Division Economic Development and Employment Division Agriculture, Fisheries and Food GLOBALGAP Smallholder QMS Set-up Guide

Transcription

1 Division Economic Development and Employment Division Agriculture, Fisheries and Food GLOBALGAP Smallholder QMS Set-up Guide How to establish a QMS in your group

2 Published by Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) GmbH Dag-Hammerskjöld-Weg Eschborn / Germany T F E trade@gtz.de I Responsible: Trade Programme Eschborn 2010 Picture Credits: Govert Nieuwland fotolia.de Harald Tøstheim fotolia.de WestPic fotolia.de Kate Shepard fotolia.de

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

4 Table of content 1 Introduction Challenge and chance for smallholders What is a QMS? QMS manual QMS representative Group types 3 2 Setting up a QMS Legal status Producer register Management structure 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 Traceability system Complaint handling Contract Internal inspections and audit Sanctions 59

5 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, 1

6 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 group s 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 someone s 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 2

7 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. 3

8 Type 1 Farmers cooperative / association 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. Type 2 Outgrower scheme of a company 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 The group has to manage itself the QMS 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. 4

9 2 Setting up a QMS This chapter is structured in the following way. GLOBALGAP Requirement This section shows GLOBALGAP requirements extracted from GLOBALGAP IFA Ver QMS Checklist_Mar08, English Version. This is the official GLOBALGAP document that is used to audit a group s 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 What to do 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. 5

10 Examples 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. 6

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12 2.1 Legal status The first step for a group towards certification is to become legally registered. GLOBALGAP Requirement QM 2 ADMINISTRATION AND STRUCTURE QM 2. 1 Legality QM QM QM Is there documentation, which clearly demonstrates that the applicant producer group is or belongs to a legal entity? 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? 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? What to do 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 group s 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. GLOBALGAP Requirement QM 2. 4 Producer Register QM 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 Does the register contain the name of each producer? QM Does the register contain the name of the contact person? QM Does the register contain the full address (physical and postal) of every producer member? 8

13 QM Contact data (telephone number and and/or fax number) QM Doe the register contain any other ID (VAT Number, ILN, UAID, etc) if required for the country of production? QM Does the register contain the product registered by each producer member? QM QM Does the register contain information on the growing/production area and/or quantity for each registered product? 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; vi and vi)? QM Does the register contain the Internal audit date for every producer member? QM QM Does the register log the current GLOBALGAP status (according to the statuses as indicated in Annex II.1) of every producer member? 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 QM 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? 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? What to do 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 , 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. 9

14 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 ( 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. 10

15 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 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 group s representative will sign the Sub-License and Certification Agreement. Some CBs will send it as an 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. Examples 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. 11

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18 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. GLOBALGAP Requirement QM 3 MANAGEMENT AND ORGANISATION QM 3. 1 Structure QM 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 Is the organizational structure of the group documented? QM QM QM Does this include information about the GLOBALGAP management representative - person or department responsible for managing the implementation of GLOBALGAP in the group? 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)? 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 QM QM QM 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? Are the internal auditors suitably trained and independent of the area being audited? Does the CB evaluate the competence of the internal auditor during the external audit by checking compliance with Appendix III.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 QM Does this include information about the Agricultural or livestock technical person/department person(s) responsible for technical advice to the group? 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 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 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? 14

19 QM 4. 2 QM 4. 3 QM 4. 4 QM 4. 5 QM 1 QM 1. 1 QM 1. 2 QM 14 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? Are records of qualifications and training maintained for all key staff (managers, auditors, inspectors, etc.) involved in compliance with GLOBALGAP requirements to demonstrate competence? 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? 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? WHAT IS A PRODUCER GROUP? Does the structure of the producer group enable the application of a Quality Management System across the whole group? Is the Quality Management System (QMS) in place sufficiently robust to ensure (and to demonstrate through audits) that the group s registered producer members/production locations comply in a uniform manner with the GLOBALGAP standard requirements? INTERNAL PRODUCER GROUP INSPECTOR QM FORMAL QUALIFICATIONS QM QM Have the internal inspectors' qualifications and experience been verified for each sub-scope by the producer group? 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 TECHNICAL SKILLS AND QUALIFICATIONS QM QM QM QM QM QM QM QM QM QM Did the internal inspector follow a one-day practical inspection course setting out basic principles of inspection? Did the internal inspector follow two witness inspections (accompanying an audit, could be GLOBALGAP (EUREPGAP) or other) OR 2 shadow audits by the CB? If the group has more than one internal inspector, are there records of shadow audits between them? Does the internal inspector comply with the following requirements: 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? Food hygiene training either as part of formal qualifications or by the successful completion of a formal course? For Crop Scope: Plant protection, fertilizer and IPM training either as part of formal qualifications, or by the successful completion of a formal course? For Livestock and Aquaculture scopes: Basic veterinary medicine and stockmanship training including animal health and welfare issues? 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? Are exceptions to this rule consulted beforehand with the GLOBALGAP Secretariat? 15

