Leveraging lead and lag indicators to drive performance
For medical device manufacturers implementing new (or trying to measure existing) production and process controls, understanding the lead and lag indicators is critical to meeting production and performance goals. This is particularly important when doing so to meet ISO 13485 and FDA 21 CFR part 820 requirements.
A lag indicator is a performance measurement that reflects the outcomes or results of processes after they have occurred. Manufacturers need to measure the success of a process to understand if the controls they’ve put in place are effective. Otherwise, you may be adding controls that add cost, don’t add value, and worse, don’t meet those critical requirements. Lag indicators are often used to assess the effectiveness of production processes, identify areas for improvement, and make informed decisions for future actions.
Conversely, a lead indicator is a performance measurement that provides early signals about future performance or potential issues in the production process. Lead indicators are critical in understanding if performance is starting to drift before serious issues occur. They are proactive and predictive, helping organizations anticipate and prevent problems, optimize processes, and improve overall efficiency. However, lead indicators can be some of the most difficult to identify correctly.
The Worst Indicator
The worst indicator for any medical device manufacturer is being under an FDA consent decree. In this situation, you have lost control over your own plant and decision-making processes. Getting in front of the problem with the right measures will ensure you aren’t getting into this situation.
What is an FDA Consent Decree?
An FDA consent decree is an agreement made between an entity and the U.S. Food & Drug Administration (FDA) to enforce rules and regulations set by the FDA. It typically involves a negotiated, court-approved order barring an FDA-regulated firm from violating the FDCA, subject to certain pre-specified remedies. The FDA works with the Department of Justice (DOJ) to file a complaint against a business in Federal District Court to obtain a consent decree. A consent decree is the maximum enforcement action the FDA can take. Violating a consent decree can be devastating to a business.
Potential Lead Indicators Leading to an FDA Consent Decree
Typical lead indicators include an increased number of product recalls (a lag indicator of poor quality) and 483 warning letters (a lag indicator of an FDA inspection).
Lead Indicators for FDA Inspections and Recalls
What are the lead indicators for a potential FDA inspection or a looming product recall? These often include an increase in Corrective and Preventive Actions (CAPAs) driven by customer complaints and a high number of Medical Device Reports (MDRs). It is no surprise that while MedTech recalls are piling up fast in 2024, CAPA issues (21 CFR Part 820.100) are the highest contributor to inspection citations.
Connecting Quality Issues and Lead Indicators
While CAPAs are a lead indicator for potential FDA inspections and recalls, they are also a lag indicator driven by quality issues such as high scrap rates and Non-Conformance Reports (NCRs). Often, quality problems start with unmeasured repair or rework to fulfill customer requirements, known as “The Hidden Factory.” Measuring and acting on trends in repair/rework is an essential starting point for connecting the dots from lag to lead indicators.
The Importance of Gemba Walks
Your morning Gemba walk should include reviewing your product lead and lag indicators and their trend lines. This practice helps you maintain a continuous improvement cycle and stay ahead of potential issues.
How Seraph’s Services Support Lead and Lag Indicators
Seraph helps clients solve their most challenging operational problems by leveraging a proactive, hands-on approach that directly impacts output, product quality, efficiency, and cost balance. Seraph can also help to identify which metrics will be most effective in not only avoiding significant issues but also avoiding costly production-related delays and missing customer deadlines. Here’s how Seraph’s services align with and enhance these crucial performance metrics:
1. Quality Management
Seraph’s Quality Management services are instrumental in addressing lead indicators like CAPAs by identifying potential quality issues early. Identification of potential or ongoing issues and implementing effective corrective and preventive actions are how Seraph can help prevent minor issues from becoming major ones that can lead to potential product recalls and customer complaints.
2. Turnaround
Seraph’s turnaround services stabilize operations when falling behind, missing targets or failing to achieve goals. By improving production line efficiency, optimizing material flow, and maximizing performance, Seraph helps convert low production rates and missed shipments into actionable improvements that serve as a blueprint for operational stability.
3. Mergers, Acquisitions & Spinoffs
During mergers and acquisitions, Seraph’s approach mitigates risks that can otherwise lead to disruptions in production or quality issues. Implementing value-creation plans and detailed risk assessments ensures the success of these major transitions, ensuring future operational integrity and profitability.
4. Relocation and Consolidation
Relocating and consolidating production lines can be fraught with risk, negatively impacting output and product quality if not appropriately handled. Seraph’s structured approach ensures that these transitions are smooth and compliant, preventing potential missed MDR compliance or supply interruptions.
5. Project Management
Seraph’s project management services help medical device manufacturers stay on track with planned product or production milestones and process improvements. Properly managed projects reduce the likelihood of delays and quality problems.
6. Logistics and Supply Chain Optimization
Inefficient logistics and supply operations can lead to delays, missed customer deadlines and increased costs. Seraph’s expertise in supply chain management, including lean material flow and supplier qualification, reduces the risk of disruptions, preventing delayed shipments or compliance issues from materializing.
7. Production Data Collection
Seraph’s operational software provides real-time data transparency, which highlights process deviations early on. Learn more here Production.net Services | Seraph
8. Strategy Development and Implementation
By providing strategic guidance, Seraph helps manufacturers establish or refine production goals, addressing resource allocation and supply chain resilience. Effective strategy execution helps avoid lagging performance metrics such as profitability drops or operational inefficiencies.
9. Assessment & Appraisal
Through comprehensive assessment and appraisal services, Seraph identifies risks and creates clarity regarding operational gaps. This rigorous evaluation ensures adherence to regulatory standards and ultimately can assist companies in avoiding serious issues like FDA consent decrees or major compliance failures.
By focusing on early detection, process optimization, and risk mitigation, Seraph helps manufacturers maintain a balance between addressing existing challenges and preventing future ones, driving sustainable operational excellence.
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