETENCY AND TRAINING OF STAFF
QM 4 . 1
Does the group ensure that all personnel with responsibility for compliance with the
GLOBALGAP standard are adequately trained and meet defined competency
requirements?
GLOBALGAP Requirement
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QM 4 . 2
Are the competency requirements, training and qualifications for key staff
documented and does it meet any defined competency requirements laid out in the
GLOBALGAP standard?
QM 4 . 3
Are records of qualifications and training maintained for all key staff (managers,
auditors, inspectors, etc.) involved in compliance with GLOBALGAP requirements
to demonstrate competence?
QM 4 . 4
Do the internal auditor(s) and inspector(s) undergo training and evaluation, e.g. by
documented shadow audits, to ensure consistency in their approach and
interpretation of the standard?
QM 4 . 5
Is there a system in place to demonstrate that key staff is informed and is aware of
development, issues and legislative changes relevant to the compliance to the
GLOBALGAP standard?
QM 1 WHAT IS A PRODUCER GROUP?
QM 1 . 1
Does the structure of the producer group enable the application of a Quality
Management System across the whole group?
QM 1 . 2
Is the Quality Management System (QMS) in place sufficiently robust to ensure
(and to demonstrate through audits) that the groups registered producer
members/production locations comply in a uniform manner with the GLOBALGAP
standard requirements?
QM 14 INTERNAL PRODUCER GROUP INSPECTOR
QM 14 . 1 FORMAL QUALIFICATIONS
QM 14 . 1 . 1
Have the internal inspectors' qualifications and experience been verified for each
sub-scope by the producer group?
QM 14 . 1 . 2
Does the internal inspector have at least a post-high school diploma in a discipline
related to the scope of certification (Crops and/or Livestock and/or Aquaculture) or
an Agricultural high school qualification with 2 years of experience in the relevant
sub-scope after qualification?
QM 14 . 2 TECHNICAL SKILLS AND QUALIFICATIONS
QM 14 . 2 . 1
Did the internal inspector follow a one-day practical inspection course setting out
basic principles of inspection?
QM 14 . 2 . 2
Did the internal inspector follow two witness inspections (accompanying an audit,
could be GLOBALGAP (EUREPGAP) or other) OR 2 shadow audits by the CB?
QM 14 . 2 . 3
If the group has more than one internal inspector, are there records of shadow
audits between them?
QM Does the internal inspector comply with the following requirements:
QM 14 . 2 . 4
Training in HACCP principles either as part of formal qualifications or by the
successful completion of a formal course based on the principles of Codex
Alimentarius?
QM 14 . 2 . 5
Food hygiene training either as part of formal qualifications or by the successful
completion of a formal course?
QM 14 . 2 . 6
For Crop Scope: Plant protection, fertilizer and IPM training either as part of formal
qualifications, or by the successful completion of a formal course?
QM 14 . 2 . 7
For Livestock and Aquaculture scopes: Basic veterinary medicine and
stockmanship training including animal health and welfare issues?
QM 14 . 2 . 8
Does the inspector have working language skills in the corresponding
native/working language? Does it include the locally used specialist terminology in
this working language?
QM 14 . 2 . 9
Are exceptions to this rule consulted beforehand with the GLOBALGAP
Secretariat?
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QM 14 . 3 KEY TASKS
QM 14 . 3 . 1
Are Inspection of farms of the producer group undertaken to assess compliance
with the GLOBALGAP (EUREPGAP) standard?
QM 14 . 3 . 2
Does the internal inspector produce timely and accurate reports on such
inspections (see 1.8.2.iv)?
QM 14 . 3 . 3 Do inspectors not inspect their own daily work?
QM 14 . 3 . 4
Does the relevant CB have a complete and current list of all the producer group
internal inspectors and are these internal inspectors approved by the CB during the
external inspections.
QM 15 INTERNAL PRODUCER GROUP AUDITOR
QM 15 . 1 FORMAL QUALIFICATIONS
QM 15 . 1 . 1
Have the internal auditors' qualifications and experience been verified for auditing
the Quality Management System producer group?
