European Code of Practice For Feed Additive and Premixture operators

Transcription

1 Eurpean Cde f Practice Fr Feed Additive and Premixture peratrs INTRODUCTION This Eurpean Cde f Practice fr peratrs in the feed additives and premixtures sectr respnds t the future regulatin f the Eurpean Parliament and the Cuncil laying dwn requirements fr the feed hygiene. Articles 21 t 23 encurage the develpment f guides t gd practice fr hygiene and the applicatin f HACCP principles. With this industry cde, it shuld be ensured that all kinds f feed additives and premixtures are safe, that respective businesses perate in accrdance with hygiene requirements harmnised n a Eurpean level and that traceability is imprved. In rder t bring this in line with current animal feed legislatin and varius activities n natinal, industrial and/r assciatin levels, it takes int accunt the principles f feed and fd safety as well as HACCP principles that are spelt ut in: EN ISO 9001:2000, Quality management systems The Cmmissin s white paper n fd safety Directives 95/69/EEC and 98/51/EEC Regulatin f the Eurpean Parliament and f the Cuncil n additives fr use in animal nutritin 1831/2003/EC Regulatin 178/2002/EC f the Eurpean Parliament and f the Cuncil f 28 January 2002 laying dwn the general principles and requirements f fd law, establishing the Eurpean Fd Safety Authrity Prpsal fr a regulatin f the Eurpean Parliament and f the Cuncil laying dwn requirements fr feed hygiene COM (2003) 180 final The relevant cdes f practice f the Cdex Alimentarius The principles f HACCP, re. Cdex Alimentarius, General principles f Fd Hygiene, (CAC/RCP , Rev , Amd. (1999), Annex n Hazard Analysis and Critical Cntrl Pint (HACCP) System and Guidelines fr its Applicatin), Management systems develped by assciatins in different Member States, like Cde f Practice (FEFAC, EU), FEMAS (UKASTA, UK), GMP (OVOCOM, B), GMP+ (PDV, Nl), Q+S (DVT, D). The cmbinatin f these principles prvides guidance fr the feed additives and premixtures peratrs, the measures required and their implementatin in rder t cntribute t feed safety in Eurpean and internatinal manufacturing and trade. Versin 1, 15 July 2004 Page 1/34

2 In the exceptinal case where a direct r indirect risk t human r animal health is related t a prduct manufactured and marketed under this Cde, the infrmatin and recall prcedures (including the rapid alert system) as defined amng thers in Regulatin 178/2002 shall apply. This Cde is designed as a guide t specify the general requirements. A checklist is included in rder t further detail the requirements. In additin it can be used as a tl fr detailed guidance f the peratrs and auditing the Cde. The FAMI-QS dcument 'FAMI-QS Certificatin Prcess Descriptin', explains the details f the certificatin prcess. Versin 1, 15 July 2004 Page 2/34

3 TABLE OF CONTENTS 3.1. General requirements Quality Management Principles General dcumentatin requirements Management cmmitment Quality and safety plicies Respnsibility, authrity and cmmunicatin Management representative Management review Prvisin f resurces Human resurces Infrastructure Wrk envirnment Prduct requirements Determinatin f requirements related t the prduct Cmpliance f the prduct t the requirements Custmer cmmunicatin HACCP Prgram Design and develpment Develpment f new prducts and prcesses Change cntrl Handling f incming materials Surcing f incming materials Verificatin f incming materials Prductin f finished gds Quality Cntrl and prductin Verificatin f prcesses fr prductin Identificatin and traceability Preservatin f prduct Transprt Cntrl f mnitring and measuring devices Cleaning Pest cntrl General requirements Internal audits General requirements Cmplaint handling system Versin 1, 15 July 2004 Page 3/34

4 8.3. Recall...32 Versin 1, 15 July 2004 Page 4/34

5 1 SECTION 1 Scpe This Eurpean Cde f Practice shall apply t feed additives and premixture peratrs at all stages frm the first placing n the market f feed additives and premixtures. Therefre it als applies t the placing n the market f feed additives and premixtures after imprt frm third cuntries. The aim f this Cde f Practice is t establish an industrial standard t reduce risk related t adulterated feed additives and premixtures entering the feed chain. This Cde f Practice is a standard implementing the bjectives f the feed hygiene regulatin (COM(2003)180 final). In additin, it prvides measures t ensure that ther applicable regulatry requirements are met. Versin 1, 15 July 2004 Page 5/34

