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Product Recall ISO Guidelines

Intro: There is a wide variety of products available to consumers in the global marketplace. Products routinely travel across borders in order to meet increasing consumer demand as suppliers seek to lower cost and expand markets. While many products are safe and fit for intended use, statistics show that, each year, millions of people suffer injuries or illness, or die from unsafe products.
Examples defective products:
Picture 1: Takata airbag ? Takata is an automotive parts company based in Japan. In 2013, a series of deaths and injuries associated with defective Takata airbag inflators manufactured by their Mexican subsidiary in Coahuila, had led Takata to initially recall 3.6 million cars equipped with such airbags. Further fatalities caused by the airbags have led the National Highway Traffic Safety Administration (NHTSA) to order an ongoing, nationwide recall of more than 42 million cars, the largest automotive recall in U.S. history. In June 2017, Takata filed for bankruptcy.
Picture 2: SAMSUNG ? Samsung suspended sales of the Galaxy Note 7 and announced an informal recall, after it was found that a manufacturing defect in the phones? batteries had caused some of them to generate excessive heat, resulting in fires.
Picture3: Hoverboard ? After the US government declared all self-balancing scooters unsafe, eight more hoverboard brands are being recalled. The latest fire, caused by the LayZ Board, destroyed one home and damaged four others last month, according to the US Consumer Product Safety Commission? (CPSC).
While regulations and standards exist in many countries, and industries do all they can to make products safe and fit for intended use, problems related to design flaws, manufacturing defects, inadequate warnings or instructions still result in unsafe products entering the marketplace. In those instances, it is critical that corrective actions, which include recall, are carried out quickly and effectively. Although many countries have regulatory requirements and guidance for suppliers to conduct product recalls, many do not. Even in countries with well-developed requirements, recalls may be ineffective. As a result, there are inconsistencies in the approaches to product recall and other corrective actions, and products that pose health or safety risks to consumers remain in the marketplace.
After the first bullet: This International Standard is designed to provide practical guidance in determining whether corrective actions, including recalls, need to be carried out by the supplier of consumer products. It also provides best practices for conducting a product recall if it is necessary. The guidance provides information and tools that suppliers of all sizes can use to develop a documented and validated product recall programme that will help them implement timely and cost-effective recalls, minimize legal and reputation risks, and reduce health or safety risks to consumers.
Although this International Standard is intended for suppliers, it might also help government agencies in developing or improving product recall policies and guidelines.
Broad application of this International Standard will lead to a more consistent approach to removing unsafe products from the global marketplace, to improving coordination between government and consumer products organizations in different countries, and to increasing consumer confidence in the safety of products available in the marketplace.
After the paragraph: A product recall programme is a key element of the supplier?s overall product safety programme. Suppliers should demonstrate their commitment to consumer product safety by adhering to the principles documented in PNS ISO 10393:2018.
Intro: A product recall programme is a key element of the supplier?s overall product safety programme. Suppliers should demonstrate their commitment to consumer product safety by adhering to the principles documented in PNS ISO 10393:2018. These principles include the following:
Intro: Management should establish procedures to control and maintain all documents and record data relating to the recall programme for continual improvement, data analysis and facilitation of incident investigation, product identification and traceability, such as the following:
Intro: The supplier should ensure that it has the expertise to investigate the incident, to assess the risk, to make the recall decision and to carry out the recall. In larger suppliers, this may require the establishment of a recall management team made up of staff from a range of functional areas.
Regardless of size, suppliers may need outside assistance from advisors and consultants. Arrangements should be made with advisors and consultants so that they can develop an understanding of its recall programme before an incident occurs.
The objectives of the people responsible for managing the recall are as follows:
Intro: The supplier should identify the person or people who have the authority to make the decision to recall the product.
The key decisions that may need to be made are as follows:
Intro: The staff responsible for the recall should be familiar with the supplier?s product recall plan and have the capabilities and personal attributes needed to implement the recall.
Intro: It may be difficult for smaller organizations to conduct a recall simulation. In such cases, key managers should review their recall plan annually and discuss potential incidents and how the plan will be implemented if a recall becomes necessary. This should include involvement of an external consultant or advisor whose expertise has been identified as necessary
A supplier should do the following:
After all the bullets: (Please see table 1, next slide)
Incident Notification ? Suppliers should have in place a system for collecting information on product incidents and communicating these to stakeholders, as necessary.
As required by regulatory requirements and contractual obligations, the supplier should notify regulators, certification bodies and other organizations of reports that a product has created harm, or has the potential to create harm.
