Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
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. Regulators will continue to focus in this area as data shows that scrutiny is warranted. For example, from the FDA for Medical Devices (just a portion of the life science market), 24% of all observations made in the period ending September 30th, 2017, were due to supplier issues.
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. Your 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.
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, quality needs to move outside the four walls of our organizations to include our suppliers, and sometimes their suppliers as well. A short list of those regulations include:
- 21 CFR Part 820
- ISO 13485:2016
- EU MDR
- ICH Q10
- ICH Q9
- FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
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 within the organization’s supply chain.
Quality Portal: Supplier
When supplier product or service issues occur, 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 suppliers can help shrink this gap so that when an issue is identified and corrective and preventative actions are needed, you and your supplier can address it quickly.
Bringing suppliers into the process, closer to the point of the incident, will shorten cycle times. A web-based portal that provides your personnel with access to just the right forms they need to report investigation results, subsequent actions, and the effectiveness of those actions to the quality and regulatory team is the next right step. This type of portal can get supplier data captured quickly, accurately, consistently, and securely so it can be evaluated and moved to the next phase of the process, minimizing the risk to your supply chain.
Getting Regulators Involved
At a certain point, regulators may need access to your quality data. 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 its draft guidance on the Submission of Quality Metrics Data in November 2016. The metrics they selected focus 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 mobility; purpose-driven apps and mobile-enabled solutions that allow everyone to perform their work on the go.
Whether you need to record the results of a supplier 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.
Quality In, Quality Out
Regulatory Drivers of Supplier Quality Management in the Medical Device Industry (Part 2 of 4).