FAMI-QS: safety and quality for specialty ingredients.

Specialty ingredients. Focused controls.

Eligibility should not be inferred from a trade name or an additive/premixture label alone. Describe the function, composition, intended use and manufacturing route. Unclear cases should follow the evaluation route provided by FAMI-QS. This grounds the project in a realistic scope rather than an informal interpretation of specialty ingredients.

Process analysis should distinguish synthesis, fermentation, extraction, formulation, mixing and other applicable routes. Processing aids, solvents, concentrations and transformations can change hazards and necessary controls. A generic diagram of receipt, processing and dispatch is insufficient to understand the risk of a particular ingredient.

Safety and quality need distinct but coordinated criteria. A batch may meet a commercial specification while presenting a hazard, or be safe but outside specification. Define parameters, methods, limits, release authorities and treatment of out-of-specification results. Any rework needs a documented assessment of eligibility and its effects.

Fraud assessment considers substitution, dilution, false claims and supply-chain vulnerabilities. Product defence considers intentional acts and unauthorised access. These exercises are more than an HACCP hazard list: they need scenarios, proportionate controls, responsibilities and review when circumstances change.

This guide describes a preparation method and does not replace official documents. Adapt controls to scope, risk and applicable legislation. References reviewed: 31 October 2026.

From requirements to daily controls

A system works when decisions are understandable and evidence follows processes. The following areas help organise the work and should be checked against the applicable requirements of FAMI-QS.

Define the scope before writing the manual

Scope describes what a business actually does: products, sites, commercial roles, processes, services and destinations. A flow map distinguishes product ownership, physical custody and control responsibility. For each outsourced activity, identify who decides, which information is provided and what evidence returns to the business. Exclusions require justification: calling something an external service does not make it irrelevant. A useful scope description is understandable to staff and the certification body, and consistent with orders, contracts, permissions and facilities.

Turn requirements into an operational matrix

For each applicable requirement, record the reference document, affected area, owner, procedure and expected evidence. The matrix distinguishes a documentation gap from a control that is not implemented. It also supports change management: a revision triggers review of affected rows rather than rewriting the whole manual. Having a procedure does not automatically close the assessment. Check that people understand it and records demonstrate the activity. Keep the matrix readable and connected to processes, rather than a collection of copied requirements.

Build a team that understands the process

The working team should understand purchasing, products, facilities, logistics and quality control in proportion to business complexity. In a small company, one person may hold several roles if competence and cover arrangements are clear. A consultant can facilitate the method but cannot invent operational site knowledge. Define responsibility for specification approval, batch holds, release and incident communication. Critical decisions must remain possible during holidays, night shifts and the normal manager’s absence. Test the organisation chart against a practical situation.

Describe the product and intended use

A product specification should explain identity, origin, relevant composition, safety characteristics, storage conditions and intended destination. It is more than a sales document. For a variable ingredient, understand the factors affecting composition and risk, including the originating process and seasonality. Compare supplier information with what is ordered, received and declared to customers. Where intended use is limited to particular animal categories or applications, those conditions should be visible in purchasing and release decisions. Approve specifications and update them when assessed conditions change.

Verify the flow diagram in the workplace

Follow the product through often overlooked steps: waiting, transfers, returns, rework, sampling, external storage and transport. Workplace verification compares each step with actual operations and departmental interfaces. A trader can also map the information flows and decisions under its control. An approved version records the date, owner and material changes. If an operator describes a different route, resolve the discrepancy before completing the analysis. An attractive but incomplete diagram can conceal real hazards and responsibilities.

Assess hazards with an explainable method

Consider biological, chemical and physical hazards plausible for the product, process and intended use. Explain the basis for likelihood and severity rather than recording a score alone. Useful inputs include process knowledge, testing, incidents, supplier information and relevant sector documents. Identify control measures and management criteria for significant hazards. Not every control is a CCP, and not every process necessarily needs one. Classification should follow the chosen method and applicable requirements, preserving the connection between hazard, measure, evidence and decision.

Make prerequisite programmes verifiable

Cleaning, maintenance, pest control, hygiene, water and waste management need risk-proportionate measures. Each programme should define areas, frequencies, methods, responsibilities and verification. A service contract alone does not prove adequacy: review reports, exceptions and required follow-up. Records should distinguish work performed from verification results. If cleaning is recorded but inspection finds residues, the system needs to address the discrepancy. Photographs and checklists can help when properly contextualised, but they should not replace a competent decision.

