Your Quality System Should Work Every Day

Not just for the auditor. Not just on paper. For the people who do the work.

ISO 9001, AS9100, ISO 13485, 21 CFR 820 — these aren't compliance frameworks. They're how good manufacturing actually works, written down so anyone can use it.

If your quality system lives in a binder nobody opens — if your corrective actions close with "retrain operator" and the same problem comes back next quarter — if your procedures describe a process nobody actually follows — you don't have a quality problem. You have an operations problem wearing a quality label.

That's what I fix.

$750 Gap Assessment — One Day On-Site

Your floor. Real findings. No long-term engagement required.

Get Started →

One day on-site. Clear findings. No long-term engagement required.

Who This Is For

Regulated manufacturers. Four different seats at the same table.

The Stretched QA Manager

You already know what's broken. The problem isn't knowledge — it's authority. Leadership hears "quality" and thinks "paperwork." You need someone from outside the org chart to say what you've been saying, with the data to make it stick.

What you get:

A gap assessment that translates quality concerns into business risk — the language leadership responds to. A prioritized roadmap that gives you the evidence and authority to get things fixed.

The Ops Manager Wearing the QA Hat

You inherited a QMS binder that's five years old. Nobody has a quality background. You're running production and somehow also supposed to own document control, CAPAs, and internal audits. Every consultant you've talked to wants to add 50 new procedures.

What you get:

An assessment that starts with your actual operation — not the binder. What's costing you time, rework, and risk — and what to fix first, in a way that removes friction instead of adding it.

The Owner Who Sees the QMS as a Pandora's Box

You know the quality system needs attention. You also know that opening it up could become uncontrollable. Meanwhile, you're carrying risk: a regulatory gap that could become a recall, a valuation question that won't go away.

What you get:

Clarity on where your actual risk is — translated into dollars, not clause numbers. A missing CAPA process isn't just a documentation gap — it's a $15M recall risk. One day, clear answers, no Pandora's box.

The Shop Without Certification

You're not registered to ISO anything. Maybe a customer is asking for it. Maybe you just want the discipline without the overhead. Either way, you don't want to pay $50K for a consultant who builds a system you'll never sustain.

What you get:

The operational discipline that makes manufacturing work — without the registration overhead unless you decide it's worth it. Cert or no cert.

The $750 Gap Assessment — 1 Day On-Site

Here's what actually happens.

The first 30 minutes, I'm on your floor. Not in a conference room — on the floor. How does work actually flow? Are operators referencing procedures or working from memory? Are travelers current or batch-completed? Where does nonconforming material go?

The floor tells the truth that documents lie about.

Then I look at the records: your CAPA log, internal audit results, management review minutes, calibration records. I'm not checking boxes against a standard — I'm reading the evidence of whether your system functions or performs.

By end of day, you get a debrief. Within a week, the written deliverable.

What You Leave With

  • Floor-first assessment of how work actually happens vs. what procedures say
  • CAPA and internal audit review — are they finding root causes or closing records?
  • Findings matrix — every gap prioritized by operational risk, not clause number
  • Executive summary in language your leadership team can act on
  • Clear next steps — what to fix first, second, and third

What This Assessment Is Not

  • Not a pre-audit simulation. I'm not playing registrar.
  • Not a binder review. I check whether the system works, not whether the paperwork exists.
  • Not the start of a 12-month engagement. You get answers in one day.

Why This Is Different

I've been on the other side of this table.

I've been the ops manager who inherited the binder nobody uses. The quality manager who needed air cover from leadership. The plant manager trying to ship product while the quality system fought against the people doing the work. I've run all three legs — Operations, Quality, and Manufacturing Engineering — simultaneously, under P&L pressure, on real shop floors.

I learn before I change.

The #1 way consultants destroy value is walking in and rewiring everything to match their last job. Your system evolved for a reason. I find out why before I propose changing anything.

I fix the operation, not the paperwork.

Most consultants are hired by quality and deliver quality solutions. I deliver operations solutions that happen to fix the quality problem. That's why the fix sticks.

I leave you stronger, not dependent.

If you need me back in 12 months, I've failed. I build capability, not consultant dependency.

Professional Photo of Richard Snyder

Richard Snyder

  • ✓ 30+ years ops, quality, and manufacturing engineering leadership
  • ✓ MBA + Mechanical Engineering
  • ✓ ASQ Certified Manager of Quality & Organizational Excellence
  • ✓ Medical device, aerospace, precision manufacturing

If you want a checkbox for your auditor, I'm not your guy.

If you want a quality system your people actually use — one that makes Monday morning easier and happens to satisfy any auditor — let's talk.

Common Questions

"We hired a consultant before and got a binder nobody uses."

I've been the person who inherited those binders. That's exactly why I start on the floor, not in the document library. The assessment evaluates whether your system works — not whether the paperwork exists.

"We don't have bandwidth to manage a consultant."

You don't manage me. I come in, assess, and deliver findings. Your only commitment is one day of access and someone who can answer questions about how the operation runs.

"What's the ROI?"

Clarity and prioritization. Instead of guessing where the risk is, you get a clear view of what's creating rework, delay, and exposure — and what to fix first. In most shops, one avoided mis-prioritized project or one prevented recurring quality issue more than covers the cost.

"Our registrar already tells us what to fix."

Your registrar checks whether you've documented what you do. I check whether what you do actually works. Those are different questions.

"We're not looking to get certified."

Good — this isn't about certification. The operational discipline that these standards capture is valuable whether you register or not. The cert question is separate.

"What happens after the assessment?"

You get a prioritized roadmap. Many clients implement it themselves. If you want help with implementation, we can talk — but there's no pressure and no assumed next engagement. If you never call again but your system works better, I did my job.

Ready to know where you actually stand?

$750. One day. Your floor. Real answers.

Book a gap assessment. You'll know exactly what's working, what's not, and what to fix first — in language your leadership team can act on.

Get Started →

Or call: 503-901-8645

One day on-site. Clear findings. No long-term engagement required.