“fami-qs” european f eed a dditives and pre mi xtures q uality s ystem

“FAMI-QS”European Feed Additives and PreMIxtures

Quality System

Context and insights

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June 2005 (V3)The Expert Group of FAMI-QS2

Comment

Please use the link “back” in the upper right corner to jump to the general content page

Please use the links in the various pages starting the different chapters to take you quickly to your point of interest

Please use the links to the internet to access some information there quickly

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Content

Regulatory background The FAMI-QS Concept The Association The Certification The Code

– Products– Manufacturing– HACCP– Non-Conformances

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Content


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Hygiene in the feed chain

Directive 95/69/EC– (present)

The Feed hygiene Regulation proposal– (finalized 12/04, published January 2005 as

183/2005/EC, effective as of 01/01/06)

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Directive 95/69 – “Establishments”

Approval for activities which, are considered potentially hazardous to animals, humans or the environment.

Registration for products considered less sensitive.

In both cases establishments and intermediaries must comply with detailed "quality control" requirements.

Compliance is a precondition before approval (inspection by the competent authority) can be given.

The obligation to comply with those requirements continues once approval/registration has been obtained.

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Feed Hygiene Regulation

95/69 'enriched' by the Feed Hygiene Regulation Integrate the manufacturing and distribution of feed

additives, premixtures and complete feedingstuffs in a global food chain

Integrate, in particular, HACCP principle Scope

– Feed Business Feed additives, premixtures, feed materials, feedingstuffs

– Farmers– Imports

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Obligations for the chain:– Good Manufacturing Practices (including logistics)– Microbiological criteria (specific)– Hazard Analysis of Critical Control Points (HACCP)– Financial Guarantees– Approval / Registration

Guides for application of:– Good Manufacturing Practices– HACCP

Feed Hygiene Regulation

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Content


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Optimisation of efforts for feed safety by agreed upon measures

Auditable harmonized code throughout EU, thus

Minimization of need for checks by authorities, users

Advantages

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A tool for complying with the Feed Hygiene Regulation, which:– encourages the development of systems to good

practice for hygiene– requires the application of HACCP principles

Positive dynamic with chain partners

Compliance

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Basis

Code is based on established guidelines such as– Codex Alimentarius (HACCP)– EN ISO 9001:2000– Management systems developed in different

countries like GMP+, FEMAS, Q+S, …– EU proposal on feed hygiene

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Information

Information about the Code itself, as well as the association and the certification process can be found under

www.fami-qs.org

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Content


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The Association

'European Feed Additives and PreMIxtures Quality System Association'

'Not-for-profit' association (Asbl under Belgian law) Formally created on May 04, 2004 First General Assembly in Brussels in May 2004 Second General Assembly in Brussels in January

2005

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Purpose and Activities

Manage and co-ordinate all activities related to the EU Feed Additives and premixture Quality System – FAMI-QS

Establish, register and maintain the FAMI-QS system

Rule the use of the code Coordinate adequate certification systems

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Membership Structure

Full members– Manufacturers or traders of FA or PM– Members of FEFANA– Min. 5, no max., full voting rights

Associate members– Involved in the feed additive or premixture

business– FAMI-QS certified

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The Full Members*

Adisseo ADM Ajinomoto Alltech BASF Degussa

DSM FinnFeeds Lohmann Novus Novozymes Phytobiotics

*status June 2005

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The Board, Secretary General and Quality Manager

Rolf-Dieter Reinhardt (BASF) Hermann Roth (Phytobiotics) Matthew Russel (Alltech) Manfred Peisker (ADM)

Didier Jans (Secretary General) Ioan Paraian (Quality Manager/Coordinator)

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FAMI-QS Asbl flowchart

Board

Secretary General

Expert Panel Quality Manager

Accredited Certification Cies Platform

AuditorsConsultative Panel

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The History

Development of the Code of Practice (April ’03 – April ’04) FAMI-QS founded (May ’04) Training of certification bodies (June ‘04) Coordination meeting with Partner Platform (national

organisations for feed quality systems, June ‘04) FAMI-QS internal approval of certification bodies (mid-July) Final versions (ver. 1) of Code of Practice and Description of

