Tim, can you please explain component traceability as it relates to medical device manufacturing?
When we manufacture medical devices, traceability is required in most cases by regulatory bodies like the FDA. Traceability involves tracking all of the components that go into a medical device. It includes data that identifies the origin, date and batch number of each component, as well as what subassemblies and finished devices that components are integrated into. The data is documented in a device history record (DHR) and increasingly via an electronic device history record (eDHR).
As a manufacturer, we have to provide both forward and reverse traceability. Being able to link all of this information together helps regulators and medical device companies pinpoint and troubleshoot an issue if a product malfunctions out in the field. In the unfortunate event of a product recall, it helps them quickly isolate products that should be removed. This is common in regulated industries like the medical and automotive markets, where people’s lives could be impacted if a product were to malfunction.
Prior to manufacturing a medical device, it’s critical to have traceability procedures and controls in place to ensure every supplier, material and component is consistently and accurately tracked. Quite often, component suppliers won’t provide this information if you don’t request it in advance. These methods must be applied every time you set up the supply chain for the production of a medical device.
What are the benefits?
In addition to fulfilling mandatory requirements, traceability helps to identify component discrepancies during production. This enables us to separate out any affected parts into smaller batches so that we can determine the root cause of an issue. Being able to proactively identify and resolve non-conformances early in production helps prevent bigger issues down the road.
For example, maybe we’re not seeing the yield, or percentage of non-defective items, that we expected during production. We can go back, narrow it down to certain components and figure out where the problem started using traceability data. If it’s a problem with a batch we received from a supplier, we can work with them to quickly resolve the problem.
Is anything else tracked during medical device production?
Along with tracking components, we also track production processes. A popular approach to ensure predetermined processes and methods are used during manufacturing is called ‘forced routing.’ This method ensures that all production steps are taken in the right sequential order.
Cloud-based MES platforms are ideal for enabling this approach. As bar codes are scanned at each workstation to track equipment, materials and operator’s badge numbers on the production floor, the data is sent to the cloud for tracking and analysis. If a key component is scanned prior to assembly and it’s the wrong revision, the system will prevent that component from being used. Integration of the shop floor system with the training database ensures that an employee’s training record is checked before they can perform an operation. If the operator hasn’t yet been trained on a recently updated work instruction, they are prevented from logging into that workstation until the training is completed. If an assembly inadvertently arrives at the wrong step in the process, the assembly will automatically be rejected.
Are there any big challenges when it comes to maintaining traceability?
High level assemblies and larger components and subassemblies have enough surface area to support a label or etching that includes all of the key details for seamless tracking. Much smaller components, however, don’t have enough real estate for a label and date codes or batch numbers must be matched to work orders and serial numbers during manufacturing.
For very tiny devices, data must be pulled from the tape and reel that the component is delivered on. There can be thousands of tiny components on a tape and reel. It might take a little longer for a plant to match those details with the overall assembly data so that we can share that information with a customer or notified body.
How is traceability data used when there’s a device malfunction in the field or a product recall?
We have to be prepared to support forward and reverse traceability, as requests can come in a variety of ways, based on particular scenarios. For instance, a customer could say, ‘Hey, we’ve already investigated this device and we know that a particular circuit with certain components is having problems. Can you tell us when those components were manufactured by your supplier?’ Or they could say, ‘One of your devices has failed and we’ve identified the affected capacitors and the date they were manufactured. Can you tell us which devices are using those capacitors that have the same serial numbers?’
Requests can also come from the FDA. it could be due to a known problem with a supplier that has identified a batch of components manufactured within a certain month that turned out to be bad. In this scenario, our job would be to tell them which devices that the faulty components went into so they can replace them.
During product recalls, traceability data can help speed up pinpointing an issue or solving a problem. If you can identify an issue and only recall a select amount of medical devices, it’s a much better approach than having to recall three years of product. That would be a major undertaking that could result in negative financial and brand implications for a medical device company.
How does traceability data help audits?
Every year, we go through a great deal of audits, including annual audits with registrars for our nineteen ISO13485 certified plants and three ISO13485 design centers. We also have ten MDSAP sites and ten FDA registered sites that must have annual audits with registrar bodies, the FDA and customers.
For a normal FDA audit of our quality system, a routine inspection is conducted to ensure that everything is in place for a compliant traceability program. Traceability data could also come into play during a ‘for cause’ audit, meaning there’s a problem with a medical device out in the field that must be investigated. We’ve never had a ‘for cause’ audit at Sanmina but in the event it happens, the FDA would require traceability information about everything we shipped, going all the way back to the start of the issue.
One advantage we have at Sanmina is the use of the 42Q cloud-based MES platform to store and monitor our traceability data, making it easy to remotely compile and send the requested reporting information. Previously, the data was stored via on premise servers but their bandwidth was limited. Before traceability software, everything was tracked via paper documentation, which was labor intensive and the stacks of files took up a lot of warehouse storage space.
Were audits and traceability programs affected by Covid lockdowns at the height of the pandemic?
Fortunately, we didn’t miss a beat during the height of lockdowns from the pandemic. Remote audits became popular and were very successful. Our online tracking systems made it easy to transition to this approach. Some organizations are still conducting remote audits today. For standard surveillance audits, which happen on a three year cycle, registrar bodies can still do them remotely. This may change eventually but the remote audits have been working very well.
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