Incident investigation ? The process will generally include the following steps:
Intro: There are various methods for assessing the risk of harm in consumer products.
The supplier should establish a process for assessing the risk of harm, which generally includes the following steps:
Intro: Suppliers should be aware of the one step down/one step up traceability principle referred to in ISO 10377. Product traceability will facilitate the recall process by allowing the supplier to determine quickly where the affected product was sold and to be able to target the recall notification to the appropriate audience.
The traceability attributes will also help consumers verify whether the product they are using is impacted by the recall, thereby avoiding a situation where all of the supplier?s products are perceived as defective.
Affected product ? The recall notification should clearly identify the product or products that are within the scope of the recall. This identification should be as precise as possible and should distinguish the key characteristics of the affected product.
Examples of key characteristics can include product variants, e.g. lot, colour, size, amperage, formulation or product packaging. Each recalled product should be uniquely identified. Ideally, this identification should be globally unique. Examples of globally unique product identification include the Universal Product Code (UPC) and the Global Trade Item Number (GTIN).
Product recall decision ? Once the assessment of risk has been completed, the supplier should determine if the level of risk exceeds the tolerable risk (see ISO 10377 for guidance). If the level of risk does exceed the tolerable risk, the supplier should make a determination on the need for a product recall. There is no automatic link between an identified level of risk and implementing a product recall, as decisions should be made on a case-by-case basis using all available information.
The supplier should consider all the relevant facts and circumstances that influence the probability of harm, the nature of the potential harm and the severity of the potential harm. In particular, they should consider the impact of the recall, including the following:
After all the bullets: For situations where very serious injury or substantial property damage could occur, consideration should be given to implementing a product recall, even if the probability of risk cannot be accurately determined.
Experts may be consulted to help determine the risks, the practicality, the impact and the effectiveness of the product recall. As new information becomes available, it should be used to review the decision and the processes used.
The decision to recall should be made in consultation with relevant regulators. In some countries, regulators have the authority to require a product recall under specific circumstances.
Intro: When the decision is made that a product recall is necessary, the supplier should communicate with the supply chain to determine the supplier responsible for the recall. In some countries, the supplier responsible for the recall may be specified by regulation. The decision to implement a recall is based on the process outlined in the Assessing the need for a product recall.
Once a decision has been reached to implement a recall, the processes described in the Initiate Recall Action to Review and adjust recall strategy should be followed, as illustrated in the flowchart in Figure 3.
Initiate the recall action ? The recall action should provide guidance on the processes to be used and resources that are needed to achieve an effective recall. It should provide guidance to those implementing the recall on the approach to be taken, what objectives are to be met and when they are to be achieved. It should provide criteria for determining the effectiveness of the recall and guide the decision on when the supplier responsible for the recall can cease active recall operations.
Intro: The recall strategy should provide a clear overview of the reasons why the recall action is being taken, what is to be achieved by the action, how the supplier responsible for the recall will communicate with affected consumers, supply chain and appropriate regulatory authorities. It should outline the actions that should be taken to reduce the risk associated with the product.
In some countries, the regulator may require the supplier responsible for the recall to discuss the proposed recall strategy and communications with it prior to taking action
The recall strategy should include an explanation of the following:
Intro: The objectives should outline what is to be achieved by the recall actions and by when they are to be achieved.
Recall objectives should generally include the following:
Intro: The process for retrieving, repairing, modifying or replacing should be designed to make it as easy as possible for the supplier and the consumer to take the recommended action. Using a simple process will make it more likely that affected consumers will be willing to take the requested action, and therefore make the recall more effective.
After all the bullets in the slide: Each product recall notice should be uniquely identified. This ensures that the recall can be distinguished from other product recall in the market. This is accomplished by assigning a globally unique identifier to the original recall notice.
Similarly, as necessary recall updates or modifications are communicated, each update should also be uniquely identified. Examples of updates include changes to the scope of products involved or the provision of supporting documentation (e.g. media releases, disposal or return instructions, product specifications). Assigning a unique identifier to product recall updates enables all affected parties to maintain a record, or audit trail, of changes over the life of the recall.
An updated product recall notification should clearly state that it supersedes the previous notification.
In designing the recall process, the supplier responsible for the recall should consider vulnerable consumers.
Intro: The recall plan should identify how the costs of a recall will be met. The costs of product recalls can sometimes be covered by a comprehensive product recall insurance policy.