NOTE: Where the internal auditor does not have the necessary Food Safety and
GAP training (3.3.2 below), but only QMS training/experience, another person with
these qualifications (and identified in the QMS) must form part of the audit team to
do the approval of the farm inspections (key task 3.4.2)
QM 15 . 1 . 2
Does the internal auditor have at least a post-high school diploma in a discipline
related to the scope of certification (Crops and/or Livestock and/or Aquaculture) or
an Agricultural high school qualification or 2 year experience of Quality
Management Systems with 2 years of experience in the relevant sub-scope after
qualification?
QM 15 . 2 TECHNICAL SKILLS AND QUALIFICATIONS
QM 15 . 2 . 1
Does the internal auditor have practical knowledge of Quality Management
Systems?
QM 15 . 2 . 2
Did the internal auditor complete a short (2 days) internal auditor-training course
related to QMS?
QM 15 . 2 . 3 Does the internal auditor comply with the following requirements:
QM 15 . 2 . 4
Training in HACCP principles either as part of formal qualifications or by the
successful completion of a formal course based on the principles of Codex
Alimentarius or training in ISO 22000?
QM 15 . 2 . 5
Food hygiene training either as part of formal qualifications or by the successful
completion of a formal course?
QM 15 . 2 . 6
For Crop Scope: Plant protection, fertilizer and IPM training either as part of formal
qualifications, or by the successful completion of a formal course?
QM 15 . 2 . 7
For Livestock and Aquaculture scopes: Basic veterinary medicine and
stockmanship training including animal health and welfare issues?
QM 15 . 2 . 8
Does the auditor have working language skills in the corresponding native/working
language? Does it include the locally used specialist terminology in this working
language?
QM 15 . 2 . 9
Are exceptions to this rule consulted beforehand with the GLOBALGAP
Secretariat?
QM 15 . 3 KEY TASKS
QM 15 . 3 . 1
Are auditing and assessment of the QMS of the producer group for compliance with
the GLOBALGAP (EUREPGAP) standard (according to the QMS Checklist)
conducted?
QM 15 . 3 . 2 Does the internal auditor produce timely and accurate reports on such audits?
QM 15 . 3 . 3
Is the approval of the members of the group, based on inspection reports of the
internal producer group inspector? (Refer to 3.1.i)
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QM 15 . 3 . 4 Do internal auditors not approve any producer inspections done by him/herself?
QM 15 . 3 . 5
Do internal auditors not audit the QMS if he/she implemented or operates the QMS
for the group?
QM 15 . 3 . 6
Does the relevant CB have a complete and current list of all the producer group
internal auditors and are these internal auditors approved by the CB during the
external inspections.
At a group meeting, nominate the following personnel as GLOBALGAP Management Team:
GLOBALGAP Management Representative (GMR): Someone who represents the
group for all the GLOBALGAP related issues
QMS Representative (QMR): Someone who is responsible for the QMS issues.
Technical Manager: Someone who technically advises and monitors the members.
Internal Inspectors: Someone who conducts farm inspections internally before a CB
conducts external inspections. Internal inspections have to be conducted for all the
GLOBALGAP registered members. If the group has many members, it may be
necessary to have more than one internal inspector.
Internal Auditor: Someone who conducts QMS audit internally before a CB conducts
an external audit.
Different functions could be performed by one person. Once the group has all the personnel to
form a GLOBALGAP Management Team, write down the management structure of the group
using a table or an organogram. The document should contain the following information for
each position.
Title
Name
Responsibility
Required qualification
However, internal inspectors and auditors have to meet the following qualification already
defined by GLOBALGAP.
Internal inspector qualifications
Post-high school diploma in horticulture
One-day practical course on basic principles of inspection
Two witness inspections (accompanying an audit) or two shadow audits (If the group
has more than one inspector, the inspectors conduct an inspection together and
compare the results.)
Training in HACCP
Food hygiene training
GAP training (plant protection, fertilizer and IPM)
Working language skills
Internal auditor qualifications
Post-high school diploma in horticulture
Practical knowledge of QMS
Completion of 2-day internal QMS auditor training course
Training in HACCP
Food hygiene training
GAP training (plant protection, fertilizer and IPM)
What to do
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Working language skills
These are very difficult criteria for smallholders to meet. Most groups do not have someone who
meets all the criteria. There are a few things that can be done to overcome this challenge.
Strategy 1: Organize training
The following qualifications can be met just by taking a training course.