Approve suppliers and critical services

Approval starts with the purchase and its associated risk. Assess supplier identity, site, certified scope, specification, safety information and performance history. Define service-specific criteria for transport, storage, cleaning and testing. An expired or suspended certificate, or one covering another site, requires assessment before proceeding. State who maintains checks and how urgent purchases are handled. Exceptions should be authorised under applicable requirements, justified and traceable so a temporary exception does not become uncontrolled routine practice.

Control receipt and release

At receipt, connect the product with the order, supplier, batch and relevant documents. Assess visible conditions, identification and information needed for a decision. Checks should reflect risk and available evidence. An expected test result is not the same as a favourable result already received. Distinguish released, pending and blocked stock even when physical space is limited. Release needs a designated authority and understandable criteria. For rejected or conditionally accepted deliveries, retain the reason, communications and final destination.

Manage cross-contamination and sequencing

Contamination can originate from equipment, residues, dust, people flows, maintenance materials and previous loads. Assess how a contaminant can reach the product and which measures interrupt that route. In production, assess sequences and cleaning against actual products. In storage, check separation, identification and shared equipment. In transport, verify compartment suitability. Where validation demonstrates control effectiveness, test conditions and acceptance criteria should represent intended use. Material changes may require reassessment.

Sample to obtain usable information

Reliable results also depend on representative sampling and identification. Link product, hazard, batch, method, frequency and responsibility in the plan. Storage, transport to the laboratory and timing can affect interpretation. Before comparing a result with a limit, check units, matrix and reporting basis. Competent laboratories and suitable methods are essential but cannot correct poor sampling. Review trends and changes as well as exceedances. Document proportionate decisions about batches and suppliers.

Test traceability using a real batch

Follow records and quantities from supplier to recipient, including splits, mixtures, justified losses, stock and returns. Elapsed time is useful but not the only criterion: completeness and ability to make decisions matter too. Explain quantity differences instead of merely forcing a spreadsheet to balance. A recall simulation also checks contacts, decision authority and communication. For businesses without physical custody, test timely access to data held by warehouses and carriers.

Manage exceptions while retaining batch control

First control the product and prevent further unauthorised use. Then assess risk, identify affected batches and document the decision. Corrective action addresses the cause and includes an effectiveness check. Immediate correction and prevention of recurrence are different: cleaning an area resolves a condition but does not explain a recurring problem. Assess customer, certification-body and authority notifications against applicable duties and procedures. Records should reconstruct timing, people involved and decision reasons.

Verify competence, not attendance alone

Training starts with job tasks and mistakes that could undermine control. Drivers, buyers and production managers have different needs. Check understanding using a document, an exception or a decision requiring explanation. Records should identify the topic, participants, date and assessment result. A role change should trigger review of training needs. Translated instructions and visual aids may be needed. The most useful method enables people to perform the task correctly and recognise when to ask for help.

Use internal audits and review to make decisions

Internal audits sample activities and evidence against defined criteria. They should expose differences between intended and actual practice. The programme considers risk, changes and previous results; an audit may follow a process or a batch. Management review evaluates performance, incidents, resources, audit results and needed changes. Useful minutes contain decisions, owners and deadlines rather than a list of discussion topics. Action closure needs adequate evidence. Repeating the same document every year without evaluating real data reduces the system’s value.

Define hold criteria and decision authority

A hold should be understandable to the people handling a product, rather than only the quality team. Identify pending batches in information systems and, where relevant, in physical storage. Define how accidental use or dispatch is prevented and who can change the status. For stock held by third parties, obtain confirmation that the instruction was received and implemented. The final decision considers evidence, destination and applicable conditions. Record release from hold too. An unread email or a label not connected to a batch may leave stock available precisely when the business assumes it has been stopped. A practical exercise should therefore check both the instruction and its effect on the people or systems that can move the product.

