Precision Medical Systems: Understanding Production, Not Just Monitoring It

What the Team Was Living With

Precision Medical Systems manufactures Class II and Class III medical devices in an FDA-regulated cleanroom. The stakes are high — every component needs full traceability, every process needs documentation, and every quality issue has consequences.

But the team’s frustration wasn’t about regulation. It was about understanding.

Quality issues were surfacing late — sometimes not until final inspection. By then, rework was expensive and root causes were hard to trace. Process monitoring was manual and intensive. Engineers spent hours assembling data that should have been available in minutes. And audit preparation consumed weeks of time that could have gone toward actually improving the process.

The team didn’t lack discipline. They lacked visibility.

• Late defect discovery — problems found at final inspection instead of at the source
• Manual process monitoring — time-consuming and still incomplete
• Audit preparation as a separate project — weeks of work to assemble what the team already knew
• Traceability gaps — full component history was possible but painful to reconstruct

What Changed

A Shared, Validated Picture of Production

Attainment Tracker was deployed following full IQ/OQ/PQ validation — the same rigor the team applies to everything in their cleanroom. The system was built to meet 21 CFR Part 11 requirements for electronic records, role-based access, and electronic signatures.

But the real value wasn’t compliance features. It was that the team could finally see production as it happened — what was running, what was blocked, where quality signals were drifting — and act on that understanding in real time.

Visibility Into Quality Patterns

Instead of discovering problems at final inspection, the team now sees quality signals at every station:

• Measurement data captured directly from gauges
• Process trends visible as they develop, not after the fact
• When something drifts, the people closest to the work see it first
• Photo documentation gives context that numbers alone can’t

Traceability That Comes from Understanding

Full component-to-assembly history is available — not because the system surveils the process, but because production visibility and traceability are the same thing. When you understand where every component went, what happened at every step, and what the process parameters were, you can answer any question — from your own team or from a regulator.

• Component genealogy from receipt through assembly
• Time-stamped process parameters at every station
• Device History Records generated from the same data the team uses daily

What the Team Discovered

Once the team could see production clearly, the improvements followed. Quality issues that used to surface at final inspection started getting caught — and understood — at the station where they originated. Engineers could trace a defect back to its root cause in minutes instead of days.

First-pass quality improved from 94.1% to 99.2%. Scrap rate dropped from 3.2% to 0.4%. Rework hours fell from 120 per week to 18. These weren’t the result of tighter controls or more surveillance. They came from people understanding what was happening well enough to catch and correct problems early.

Audit preparation went from 40 hours to 4 — not because the team automated their way out of it, but because the records they use every day are the same records auditors need. When FDA inspectors visited, the team didn’t have to prepare a story. They could simply show what they already knew.

How It Came Together

Medical device deployments require formal validation. The Attainment Tracker rollout respected that reality — setup is real work, and in this environment, validation is part of setup.

Weeks 1-2: Installation Qualification (IQ)

• System architecture documented
• Hardware installation verified
• Network and security assessment completed

Weeks 3-4: Operational Qualification (OQ)

• Functional testing against requirements
• Access controls verified
• Audit trail validated

Weeks 5-6: Performance Qualification (PQ)

• Production environment testing with the team
• User acceptance testing — operator and engineer feedback shaped the final configuration
• Standard operating procedures finalized

Weeks 7-8: Go-Live

• Controlled production launch
• Enhanced monitoring period while the team built confidence
• Training completed across all roles

What Made It Work

1. Transparency, not surveillance — the system shows what’s happening in production so people can understand it and improve it
2. Compliance as a byproduct of understanding — when you know your process deeply, proving it to a regulator is straightforward
3. Validation treated as real work — eight weeks of careful setup, not rushed to hit a deadline
4. The team shaped the system — operator and engineer input made the data accurate and the views useful

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Building medical devices and want this kind of production clarity? Start a conversation.