If my phone locks up today and I can’t pay for my skinny mocha latte at Starbucks without pulling out crumpled bills and coins, it costs only my irritation and a slight delay in the line as the cashier and I struggle through an actual cash transaction. However, the failure of my hip implant (too much skiing?) would mean increased pain, possible poisoning, and possibly the eventual removal and replacement of said metal-on-metal implant. It would be a big deal to me. The failure would also be costly for the medical device company that created the implant; for my company (lost wages and productivity); for the government (increased Medicare expenses); and for all taxpayers who would bear the burden of actual costs.
Medical technology improves and sustains lives like never before. When a problem occurs with a medical device, actions that correct the problem and prevent it from happening again have to be defined and implemented. More and more, medical devices contain electronic component content—putting electronics OEMs on less than familiar ground in addressing potential problems.
For the reasons above, the FDA requires medical device manufacturing companies to establish and document corrective and preventive action (CAPA) processes, described in 21 CFR 820.100. All product companies, medical or otherwise, have a closed-loop CAPA process whether it’s formal, connected, or not. The first part of the loop is the typical CAPA quality process: identify, document, and approve the corrective or preventive action. The second part is taking the actions and updating the impacted systems. This second part “closes the loop” from problem identification through problem resolution. Because most CAPA processes relate to one or more elements of the product record, a CAPA system tightly connected with the product record is the most traceable and efficient choice.
Initial steps: Identify, document, & approve correction action
In these steps, a cross-functional team determines how to correct a problem documented in a complaint, returned product, quality records, or other sources of quality data, described in 21 CFR 820.100 (a) (1). A quality issue comes from an employee, a partner, or a customer. The documentation includes information including a problem description, the severity of the problem, product identification information (serial or lot number), and relevant usage information, like the operating environment.
A cross-functional CAPA team then works to analyze the issue and identify a solution. Customer support and quality teams research this problem, then reproduce it. The quality team proceeds to better understand the root causes. The CAPA team uses the root cause information to determine the best resolution, then documents it. That proposed resolution is then reviewed by the impacted groups for approval. These activities conform with 21 CFR 820.100 (2, 3, 4, and 7).
Typically, the solution addresses one or more of these elements—all part of the product record:
- Personnel training
- Product design
- Manufacturing and test documentation
- Purchased product or service
Closed-loop steps: Change product records, update downstream systems
Because CAPA resolutions relate directly to one or more parts of the product record, a closed-loop CAPA process manages the steps to identify, analyze, and resolve product issues while documenting the resolution and linking it to the product record, as described in 21 CFR 820.100 (5). This ensures all impacted teams, from design to purchasing, know about outstanding issues and can easily participate in the CAPA process. A product-centric QMS system provides this connection between the CAPA process and the product record.
If an issue is traced to an employee or an external team member who is not following the latest instructions or procedures, training may be the resolution. A product-centric QMS system includes training-record management that notifies the person, tracks training activity, and tests for competency. The CAPA loop closes when the training record is linked with the product record and training plans. Any required changes to personnel training can be documented, corrected, and linked via a corrective action request (CAR).
When the team decides the product needs to be changed, an engineering change process manages this resolution. An engineering change order (ECO) describes the change, the reason for it, and tracks the change to the product record. A redlined bill of material (BOM) clearly describes changes to the bill of materials (BOM).
The CAPA loop on product design issues closes when the product-centric quality management system (QMS) links the ECO with the CAPA that initiated that ECO.
Manufacturing & test documentation
Occasionally, the documentation, like an assembly instruction, does not reflect the most recent change to the product design causing the product problem. In this case, a change order will drive the updates to the document. Change orders list the change descriptions and reasons for them.
For documentation issues, the CAPA loop is closed when the change order links to the impacted documentation as part of the CAPA. All team members can see the change and what started it, and then access the updated released revision of the documentation as needed.
Purchased product or service issues
Finally, a problem may be traced to a purchased product or service. If a purchased part or service is the root cause of a product problem, the product company will find an alternate and update the approved manufacturers list to document the change. The CAPA loop is closed through the captured link between the CAPA process and the change process, implementing the new approved manufacturers list.
Product-centric QMS provides your extended product team the controlled access to quality records and product records they need. So, they can see the quality issues and resolutions with respect to the product record. And, they can see all the product record changes, including BOM, approved manufacturers list, and documentation, with respect to the quality process. Without a product-centric QMS, you would need to manually reference between your QMS and your product record control systems (or paper/shared-drive system), require your teams to jump back and forth, and increase your risks of failure to close the loops—ultimately increasing your risk of product failures.
Connecting to downstream systems
A product-centric QMS system also closes the loop further by connecting with downstream systems. When a product change is released, operations and other impacted teams need to know, as described in 21 CFR 820.100 (6 and 7). So, product-centric QMS updates the downstream systems they use—often enterprise resource planning (ERP) systems. This automatic integration makes the changes to the product record—product design, product documentation, or supplier information—in the enterprise resource planning (ERP) system.
When comparing product-centric QMS and document-centric QMS, this is a priority requirement for product companies. Automated integration is the key ingredient missing from paper-based, hybrid, and document-centric quality systems. Integrating cannot be done automatically with a paper-based system, of course. And, with document-based QMS systems, integrations are incomplete and typically expensive custom coding efforts.
The big deal
The big deal is your product that enhances and saves lives. With quality process connected with the product record, your visionary product gets to market sooner and works. Closed-loop CAPA enables fast and accurate resolution of issues that improve product quality.
The powerful connection between the CAPA process and the product record encompasses training, product change, and document change processes. These links give engineering the quality information they need and simplify compliance with FDA and other regulatory bodies. Product-centric QMS provides closed-loop CAPA processes—so you can change the world, which is a very, very big deal.