One-day practical course on basic principles of inspection
Training in HACCP
Food hygiene training
GAP training (plant protection, fertilizer and IPM)
GLOBALGAP does not define the depth of the training for each theme. So do not think that you
necessarily have to attend a university course on HACCP. Training can be quite basic and
short, but what is important is that it is provided by a qualified person from a recognized
organization and that the acquired knowledge will be applied afterwards. In most countries,
there is hardly any existing training on these themes, so the best way is to organize it yourself.
For example, you can ask a trainer of a relevant research institution, district director of the
ministry of agriculture, technical expert of an international organization, technical staffs of a
development agency etc. to conduct training on the theme that they are specialized in.
If you organize training just for a few persons, the cost per head would be very high,
so it is advisable to collaborate with other groups who are also looking for the same kind of
training. Then 20 or more potential internal inspectors/ auditors can take training together. This
kind of initiative is often taken by a development organization.
After the training, make sure that each participant receives an official certificate with
the content of the training, the name of the trainer, his/her title, his/her signature and the name
of the organization. Internal inspectors/ auditors will be asked to present all the relevant
certificates and diplomas in the audit. If any of the required qualifications is missing, it would risk
the groups certification.
Strategy 2: Auditor Team
GLOBALGAP allow that if someone meets almost all the criteria of internal auditor, but is only
missing Food hygiene training and GAP training, the person can pair up with someone who has
those qualifications. They together form an Auditor Team, whose qualifications complement
each other. When one auditor conducts an audit, the other will verify the audit report and
approve it.
Meeting the qualification requirement of internal inspector/ auditor is probably one of
the most challenging parts of the Option 2 certification for smallholder groups. Meeting these
requirements is not a matter of putting effort. Training courses do not exist in many countries. If
they exist, they can be extremely expensive. Two-day QMS training is often provided by
certification bodies, but the course fee per person is not something a smallholder can easily
afford. Even if you try to organize training by yourself, competent trainers may not be available.
If available, they can also be very expensive. When it comes to post-high school diploma in
horticulture, most smallholders would be out of question.
Some groups, which do not have qualified person within the group, resort to the
measure of contracting an external consultant as an internal inspector/ auditor. However, the
cost of hiring an external consultant soon becomes a huge financial burden for the group.
Internal inspections take many days, and as the group grows, even more days would be
necessary. If you consider hiring an external service, it is advisable to use it only for an internal
QMS audit. Internal QMS audit takes only one day a year, regardless of the size of the group.
The qualification requirement of an internal auditor is very demanding, so it may be a good idea
to hire a qualified external consultant for one day to conduct an internal audit.
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Examples
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2.4 QMS Manual

QM 5 QUALITY MANUAL
QM 5 . 1
Are the operating and quality management systems related to the GLOBALGAP
standard documented and contained in a Quality Manual(s)?
QM 5 . 2
Are the policies and procedures sufficiently detailed to demonstrate the groups control
of the principal requirements of the GLOBALGAP standard?
QM 5 . 3
Are the relevant procedures and policies available to the producer group registered
members and key staff?
QM 6 . 1 Quality Management System (QMS) Documents
QM 6 . 1 . 1
Do all documentation relevant to the operation of the QMS for GLOBALGAP
compliance exist and are they adequately controlled including: The Quality Manual
QM 6 . 1 . 2
Do all documentation relevant to the operation of the QMS for GLOBALGAP
compliance exist and are they adequately controlled including: GLOBALGAP operating
procedures
QM 6 . 1 . 3
Do all documentation relevant to the operation of the QMS for GLOBALGAP
(EUREPGAP) compliance exist and are they adequately controlled including: Work
instructions
QM 6 . 1 . 4
Do all documentation relevant to the operation of the QMS for GLOBALGAP
(EUREPGAP) compliance exist and are they adequately controlled including:
Recording forms
QM 6 . 1 . 5 Relevant external standards, e.g. the current GLOBALGAP normative documents.
QM 7 RECORDS
QM 7 . 1
Does the group maintain records to demonstrate effective control of the GLOBALGAP
Quality Management System requirements and compliance with the requirements of
GLOBALGAP standard?
QM 7 . 2
Are the records from the QMS related to compliance of GLOBALGAP requirements
kept for a minimum of 2 years?
QM 7 . 3
Are all records genuine, legible, stored and maintained in suitable conditions and
accessible for inspection as required?
