Establishing Current Good Manufacturing Practices (CGMPs) ensures that medical device manufacturers can better comply with regulations and standards like FDA 21 CFR part 820.100 and ISO 13485, including quality systems that identify, analyze, and correct quality issues. These corrective and preventive action (CAPA) processes are a major component of delivering and supporting medical devices in today’s highly regulated marketplace. While CAPA-related regulations do not specify every detail required to avoid or respond to quality issues, they do provide the building blocks to identify, investigate, and resolve issues with the necessary controls and documentation. Without adequate CAPA processes, manufacturers increase their risk of receiving warning letters and citations after FDA audits.
When creating a solid CAPA process, medical device manufacturers often struggle with a “Goldilocks” complex. Too many loose controls, not enough analysis—how does a company find the “just-right” balance and get appropriate support and buy-in from management?
In this blog, we address what medical device manufacturers need to drive effective CAPA processes and how a product-centric QMS approach best supports these processes.
1. The Tools to Identify, Analyze, and Resolve Issues Fast
One of the main requirements of CAPA is that organizations must identify the core issue or issues that cause quality problems using data, which can be collected from a variety of internal and external sources. This data gathering fuels root-cause analysis, which relies heavily on strong cross-team communication and sharing of related issues, policies, procedures, product designs, and related documentation.
Because CAPA processes often require multiple teams to work together, it’s a good idea to create a review board (e.g., Materials Review Board or MRB) comprised of members representing every department that has a stake in resolving quality issues. These boards will need to evaluate quality issues that are identified and move through the CAPA process to identify the root causes before corrective actions can be taken.
When organizations use manual, disconnected, or paper-based systems, it is significantly harder to gain visibility into the product design and quality action history. Additionally, if the organization relies on a QMS solution that is separate from the product and change review processes that track the product’s bill of materials (BOM), it’s harder for the review team to gather relevant design and quality information.
For today’s complex medical device manufacturers, it’s important to equip cross-functional review boards with the right solutions. Having a single product-centric QMS connects quality management to the complete product design or product record. It provides direct context and direct links between product records and related CAPA issues. This streamlines and speeds root-cause analysis and review, creating a more traceable audit trail from identification of issues through final resolution.
With dynamic live links between quality and the entire product record, Arena QMS provides enhanced visibility and insights. By managing the relational BOM with links to all parts, drawings, specifications, and other related documents, Arena offers a unique product-centric approach with a history of design and quality decisions that help quickly determine the cause of product issues.
2. A Single Platform Improves CAPA Management
It’s easy for medical device manufacturers to fall into the trap of creating silos for engineering, quality, and operations teams. While each team owns their part of the new product development and introduction (NPDI) process, every aspect of NPDI affects multiple teams.
When a change to the product occurs, design changes need input from quality, procurement, manufacturing, supply chain partners, and others. These teams need access to product design and quality information throughout the product life cycle, especially when non-conformances, defects, or other serious problems are identified.
Many devices provide functions that are critical to patient survival, making it imperative that all affected stakeholders have access to records when investigating issues. When product and quality teams use a single QMS solution, it gives every member of the review board complete visibility to identify, investigate, and resolve product quality issues fast. Only product-centric QMS solutions like Arena provide a single system for quality and the entire product record–including relational BOMs–to eliminate gaps between product design and quality processes.
3. The Ability to Document and Review Effectiveness of CAPA Process
All medical device companies will benefit by “closing the loop” on their CAPA processes, from problem identification, analysis, and documentation through problem resolution. Setting up processes that ensure continual improvement will improve how medical devices perform. How well manufacturers create and follow closed-loop processes varies, often based on the types of systems used. Since both FDA 21 CFR part 820.100 and ISO 13485 require use of effective CAPA processes, documenting and collaborating in a single system is key to ensure a closed-loop through final resolution.
Product-centric QMS systems give all affected teams an advantage when working through CAPA processes. Because many issues and related CAPA processes affect more than a single aspect of the product design, a quality system connected to the product record optimizes teams’ abilities to quickly identify and ultimately resolve defects, issues, and non-conformances.
Closed-loop CAPA management is key to success and might be accomplished with a disconnected or document-centric QMS solution. However, Arena’s single product-centric QMS solution for product and quality creates the necessary historical audit trail to follow quality problems from early identification to issue resolution and product enhancements. Arena helps close the loop by taking the output of the corrective action process and actually linking to the product design changes or engineering change orders (ECOs) that will correct any design flaws.
The key to managing your CAPA processes well is to leverage QMS solutions that enable visibility, simplify communication, and support a closed-loop process. A single product-centric QMS solution provides a holistic record of related quality and product processes to speed the identification, analysis, and resolution of issues quickly and effectively.
Are you struggling with disconnected or inefficient CAPA processes? Reach out to one of our experts today to see how you can advance CAPA management so your device gets to market faster and more efficiently.