FEMAS Scheme Manual April 2013

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2 Contents 1.0 Introduction Scope of FEMAS FEMAS Participation Scheme Rules Verification Assessment Programme Suspension and Withdrawal from the Scheme Complaints Appeals FM 05 iss3 Page 2 of 17

3 1.0 Introduction 1.1 The FEMAS Scheme for Feed Ingredients is a voluntary scheme developed by AIC in response to moves in both the UK and EU to regulate food safety more closely. 1.3 FEMAS is owned by AIC, who manage the scheme. 1.4 FEMAS requires an independent Verification that the Participant fully complies with the current versions of the Standard. 1.5 Product Authentication International Ltd (PAI) is the Certification Body for FEMAS and is accredited to EN / ISO 65 for the certification of FEMAS. 1.6 FEMAS approval demonstrates that a company meets the standards required of feed ingredient suppliers to those Feed Compounders and Merchants belonging to the AIC Universal Feed Assurance Scheme (UFAS). FEMAS also provides the assurance required by the UK Farm Assurance schemes for feed ingredients supplied for home mixing and or direct feeding to livestock. Other schemes which accept FEMAS certified companies for supply of feed ingredients include GMP+ International FSA (Netherlands), QS (Germany), OVOCOM GMP (Belgium) and FAMI-QS (Worldwide, covering speciality feed ingredients). For a full list of schemes with whom AIC have agreed mutual recognition see the AIC website By applying for certification to FEMAS, the Applicant agrees that, if accepted, they will comply with the requirements of the FEMAS Standard and any relevant associated documents, as well as the FEMAS Scheme Manual. 1.8 The Applicant or Participant will have no claim against any officers, members or employees of AIC in the event of Expulsion, Suspension or a lesser sanction and/or the publication thereof as appropriate, nor have any claim against any of the above for any damages and/or compensation or costs for any financial loss occasioned thereby. FM 05 iss3 Page 3 of 17

4 2.0 Scope of FEMAS The FEMAS standard has been designed to cover the assurance requirements for all feed ingredients used in the production of animal feed whether they are the primary products of processing or processing by-products and regardless of their country of origin. FEMAS provides a credible independent verification that the trade is meeting its legal obligations under General Food Law, Regulation (EC) No. 178/2002 and associated regulations and codes of practice. Both feed ingredient producers and compound feed manufacturers have been fully consulted during the development of the FEMAS Scheme. The scope of a participant s certification to FEMAS will be stated on the Certificate of Conformity and the FEMAS Register. The scope reflects the nature of the business and specifies the feed ingredients certified as assured by FEMAS. 3.0 FEMAS Participation 3.1 FEMAS is open to any company involved in the production and sale of feed ingredients subject to complying with these scheme rules. 3.2 A register of Participants is available on the AIC website at: Application for FEMAS Certification must be made to: Product Authentication International Ltd The Inspire Hornbeam Park Harrogate HG2 8PA United Kingdom Website: Tel: +44 (0) Fax: +44 (0) lorraine.chambers@thepaigroup.com PAI have a number of partner companies authorised to operate FEMAS outside the UK. Details of partner companies, and the countries in which they operate, can be obtained from PAI at the above address. FM 05 iss3 Page 4 of 17

5 4.0 Scheme Rules 4.1 In order to become a certified Participant, Applicants: Shall apply for certification by completing an Application Form and returning it to PAI Ltd. The participant can nominate a preferred inspection body provided that body has appropriately qualified assessors Shall liaise with PAI Ltd over the Quotation Shall confirm that they agree to comply with the Scheme Manual, the relevant FEMAS Standard and PAI Ltd s Scheme Regulations by signing the Certification Agreement contained in the quote pack and returning to PAI Shall pay the audit fee Shall agree to the assessment programme to ensure that their operations comply with the requirements of FEMAS, before a Certificate of Conformity can be issued. The assessment process comprises: Pre-Assessment (Mandatory for new participants wishing to supply markets that accept only feed ingredients that are certified as feed safe optional for other participants). Pre-assessments will evaluate new participants ability to meet the main criteria of FEMAS in order to achieve applied status. Participants who sign a Certification Agreement with the authorised Certification Body, pay any fees due and undergo a successful pre-assessment will be authorised to trade for a maximum of 6 months prior to full FEMAS certification and their company name will be added to the FEMAS Register as Applied mm/yy. At the authorised Certification Body s discretion, preassessments will involve either an on-site or desk top audit that key feed safety controls are in place. After a maximum of 6 months from the application date, participants must undergo a FEMAS initial assessment and achieve full certification to FEMAS for all products for which certification is being sought, or their company name will be removed from the FEMAS register. Re-application within 12 months will only be permitted at the discretion of the certification body Initial Assessment A formal (mandatory), in-depth, on-site assessment to confirm that participants comply with the requirements of FEMAS. The duration of initial assessments is dictated by the time required to fully assess the systems and procedures of the participant. The number of days required will be indicated prior to assessment, but may be extended if circumstances require this. Certificates of Conformity are only issued on satisfactory completion of all Action FM 05 iss3 Page 5 of 17