6 2 SECTION 2 Terms and definitins Authrised persnnel: Persns wh have skills, permissin and purpse as specified by jb descriptins, prcess descriptins r management. Calibratin: The demnstratin that a particular instrument r device prduces results within specified limits by cmparisn with thse prduced by a reference r traceable standard ver an apprpriate range f measurements. Carry-ver: Cntaminatin f a material r prduct with anther material r prduct that riginates frm previus use f equipment and wuld alter the quality beynd the established specificatins. Check/cntrl: Mnitr and measure prcesses and prduct against plicies, bjectives and requirements fr the prduct and reprt results Cde f Practice: It identifies the essential principles f feed hygiene t ensure their safety fr animals and their suitability fr animal prducts fr human cnsumptin. Cntaminatin: The undesired intrductin f impurities f a chemical r micrbilgical nature r f freign matter, int r nt a raw material, intermediate, feed additive r premixture during prductin, sampling, packaging r repackaging, strage r transprt. Crss-Cntaminatin: Cntaminatin f a material r prduct with anther material r prduct. Feed additives: Substances, micr rganisms r preparatins, ther than feed material and premixtures, which are intentinally added t feed r water in rder t perfrm, in particular, ne r mre f the fllwing functins: a) Favurably affect the characteristics f feed b) Favurably affect the characteristics f animal prducts c) Favurably affect the clur f rnamental fish and birds d) Satisfy the nutritinal needs f animals e) Favurably affect the envirnmental cnsequences f animal prductin f) Favurably affect animal prductin, perfrmance r welfare, particularly by affecting the gastr-intestinal flra r digestibility f feedingstuffs, g) Have a cccidistatic r histmnstatic effect Feed hygiene: The measures and cnditins necessary t cntrl hazards and t ensure fitness fr animal cnsumptin f a feed additive r a premixture, taking int accunt its intended use. Feed material: Varius prducts f vegetable r animal rigin, in their natural state, fresh r preserved, and prducts derived frm the industrial prcessing theref. Organic r inrganic substances, whether r nt cntaining additives, which are intended fr use in ral animal feeding either directly as such, r after prcessing, in the preparatin f cmpund feedingstuffs r as carriers f premixtures. First placing n the market: The initial placing n the Eurpean Unin market f an additive r premixture after its manufacture r the imprt f an additive r premixture. (See placing n the market). HACCP (Hazard Analysis and Critical Cntrl Pint): A system which identifies, evaluates, and cntrls hazards which are significant fr feed safety. Hazard analysis: The prcess f cllecting and evaluating infrmatin n hazards, and cnditins leading t their presence, t decide which are significant fr feed safety and therefre shall be addressed in the HACCP plan. Hazard: Prperty f a bilgical, chemical r physical agent in the feed chain with the ptential t cause an adverse health effect fr animals r cnsumers. Versin 1, 15 July 2004 Page 6/34

7 Incming material: A general term used t dente raw materials (starting materials, reagents, slvents) and prcess aids. Intermediate: Any material which has been prcessed by the peratr and nt yet been labelled as a final cmmercial prduct. Lt Number: A cmbinatin f numbers, letters, and/r symbls which identify a lt and frm which the prductin and distributin histry can be determined. Lt: A specific quantity f material prduced in a prcess r series f prcesses, that it is expected t be hmgeneus within specified limits. In the case f cntinuus prductin, a lt may crrespnd t a defined fractin f the prductin. A lt size may be defined either by a fixed quantity r the amunt prduced in a fixed time interval. Manufacture/prductin: All peratins f receipt f materials, prductin, packaging, repackaging, labelling, relabelling, quality cntrl, release, strage, and distributin f feed additives and premixtures and the related cntrls. Operatr: Any unit prducing r manufacturing feed additives, premixtures prepared frm additives, r prducts cvered by Directive 82/471/EEC and any persn ther than the manufacturer r the persn prducing fr the exclusive requirements f his hlding, wh hlds additives, premixtures prepared frm additives, r ne f the prducts cvered by Directive 82/471/EEC (amin acids and analgues) r any unit f feed additives r premixtures business (including traders and imprters). Placing n the market: Hlding prducts fr the purpses f sale, including ffering fr sale r fr the purpses f any ther frm f transfer, whether r nt free f charge, t third parties, and the sale and ther frms f transfer themselves. (See first placing n the market). Plan: Establish the bjectives and prcesses necessary t deliver results in accrdance with the rganisatin s plicies regarding quality and safety. Premixtures: Mixtures f feed additives r mixtures f ne r mre feed additives with feed materials r water used as carriers, nt intended t direct feeding t animals. Prcedure: Operatins t be perfrmed, precautins t be taken and measures t be applied directly r indirectly related t the manufacturing f a material, feed additive r premixture. Raw material: Any material which enters the manufacturing prcess f the feed additive and/r premixture. Recrd: Written dcuments cntaining actual data. Rewrking: Any apprpriate manipulatin steps in rder t ensure a feed additive r premixture will cnfrm t specificatins. Risk: Expsure t a hazard related t fd and feed safety Shall: Cmpliance with a requirement which is mandatry fr cmpliance with this standard. (Obligatin t fllw the exact requirement as stated by this cde). Shelf life: A defined time perid fr which a prduct fully cmplies with the specificatin if stred apprpriately. Shuld: Means "must" and the activities, descriptins r specificatins accmpanied by the wrd "shuld" are intended t be mandatry, unless the manufacturer is able t demnstrate that the activity, descriptin r specificatin is inapplicable r can be replaced by an alternative which must be demnstrated t prvide at least an equivalent level f quality assurance. (Obligatin t achieve the gal f the cde by apprpriate means). Sign / signature: Cnfirmatin f an authrised persn in writing r by electrnic means with cntrlled access. Versin 1, 15 July 2004 Page 7/34

8 Specificatin: A list f tests, references t analytical prcedures, and apprpriate acceptance criteria that are numerical limits, ranges, r ther criteria fr the test described. It establishes the set f criteria t which a material shall cnfrm t be cnsidered acceptable fr its intended use. Cmpliance t specificatin means that the material, when tested accrding t the listed analytical prcedures, meets the listed acceptance criteria. Traceability: The ability t trace and fllw a fd, feed, fd prducing animal r substance intended t be, r expected t be incrprated int a fd r feed thrugh all stages f prductin, prcessing and distributin. Verificatin: Applicatin f methds, prcedures, tests and ther evaluatins, in additin t mnitring t determine cmpliance with the HACCP plan. Written dcuments: These may be substituted by electrnic, phtgraphic, r ther data prcessing systems prvided that the data will be apprpriately stred during the anticipated perid f strage (archive) and can be made readily available in a legible frm. Versin 1, 15 July 2004 Page 8/34

