QUALITY CONTROL
& TESTING LAB
Dimensional and visual inspection, optical measurement, and process capability data, generated during the run by the same team that releases the product.
Caught on
the floor,
not at final
The QC Lab works inside the manufacturing process, alongside Production, Engineering, and Operations. Inspection starts at first piece approval, repeats every hour the press runs, and closes at end of run and final release. A dimension that starts to drift is found while the job is still running, so it gets corrected in process instead of discovered after the parts are made.
Every check is measured against the customer drawing and the customer's own inspection and quality requirements. Inspection records are reviewed and tied to product traceability before any lot is released.
Critical
dimensions,
agreed before
the press starts
A new job starts with the customer drawing. Before production is approved, the engineering and quality teams work with the customer to establish which dimensions are critical, then write a quality inspection plan for that specific job.
The plan defines what gets measured, how it gets measured, and at what interval. Everything that happens afterward, from first article through release, is run against that document rather than against a general standard applied to every part that comes through the building.
Six stages,
first shot to
shipment
For programs that require process validation, measurement and data review start here, against the validation lots.
Inspected at production start-up and again at every restart, before the run is approved to continue.
Sampling inspection every hour of the production run. Dimensional and visual, against the plan for that job.
Inspection at the close of the run, so the last parts made are held to the same standard as the first.
Final product inspection and record review against the drawing and the customer's own quality requirements.
Release verification and traceability review before the lot ships to the customer.
- Dimensional inspection against customer drawings and specifications
- Visual inspection against customer drawings
- Verification of customer-specific inspection and quality requirements
- Review of inspection records and product traceability
Measured by
the right
method
Keyence measurement system
Automated optical measurement. Captures multiple dimensions in a single cycle with repeatable results operator to operator.
OGP Smartscope systems
Optical measurement for profile, edge, and small-feature work that hand gauging cannot resolve.
Digital microscope
Surface condition, gate and parting line detail, and cosmetic verification at magnification.
Gauge pins and blocks
Calibrated gauge pins, gauge blocks, micrometers, and calipers for hole, thickness, and feature checks at the press.
Gauges and mating parts
Customer gauges and mating components are run in the lab when the print calls for functional fit, not just dimension.
Printed inspection fixtures
Holding and check fixtures are printed in house on the same additive equipment used for prototyping. A new fixture takes hours, not a tooling cycle.
Measurement method is selected by feature, tolerance, and customer requirement, and it is written into the job's inspection plan. All measuring equipment is calibrated annually by an outside calibration lab.
Proof the
process is
holding
Measurement produces data. The data is what shows whether a process is stable or simply passing inspection this hour. Capability studies show whether a dimension has real margin against tolerance.
- Statistical Process Control (SPC)
- Cpk and Ppk process capability studies
- Dimensional data collection and analysis
- Process performance and consistency evaluation
- Review of inspection and production quality data
- Trend review with Production and Engineering during the run
Support
through
qualification
The lab supports the documentation work that qualification and regulated programs require, from validation lots through corrective action.
- Support for IQ, OQ, and PQ process validation activities
- Validation lot measurement and data review
- Nonconforming product evaluation and disposition
- Root cause investigation and corrective action
- Customer complaint investigation
- Customer-specific documentation and certification requirements
An ISO 9001-certified manufacturer supporting the medical device industry with validated manufacturing processes, traceability, and controlled quality systems.
Where the
line is
Every production inspection is performed in house. The people who measure the parts are the people who run the process and release the lot. Three things are handled by outside partners, and they are named here rather than buried.
Calibration
All measuring equipment is calibrated annually by an independent calibration lab, so the numbers on an inspection record trace back to a standard rather than to an internal claim.
Material analysis
Material identity is confirmed through an outside analytical lab when a program requires proof that the resin running is the resin the customer specified.
Root cause testing
When an investigation requires testing beyond the competencies on this page, an outside lab is engaged in coordination with the customer requesting it. That decision is made with the customer, not around them.
Facility scope: the QC Lab described here is the Pittsfield, Massachusetts operation.
Bring the
tolerance
you worry
about
Send a print with the dimension that has caused problems before. An engineer will tell you how it would be measured here, at what interval, and what data comes back with the parts.