Brenda Percy09.13.10
Ensuring Efficient Recall Management
Determining where the quality management system fits into the process is key to mitigating risk.
Having to conduct a recall can be a trying experience within any industry. However, when dealing with devices that can pose serious injury or death to a patient if defective, there is more urgency in retrieving all defective products and in notifying the public and the myriad other stakeholders during a recall. This makes proper recall procedures in medical device manufacturing not just necessary, but imperative. In addition to the regulatory issues that must be addressed during a recall, there also are the issues of negative customer reactions, a possible effect on market share, in addition to cost to all consumers and the U.S. Food and Drug Administration (FDA).
While a recall may not be completely avoidable, there are steps that can be taken to significantly mitigate the risk. However, if it is determined that a recall is the only available course of action, it is imperative for an organization to have a system in place to guide it through the recall process from beginning to end, ensuring it is completed as quickly and efficiently as possible and nothing is left out of the quality loop.
According to the FDA’s website, “A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace.”1
This article will describe why recall management is a necessity for medical device manufacturing firms and how an automated quality management system (QMS) can streamline the recall process by enabling seamless compliance with the best practices of recall management.
Why Recall Management?
Throughout the past few years, there has been an increase of publicity surrounding product recalls in FDA-regulated industries. However, the growing increase in recalls does not immediately indicate an overall decline of quality in products, but rather an increase in FDA scrutiny. In order to effectively manage a recall, it certainly can be helpful to have a recall management system in place. A recall management system guides an organization through the recall process by allowing quick collaboration with the FDA and timely submission of recall information. This includes ensuring that all parties are notified, enabling defective products to be claimed quickly, evaluating the recall to ensure that the process has been completed with no traces of defective product left on the shelf or in the patient’s hands, and submitting final reports to the FDA. An automated system also ensures that nothing is overlooked and that all processes are conducted properly, while drastically decreasing the chance of human error.
The Best Recall Practices
Implementing a recall management system using an automated QMS can guide an organization seamlessly through the recall process and enable integration with other features across the enterprise.
Submission of all recall information to the FDA: Once it is determined that a device warrants a recall, the recall management process must begin immediately. This begins with the company sending the FDA all information related to the product, such as the name and information of the recalling firm, name of manufacturer, and reason for recall, including a description of exactly how the product is defective, how that issue affects safety and the date the issue occurred.2 An FDA Health Hazard Evaluation (HHE) form, which shows the organization’s assessment of the health risk, must then be completed and sent to the FDA. The company also must include the volume of product that was produced as well as the quantity and dates of distribution and the amount of product that is on hold due to the recall. Company officials also will need to submit the distribution pattern and inform the FDA of the number of direct accounts that they deal with in order to retrieve all products back from consumers.
At this point in the process, a recall plan must be established if the organization does not already have one in place. A recall plan is critical for ensuring efficient recall management. Every organization should have a plan in place in the event of a recall and should conduct drills, or “mock recalls” on their plan to prove its effectiveness. This helps assure that in the event of a recall, all of the necessary steps are executed thoroughly and correctly, the first time around without the need for repetition.
The recall plan covers everything—from the submission of information to the FDA, to how the public will be notified, to the evaluation of the recall. Essentially, it is the company’s “roadmap” of the recall process, telling them the exact steps to take at each point in the process. For example, the organization will need to indicate how all parties will be notified, as well as how the notification will be sent (overnight, facsimile, etc.).2 It will need to submit a report stating exactly what information has been communicated to all parties involved. If the product needs to be returned, the organization must state exactly how this process is to be conducted.
The complaint handling feature of a QMS can help in the recall process by logging and keeping track of all complaints. Complaint handling manages the investigation and resolution of customer complaints in compliance with FDA guidelines. A system that can record all complaints made by consumers and archive these records is not just ideal but necessary—the FDA mandates that any record of an adverse event be kept for a minimum of two years.
Another benefit of many QMS solutions is the ability to integrate directly with the FDA’s Electronic Submissions Gateway (ESG). This allows the user to submit electronic Medical Device Reports (eMDRs) from the QMS directly to the FDA via the ESG. This allows the user to bypass the need to fax or mail in these reports, and results in faster response time. (Editor’s note: For more information on eMDR, turn to this month’s IT Intelligence column on page 28.)
