Reliability in the Feed and Feed Additive Chain with the FAMI QS Certificate

Purpose of the FAMI QS System and Sector Scope

The FAMI QS certification system is an internationally recognized management and conformity assessment system developed to establish quality, reliability, and traceability throughout the feed and feed additive supply chain. Rather than adopting a narrow approach focused solely on final product safety, the system provides a comprehensive control framework covering all stages from the initial sourcing of raw materials through production, storage, handling, and logistics activities. In this respect, FAMI QS is based on systematic risk management across every link of the supply chain.

The primary objective of the FAMI QS system is to ensure that feed and feed additives are produced in a safe, traceable, and legally compliant manner, to manage potential quality and safety risks across the supply chain through a preventive approach, and to achieve alignment with the expectations of the European market. The system aims to instill a proactive management culture that identifies and controls risks in advance rather than relying on reactive control practices.

Within this scope, FAMI QS covers not only manufacturing facilities but all activities related to feed and feed additives. Additive manufacturers, premix producers, storage facilities, trading and distribution operations, and logistics service providers are included within the system. As a result, product safety is assured not only at the production stage but throughout the entire supply chain.

The sectoral scope of the FAMI QS system is structured to take into account the different risk profiles of actors within the feed chain. The risks associated with a manufacturing facility differ from those of an organization engaged solely in storage or distribution. The system addresses these differences by defining appropriate control and documentation requirements for each type of activity, ensuring broad applicability across the sector.

The FAMI QS certificate should not be regarded merely as a technical compliance document. It represents a strong corporate reference demonstrating an organization’s quality management approach, risk awareness, and responsibility across the supply chain. In particular, multinational customers and large feed producers consider FAMI QS certification an important criterion in supplier selection.

The system also plays a critical role in regulatory compliance. European Union feed legislation and related regulations increasingly emphasize traceability and risk management across the supply chain. The FAMI QS standard translates these regulatory expectations into operational requirements, thereby facilitating compliance for organizations.

Holding a FAMI QS certificate not only strengthens trust in existing markets but also provides a significant reference for entering new markets. The certification contributes to the reduction of customer audits, accelerates supplier approval processes, and supports the establishment of more sustainable commercial relationships, directly enhancing its commercial value.

From a sector-wide perspective, the FAMI QS system establishes a common quality language across the feed and feed additive supply chain. This shared framework enables organizations operating in different countries and activity areas to be evaluated against consistent quality and safety criteria, thereby fostering consistency and mutual trust throughout the chain.

In this context, the FAMI QS system is positioned not as a regulatory obligation but as a strategic management standard that sustainably ensures quality, safety, and market alignment for organizations operating within the feed and feed additive supply chain.

Risk-Based Approach and Critical Control Points

The risk-based approach that constitutes the foundation of the FAMI QS system is designed to systematically identify, analyze, and control quality and safety risks that may arise within the feed and feed additive supply chain. This approach is not reactive to past nonconformities; instead, it focuses on anticipating potential risks before they occur and managing them through preventive and structured control measures.

Risk-based thinking is integrated into all operational stages within the FAMI QS system. From raw material acceptance to production processes, storage, and dispatch activities, each step is evaluated in terms of potential hazards, the likelihood of occurrence, and the possible impact on product safety and quality. Based on this evaluation, risks are prioritized, ensuring that resources are allocated to the most critical control areas.

Critical control points represent the practical implementation of risk analysis in the field. These points correspond to stages where risks can be effectively monitored, controlled, and, when necessary, corrected through defined corrective actions. Within the FAMI QS framework, critical control points are determined specifically for each organization, taking into account its activity type, product range, and process structure. Therefore, a company-specific risk map is expected rather than reliance on a generic checklist.

One of the most common implementation errors is treating risk analysis merely as a documentation requirement. Under the FAMI QS system, risk analysis is regarded as a living process that must be continuously reviewed and updated. The introduction of new raw materials, process modifications, supplier changes, or capacity increases necessitates a reassessment of existing risk evaluations.

Within the scope of FAMI QS, risks are not limited to physical or chemical hazards. Inadequate storage conditions, cross-contamination risks, labeling errors, documentation deficiencies, and human-related operational mistakes are also considered system-level risks. This comprehensive perspective ensures that the standard safeguards not only product safety but also overall process reliability.

Once critical control points have been identified, appropriate monitoring methods must be defined. Monitoring may include measurement, observation, record-keeping, or verification activities. The key expectation is that defined control points are monitored regularly and that rapid intervention mechanisms are activated in the event of deviations.