Certification Process (July ‘04) Web site (August ’04) Start of certification process, audits (September ‘04) Second version of Code published in June 2005 First seven guidance with more detailed information on topics

such as transportation, HACCP, hygiene etc published

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The Status

First companies certified (15 companies / 30 sites)*

Increasing interest from other companies who plan to become certified, including companies from outside EU (India, China) (another 15 companies / 30 sites)*

* Status June 2005

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Content


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Recognised certification bodies only, certification bodies required to achieve accreditation under ISO 45011

Recognition is provided by the FAMIQS organisation Certification body responsibilities:

– Planning– Assessment of documents– Audits– Audit reports– Certification

Use of certificate is conditioned to FAMI-QS membership (associate or full)

Granting a FAMI-QS Certificate

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Certification of EU operators

All EU based operators should be certified by 01 Jan. 2006

Operators buying Feed Additives from another EU based operator should provide a verifiable plan with milestones and deadlines for ensuring the certification of their supplier (in case a supplier is not certified yet).

– This case covers the period until January 2006.

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Certification of Importers and Manufacturers outside the EU

Operators buying Feed Additives from a non EU operator should provide a verifiable plan with milestones and deadlines for ensuring the certification of the supplier and the initial manufacturer of the Feed Additive.

Deadline for the supplier and initial manufacturer to apply for FAMI-QS certification shall not be later than end 2006, and for getting certification no later than end 2007.

– It is the auditor's responsibility and obligation to check that above mentioned deadlines are respected. Failure to do this would create a critical non conformity at the operator's (this means a withdrawal of the certificate).

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One certificate for entire EU

(...)hereby certifies that the company:(...)has implemented and maintains a Quality Management System in compliance with the FAMI-

QS Standard (ver. xx, date dd/mm/yy)on the following site(s):(…)for the placing on the market of feed additives belonging to the following category(ies) and

functional group(s):(…)Audits, documented in a report, have verified that the Management System fulfils the

requirements of this standard.This certificate is valid until: (...)

The validity of this certificate can be verified on the FAMI-QS web site (www.fami-qs.org)

N.B.: For premixtures, the information about feed additive categories is not relevant

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Content


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The Code

The Code provides among other items requirements for good manufacturing of

– Products– Handling of ingredients– Traceability– HACCP– Logistics (incl. warehousing, transportation)

Its consists of text and questions which are both used to define the requirements

Details and explanations can be found in the following slides The Code can be found on the FAMI-QS homepage under

documents (or click here)

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The Code

Products

Manufacturing

HACCP

Non Conformances

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The Code

Products– Specification– Suppliers– Incoming Materials– Stability– Traceability

Manufacturing– Building and Equipment– Work Environment– Finished Goods

– Packaging & labelling– Quality Control– Verification– Blending– Warehousing & Storage– Transport– Cleaning

HACCP Non Conformances

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A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material shall conform to be considered acceptable for its intended use. “Compliance to specification” means that the material, when tested according to the listed analytical procedures, meets the listed acceptance criteria.

Specifications

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Principle:

The specification ensures that an ingredient used always has a predefined agreed upon quality.

Specifications

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Specifications are needed for– Incoming raw materials– Packaging materials– Final products– Labels

Specifications

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Specifications need to ….– Be adequate to control the quality of the material for its

intended use and contain e.g. Acceptance limits Reference to the method

– Reflect possible hazards e.g. Microbiology were applicable Undesirable substances were applicable

– Take into account regulatory requirements– Be part of the change control procedure and need to be

amended if applicable

Specifications

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Principle:

As the goal is to ensure safety throughout the whole food and feed chain the risks brought in from suppliers have to be considered and controlled equally well as risks brought in by the operator

Suppliers

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Suppliers of incoming materials must be– Evaluated

A risk consideration must be made for raw materials and primary packaging

Samples tested for at least selected criteria in case of raw materials Agreements made Statements requested

– Approved According to defined criteria including where necessary audit results

– Listed in an internal list of approved suppliers The list must be reviewed periodically, at least once a year Evaluated for their continuous performance

Suppliers

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Targets

– All suppliers of Feed additives or premixtures must be approved according to FAMI-QS

– For other raw materials appropriate risk analysis must be conducted

.

