GAP Training QUALITY MANAGEMENT SYSTEM Girish Sarda Structure of Presentation Objective: To address various clauses of Quality Management System for group Certification (Option 2) as per Global GAP Standards Clause -1 Producer Group Definition Clause -2 Administration and Structure Clause -3 Management and Organisation Clause -4 Competency and Training Requirement Clause -5 Quality Manual Clause -6 Document Control Clause -7 Records Clause -8 Complaint Handling Clause -9 Internal Audit/Inspection Clause -10 Product Traceability and Segregation Clause -11 Sanction Clause -12 Withdrawal of Certified Products Clause -13 Subcontractor 2 1
Clause 1: Producer Group In this we study in detail about the Producer Group What is a Producer Group.. Group of producers applying for certification with an internal procedure and internal control system. Robust Quality Management System (QMS) must be in place to ensure that the group s registered producer members/production locations comply in a uniform manner with the GlobalGAP standard requirements. producer group registered members must be legally responsible for their respective production locations. A producer group may have members that are not under GlobalGAP certification. 4 2
What is a Producer Group.. There need to be a structure to enable the application of a Quality Management System across the whole group. There must be contract between Producer group and each producer There must be defined entry and exit requirements for producer members A producer group is not a multi-site operation The entire crop of a registered product must be under certification. 5 Clause 2 : Administration and Structure In this we study in detail the administration and structure of the Group that undergoes certification 3
2.1 Legality Group must be a legal entity i.e. 1. Cooperative 2. Producers Association 3. Packing Company 4. Trading and or Farming Company, etc. Group that are consultancy companies, Non-Governmental Organizations, development agencies, agrochemicals distributor, etc. cannot form a GlobalGAP group. The legal entity is granted the right to carry out agricultural production and/or trading, 7 There needs to be a legal contract with group members. The legal entity is responsible for production, handling and ownership of the products as per Global GAP Legal entity is required to have a contractual relationship with GlobalGAP. This is done by having an agreement with GlobalGAP Sub-Licence and Certification Agreement with a CB such as SGS. The certificate is issued to the Legal entity which becomes the holder of the GlobalGAP certificate. 8 4
2.2 Structure Administrative structure of the Farmer Group..\Attachments\A -1 -Structure.pdf 9 2.3 Contractual Documentation All the group members needs to sign the contracts with legal entity which should have the details : Name or identification of the Farmer/Farm Contact address Individual farm location Commitment to comply with the requirements of the GlobalGAP standard 10 5
2.3 Contractual Documentation Agreement to comply with the Farmer Group documented procedures, policies and where provided, technical advice. Sanctions which may be applied in case of GlobalGAP requirements not being met. 11 2.4 Producer/Farmer Register Name or identification of the Farmer/Farm and Produce Handling Site Contact Person Contact address & Data Individual farm and Produce Handling site location Registered product (species/subspecies) grown and handled at the Produce Handling Sites. Growing area for each registered product Internal audit date Current GlobalGAP status..\attachments\producer Register.xls 12 6
Clause 3 : Management and Organisation In this we study in detail the management and Organizational structure of the Group 3.1 Structure GlobalGAP Management Representative Internal Audit Department Agricultural Technical Department Quality Systems Department Produce Handling site Management (if applicable)..\attachments\a -1 -Structure.pdf 14 7
3.2 Responsibilities & Duties Duties and Responsibilities of Key Staff must be documented. Nominated individual with sufficient seniority and resources..\attachments\a- 2 Responsibilities.pdf 15 Clause 4 : Competency and Training Requirement This Clause covers the competency and training requirements of the key staff personnel of the Group. 8
Competency & Training Requirement Key Staff Personnel must be trained and competent as per requirement of GlobalGAP standards and defined competency & qualification criteria of the group. The competency requirements, training and qualifications for key staff should be documented. More than one internal auditor - training and evaluation system. All key staff must be informed and aware of developments, issues and legislative changes relevant to the operation of the GlobalGAP Standards. 17 Clause 5: Quality Manual This clause covers the requirements for the Quality Manual. 9
Clause 5: Quality Manual The operating and quality management systems related to the GlobalGAP standard must be documented and contained in a Quality Manual. Policies and procedures should be sufficiently detailed to demonstrate the Farmer Groups control of the principal requirements of the GlobalGAP standards 19 Clause 5: Quality Manual Relevant procedures and policies should be readily available to registered member and key staff The contents of the Quality Manual needs to be reviewed periodically to ensure that this continues to meet the requirements of the GlobalGAP standard and Farmer Group. 20 10
Clause 6: Document Control This clause covers the documents needs to be controlled and the document control requirements. 6.1 QMS Documents of GlobalGAP Documents needs to be controlled - Quality Manual GlobalGAP Operating Procedure Work Instructions Recording Forms External Standards e.g GlobalGAP Standards 22 11
6.2 QMS Documents Control Requirements A written defined procedure for control of documents. System for review and approval before issue and distribution. by authorized personnel All documents must have issue number, issue date/review date and be appropriately paged. Any change in these documents must be reviewed and approved by authorised personnel prior to its distribution. 23 6.2 QMS Documents Control Requirements A copy of all relevant documentation must be available at any place where the Quality Management System is being controlled. There should be a system that ensures that documentation is reviewed and that following the issue of new documents. Obsolete documents must be effectively rescinded. 24 12
Clause 7: Records This Clause covers the requirements for the records keeping system. Records The Farmer Group need to maintain records to demonstrate effective control of the GlobalGAP quality management system and compliance with the requirements of the GlobalGAP standard. Records related to the GlobalGAP Quality systems must be kept for a minimum of two years. Records shall be genuine, legible, stored and maintained in suitable conditions and should be accessible for inspection as required. 26 13