The risk-based approach enables organizations to prioritize their controls effectively. Focusing on high-risk stages rather than applying equal control to all processes optimizes resource utilization and enhances overall system effectiveness. This practicality is one of the core strengths of the FAMI QS system.

From an audit perspective, the effective implementation of the risk-based approach is assessed through on-site observations, records, and personnel awareness. Employees’ understanding of critical control points, awareness of associated risks, and compliance with defined procedures clearly demonstrate the maturity level of the system.

An effective risk-based approach enables organizations not only to successfully pass FAMI QS audits but also to present a strong reference during customer audits and official inspections. Companies that identify and manage their risks systematically become reliable and preferred partners within the supply chain.

In this context, the effective identification and management of critical control points is one of the most decisive factors in ensuring the operational effectiveness of the FAMI QS system. Organizations adopting this approach not only meet standard requirements but also secure supply chain confidence and market compliance on a sustainable basis.

Raw Material Acceptance, Storage, and Contamination Risks

Within the scope of the FAMI QS system, raw material acceptance and storage activities represent critical stages where risks within the feed and feed additive supply chain first materialize and can be effectively controlled. Deficiencies or incorrect practices at these stages may directly compromise final product safety, regardless of how well-controlled the production processes may be. For this reason, raw material acceptance and storage are treated as clearly defined, traceable, and continuously reviewed control areas within the FAMI QS framework.

The raw material acceptance process is not limited to the physical receipt of materials at the facility. It represents a multi-layered control mechanism aimed at verifying supplier compliance, confirming shipment documentation, checking conformity with defined specifications, and preventing potential risks from entering the production process. From the FAMI QS perspective, this stage constitutes the first line of defense within the supply chain.

The storage stage focuses on maintaining the safety and integrity of accepted raw materials on a continuous basis. Warehouse layout, area segregation, environmental conditions, and personnel practices play a decisive role in managing contamination risks. Physical mix-ups, incorrect labeling, or inadequate environmental controls are among the most common causes of major nonconformities identified during FAMI QS audits.

Under the FAMI QS system, raw material acceptance and storage processes are assessed in accordance with the risk-based approach. Different control levels are defined by considering criteria such as raw material type, intended use, contamination sensitivity, and storage duration. This ensures that targeted, risk-appropriate measures are implemented instead of a uniform control approach for all materials.

Below are the primary control areas and associated risk topics that are examined in detail during FAMI QS audits for raw material acceptance and storage processes.

Under the FAMI QS approach, storage is not viewed solely as physical space management. Warehouse personnel awareness, material handling methods, and routine warehouse inspections are also assessed in terms of system effectiveness. Personnel-related errors are often treated as indicators of systemic deficiencies.

From an audit perspective, raw material acceptance and storage processes reflect the overall risk management maturity of an organization. Defined acceptance procedures, regular warehouse inspections, and disciplined record-keeping constitute strong evidence that the FAMI QS system is effectively implemented in practice.

In this context, effective management of raw material acceptance and storage is one of the most tangible indicators of the operational value of the FAMI QS certificate. Organizations that manage these processes in a risk-based, traceable, and disciplined manner sustainably support supply chain reliability and European market compliance.

Production Process Control and Process Validation

Within the scope of the FAMI QS system, production process control is one of the core management areas through which the safe, consistent, and specification-compliant production of feed and feed additives is assured. Process control demonstrates not only that production takes place, but that it is carried out within defined parameters and in a manner that minimizes risks. Therefore, production activities must be managed through documented procedures and measurable criteria rather than left to ad hoc practices.

The control of production processes begins with systematic planning under the FAMI QS approach. For each product group and each process step, inputs, process parameters, and expected outputs are clearly defined. Parameters such as mixing times, dosing ratios, temperature, pressure, and humidity have a direct impact on product safety and quality and must therefore be kept under effective control as a fundamental requirement.

Process control is not limited to automation systems or machine settings. Manual interventions, operator practices, and shift changes must also be included within the control scope. Ensuring that operators are adequately trained on process requirements, follow defined instructions, and understand how to act in case of deviations is a key focus area during FAMI QS audits.

Process validation aims to demonstrate, based on objective evidence, that production controls are effective. Validation activities include measurements, analyses, and evaluations designed to confirm that defined processes operate as planned and deliver the intended outcomes. This approach emphasizes actual on-site performance rather than theoretical compliance.

Under the FAMI QS system, process validation must be performed at defined intervals or following critical changes. New equipment investments, formulation changes, capacity increases, or revisions to process flow require existing validations to be reviewed and, where necessary, renewed. This ensures that the system remains dynamic and continuously updated.