Suppliers

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Interim measures– All EU based FA and PM operators should be certified by January 2005.– Operators buying feed additives (FA) from another EU based operator should

provide a verifiable plan with milestones and deadlines for ensuring the certification of their supplier (in the case a supplier is not certified yet). This case covers the period until January 2005, cf. 1.

– Operators buying FA from a non EU operator should provide a verifiable plan with milestones and deadlines for ensuring the certification of the supplier and the initial manufacturer of the FA. Deadline for the supplier and initial manufacturer to apply for FAMI-QS certification shall not be later than end 2006, and for getting certification no later than end 2007.

– It is the auditor's responsibility and obligation to check that above mentioned deadlines are respected. Failure to do this would create a critical non conformity at the operator's (this means a withdrawal of the certificate).

Suppliers

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Incoming material: A general term used to denote raw materials (starting materials, reagents, solvents), process aids, packaging and labelling materials

Raw material: Any material which enters the manufacturing process of the feed additive and/or premixture.

Incoming Materials

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Principle:

Incoming materials are one of the critical points to potentially include hazards for humans or environment into the product. Thus they must be strictly controlled in order to avoid such hazards.

Incoming Materials

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Requirements for approval of incoming materials must be established. They are

– Risk considerations – Sourcing only from suppliers listed

internally as approved– Specifications, including test methods

Incoming Materials

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It is important to define

– Transport – Storage– Processing– Handling

before usage of incoming materials in order to ensure that no adulteration or additional risk arises

Incoming Materials

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When the incoming material is received the operator has to verify

– supplier’s lot number– full supplier’s name of product– date of receipt– quantity received – any findings of deviations on agreed upon quality. These

are to be reported to the quality control unit

Incoming Materials

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Retained sample– To be kept for the period of shelf life, either at the

supplier or the operator

Rejected material– Must be strictly controlled by proper

identification/storage to avoid unauthorized usage

Incoming Materials

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A proper shelf life has to be established in order to indicate for the customers, how long the guaranteed specification can be expected.

– Stability has to be defined, preferably by measurements, or if applicable (e.g. in case of premixtures) theoretical considerations can be used

– Indications about storage conditions which ensure specifications throughout the shelf life period must be given

Stability

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Principle:

‘Traceability’ means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution; products (178/2002/EC)

Traceability

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Incoming materials

Maintain a register, that contains the names and addresses of manufacturers of incoming materials, additives or of intermediaries

Confirmation by the supplier to have a traceability system established or verification through an audit (future requirement)

Traceability

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Product traceability during manufacturing

Identify and record the product by suitable means throughout product realisation

The nature and quantity of the additives and premixes produced, the respective dates of manufacture and, where appropriate, the number of the batch or of the specific portion of production in the case of continuous manufacture

Traceability

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Deliveries

the name and addresses of the intermediaries or manufacturers or users to whom the additives or premixes have been delivered must be recorded

Indicate the nature and quantity of the additive or premix delivered and, where appropriate, the number of the batch or of the specific portion of production in the case of continuous manufacture

Traceability

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The Code

Products– Specification– Suppliers– Incoming Materials– Stability– Traceability

Manufacturing– Building and Equipment– Work Environment– Finished Goods

– Packaging & labelling– Quality Control– Verification– Blending– Warehousing & Storage– Transport– Cleaning

HACCP Non Conformances

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Suitable Building & Equipment

Principle: Buildings, facilities and equipment should be maintained in a good state of repair and should be of suitable size,construction, and location to facilitate cleaning, maintenance, and proper operation

Adequate building/equipment - open or closed, different level of protection, handling of product at the same time, minimizing cross-contamination, minimizing the risk of errors, hygienic design of plants and equipment permit effective cleaning and maintenance, material of construction, capable of operation

Adequate space for orderly placement of equipment and materials to prevent mix-ups

Adequate workspace - minimizing mix-ups, avoiding cross-contamination

Defined areas for the following activities: storage, production, control and laboratory operations (separate rooms for different kind of tests, microbiological tests, powder handling, weighing rooms)

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Suitable Building & Equipment cont’d

Adequate utilities - direct contact with the product i.e. compressed air (oil free), water quality should be adequate

Waste material - clearly identified and disposed in accordance with local regulations

