In the event of a product safety or functional failure or complaint, a CAPA system can help medical device companies to identify trends and what has happened in the past, as well as determine a path of remediation. These systems can help these manufacturers to be sure they do not repeat the same problems in multiple areas and transfer lessons learned between product families.
From an FDA perspective, it is mandatory that medical device manufacturers have a CAPA system in place, as per the Quality System Requirements. When the FDA conducts regular audits of medical device manufacturers, they want to be sure that companies have the right controls in place as part of their process. In such audits, the FDA will also want to be made aware of any events that have occurred within the past 12 months and see that the manufacturer can demonstrate how its CAPA system works and how it is closed.
From an auditing standpoint, it’s crucial for a manufacturer to provide evidence that they have adhered to accepted procedures. Medical device manufacturers must prepare to be sure that all phases are covered under the system procurement before it goes live. Training the right people plays a huge role in the process as the right people need to be trained on a program and system and have access to a training database. Until such time, employees cannot work within the system proper and the FDA will ask for records of employee training and test runs outside the system.
In terms of CAPA and quality management, one of the ways manufacturers can strengthen their position prior to an FDA audit is to perform self-audit. With CAPA system in place, medical device companies can use these systems to help pass audits by being able to readily answer hard questions.
Best Practices for Identifying Areas of Non-Conformance
Regardless of whether they are dealing with internal processes or external suppliers, medical device companies must take steps to prepare for inspections and identify areas of non-conformance to note in a CAPA program.
One of the first steps is to assign accountability to different portions of a project and assign timelines. If no one is assigned a timeline, no one is able to escalate an issue. Having a structured process in place can help address this problem.
According to an FDA Enforcement statistics report, non-conforming materials are the root cause of 42% of all medical device recalls in the past 5 years. Much of this stems from external suppliers and/or partners in the supply chain. If the correct individuals are not trained to abide by these conformances, it can pose a problem to the entire process. However, determining the root cause can be more of an art than a science. A decision tree can prove useful to narrow the possibilities and find the root cause in a structured manner. When used in conjunction with prior investigations conducted and trends, this can be helpful.
When dealing with external stakeholders, medical device manufacturers only have so much control over external practices. These outside stakeholders must become a part of the supplier verification and onboarding process in order to be sure that they are on the same page as far as expectations and accountability for the final product are concerned. This is not an easy feat to accomplish — but it is of the utmost importance.
It’s not trivial to assume that external suppliers may be able to connect to a medical device manufacturer’s internal system. They may have different security permissions and firewalls within their own four walls that may create a technological barrier. Assuming there are no technical hindrances, it’s important that these manufacturers break down their four walls and give all external stakeholders in the supply chain greater visibility into this system.
Discovering an internal problem and connecting it to an external cause may also be a part of the problem. To be sure the root cause is truly eliminated or targeted for remediation, it’s important to validate the information that’s been received and decide if it is acceptable and makes sense with regard to the problem at hand. For instance, if a manufacturer narrows the root cause to a cable on a portion of a med device, they may decide reinforce the connection or make the soldered connection stronger.
How often quality managers should communicate with suppliers varies depending upon the type of supplier. A commoditized material supplier does not require nearly as much communication as a one that supplies a critical component to a medical device. A breakdown in communications can result in failure of a critical process — which, in turn, may mean failure for a business.
The frequency of internal and external audits also varies, as well, depending upon agreement and how much risk a manufacturer can tolerate. Again, a critical part may require a more stringent audit. The frequency of audits can be relaxed once audits have come back with positive results or better consistent performance is recorded.
How EQMS Can Help To Drive a More Effective CAPA Process for Medical Device Manufacturers
A number of existing medical devices are often repurposed and redesigned to accommodate more specific uses derived from an original, more broadly used product.
Many times, design changes don’t begin from the quality side. However, in the event of a recall or if an issue is detected, some design changes can be a part of a CAPA process. Using an enterprise quality management solution (EQMS), a notification can be issued that a change has been input in PLM noting why the design was changed, what was the root cause and what was done about the problem. This is part of the CAPA itself. Once the design change has been updated in PLM, it can notify the EQMS to close the loop of the CAPA with information on the date the change was signed off on and why.
Although many medical device manufacturers have systems of record, when some manufacturing execution systems (MES) are used, some parts of the supply chain are siloed and do not have access to that info. Manual entry of information may result in broken continuity in terms of tracking, tracing and reporting.
EQMS acts as a cohesive element, helping to tie all pieces of the supply chain to a central database. All of the relevant data is centralized, including what machinery has been used or the situation / conditions in which a problem manifested. With this information readily available to all external and internal stakeholders, when information needs to be pushed back to manufacturing or a supplier, everyone else in the supply chain can be notified.
To learn more about how medical device manufacturers can prepare for a more formal audit, download our whitepaper, Prevent Quality System Deficiencies by Conducting Effective Internal Audits White Paper.
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