Clause 8: Complaint Handling This clause covers the requirements for complaint Handling System. Complaint Handling The Farmer Group should have a system for effectively managing customer complaints. There should be a documented procedure which describes how complaints are received, registered, identified, investigated, followed up and reviewed. The procedure should be available to customers as required. The procedure should cover both complaints to the Farmer Group and against individual Farmers, Farms or Produce handling sites. 28 14
Clause 9: Internal Audits and Inspection This clause covers the Internal Audit System requirement, Quality System Audits, Internal Auditor Qualification, Internal Inspections, Internal Inspector Qualification, Non compliance and corrective action system. Internal Audit System Requirement To assess the adequacy and compliance of the QMS amongst the group. documented To assess the compliance of the farmers unit against the GlobalGAP standards. 30 15
9.1 Quality System Audits The quality management system for the GlobalGAP scheme needs to be audited at least annually. Internal Auditors must be suitably trained and independent of the area being audited. Records of the internal audit plan, audit findings and follow up of corrective actions resulting from an audit needs to be maintained and available at the unit. 31 Internal Auditor Qualifications 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. Practical knowledge of Quality Management Systems Completion of a short (2 days) internal auditor-training course related to QMS. 32 16
Internal Auditor Qualifications HACCP and Food Safety training Training in Pesticide, Fertiliser and IPM Practical Experience, applicable to the scope Working language skills 33 9.2 Farmers/Farm Inspection At least one internal inspection for all the registered farmers. There shall be a process for the review of the inspection reports and Farmers/Farms status. The original inspection reports and notes shall be maintained and be available for inspection as required. 34 17
9.2 Farmers/Farm Inspection The inspection report needs to contain the following information: Identification of registered Farmer Signature of auditee (registered member) Date of inspection carried out. Inspector Name and Signature 35 9.2 Farmers/Farm Inspection Registered products Evaluation result against each GlobalGAP control points Details of any non-compliances identified & time period defined for the corrective action. GlobalGAP status. 36 18
Internal Inspector qualifications Post High School qualification applicable to the scope One-day practical inspection course setting out basic principles of inspection. 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, there must be records of shadow audits between them. 37 Internal Inspector qualifications HACCP and Food Safety training Training in Pesticide, Fertiliser and IPM Practical Experience, applicable to the scope Working language skills 38 19
9.3 Non Compliance and Corrective Action System Procedure to be in place to handle corrective actions arises from internal & external inspections, customers complaints & failures of the quality system. Documented procedure for identification & evaluation of NC s to the quality systems or operation. Corrective actions following a non-compliance to be evaluated and a timescale defined for action. Responsible person to be identified for implementing and resolving corrective actions. 39 Clause 10: Product Traceability and Segregation This clause covers the requirements for traceability and segregation system to prevent the mixing. 20
Product Traceability & Segregation Traceability : Definition The ability to retrace the history, use or location of a product (that is the origin of materials and parts, the history of processes applied to the product, or the distribution and placement of the product after delivery) by the means of recorded identification". Traceability System must be in a place to prevent mixing. There shall be a documented procedure for the identification of registered products and to enable traceability from the field/orchard/greenhouse to the Produce handling site. 41 Product Traceability & Segregation The Produce Handling site shall operate procedures which enable registered product to be identifiable and traceable from receipt, through handling, storage and dispatch. Effective systems and procedures needs to be in place to negate any risk of mislabelling or mixing of GlobalGAP registered and non- GlobalGAP approved products. 42 21
Clause 11: Sanction This clause cover the points to operate a system of sanctions with their Farmers/Farms to meet the requirements defined in the GlobalGAP General Regulation Sanctions The Farmer Group shall operate a system of sanctions with their Farmers/Farms which meet the requirements defined in the GlobalGAP General Regulation. Contracts with individual Farmers/Farms shall define the procedure for sanctions Contract must include type of sanctions i.e. Warning Suspension Cancellation. 44 22
Sanctions The Farmer Group shall have mechanisms in place to notify the GlobalGAP approved Certification Body immediately of Suspensions or Cancellations of registered Farmers/Farms. Records shall be maintained of all sanctions including evidence of subsequent corrective actions and decision making processes. 45 Clause -12: Withdrawal of Certified Products This clause covers the requirements of GlobalGAP for Product Recall. 23
Withdrawal of Certified Product Needs to have a documented procedure for withdrawal of registered products Procedure must include the events in case product recall will be applicable. Responsible person must be identified for taking the decision for withdrawal, notifying the customers & GlobalGAP approved CBs. The procedure should be capable of being operated at any time. The procedure needs to be tested in an appropriate manner at least annually to ensure that it is effective and records of the test retained. 47 Clause -13: Subcontractor This clause covers the requirements to be comply for subcontracting any services from third party. 24
Subcontractor Procedure must exist to ensure that any services subcontracted to third parties are carried out in accordance with the requirements of the GlobalGAP Standards. Records to be maintained to demonstrate the competency of subcontractor is assessed and meets the requirements of the standard. Subcontractors needs to work in accordance with the Farmer Group Quality System and relevant procedures and this must be specified in service level agreements or contracts. 49 50 25