QM 7 . 4
Are records that are kept on-line or electronically valid? If a signature is required, is
there a password or electronic signature that ensures the unique reference and
authorization of the person signing? If a written signature of the responsible person is
needed, is this present? Are the electronic records available during the CB inspections
and are back-ups available at all times?
GLOBALGAP Requirement
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1. The QMS manual needs to cover all the activities conducted by the members and by the
group. All the key issues to address are already defined in the GLOBALGAP standard
document, GLOBALGAP Control Points and Compliance Criteria Integrated Farm
Assurance Ver.3.0-2 Sep07. All standard documents are available on the GLOBALGAP
website (www.GLOBALGAP.org). When you open the homepage, click The Standard
Documents. For horticulture, choose the following three modules of the standard document.
All Farm Base module
Crop Base module
Fruits and Vegetables module
When you read through these three documents, you can tell what should be included in the
QMS manual as basic rules. On top of what is already required by GLOBALGAP, you can
add what would be necessary to manage the group.
2. Most QMS manuals address the topics listed below. If you set rules for all of them, based on
the above three GLOBALGAP documents, you probably did not miss anything. If the group
does not conduct a certain activity (e.g. irrigation), you can skip the topic. GLOBALGAP
calls it Non-Applicable (N/A). The following list may look long, but each topic could be just
one page or even half a page. It depends on the complexity of the system.
Site management
Planting material
Soil management and fertilizer use
Irrigation (Your group may be N/A.)
Plant Protection Products (pesticides or agro-chemicals)
Harvesting (Your group may be N/A, Only if produce handling is also done by the
harvester and if approval has been received by GLOBALGAP.)
Produce handling (Your group may be N/A.)
Workers health, safety and welfare
Waste and pollution management
Environmental conservation
Document control
Traceability
Complaint handling
Withdrawal of product
Subcontractors
Internal inspection
Sanctions
3. Some topics, such as plant protection products, harvesting and produce handling, will
contain not only policies but also procedures, work instructions and recordkeeping forms.
Policy is a general guideline or a belief of the group. Procedures are more concrete rules.
Work instructions are step-by-step description of what an operator/ harvester/ packer has to
do. Recordkeeping is the way to document what has been done and to ensure that the work
instructions are respected. If your group members are computer-literate, records can be
kept electronically. In this case, make sure you print them out on a regular basis, since
technology can fail you.
4. As you write the QMS manual, please keep the following points in mind.
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Key point 1: Keep it simple
Some QMS manuals are 100 pages, 200 pages or more. If the operation of the group is very big
and complicated, it is necessary to have many rules. Many smallholder groups have a very
simple operation, and a good QMS for such a group could be just 20 or 30 page long. The most
important thing is that all the groups activities are covered and the system is well-structured.
Words can be simple and easy. Sentences can be short and concise.
When the groups operation is quite simple but the QMS manual is 200 pages, this
situation indicates either (1) that the designed system is unnecessarily complicated or (2) that
wordings in the manual are unnecessarily long. There are many disadvantages in both
situations:
(1.) When a group designs a system that is way more complicated than what is necessary, the
group suffers as it implements such a system. There is more work, more papers, more
procedures and more time and money to be consumed, than necessary. As you write a
QMS manual, it is important to think well the activities that take places in the group and the
risks involved, so that the system would not be unnecessarily complicated.
(2.) When the system is simple but the QMS manual is written in a lengthy way, it makes it
difficult and time-consuming for any readers to understand, for the members to understand
and implement, for inspectors to read and verify, and for the QMS Representative of the
group to revise the document every year. When a document is so long and complicated, no
one in the group may be able to read it all, understand the content and implement it. Then
the group cannot fully implement the QMS described in the manual, and nobody can
conduct the annual revision of the system and the manual. As a result, the group may not
get certified, or may lose the certificate from the following year.
Therefore, it is crucial that QMS is simple but adequate enough to address all the
operation of the group, and that a QMS manual is written in a simple and concise manner.
Key point 2: Write what you do. Do what you write.
When writing a QMS manual, try to be as realistic as possible. Do not write something that the
group or the members can never do. Think what would the most suitable way for the group to
meet the requirement. If you write something that sounds really good on paper, but is too far
away from the reality, it would stay just on paper and nobody would implement it.
It is advisable to consult the group members for the ideas for QMS. If the QMS
Representative decides everything alone with having the members consent, the QMS may not
be well accepted and implemented by the members. However, degree of consultation would
depend on the size of the group. It is much easier to consult 30 members than 1000 members.
