Feed Safety Incident and Crisis Management Procedure for Operators and CBs. P-CM-001 Version 1 /

Transcription

1 Feed Safety Incident and Crisis Management Prcedure fr Operatrs and CBs P-CM-001 Versin 1 /

2 Page 2 f 8 CONTENTS 1. INTRODUCTION 2. SCOPE 3. KEY TERMS 4. PROCEDURE Step 1 - Use the crisis tree Step 2 - Define the status f the prduct Step 3 - What t d? Step 4 - Crisis identificatin Step 5 - Crisis management Step 6 - Crrective actins Step 7 - Fllw-up and clsure 5. CONFIDENTIALITY 6. ANNEX

3 Page 3 f 8 1. INTRODUCTION FAMI-QS is a Quality and Safety System fr Specialty Feed Ingredients and their Mixtures. The FAMI-QS Cde f Practice in its respective current versin is a recgnized Cmmunity Guideline mutually acknwledged by ther Eurpean, natinal r lcal standards. Fr the types f feed cvered by FAMI-QS, the Cde addresses safety, quality and regulatry cmpliance. Prper assurance f feed safety wrldwide is a high pririty. Because feed safety has been a tp issue internatinally, bth plitically and cmmercially, and because serius incidents in the feed sectr can ccur, demnstrable assurance f feed safety has becme a sales prerequisite. Preparing fr crisis situatins and respnding apprpriately t them is an imprtant part f feed safety. Fr this purpse, a Feed Safety Incident and Crisis Management Prcedure has been initiated and is described here. 2. SCOPE This dcument is fr all FAMI-QS certified Operatrs/cmpanies and Certificatin Bdies. In the event that the Operatr becmes aware r has reasns t suspect a feed safety incident, r in the event f a prduct recall in relatin t such incidents, where the Operatr is invlved, the Operatr shall immediately make the FAMI-QS Crisis Management Team and the Certificatin Bdy aware f the situatin. Tgether with the Operatr, the Certificatin Bdy in turn shall take apprpriate steps t assess the situatin and any implicatins fr the peratr s certificate. The Certificatin Bdy shall infrm FAMI-QS Team f the result frm this assessment and f its further prgress. During each regular audit, the auditr shall verify whether a feed safety incident has ccurred. 3. KEY TERMS Issue - Usually a tpic f n-ging debate (e.g. in the media) which ccasinally peaks when attentin is fcused n it. At that stage, it can turn int an incident r a crisis. Incident - Usually an islated event which, while relatively insignificant in its business impact, has the ptential t grw int a crisis. In general, if handled prperly, lw/n media attentin. Feed safety incident is an incident assciated with imprted, prduced, cultivated, prcessed, manufactured, traded r transprted prduct fr which there is a suspicin that it culd be harmful t the health f humans, animals r plants r t the envirnment and/r nn-cmpliant with legal prvisins established by legislatrs in rder t secure a high level f prtectin f humans, animals r the envirnment. Crisis - A situatin invlving damage r danger, whether deliberate r accidental, t at least ne FAMI-QS certified cmpany. It culd invlve peple, perfrmance, reputatin, prduct and demands immediate management decisin and actin. It is wrthy f public/media attentin and therefre culd affect the reputatin f the cmpany and the FAMI-QS cde/system. A crisis has the ability t grw frm lcal t natinal r even internatinal scale withut yu nticing, and can be picked up by the press. Every crisis is different and will need t be managed by different teams and using different criteria. -3-

