In 1987 when product liability and consumer protection legislation was introduced in UK and US, there was considerable speculation that product recall would become one of the most crippling side -effects of such legislation. Since then the fear has become a reality for some organization.
The Consumer Protection Act 1987 states: " The manufacturer of a product being held liable if a defect in the product or in its design could be determined to have resulted in an injury." This means that a product would be regarded as perfectly in accordance with the design itself that would be deemed defective.
So what impact has the legislation made on the number of product recalls? Famous product recall incidents include the chemical contamination of Perrier water in 1990-almost forcing the company to change its name -and Mercedes narrowly avoided a complete disaster when its new A Class was found to be unstable that it was capable of rolling over in relatively foreseeable conditions. Honda laso announced a recall of its Jazz cars due to the discovery of a defect in the design of the handbrake.
Away from the automotive industry Sainsbury's issued a recall for its frozen thin and crispy vegetable stonebake pizza in April 2009, following discovery of metal fragments in some pizzas. In another food related recall, KP announced that free milk caps in packets of KP Skips had caused distress as people had accidentally put them in their mouths.There was nothing specifically wrong with the product itself , yet KP felt obliged to create adverts to limit the potential damage to their brand.
Anytime, anywhere
A product liability situation can arise at anytime and almost always without warning. It can happen to the most quality conscious organization as well as the most careless. So what can your organization do to protect itself? There are four possibilites:
1. Ignore the risk and hope it doesn't happen. If you are lucky, this is the least expensive approach. If you are unlucky , it could destroy the company.
2. Insure against the risk by passing it on to others. This assumes that insurance is available, but in many cases it will not be. Even if it is initially available, as soon as an event has taken place, future premiums will be prohibitive.
3. Reduce the risk through the application of quality. This will reduce the risk and the right approach will also cut cost significantly. The intensive application of the project improvement process using the outputs of design failure modes and effects analysis and process failure modes and effect analysis are essential.
4. Establish a product recall procedure to minimize potential hazard which will require the fastest possible location of every item responsible for the risk and its removal from the market. Experience indicates that with the best will in the world this is close to impossible if an effective procedure is not in place.
For example, in the 1960s ITT, an engineering and manufacturing company, established a scheme through which every purchaser of its steam irons was logged into a database in order to be prepared for a recall. Furtheremore, the company created an in-built incentive to encourage subsequent second hand users to record the change of ownership of the product.
Even with this level of information, when the need for a recall arose, only months after the initial distribution of the product and additional intensive television and other media advertising of the recall, the company was only able to recover about 70% of the defective products. The remainder simply disappeared without a trace. Organizations should also note that attempting but failing to recover such items does not absolve the distributor of its responsibility. Any one of the missing 30% could remain as a hazard both to user and to the company.
Clearly, failure to act quickly, or acting without a plan, could result in chaos. The resulting costs will also be appreciably higher than if a proper plan is ready. To be effective , a product recall plan must be capable of instant implementation.
In a worst case scenario, decisions will need to be made on each of the following:
- Recall of products from overseas
- Tracing of individual purchasers
- Television/newspaper/online advertising
- Withdrawal or freezing of stock in warehouse and retail outlets
- Stock repleneshment
- Issuing of instructions for the safe use of the product or its disposal
- Subsequent monitoring of the health of those who may have inhaled or consumed doubtful chemicals, food stuffs, gases or radiation
- Internal costs of product modification and replacement.
-Administration of the plan
State of the Art
Apart from the pharmaceutical industry, where the Medicine Act 1968 imposes certain obligations on license-holders with regard to strategies for the withdrawal and recal of sale.
In addition, it was rarely possible for the ultimate consumer to bring a successful action against manufacturer, because it was not usual to buy the product from them directly and no contract of sale existed between them. It was only possible in exceptional cases to prove that the injury was directly caused by negligence on the part of the manufacturer.
Insurance companies do not look favorably on the idea of product recall insurance. This is because the most costly recalls are likely to be initiated as the result of the new design fault. The more limited recalls will most likely be caused by a manufacturing fault, such as a mix up with labels. Therefore insurance companies generally regard innovation as a development risk that should be borne by the company. Consequently, for the unfortunate company confronted with the reality, exposure may be unavoidable.
Speed of action is essential if a recall is necessary. This is not the time to have long discussions as to who should be in charge as this should have been decided long before such an event. Ideally, and in general, this responsibility should fall upon the shoulders of the quality professionals because he or she will be the most familiar with the systems in operation. However, there will be many specific cases where others may be more appropriate , such as the risk management team.
Whoever is selected will be responsible for calling together a team of qualified people as soon as a situation demands and he or she should report directly to CEO for this purpose. The team leader will be responsible for leading the resources assigned to deal with the media should the need arise. In the case of urgent or serious product recalls, which may be costly , likely to damage the company's reputation or receive any form of national or local publicity , it will ususally be necessary to obtain board approval for any announcements or interviews that may take place.
The Recall Process
It can be difficult to judge when a recall is necessary, but a recall should always be initiated when it has been ascertained that there is a definite or potential danger to life or health and when the continued use or circulation of the product is likely to result in legal action.
A recall may also be initiated when it is found that a fault in the product, or lack of performance , is likely to affect the reputation of the company and when the lack of performance fails to justify the claims made in advertisements. This would also include drugs, where the dosage advised was found to be at variance with requirements.
