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Doc. No. :Rev. No. :Page No. :TRACEABILITY AND RECALL PROCEDUREGGMP-00400Page 1 of 6REVISION HISTORYREVDocumentChange NoticeNo.000Review/ApprovalCHANGE DESCRIPTIONEFF. DATEORIGINATORDOC CONTROLLERInitial ReleaseNameSignatureDateDepartmentPrepared by:Reviewed by:Approved by:PROPRIETARY NOTICETHIS DOCUMENT CONTAINS INFORMATION PROPRIETARY TO Soling’s Food Products. ANY DISCLOSURE OR USE IS EXPRESSLYPROHIBITED EXCEPT UPON WRITTEN PERMISSION BY Soling’s Food Products.
ABC Food ProductsTRACEABILITY AND RECALL PROCEDUREDoc. No. :Rev. No. :Page No. :GGMP-00400Page 2 of 61.0 OBJECTIVES1.1 To ensure that all raw materials and packaging products have an effective traceability andproduct recall when required.1.2 To establish system for product recall that shall be strictly followed in the event of anyunintended release or customer complaint on out-of-specification product into thedistribution system.1.3 This procedure will be enforced in the event of an incident occurring which would constitutea food safety, quality or legality risk to the consumer.1.4 To closely monitor the effectiveness of the company‟s recall actions and to providescientific, technical and operational advice.1.5 In case of the customer complaint regarding the delivered products, the company shall takeappropriate action to remove the products from customer or end user.2.0 SCOPE2.1 This procedure applies to all production of ABC’S FOOD PRODUCTS which will be strictlyfollowed in the event of any unintended release or customer complaint on out-ofspecification product into the distribution system.2.2 This procedure will be imposed on delivered ABC’S FOOD PRODUCTS products whichwould constitute a food safety, quality or legality risk to the consumer.3.0 DEFINITION OF TERMS3.1 Class I Recall – A serious emergency recall situation involving product which may have animmediate or long range effect on the life or health of aquatic animals or human consumers.3.2 Class II Recall – A priority situation involving product which may be a potential hazard tohuman or animal life or health.3.3 Class III Recall – A situation involving product which does not pose a health threat, butwhich may have serious or wide-spread customer or public relations implications.3.4 External Recall – The removal of product from the market in which distribution has beenmade beyond the direct control of the organization.3.5 GMP – Good Manufacturing Practices3.6 HACCP – Hazards Analysis and Critical Control Point – Identify and control hazard, andthen monitor the effectiveness of the implemented controls.PROPRIETARY NOTICETHIS DOCUMENT CONTAINS INFORMATION PROPRIETARY TO Soling’s Food Products. ANY DISCLOSURE OR USE IS EXPRESSLYPROHIBITED EXCEPT UPON WRITTEN PERMISSION BY Soling’s Food Products.
ABC Food ProductsTRACEABILITY AND RECALL PROCEDUREDoc. No. :Rev. No. :Page No. :GGMP-00400Page 3 of 63.7 Internal Recall – The removal of product from the market, none of which has left the directcontrol of the manufacturer.3.8 Product Withdrawal – means a firm‟s removal from further sale of use, or correction of amarketed product that does not violate legislation administered by the Health department. Itis not considered to be a recall.3.9 Quality Control – a set of checking procedures whose purpose is to ensure that materialsand finished products are being produced within the foreign materials and physical,chemical and bacterial specifications for each product.3.10 Quality Control operation – a planned and systematic procedure for taking actionsnecessary to ensure safety of food packaging.3.11 Recall – the company‟s removal or correction of a marketed products that authorizedgovernment agency considers being in violation of the law. Recalls are assigned adesignation to indicate the relative degree of health hazard presented by the product beingrecalled. All recalls must have planned, specific course of action to be taken, whichaddresses the depth of the recall, the needs for public warnings and the extent ofeffectiveness checks for the recall.Recall is an effective method of removing or correcting volatile products that may representa health hazard to the consumer or user.3.12 Recalling firm – means the firm that initiates a recall. It is usually the firm that hasprimary responsibility for the manufacture/ import and marketing of the product to berecalled.3.13 Recall strategy – means a planned specific course of action to be taken in conducting aspecific recall, which addresses itself to matters such as depth of recall, need for publicwarnings, and extent or effectiveness checks for the recall.3.14 Retention – holding product from the market or from further processing or shipmentwhen there is evidence of a quality or labeling deviation.3.15 Stock recovery – means a firms removal or correction of a product that has not beenmarketed or that has not left the direct control of the firm. It is not considered to be a recall.PROPRIETARY NOTICETHIS DOCUMENT CONTAINS INFORMATION PROPRIETARY TO Soling’s Food Products. ANY DISCLOSURE OR USE IS EXPRESSLYPROHIBITED EXCEPT UPON WRITTEN PERMISSION BY Soling’s Food Products.
