Our rigorous process ensures our specimen collection kits meet the highest regulatory standards—reliably and repeatedly.

Quality matters.

GBF adheres to lean manufacturing principles and conforms to the         ISO 13485 compliance standards.

We have a culture of continuous improvement.

Our operations team constantly reviews internal and external processes, drawing on the principles of Six Sigma lean manufacturing for optimal performance.

Our process and facility meet all regulatory standards.

We’re a cGMP-compliant company, with systems in place to ensure compliance. Designed for security, our facility includes temperature-controlled warehousing and an ISO-7 clean room.

Kit production is consistent, repeatable and documented.

COLLECTION KITS comply with the Department of Transportation’s Title 49 CFR Part 40, Appendix A.

TRANSPORT VIALS are certified 95kPa compliant and meet IATA pressure requirements.

Our unique quality assurance process

Our quality process includes multiple layers of control to ensure kits are produced exactly to the customer’s specifications.

Working with the customer, we design a kit and create a prototype. Our team creates a Customer Specification Document (CSD) that defines the
components, as well as the physical construction of the box, including assembly instructions.

We inspect incoming components.

This process includes confirming quantity, lot number, expiration, package integrity and more.

We design a custom production line.

After confirming all components have arrived, been logged and passed inspection, we assign specific tasks for each team member, in order.

The production and inspection teams get an illustrated instruction manual.

Every phase of the run is photographed. We create a pictorial layout including photos of the prototype, as well as instructions on labeling components and assembling the kit. When production begins, roaming inspectors document the initial run, comparing the process and components to the job order. 

Kamishibai lean manufacturing tool guides rigorous oversight.

Our inspectors use a powerful visual overview of the custom process to evaluate production as soon as it starts. They monitor every checkpoint to compare our production to the standards we set, and make corrections when necessary.

Examples of what inspectors examine:
·   Is the kit closed/sealed correctly?
·   Are the correct labels on the outside?
·   Are the labels in the correct positions?
·   When the kit is opened, are all the components included?
·   Are the components in the right places?
·   If there’s an instruction sheet, is it in the right place?

Human inspection is augmented by computer-aided verification.

We scan each kit to verify and track components, registration, kit pairing and other key data.

We analyze performance indicators to inform improvement.

Team members review the initial production run, using a Kanban board technique to identify details.

Review and analysis lead to quick modifications.

It’s part of our culture of continuous improvement. It’s how we serve all stakeholders in the best way.  

Stakeholder Satisfaction

Our process of continuous improvement delivers optimal results for everyone we serve—whether directly or indirectly. 

We’re ready to listen.