Keep measurement equipment under control

Equipment affecting a safety decision needs control appropriate to its use. Identify the measurement, required accuracy and how suitability is demonstrated. Calibration evidence should identify the instrument and cover its operating range. If a deviation is found, assess the reliability of decisions since the last valid check. Equipment maintenance does not automatically confirm measurement accuracy. For automated systems, consider sensors, recording, alarms and resulting actions. A practical check should establish whether the system detects an unacceptable condition and whether staff respond as intended. Keep the assessment proportionate: a scale used for an indicative estimate may require a different approach from a sensor used to release a batch against a safety criterion. Explain that distinction in the equipment register.

Protect records and operational information

Paper and digital records should remain legible, identifiable and retrievable. Define access, responsibilities and version control for shared files. Changes to data supporting release or traceability need an explanation. A backup helps only if it can be recovered when needed. Recovery exercises are particularly useful when records sit on one computer or with an external provider. During an information-system outage, staff should know how to preserve identification, holds and delivery information. Information protection supports continuity without necessarily requiring complex tools: it needs workable rules and people who understand them. Consider staff turnover as well: a former employee’s account or personal mailbox should not be the only route to records needed for the next delivery or an incident response.

Review changes before introducing them

A new input, reformulation, modified line or different warehouse can change hazards and responsibilities. Review the change before introduction with relevant functions involved. Identify documents to update, necessary trials, training and start-up criteria. Changes do not all need the same depth of assessment; make the approach proportionate and explain it. After introduction, check whether actual conditions match those assessed. If a temporary arrangement remains in place, review it as part of the normal system. This prevents emergency solutions from remaining outside documented controls. The review should also ask whether customer information or the declared certification scope is affected, and whether the certification body needs notification under its applicable rules before the changed activity begins.

Compare records, interviews and observations

Evidence is stronger when different sources support one another. A procedure may describe a daily check, a record may document it and an operator may demonstrate how it is done. If those sources differ, establish why instead of seeking a favourable answer at any cost. An interview does not test memorised clause numbers; it checks understanding of work and decisions. Workplace observations also need context: timing, product and conditions matter. An audit report should separate observed facts from interpretation and identify the criterion used. This makes follow-up clearer and reduces arguments based on impressions. Sampling limits should remain visible too: reviewing a small number of records supports a conclusion about that sample and process, rather than a claim that every past delivery has been checked.

Measure improvement using useful indicators

Indicators should support decisions. Complaints, overdue actions, cleaning failures and test results can be useful if data are defined and comparable. An objective should state the starting position, expected result, owner and measurement method. If checking frequency changes, interpret comparisons carefully. Improvement does not always mean a smaller number: more reports can reflect better detection. Management review should therefore evaluate what the data mean and choose proportionate action. Reconsider an indicator that never informs a decision instead of retaining it merely to complete a table. Where an objective depends on checks being performed, retain evidence of those checks; a positive statement in meeting minutes cannot demonstrate progress when the underlying measurements were never recorded or cannot be reconstructed reliably.

Which evidence to prepare

A checklist is useful when every item leads to a document, a record or a workplace check. Select a sample representing relevant products, shifts and circumstances. Items do not apply identically to every business; keep the reasoning visible.

• Scope: clearly defined activities, products, sites, outsourcing and responsibilities.
• Requirements: applicable-document register with versions and last-check dates.
• People: assigned roles, cover arrangements and task-appropriate competence.
• Products: approved specifications, intended use and available safety information.
• Suppliers: product- or service-specific approval and documented periodic checks.
• Process: verified flow diagram, implemented prerequisites and reasoned hazard analysis.
• Controls: acceptance criteria, recording method and deviation management.
• Transport and storage: identification, cleaning, segregation and proportionate checks.
• Testing: plan, identified samples, evaluated results and follow-up to exceptions.
• Traceability: a real-data exercise explaining quantity differences.
• Audits and review: results, decisions, owners and corrective-action verification.
• Changes: assessment before introducing new products, processes, suppliers or sites.

A project with verifiable outcomes

At the outset we agree scope, working arrangements, data availability and expected outcomes. Timing depends on complexity and system maturity; no standard deadline is promised without assessment. Work can include document review, site visits, remote meetings, training and internal auditing. The plan distinguishes what Belevo prepares from what the business must approve and implement.

The final report should make clear what was reviewed and the limits of the assessment. Each gap needs a priority, expected outcome, owner and closure criterion. Unavailable evidence leaves an item open rather than compliant on the basis of an intention. Follow-up checks implementation and effectiveness, rather than merely receipt of a revised document.