When a group is small enough, QMS Representative can directly consult individual members to
see what they think would be feasible. When a group is big, QMS Representative should rather
consult the representatives of the members who know the situation on the ground very well.
After the QMS manual is written, it has to be implemented in reality. Implementation
is a critical part of the work of QMS Representative. Auditors would check whether what has
been written is being done. Even if the system is beautifully phrased in the manual, if it is not
implemented in the reality, the group would risk the certification. Keep the key phrase in mind,
Write what you do. Do what you write.
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Key point 3: Centralize or decentralize?
When designing a system, you can keep in mind that there is a spectrum on the level of
centralization. You can create a system that is very centralized, very decentralized or
somewhere in between. In a centralized system, most decisions are made at the group level,
and individual members have less decision making. For example, the groups technical
manager may decide what product to apply, when, how, its dosage etc., and the members
cannot apply anything without the technical managers authorization. The group keeps records
of all the members farms, and the members are just given copies. In a decentralized system,
individual members decide what goes on in his/her farm, and the group has less say in it. For
example, each member decides what product to apply, when, how etc., and keep his/her own
record. The group only monitors to ensure that what he/she is doing meets the GLOBALGAP
requirement.
Centralized system Decentralized system
Example
The groups technical manager
decides what members should do
on a farm.
Records are kept by the groups
technical manager.
The group has its own sprayer
team and harvesting team, and
sends them to members farms.
Example
Each member decides what to do
by him/ herself.
Each member keeps his/her
record.
Each member conducts all the
activities, including spraying and
harvesting.
Advantage
It is easier to ensure the
compliance of all the members.
Disadvantage
The group needs to be
technically and financially
competent to conduct all the
services for the members.
Members have less autonomy of
their farms.
Advantage
The group does not need to have
high levels of technical and
financial capacity.
Members feel that they are more
autonomous. They can decide and
do what they think is the best.
Disadvantage
There is more risk of non-
compliance.
General tendency is that a farmers association or a cooperative usually starts with a more
decentralized system where the group executes loose control over its members. As the group
starts to export and have more income, the group may start to hire personnel to do the technical
advice, recordkeeping, spraying or harvesting for the members. Then the groups activities
become more and more centralized. On the other hand, outgrower scheme of a company tends
to have a centralized system from the beginning. Each group can choose its own path, so QMS
Representative can decide, for each activity, whether centralized system or decentralized one
would be more suitable for the group.
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This section presents examples of the following topics of a rather decentralized system. The
other topics will be covered in later chapters of this Guide.
Site management
Planting material
Soil management and fertilizer use
Irrigation
Plant Protection Products
Harvesting
Produce handling
Workers health, safety and welfare
Waste and pollution management
Environmental conservation
Site Management
Examples
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Planting material
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Soil management and fertilizer use
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Irrigation
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Plant Protection Products
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Harvesting
For the topic of harvesting, it is recommended to conduct a risk assessment first. Once the risks
are identified, you can develop policies and rules to address the risks.
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Produce handling
For produce handling, it is advisable to conduct risks assessment first. Then the policies and
procedures can be developed based on the risks identified.
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Workers health, safety and welfare
You can conduct a risk assessment first, and then develop policies based on the risks identified.
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Waste and pollution management
Please identify potential wastes and pollution sources first, and then develop a management
plan based on the wastes and pollution sources identified.
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Environmental conservation
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2.5 Document control
QMS Manual, once developed, cannot stay the same permanently. It has to be revised to
incorporate changes and to improve the system. When a revision takes place, it is extremely
important to keep track of the documents. If not, you end up having various documents with the
same title and the same look outside but with various contents inside. When old versions and
new versions are mixed, it would create a lot of confusion. Document control is very important to
avoid such confusion.
QM 5 . 4
Is the contents of the Quality Manual reviewed periodically to ensure that it continues
to meet the requirements of the GLOBALGAP standard and those of the producer
group? Are the relevant modifications of the GLOBALGAP standard or published
guidelines that come into force incorporated into the Quality Manual within the time
period given by GLOBALGAP?
QM 6 . 2 . 1 Is there a written procedure defining the control of documents?
QM 6 . 2 . 2
Are all documentation reviewed and approved by authorized personnel before issue
and distribution?
