“fami-qs” european f eed a dditives and pre mi xtures q uality s ystem
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“FAMI-QS” European F eed A dditives and Pre MI xtures Q uality S ystem. Context and insights. Comment. Please use the link “back” in the upper right corner to jump to the general content page - PowerPoint PPT PresentationTRANSCRIPT
“FAMI-QS”European Feed Additives and PreMIxtures
Quality System
Context and insights
Back End
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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June 2005 (V3)The Expert Group of FAMI-QS3
Content
Regulatory background The FAMI-QS Concept The Association The Certification The Code
– Products– Manufacturing– HACCP– Non-Conformances
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June 2005 (V3)The Expert Group of FAMI-QS4
Content
Regulatory background The FAMI-QS Concept The Association The Certification The Code
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June 2005 (V3)The Expert Group of FAMI-QS5
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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June 2005 (V3)The Expert Group of FAMI-QS6
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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June 2005 (V3)The Expert Group of FAMI-QS7
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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June 2005 (V3)The Expert Group of FAMI-QS8
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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June 2005 (V3)The Expert Group of FAMI-QS9
Content
Regulatory background The FAMI-QS Concept The Association The Certification The Code
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June 2005 (V3)The Expert Group of FAMI-QS10
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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June 2005 (V3)The Expert Group of FAMI-QS11
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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June 2005 (V3)The Expert Group of FAMI-QS12
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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June 2005 (V3)The Expert Group of FAMI-QS13
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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June 2005 (V3)The Expert Group of FAMI-QS14
Content
Regulatory background The FAMI-QS Concept The Association The Certification The Code
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June 2005 (V3)The Expert Group of FAMI-QS15
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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June 2005 (V3)The Expert Group of FAMI-QS16
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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June 2005 (V3)The Expert Group of FAMI-QS17
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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June 2005 (V3)The Expert Group of FAMI-QS18
The Full Members*
Adisseo ADM Ajinomoto Alltech BASF Degussa
DSM FinnFeeds Lohmann Novus Novozymes Phytobiotics
*status June 2005
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June 2005 (V3)The Expert Group of FAMI-QS19
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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June 2005 (V3)The Expert Group of FAMI-QS20
FAMI-QS Asbl flowchart
Board
Secretary General
Expert Panel Quality Manager
Accredited Certification Cies Platform
AuditorsConsultative Panel
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June 2005 (V3)The Expert Group of FAMI-QS21
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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June 2005 (V3)The Expert Group of FAMI-QS22
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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June 2005 (V3)The Expert Group of FAMI-QS23
Content
Regulatory background The FAMI-QS Concept The Association The Certification The Code
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June 2005 (V3)The Expert Group of FAMI-QS24
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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June 2005 (V3)The Expert Group of FAMI-QS25
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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June 2005 (V3)The Expert Group of FAMI-QS26
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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June 2005 (V3)The Expert Group of FAMI-QS27
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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June 2005 (V3)The Expert Group of FAMI-QS28
Content
Regulatory background The FAMI-QS Concept The Association The Certification The Code
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June 2005 (V3)The Expert Group of FAMI-QS29
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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June 2005 (V3)The Expert Group of FAMI-QS30
The Code
Products
Manufacturing
HACCP
Non Conformances
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June 2005 (V3)The Expert Group of FAMI-QS31
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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June 2005 (V3)The Expert Group of FAMI-QS32
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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June 2005 (V3)The Expert Group of FAMI-QS33
Principle:
The specification ensures that an ingredient used always has a predefined agreed upon quality.
Specifications
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June 2005 (V3)The Expert Group of FAMI-QS34
Specifications are needed for– Incoming raw materials– Packaging materials– Final products– Labels
Specifications
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June 2005 (V3)The Expert Group of FAMI-QS35
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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June 2005 (V3)The Expert Group of FAMI-QS36
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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June 2005 (V3)The Expert Group of FAMI-QS37
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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June 2005 (V3)The Expert Group of FAMI-QS38
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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June 2005 (V3)The Expert Group of FAMI-QS39
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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June 2005 (V3)The Expert Group of FAMI-QS40
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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June 2005 (V3)The Expert Group of FAMI-QS41
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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June 2005 (V3)The Expert Group of FAMI-QS42
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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June 2005 (V3)The Expert Group of FAMI-QS43
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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June 2005 (V3)The Expert Group of FAMI-QS44
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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June 2005 (V3)The Expert Group of FAMI-QS45
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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June 2005 (V3)The Expert Group of FAMI-QS46
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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June 2005 (V3)The Expert Group of FAMI-QS47
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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June 2005 (V3)The Expert Group of FAMI-QS48
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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June 2005 (V3)The Expert Group of FAMI-QS49
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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June 2005 (V3)The Expert Group of FAMI-QS50