6 Points identified at Initial Assessment. The details and scope of certification for certified sites will be added to the FEMAS Register. 4.2 When the Applicant has been audited and has corrected any non-compliance that may have been identified, and settled any outstanding accounts, PAI Ltd will issue a Certificate of Conformity. PAI Ltd will also authorise AIC to change the status of the participant to Certified on the FEMAS Register. 4.3 Certificates of Conformity will be valid for three years from the date on which the Applicant demonstrated compliance with the Standard and expire on the third anniversary of the date of the assessment plus 60 days. Certificates are issued subject to a satisfactory annual Routine Assessment. Annual visits are due on the anniversary of the initial assessment and the extra 60 days added to the Certificate expiry date is to ensure all corrective actions are completed before that date. 4.4 The Routine (Surveillance) Assessment will be a formal mandatory on-site assessment of certified sites, scheduled annually to ensure that the requirements of FEMAS continue to be met and that any amendments/updates to the FEMAS Standard have been implemented. 4.5 Participants will be contacted prior to the anniversary of their original audit to arrange a Routine Assessment. 4.6 Participants shall comply with the Scheme Requirements at all times as defined in the Scheme Manual and the FEMAS Standard. 4.7 Participants shall advise PAI Ltd of any changes to the business, typically but not limited to: Company ownership; Scope of operations; Key management. 4.8 Participants and Applicants shall advise PAI Ltd in the event of being subject to legal action that relates to their FEMAS activities. Participants accept that in the event of their business being involved or implicated in a feed safety incident, details may be discussed in confidence between representatives of AIC and The Competent Authority. 5.0 Verification 5.1 PAI Ltd or the nominated inspection body will conduct an audit of a Participant s compliance with the Standard on an annual basis. PAI Ltd shall FM 05 iss3 Page 6 of 17

7 be given access to all relevant information needed to confirm compliance with the Scheme and right to inspect third parties subcontracted to perform work covered by the Standard, at the Participant s cost. 5.2 PAI Ltd will produce a written report for its own assessment purposes and identify any non-compliances to the Participant at the end of the audit. Once a Participant has rectified the areas of non-compliance to the satisfaction of PAI Ltd and within time limits specified below PAI Ltd will notify the client of continued certified status or issue a FEMAS certificate of compliance whichever is appropriate. The non-compliances will be classified as per 5.3 below, and acted upon as per 5.4. FM 05 iss3 Page 7 of 17

8 5.3 Classification of non-compliances Classification Critical Major Minor Cause A gross or deliberate feed safety regulatory violation, or; A feed safety failure resulting in unsafe feed, or; A loss of traceability such that recall of unsafe goods would be impossible, or; A recurrence of a Major Non-compliance raised at the preceding audit, or; A complete unwillingness to cooperate in the audit. A complete failure to implement a requirement of FEMAS or a failure that may result in unsafe feed, or; A recurrence of a Minor Non-compliance raised at the preceding audit. A partial failure to implement a requirement of FEMAS or poor evidence to demonstrate implementation. 5.4 Response to Non-compliances Classification Initial audit Surveillance audit Critical Certification refused. Full reapplication and audit required. Certification suspended with immediate effect. Re-audit required Major Minor Certificate not granted until nonconformances rectified. Plan of corrective actions to be submitted within 15 days of audit, and timescales to be agreed with Scheme Manager. Certificate not granted until nonconformances rectified. Plan of corrective actions to be submitted within 30 days of audit, and timescales to be agreed with Scheme Manager. 5.5 Appeals and complaints are covered in sections 8 & 9. prior to reinstatement of certification. Certification continues. Plan of corrective actions to be submitted within 15 days of audit, and timescales to be agreed with Scheme Manager, typically no more than 60 days from audit. Failure to implement corrective actions within agreed timescales will lead to suspension. Certification continues. Plan of corrective actions to be submitted within 30 days of audit, and timescales to be agreed with Scheme Manager, typically no more than 60 days from audit. Failure to implement corrective actions within agreed timescales will lead to suspension. FM 05 iss3 Page 8 of 17

