Product Recall and Withdrawal Procedure

1.0 Purpose 1.1 1.1 Company ABC objective is that only products which are safe for use with food products and comply with all legal requirements are delivered to the customer. Despite all of the precautions we take it can happen that a product is distributed which is subsequently found to be unfit for use with food products. n these cases we must act quickly in order to! 2.0 Scope #.1 $or a fully functioning recall system it is essential to have implemented a well defined procedure with clearly defined responsibilities to ensure that! %roblems are identified as early as possible and follow&up actions are taken 'he source of the problem is identified and eliminated or minimi"ed 'he implementation of the recall is fast and effective once the recall decision is taken All responsibilities for internal and e(ternal communication are clearly specified to assure a rapid and appropriate response protect the health of consumers and minimi"e the impact on the company image and the brands of our customers

3.0

Documents %roduct )ecall ncident )eport *D 1+.#,

4.0

Definitions -.-/.

5.0

Procedure 0.1 1evels of recall

0.1.1 )ecalls can be operated at different levels2 depending on the nature of the defect. 'he risk to the consumer or the risk to the brand determines the type and the depth of the recall. T pe 1 Recall !ur"ent#$ a product has a reasonable probability of causing a serious health consequence or death if used 3e.g. presence of chemical to(ins that could cause acute to(icity2 product tampering4.

T pe 2 Recall$ a product has a reasonable probability of causing a temporary health consequence if used e.g. presence of foreign body objects 3glass2 sharps2 blades etc.4. T pe 3 Recall$ a product has no adverse health consequences but is in violation of official regulations2 e.g. incorrect labeling2 incorrect filling weight2 inappropriate nutritional claims. Product withdrawal is the voluntary removal of a product because it poses no ha"ard to health and does not violate any regulations2 but does not meet own quality standards and may result in consumer dissatisfaction.

0.#

Depth of )ecall %ontrolled product reco&er $ products which have to be withdrawn are in the factory2 in transit or in company warehousing. /.g. -ot at customer or retail level. Trade le&el remo&al$ the suspect product is already at retail level2 but there is no risk for the consumer5 the product is removed from warehousing2 not from retail shelves. Retail remo&al$ a product needs to be removed from the retail shelves2 but public notification is not required. Pu'lic recall$ recall down to the consumer level5 a public recall is required when the recall is assessed as type 314 or possibly type 3#4 as defined in 0.1. 6arning through the media is necessary.

0.7

)ecall Committee

0.7.1 A recall committee formed by members of different functions e.g. quality2 technical2 sales2 marketing2 logistics and at least one 8anager has to be established to deal with all potential issues and guarantee a controlled recall procedure! 'he recall committee! Completes a risk assessment and recommends the type and depth of the recall or withdrawal. Decides the necessary actions which have to be taken. Decides the timescales for contacting all relevant stakeholders. 'his will not e(ceed #, hours even for the lowest risk level recall. Assures proper internal and e(ternal communication $ollows up the corrective actions

0.,

)ecall Coordinator

0.,.1 'he recall committee is headed by the )ecall Coordinator. 'he )ecall Coordinator is the designated *uality and 9ygiene systems 8anager or his direct deputy. n this capacity the person reports directly to top management. 0.0 %roduct recall

0.0.1 'he effectiveness of the product recall procedure is tested annually and the results are recorded on Product Recall (ncident Report )D 1*.24. 'he responsibilities include! to coordinate all activities during the recall. to gather all necessary information 3production2 stock2 distribution details2 details of the product defect2 potential health risks etc.4 and to provide the recall committee with the necessary information for the decision on the steps that have to be taken. to forward relevant information to all parties involved in the recall 3internal and e(ternal4. to document details of the product recall on Product Recall (ncident Report )D 1*.24 and develop action plans for improved operations. 'o ensure that the recall system is reviewed regularly and that it functions in any circumstances.

0.+

'raining

0.+.1 All staff that may be involved in a recall must be trained regularly in the recall procedure and related actions. 'he training will include being part of mock recall tests. 0.: 'raining

0.:.1 'he recall must be tested regularly 3at least every two years4 to assure the functionality of the procedure. 'he review process should include regular practical e(ercises2 including a traceability e(ercise at internal and wholesale level. Challenging targets should thereby be set for rate of recovery within a given time frame.