4 Page 4 f 8 Special audits (based n ISO 17021:2011) - It may be necessary fr the Certificatin Bdy t cnduct audits f certified clients at shrt ntice t investigate changes after a feed safety incident r crisis, r as a fllwup n suspended clients. In such cases: the Certificatin Bdy shall describe and make knwn in advance t the certified clients the cnditins under which these shrt ntice visits are t be cnducted, and the Certificatin Bdy shall exercise additinal care in the assignment f the audit team because f the lack f pprtunity fr the client t bject t audit team members. 4. PROCEDURE This sectin utlines the elements f a prduct recall plan and the actins t take when prducts f the scpe f FAMI-QS (Specialty Feed Ingredients and their Mixtures) are harmful t the health f humans and animals r t the envirnment. When these prducts are nn-cmpliant with legal prvisins established by legislatrs in rder t secure a high level f prtectin f humans and animals r f the envirnment, they must be remved frm the feed and/r fd chain in the event f a crisis. The first bjective f this prcedure is t prtect public health by infrming authrities and cnsumers (when necessary) f the presence f a ptentially hazardus FAMI-QS certified prduct n the market. The secnd bjective is t facilitate a rapid identificatin, in rder t stp directly usage f applicable prducts and t remve them frm the prductin and distributin chain. Here belw is a flwchart (STEP 1) which shuld be the tl t evaluate whether the feed is safe r unsafe and if the FAMI-QS Crisis Management Team and the CB must be ntified. STEP 1 - USE THE CRISIS TREE TO DECIDE WHETHER THE FEED IS SAFE OR UNSAFE AND WHEN TO NOTIFY FAMI-QS TEAM (see flwchart n fllwing page) STEP 2 - DEFINE THE STATUS OF THE UNSAFE FEED AND WHEN TO NOTIFY THE COMPETENT AUTHORITIES The fllwing definitins are relevant: a. the defined amunt f the prduct is n lnger under the cntrl f the peratr thrugh: being held at distributrs with a view t sale; being used by a custmer; being held at a custmer with a view t use; r being transprted and cmplete cntrl is questinable. b. the defined amunt is still under cmplete cntrl f the peratr by either having nt left the peratr s premises; being transprted but cmplete cntrl is manageable. -4-

5 Page 5 f 8 STEP 1: USE THE CRISIS TREE TO DECIDE WHETHER THE FEED IS SAFE OR UNSAFE AND WHEN TO NOTIFY FAMI-QS TEAM -5-

6 Page 6 f 8 Depending n the status f the unsafe prduct: a r b (STEP 2). Fllw the steps marked with X in the sequence up-dwn. Steps marked with -- d nt need t be fllwed. Status f the prduct: a b Segregate existing stck X X Initiate a recall prcess X X Infrm the cmpetent authrities (Art. 20 f Regulatin (EC) 178/2002 and/r lcal regulatins) X -- Infrm the cmpetent authrities (Art. 20) in case ther Feed Business Operatrs culd have ptentially similar prblems with their imprted, prduced, prcessed, manufactured r distributed feed. X X Cperate with the cmpetent authrities in respect f handling the crisis, e.g. infrmatin n names f suppliers/custmers destructin r reprcess f the batch/batches, lt/lts r cnsignment/cnsignments ther infrmatin needed t supprt the Rapid Alert System X -- Cnduct necessary crrective and preventive actins X X STEP 3 - CRISIS IDENTIFICATION AND REPORTING TO FAMI-QS TEAM Any incident indicating ntify FAMI-QS Team n the decisin tree (STEP 1) results in filling the Ntificatin Frm established by FAMI-QS. The bjective f this ntificatin is the early reprting f irregularities in animal feeds and the allwance f rapid respnse and cmmunicatin thrughut the animal feed prductin chain, with the aim f preventing r limiting the harmful cnsequences fr man, animals and the envirnment. A blank frm f the Ntificatin Frm (Wrd versin) fr making a ntificatin t FAMI-QS Secretariat is prvided n the FAMI-QS website (see annex 1). Send the frm t the FAMI-QS Crisis Management Team by fax r by (cntact list belw). If yu have any analysis supprting yur reprt, please send it t. Initial ntificatin t FAMI-QS must be perfrmed within 2 days. FAMI-QS Crisis Management Team Mail: ntificatin@fami-qs.rg Phne: Fax Didier Jans (Secretary General) Emmanuel Geneiatakis (Quality Manager) Laetitia Cirilli (Prcess Manager) NOTE: A reprt t FAMI-QS Secretariat des nt substitute a reprt t the lcal authrities. If the nncnfrmity is a legal breach, yu will als need t reprt t the authrities in yur cuntry. What t reprt? Regulatin (EC) 178/2002 (Art. 20) requires any feed business peratr t infrm immediately the cmpetent authrities if it cnsiders r has reasn t believe that a feed placed n the market may nt satisfy the feed safety requirements which encmpasses: risk t animal health, human health r the envirnment; -6-

