Product Recall for the Bottled Water Industry

Transcription

1 memberresources Product Recall for the Bottled Water Industry The purpose of this document is to provide member companies with a set of principles and guidelines for a product recall procedure plan which could be adapted by the smaller bottled water manufacturer or used as a guide by the larger manufacturers in developing their own procedures. Although it may be most unlikely, it is possible that a time may come when an emergency recall of a particular product is necessary. This may come about by failures in quality assurance and in the quality control program, through accidents or unforeseen circumstances. These might constitute a health risk of a greater or lesser nature and so could affect consumer acceptability of the products concerned. Sponsor A sponsor of a beverage is the provider of the product to the wholesale or retail market. A sponsor may be a manufacturer or an importer. Withdrawal A product may be withdrawn from sale because of a quality defect that does not pose a potential risk to public health or safety, or a withdrawal may be undertaken prior to a recall, pending a further investigation that may or may not lead to a recall. Recall A recall is constituted by action taken to remove from sale, distribution and consumption, foods which may pose a safety hazard to consumers. A recall may be permanent or temporary, whereby product may be returned to the market after rectifying action has been taken. Trade Recall A trade recall occurs when trade level ingredients are recalled, for example, detergent that may be out of specification, flavouring that is not permitted in that food, colouring not approved in that country, presence of an undeclared allergen or as a result of poor hygiene in manufacturing practice. Customer Recall A consumer recall occurs when consumer goods are faulty; for example, grocery items that do not meet microbiological criteria, or incorrect packaging. Mock Recall A mock recall is a created or theoretical event conducted by the recall committee to practice procedures. Participation in this event ensures all aspects of the recall plan are up to date. Mock recalls are valuable because they demonstrate that systems of documentation are adequate to enable timely removal from sale, distribution and consumption, beverages which may pose a safety hazard to consumers.

2 Consumer product standards, bans and recalls all come under the Commonwealth Trade Practices Act. This Act gives the Minister (in practice the Minister for Consumer Affairs or the Attorney-General), power to order a recall of consumer goods if a voluntary recall is considered to be inadequate and to issue public warning notices. Section 65R of the Act also requires that a supplier must notify the Minister within two days of a voluntary recall when goods will or may cause injury to any person. Severe penalties can be imposed by the Federal Bureau of Consumer Affairs through the federal court for breeches of not only standards and bans, but also recalls. Complimentary State laws also exist, so it is advisable to check the precise details of the provisions of these laws. Most states require that a party responsible for a food or beverage subject to a mandatory recall, be liable to recall that product from members of the public. Full co-operation with the Food Standards Australia New Zealand (FSANZ) State Health Departments and Office of Consumer Affairs in a product recall is of great importance. Bottled water manufactures may lodge a copy of their product recall procedures with the State Health Departments or authorise ABWI to lodge a copy of its recommended recall procedures on their behalf. However, whilst this is not mandatory that the full set of procedures be lodged, it is essential that the following details be lodged: 1. company name 2. contact names and positions 3. contact address, 24 hour telephone and fax contact numbers 4. beverage type and brands involved Enquiries about the enforcement of product standards, bans and recalls can be addressed to: Food Standards Australia New Zealand (FSANZ) 55 Blackall Street Barton ACT 2600 PO BOX 7186 Canberra MC ACT 2610 Ph (02) Fax (02) Please refer to the FSANZ Food Recall Action Officer list. It is of utmost importance that company employees in key positions, as set out in the product recall procedures, be aware of the product recall plan and of the part which their sections play in that plan. Recall Objectives The prime objectives of a recall plan are:- To locate and retrieve affected stock. To notify the trade, consumers and Government Authorities as necessary, of the product recall. To provide accurate information. Page 2 of 8

