// Process engineering consultancy · Donostia

Scale up
with
confidence.

A process engineering team for manufacturers that need to move from artisan output to validated, documented, statistically defensible production. Scope, depth, and deliverables are defined per engagement.

Process validation and statistical capability for manufacturers that need to scale.
Donostia · Euskal Herria
// 01 — Processes
Process design & validation.
// 02 — Quality
Method validation & MSA.
// 03 — People
Roles & restructuring.
// 04 — Documentation
Technical documentation.
// Capabilities

Four areas.
Scoped per client.

Every engagement is configured to the client's process maturity, regulatory regime, and budget. There is no fixed methodology and no standard duration — the work is shaped by what the line actually needs.

// 01 — Processes

Process validation, line design, capability analysis.

IQ/OQ/PQ protocols, layout and takt design, Cp/Cpk studies, SPC implementation, DOE for parameter optimization.

// 02 — Quality

Method validation, with statistical rigor.

Test method validation, Gage R&R studies, measurement system analysis (MSA), first-pass yield audits, defect classification frameworks.

// 03 — People

Role design, restructuring, and project management.

Role and responsibility definition, training matrices, and knowledge transfer protocols. Project management for cross-functional initiatives, with reporting against measurable engineering outcomes.

// 04 — Documentation

Technical documentation written to be used on the floor.

Procedures, work instructions, batch and device-history records, validation reports — under whichever regulatory framework applies.

Full capability list →
// Diagnostic

Five questions.
Honest answers.

A two-minute self-assessment of where your process actually stands. No email, no funnel — just a private read on whether validation work would move the needle for you right now.

// Question 01 — Processes

Are your critical process parameters documented with defined operating ranges?

// Question 02 — Quality

Have your test methods been validated with a Gage R&R or equivalent study?

// Question 03 — Capability

Do you know your Cpk for the parameters that drive product quality?

// Question 04 — Documentation

If a key operator left tomorrow, could a new hire run the line from the SOPs alone?

// Question 05 — Pressure

Is an audit, certification, or scaling event on the horizon in the next 12 months?

// Diagnostic result
Tier 2

→
// Engagements

No fixed phases. No standard duration. The scope is defined by the process, not the calendar.

Engagement model

Fixed-scope projects, retained advisory, or interim process engineering. Defined per client.

Ready to
scale with confidence?

Book a 30-min call →