Robert Lahaderne, MBA

Using risk management as the inspection roadmap - and increasing visibility into management review, internal audits, and supplier audits -, puts leadership ownership and system effectiveness squarely in focus.

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Today, FDA published its weekly list of recent Warning Letters. This Warning Letter to ASP Global only cited one QMS area - purchasing controls, while also citing violations related to the MDR regulation, Corrections and Removals regulation, and a failure to get clearance before marketing a significantly changed device. This one statement in sub-section C of citation 1 (Purchasing Controls) struck me as particularly interesting: "C. (b)(4) [the supplier] was audited by FDA in (b)(4) and received four observations, but ASP Global was not notified until April 29, 2025, after (b)(4) was placed on Import Alert, despite working closely with (b)(4) on SCAR-339 from February to March 2025. The ASP/(b)(4) Quality Agreement, Section 2.3, Page 6 of 15, states "(b)(4) shall notify ASP in writing within (b)(4) if any of the following occurs: (c) (b)(4) becomes aware of any inspection or audit findings that affect safety, effectiveness, conformity, or availability of product."" Effectively, ASP Global was cited in the Warning Letter because its supplier failed to notify it of the outcome of an FDA inspection (i.e., import alert) despite a requirement to provide such notification in the Supplier Quality Agreement (SQA). Initially, it seems unfair that FDA would cite a firm for something its supplier failed to do, but it speaks to a very important need within supplier quality teams at medical device manufacturers. SQAs cannot be once-and-done documents. The ongoing monitoring of suppliers (21 CFR 820.50 and ISO 13485:2016, clauses 4.1.5, 7.4.2) must include ensuring that the supplier is meeting all of its obligations under the SQA. As we see from this WL, FDA may hold you accountable for a supplier not complying with an SQA if they feel you haven't done your job in enforcing its provisions. https://lnkd.in/gsQ-cyjZ

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In the effort to follow the letter of the regulations, I have witnessed many organizations holding the required management reviews to "evaluate the suitability, adequacy, and effectiveness of a Quality Management System". However, the "compliance only" mindset is focused on evaluating the ability of the QMS "to function as a QMS", a siloed activity that is not operationally connected to affect the quality, safety, and performance of the manufactured products that the quality processes are intended to support.

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If you needed any more convincing that FMEA is not risk management, look no further than FDA's Compliance Inspection Manual published 30-Jan-26. Risk is not just about failure modes. Risk is about anything that can go wrong, even when everything is working as intended. Risk assessment, evaluation and control must include use and user-related risks, design, process, supply chain, biological, clinical, environmental and more AND throughout the entire product life-cycle, not just pre-market. Manufacturers who've had a US-only focus must have this in their risk management system already because the transition period is over and FDA is not waiting for you! https://lnkd.in/gQr5gRgX

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Understanding the Why… #TPS From the book, Connecting The Dots… During 1930s, most manufacturers operated under a mass-production paradigm. Efficiency was measured by how fully machines and labor were utilized, and production was scheduled based on the capacity of operations rather than actual demand. The result was overproduction, which led to large inventories of parts and finished goods. These inventories required additional space and tied up capital. They also created an illusion of stability because defects could remain hidden within stockpiles. For a resource-constrained company like Toyota, such waste was unacceptable. More details here - https://lnkd.in/dK76EWKn Foreword written by Bruce Hamilton (Toast Kaizen teacher). Venkatesh Krishnamurthy Laksh Raghavan

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Quality culture isn’t defined by procedures it’s defined by behavior In many organizations, quality operates below the line when risks are seen but ignored, workarounds are accepted, and silence feels safer than speaking up. Issues are known but unspoken. Risks are seen but tolerated. Deviations become the normal way of working and preventing recurrence is absent. That kind of culture doesn’t fail loudly. It fails quietly. A strong quality culture requires moving above the line where issues are visible, owned, and addressed before they reach the customer or patient. See something - notice risks, defects, or weak signals early Say something - speak up without fear, blame, or repercussions Do something - take action to fix issues at the source and prevent them from happening again. A culture of quality must be supported from the top through leadership behaviors, priorities, and decisions. But it starts from the bottom up and has the greatest impact with the people who touch the product every day. Quality isn’t owned by a department it’s owned by the entire organization. It’s built by every person, every day, in every role, through the work they do. You know your culture is truly above the line when product builders and operators feel empowered to stop, speak up, and build quality at the source and not rely on inspection to catch problems later. What’s your organizational Culture of Quality Like?

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Today during Quality Week, Martin Lush delivered a compelling keynote on Human Error Reduction, emphasizing the need to think differently in quality and our work. The discussion centered around the importance of designing systems that take into account human factors, prompting us to question whether we are streamlining processes and procedures for users or unintentionally introducing unnecessary complexity. #QualityImprovement #HumanFactors #SystemDesign #GuardantHealth

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This post is spot on with the issues I have seen. It can get especially complicated in situations under intense scrutiny by regulators. At the end of the day to avoid these traps, I like to remember: 1) Patient safety is paramount and the QMS needs to be functionable to deliver on patient, business and QMS user needs 2) The foundation of Quality is process improvement. The QMS is never done, it's a living, breathing thing. As a business evolves the QMS needs to continue to evolve and improve! #meddevice #quality

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Many startups treat QMS as something you install before inspection. Regulators see it as proof that your success wasn’t accidental. A QMS isn’t about paperwork — it’s about demonstrating repeatability, control, and accountability as complexity grows. This section reframes QMS as an operating backbone: 🎾 Why results without systems aren’t trusted 🎾 What “minimum viable QMS” really means for startups 🎾 How QMS supports evidence integrity and submissions 🎾 Design controls as strategic protection, not overhead 🎾 Common shortcuts that fail under audit 🎾 When to scale QMS sophistication and when not to If your QMS lives in a binder, your approval is living on borrowed time. https://lnkd.in/gHhJB5VG #RegulatoryStrategy #DiagnosticRegulation #IVDRegulatory #IntendedUse #ClaimsArchitecture #AnalyticalValidation #ClinicalValidation #IRB #IDE #FDA_PreSub #RegulatoryExecution #QMS #ChangeControl #PostMarketSurveillance #RegulatoryReadiness

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Really great breakdown of what strong audit readiness looks like in the medical device space. Clear, simple, and spot‑on, Nanda Filkin. Proud of the work Arete Biosciences is doing to help companies build confidence ahead of audits.

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