9 3 SECTION 3 Quality Management System (QMS) 3.1. General requirements The peratr shall establish, dcument, implement and maintain a quality management system in accrdance with the requirements f this Cde f Practice. It shall be cntinually adapted t regulatry develpments. The structure f the quality management system shall be specific t the rganisatin f the peratr and includes plicies, requirements and prcess dcuments that reflect the best practice f the peratr. The quality system shall ensure that all thse activities within the peratr that culd impact n the quality f the prduct are cnsistently defined, implemented and maintained at all levels in the rganisatin. ISO standards as well as ther appraches may be used t define the QMS. 3.1 Questinnaire Remark List ther quality standards the peratr may cmply with: 3.2. Quality Management Principles Invlvement f all persns cncerned in manufacturing shall be demnstrated Each peratr shall perfrm and recrd the evaluatin f risks and the level f requirements t be applied t the manufacturing prcess based n HACCP principles All quality related activities shall be recrded directly after they are perfrmed Effective change cntrl and investigatin prcedures shall be implemented t manage bth planned and unplanned deviatins Prcedures shall exist fr ntifying respnsible management in a timely manner f a quality critical situatin (critical cmplaints, recalls, audit findings) 3.2 Questinnaire YES NO Remark Are there any dcuments which give evidence that the emplyees are invlved in quality? Are HACCP principles applied? Is an effective change cntrl system implemented? Is a system in place t infrm management n critical situatins? Des the peratr have a system in place t ensure that management is kept updated n all relevant legislatin, feed and fd safety issues, and relevant quality guidelines? Versin 1, 15 July 2004 Page 9/34

10 3.3. General dcumentatin requirements The peratr shall have a system f dcumentatin which shall reflect all aspects f this Cde. It has t be designed in rder t define and ensure mastery f the Critical Cntrl Pints (CCPs) in the manufacturing prcess and t establish and implement a quality cntrl plan. Manufacturing recrds shall cntain all relevant data that will permit investigatin f the histry f any suspected prduct. The design and use f recrds depend upn the manufacturer. This QMS dcumentatin shuld include: a) Written quality plicy and quality bjectives b) A quality manual c) Dcumented prcedures and recrds required by this Cde f Practice d) Infrmatin needed by the peratr t ensure the effective planning, peratin, and cntrl f its prcesses Dcument cntrl: Dcuments shall have unambiguus cntents: the title, nature and purpse shall be clearly stated. Dcuments shall be apprved, signed and dated by apprpriate authrised persns. N dcument shall be changed withut authrisatin. Dcuments shall be kept up t date. Minimum dcuments required are: Quality Plicy: Specificatins and testing prcedures fr incming materials and finished prduct Master frmulae and perating instructins fr a prduct r a grup f prducts Batch prcessing recrds fr each prduct Standard Operating Prcedures (SOPs) Is apprpriate t the purpse f the peratr Prvides a frame wrk fr establishing and reviewing quality bjectives Is cmmunicated and understd within the peratr Quality Manual: The quality manual shuld include: a) The scpe f the QMS, including details f and justificatin fr any exclusin b) The dcumented prcedures established fr the QMS r reference t them c) A descriptin f the interactin between the prcesses f the QMS 3.3 Questinnaire YES NO Remark Des a quality management system exist? Is a quality manual: In place Apprved and signed by authrised persns? Dated Versin 1, 15 July 2004 Page 10/34

11 3.3 Questinnaire YES NO Remark And updated? Des a written quality plicy exist? D adequate quality bjectives exist? Des the QMS state the peratr s intentin t meet its bligatins t prduce and market safe prducts? Des the QMS state the peratr s respnsibility t its custmers? Is the QMS manual readily available t relevant staff? Is a traceable dcument cntrl system in place? Des the QMS system include specificatins n raw materials finished prducts labels ther, describe:.. D master frmulas exist fr all relevant prducts? D written cntrlled perating instructins and batch prcess recrds fr each prduct exist? Are Standard Operating Prcedures (SOPs) available and adequate t ensure cntrlled prductin? Versin 1, 15 July 2004 Page 11/34

12 4 SECTION 4 Management Respnsibility 4.1. Management cmmitment Management shall be cmmitted t the implementatin f this Cde f Practice in rder t ensure feed quality and safety. Dcumentary evidence shall be prvided t demnstrate this. 4.1 Questinnaire YES NO Remark Des the management shw cmmitment t quality? Is evidence dcumented t shw this cmmitment? 4.2. Quality and safety plicies Management shall: Establish the quality plicy and ensure that quality bjectives are established; Define the scpe f the HACCP management system, by identifying the prducts/prduct categries and prductin sites which are cvered by the system and ensure that the safety bjectives are established; Ensure that these bjectives and plicies are in cmpliance with the business gals f the rganisatin, the statutry and regulatry requirements, and any specific additinal safety requirements frm custmers. 4.2 Questinnaire YES NO Remark Des the quality plicy specify bjectives? Are the requirements apprpriate t the peratr s activities and business gals? Is the HACCP scpe defined in the HACCP prgram? Is the HACCP scpe cmmunicated t all invlved persns? 4.3. Respnsibility, authrity and cmmunicatin Management shall ensure that respnsibility and authrity are defined, in written frm and cmmunicated within the rganisatin t ensure the effectiveness f the quality and safety management systems implemented. The staff appinted by the senir management has defined respnsibility and authrity t: Identify and recrd any prblems with regard t prduct quality, safety and HACCP management system; Initiate remedial measures and cntrl t these prblems; Initiate actin t prevent the ccurrence f nncnfrmities relating t the prducts quality and safety; Appint a HACCP team and team leader. Versin 1, 15 July 2004 Page 12/34