When conducting a recall, a company must obtain all defective products within 30 days; therefore, traceability is key. A product returns feature allows the organization to identify and track returns, identify the reason for the return, as well as identify the material and quantities that need to be returned. This feature also records and tracks the disposition of the returned product.
Public notification: Once the recall information has been submitted to the FDA and the recall plan has been put into place, the organization must notify all parties involved—whether consumer, patient, hospital, etc. This can be done through various media channels, such as press releases or recall notification letters to all parties. All recall notification letters must include the identification and description of the problem as well as the depth to which the recall has been implemented—whether retail, wholesale or user level.2 This step also must include detailed return instructions for customers as well as a return response form. This is where the QMS’s document control feature comes in.
Having the required documentation such as notification letter templates, website templates, press release templates, work instructions and similar records is a key element of providing a quick response during a recall. Using a revision-controlled document control system, organizations can ensure that the necessary documentation is available within the system and is accurate and controlled, and ensures management of the creation, approval, distribution and archiving of these controlled documents.
Recall evaluation: Once the public has been notified and the recall has been initiated, the organization must then conduct a recall evaluation to check its effectiveness. This will enable the organization to benchmark its effectiveness and assess the progress of the ongoing recall. During this stage, recall status reports must be created. These status reports should consist of the date each customer was notified, the number of customers who were notified, the number of customers who responded, the quantity of product that was accounted for or returned, as well as the details of the effectiveness check.
Once the root cause of the recall is discovered, this information should be sent to the FDA’s local district recall manager, along with any corrective actions that have been established at this point. Termination of the recall is the final step and can be started once it is determined that all parties involved have been notified and all traces of the product have been recovered. Before the FDA will consider termination, a final status report also should be sent to the agency’s district recall manager.2 The QMS’s corrective and preventive action (CAPA) aides in this process.
In addition to determining root cause and investigation, CAPA provides a method for recording and tracking any corrective actions taken, as well as verification of effectiveness of the corrective action. Using quantitative risk assessment, organizations can conduct a risk assessment at the root cause phase, as well as at the effectiveness phase, to ensure that corrective actions reduce the risk or recurrence to acceptable risk levels. An automated CAPA should have the ability to generate multiple report types throughout the process, including a CAPA history report which details the CAPA process from start to finish, as well as any other related records that are critical to the CAPA. This type of reporting is critical to the recall process, and provides complete transparency when submitting information to the FDA.
Once the recall is executed, it is necessary to provide a comprehensive report on the recall, from start to finish. Through use of real-time, enterprise reporting tools, organizations can create status reports for each phase of the recall process. This type of reporting provides visibility into the overall causes of the recall, provides a clear report for the FDA to review at each phase, and helps to foster continuous improvement in identifying trends to prevent similar occurrences in the future, or execute a product or process change. This leads us to the QMS’s change management capabilities.
Forty-four percent of medical device recalls are caused by inadequate design control.3 Change management links quality into the product lifecycle and maps quality at each step in the process starting from product design. Change management applications provide the workflow and business rules necessary to execute and manage a change within the organization, across multiple operational areas. Design, supply chain, production, and post-market data all are linked to a holistic change management process, with quality and compliance as the backbone. Furthermore, the recall information is integrated into every phase of the process, enabling the data retrieved during the recall to be factored into the design, production, and execution of the change. This ensures that once the recall is closed, the change management process “learns” from the data collected, and mitigates the risk of reoccurrence in the next product lifecycle.
Reaping the Benefits
The recall process can be time consuming and extremely complex. It must be thoroughly executed at every level necessary in order to receive the desirable end result—a termination of the recall. Items left unaccounted for or failure to communicate with affected parties only will prolong the recall process, leading to cost overruns or decreasing consumer confidence and brand equity. An automated recall management system offers an organization the ability to go through every step of the recall process, leaving nothing overlooked and ensuring that the FDA, consumers, patients and healthcare facilities receive all of the necessary information. The process seamlessly is automated through the use of enterprise quality management systems. Familiar QMS features such as document control, CAPA, complaint handling, product returns, centralized reporting and similar features can be leveraged. Use of the automated recall management system within the QMS mitigates risks within the process by taking an organization through the process, step by step, automatically assigning tasks and deliverables through a workflow-based system. If properly executed, a QMS’s recall system enables an organization to operate the process seemlessly.