Intro: Communication is critical to the effective implementation of a recall. The supplier responsible for the recall should ensure that its communications are clear, consistent and accurate. Communication should be designed to meet the needs of the various stakeholders that are affected by the recall, so that they understand the risk and what action they should take to minimize the risk. The communication plan should also allow for affected stakeholders to communicate with the supplier responsible for the recall.
Develop the communication plan ? The supplier responsible for the recall should provide a means for consumers to contact it to carry out the instructions they are given, or to address any questions or concerns they may have. For a consumer level recall, this may involve establishing a call centre, with an appropriate means of communication for all geographical locations where the product is available. This may include a contact number and a contact form on the supplier?s website. Appropriate resources should be identified in the recall plan.
In a larger scale recall, the supplier responsible for the recall may receive a very large number of enquiries from consumers and, potentially, the media. Consideration should be given as to how it will cope with a large increase in enquiries, and this may include identification of third party call centres and communication support.
Communications should be distributed as soon as possible after the decision to recall is made. Appropriate arrangements should be in place before communications are released, and all affected parties should be fully briefed on the recall strategy and the actions they should take to support the recall. In some countries, it is appropriate to discuss the content, the intended audience and the timing of the communication with the regulator prior to release.
The recall plan should provide a list of the audiences that should receive communications, the most appropriate means for these communications and the people who will be responsible for those communications.
Communication with regulators ? There is a legal requirement in many countries to notify and provide required information to a regulator at various stages of the recall.
Communicate with supply chain ? The supplier responsible for the recall should identify who received the affected product and establish a process for:
The process for retrieving, replacing or destroying the affected product, as well as a method for recording receipt, destruction or other agreed action, needs to be established.
Communication with consumers ? The objective of communicating with consumers is to ensure that they understand the risk associated with the affected product and to give them clear guidance or instructions on what actions they should take. Well-designed communications will be a key factor in making sure the recall is effective.
Where direct contact cannot be made with the consumer, contact should be made using the most appropriate channel for the target audience. While traditional means of communicating a recall notice is often through a newspaper advertisement, a number of other effective channels exist.
Some of the channels that should be considered include the following:
In designing recall communications, consideration should be given to consumers that have special needs, e.g. consumers living in isolated areas, or those with disabilities. In addition, there may be support organizations that can assist in communicating with consumers that have special needs.
Intro: The recall notice should include the following:
Intro: A supplier responsible for the recall should give clear instructions to the supply chain to stop the sale of the affected product, and should store the product securely to prevent its sale or distribution until retrieval can be arranged.
Retrieve, replace and repair affected product ? Retrieval of products could be accomplished through using an internal distribution system, an internal sales and delivery network, or through using an external retrieval service. Consideration should be given as to how additional stock, parts or other components will be arranged for replacement. In addition, authorized installers or repairers should be arranged if modifications or repairs are necessary.
Where the consumer is expected to return the product to place of purchase, arrangements need to be made for the retailer to collect and store the product securely to prevent resale. In the event of consumers returning the product by mail or courier, the supplier responsible for the recall should arrange for prepaid stamped self-addressed packaging, and a facility established to collect and dispose of the product and arrange replacement.
Depending on the amount of affected product, there may be a requirement for temporary warehousing.
Destroy or dispose of the affected product ? Recalled products that are not to be repaired, reworked and redistributed through authorized channels should be destroyed, preferably using recycling, where possible. This reduces the risk of recalled products being inadvertently reused or resold, or shipped into other markets. Verification or objective evidence of destruction or recycling may be appropriate.
Affected product should be destroyed or disposed of in an appropriate manner consistent with any and all applicable environmental regulations. If verification is required, a signed statement describing the method, place, date, and number of products should be obtained from those responsible for the product?s disposal or destruction. The supplier responsible for the recall should also consider the environmental consequences of destroying the product and obtain advice on appropriate destruction methods.
Recalled products should not be exported to other countries or markets unless:
Intro: The progress of the recall should be carefully monitored to ensure that the recall is effective and achieves the objectives. It is important to collect accurate and up-to-date information that can be used for internal and external reporting.
Manage information ? The supplier responsible for the recall should establish a process for continually monitoring the implementation of the recall, in order to ensure that the objectives are being achieved and to provide regular reports to senior management and, where required, to regulators.
Data collected should be sufficient to measure the progress of the recall against previously agreed objectives, and may include the following:
Establish reporting requirements ? Where reporting to a regulator is required, the frequency of reporting should be agreed at the start of the recall action, and the report deadlines should be met. In instances where there is a higher risk to public health or safety, more frequent reporting may be required.