QM 6 . 2 . 3
Are all controlled documents identified with an issue number, issue date/review date
and be appropriately paged?
QM 6 . 2 . 4
Is any change in these documents reviewed and approved by authorized personnel
prior to its distribution? Wherever possible, is the explanation of the reason and
nature of the changes identified?
QM 6 . 2 . 5
Is a copy of all relevant documentation available at any place where the QMS is
being controlled?
QM 6 . 2 . 6
Is there a system in place to ensure that documentation is reviewed and that
following the issue of new documents, obsolete documents are effectively rescinded?
Decide on the following issues, and write them into a policy document to be included in the
QMS manual:
How often the QMS will be reviewed (please keep in mind that GLOBALGAP standard
is revised every 3-4 years, and QMS has to incorporate the changes of GLOBALGAP
accordingly.)
How to incorporate changes before the regular revision time (some situation of the
group may change, and it may become necessary to change some parts of QMS
urgently before the next revision time. There should be a procedure for this.)
How the old versions and new versions can be easily differentiated (issue no., issue/
review date, page no., authorization of new documents, withdrawal of old versions,
etc.)
What to do
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Followings are examples of a document control policy and a document amendment form. See
how the policies are carried out on the corer page of the QMS manual and at the bottom of each
page.
Examples
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2.6 Traceability system
QM 10 PRODUCT TRACEABILITY AND SEGREGATION
QM 10 . 1
Is the product meeting the requirements of the GLOBALGAP standard and marketed as
such, traceable and handled in a manner that prevents mixing with non-GLOBALGAP
approved products?
QM 10 . 2
Is there a documented procedure for the identification of registered products and to
enable traceability of all product, both conforming and non-conforming to the applicable
production sites? Has a mass balance exercise been carried out to demonstrate
compliance within the legal entity?
QM 10 . 3
Does the produce handling site (for Fruit and Vegetables) operate procedures which
enable registered product to be identifiable and traceable from receipt, through handling,
storage and dispatch?
QM 10 . 4
Are there effective systems and procedures in place to negate any risk of mis-labeling or
mixing of GLOBALGAP certified and non-GLOBALGAP certified products?
QM 12 WITHDRAWAL OF CERTIFIED PRODUCT
QM 12 . 1
Are there documented procedures in place to effectively manage the withdrawal of
registered products?
QM 12 . 2
Are there procedures that identify the types of event which may result in a withdrawal,
persons responsible for taking decisions on the possible withdrawal of product, the
mechanism for notifying customers and the GLOBALGAP approved Certification Body
and methods of reconciling stock?
QM 12 . 3 Is the procedure capable of being operated at any time?
QM 12 . 4
Is the procedure tested in an appropriate manner at least annually to ensure that it is
effective and records of the test retained?
1 Design a traceability system that would suitable for your groups operation. Consider the
following issues, when designing the system.
What information should the code contain?
When and where should the traceability code be given to the produce?
Where the code should be displayed?
How can the system ensure that non-certified produce would not be mixed with
certified produce?
If a problem is found on a certain product after shipment, can the other products with
the same problem be identified and be recalled back?
2 Test the system and see whether it works.
3 Once the shipment starts, test the withdrawal procedure to see whether it works. A recall
procedure is difficult to test, but you could ask your client to cooperate with you. For example,
you can call them by phone and ask them whether they can find the specific box in which you
intentionally put shoes instead of mangos.
GLOBALGAP Requirement
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Examples
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2.7 Complaint handling
The topic of complaint handling is already discussed as an example at the beginning of this
chapter.
2.8 Contract
A contract is a legal document that determines the relation between the producers and the
group, and defines each partys responsibilities and rights. By signing a contract, both the
producer and the group formally promise to each other that they will adhere to what is written in
the groups QMS manual and the GLOBALGAP standard.
QM 2 . 3 . Contractual Documentation
QM 2 . 3 . 1 Is there written signed contracts between each producer and the legal entity?
QM 2 . 3 . 2 Does the contract include the following information?
QM 2 . 3 . 3 Name or fiscal identification of the producer
QM 2 . 3 . 4 Contact address
QM 2 . 3 . 5 Details of the individual production locations
QM 2 . 3 . 6 Commitment to comply with the requirements of the GLOBALGAP standard
QM 2 . 3 . 7
Agreement to comply with the groups documented procedures, policies and where
provided, technical advice.
