BUILD BETTER

Products

Reduce Defects. Improve Capacity. Accelerate Results.

  1. 01

    Root Cause Analysis

    • Routine trend analysis
    • Nonconformance investigation
    • CAPA investigation

  2. 02

    Process Optimization

    • Design of Experiments (DOE)
    • Statistical Process Control (SPC)
    • Gauge R&R

  3. 03

    Capacity Analysis

    • Value stream mapping
    • Balancing rate, quality, and availability
    • We can help you ramp

  4. 04

    Equipment & Parts Support

    • Sourcing obsolete and hard-to-find parts
    • Refabricating discontinued parts
    • Quoting and vendor coordination
    • Spare parts and maintenance planning
    • Equipment upgrades and retrofits

  5. 05

    Agency Reporting

    • Reporting to support FDA submission
    • Nonconformance and CAPA reporting
    • Regulatory compliance review
    • Validation standards

Our Problem-Solving Method

Observe
Are we measuring the right thing? Can we detect the difference that matters?
Orient
What is the goal? How does the measurement relate to the goal?
Decide
What action drives the change to the process that matters?
Act
Implement the improvement. Measure the impact. Did we get where we need to go?

A Pipeline of Support

We develop modern processes and tools to ensure repeatability. We deploy AI intelligently and validate outputs. We maintain robust quality assurance practices. We ensure data integrity and security.

We manage and report data using validated systems and processes.

Results

Vehicle Sale Value
$631.4M

EV battery lines: 12,480 carsets / yr

Production Capacity Increase
5×

Implanted medical device battery scale-up

Revenue Preserved
$4.8M

Endotoxin FDA audit recovery

Annual Cost Savings
$770K

Battery electrolyte backfill DMAIC yield improvement

Business Built
1

CrowFootUSA, from wrench design to drop shipping

Let's Solve Your Manufacturing Challenge

Get in touch with our engineering team. We'll review your inquiry and reach out with next steps.

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