Implementation & Pilot Strategy
Get Evidence Fast —
Then Scale At The Pace Your Risk Model Allows
A practical framework for getting to decision-ready evidence without pausing production or rewriting your QMS
If you're in a regulated industry, you've probably developed a healthy allergy to "90-day transformations." You know what happens next — someone produces a slide full of heatmaps, calls it "assurance," and your Quality team quietly asks the only question that matters: what decision does this actually support?
That's why most in-situ monitoring pilots stall. Not because the system can't detect anomalies, but because the pilot is framed as a technology trial instead of an evidence program.
At Additive Assurance, we prefer a simpler promise. We can get you to first evidence in 30 days, and then we proceed at the pace your risk acceptance, customer requirements, and certification reality demand. Some programs move fast, some take months, and some take years. That isn't failure; that's what appropriate governance looks like.
The goal is not to "finish a pilot." The goal is to establish a repeatable way to generate decision-ready evidence from builds — without pausing production or rewriting your QMS.
Phase 1 - 0–30 Days
Deployment & First Evidence, With Minimal Disruption
The first month should feel operational, not experimental. This phase is about getting AMiRIS installed and producing outputs your team can actually use. But the real work is alignment — and you're answering three questions:
What decision are we trying to enable?
Be concrete. Release-to-postprocessing? Hold for review? Trigger targeted audit inspection? Escalate to engineering? If the decision is vague, the pilot will drift.
What does "good evidence" look like here?
Quality doesn't need more data. It needs evidence that can be reviewed quickly, documented consistently, and defended later. Agree in advance on which fields must be captured — part/build identity, criteria, thresholds, disposition — and how exceptions are handled.
What is the minimum viable report?
Start small and usable. A short summary that states what happened, where it happened, and why it matters will beat a thousand-layer visualisation every time.
The deliverable at the end of Phase 1 is a tight deployment checklist, a pilot decision charter (who reviews, when, and what triggers escalation), and a decision-ready report format that fits your existing QMS.
If assurance is "working" by day 30, you'll see it in behaviour — fewer arguments, faster prioritisation, and a consistent way to package what happened during the build.
Phase 2 - Timeline Set By Risk
Validation Depth & Smarter Inspection Strategy
This is where many teams want a calendar promise. In regulated manufacturing, that's usually the wrong instinct. Validation is not a single activity — it's a spectrum, determined by what you're trying to prove, and to whom.
Some organisations want to use in-situ evidence to reduce blanket inspection. Others want it to improve process control while keeping inspection unchanged. Some want to correlate in-situ signatures to CT or other methods and build a defensible risk-based audit strategy. All are valid, but they have very different timelines. As a result, Phase 2 is deliberately elastic — it can be a short sprint or a long program. The key is that the pilot doesn't become a science project. You expand validation only as far as your risk model requires.
Practically, that means:
- •Choosing representative builds — not best-case samples,
- •Defining acceptance criteria and escalation rules,
- •Using verification (CT, metallography, etc.) where it adds confidence rather than just cost, and
- •Tightening the evidence pack until it can survive scrutiny from Quality, customers, and auditors.
The output isn't "more monitoring." It's a repeatable inspection strategy that blends in-situ evidence with targeted verification — so you're buying down risk efficiently.
Phase 3 - Adoption
Scale-Out — Only When The Evidence Is Accepted
Once your evidence model is accepted, scale becomes a practical exercise — extend to more parts, more machines, more programs, without losing governance. This is also where IT/Security topics stop being blockers and become routine: access control, retention policy, storage sizing, and auditability. Nothing glamorous, everything essential.
A good pilot doesn't promise speed. It proves credibility.
If you want to move quickly, we can. If you need to move cautiously, we can do that too. The win is the same: a low-disruption path to decision-ready evidence that fits how regulated manufacturing actually works.
Request the 30-Day Deployment Checklist
We'll run a short consultation to map our deployment checklist to your environment and risk posture — so your first 30 days have a clear structure from day one.
Request Checklist