13 The rganisatin management shall prvide adequate resurces fr the implementatin and cntrl f the quality and HACCP management systems. Further infrmatin n HACCP is fund in sectin Questinnaire YES NO Remark D functin descriptins fr each individual, r a grup f individuals, exist? Is respnsibility defined? Are these descriptins updated? Is legal infrmatin cmmunicated thrughut the rganisatin? 4.4. Management representative Senir management shuld appint a member f management wh shall have respnsibility and authrity that includes: Ensuring that prcesses needed fr the quality and HACCP management systems are established, implemented and maintained; Reprting t tp management n the perfrmance f the quality and prduct safety management systems and any need fr imprvement, Ensuring the prmtin f awareness f custmer requirements thrughut the rganisatin. 4.4 Questinnaire YES NO Remark Is a management representative with respnsibility t quality and safety issues appinted? Des the manager reprt t the peratr s tp management? Des the respnsibility include awareness f custmer requirements? 4.5. Management review The management shall review, at defined intervals, the cntinuing suitability and effectiveness f quality and safety management systems. This review shall include assessing pprtunities fr imprvement and the need fr changes t the quality and safety management systems. 4.5 Questinnaire YES NO Remark Des a frmal dcumented management review f the suitability and effectiveness f the QMS exist? Des the review include Quality Prduct safety? Cmplaints? Other, describe:.. Hw ften is the review: Annually? Biannually? Versin 1, 15 July 2004 Page 13/34

14 4.5 Questinnaire YES NO Remark Quarterly? Bimnthly? Mnthly? Are cnclusins drawn and dcumented actins taken resulting frm the review? Versin 1, 15 July 2004 Page 14/34

15 5 SECTION 5 Resurce management 5.1. Prvisin f resurces Management shall identify and prvide the necessary resurces s that the manufacture f prducts is carried ut in an efficient and safe manner. T accmplish this, the peratr shall: Prvide sufficient and apprpriately designed equipment & premises Emply sufficient and apprpriately trained staff Clearly assign the respnsibility and authrity fr assuring cmpliance with regulatry requirements and industry cdes f practice t cmpetent persns. Issue, maintain and make available t the peratr and external bdies an rganisatinal chart and jb descriptins. 5.1 Questinnaire YES NO Remark Des the peratr have sufficient equipment? Is the equipment apprpriately designed? Des the peratr have sufficient staff? Is the staff skilled t cmply with expected tasks and requirements? Has the peratr assigned respnsibilities t appinted persns t cmply with external requirements? Des the peratr have an rganisatinal chart? Is the rganisatinal chart updated? Are jb descriptins available? 5.2. Human resurces The emplyees and managers shall have the necessary skills, qualificatins and training t be able t execute their tasks. The rganisatin shall ensure that apprpriate cmpetences, qualificatins, training and awareness are present t achieve cnfrmity t prduct requirements, quality and feed safety: Staff shall be adequately educated and trained in the apprpriate prcedures Educatin and training shall be dcumented and maintained The peratrs shall be trained in apprpriate standards f hygienic behaviur in rder t cntribute t the verall feed safety, as part f the fd chain. 5.2 Questinnaire YES NO Remark Are qualificatins dcumented? Is staff trained in apprpriate disciplines: Versin 1, 15 July 2004 Page 15/34

16 5.2 Questinnaire YES NO Remark Feed safety? HACCP principles? Hygiene? Quality? Health and safety? Envirnment? Is training dcumented and maintained? 5.3. Infrastructure The peratr shall prvide applicable prductin cnditins t the degree f necessity: Adequate buildings Adequate utilities Adequate prcess equipment Adequate wrkspace The facilities and manufacturing equipment shuld be lcated, designed, cnstructed and maintained t suit the manufacture f the prducts cncerned. The lay-ut, design and peratin f the facilities and equipment shall be s as t minimise the risk f errr and permit effective cleaning and maintenance in rder t avid cntaminatin, crsscntaminatin, carry ver and any adverse effects generally n the quality f the prducts. Any waste materials shall be clearly identifiable and dispsed f in accrdance with lcal regulatins and feed safety. 5.3 Questinnaire YES NO Remark Des the building seem t be adequate? Are the buildings built f durable materials? Are the building well maintained? Are necessary utilities installed? Water Steam Pressured air Heating system Others:. Extractin units Are waste materials prperly identified t avid mix-up with prductin prducts? Is waste labelled and handled prperly t avid risks fr wrkers r envirnment? Internally Externally 5.4. Wrk envirnment Where applicable, the peratr shall prvide adequate wrk envirnment in accrdance with lcal regulatins t achieve prduct cnfrmity, e.g.: Adequate ventilatin Adequate cntrl f humidity Adequate cntrl f temperature Versin 1, 15 July 2004 Page 16/34

17 Adequate lighting Adequate hygienic design f plants and equipment 5.4 Questinnaire YES NO Remark Des the peratr seem t have established adequate wrk envirnment t maintain prduct cnfrmity: Ventilatin Humidity cntrl Temperature cntrl Lighting Hygienic design Others:. Versin 1, 15 July 2004 Page 17/34

18 6 SECTION 6 Prduct realisatin 6.1. Prduct requirements Determinatin f requirements related t the prduct The rganisatin shall determine: a) Statutry and regulatry requirements related t the prduct, b) Requirements specified by the custmer, including the requirements f delivery and pstdelivery activities. c) Requirements nt stated by the custmer but necessary fr specified r intended use, where knwn Questinnaire YES NO Remark Des the peratr have a system t identify external requirements? Des the peratr cmply with external requirements? Is cmpliance dcumented? If there are requirements specified by custmers is there a system t cntrl their implementatin? Are ther requirements identified and cntrlled? Cmpliance f the prduct t the requirements The rganisatin shall review the cmpliance related t the prduct and shall ensure that: a) Prduct requirements are defined, b) The rganisatin has the ability t meet the defined requirements. c) The existence and handling f prducts fr exprt utside f the EU and which cannt, frm a regulatry pint f view, be placed n the EU market, shuld be described in the peratr's QMS. The peratr shuld maintain a list f prducts in and ut f the FAMI-QS certificatin scpe, t be checked by the auditr. Where prduct requirements are changed, the rganisatin shall ensure that relevant dcuments are amended and that relevant persnnel are made aware f the changed requirements; see sectin Questinnaire YES NO Remark Are there prcedures t check the ability t cmply with the identified requirements? Custmer cmmunicatin The rganisatin shall determine and implement effective arrangements fr cmmunicating with custmers in relatin t: a) Prduct infrmatin, Versin 1, 15 July 2004 Page 18/34

