Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions
Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by regulatory bodies around the world, and in fact, your suppliers’ suppliers are not immune to that scrutiny. The list of organizational quality stakeholders continues to grow as the value chain expands to include suppliers and even regulators themselves.
This means that a Quality Management System (QMS) needs to be enterprise strong and it needs to be global if an organization is to respond to harmonization of standards, guidelines, and regulations around the world regarding the organization’s value chain.
Envisioning quality management beyond your organization’s four walls requires expansions to your quality system that provide the process control and visibility you need to stay compliant in a global regulatory setting.
Quality and Insight Throughout the Supply Chain
Key regulations all echo the same need for proper planning, selection, evaluation, control, and monitoring of suppliers (harmonization), so for compliance reasons alone, we need to move quality outside the four walls of our organizations to include our suppliers, and sometimes their suppliers as well.
As you look to the future of your quality system, consider whether you have the tools you need to manage supplier quality. This includes supplier evaluation and selection, and supplier performance data such as audit records, incoming inspection data, nonconformance records, and CAPA responses. Best-practice processes, structured supplier quality data, and vendor quality portals can help you better capture and understand supplier performance. This enables your team to make data-driven decisions and communicate them with your suppliers quickly. It’s important for suppliers to participate in that process with the ultimate goal of delivering high-quality products to customers and preventing serious adverse events in patients around the world.
However, there are other important reasons to move QMS outside the four walls of the quality group: product quality (right the first time) and operational efficiencies (shortened cycle times, improved product compliance, improved first pass yield, reduced supplier defect rates, and improved new product introductions) can be achieved when quality becomes everyone’s job.
Case Intake for Field Personnel
When a patient incident or potential complaint occurs, your goal is to shrink cycle time; the timeframe from when someone in your organization becomes aware of the incident to when you take action. Extending quality management capabilities to your field personnel can help shrink this gap so that when an adverse event is identified, you can address it quickly. Then if reporting is needed, you can report it in a timely fashion.
The right step? Bringing field personnel into the process, closer to the point of the incident will shorten cycle times. A web-based case intake portal that provides your field personnel with access to just the right forms and fields they need to accurately report the incident to the quality and regulatory team. This type of portal can get your data captured quickly, consistently, and securely so it can be evaluated and moved to the next phase of the process.
Getting Regulators Involved
At a certain point, regulators may need access to your quality data as well, specifically in the areas of patient safety and reporting.
Post-market electronic Medical Device Reporting (eMDR) submissions, for example, are already required to be sent electronically. There are numerous options for managing electronic submissions, but a fully automated eMDR process will help you become more efficient – and timely – as your organization grows.
The FDA recently launched additional initiatives that will require organizational reporting to the FDA. The Center for Devices and Radiological Health (CDRH) office kicked off the Case for Quality in 2011 to determine how to shift focus from compliance to quality. This was driven by the lack of demonstrable improvement in patient safety over many years. The Case for Quality is part of CDRH’s 2016-2017 strategic priority to promote a culture of quality and organizational excellence. This initiative will require the reporting of pre-production, production, and post-production metrics which drive a right-the-first-time mentality.
The Center for Drug Evaluation and Research (CDER) also issued their draft guidance on the Submission of Quality Metrics Data in November 2016. The metrics they’ve selected are focused on quality as well; Lot Acceptance Rate, Product Quality Complaint Rate and Invalidated Out of Specification Rate (IOOSR). The reporting of quality metrics data is just another way the regulators are beginning to move from a pure compliance focus to one that considers quality and sustainability.
Quality on the Go
As the needs of the quality system move beyond the organization’s four walls, quality professionals will be moving outside those four walls as well. This means that your team will need purpose-driven apps and mobile-enabled solutions that allow you to perform your work on the go.
Whether you need to record the results of a vendor audit, dig into a report, or respond to a CAPA remotely, you’ll need a quality system that is accessible wherever you happen to be.
The Bottom Line
Compliance is still a regulator’s objective, but the focus of regulatory bodies around the globe has shifted from one of compliance to quality. With the continued cooperation of regulatory and standards bodies around the world, global visibility of quality throughout the organizational value chain is a key to an organization’s compliance.
Pilgrim’s quality management software solutions are here to help you every step of the way. Join us for an upcoming webinar to learn how Pilgrim SmartSolve® can extend your complaint management process beyond your four walls from case intake to post-market submissions and much more.
The Case for Quality System Transformation
Learn how compliance, quality system maturity, and a quality culture all feed into a successful global quality system.