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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June 2005 (V3)The Expert Group of FAMI-QS51
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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June 2005 (V3)The Expert Group of FAMI-QS52
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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June 2005 (V3)The Expert Group of FAMI-QS53
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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June 2005 (V3)The Expert Group of FAMI-QS54
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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June 2005 (V3)The Expert Group of FAMI-QS55
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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June 2005 (V3)The Expert Group of FAMI-QS56
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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June 2005 (V3)The Expert Group of FAMI-QS57
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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June 2005 (V3)The Expert Group of FAMI-QS58
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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June 2005 (V3)The Expert Group of FAMI-QS59
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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June 2005 (V3)The Expert Group of FAMI-QS60
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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June 2005 (V3)The Expert Group of FAMI-QS61
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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June 2005 (V3)The Expert Group of FAMI-QS62
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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June 2005 (V3)The Expert Group of FAMI-QS63
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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June 2005 (V3)The Expert Group of FAMI-QS64
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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June 2005 (V3)The Expert Group of FAMI-QS65
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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June 2005 (V3)The Expert Group of FAMI-QS66
The Code
Products
Manufacturing
HACCP
Non Conformances
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June 2005 (V3)The Expert Group of FAMI-QS67
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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June 2005 (V3)The Expert Group of FAMI-QS68
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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June 2005 (V3)The Expert Group of FAMI-QS69
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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June 2005 (V3)The Expert Group of FAMI-QS70
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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June 2005 (V3)The Expert Group of FAMI-QS71
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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June 2005 (V3)The Expert Group of FAMI-QS72
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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June 2005 (V3)The Expert Group of FAMI-QS73
Hazard analysis – Ex. 1
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June 2005 (V3)The Expert Group of FAMI-QS74
Hazard analysis – EX. 2
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June 2005 (V3)The Expert Group of FAMI-QS75
Hazard analysis – EX. 2 cont.
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June 2005 (V3)The Expert Group of FAMI-QS76
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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June 2005 (V3)The Expert Group of FAMI-QS77
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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June 2005 (V3)The Expert Group of FAMI-QS78
The Code
Products
Manufacturing
HACCP
Non Conformances– Products– Audits
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June 2005 (V3)The Expert Group of FAMI-QS79
The Code
Products
Manufacturing
HACCP
Non Conformances– Products– Audits
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June 2005 (V3)The Expert Group of FAMI-QS80
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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June 2005 (V3)The Expert Group of FAMI-QS81
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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June 2005 (V3)The Expert Group of FAMI-QS82
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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June 2005 (V3)The Expert Group of FAMI-QS83
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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June 2005 (V3)The Expert Group of FAMI-QS84
The Code
Products
Manufacturing
HACCP
Non conformances– Products– Audits
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June 2005 (V3)The Expert Group of FAMI-QS85
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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June 2005 (V3)The Expert Group of FAMI-QS86
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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June 2005 (V3)The Expert Group of FAMI-QS87
Critical non-conformance
Example 1:
Intentional violations of European and/or national legislation, e.g.
No traceability system in place
Back End
June 2005 (V3)The Expert Group of FAMI-QS88
Critical non-conformance
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
Back End
June 2005 (V3)The Expert Group of FAMI-QS89
Critical non-conformance
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
Back End
June 2005 (V3)The Expert Group of FAMI-QS90
Critical non-conformance
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
Back End
June 2005 (V3)The Expert Group of FAMI-QS91
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
Back End
June 2005 (V3)The Expert Group of FAMI-QS92
Major non-conformance
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
Back End
June 2005 (V3)The Expert Group of FAMI-QS93
Major non-conformance
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
Back End
June 2005 (V3)The Expert Group of FAMI-QS94
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
Major non-conformance
Back End
June 2005 (V3)The Expert Group of FAMI-QS95
Example 4:
- No requirement for cleaning in the quality system even though the premises are in an acceptable state of cleanliness
Major non-conformance
Back End
June 2005 (V3)The Expert Group of FAMI-QS96
Example 5:
- Retained samples not kept for RM or not ensured to be kept by supplier
- Retained samples not kept for finished products
Major non-conformance
Back End
June 2005 (V3)The Expert Group of FAMI-QS97
Major non-conformance
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
Back End
June 2005 (V3)The Expert Group of FAMI-QS98
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
Back End
June 2005 (V3)The Expert Group of FAMI-QS99
Minor non-conformance, cont.
Example 1:
– Cleaning is said to be done, but documentation is incomplete
Back End
June 2005 (V3)The Expert Group of FAMI-QS100
Example 2:
– Incomplete SOPs for handling of materials and products and thereby risk of safety
Minor non-conformance, cont.
Back End
June 2005 (V3)The Expert Group of FAMI-QS101
Example 3:
– Inadequate specifications, and consequently the documentation is incomplete
Minor non-conformance, cont.
Back End
June 2005 (V3)The Expert Group of FAMI-QS102
Example 4:
– No organization chart
Minor non-conformance, cont.
Back End
June 2005 (V3)The Expert Group of FAMI-QS103
Example 5:
– Some documents not updated, but the QMS system is working
Minor non-conformance, cont.
Back End
June 2005 (V3)The Expert Group of FAMI-QS104
Thank you for your attention
…the European Quality Standard for Feed Additives and Premixtures