Reducing the Fallout
A recall is always undesirable—with a number of consequences for the medical device firm, patients, physicians and other stakeholders. In the medical device industry, much like other industries, a recall also can have dramatic adverse effects on the business “health” and customer perception of an organization. If this occurs, an organization with a recall management system will better be able to streamline the process by informing all affected parties, retrieving and disposing of all affected products, and closing the recall as quickly as possible, reducing the amount of time and money spent in the process. Automating internal processes through the use of a QMS helps to mitigate the risk of recall by drastically decreasing the chance of errors or missteps along the way.
Through each process—whether FDA notification, notification of the public, execution of the recall, or the identification and correction of the event that caused the recall—QMS solutions exist to provide a seamless environment for a recall management process.
When creating a recall plan and conducting a mock recall or a recall from an adverse event, the key is complete transparency to the FDA and all affected parties, and in providing a centralized environment where all information is gathered, tracked, and reported on. Through the use of an automated QMS, all information is integrated and managed, all processes are streamlined, and communication of data is more easily executed. Once an organization has gone through with its recall management plan, it still must be aware that the recall cannot be terminated until every defective item has been returned, all parties involved or affected have been notified, and processes have been put in place to mitigate the risk of reoccurrence. Once the recall has been closed, the organization can then seek out ways to improve quality, foster continuous improvement, and can begin to rebuild brand equity.
References:
1. Guidance for Industry: Quality systems Approach to Pharmaceutical cGMP Regulations.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070337.pdf
2. ORA/Office of Enforcement. Guidance for Industry: Product Recalls, IncludingRemovals and Corrections. ORA/Office of Enforcement. Guidance for Industry: Product Recalls, Including Removals and Corrections. http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm.
3. An Introduction to Design Control. http://www.omnica.com/omniview_design_control.htm
Brenda Percy is the product marketing analyst for EtQ Inc., headquartered in Farmingdale, N.Y. Prior to EtQ, Brenda was a marketing communications analyst at STG Inc., where she specialized in corporate research and reports with respect to advances in technology and compliance capabilities. At EtQ, Percy is responsible for communicating overall technology trends and compliance initiatives to the market, and has extensive background in information, food and beverage and medical device technologies. EtQ Inc. specializes in enterprise quality and compliance management software for identifying, mitigating, and preventing high-risk events through automation. She can be reached at bpercy@etq.com.
Determining where the quality management system fits into the process is key to mitigating risk.
Having to conduct a recall can be a trying experience within any industry. However, when dealing with devices that can pose serious injury or death to a patient if defective, there is more urgency in retrieving all defective products and in notifying the public and the myriad other stakeholders during a recall. This makes proper recall procedures in medical device manufacturing not just necessary, but imperative. In addition to the regulatory issues that must be addressed during a recall, there also are the issues of negative customer reactions, a possible effect on market share, in addition to cost to all consumers and the U.S. Food and Drug Administration (FDA).
While a recall may not be completely avoidable, there are steps that can be taken to significantly mitigate the risk. However, if it is determined that a recall is the only available course of action, it is imperative for an organization to have a system in place to guide it through the recall process from beginning to end, ensuring it is completed as quickly and efficiently as possible and nothing is left out of the quality loop.
According to the FDA’s website, “A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace.”1
This article will describe why recall management is a necessity for medical device manufacturing firms and how an automated quality management system (QMS) can streamline the recall process by enabling seamless compliance with the best practices of recall management.
Why Recall Management?
Throughout the past few years, there has been an increase of publicity surrounding product recalls in FDA-regulated industries. However, the growing increase in recalls does not immediately indicate an overall decline of quality in products, but rather an increase in FDA scrutiny. In order to effectively manage a recall, it certainly can be helpful to have a recall management system in place. A recall management system guides an organization through the recall process by allowing quick collaboration with the FDA and timely submission of recall information. This includes ensuring that all parties are notified, enabling defective products to be claimed quickly, evaluating the recall to ensure that the process has been completed with no traces of defective product left on the shelf or in the patient’s hands, and submitting final reports to the FDA. An automated system also ensures that nothing is overlooked and that all processes are conducted properly, while drastically decreasing the chance of human error.
The Best Recall Practices
Implementing a recall management system using an automated QMS can guide an organization seamlessly through the recall process and enable integration with other features across the enterprise.