Recall data
The first stage in a recall program will be some form of notification of a hazard. This could come from a number of sources and in many forms, depending upon the product. The most likely sources include:
- The user
- An independent test house report
- Government sources
- The company's own reliability test program or research
- Research institutes and laboratories
- Overseas sources
Hazard Evaluation Report
Immediately a hazard has been identified by any source, it will be necessary to evaluate the level of danger, and the category of recall, if required.
Levels may be set as:
- User level recall. The most widespread and therefore expensive type of recall, most likely in the case of consumer products. It would be essential in all urgent cases and probably in most serious cases and entails recall from users, retail outlets and warehouses. It would be necessary to reimburse the owners for losses sustained as a result of the withdrawal. The order for such recall would always be made at board level.
- Retail level recall . This would apply particularly in cases where an existing product has been in widespread use for some considerable time and information has now revealed a minor hazard.
- Wholesale level recall. This would entail product recovery from the first stage in the distribution chain and may be applied in the case of non-safety critical situations.
-Limited recall- This would mean the recall of individual batches and consignments. It would be probably occur most often when manufacturing faults have been discovered or suspected in an established product.
An evaluation of the level of recall that is needed should be carried out by the manager responsible for the recall program. In any case, it is recommended that a hazard report be prepared and circulated to all concerned within two days of instigation-regardless of the action taken.
The report should include a description of the type of hazard, the category and the recall level. Apart from good husekeeping, hazard reporting provides a good source of data for future risk probability evaluation. As with accidents , near misses are far more numerous than actual events. By recording near-miss recalls , the company will soon be able to evaluate the likelihood of an actual event and its consequences.
The report should report a nil return, where applicable, on the following aspects:
1. No health and safety hazard and no action required for product improvement or modification. The hazard evaluation report should state: "No hazard expected ", followed by the date and name of the responsible person(s) making the assessment and brief reasons for the assessment.
2. If a hazard is considered possible, all relevant information must be obtained for assessment by the recall team. The evaluation information shuld state:
- Whether any disease or injuries have already occurred
- Whether the use of the product in any particular cirumstances could lead to a hazard. This should be supported wherever possible by the appropriate supporting evidence or research data. It should also give the following:
- An assessment of the particular segments of the population at risk such as work people in general, work people in specific occupations, the public, medical patients, people engaged in leisure pursuits.
- An assessment of the seriousness of the hazard
- An assessment of the consequences of occurence
- An assessment of the probabability of occurence
- An assessment of the appropriate remedial action required
- Estimated consequential cost of the hazard
- A statement signed by the CEO authorizing the intiation of the recal
Product recall initiation
Upon receipt of the agreement by the CEO or his nominee to intitiate the recall program, a hazard warning notice maybe required. This should contain all the information necessary to bring the risk to the attention of all those likely to be exposed to the hazardous product and the circulation may include:
- Field specialists including service staff
- Appropriate government or local authority departments
- Police and emergency services
- Press, local and national
- Retail outlets
- Customers, where possible
- Trade journals and trade associations
- Professional institutions and reserach establishments
- Export agencies/licensees, foreign governments
- Relevant test houses
Depending upon circumstances, the warning notice may include:
1. A statement of the hazard and likely consequences
2. Clear instructions and illustrations to enable the repair, correction, removal, immobilisation or shielding of the product.
3. Warning of hazard signs, which may be detached from the notice and attached to the product and its container
4. Instructions appertaining to the return of the product nd a recall return card, preferably reply paid. This could take the form of a tear-off portion of the letter.
Recall effectiveness assessment
Once the recall procedure is underway, it will then be necessary to fully assess the effectiveness of the procedure that have been adopted and to consider the possibility of stepping up the campaign a notch. Similarly, it will also be necessary to make a decision to terminate the recall when all possible items have been returned.
Post recall investigation
The initiation of a product recall must be regarded as a catastrophic failure of the quality plan. Even in the case of a limited recall with the return of a small number of items from a retailer, there must be a review.
The review should be conducted by the most senior personnel from the departments implicated, headed by a senior executive and supported by the quality maanger. The objective will be to determine the organizational weaknesses that allowed the event to occur. Failure to do so means that the same thing could potentially happen again.
This should not turn into a witch hunt. Except for a specific cases where negligence may have been involved the problem is more likely to reflect on the management system in place than on actions of any individual. The most effective approach is to examine the management process to identify where weaknesses occur.
The cross functional project by project improvement process (when correctly applied) is the most effective method for resolving such problems. However, typical places to look for causes are:
- Lack of relevant training
- Insufficient reliability testing of prototypes, components and pre-production models.
- Inadequate research, in the case of products using chemicals; insufficeient knowledge of existing data
- Lack of coordination of production feasibility before release for production
- Inadequate specifications for the testing of incoming materials or components
- Lack of coordination between design and other departments, particularly market research , reliability enginering and production, resulting in the production of inadequate specifications
- Too much pressure to rush designs through, with the consequence that short-cuts are taken
Rigth first time
Hopefully the prospect of being faced with the consequences of having to implement the procedures described in this article will be sufficient to convince everyone of the crucial importance of attempting to "get things right the first time". Recently, the number of major source of worry to industry.
Apart from the actual costs of managing such a project, the damage to reputation of the company can be lasting. There is also the question of negative impact on brand. Most organizations spend enormous sums attempting to convince the world that they are the best in their field. having spend similar sums of money explaining that their product is actually quite harmful can have untold effects on the brand.
But even with the most intense application of quality related concepts, the risk can never be reduced to zero. After all , Ford is probably one of the biggest advocates of failure mode and effects analysis and even they get wrong sometimes.
Walang komento:
Mag-post ng isang Komento