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Work Environment

adequate ventilation and exhaust systems - prevent contamination of the product, attention to re-circulating systems

adequate control of humidity

adequate control of temperature

adequate lighting - to enable all operations to be carried out accurately and safely, according to National regulations (Health & Safety)

adequate clothing requirements should apply to all personnel, facilities for changing cloth, showering (special hygiene practice should be applied)

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Production of Finished Goods

Finished product - written specification, unique name or code to avoid mix-ups

Work instructions - product specific procedures for all stages of production ensuring re-produceability, mastering the critical points, details of necessary precaution to be taken to avoid cross-contamination and errors, sampling instructions, weights and measures of components used, persons performing the operation

Records - confirmation that procedures are followed, identify deviations

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Production - Packaging & Labeling

Principle: Where products are packaged, care must be taken to avoid contamination during the packaging process, and to ensure that packaged products are correctly identified and labelled in compliance with the provisions of feed regulations in force. Packaging must be appropriate to product type and to maintain contents for their intended shelf life

Packaging material is appropriate - no detrimental effect on the product (primary packaging material)

Each package must be labelled - name of the product, batch/lot number, shelf life (traceability)

Label control - identification, examination of identity and conformity with a master, release, reconciliation (numbers of labels printed vs. number of labels used)

One labeling operation at the same time - to avoid mix-ups

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Production - Quality Controls

Principle: Quality control ensures that the necessary tests are actually carried out and that finished products are not released for use until their quality has been judged to be satisfactory

All finished product should be inspected prior to dispatch - ensure that the customer receives material which is released; product is meeting written specifications

In-Process testing - monitoring the process

Analytical methods and test procedures - level of detail that analyst are able to understand how to proceed

Measuring and test equipment - properly calibrated and maintained

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Production - Verification of the Process

Principle: Any process where the resulting output cannot be controlled by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or has been delivered

Verification shall demonstrate the ability of a process to achieve planned results - focus on deemed critical operations i.e. blending (homogeneity), to built in quality into the process

The operator shall establish arrangements for these processes including, Defined criteria for review and approval of the manufacturing processes - monitoring of CCPs Approval of equipment - equipment including instrumentation is qualified (qualified operating range) Qualification of personnel - proper training of personnel, adequate number, appropriate education,

experience Use of specific methods and procedures - additional testing Requirements for records - record keeping

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Production - Blending of Finished Products

Principle: Manufacturer should not rely on blending - mixing adultered feed with good feed to bring the contaminant to a suitable low level - instead exercising maximum effort to avoid contamination in the first place

Before starting a blending operation an assessment of the risks has to be done

Blending process should be controlled to ensure homogeneity with respect to critical product attributes

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Warehousing – Storage

Principle: The finished product, intermediates and raw materials should be handled and stored under appropriate conditions so that their quality and purity are not affected

Storage areas should be of sufficient capacity - to allow orderly storage of various categories: raw materials, packaging materials, intermediates, finished product, products in quarantine, released, rejected, returned or recalled products, hazardous/unstable chemical

A stock rotation system should be in place - FIFO

Materials should be stored in a manner to prevent degradation, contamination, and cross-contamination

Storage areas should be clean, dry and maintained - to minimise the risk of damage of packaging and spillage of material

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Warehousing - Storage cont’d

All containers should be clearly marked with unique identifier(s)which reflect at least name of the material, lot number, shelf life/best use before date, storage conditions

Storage conditions based on label claim - where special storage conditions are required on the label (T, % rH) monitoring and recording is required, retention time for records is at least shelf life

All returned goods should be placed in quarantine and returned to saleable stock only after this has been approved by nominated person following a satisfactory quality re-evaluation

Pallets must be serviceable, e.g. depending on risk considerations clean and dry. All pallets, which are returned, must be inspected and if necessary cleaned before re-use

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Warehousing - Pest Control

Principle: Buildings should be free of infestation by rodents, birds, insects and other vermin

There should be a written program - location, frequency, agents Pest-control agents - safe, approved, MSDS available to the

operator Record keeping - date, name, results, Included into HACCP plan - risk of cross-contamination due to

infestation or use of pesticides If done by an outside contractor all requirements must be laid

down in a contract

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Transport

Principle: Products should be transported in such a way that their integrity is not impaired and that storage conditions are maintained

The outside container should offer adequate protection from all external influences and should be clearly labeled

Special attention should be paid for vehicle hygiene and cleanliness, correct loading and avoidance of contamination and cross-contamination which must be verified by visual inspection prior to loading.