Submission of all recall information to the FDA: Once it is determined that a device warrants a recall, the recall management process must begin immediately. This begins with the company sending the FDA all information related to the product, such as the name and information of the recalling firm, name of manufacturer, and reason for recall, including a description of exactly how the product is defective, how that issue affects safety and the date the issue occurred.2 An FDA Health Hazard Evaluation (HHE) form, which shows the organization’s assessment of the health risk, must then be completed and sent to the FDA. The company also must include the volume of product that was produced as well as the quantity and dates of distribution and the amount of product that is on hold due to the recall. Company officials also will need to submit the distribution pattern and inform the FDA of the number of direct accounts that they deal with in order to retrieve all products back from consumers.
At this point in the process, a recall plan must be established if the organization does not already have one in place. A recall plan is critical for ensuring efficient recall management. Every organization should have a plan in place in the event of a recall and should conduct drills, or “mock recalls” on their plan to prove its effectiveness. This helps assure that in the event of a recall, all of the necessary steps are executed thoroughly and correctly, the first time around without the need for repetition.
The recall plan covers everything—from the submission of information to the FDA, to how the public will be notified, to the evaluation of the recall. Essentially, it is the company’s “roadmap” of the recall process, telling them the exact steps to take at each point in the process. For example, the organization will need to indicate how all parties will be notified, as well as how the notification will be sent (overnight, facsimile, etc.).2 It will need to submit a report stating exactly what information has been communicated to all parties involved. If the product needs to be returned, the organization must state exactly how this process is to be conducted.
The complaint handling feature of a QMS can help in the recall process by logging and keeping track of all complaints. Complaint handling manages the investigation and resolution of customer complaints in compliance with FDA guidelines. A system that can record all complaints made by consumers and archive these records is not just ideal but necessary—the FDA mandates that any record of an adverse event be kept for a minimum of two years.
Another benefit of many QMS solutions is the ability to integrate directly with the FDA’s Electronic Submissions Gateway (ESG). This allows the user to submit electronic Medical Device Reports (eMDRs) from the QMS directly to the FDA via the ESG. This allows the user to bypass the need to fax or mail in these reports, and results in faster response time. (Editor’s note: For more information on eMDR, turn to this month’s IT Intelligence column on page 28.)
When conducting a recall, a company must obtain all defective products within 30 days; therefore, traceability is key. A product returns feature allows the organization to identify and track returns, identify the reason for the return, as well as identify the material and quantities that need to be returned. This feature also records and tracks the disposition of the returned product.
Public notification: Once the recall information has been submitted to the FDA and the recall plan has been put into place, the organization must notify all parties involved—whether consumer, patient, hospital, etc. This can be done through various media channels, such as press releases or recall notification letters to all parties. All recall notification letters must include the identification and description of the problem as well as the depth to which the recall has been implemented—whether retail, wholesale or user level.2 This step also must include detailed return instructions for customers as well as a return response form. This is where the QMS’s document control feature comes in.
Having the required documentation such as notification letter templates, website templates, press release templates, work instructions and similar records is a key element of providing a quick response during a recall. Using a revision-controlled document control system, organizations can ensure that the necessary documentation is available within the system and is accurate and controlled, and ensures management of the creation, approval, distribution and archiving of these controlled documents.
Recall evaluation: Once the public has been notified and the recall has been initiated, the organization must then conduct a recall evaluation to check its effectiveness. This will enable the organization to benchmark its effectiveness and assess the progress of the ongoing recall. During this stage, recall status reports must be created. These status reports should consist of the date each customer was notified, the number of customers who were notified, the number of customers who responded, the quantity of product that was accounted for or returned, as well as the details of the effectiveness check.
Once the root cause of the recall is discovered, this information should be sent to the FDA’s local district recall manager, along with any corrective actions that have been established at this point. Termination of the recall is the final step and can be started once it is determined that all parties involved have been notified and all traces of the product have been recovered. Before the FDA will consider termination, a final status report also should be sent to the agency’s district recall manager.2 The QMS’s corrective and preventive action (CAPA) aides in this process.
In addition to determining root cause and investigation, CAPA provides a method for recording and tracking any corrective actions taken, as well as verification of effectiveness of the corrective action. Using quantitative risk assessment, organizations can conduct a risk assessment at the root cause phase, as well as at the effectiveness phase, to ensure that corrective actions reduce the risk or recurrence to acceptable risk levels. An automated CAPA should have the ability to generate multiple report types throughout the process, including a CAPA history report which details the CAPA process from start to finish, as well as any other related records that are critical to the CAPA. This type of reporting is critical to the recall process, and provides complete transparency when submitting information to the FDA.