19 b) Enquiries, cntracts r rder handling, including amendments, c) Custmer feedback, including custmer cmplaints Questinnaire YES NO Remark Has the peratr relevant prduct infrmatin (e.g. technical prduct infrmatin, specificatin, material safety data sheet) in place? Is a system in place t cmmunicate this infrmatin t the custmers? Is a system in place t receive and prcess infrmatin prvided by the custmers? 6.2. HACCP Prgram In the hazard analysis a survey is t be prvided f all ptential hazards. Based n this analysis, hazards shall be classified accrding t risk. Special attentin shall be paid t hazards requiring specific cntrl measures. It is recmmended t fllw the HACCP system as specified in the Cdex Alimentarius. Other requirements t the HACCP system are mentined in sectins 3.2, 4.2, 4.3, 4.4, 6.3.1, 6.4.1, and Questinnaire YES NO Remark Des the peratr have a HACCP prgram in place? Des the peratr have a multidisciplinary HACCP team? Des the peratr have an appinted team leader? D the team members have adequate training and experience? Is the HACCP system based n an adequate prerequisite quality system? Are the fllwing basic principles cnsidered: - Is the HACCP analysis perfrmed and dcumented? - Are the Critical Cntrl Pints (CCPs) identified? - Are critical limits fr the CCPs specified? - Is a mnitring prcedure specified? - Are deviatin prcedures established and dcumented? - Are verificatin prcedures established and implemented? - Are all prcedures and recrds archived? Des the HACCP plan cnsider all pssible bilgical, physical and chemical hazards? Versin 1, 15 July 2004 Page 19/34

20 6.3. Design and develpment Develpment f new prducts and prcesses The rganisatin shall plan and cntrl the design and develpment f prducts r prcesses related t safety. The safety f feed additives shall be taken int accunt during the develpment prcess f a new prduct by implementing HACCP rules Questinnaire YES NO Remark Are develpment plans issued prir t relevant phases f the develpments prcess? Des the develpment plans cnsider risks related t safety? Is HACCP cnsidered? Change cntrl Design and develpment changes shall be identified and recrds maintained. The changes shuld be reviewed, verified and validated, as apprpriate, and apprved befre implementatin. The review f design and develpment changes shall include evaluatin f the effect f the changes n prduct safety. Recrds f the results f the review and any necessary actins shall be maintained Questinnaire YES NO Remark Des a frmal change cntrl prcedure exist? Are changes apprved befre implementatin? Are changes cntrlled and dcumented? Are implemented changes reviewed? Are implemented changes verified? Are changes archived in a prper manner? Are the fllwing items included in the change cntrl prcedure Safety? (Feed, wrkers, envirnment) Legality? Quality? 6.4. Handling f incming materials Surcing f incming materials Purchasing infrmatin shall describe the prduct t be purchased including, where apprpriate, requirements fr apprval f prduct. Selectin and apprval f all raw materials shall cnsider their rigin, transprt, strage, prcessing and handling. Every raw material shall be evaluated t assess any ptential hazard arising frm it. Versin 1, 15 July 2004 Page 20/34

21 Each raw material shall have a written specificatin which is amended when any change takes place. In additin t the analytical characteristics, the specificatin shuld include where apprpriate, the risk f undesirable substances and thse hazards r limitatins that are cnsidered in the peratr's HACCP prcess. In case the material is a feed additive r premixture imprted frm utside the Eurpean Unin, a written cnfirmatin f the cmpliance with the EU current feed regulatins issued by the supplier is needed. Feed additives and premixtures imprted frm utside the EU shuld nly be supplied by FAMI-QS certified peratrs. There shall be a list f internally apprved suppliers and each supplier shall be subject t review peridically. The rganisatin shall evaluate and select suppliers based n their ability t supply prducts in accrdance with the rganisatin s requirements. Criteria fr selectin, evaluatin and reevaluatin shall be established. Recrds f the results f evaluatins and necessary actins arising frm the evaluatin shall be maintained Questinnaire YES NO Remark Is there an apprval prcess fr new suppliers? Is there an up-t-date list f apprved suppliers? Are apprved suppliers reviewed and re-evaluated? What is the frequency f checking the list f apprved suppliers: Annually? Biannually? Others:.. Des each purchased incming material have an agreed upn specificatin? D they cnsider cmpliance with feed safety and legislative requirements? Verificatin f incming materials Each lt entering the site shall be uniquely registered by means f a lt number, full name f prduct, date f receipt, quantity received. Any damage shall be reprted t an apprpriate respnsible unit, e.g. the quality cntrl unit. Incming materials have t be checked and frmerly apprved accrding t written prcedures prir t use. Where apprpriate, a retained sample shall be available fr the at least the shelf life f the incming material, either at the supplier r the peratr. Prper handling f the received prduct accrding t its released status has t be ensured. If incming materials are rejected and nt incrprated by reasn f nn-cmpliance with specificatin r any ther reasn cnnected with their quality r acceptability, their dispsal, destinatin, r return t supplier shall be recrded Questinnaire YES NO Remark Des a frmal written prcedure n handling f incming materials exist? Are incming materials registered uniquely accrding t: Supplier s name/lt/batch number? Operatr s lt/batch number? Legality? Versin 1, 15 July 2004 Page 21/34