Dispatch records should be established - date, customer’s name and address, name of the product, lot number, quantity, transport and storage conditions

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Transport cont’d

For bulk deliveries the transportation agent shall provide information about the two previous loads

In case the two previous loads consisted of products which may compromise the safety of the final product or are not allowed to be used in feedingstuff according to existing regulations - cleaning certificate, information about the means of cleaning and drying and guarantee that a clean, empty, dry and odourless cargo compartment and discharge equipment is made available

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Cleaning

A written cleaning program (building, warehouse, equipment, multi use packaging material) available defining responsibility, schedule, methods and materials; for equipment: instruction for dissembling and reassembling, protection after cleaning

Cleaning activities should be documented. This should beaddressed as part of the Hazard analysis

Containers and equipment used for internal transport, storage, conveying handling and weighing shall be kept clean

Adequate resources to ensure good state of cleanliness

If there is a risk - potential for carry-over should be determined

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The Code

Products

Manufacturing

HACCP

Non Conformances

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HACCP

www.codexalimentarius.net CAC/CRP1 General principles on food hygiene Annex on Hazard Analysis and Critical Control Point

and Guidelines for its Application

Principle: Reference is made to the guideline published in Codex Alimentarius

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HACCP

It is important that the HACCP plan is integrated with the operator’s quality system, prerequisite system

Hazard analysis should be conducted after all prerequisite programs are designed and implemented

Principle: Prior to application of HACCP to any operator in the feed chain that operator should be operating according to a quality system (prerequisite program)

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HACCP

Two principles

– specific to one product and defined process line

– general to a group of products following the same unit operations

unit operations are individual stages of manufacturing process, from incoming ingredients to packaging the final product, e.g. drying, extruding and blending, etc.

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HACCP Plan

Conduct a hazard analysis– on each product– on a group of products

Determine CCP’s Establish critical limits Establish monitoring procedures Establish corrective actions Establish verification procedures Establish record-keeping and documentation procedures

Important: The fundamental principles have to be addressed

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Hazard Analysis

Conditions or incidents most likely to happen, because– it historically has occurred– there is a reasonable possibility that it might occur in the absence of

such control Identify the true feed safety hazards Develop a list of hazards which are of such significance that they

are reasonably likely to cause injury or illness if not effectively controlled

Each identified potential hazard should be evaluated, giving consideration to its severity and likely occurrence

The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for feed/food safety and therefore should be addressed in the HACCP plan

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CCP definition

Measurement giving a ”GO” or ”NO-GO” situation

Identify the point/points in the process where the identified hazards best can be controlled

CCP: Critical Control Point is a point, step or procedure at which control can be applied and a safety hazard can be prevented, eliminated or reduced to acceptable levels.

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Hazard analysis – Ex. 1

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Hazard analysis – EX. 2

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Hazard analysis – EX. 2 cont.

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Hazard analysis – EX. 3

PROCESS STEPS

HAZARD CATE-GORY

HAZARD DESCRIP-TION SEVERITY LIKELIHOOD

PREVENTIVE MEASURES RELEVANCY

Hazards are categorized:

Assessment of severity for health consequences if potential hazards are not controlled:

Classification according to occurrence of the hazard:

Reference to prerequisite program or no control exist

A function of severity, likelihood and preventive measures:

Biological

Physical

Chemical

1 means low severity

2 means medium severity

3 means high severity

0 means highly unlikely to occur

1 means low likelihood

2 means medium likelihood

3 means high likelihood

YES means that the potential hazard is controlled as a CCP

NO means that the control is otherwise controlled

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HACCP Summary

HACCP is the best way to control safety hazards that are likely to occur

Every HACCP plan can be different and still be effective

Allow flexibility in designing the optimal HACCP system to control safety hazards

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The Code

Products

Manufacturing

HACCP

Non Conformances– Products– Audits

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Non-conforming products

– General requirementsInspection and release of product

(internal)Ensure no mix-up with approved

batches

Principle: The operator shall ensure that products which do not conform to expected requirements are identified and controlled to prevent its unintended use or delivery.