3 Sources of Complaints Examples of likely sources of complaints are:- Government Agencies Medical Sources Consumers Company Sources (e.g.: Sales Force, Quality Control Staff) Media Classification of Recalls Product may be withdrawn from the market by way of a recall or a withdrawal. A withdrawal will occur in a situation where the use of the product is not likely to cause adverse health consequences. Examples would be incorrect labeling (with the exception of incorrect labeling that may lead to a health risk; for example, labeled as low sodium when there is a high sodium content), aesthetically undesirable foreign matter, incorrectly formulated product. This does not warrant a voluntary recall notification to the Minister for Consumer Affairs. A recall will take place when there is a reasonable probability that the consumption of the product will cause serious adverse health consequences or where the consumption of the products may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Examples would be the presence of toxic contaminants or harmful foreign bodies. It should be noted that a compulsory recall can however, be ordered if it is deemed that insufficient action has been taken with safety related defects. A hazard / risk assessment will be carried out to determine the exact classification of the recall. It is critical that all necessary information is obtained and thoroughly analysed prior to a decision being made for a recall. Levels of Recall There are three levels of recall, these being: a) Warehouse (trade) recall b) Retail recall c) Consumer recall The level of recall will be determined by the Recall Committee. This may be arrived at after consultation with the Australian Recall Coordinator. An initial withdrawal may, after further investigation, be converted to a full recall at any one of the three levels. Identification of Product for Recall A manufacturer facing a voluntary recall of a particular product has to determine how much of that product, in the field, needs to be brought back. There are two methods of achieving this objective:- a) recall all the particular product or b) date mark or code all containers/cartons so that recall can be limited to a specific date(s) or code(s). Page 3 of 8

4 The choice rests with the individual manufacturer who will decide on the basis of cost-benefit or prevailing Local, State or Commonwealth regulations. Records Records adequate to identify the processing history of each batch, should be retained for suitable periods of time, relative to the expected shelf-life of the product and product turnover periods. Organisation for Recall A predetermined recall structure within each bottling plant or company is necessary. The appointment of a Recall Co-ordinator, operating from within the framework of the company concerned, is essential. This person would be the manager in a small company or an experienced executive, reporting directly to the top management. A Product Recall Co-ordinating Committee should be formed with roles which include:- Assessment of the overall problem Evaluation of the hazard and decision of the strategy to be followed Recommendation as to whether or not to close the production plant Provision of a sole contact with the media and Government Authorities Provide information requested by the Government Authorities on the progress of the voluntary recall action Recommendation of when production may recommence Membership of the Product Recall Co-ordinating Committee should comprise appropriate representatives from the following functional areas within the company:- Marketing and Sales Quality Assurance Warehousing and Distribution Manufacturing Finance Public relations aspects and legal implications to be handled by the Recall Co-ordinator directly with the sections concerned. Recall Plan The following activities are suggested for the implementation of the Product Recall Plan upon evidence of a possible product fault. Page 4 of 8

5 Documentation Product Non-Conformance Reported to Management Institute a log of events and actions taken, to be maintained until all aspects of the recall are finalised. Ensure that original manifests, vouchers, notices, repots and papers are retained for later official (etc.) scrutiny if this becomes necessary. Action The appropriate company executive (e.g.: Quality Assurance Manager) considers the evidence and makes the preliminary decision as to the potential hazards. Decision is made whether a recall is necessary. It is expected that this decision would be made by the chief executive of the company or operating division concerned. Recall Co-ordinator convenes the product Recall Co-ordinating Committee which collates and evaluates all information immediately available on the extent and nature of the problem and decides the recall classification. Notify company management and company functional areas of the situation for which an appropriate list is included in the plan. Prepare further information as it becomes available for all interested parties whilst continuing log. Review procedure to avoid further nonconformance Immediate actions are taken to:- Discontinue distribution of the product Determine total quantity of product suspected as faulty and subject recall. Locate the product and commence recall, notifying customers, wholesalers and retailers Continue investigation into the nature, extent, cause and remedy of the problem Consider the need to discontinue production of the product and issue necessary instructions Notify Government Departments through the local Food Recall Action Officer. Notify industry bodies, as considered appropriate. Notify the media and the public of the situation, if appropriate to the circumstances. Notify the company staff of the situation. Determine the necessity for storage, isolation and method of disposal of the affected stock and/or ingredients. Maintain periodical checks of the effectiveness of the recall by relating total quantity recalled compared with total subject recall. This suggested Product Recall Plan is for those members not wishing to develop their own plan and it is realised that in the very small company one executive may be responsible for several of the functions concerned. An example of a Production Recall Action Plan is attached, which has been adapted from one which was used successfully by an Australian based company in recent times. This is an outline plan only, as any company may wish to develop its own action plan in accordance with its particular needs and circumstances. Page 5 of 8

