FAMIQS European Feed Additives and PreMIxtures Quality System

1
FAMI-QSEuropean Feed Additives and
PreMIxtures Quality System

• Context and insights

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Comment

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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

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

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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

8
Feed Hygiene Regulation

• 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

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Content

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

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Advantages

• Optimisation of efforts for feed safety by agreed
  upon measures
• Auditable harmonized code throughout EU, thus
• Minimization of need for checks by authorities,
  users

11
Compliance

• 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

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Basis

• Code is based on established guidelines such as
• Codex Alimentarius (HACCP)
• EN ISO 90012000
• Management systems developed in different
  countries like GMP, FEMAS, QS,
• 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

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

15
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
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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

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

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Granting a FAMI-QS Certificate

• 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)

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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

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

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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

• Packaging labelling
• Quality Control
• Verification
• Blending
• Warehousing Storage
• Transport
• Cleaning
• HACCP
• Non Conformances

• Products
• Specification
• Suppliers
• Incoming Materials
• Stability
• Traceability
• Manufacturing
• Building and Equipment
• Work Environment
• Finished Goods

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Specifications

• 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.

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Specifications

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

34
Specifications

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

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Specifications

• 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

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Suppliers

• 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

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Suppliers

• 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

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Suppliers

• 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
• .

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Suppliers

• 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).

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Incoming Materials

• 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.

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Incoming Materials

• 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.

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Incoming Materials

• 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

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Incoming Materials

• 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

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Incoming Materials

• When the incoming material is received the
  operator has to verify
• suppliers lot number
• full suppliers 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

45
Incoming Materials

• 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

46
Stability

• 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

47
Traceability

• 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)

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Traceability

• 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)

49
Traceability

• 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

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Traceability

• 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

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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

52
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)

53
Suitable Building Equipment contd

• 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

54
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

57
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

58
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

60
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 contd

• 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

62
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

63
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,
  customers name and address, name of the product,
  lot number, quantity, transport and storage
  conditions

64
Transport contd

• 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

65
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

66
The Code

• Products
• Manufacturing
• HACCP
• Non Conformances

67
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
68
HACCP

• It is important that the HACCP plan is integrated
  with the operators 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)
69
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.

70
HACCP Plan
Important The fundamental principles have to be
addressed

• Conduct a hazard analysis
• on each product
• on a group of products
• Determine CCPs
• Establish critical limits
• Establish monitoring procedures
• Establish corrective actions
• Establish verification procedures
• Establish record-keeping and documentation
  procedures

71
Hazard Analysis
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

• 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

72
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.
73
Hazard analysis Ex. 1
74
Hazard analysis EX. 2
75
Hazard analysis EX. 2 cont.
76
Hazard analysis EX. 3
77
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

78
The Code

• Products
• Manufacturing
• HACCP
• Non Conformances
• Products
• Audits

79
The Code

• Products
• Manufacturing
• HACCP
• Non Conformances
• Products
• Audits

80
Non-conforming products
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.

• General requirements
• Inspection and release of product (internal)
• Ensure no mix-up with approved batches

81
Non-conforming products
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

• Complaint handling system
• Recall system

82
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

83
Recall

• Formal procedure
• Responsibility
• Flow description, competencies, step-by-step
• Documentation archiving
• Implementation of mock recalls documentation
• Evaluation corrective actions
• Information to authorities

84
The Code

• Products
• Manufacturing
• HACCP
• Non conformances
• Products
• Audits

85
Non-conformance

• 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

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.
86
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
87
Critical non-conformance
?

• Example 1
• Intentional violations of European and/or
  national legislation, e.g.
• No traceability system in place

88
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

89
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

90
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

91
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
92
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

93
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

94
Major non-conformance
?

• 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

95
Major non-conformance

• Example 4
• - No requirement for cleaning in the quality
  system even though the premises are in an
  acceptable state of cleanliness

?
96
Major non-conformance
?

• Example 5
• Retained samples not kept for RM or not ensured
  to be kept by supplier
• Retained samples not kept for finished products

97
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

98
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
99
Minor non-conformance, cont.
?

• Example 1
• Cleaning is said to be done, but documentation is
  incomplete

100
Minor non-conformance, cont.

• Example 2
• Incomplete SOPs for handling of materials and
  products and thereby risk of safety

?
101
Minor non-conformance, cont.

• Example 3
• Inadequate specifications, and consequently the
  documentation is incomplete

?
102
Minor non-conformance, cont.
?

• Example 4
• No organization chart

103
Minor non-conformance, cont.
?

• Example 5
• Some documents not updated, but the QMS system is
  working

104
the European Quality Standard for Feed Additives
and Premixtures

• Thank you for your attention