20 QM KEY TASKS QM QM Are Inspection of farms of the producer group undertaken to assess compliance with the GLOBALGAP (EUREPGAP) standard? Does the internal inspector produce timely and accurate reports on such inspections (see iv)? QM Do inspectors not inspect their own daily work? QM QM 15 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. INTERNAL PRODUCER GROUP AUDITOR QM FORMAL QUALIFICATIONS QM QM 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) 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 TECHNICAL SKILLS AND QUALIFICATIONS QM QM Does the internal auditor have practical knowledge of Quality Management Systems? Did the internal auditor complete a short (2 days) internal auditor-training course related to QMS? QM Does the internal auditor comply with the following requirements: QM QM QM QM QM 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? Food hygiene training either as part of formal qualifications or by the successful completion of a formal course? For Crop Scope: Plant protection, fertilizer and IPM training either as part of formal qualifications, or by the successful completion of a formal course? For Livestock and Aquaculture scopes: Basic veterinary medicine and stockmanship training including animal health and welfare issues? 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 QM KEY TASKS Are exceptions to this rule consulted beforehand with the GLOBALGAP Secretariat? QM 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 Does the internal auditor produce timely and accurate reports on such audits? QM Is the approval of the members of the group, based on inspection reports of the internal producer group inspector? (Refer to 3.1.i) 16

21 QM Do internal auditors not approve any producer inspections done by him/herself? QM QM Do internal auditors not audit the QMS if he/she implemented or operates the QMS for the group? 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. What to do 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) 17

22 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 group s 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. 18

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26 2.4 QMS Manual GLOBALGAP Requirement QM 5 QUALITY MANUAL QM 5. 1 QM 5. 2 Are the operating and quality management systems related to the GLOBALGAP standard documented and contained in a Quality Manual(s)? Are the policies and procedures sufficiently detailed to demonstrate the group s 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 Do all documentation relevant to the operation of the QMS for GLOBALGAP compliance exist and are they adequately controlled including: The Quality Manual QM QM QM QM Do all documentation relevant to the operation of the QMS for GLOBALGAP compliance exist and are they adequately controlled including: GLOBALGAP operating procedures Do all documentation relevant to the operation of the QMS for GLOBALGAP (EUREPGAP) compliance exist and are they adequately controlled including: Work instructions Do all documentation relevant to the operation of the QMS for GLOBALGAP (EUREPGAP) compliance exist and are they adequately controlled including: Recording forms Relevant external standards, e.g. the current GLOBALGAP normative documents. QM 7 RECORDS QM 7. 1 QM 7. 2 QM 7. 3 QM 7. 4 Does the group maintain records to demonstrate effective control of the GLOBALGAP Quality Management System requirements and compliance with the requirements of GLOBALGAP standard? Are the records from the QMS related to compliance of GLOBALGAP requirements kept for a minimum of 2 years? Are all records genuine, legible, stored and maintained in suitable conditions and accessible for inspection as required? 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? 22

27 What to do 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 Sep07. All standard documents are available on the GLOBALGAP website ( 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.) Worker s 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. 23

28 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 group s activities are covered and the system is well-structured. Words can be simple and easy. Sentences can be short and concise. When the group s 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. 24

29 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 group s technical manager may decide what product to apply, when, how, its dosage etc., and the members cannot apply anything without the technical manager s 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. Example Centralized system The group s technical manager decides what members should do on a farm. Records are kept by the group s technical manager. The group has its own sprayer team and harvesting team, and sends them to members farms. 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. Example Decentralized system 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 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 noncompliance. General tendency is that a farmer s 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 group s 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. 25

30 Examples 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 Worker s health, safety and welfare Waste and pollution management Environmental conservation Site Management 26

31 Planting material 27

32 Soil management and fertilizer use 28

33 Irrigation 29

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35 Plant Protection Products 31

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38 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. 34

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40 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. 36

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43 Worker s health, safety and welfare You can conduct a risk assessment first, and then develop policies based on the risks identified. 39

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47 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. 43