7 Page 7 f 8 nn-cmpliance with a regulatry prvisin implementing feed legislatins Directive 2002/32/EC n undesirable substances in animal feed. Regulatin (EC) 999/2001 laying dwn rules fr the preventin, cntrl and eradicatin f certain transmissible spngifrm encephalphaties. Cmmissin Regulatin (EU) 574/2011 amending Annex I t Directive 2002/32/EC as regards maximum levels fr nitrite, melamine, Ambrsia spp. and carry-ver f certain cccidistats and histmnstats and cnslidating Annexes I and II theret. STEP 4 - ASSESSMENT AND COMMUNICATION FAMI-QS Team is bliged t handle the data in cnfidence: the prvided infrmatin and reprt frm will be available nly t the FAMI-QS Crisis Management Team; FAMI-QS Secretariat will allcate an annymus serial number t the reprt s that the reprt may be discussed annymusly; all reprts will be treated in cnfidence, n business-specific infrmatin r pst-crisis review will be prvided t third parties withut the permissin f the reprting bdy; the reprt frm is archived n a secured system, a passwrd is required t pen the dcument, nly FAMI-QS staff can access thse dcuments and the reprt frm is archived fr 10 years. The reprt will be assessed by the FAMI-QS Crisis Management Team. After assessing the reprt, there are three pssible utcmes: a. Alert The situatin is urgent and nt (cmpletely) under cntrl, an alert message will be published n the FAMI-QS website r by . This alerts all FAMI-QS certified cmpanies and gives them a pssibility t take apprpriate cunter measures. b. General reprt within the framewrk f FAMI-QS The situatin is under cntrl, but it is useful t infrm the ther FAMI-QS Members abut what happened. With this infrmatin, the ther FAMI-QS Members can evaluate and take cunter measures. c. N publicatin The situatin is under cntrl and there is n need t infrm the FAMI-QS certified cmpanies. The reprting peratr will be infrmed abut the utcme f the assessment. In the case f a r b, the peratr will als receive a draft f the alert message t be apprved within 24 hurs. STEP 5 - CORRECTIVE ACTIONS Operatrs - In case an peratr is invlved in a crisis, crrective actins must be implemented. - A prgress reprt must be sent t FAMI-QS Crisis Management Team within 3 weeks. Depending n the develpment f the crisis situatin, anther reprting date can be set in agreement with FAMI-QS Staff. Certificatin Bdies - After cnsulting the peratr, the CB shall chse the tls t assess the situatin (as e.g. audit dcumentatin review, special audits). -7-

8 Page 8 f 8 - CBs can perfrm a special audit if circumstances make it necessary, by implementing sectin 7 f the rules fr CBs. - If a special audit is nt necessary, CBs shall verify the implementatin f the crrective actins during the next regular audit. CBs shall als check that the peratr has sent the initial ntificatin and the prgress reprt t FAMI-QS Team within the set timeframe. If nt, a minr nn-cnfrmity shall be issued. STEP 6 - FOLLOW-UP AND CLOSURE T fllw-up and clse a case, FAMI-QS Secretariat needs a decisin n the further certificatin status frm the CB either by r letter. The CB defines the criteria t suspend r withdraw a certificatin. The withdrawal f a certificate remains the respnsibility f the CB. Once the withdrawal is cnfirmed, the name f the peratr will be remved frm the FAMI-QS register n the website ( Valid certificates can be fund n the FAMI-QS website. Nt ntifying FAMI-QS Team and the CB abut a feed safety incident culd be a ptential reasn fr withdrawing the certificate. In case a special audit was cnducted, FAMI-QS Secretariat needs the special audit summary reprt frm the CB, shwing that the crrective actins have been implemented and the rt cause has been identified. If n special audit is needed, the issue must be checked during the next regular audit and dcumented by the CB in the audit summary reprt. FAMI-QS Crisis Management Team will write a pst-crisis review fr their archive. This pst-crisis review signals the transitin t nrmal peratins and the end f the crisis. The review is an pprtunity t see what was learned frm the crisis and prvides pprtunities fr updates f risk management systems and best practices. 5. CONFIDENTIALITY Any exchange f infrmatin related t the purpse f this prcedure will be kept strictly cnfidential and shall nly be cmmunicated between the parties invlved (FAMI-QS, Certificatin Bdy and Feed Business Operatr). All infrmatin btained frm the Operatr and by the Certificatin Bdy will be handled in a strictly cnfidential way by FAMI-QS Staff. FAMI-QS Team will nt use it fr purpses apart frm thse established in the frame f the crisis management prcedure. 6. ANNEX - NOTIFICATION FORM D-CM