ABC Food ProductsTRACEABILITY AND RECALL PROCEDUREDoc. No. :Rev. No. :Page No. :GGMP-00400Page 4 of 63.16 Traceability – the ability to identify the origin of food inputs, through all stages ofproduction, processing and distribution. Traceability systems are record keeping proceduresthat show the path of a particular input from supplier (s) through processing, to customers.Traceability relies on the „one up-one down‟ approach where establishments and peopleraising documentation in relation to product delivery, have a system in place enabling themto identify who they receive product from and what they receive, and who they supplyproduct to and what they supply.4.0 REFERENCE DOCUMENT4.1 GMP and Quality Manual5.0 RESPONSIBILITY5.1 The Operations Manager is responsible for the implementation of this procedure.5.2 Sales and marketing is responsible to comply with all established Recall procedure.5.3 All concerned employees are responsible to comply with all established Recall procedure.6.0 PROCEDURE DETAILS6.1 Potential product calls are required to be quickly reported and investigated by a responsibledecision-maker who has the authority to assign the recall classification to the situation.6.2 All information received and communication released regarding the recall shall be approvedby Top Management.6.3 Complete records and samples will be kept in the control of the Operations manager.6.4 When the potential for a recall becomes evident, the Operations manager will be informedimmediately.6.5 The Operations manager may assure the responsibility to immediately investigate, usingany resource within the company, to determine whether the situation is a Class I, II, or IIIrecall or is of lesser priority. The Operations manager shall make the classification decisionas quickly as possible.6.6 If the decision is that is a Class I, II, or III recall, the Operations manager will co-ordinate allrecall activities, keeping the concerned employees informed.PROPRIETARY NOTICETHIS DOCUMENT CONTAINS INFORMATION PROPRIETARY TO Soling’s Food Products. ANY DISCLOSURE OR USE IS EXPRESSLYPROHIBITED EXCEPT UPON WRITTEN PERMISSION BY Soling’s Food Products.
ABC Food ProductsTRACEABILITY AND RECALL PROCEDUREDoc. No. :Rev. No. :Page No. :GGMP-00400Page 5 of 66.7 The Operations manager will decide the quickest and best overall procedure for handlingthe recall. Since each situation will be unique, the following are the basic guidelines:6.7.1Determine the suspected product‟s identification codes and the dates of itsmanufacture.6.7.2Determine where the entire product is located.6.7.3Immediately notify all locations where the product was delivered. Mandate a“stop sale”. If the product has been sold to consumers, contact the sellers(distribution) and ask them to make listing of all consumers who received theproduct.6.7.4Get the input as to how to handle all contacts outside the company, such asconsumers, agents, dealers, media, etc.6.8 Sales and Marketing personnel are assigned to make and retain accurate records of whatwas produced, shipped and later accounted for, and finally disposed. Also a record of recallactions and their date and time may be needed for legal protection.6.9 In any case of suspicion noted in the products, the senior management will be informed anda Recall Report will be completed.6.10The clients shall be given details that will enable them to trace the affected product.6.11 These details include the reference number of the product, the production date, thedelivery date, etc.6.12 In the event that the incidence has been notified by one of the customers, theconcerned employee/s will trace back the product through various records to identify all theclients packed for, the assessment details and the delivery details.6.13 He/ She continue with the traceability through the delivery records, which will give thedetails of the product and the quantities.Product traceability systems:-Identification of units/batches of all inputs (Product Traceability information)Lot identification of processed product (Production records and lot or batch labelling)Information on when and where they are moved and/or transformed (Documentatione.g. Delivery Receipt)6.14 In case any of the records in the chain are showing a loss of control then all the clientsidentified as the recipient of the affected product may be asked to withdraw the product fromthe system immediately.PROPRIETARY NOTICETHIS DOCUMENT CONTAINS INFORMATION PROPRIETARY TO Soling’s Food Products. ANY DISCLOSURE OR USE IS EXPRESSLYPROHIBITED EXCEPT UPON WRITTEN PERMISSION BY Soling’s Food Products.
ABC Food ProductsTRACEABILITY AND RECALL PROCEDUREDoc. No. :Rev. No. :Page No. :GGMP-00400Page 6 of 66.15 The information to the client will detail the cause of the problem, the corrective actionput in place and the monitoring system to ensure the problem is eliminated.6.16 In case of any product to be withdrawn or recalled, the clients shall be advised tocontact the Sales and Marketing manager or any of his/her representatives.6.17All product recall when proven to be hazardous to health shall be scrapped.6.18Health Hazard Evaluation and Recall Classification6.18.1 Before initiating a recall, the company will normally gather, correlate andevaluate all known information on the nature and extent of the reputed healthrisk from the product.6.19Recall Strategy6.19.1 Results of health hazard evaluation6.19.2 Ease in identifying the product6.19.3 Degree to which the product‟s deficiency is obvious to the consumer or user6.19.4 Degree to which the product remains unused in the market.PROPRIETARY NOTICETHIS DOCUMENT CONTAINS INFORMATION PROPRIETARY TO Soling’s Food Products. ANY DISCLOSURE OR USE IS EXPRESSLYPROHIBITED EXCEPT UPON WRITTEN PERMISSION BY Soling’s Food Products.
Also a record of recall actions and their date and time may be needed for legal protection. 6.9 In any case of suspicion noted in the products, the senior management will be informed and a Recall Report will be completed. 6.10 The