QM 2 . 3 . 8
Sanctions that may be applied in case of GLOBALGAP and any other internal
requirements not being met.
QM 1 . 3
Are producer group registered members legally responsible for their respective
production locations?
QM 1 . 4
Is the producer group not a multi-site operation where an individual or one
organisation owns several production locations or farms, which in itself are NOT
separate legal entities?
QM 2 . 2 . 1
Is the administrative structure of the producer group documented and does it clearly
identify the relationship between the producers and the legal entity?
1 Draft a contract that addresses the members responsibilities and the groups
responsibilities based on the QMS manual.
2 Discuss the content within the GLOBALGAP management team. If possible, consult some
members to have their feedback.
3 Once the final contract is ready, explain the content to each member and ask him/her to
sign. The representative of the group will also sign.
4 Photocopy the signed contract. Keep the original at the groups office. Give the copy to the
producer.
Following is an example of contract of a papaya producer group:
What to do
GLOBALGAP Requirement
Examples
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2.9 Internal inspections and audit
The group has to check, at least once a year, whether the registered members and the QMS
comply with the GLOBALGAP standard.
QM 9 INTERNAL AUDITS AND INSPECTIONS
QM 9 . 1 Quality Management System Audit
QM 9 . 1 . 1
Is an internal audit system in place both to assess the adequacy and compliance of the
documented QMS and to inspect the producers and farms against the GLOBALGAP
standard?
QM 9 . 1 . 3 Is the QMS for the GLOBALGAP scheme audited at least annually?
QM 9 . 1 . 6
Are records of the internal audit plan, audit findings and follow up of corrective actions
resulting from an audit maintained and available?
QM 9 . 2 Producer and Production Location Inspections
QM 9 . 2 . 1
Is an internal audit system in place to inspect the producers and farms against the
GLOBALGAP standard?
QM 9 . 2 . 3
Are inspections carried out at each registered producer and production location at least
once per year against the GLOBALGAP Control Points and Compliance Criteria, based
on the GLOBALGAP Checklist? Have all Major and Minor Musts as well as
Recommended control points been inspected in full?
QM 9 . 2 . 4 Is there a process for the review of the inspection reports and producer status?
QM 9 . 2 . 5
Are new members of the group always internally inspected prior to them entering into the
GLOBALGAP registered producers list?
QM 9 . 2 . 6
Are the original inspection reports and notes maintained and available for the CB
inspection as required?
QM 9 . 2 . 7
Does the inspection report contain the Identification of registered producer and
production location(s)?
QM 9 . 2 . 8 Does the inspection report contain the Signature of the registered producer?
QM 9 . 2 . 9 Does the inspection report contain the Date of the inspection?
QM 9 . 2 . 10 Does the inspection report contain the Inspector name?
QM 9 . 2 . 11 Does the inspection report contain the Registered products?
QM 9 . 2 . 12
Does the inspection report contain the Evaluation result against each GLOBALGAP
control point?
QM 9 . 2 . 13
Does the checklist include details of what was verified in the comments section of the
checklist of All Major Musts in order to enable the audit trail to be reviewed after the
event?
QM 9 . 2 . 14
Does the inspection report contain the Details of any non-compliances identified and time
period for corrective action?
QM 9 . 2 . 15 Does the inspection report contain the GLOBALGAP status of the producer member?
QM 9 . 3 Non-Compliances and Corrective Action Systems
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QM 9 . 3 . 1
Is there a procedure to handle non-compliances and corrective actions which may result
from internal or external audits and/or inspections, customer complaints or failures of the
QMS?
QM 9 . 3 . 2
Are there documented procedures for the identification and evaluation of non-
compliances to the QMS by the group or by its members?
QM 9 . 3 . 3
Are the corrective actions following non-compliances evaluated and a timescale defined
for action?
QM 9 . 3 . 4 Is the responsibility for implementing and resolving corrective actions defined?
QM 13 SUBCONTRACTORS
QM 13 . 1
Are there procedures to ensure that any services subcontracted to third parties are
carried out in accordance with the requirements of the GLOBALGAP standard (see
control point All Farm AF.3.6.1)?
QM 13 . 2
Are records maintained to demonstrate that the competency of any subcontractor is
assessed and meets the requirements of the standard?
