"Our Quality System has identified..."

Product recall notices: We have all seen them; many of us have been affected by them; and businesses hope that they never have to issue one. They signify that "something" has gone wrong and strive to give consumers and others in the supply chain the opportunity to take action to prevent the "something" from damaging their person, property or reputation. Product recall can affect both consumer and commercial products, even though the implementation of the recall can differ. In this article I will explore some of the general implications for recall of consumer products, generally under the General Product Safety Directive, and under CE directives such as the Low Voltage Directive.

Let us take two examples of how a product recall may affect you. Firstly there is the General Product Safety Regulations 1994, which in section 8 has a "requirement as to information" including provision for withdrawing products from the market. The General Product Safety Regulations (see figure 1) are not derived from a CE marking directive however they may affect CE marked products where safety is not covered by the specific directive (e.g. for electrical products CE marked for EMC but outside of the scope of the LVD, i.e. battery powered equipment). The EU Commission has recently proposed changes to this foundation of consumer protection legislation with the aim of sharpening up its requirements including those covering product recall. The second example is the LVD itself which requires, under Article 10, that all appropriate measures are taken to ensure that an unsafe product is withdrawn from the market. With such clear requirements, it is critical that product recall is understood by everyone involved in the supply of equipment.

The General Product Safety Regulations 1994

The General Product Safety Directive is intended to fill gaps in European consumer safety legislation. This is achieved by: Specifying that products supplied to consumers, whether for a consideration or provided free for charge, must be safe; defining a safe product; and laying down a framework for assessing safety.

The General Product Safety Directive and hence the Regulations place responsibilities on producers and distributors. Both of these parties have to supply only products which are safe and must also undertake relevant activities, including monitoring, where appropriate, to help ensure that a product remains safe throughout its reasonably foreseeable period of use. Steps must be taken to ensure the products supplied are safe, to provide customers with relevant information and warnings and to keep them informed about risks.

The General Product Safety Regulations do not apply to products that are controlled by a specific Directive in which comprehensive terms of safety are contained (i.e. the LVD). However where this is not the case, safety will be assessed taking into account voluntary European standards, Community technical specifications, national standards; accepted industry codes of practice and state of the art/technology. From this list it may be concluded that the simplest route to compliance is by using an appropriate EN standard, this being a demonstratable document containing "best industry practice". Although it must be noted that standards do not necessarily provide for an automatic defence against any claim for breach of the legislation.

The UK Department of Trade and Industry (DTI) has produced a guide to consumer product recall (November 1999) that can be downloaded from the DTI website. This contains practical guidance on recall policy and procedures. The guide also contains some useful real life examples including the case of a faulty mains charger for a mobile phone. The cost of this recall (excluding the shipping and replacement of 35,000 chargers) was in excess of £200,000. Other guidance documents on consumer safety and product design are available from the DTI.

When is a recall necessary? In cases of obvious and substantial hazards and risk then this question is easily answered. However, in reality these matters are seldom so straightforward and generally require a degree of judgement. Within all but the smallest of organisations it is best for this judgement to be proceduralised so that events can be controlled even in the heat of a crisis. Good policy usually results from careful planning rather than from a shoot-from-the-hip reaction. The decision to recall is a function of a number of factors including the risk of the hazard causing injury, the number of faulty products and the length of time the product has been on the market. Neither the General Product Safety Regulations or the LVD have a mandated requirement for product recall; it is merely one of a number of measures available to ensure safety. However, the proposed amendment to the General Product Safety Regulations includes provision for a mandatory recall procedure whereby enforcement authorities can order a product recall, where they believe a recall is necessary (see figure 4).

OXFAM concern over new EU regulations

OXFAM were responding to a proposal circulated by the DTI as a result of a EU Commission review of the current directive (implemented in the UK as the General Product Safety Regulations). The Commission concluded that whilst the structure is sound it could benefit from some improvements. These improvements include providing a system for mandating standards, placing a duty on suppliers to notify unsafe products to enforcement authorities, new requirements for product recall and strengthening market surveillance. There is also an interesting section that aims to ban the export of unsafe products outside of the EU. This latter requirement could effect products that should be covered by a CE directive but for whom the regulations are dis-applied by virtue of use outside of the EU.

If a recall becomes necessary then there is an obligation to alert anyone who is at risk. The DTI advocates three main ways of tracing owners and users and suggests that more than one approach may be necessary to achieve an effective recall. The first method involves purchase records including your own sales data (particularly from commercial or industrial products), retailer's lists, warranty contracts or guarantee/registration cards. It is therefore in your interest to encourage completion of these records at time of purchase, perhaps by some form of incentive. For commercial products a good sales database and a well-trained sales force are important. The second method is less specific and targets likely owners/users through in-store advertising, trade magazines or your website). The final method, and probably the least specific, is general advertising. This latter method is most appropriate where there are a large number of products in the market. However, it should be recognised that it is an unfocussed approach and may product sporadic results. Remember that recalls often only recover 10-15% of defective product and that the liability for the remaining products is not removed just because you tried to get the product back by a recall. Product recall is responsible way of minimizing your liability and the consequent negative publicity.

Identifying how you reach your target audience is of course only the first step. You must present your message to these people and affect a response on their behalf. The DTI guidance recommends absolute clarity in this message and includes a checklist and some examples to help you design an appropriate notice for your company. Key points are: To clearly identify the notice as a safety warning; to describe the product, the problem and risks so that the reader understands; and inform the reader what action they must take (i.e. return to shop/distributer or telephone this number).

Having identified who has the product and how your message is to be presented, your recall policy needs to be communicated to all interested parties so that it can be completed with minimum complication. Critical points are to ensure that refunds are controlled to avoid fraud and that the logistics of product exchanges are effective. For commercial products, the recall may in fact be a re-fit. In this case it is imperative that the agents employed to undertake the re-fit are properly briefed so that the correct message is delivered to owners and operators. A poorly run recall can seriously damage your brand reputation, whereas an efficient recall sends a clear message of efficiency and responsibility.

Everyone hopes that their product will never be involved in a recall. The DTI guide includes a list of tips for preventing a recall (figure 2). Many of these elements for prevention are also covered by the example regulations that I cited earlier (i.e. General Product Safety Regulations and the LVD). In the case of both of these sets of regulations, there is heavy emphasis on good design, the use of standards to assess the design, good documentation and quality assurance procedures. Close adherence to regulations such as the General Product Safety Regulations and LVD is an effective method of preventing recall (see figure 3 for guidance on good design and production practice).

Tips for preventing a recall

1. Check that design and manufacture are geared towards the production or sale of safe products.
2. Ensure compliance with relevant legislation and appropriate safety standards.
3. Make stringent checks on components before production and use quality assurance at each stage of production.
4. Set up systems to trace components and the final destination of your products.
5. Clearly batch mark products.
6. Make safety instructions clear.
7. Monitor complaints form the supply chain.
8. Set up a consumer feedback system.
9. Monitor warranty and insurance claims.
10. Build good relationships with your local trading standards department.

Good design and production practices for electrical products

1. Control the elements of your design properly. Use approved components with supporting paperwork.
2. Test your design and hold test reports. Ensure that these repots describe the product and list the critical parts that your need to control during production.
3. Ensure that purchasing functions only buy listed critical parts. Use purchasing to request and remind suppliers that compliance depends upon their components.
4. Manufacture in accordance with written procedures. Use quality assurance procedures to check production. Test products at the end of the line before shipping.
5. Adopt procedures for reviewing designs and coping with changes in components, etc.

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