9 6.0 Assessment Programme Types of Assessment There are a number of types of assessment within the FEMAS Scheme: Initial Assessment a formal assessment for new applicants to the FEMAS Scheme Routine Assessment a formal annual assessment for certified participants of the FEMAS Scheme Immediate Assessment an assessment carried out by the Certification Body in addition to Routine Assessment in order to investigate potential breaches of scheme rules Unscheduled Assessment an assessment carried out by the Certification Body as part of a programme of short notice audits each year. Extra Assessment these may be required by the certification body in order to verify compliance with the FEMAS Standards. Extra assessments will be carried out at the cost of the participant, and circumstances where they may be required include, but are not limited to: o Signing off action points following an assessment, particularly if the action points related to Major or Critical non-conformances o Assessments at the sites of suppliers to verify controls over the supply chain (e.g. for Surplus Foods Processors or FEMAS Intermediate Suppliers) FEMAS assessments are not of fixed duration and quotations will be provided on a case-by-case basis, prior to work commencing. The authorised Certification Body administers the programme and in most cases will perform the on-site assessment. However, the participant may select, if they wish, an alternative organisation to carry out the on-site assessment activity from a list of approved and qualified Inspection Bodies appointed by the authorised Certification Body for this purpose. The list of approved Inspection Bodies is available from the authorised Certification Body Sampling of Sites: 6.1 Where a business entity operates on multiple sites with the same scope, common quality system and effective central controls then at the PAI Scheme Manager s discretion, sampling of sites may be possible. In these circumstances all sites must be audited before a certificate can be issued however the surveillance assessment programme may include sampling of sites in years two and three, provided all sites are audited again by the end of the third full year of certification. Immediate Assessment 6.2 Where, in order to determine whether there has been any breach of the FEMAS Rules, it is necessary to request an immediate assessment, the cost of such an assessment (additional to the routine annual assessment) and also any extra assessment(s) to check if any non-conformances identified by the Verifier have been rectified or otherwise have been carried out, shall be at the cost of the Applicant or Participant. Refusal to allow access may result in suspension of certification. Unscheduled Assessment 6.3 PAI Ltd will undertake a number of unscheduled/ short notice assessments FM 05 iss3 Page 9 of 17

10 each year in order to determine continued compliance with FEMAS requirements. These will not affect all certified sites each year, but the authorised Certification Body retains the right to undertake unscheduled assessments of any and all FEMAS certified sites at its discretion The unscheduled assessment programme will be funded from a small levy included in the cost of all initial and routine assessments and no additional charges will be made for unscheduled assessments, however any extra assessments required to verify corrective actions will incur a fee Clients will be informed of Unscheduled Assessments the day before the visit. Account is taken by the assessor during short notice audits of the fact that key personnel may not be available however the continued operation of the business to FEMAS requirements is always expected Refusal of entry to premises will result in the client being charged for the next unscheduled assessment which will take place within 2 months of the original planned date. Refusal to allow access may result in suspension of certification. FM 05 iss3 Page 10 of 17

11 7.0 Suspension and Withdrawal from the Scheme 7.1 PAI Ltd, in conjunction with AIC, may suspend a Participant's Certificate of conformity when the Participant has: Non-compliances against the relevant FEMAS Standard or the FEMAS Scheme Manual, which are not resolved within the required time limits; Critical or Major non-compliances that have, or are likely to have, an adverse effect on product safety or legality; Refused access for an Immediate or Unscheduled Assessment 7.2 Participants suspended for reasons of feed safety must correct the non-compliances and have a follow-up assessment by PAI Ltd to confirm that all the non-compliances have been fully resolved within 1 month of suspension, in order to have their certification re-instated Participants suspended for non-payment of fees or non-feed safety issues will be reinstated provided all matters are resolved within 1 month of suspension date. 7.3 Participants that do not demonstrate to PAI Ltd that non-compliances have been resolved within 1 month of suspension will have their certificates of conformity withdrawn. 7.4 Participants that have their certification withdrawn will be required to undergo the complete assessment process and will be considered as new Applicants 7.5 PAI Ltd will pass all necessary information to AIC to allow the FEMAS Register to be updated with details of a Participant's changing certification status The FEMAS Register Those companies that achieve FEMAS certification are listed on the FEMAS Register. The Register includes details of the scope under which FEMAS certificates have been granted. Interested parties may view the Register via the Feed and Assurance links of the Agricultural Industries Confederation website at: Suspended and Withdrawn Participants may not claim to be FEMAS approved. No new contracts may be agreed with customers that require their suppliers of feed ingredients to be certified, until suspension has been lifted or re-application successfully completed. FM 05 iss3 Page 11 of 17