Intro: It is important to evaluate effectiveness continually in order to ensure that objectives are being met and, if necessary, to adjust the recall strategy to improve effectiveness.
Locating affected product ? The supplier responsible for the recall should be able to identify and confirm where it distributed all affected product. The supplier should also confirm that notice of the recall has been received and understood by consumers.
Return Rate ? The return rate refers to the amount of affected product retrieved, repaired or modified. The return rate will be affected by a number of factors, and therefore determining an actual rate as ?effective? will vary depending on the product, its distribution and the characteristics of users, and on the cost and ease of return. Historical data for similar types of products may be useful in providing a guide for appropriate return rates.
The supplier responsible for the recall should measure the effectiveness by monitoring and verifying that affected product has been removed from various parts of the supply chain, e.g. warehouse and retailers.
Disposal rate ? This refers to the amount of product that has been appropriately disposed of, or destroyed. In the case of higher risk product, particularly one which poses significant public health or safety risk, or where disposal may cause an environmental hazard, independent certification and verification of disposal may be appropriate.
Injury rate ? If injuries have occurred as a result of the product incident, the reduction and eventual elimination of injuries is a key measure of effectiveness.
Enquiry Rate ? Enquiry rates are generally high in the early stages of a recall. A significant reduction in enquiry rate can be used in conjunction with other measures as an indicator of effectiveness.
Communication ? The effectiveness of communication is an important measure. Direct and targeted communication is the most the effective means of informing people of the recall and will improve the effectiveness of the recall. Where there are low levels of response, more direct, targeted communications will help to improve the response.
The supplier responsible for the recall may measure the effectiveness of communication by sampling target groups to determine whether they are aware of the recall, whether they have the affected products and whether they know what actions they should take.
Intro: If monitoring indicates the recall is not meeting objectives, the recall strategy may need adjustments to improve effectiveness. Adjustments that could be made to improve effectiveness may include the following:
Cease active recall operations ? Before active recall operations cease, the supplier responsible for the recall should consider the following:
After the bullets of Cease active recall operations : Once the recall objectives have been met, a decision can be made to cease active recall operations. In countries where there is oversight by government authorities or a legal requirement to do so, this decision may need to be made in consultation with the regulator.
The decision to cease active recall operations should not preclude the resumption of the recall if it becomes clear that affected product posing a health or safety risk remains in the marketplace. In addition, consumers should continue to be able to return defective products that pose a health or safety risk at any time. The supplier responsible for the recall should therefore continue to provide the capability to receive products that are subject to recall, even though active recall operations have ceased.
Adjustment of the recall ? The decision to adjust a recall should be taken if no changes have been made to the original recall notification and the affected products. The process should follow the steps indicated in Figure 3
Expansion of the recall ? If additional products need to be added to increase the scope of the original recall, a new recall notification should be created and a new unique notification number assigned. This is to ensure that only one active recall notification exists for a product at any one time and that the actions taken are easily audited (see Figure 3).
Intro: Continual improvement should be a permanent objective of the supplier. The supplier should continually improve its recall procedures by reviewing the communication plan, operations and other activities, the results of risk assessment and the effectiveness of recalls.
Fundamental to effective and efficient improvement is making informed decisions on the basis of data analyses and the incorporation of lessons learned. All continual improvement activities and their outcomes should be regularly documented and reviewed by management in order to ensure that continual improvement is occurring and that changes do not inadvertently cause another safety problem.
Figure 4 illustrates continual improvement for product recall.
After Reviewing the recall Bullet: After the recall, the supplier should document its observations and experience, and a meeting should be held to discuss opportunities for improvement.
A member of staff should be assigned responsibility for ensuring that opportunities for improvements are implemented.
Corrective actions to prevent reoccurrence- This can be accomplished by initiatives such as redesigning the product to remove the potential harm, identifying the kind of materials during the manufacture and redesigning labels and instruction manuals.
The supplier should periodically review the effectiveness of the corrective actions that were implemented in accordance with 6.5 in order to address the identified root causes. If the corrective actions have not reduced the probability of the incident reoccurring to the desired level, then the supplier should consider implementing additional or revised corrective actions.
The supplier should also periodically review all root causes to identify trends or patterns in product safety, in order to determine if additional or revised corrective actions should be implemented to the same or similar products.
Corrective actions include changes in the following:
After all the Bullets: PNS ISO 10393:2018 also provides examples of identification of hazard, evaluation and types of use and misuse of products, Product Recall Checklist, and recall effectiveness. It also gives different sample product recall posters and press releases such as the following: (next slide)