How a QMS Helps in Managing Product Recalls

In a recent survey, 83% of organizations reported that having a QMS helped them recover from a product recall, reducing costs and making the process simpler and faster.

There are several ways a digital QMS can help in managing product recalls. In this article, we look at:

major product recalls in US and Europe
challenges in managing product recalls
ways a QMS simplifies managing product recalls
recommendations for managing product recalls
how isoTracker can help.

Recent product recalls

Across industries, major product recalls hit the news in 2021. In North America, there were 21 major safety product recalls in the food, auto and consumer product sectors.

Tyson Foods Inc, the second largest processor and marketer of chicken, beef and pork in the world, recalled 3,860,378 kilos of ready-to-eat chicken products because of fears of listeria contamination.

More than 3,000,000 infant loungers were recalled for a potential suffocation risk after eight infant deaths associated with products from The Boppy Company of Colorado.

Ford issued three safety recalls covering more than 800,000 vehicles for separate issues.

In Europe, the number of product recalls spiked by more than 25% in 2021 across seven key industries. Medical device recalls surged 40% from 2,061 in 2020 to 2,886. Quality issues accounted for the majority of recalls.

Recalls can have devastating consequences for organizations, including crippling costs, government prosecution – especially for heavily regulated industries – and irreversible reputational damage.

Complexities in managing product recalls

Managing product recalls is complex and challenging. If a company is to recover from a product recall, it must manage certain processes efficiently.

Firstly, an organization must maintain an open dialogue with customers throughout the product recall and following it. This is crucial for ongoing safety and to support the company’s reputation.

Internal quality operations must be audited and supply chain quality evaluated. Corrective actions to mitigate immediate damages and prevent future incidents are essential.

How a digital QMS simplifies management of product recalls

A digital QMS simplifies the management of product recalls. It makes it easier to understand existing processes, evaluate potential corrective actions and assess the financial impact of quality-related decisions.

It increases the efficiency of each process, which reduces the costs of product recall recovery and makes it much faster.

Here are six ways a digital QMS simplifies the management of product recalls.

Rapid, reliable access to all required data and records. The data is accessed from an archived and centralized repository, which simplifies auditing and reporting.
Easy assignment of document access rights to members of a response team.
Streamlining of data entry using templates.
Central control of document authorizations and document versions. This is important for risk and quality control, and for managing communications during a crisis.
Automated notifications and alerts for designated recipients.
Corrective and preventive action tracking with assignment of responsible individuals and deadlines, automated follow-ups, and automatic escalation.

General recommendations for managing product recalls

There are a number of factors to consider when managing product recalls. For starters, it’s easier to manage when there’s a recall process and team already in place.

A cross-functional team should be created, consisting of a management representative, product manager, chief engineer, quality control manager, PR expert and an attorney.

A product recall action plan must be followed if a recall is instituted. It can be adjusted as necessary as the recall unfolds.

Even with an established culture of quality, human error, systems failures, and product or component failures can lead to product recalls. If one of these errors necessitates a product recall, it’s important to have a documented response plan and process in place.

This will ensure as few people and organizations as possible are affected by the recall and recall expenses are reduced.

When a recall happens, to reduce and contain risk, the recall team should document all recall actions, including customer, distributor, user and public communications. All recall-related costs must be tracked.

Armed with advanced planning, the team can respond rapidly to manage a product recall.

How isoTracker can help in managing product recalls

At isoTracker, we offer modular, cloud-based quality management software that helps prevent and manage product recalls.

It does this by providing centralized data storage; workflows and automated notifications for ensuring no complaints, defects or issues are overlooked; and easy, accurate recordkeeping.

The QMS includes a document control module, as well as complaints management, audit management, and training modules, with built-in CAPA capabilities. The modules can stand alone or work as an integrated system.