12 7.7 Suspended and withdrawn participants must notify any customers with whom they have existing contracts for both goods and services immediately on their change of status. PAI Ltd will write to the participant confirming the reason for suspension or withdrawal from the scheme and a copy of this letter must be provided to customers when notifying of the change in status. Evidence of the notifications will be examined during the re-assessment following suspension and compliance with this requirement will be a condition of reinstatement. 7.8 Participants in all AIC schemes should generate a list of their suppliers of both goods and services. Where those suppliers are also participants in an AIC scheme, this can be done by using My Favourites on the Scheme Register Checker on the AIC web site FM 05 iss3 Page 12 of 17

13 8.0 Complaints Complaints about either a FEMAS Participant or PAI Ltd should be directed to PAI Ltd where they will be acknowledged, reviewed and actions taken to resolve the cause of any problems. PAI Ltd is accredited by the UK Accreditation Service (UKAS) and works to strict codes of conduct. If Participants are not satisfied with the way in which PAI Ltd handles the complaint then they should refer the matter to AIC. 9.0 Appeals 9.1 A participant has the right of appeal against decisions made by PAI Ltd. 9.2 Appeals shall be made in writing to PAI Ltd within 14 days of being advised of the decision that is the subject of the appeal. 9.3 PAI Ltd will acknowledge the appeal and carry out an initial investigation to check the merits of the appeal. 9.4 If the Scheme Manager concurs with the appeal then PAI Ltd will correct the erroneous decision. 9.5 If the Scheme Manager does not concur with the Appeal then an independent panel, which will include an AIC representative, is convened to handle the appeal. 9.6 PAI Ltd, including the Scheme Manager, AIC and the Participant are entitled to attend the Appeals Panel and present information to the Panel. 9.7 The independent Appeals Panel make a ruling based on the information supplied during the hearing. 9.8 The Appeals Panel will be convened within 30 days of the receipt of the appeal. 9.9 The ruling of the Appeals Panel is binding and final on PAI Ltd and the Participant. FM 05 iss3 Page 13 of 17

14 10 Definitions For the purposes of the FEMAS scheme, the following definitions apply: Batch: An identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packaging, packer, consignor or labelling, and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units, when produced in continuous order and stored together. (Regulation (EU) No 225/2012) Calibration: The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements. Check: Monitoring and measuring of processes and products against policies, objectives and requirements for the product, with the reporting of results. Contamination: The undesired introduction of impurities of a chemical or microbiological nature or of foreign matter during production, sampling, packaging or repackaging, storage or transport. Control Measure: Any action and activity that can be used to prevent or eliminate a feed / food safety hazard or reduce it to an acceptable level. (Codex adapted) Corrective Action: Any action to eliminate a non-conformity. Cross-Contamination: Contamination of a material or product with another material or product. Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a feed / food safety hazard or reduce it to an acceptable level. (Codex adapted) Critical Limit: A criterion that separates acceptability from unacceptability. (Codex) Feed (or Animal Feed): Any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals. (Regulation (EC) No 178/2002) Feed Additives: Any intentionally added ingredient not normally consumed as feed by itself, whether or not it has a nutritional value, which affects the characteristics of feed or animal products. (Codex) Feed Ingredients: A component part or constituent of any combination or mixture making up a feed, whether or not it has a nutritional value in the animal s diet, including feed additives. Ingredients are of plant, animal or aquatic origin, or other organic or inorganic substances. (Codex) FM 05 iss3 Page 14 of 17