22 6.4.2 Questinnaire YES NO Remark Name f material? Date f receipt? Quantity received? Expiry date? Are incming materials inspected? Befre unlading? During unlading? After unlading? Des the inspectin include: Pest infestatin? Dcumentatin f findings? Are nn-cnfrmities recrded? Damages? Dirt? Are recrds f inspectin results dcumented and maintained? Are recrds f supplier guarantees r certificatins maintained? Are incming materials released befre being used? Are materials returned t supplier dcumented? 6.5. Prductin f finished gds Quality Cntrl and prductin The rganisatin shall plan and carry ut prductin and service prvisin under cntrlled cnditins. Prductin area shall be cntrlled s that access fr nn-authrised persnnel can be prevented. Cntrlled cnditins shuld include, as applicable: a) The availability f infrmatin that describes the characteristics f the finished prduct: Each prduct shall have a written specificatin, which is amended when any change takes place. Each prduct shall have a unique name r cde. Details f packaging and labelling shall be available. Each package shall be labelled by a unique identifier (which can be a cmbinatin f cdes) that the batch t which it belngs can subsequently be identified and traced back. All finished prduct shuld be inspected prir t dispatch accrding t a written plan t ensure it meets specificatin and a retentin sample shall be taken f each batch and held until the expiry f that batch at least. If prducts are rejected and nt put int circulatin by reasn f nn-cmpliance with specificatin, r any ther reasn cnnected with their quality r acceptability, their dispsal, destinatin, r return t supplier shall be recrded. Further details are fund in sectin 8 (SECTION 8 Cntrl f nn-cnfrming prducts). b) The availability f wrk instructins The different stages f prductin shall be carried ut accrding t written prcedures aimed at defining, checking and mastering the critical pints in the manufacturing prcess. These include details f necessary precautin t be taken t avid crss-cntaminatin and errrs. Recrds shall be kept which cnfirm that prcedures are fllwed and/r identify any departure frm them. Prcedures shall be subject t regular critical appraisal t ensure that they cntinue t be effective. Versin 1, 15 July 2004 Page 22/34

23 c) The implementatin f rules gverning packaging Where prducts are packaged, care shall be taken t avid cntaminatin during the packaging prcess, and t ensure that packaged prducts are crrectly identified and labelled in cmpliance with the prvisins f feed regulatins in frce. Packaging shall be apprpriate t prduct type and t maintaining cntents fr their intended shelf life. Packaging shall be cnsidered under HACCP analysis. Pallets shall be serviceable, clean and dry. All pallets which are returned, shall be inspected and if necessary cleaned befre re-use. d) The implementatin f rules cntrlling strage Finished Prduct shall be clearly identified and stred in clean dry cnditins. Access t these materials is restricted t authrised persnnel nly. Incming materials, active substances, carrier substances, prducts which meet the specificatins and thse which d nt shall be stred in suitable places designed, adapted and maintained in rder t ensure gd and apprpriate strage cnditins, t exclude cntaminatin and the presence f harmful rganisms. Packed materials shall be stred in apprpriate packaging. Materials shuld be stred in a way as t be easily identifiable, t avid any cnfusin r crsscntaminatin and t prevent deteriratin. A stck rtatin system shuld be in place. The strage envirnment shuld be set up in a way t minimise the risk f damage f packaging and spillage f material. e) The implementatin f rules cncerning lading and delivery Prducts shall be delivered with the prtectin f animal and human health as prime cnsideratins. Cntainers and equipment used fr internal transprt, strage, cnveying handling and weighing shall be kept clean. Cleaning prcedures shuld be intrduced. A final inspectin shall take place t ensure delivery f crrect prduct Questinnaire YES NO Remark Are the prductin areas accessible t authrised persnnel nly? Is the prductin run accrding t frmal prductin planning? Is the plan distributed t the relevant persns? Des the peratr keep recrds n prductin in rder t prve demnstrate that prductin has been fllwed accrding t planned methds? Are there any systems t prevent and cntrl crss-cntaminatin? Des each prduct have a specificatin? Des each prduct have a unique name and/r cde? Des each prduct have a predefined label? Are finished prducts clearly marked and identified? Des each prduct have a predefined Packaging instructin? D packaging specificatins exist? Versin 1, 15 July 2004 Page 23/34

24 6.5.1 Questinnaire YES NO Remark Is the packaging prcess cntrlled t avid cntaminatin and ensure prper labelling? Are all deliveries inspected prir t dispatch? Is this inspectin dcumented? Are nn-cnfrming prducts stred segregated and in a manner t prevent failures? Are the strage facilities adequate? Are strage facilities perated in a suitable manner with separatin between varius purchased materials? Are apprpriate strage facilities available? Clean areas/rms? Ventilated? Dry? Temperature cntrlled? Is a stck rtatin system in place? Are utdated stck cntrlled and segregated? Are lse bulk materials cntrlled and segregated efficiently frm ther lse bulk materials? Verificatin f prcesses fr prductin The peratr shall verify any prcesses fr prductin where the resulting utput cannt be cntrlled by subsequent mnitring r measurement. This includes any prcesses where deficiencies becme apparent nly after the prduct is in use r has been delivered. Verificatin shall demnstrate the ability f these prcesses t achieve planned results. The peratr shall establish arrangements fr these prcesses including: a) Defined criteria fr review and apprval f the manufacturing prcesses, b) Apprval f equipment c) Qualificatin f persnnel, d) Use f specific methds and prcedures, e) Requirements fr recrds Questinnaire YES NO Remark Is there a verificatin prcedure? Des this shw that the equipment is able t ensure prper peratin? Des this shw the prcess will result in material cmplying with predetermined requirements? Versin 1, 15 July 2004 Page 24/34