Once the recall is executed, it is necessary to provide a comprehensive report on the recall, from start to finish. Through use of real-time, enterprise reporting tools, organizations can create status reports for each phase of the recall process. This type of reporting provides visibility into the overall causes of the recall, provides a clear report for the FDA to review at each phase, and helps to foster continuous improvement in identifying trends to prevent similar occurrences in the future, or execute a product or process change. This leads us to the QMS’s change management capabilities.
Forty-four percent of medical device recalls are caused by inadequate design control.3 Change management links quality into the product lifecycle and maps quality at each step in the process starting from product design. Change management applications provide the workflow and business rules necessary to execute and manage a change within the organization, across multiple operational areas. Design, supply chain, production, and post-market data all are linked to a holistic change management process, with quality and compliance as the backbone. Furthermore, the recall information is integrated into every phase of the process, enabling the data retrieved during the recall to be factored into the design, production, and execution of the change. This ensures that once the recall is closed, the change management process “learns” from the data collected, and mitigates the risk of reoccurrence in the next product lifecycle.
Reaping the Benefits
The recall process can be time consuming and extremely complex. It must be thoroughly executed at every level necessary in order to receive the desirable end result—a termination of the recall. Items left unaccounted for or failure to communicate with affected parties only will prolong the recall process, leading to cost overruns or decreasing consumer confidence and brand equity. An automated recall management system offers an organization the ability to go through every step of the recall process, leaving nothing overlooked and ensuring that the FDA, consumers, patients and healthcare facilities receive all of the necessary information. The process seamlessly is automated through the use of enterprise quality management systems. Familiar QMS features such as document control, CAPA, complaint handling, product returns, centralized reporting and similar features can be leveraged. Use of the automated recall management system within the QMS mitigates risks within the process by taking an organization through the process, step by step, automatically assigning tasks and deliverables through a workflow-based system. If properly executed, a QMS’s recall system enables an organization to operate the process seemlessly.
Reducing the Fallout
A recall is always undesirable—with a number of consequences for the medical device firm, patients, physicians and other stakeholders. In the medical device industry, much like other industries, a recall also can have dramatic adverse effects on the business “health” and customer perception of an organization. If this occurs, an organization with a recall management system will better be able to streamline the process by informing all affected parties, retrieving and disposing of all affected products, and closing the recall as quickly as possible, reducing the amount of time and money spent in the process. Automating internal processes through the use of a QMS helps to mitigate the risk of recall by drastically decreasing the chance of errors or missteps along the way.
Through each process—whether FDA notification, notification of the public, execution of the recall, or the identification and correction of the event that caused the recall—QMS solutions exist to provide a seamless environment for a recall management process.
When creating a recall plan and conducting a mock recall or a recall from an adverse event, the key is complete transparency to the FDA and all affected parties, and in providing a centralized environment where all information is gathered, tracked, and reported on. Through the use of an automated QMS, all information is integrated and managed, all processes are streamlined, and communication of data is more easily executed. Once an organization has gone through with its recall management plan, it still must be aware that the recall cannot be terminated until every defective item has been returned, all parties involved or affected have been notified, and processes have been put in place to mitigate the risk of reoccurrence. Once the recall has been closed, the organization can then seek out ways to improve quality, foster continuous improvement, and can begin to rebuild brand equity.
References:
1. Guidance for Industry: Quality systems Approach to Pharmaceutical cGMP Regulations.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070337.pdf
2. ORA/Office of Enforcement. Guidance for Industry: Product Recalls, IncludingRemovals and Corrections. ORA/Office of Enforcement. Guidance for Industry: Product Recalls, Including Removals and Corrections. http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm.
3. An Introduction to Design Control. http://www.omnica.com/omniview_design_control.htm
Brenda Percy is the product marketing analyst for EtQ Inc., headquartered in Farmingdale, N.Y. Prior to EtQ, Brenda was a marketing communications analyst at STG Inc., where she specialized in corporate research and reports with respect to advances in technology and compliance capabilities. At EtQ, Percy is responsible for communicating overall technology trends and compliance initiatives to the market, and has extensive background in information, food and beverage and medical device technologies. EtQ Inc. specializes in enterprise quality and compliance management software for identifying, mitigating, and preventing high-risk events through automation. She can be reached at bpercy@etq.com.