15 Flow Diagram: A systematic representation of the sequence of steps or operations used in the production or processing of a particular feed ingredient. (Codex adapted) Food (or Foodstuffs): Any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Food includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. Food shall not include: feed; live animals unless they are prepared for placing on the market for human consumption; plants prior to harvesting; medicinal products; cosmetics; tobacco and tobacco products; narcotic or psychotropic substances; residues and contaminants. (Regulation (EC) No 178/2002) GMP: Good Manufacturing Practice. Series of procedures in a branch or sector in which the standard of conduct is laid down (often with respect to hygiene and safety). HACCP (Hazard Analysis & Critical Control Points): A system that identifies, evaluates and controls hazards that are significant for food / feed safety. (Codex adapted) HACCP Plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards that are significant for food / feed safety in the sector of the feed chain under consideration. (Codex adapted) Hazard: A biological, chemical or physical agent in, or condition of, food / feed with the potential to cause an adverse health effect. (Codex adapted) Hazard Analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food / feed safety and therefore should be addressed in the HACCP plan. (Codex adapted) Litter: Cans, wrappers, bottles, plastic, paper and cardboard packaging or other items discarded after the foodstuffs, cigarettes or other consumables they were originally associated with have been consumed. Monitor: The act of conducting a planned sequence of observations or measurements to assess whether an expected outcome is being achieved. (Codex adapted) Participant: A producer or processor seeking certification against this standard for the production and supply of feed ingredients intended for feeding to livestock (from which products will be derived for human consumption) or to companion animals. Process Aid: Any substance not consumed as a feeding stuff by itself, intentionally used in the processing of feeding stuffs or feed ingredients to fulfil a technological purpose during treatment or processing which may result in the unintentional but FM 05 iss3 Page 15 of 17

16 technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed. (Regulation (EC) No 1831/2003) Purchaser: The party supplied with the feed ingredient by the participant. Quality Control: A system based upon sampling and testing, with the intention of ensuring compliance with specification and identifying non-conforming products. Quality Management System: An organised system of documented procedures, controls and practices with the specific purpose of ensuring that the standards of food / feed safety and quality intended by the company are met during the course of its activities. Raw Materials: All materials used by participants for manufacturing, processing or blending into feed ingredients. Record: A document providing evidence of a necessary action having been carried out. Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard. (Regulation (EC) No 178/2002) Safe: Feed ingredients shall be deemed to be safe if they do not have an adverse effect on human or animal health and do not make the food derived from foodproducing animals injurious to health or unfit for human consumption when the feed ingredient concerned is used as intended and in accordance with normal industry or feeding practice (Regulation (EC) No 178/2002; adapted). In addition, safe procedures and practices shall ensure the maintenance of those quality parameters that if breached may cause harm to a target class of livestock, or to humans subsequently consuming affected livestock products, through the excess or deficit of critical nutrients or the presence of anti-nutrients not expected under normal circumstances nor declared by the participant to the purchaser. Site: Factories / buildings sharing the same premises, under the same senior management control and involved in various stages of the same continuous process. Specification: 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 should 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. FM 05 iss3 Page 16 of 17

17 Standard: The document containing the essential principles of assurance, compliance with which will confirm adherence to the requirements of the FEMAS Programme. Step: A point, procedure, operation or stage in the food / feed chain including raw materials, from primary production to final consumption. (Codex adapted) Supplier: The external organisation(s) or person(s) that provides the raw materials (from which the participant will produce feed ingredients) and services related to feed ingredient production, processing, transport and storage. Technological Additives: Any substance added to feed ingredients for a technological purpose, i.e. preservatives, antioxidants, emulsifiers, stabilisers, thickeners, gelling agents, binders, substances for the control of radionucleide contamination, anti-caking agents, acidity regulators, denaturants. (Regulation (EC) No 1831/2003) Traceability: The ability to trace and follow a substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution. (Regulation (EC) No 178/2002) Undesirable Substances: Any substance or product, with the exception of pathogenic agents, which is present in and / or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production. (Directive 2002/32/EC) Validation: Obtaining evidence of effectiveness. (Codex adapted) Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance. (Codex adapted) Waste: Those substances or objects that fall out of the commercial cycle or out of the chain of utility. Waste is a substance or object which: a) Someone wants to get rid of and cannot be used for any other purpose, b) Is destined for dumping / land filling, c) Is not intended for re-use, recovery or recycling as animal feed, d) Cannot be used for any other purpose. FM 05 iss3 Page 17 of 17