25 Identificatin and traceability T ensure traceability, the manufacturer shall: Identify and recrd the prduct by suitable means thrughut prduct realisatin. Maintain a register, that cntains: The names and addresses f manufacturers f incming materials, additives r f intermediaries. Incming materials shall be verified accrding t sectin The nature and quantity f the additives and premixes prduced, the respective dates f manufacture and, where apprpriate, the number f the batch r f the specific prtin f prductin in the case f cntinuus manufacturing, and the name and addresses f the intermediaries r manufacturers r users t whm the additives r premixes have been delivered. Indicate the nature and quantity f the additive r premixture delivered and, where apprpriate, the number f the batch r f the specific prtin f prductin in the case f cntinuus manufacturing Questinnaire YES NO Remark Is a traceability system in place? Can traceability be shwn by examples? Can supplied incming materials be traced t suppliers? D recrds allw tracing back frm the final prduct thrugh quality cntrl data and batch recrds t the raw materials used? Can deliveries be traced t custmers? Is name f custmer related t delivered batch and amunt? Preservatin f prduct The rganisatin shall establish the shelf life f a prduct, preserve the cnfrmity f prduct during prcessing and delivery t the intended destinatin. This preservatin shall include identificatin, handling, packaging, strage and prtectin. Preservatin shall als apply t the cnstituent parts f a prduct Questinnaire YES NO Remark Is a stability prgram installed? Is prduct envirnment cntrlled during strage t preserve cnfrmance with quality requirements? 6.6. Transprt Where third party distributin r haulage is used, this shall be selected t be safe and reliable. Special attentin shall be paid t vehicle hygiene and cleanliness, crrect lading and avidance f cntaminatin and crss-cntaminatin. This shall be verified by visual inspectin prir t lading. Fr bulk deliveries the transprtatin agent shall prvide infrmatin abut the tw previus lads. In case the tw previus lads cnsisted f prducts which may cmprmise the safety f the final Versin 1, 15 July 2004 Page 25/34

26 prduct r are nt allwed t be used in feedingstuff accrding t existing regulatins, the transprtatin agent shall prvide a cleaning certificate, infrmatin abut the means f cleaning and drying and guarantee that a clean, empty, dry and durless carg cmpartment and discharge equipment is made available. 6.6 Questinnaire YES NO Remark Are third party transprters used? Are these evaluated and meet current (feed) quality requirements? Des the system ensure a check that the bulk transprters prvide cleaning certificates fr the carg cmpartment and discharge equipment? In case a cleaning certificate fr bulk transprters is nt available: is a system in place which ensures that a check is being dne whether the tw previus lads are acceptable? Is the carg cmpartment and discharge equipment being checked fr cleanliness if a cleaning certificate is required? Des a final inspectin take place befre shipping, and is this inspectin dcumented? 6.7. Cntrl f mnitring and measuring devices The rganisatin shall establish prcesses t ensure that mnitring and measurement can be carried ut and are carried ut in a manner that is cnsistent with the mnitring and measurement requirements. Where necessary t ensure valid results, measuring equipment shall: a) Be calibrated r verified at specified intervals r prir t use, against measurement standards traceable t internatinal r natinal measurement standards. Where n standards exist, the basis fr calibratin r verificatin shall be recrded; b) Be adjusted r re-adjusted as necessary; c) Be identified t enable the calibratin status t be determined; d) Be safeguarded frm adjustments that wuld invalidate the measurement result; e) Be prtected frm damage and deteriratin during handling, maintenance and strage. In additin, the rganisatin shall assess and recrd the validity f the previus measuring results when the equipment is fund nt t cnfrm t requirements. The rganisatin shall take apprpriate actin n the equipment and any prduct affected. Recrds f the results f calibratin and verificatin shall be maintained. A dcumented plant maintenance prgram shall be in peratin in rder t functin in accrdance with pre-determined standards. A recrd shall be kept f wrk carried ut. When used in the mnitring and measurement f specified requirements, the ability f cmputer sftware t satisfy the intended applicatin shuld be verified. This shuld be undertaken prir t initial use and recnfirmed as necessary. Versin 1, 15 July 2004 Page 26/34

27 6.7 Questinnaire YES NO Remark Is a frmal calibratin system in place? Des this include identificatin f items t be calibrated? Are apprpriate calibratin perids defined based n evidence? Is calibratin recrded? Des a frmal preventive maintenance prgram exist? Are maintenance intervals defined? Is maintenance wrk dcumented? Is the safety f prducts ensured during maintenance wrk? 6.8. Cleaning Bth inspectin and cleaning shall be dcumented. This shall be addressed as part f the Hazard analysis. 6.8 Questinnaire YES NO Remark Des a frmal cleaning prgram exist? Des it include apprpriate frequency? Peridic deep cleaning Maintenance cleaning Daily huse-keeping Des it define respnsibility? Des it describe pst-evaluatin? Des it appear t be up-t-date? D detailed prcedures n cleaning f equipment exist? D the cleaning prcedures appear t supprt hygiene and feed safety efficiently? Are the emplyees trained in cleaning prcedures? Is the training dcumented? Des the plant appear in a clean state? 6.9. Pest cntrl There shuld be a written plan fr pest cntrl including descriptin f peridic inspectins. Results f such inspectins shall be recrded. Details n any fumigatin r use f chemicals such as pesticides shall be recrded. The HACCP plan shall deal with the risk f crss-cntaminatin due t infestatin r use f pesticides. Versin 1, 15 July 2004 Page 27/34

28 6.9 Questinnaire YES NO Remark Is a frmal, written preventive pest cntrl system in place? Is the prgram undertaken In-huse? Outside cntractr? Name (if cntracted):. Are preventive measures n place fr: Rdents, utside? Rdents, inside? Birds? Flying insects? Crawling insects? Other, describe: D maps r schematics shwing the lcatins f the preventive measures exist? Are pest activities dcumented? Are pesticide/chemicals applied and their suitability dcumented? Des the usage f the suitable pesticides / chemicals cmply with lcal regulatins? Des the plant seem t be reasnably cleared t prevent infestatin? Versin 1, 15 July 2004 Page 28/34