48 Environmental conservation 44

49 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. GLOBALGAP Requirement 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 Is there a written procedure defining the control of documents? QM QM QM QM QM Are all documentation reviewed and approved by authorized personnel before issue and distribution? Are all controlled documents identified with an issue number, issue date/review date and be appropriately paged? 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? Is a copy of all relevant documentation available at any place where the QMS is being controlled? 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? What to do 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.) 45

50 Examples 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. 46

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52 2.6 Traceability system GLOBALGAP Requirement QM 10 PRODUCT TRACEABILITY AND SEGREGATION QM QM QM 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? 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? 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 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 QM Are there documented procedures in place to effectively manage the withdrawal of registered products? 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 Is the procedure capable of being operated at any time? QM Is the procedure tested in an appropriate manner at least annually to ensure that it is effective and records of the test retained? What to do 1 Design a traceability system that would suitable for your group s 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. 48

53 Examples 49

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55 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 party s 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 group s QMS manual and the GLOBALGAP standard. GLOBALGAP Requirement QM Contractual Documentation QM Is there written signed contracts between each producer and the legal entity? QM Does the contract include the following information? QM Name or fiscal identification of the producer QM Contact address QM Details of the individual production locations QM Commitment to comply with the requirements of the GLOBALGAP standard QM QM QM 1. 3 QM 1. 4 QM Agreement to comply with the group s documented procedures, policies and where provided, technical advice. Sanctions that may be applied in case of GLOBALGAP and any other internal requirements not being met. Are producer group registered members legally responsible for their respective production locations? 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? Is the administrative structure of the producer group documented and does it clearly identify the relationship between the producers and the legal entity? What to do 1 Draft a contract that addresses the members responsibilities and the group s 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 group s office. Give the copy to the producer. Examples Following is an example of contract of a papaya producer group: 51

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58 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. GLOBALGAP Requirement QM 9 INTERNAL AUDITS AND INSPECTIONS QM 9. 1 Quality Management System Audit QM 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 Is the QMS for the GLOBALGAP scheme audited at least annually? QM 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 QM Is an internal audit system in place to inspect the producers and farms against the GLOBALGAP standard? 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 Is there a process for the review of the inspection reports and producer status? QM QM QM Are new members of the group always internally inspected prior to them entering into the GLOBALGAP registered producers list? Are the original inspection reports and notes maintained and available for the CB inspection as required? Does the inspection report contain the Identification of registered producer and production location(s)? QM Does the inspection report contain the Signature of the registered producer? QM Does the inspection report contain the Date of the inspection? QM Does the inspection report contain the Inspector name? QM Does the inspection report contain the Registered products? QM QM QM Does the inspection report contain the Evaluation result against each GLOBALGAP control point? 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? Does the inspection report contain the Details of any non-compliances identified and time period for corrective action? QM Does the inspection report contain the GLOBALGAP status of the producer member? QM 9. 3 Non-Compliances and Corrective Action Systems 54

59 QM QM QM 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? Are there documented procedures for the identification and evaluation of noncompliances to the QMS by the group or by its members? Are the corrective actions following non-compliances evaluated and a timescale defined for action? QM Is the responsibility for implementing and resolving corrective actions defined? QM 13 SUBCONTRACTORS QM QM QM 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)? Are records maintained to demonstrate that the competency of any subcontractor is assessed and meets the requirements of the standard? Do subcontractors work in accordance with the group s QMS and relevant procedures and is this specified in service level agreements or contracts? QM Do inspectors not inspect their own daily work? QM QM Is the approval of the members of the group, based on inspection reports of the internal producer group inspector? (Refer to 3.1.i) Do internal auditors not audit the QMS if he/she implemented or operates the QMS for the group? What to do 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. 55

60 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 timeconsuming. 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 Inspector s name Farmer s name Farmer s 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. 56

61 Examples 57

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63 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. GLOBALGAP Requirement QM 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 QM QM QM Does the group operate a system of sanctions and non-conformances with their producers, which meet the requirements defined in the GLOBALGAP General Regulations? Do the contracts with individual producers define the procedure for sanctions including the levels of Warning, Suspension and Cancellation? Does the group have mechanisms in place to notify the GLOBALGAP approved Certification Body immediately of Suspensions or Cancellations of registered producers? Are records maintained of all sanctions including evidence of subsequent corrective actions and decision-making processes? What to do 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. 59

64 Examples 60

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66 Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) GmbH Dag-Hammarskjöld-Weg Eschborn / Germany T F E info@gtz.de I