6 Publicity The supply of facts to the media is of prime importance as it can be expected that any significant product recall could constitute important news for the press, radio and television. The policy should be based strictly on the following:- 1. Only one source within the company to be authorised to issue press statements to the media. These must be in writing. 2. Only substantiated facts should be given. 3. Unless companies are frank and open with the media, there is the risk that the media, there is the risk that the media will present its own story, based on rumour, mis-information and unrelated circumstances. Advice To Government And The Media The following material should be covered in advices to Government Departments and to the media, in the event of a product recall. Product 1. Description of the product with name, size of the container, all possible codes on the individual container and the bulk package (including their location on the package concerned). 2. Batch, lot or code numbers as appropriate 3. Method for consumer identification. 4. Contact person within sponsor s organisation. 5. A name, address and telephone number of the sponsor. 6. National distribution 7. Overseas distribution of export product Problem 1. A description of the contamination / faulty product / misleading labelling / etc, that has led to the recall. 2. Details of the person, company or government authority reporting the problem. 3. Date of the report. 4. Number of similar or related reports. 5. Action being taken by the consumers. 6. Action being taken by the sponsor 7. Results of any testing or other investigations carried out by the sponsor. Other Relevant Information 1. Availability of suspect or other samples for investigation. 2. Type of hazard and assessment of risk. 3. Action proposed by the sponsor 4. Product recall level. Page 6 of 8

7 Post Recall Action One month after the recall, an interim report should be sent to the Australian coordinator. The final report should be provided two months after the recall. The reports are to contain: 1. a copy of the recall letter or fax sent to consumers, 2. the circumstances leading to the recall, 3. the action taken by the sponsor, including an6y publicity, with names of newspapers in which the 4. advertisements appeared, 5. the extent of distribution of the relevant batch in Australia and overseas, 6. the result of the recall, including quantity of stock returned, corrected, outstanding, etc., 7. the method of disposal or otherwise of recalled stock, with certificates of destruction, 8. action proposed for the future to prevent a recurrence of the problem, 9. any difficulties experienced in conducting the recall. 10. whether any government agencies or industry organisations helped with the recall and, if so, what written information they provided. Where it is considered that the reports are unsatisfactory, further recall action may be considered by the regulators. Export Product Section 65F(7) of the Act provides for exported product. This requires that for goods that have been exported and for which a recall is subsequently required, a sponsor must notify, in writing as soon as practicable, overseas recipients of the recalled stock. The notification must state that the foods are subject to recall and, if the goods contain a defect, have a dangerous characteristic or don not comply with a prescribed consumer safety standard, set out the nature of the problem or in the last case, the nature of the non-compliance. The sponsor must also provide a copy of the overseas notification to the Minister for Consumer Affairs within 10 days of sending the letter or telex notification. The penalties for breaches of Section 65F are the same as those for breaches of Section 65R. Page 7 of 8

8 Sample Flow Chart for Recall Process Provide report of nonconformance to sponsor Initial assessment of need for immediate action by the recall team Seek assistance from an Australian Recall Coordinator where required Recall Withdraw Determine level of recall required For Further Information: Australian Beverages Council Ltd Contact Australian Recall Coordinator, Correct as at 17th State October, Health Departments Within two days, write to advise the Federal Minister of Consumer Affairs Determine the need to advise industry bodies such as ABWI and do so. Stop production and distribution Contact warehouse, retail or other consumers depending on level of recall Place advertisements in media and newspapers where required Arrange isolation of contaminated product including full investigation & testing Return products to stock or destroy No further notificat ion required Complete final reports and recommendations. Instigate action to prevent recurrence. Assess effectiveness of recall procedures. Page 8 of 8