29 7 SECTION 7 System Review 7.1. General requirements The peratr shall dcument that the quality system is wrking efficiently by planning, implementing and mnitring prcesses in rder t demnstrate cnfrmity f the prducts and cnfrmity f the quality management system. Mnitring prcesses include cllectin f measurements, analysis f data, cnclusins, and if relevant, issuing f prcedures which imprve the quality system. 7.1 Questinnaire YES NO Remark Des a frmal review system exist? Des the system include cllectin f data? Des the system include analysis f data? Des the system include cnclusins? Des the system include imprvements based n cnclusins? 7.2. Internal audits The peratr shall ensure that internal audits are perfrmed t verify that the quality management system is: Effectively implemented and maintained In cmpliance with regulatry and ther defined requirements Internal audits may als be carried ut t identify ptential pprtunities fr imprvements. The schedule fr cnducting internal audits shall be dcumented and include planning, reprts and imprvements. The detailed audit prgram shuld as a minimum include: Preparatin and issuing f audit plans Scpe f the audits Frequency f the audits Methds t cnduct the audits Reprting f findings Distributin f reprts Implementatin f crrective actins and fllw-up activities Selectin and training f cmpetent auditrs 7.2 Questinnaire YES NO Remark Des the cmpany have an audit system in place? Are internally audits carried ut? Which issues are included in the audits: Versin 1, 15 July 2004 Page 29/34

30 7.2 Questinnaire YES NO Remark Prduct safety? Legality? Quality? Health and safety? Envirnment? Other, describe: Des the peratr have a scheduled audit prgram? Are the auditrs being trained? Are the audits reprted and dcumented? Des each audit define a scpe? Are feed safety issues included in the audits? Are nn-cnfrmities fund during the audit reprted? Are fllw-up n nn-cnfrmities reprted? Are crrected nn-cnfrmities verified? Versin 1, 15 July 2004 Page 30/34

31 8 SECTION 8 Cntrl f nn-cnfrming prducts 8.1. General requirements The peratr shall establish a dcumented prcedure fr dealing with prducts which d nt cmply with the intended requirements. This includes: Identificatin f prduct and batch cde Dcumentatin Evaluatin f the cause Segregatin f batch r batches Dispsal f prducts Internal infrmatin f relevant parties The respnsibility fr review and dispsal f the nn-cnfrming prduct shall be defined. A nn-cnfrming prduct shuld be reviewed in accrdance with dcumented prcedures by ne f the fllwing ways: a) Rewrk b) Reclassificatin r dispensatin c) Rejectin and subsequent destructin r dispsal The archiving prcedure needs t be defined and the recrds kept accrdingly. The apprval and use f rewrks (e.g. frm quality rejects, custmer returns r spillage) shall always be cnsidered within the HACCP system. Ptential rewrks, which are nt apprved, becme waste material and shall be dealt with accrdingly. 8.1 Questinnaire YES NO Remark Des a frmal system t handle nn-cnfrming prducts exist? Are the fllwing areas cvered: wrk-in-prgress? Finished prducts? Returned prducts? D the persnnel seem t be aware f these prcedures? D the prcedures include: Clear marking f the nn-cnfrming prducts? Dispsitin with rejectin? Acceptance with restrictins? Regarding fr alternative use? D the prcedures address cntrl f the nn-cnfrming batch/lt? D written prcedures exist n hw t handle rejected materials and prducts? Is handling f rejected materials and prducts defined? Versin 1, 15 July 2004 Page 31/34

32 8.2. Cmplaint handling system A frmalised dcumented prcedure n cmplaint handling shall exist and shuld include: Allcatin f respnsibilities fr cntrlling cmplaints Name f cmplaining custmer Prduct name and identificatin cde Cause f cmplaint Reply t custmer Depending n seriusness and frequency f the identified cmplaint issues, the crrecting actins shuld be carried ut timely and effectively. Where apprpriate, cmplaint infrmatin shall be used t avid recurrence and implement nging imprvements. 8.2 Questinnaire YES NO Remark Des a frmal custmer cmplaint handling system exist? Are cmplaints be evaluated accrding t Cause f cmplaint? Seriusness? Custmer Identificatin f envirnmental, health and safety risks? Other, describe. Are cmplaints used t prevent recurrence? Are crrective actins initiated and carried thrugh? 8.3. Recall A frmal recall prcedure shall be dcumented s that custmers can be infrmed immediately f any irregularity which cmprmises prduct safety. The recall prcedure shall be regularly reviewed t ensure cnfrmance with the quality system. The recall prcedure shuld describe necessary actins t be cnducted, e.g.: Allcate the cmpetency t the persn respnsible fr the recall prcess Identify the nn-cnfrming prduct and batch, including cnsequences t ther prducts, batches r raw materials Identify the destinatin f affected lts Describe prcedures fr dispsal f returned prduct/s, including segregatin frm ther prducts Describe maintenance f relevant registers which link the rute frm prductin t custmers In case f a serius risk t human r animal health the recall shall include infrmatin f the authrities as laid dwn in the relevant regulatins. The recall prcedure shall be tested at least annually t ensure functinality. Such tests shall be dcumented and evaluated fr imprvements. 8.3 Questinnaire YES NO Remark Versin 1, 15 July 2004 Page 32/34

33 8.3 Questinnaire YES NO Remark Des a frmal recall prcedure exist? Des the recall prcedure define respnsibility t an assigned, respnsible persn? Des the prcedure describe the recall prcess flw in a cmpetent manner? Are recalls dcumented? Is the recall prcedure tested regularly? Are the test results dcumented? Are the test results evaluated and used fr imprvement? Des the recall prcedure include requirements n infrmatin t authrities? Versin 1, 15 July 2004 Page 33/34