QM 13 . 3
Do subcontractors work in accordance with the groups QMS and relevant procedures
and is this specified in service level agreements or contracts?
QM 14 . 3 . 3 Do inspectors not inspect their own daily work?
QM 15 . 3 . 3
Is the approval of the members of the group, based on inspection reports of the internal
producer group inspector? (Refer to 3.1.i)
QM 15 . 3 . 5
Do internal auditors not audit the QMS if he/she implemented or operates the QMS for
the group?
1 Design a form to record non-compliances and corrective actions. The form should address
the following information.
Date of inspection
Farm inspected
Inspector
Corresponding GLOBALGAP No.
Non-compliance
Corrective action
Deadline
Person responsible
Follow-up check (to record whether the non-compliance is closed or not)
2 Design a form to program internal inspections/ audit. The form should contain the following.
Date
Starting time
Ending time
Farmer
Location
Internal inspector
3 Using the above-designed form, plan internal inspections for all the members, and one-day
internal audit for QMS. Normally an internal inspector can conduct 2~4 inspections a day.
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When programming the internal inspections/ audit, please keep in mind the following.
Program internal inspections sufficiently before the external inspections. The whole
process of internal inspections, corrective actions and follow-up can be very time-
consuming. Do not wait until the last minutes before the external inspection.
When an internal inspector is also a registered member, make sure that he/she is not
inspecting his/her own farm.
QMS representative cannot be the internal QMS auditor.
If any service, such as spraying, harvesting and produce handling, is subcontracted,
the subcontractors need to be inspected as well.
4 Internal inspectors/ auditors carry out internal inspections/ audit. When going to an internal
inspection, internal inspector/ auditor should always bring the following two documents.
GLOBALGAP Checklist
Non-compliance and corrective action form
5 During the audit, ensure that all the control points on the checklist are answered by Yes, No
or N/A. Do not leave any control point blank. Before leaving the farm, check whether the
cover sheet of the checklist contains all the following information. Do not forget to ask the
farmer to sign.
Date
Product inspected
Inspectors name
Farmers name
Farmers signature
6 Follow-up inspections/ audit have to take place within the set period to check whether the
corrective actions are taken. Follow-ups have to continue until all the non-compliances are
closed.
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2.10 Sanctions
After follow-up inspections, some members may still have outstanding non-compliances. If the
overall performance is less than 100% compliance of Major Musts and 95% compliance of
Minor Musts of one member, sanctions have to apply. When a registered member is detected
with non-compliances during the year, sanctions also apply. Every member of the group must
fulfill the minimum requirements of GLOBALGAP. Bad results cannot be compensating with
better results.
QM 9 . 2 . 16
Does the internal auditor (or audit team; see Appendix III.2) make the decision on whether
the producer is compliant with the GLOBALGAP requirements, based on the inspection
reports presented by the internal inspector?
QM 11 SANCTIONS AND NON-CONFORMANCES
QM 11 . 1
Does the group operate a system of sanctions and non-conformances with their
producers, which meet the requirements defined in the GLOBALGAP General
Regulations?
QM 11 . 2
Do the contracts with individual producers define the procedure for sanctions including the
levels of Warning, Suspension and Cancellation?
QM 11 . 3
Does the group have mechanisms in place to notify the GLOBALGAP approved
Certification Body immediately of Suspensions or Cancellations of registered producers?
QM 11 . 4
Are records maintained of all sanctions including evidence of subsequent corrective
actions and decision-making processes?
1. Decide on the sanction policy of the group. There should be three stages: Warning,
Suspension and Cancellation, of the status as a GLOBALGAP registered producer.
2. After internal inspections, QMS representative needs to update the Producer Register.
Producer Register has a column on the registered members GLOBALGAP status. This part
should be filled as Certified, Suspended, Warning or Cancelled.
3. If any member receives Suspension or Cancellation, the sanction needs to be
communicated to the member by a letter signed by the GLOBALGAP Management
Representative (GMR). CB also has to be notified about the sanction right away.
GLOBALGAP Requirement
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Examples
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Technische Zusammenarbeit (GTZ) GmbH
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Deutsche Gesellschaft fr
Technische Zusammenarbeit (GTZ) GmbH
Dag-Hammarskjld-Weg 1-5
65760 Eschborn / Germany
T 06196 79 - 0
F 06196 79 - 1115
E info@gtz.de
I www.gtz.de