Methods used for validating production processes may vary depending on the organization’s activity scope. Physical measurements, process monitoring records, sample analyses, and performance evaluations are commonly used tools. The key expectation is that selected validation methods adequately address identified risks and produce interpretable results.

From an audit perspective, process control and validation activities directly reflect the maturity of an organization’s management system. Consistency between documented procedures and on-site practices, disciplined record-keeping, and improvement actions based on validation outcomes provide strong evidence of effective system implementation.

Recording the results of process control and validation activities is critical for traceability and auditability. These records serve as primary evidence of system continuity during both FAMI QS audits and customer inspections. Incomplete or inconsistent records may undermine system effectiveness even when validation activities have been conducted.

An effective approach to process control and validation delivers benefits beyond certification compliance. It enhances production efficiency, product consistency, and customer satisfaction. In this respect, the FAMI QS system establishes a direct link between quality management and commercial performance.

In this context, production process control and validation clearly demonstrate that the FAMI QS certificate represents not merely a formal document, but a disciplined, measurable, and continuously improved production management system. Organizations that implement this system effectively position themselves as reliable and preferred partners within the supply chain.

Supplier Evaluation and Approval Mechanism

Within the scope of the FAMI QS system, the supplier evaluation and approval mechanism is one of the most critical pillars determining the reliability of the feed and feed additive supply chain. Since final product safety is largely dependent on the quality of supplied raw materials and services, supplier management must be addressed not merely as part of procurement activities but as a strategic control area at the core of the overall risk management system.

Under the FAMI QS approach, supplier evaluation is not designed as a one-time compliance check. Instead, it represents a continuous and dynamic management cycle extending from supplier selection and approval to performance monitoring and, where necessary, suspension. This approach enables the early identification of risks within the supply chain and their control at the source.

The initial stage of supplier evaluation focuses on analyzing the supplier’s scope of activity, the impact of the supplied product or service on feed safety, and the level of risk associated with that impact. High-risk raw materials or critical service providers are subject to more detailed evaluation and verification processes. This differentiated approach is fully aligned with the risk-based logic of the FAMI QS system.

When establishing a supplier approval mechanism, evaluation criteria are expected to be documented and objective. Decisions based on personal judgment or habitual practices weaken system reliability. Therefore, all criteria used in the approval process must be predefined, recorded, and readily available for review during audits.

Supplier evaluation criteria are not limited to regulatory compliance alone. Technical competence, traceability capability, quality management infrastructure, and historical performance are also assessed in a holistic manner. This evaluation not only reflects the supplier’s current status but also its potential to function as a sustainable business partner.

Below are the primary criteria commonly applied during supplier evaluation within the FAMI QS system.

• Legal and Regulatory Compliance: Verification that the supplier operates in compliance with applicable feed and feed additive legislation and holds required permits.
• Certification Status: Availability of FAMI QS, GMP+, ISO, or equivalent quality and safety management system certifications.
• Product and Raw Material Traceability: Existence of batch-based record systems and the practical implementation of traceability.
• Technical Documentation Adequacy: Completeness of specifications, analysis reports, safety data sheets, and composition declarations.
• Past Performance and Reliability: History of nonconformities, complaint records, and effectiveness of corrective actions in previous collaborations.

Supplier approval does not mark the end of the process. The FAMI QS system requires periodic monitoring of approved supplier performance. This monitoring enables the early detection of changes and emerging risks within the supply chain.

Performance monitoring activities typically address criteria such as delivery conformity, product quality, lead times, and nonconformity management. Based on these evaluations, suppliers may be classified as approved, conditionally approved, or suspended, allowing the system to dynamically adjust according to risk levels.

• Conformity of deliveries with specifications and contractual requirements
• Packaging and transportation conditions during shipment
• Responsiveness to identified nonconformities
• Effectiveness of corrective and preventive actions
• Timely communication of process or product changes

From an audit perspective, the supplier evaluation and approval mechanism is a strong indicator of how thoroughly an organization has adopted the FAMI QS system. Defined criteria, regular evaluations, and documented decision-making processes demonstrate that the system is applied in practice rather than existing solely on paper.

Organizations adopting this approach extend the reliability benefits of the FAMI QS certificate beyond their own operations to their entire network of business partners, strengthening their position as trusted and preferred actors within the sector.

