Every project is configured after the initial review. We define which capabilities apply, in what depth, and on what timeline — together with the client. Nothing is bundled, nothing is mandatory.
The structure is consistent across every project. What changes is the scope, the depth, and the regulatory framework. The client knows what to expect at each phase before the work starts.
30-minute technical call. You describe the process, the constraint, and the regulatory context. We assess fit and define whether a scoped engagement makes sense.
A formal review of the current state — on-site or remote depending on the line: process documentation, measurement systems, production data, team structure. The first scoped piece of work, with its own deliverable.
We propose a written scope: which capabilities, in what sequence, with what deliverables, over what timeline. The client reviews and signs before the next phase begins.
The work. Remotely and/or with on-site visits when the line requires it. No surprises on scope or timeline without a prior conversation.
All documentation, data files, and protocols transferred to the client's QMS or shared drive in the format they use. A final session with the team that will own the process going forward.
Installation, operational, and performance qualification protocols. Acceptance criteria, sampling plans, and execution under GMP, ISO 13485, or IATF 16949 depending on the regime that applies.
Statistical assessment of process stability and capability. Control chart strategy, capability indices (Cp, Cpk, Pp, Ppk), and the rules that turn statistical signals into clear operational responses on the floor.
Cell layout against measured takt, station balancing, buffer sizing, material flow.
Structured experimentation to optimize parameters and characterize the process. The design is chosen to fit the question being asked and the constraints of the line.
Validation of analytical and physical test methods with statistical justification at every step. Protocols, raw data, and reports defensible against regulatory inspection.
Crossed and nested Gage R&R studies, attribute MSA (kappa), bias and stability assessment. Output identifies whether observed variation is in the part, the gauge, or the operator — and what to do about it.
First-pass yield and rolled throughput yield measurement at every station. Scrap categorized by defect mode and origin station.
Definition of operator, lead, and supervisor roles tied to the actual process. RACI matrices for cross-functional decisions. Skill matrices that name what each role must demonstrate.
When a production team needs to grow, contract, or reorganize, we model headcount against takt and design the transition.
Project management for cross-functional initiatives — scope definition, planning, tracking against milestones, and stakeholder reporting tied to measurable engineering outcomes rather than activity.
Procedures and work instructions written to be readable on the floor by the person doing the work. Numbered, versioned, and integrated with the QMS in use.
Batch records and device history records that capture what was actually made, by whom, with which materials, against which version of which procedure. Templates compatible with paper, hybrid, or eBMR systems.
Validation master plans, protocols, executed protocols, and summary reports — written to survive an audit and to be useful to the next engineer who has to revise them.
Value stream mapping, waste identification, and flow optimization tied to measured takt and cycle data, not generic frameworks.
Single-minute exchange of die for high-mix lines. Setup decomposition into internal and external steps, with a validated procedure ready for shop-floor execution.
Structured investigation of failures and deviations using 8D, Ishikawa, or 5 whys depending on the failure mode. Output is documented to close CAPA and NCR records cleanly.
Plan-Do-Check-Act loops with measurable hypotheses, data collection design, and statistical confirmation of improvement — not opinion-driven.