Standards

Quality & Performance

Certifying Inlay Quality & Performance

While RFID has become cheaper and more reliable over the years, performance varies greatly based on manufacturing processes, QA workflows, and the challenging environments in which these RFID-tagged drugs will be scanned.

  • Performance starts with existing standards (managed by other organizations) like RAIN and GS1 EPC UHF Gen 2 AIP. DoseID makes use of these, but adds additional concepts to ensure items scan well in the presence of RF-inhibiting factors — liquids, metals, high tag density, etc. — commonly found in healthcare workflows.
  • Quality ensures that inlay manufacturers and label converters have proper quality management system (QMS) in place and follow robust process from requirements gathering to final shipment.
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Independent Testing & Verification

DoseID relies on an independent 3rd party to conduct testing & certification of candidate inlays and systems.

The RFID Lab at Auburn University is a respected, independent organization that has been working with industry for the last 16 years with…

  • A focus on business cases and value
  • Experience with RFID in healthcare, retail, aviation, aerospace, and more.
  • A program comprised of Education, Research, and Support to enable successful adoption of RFID

The ARC Program, one of the Lab’s primary programs, will be responsible for DoseID testing and certification to ensure that DoseID products meet or exceed the levels of performance and quality needed to provide a benefit to the end user in a consistent and cost effective manner.

ARC Lab Certification Process

1

Is there evidence of a strong QMS?

Third party audits and certification

2

Does the QMS cover all the critical aspects of RFID

Questionnaire focusing on:

  • Design & development
  • Supplier & raw material
  • Non-conforming product - identification, isolation, and analysis
  • Experience, expertise, and resources

3

Site inspection / Interviews

  • Design & development
  • Supplier & raw material
  • Non-conforming product - identification, isolation, and analysis
  • Experience, expertise, and resources

4

Testing Each New Inlay model

4000 tags
Consistency

5

Industry level Audits

Regular inspection in the supply chain and in the deployment

ARC Lab - Inlay Certification

Inlay Enrollment Process

  • Inlays may be submitted only directly from the inlay manufacturer. Third party submissions of inlays will not be accepted.
  • The manufacturer fills out and submits the Inlay Enrollment Application.
  • Upon submission of the enrollment application, ARC will add the inlay to the testing queue. The testing will be performed in a reasonable amount of time based on the current workload. An estimate of time of testing completion will be sent to the manufacturer.
  • Inlays will be tested according to the published ARC Benchmarking Methodology to create the Inlay Performance Profile.
  • Upon completion of testing, the Inlay Performance Profile will be added to the ARC Database.
  • If the Inlay meets the criteria of any current Performance Specs/Grades, the inlay will be added to any appropriate published Approved Inlay Lists.
  • Manufacturers will be notified as any future Performance Specs/Grades becomes available after the inlay is enrolled. By request of the manufacturer, ARC will perform any additional custom testing required by subsequent Performance Specs/Grades, and the data will be added to the Inlay Performance Profile and the ARC Database.

Inlay Enrollment and Maintenance

  • There is a cost associated with enrolling an inlay to the ARC program. Payment is due after completion of testing on receipt of test results.
  • An inlay will be enrolled in the program for the production life of the inlay.
  • An inlay can be removed from the program at any time by request from the manufacturer.
  • An inlay will be considered for any future Performance Specs/Grades that require no custom testing for the life of the inlay.
  • Any custom testing to satisfy Performance Specs/Grades added after the enrollment of the Inlay will be performed at no additional fee for the first year of enrollment in the program.

Living Document Status

  • The testing methodology and testing equipment documents are living documents and will be changed and revised as new technology emerges.
  • Any re-testing required due to changes or revision of documents, specifications, equipment, and methodology will be handled internally by ARC.
  • A full set of documentation including invoicing, reporting, and terms and conditions are available from the university upon ARC engagement.