Audit Structure, Nonconformity Management, and Continuity

Within the FAMI QS system, the audit structure is not designed merely as a result-oriented control mechanism, but as a strategic evaluation tool that comprehensively assesses an organization’s risk management approach, process control capability, and level of organizational discipline. Audits aim to determine not only whether the system exists, but also to what extent it is effectively implemented, sustained, and embedded in daily operations. For this reason, audit performance is directly linked to long-term system maturity rather than short-term preparation efforts.

FAMI QS audits focus on the extent to which organizations implement their own defined processes. From the auditor’s perspective, the key question is not “Are the documents available?” but “Do the documents have practical application on-site?” Procedures, instructions, and risk analyses must be clearly reflected in production areas, storage practices, and employee behaviors to be considered effective.

One of the most critical outcomes of audits is the identification of nonconformities. However, under the FAMI QS approach, nonconformities are not treated as indicators of failure, but as analytical data points that reveal areas requiring system improvement. This perspective shifts nonconformity management from a defensive reaction to a core element of organizational learning and continuous improvement.

Nonconformity management extends beyond the simple correction of identified deficiencies. The primary expectation is a thorough analysis of root causes and the elimination of underlying systemic weaknesses that led to the nonconformity. Temporary fixes, audit-day-only corrections, or actions dependent on individuals are not considered sustainable within the FAMI QS system.

The manner in which nonconformities are addressed during audits clearly reflects an organization’s system maturity. Organizations that acknowledge nonconformities, analyze their causes transparently, and implement realistic corrective actions are perceived by auditors as more reliable and manageable. This approach supports an audit process that is developmental rather than punitive.

The concept of continuity within the FAMI QS system is not limited to the validity period of the certificate. Continuity encompasses keeping risk analyses up to date, maintaining uninterrupted process controls, managing changes in a controlled manner, and sustaining employee awareness. Without this holistic perspective, successful audits alone cannot ensure long-term compliance.

System continuity is directly related to an organization’s capacity for self-assessment. Internal audits, management reviews, and performance evaluations enable the identification of potential nonconformities before external audits occur. This structure demonstrates that the FAMI QS system is managed proactively rather than reactively.

From an audit standpoint, sustainable systems share common characteristics: processes are not person-dependent, records are consistent and complete, changes are controlled, and employees are aware of their roles and responsibilities. These elements are verified not only through documentation but also through observable practices on-site.

The FAMI QS audit structure provides organizations with more than confirmation of compliance. It offers an opportunity to evaluate and improve systems through an independent perspective. Organizations that leverage this opportunity effectively manage audits not as a risk, but as a natural component of organizational development.

In this context, the FAMI QS system delivers tangible value for organizations that view audits not merely as a compliance requirement, but as a strategic management model that enhances system maturity, strengthens risk awareness, and supports corporate reputation.

European Market Alignment and the Relationship with Customer Specifications

The FAMI QS certificate represents more than a formal certification requirement for organizations operating within the feed and feed additive supply chain; it constitutes a fundamental trust element in commercial relationships with the European market. European Union feed legislation establishes high expectations regarding traceability, risk management, and accountability throughout the supply chain. When combined with individual customer specifications, these expectations effectively position the FAMI QS system as a de facto market standard.

Major feed producers and multinational livestock groups operating in the European market evaluate suppliers not only on product quality, but also on their risk management capability and system maturity. The FAMI QS certificate serves as a common reference point that objectively demonstrates a supplier’s technical competence and organizational discipline within this evaluation process.

Customer specifications often include requirements that go beyond statutory obligations. These specifications may impose additional expectations related to raw material sourcing, process control depth, traceability detail, and supplier management practices. Because the FAMI QS system is structurally designed to address most of these requirements, it enables customer audits to be conducted in a more predictable and manageable manner.

One of the strongest aspects of the FAMI QS system in terms of European market alignment is its ability to establish a shared quality and safety language across the supply chain. This common framework enables organizations operating in different countries to be assessed against the same criteria, transforming customer specifications from ambiguous documents into systematically managed requirements.

Below are the key areas illustrating the relationship between the FAMI QS certificate, European market expectations, and customer specifications.

From an audit perspective, the effective alignment of customer specifications with FAMI QS requirements clearly reflects system maturity. Organizations that manage specifications manually and inconsistently exhibit lower audit performance compared to those that integrate these requirements into their management systems.

European market alignment is not limited to meeting the expectations of existing customers. The FAMI QS certificate also serves as a strong reference for acquiring new customers and entering new markets. In this respect, the certificate functions not only as a technical requirement but also as a commercial development instrument.

In this context, the FAMI QS certificate has become a strategic necessity for organizations seeking to maintain a long-term presence in the European market, manage customer specifications effectively, and demonstrate supply chain reliability at an institutional level.