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Non-conforming products

– Complaint handling system– Recall system

Principle: When non-conforming products are detected after delivery or use has started, the operator shall take action appropriate to the effects, or potential effects, of the non-conformance

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Compliant handling system

Formalized system– Definition of responsibilities– Traceability– Evaluation of cause of complaint

Categories (product, packaging or transport) Seriousness (health & safety)

– Feed-back to customer– Measurement & recurrence– Corrective actions

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Recall

Formal procedure– Responsibility– Flow description, competencies, step-by-step– Documentation & archiving

Implementation of mock recalls & documentation Evaluation & corrective actions Information to authorities

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The Code

Products

Manufacturing

HACCP

Non conformances– Products– Audits

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Non-conformances are classified according to the degree of severeness:

Critical

Major

Minor The risk assigned will be in relation to the nature of the non-

conformances as well as the number of occurrences

Non-conformance

Principle: A non-conformance, deviation or deficiency to CoP noted by an inspector during an inspection of an establishment that is conformed in writing to the company in the exit notice.

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Critical non-conformance

When the auditor observes a regulatory violation or a feed safety failure which may require that the operator:

– Immediately interrupts production– Holds products in quarantine– Discontinues shipping to customers– Recalls of products

Principle: Observation describing a situation that is likely to result in a noncompliant product or a situation that may result in an immediate or latent safety risk or any observation that involves fraud, misrepresentation or falsification of data

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Example 1:

Intentional violations of European and/or national legislation, e.g.

No traceability system in place

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Example 2:

Direct observation of products being produced, packed or held in a manner which poses a clear threat to animal and/or human health, e.g.

safety of raw material/product cannot be assured due to cross contamination, infestation, or unsanitary conditions

use of bovine material in products used for cattle

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Example 3:

Discovery of records showing that products are being or have been produced in a manner which poses a clear threat to animal and/or human health, e.g.

Recorded mixing time is below minimum rangeand thereby violating product safety

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Example 4:

The product is adulterated such that it contains an added poisonous or deleterious substance, e.g.

pesticides for pest control are being used

inconsistently with the labelled directions

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Major non-conformance

Observation that may result in the production of a product not consistently meeting its market authorization

A minor non-conformance from a previous audit which has not been corrected

Principle: A complete failure to implement a requirement of the FAMI-QS Code of Practice

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Example 1:– Complete failure to implement a requirement,

e.g.:Some of the HACCP principles are not

implemented Recall procedure is missing or incomplete to a

extent where it becomes evident that the recall process is not going to work

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Example 2:– No calibration program for mechanical,

electronic or other critical measuring equipment, or no records maintained

– Feed safety programs are deficient in such a manner that they do not comply with the FAMI-QS Code of Practice

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Example 3:- Delegation of responsibilities for persons to

insufficiently qualified persons, and no training program is available

- Insufficient training for personnel involved in production and QC resulting in related GMP deviations


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Example 4:

- No requirement for cleaning in the quality system even though the premises are in an acceptable state of cleanliness


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Example 5:

- Retained samples not kept for RM or not ensured to be kept by supplier

- Retained samples not kept for finished products


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Example 6:

– An imminent feed/food safety hazard exists, e.g. birds residing in processing areas or

warehouses,evidence of rodent excreta or gnawing on raw

materials or finished products

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Minor non-conformance

Observation that is neither critical nor major but a deviation from the FAMI-QS Code of Practice

Principle: A requirement of the FAMI-QS Code of Practice has been addressed, but there is insufficient evidence to demonstrate it has been properly controlled or implemented

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Minor non-conformance, cont.

Example 1:

– Cleaning is said to be done, but documentation is incomplete

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Example 2:

– Incomplete SOPs for handling of materials and products and thereby risk of safety


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Example 3:

– Inadequate specifications, and consequently the documentation is incomplete


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Example 4:

– No organization chart


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Example 5:

– Some documents not updated, but the QMS system is working


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Thank you for your attention

…the European Quality Standard for Feed Additives and Premixtures

“fami-qs” european f eed a dditives and pre mi xtures q uality s ystem

Documents

v3the expert group of

famiqseuropean feed

feed hygiene regulation9569

feed materials

feed chaindirective

feed safety

distribution of feed

good practice