When companies bring in an outside quality consultant, it’s rarely because everything is going smoothly.
There’s usually some kind of pressure or triggering event—an inspection looming, a warning letter on the table, or a quality system that’s grown faster than the organization’s ability to manage it (just to name a few).
In those moments, technical expertise matters. But experience, judgment, and how problems are approached matter just as much.
We recently sat down with Neal Siegel, PhD, a senior life sciences consultant who has spent decades working inside large global manufacturers, supporting FDA investigations, and helping companies navigate some of the most consequential moments in their quality journeys.
What follows are the most important lessons he’s learned, and why they’re still relevant today.
Lesson 1: Most QA failures aren’t people problems—they’re system problems
“It’s never a single person. It’s a system. If someone made a mistake, there’s training behind it, there’s management behind it. You have to look at the whole thing.”
One of the most consistent themes in Neal’s career is this: when something goes wrong, the root cause is almost never a single individual. It’s tempting—especially under regulatory pressure—to look for someone to blame. But that approach rarely fixes the underlying issue and often creates new ones.
In Neal’s experience, quality failures typically point to:
Gaps in training.
Poorly designed or poorly maintained systems.
Misaligned incentives.
Inadequate oversight or resourcing.
Processes that evolved without being formally updated.
Blame-focused responses may feel decisive, but they tend to obscure the real work: understanding why the system allowed the issue to occur in the first place.
This mindset is especially critical during audits, inspections, and remediation efforts, where emotional reactions can make already difficult situations worse.
Lesson 2: A good consultant is a guest, not a judge
“I’m essentially going to someone’s home when I’m brought in. If I’m a consultant, I’m a guest. I’m not there to be rude or put anyone on the spot. I’m there to solve an issue.”
When a company brings in an external consultant, it’s often during a vulnerable moment. Tension is understandably high. Reputations are often at stake. Teams are already under pressure. In those situations, the consultant’s role isn’t to lecture, embarrass, or “win” an argument. It’s to help the organization understand what’s happening and move forward.
That means:
Listening before diagnosing
Asking questions instead of assigning fault
Working with internal teams, not around them
Maintaining empathy without compromising regulatory rigor
This approach strengthens compliance because solutions are more likely to stick when the people responsible for executing them understand and trust the reasoning behind them. It’s a mindset and approach we bring to every engagement.
Lesson 3: Consent decrees are career-defining for a reason
“That was when I really learned what the FDA was and how things are done. There was no pressure at all—except everything mattered.”
Early in his industry career, Neal worked at a large global diagnostics manufacturer during a period when the company entered into a consent decree with the FDA. That experience fundamentally shaped how he understands regulatory expectations.
Consent decrees are often discussed abstractly. Living through one is different.
They expose:
The gap between written procedures and real-world execution
The operational consequences of underinvesting in quality
The importance of validation, documentation, and management oversight
How the FDA evaluates not just individual findings, but organizational behavior over time
For Neal, that period became the foundation of his regulatory judgment. It’s also why he’s cautious about oversimplified compliance advice, because he’s seen firsthand how complex remediation really is.
Lesson 4: Expertise means knowing what you don’t do
“You can’t say everything. You have to know what you’re good at—and when you need someone else. Guessing doesn’t help anybody.”
One of the most practical pieces of advice Neal offers—especially for consultants—is deceptively simple: you have to know exactly what you’re an expert in. Teams don’t benefit from consultants who claim to do everything. They benefit from consultants who:
Are deeply knowledgeable in their core areas
Know when to bring in additional expertise
Can identify issues outside their specialty without guessing
Understand how different quality domains intersect
That same principle applies to companies hiring external support. The goal isn’t to find one person who can fix everything. It’s to build the right combination of expertise for the problem at hand.
Lesson 5: Teaching often matters more than fixing
“It does not help the client—or The FDA Group—if I walk out and they’re just as unknowledgeable as when I came in.”
Consulting engagements end. Quality systems don’t! One of the clearest indicators of effective consulting, in Neal’s view, is whether the client understands the issue better after the consultant leaves than they did before.
That means explaining FDA expectations in plain language and showing how similar issues have appeared in public warning letters. It also means:
Helping teams understand not just what needs to change, but why.
Leaving behind processes and knowledge that reduce the likelihood of repeat issues.
When consulting is done well, organizations don’t just resolve today’s problem; they’re better prepared for the next one.
Lesson 6: Adaptability is now a core quality skill
“If you’re focused on only doing things one way because that’s how you were taught, it’s going to be very difficult to advance and provide good service today.”
Over the span of Neal’s career, the industry has moved from:
Paper records and manual integrations
Analog laboratory processes
Limited computing power
…to highly digital, data-rich environments shaped by automation, advanced analytics, and now AI.
The lesson for professionals, whether you’re working in-house or consulting, is adaptability.
Regulations evolve. Technology evolves. Expectations evolve. Professionals who succeed in this environment aren’t the ones rigidly attached to how things were done in the past. They’re the ones who can evaluate new tools and methods critically, adopting what helps, questioning what doesn’t, and adjusting without losing sight of regulatory fundamentals.
Neal Siegel, PhD is a senior life sciences quality and regulatory consultant with more than 30 years of experience supporting medical device, pharmaceutical, combination product, and IVD manufacturers. His background spans quality system design, validation, risk management, remediation following FDA warning letters and consent decrees, and extensive GMP auditing across FDA-regulated industries.
Neal has led or supported hundreds of audits and compliance initiatives under 21 CFR Parts 210, 211, and 820, as well as ISO 13485, ISO 14971, IEC 62304, and related standards. Earlier in his career, he held senior technical, statistical, and validation leadership roles at Abbott Laboratories, where he gained formative experience during a large-scale FDA consent decree. He has also served as an FDA contractor, expert witness, and ASQ-certified quality auditor.
He holds a PhD from Michigan State University and has taught quality and applied statistics at the university level. Neal is known for his systems-focused, pragmatic approach to compliance and his ability to help organizations resolve complex quality challenges without assigning blame.
Why these perspectives matter
At The FDA Group, we work with consultants who have lived through inspections, remediation efforts, consent decrees, and large-scale quality transformations, not just studied them.
Conversations like this spotlight something we believe deeply: effective quality work is as much about judgment, communication, and systems thinking as it is about regulations and checklists.
If you’re facing a complex quality challenge, or simply want to understand how experienced practitioners think when the stakes are high, we think you’ll find this discussion valuable.
Who is The FDA Group?
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations.
With over 3,750 resources worldwide, over 325 of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee.
Here’s why 17 of the top 20 life science firms access their consulting and contractor talent through us:
Resources in 75 countries and 48 states.
26 hours average time to present a consultant or candidate.
Exclusive life science focus and expertise.
Dedicated account management team.
Right resource, first time (95% success).
97% client satisfaction rating.
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