In brief

Agree labelled challenge samples and expected results for each closure, code and visible check. Record the tested views and formats, missed defects and rejected good samples separately, and the response to missing or uncertain results. Challenge how the complete result set stays with the vial through disposition using the in-line sequence.

For in-line inspection using vial closure, code and visible checks, describe the realistic range and how changes in false-accept, false-reject and challenge criteria affect the result you need.

On the production floor

Turn your production information into clearer decisions — Vial Closure Code and Visible Checks

Plan vial closure code and visible checks around representative good, bad and marginal samples, line presentation, lighting, reject handling and challenge criteria. Discuss an optical feasibility trial with Oxford Vision Systems. Use this guide to resolve false-accept, false-reject and challenge criteria before it limits the final system.

Discuss your application
What to record

False-Accept, False-Reject and Challenge Criteria: condition, range and effect on your process

Current condition

Keep the approved sample identity and expected result alongside the observed result for each check. Record vial format, presentation, lighting, active job and recipe version, together with the observed removal or review outcome.

Realistic range

Cover the agreed normal and marginal samples, format and presentation range, consecutive failures and interruptions. Include incomplete result sets on restart, and record which combinations or regions were not demonstrated rather than extending a limited result to the whole application.

Effect on the system

Separate the optical decision from tracking, removal confirmation and the final release decision. Record missed defects, rejected good samples and uncertain outcomes distinctly, with an owner for unresolved cases. Integrity, sterility and other product-release requirements need their separately defined evidence.

Before you contact us

Five questions about false-accept, false-reject and challenge criteria for your application

  1. Who can confirm this information?Identify the person responsible for false-accept, false-reject and challenge criteria in production, quality, engineering or operations.
  2. How representative is the sample?Include age, supplier, batch, environment and upstream process state where they affect vial closure code and visible checks.
  3. What is the difficult condition?Include the slow, reflective, flexible, dirty, damaged, marginal or uncommon case that your system must still handle.
  4. How will you judge the result?Agree the method, repetitions, acceptable range, result record and the response if the observed result falls outside the agreed range.
  5. What else must be coordinated?Your final vial closure code and visible checks scope must also account for recipe, reject and line-control interfaces, false-accept, false-reject and challenge criteria, current regulations and the conditions at your site.
Connected details

Review false-accept, false-reject and challenge criteria as part of the complete system

Question 1

Visible Defect or Measurement Definition for Vial Closure, Code & Visible Checks

For Vial Closure Code and Visible Checks Challenge-test checklist, describe the current position, required outcome, acceptable limits and known exceptions for visible defect or measurement definition for vial closure, code & visible checks. That lets us compare options against your real production rather than one nominal value.

Question 2

Good, Bad and Marginal Sample Range

For Vial Closure Code and Visible Checks Challenge-test checklist, describe the current position, required outcome, acceptable limits and known exceptions for good, bad and marginal sample range. That lets us compare options against your real production rather than one nominal value.

Question 3

Part Presentation and Production Speed

For Vial Closure Code and Visible Checks Challenge-test checklist, describe the current position, required outcome, acceptable limits and known exceptions for part presentation and production speed. That lets us compare options against your real production rather than one nominal value.

Question 4

Optics, Lighting and Environmental Conditions

For Vial Closure Code and Visible Checks Challenge-test checklist, describe the current position, required outcome, acceptable limits and known exceptions for optics, lighting and environmental conditions. That lets us compare options against your real production rather than one nominal value.

Question 5

Recipe, Reject and Line-Control Interfaces

For Vial Closure Code and Visible Checks Challenge-test checklist, describe the current position, required outcome, acceptable limits and known exceptions for recipe, reject and line-control interfaces. That lets us compare options against your real production rather than one nominal value.

Question 6

False-Accept, False-Reject and Challenge Criteria

For Vial Closure Code and Visible Checks Challenge-test checklist, describe the current position, required outcome, acceptable limits and known exceptions for false-accept, false-reject and challenge criteria. That lets us compare options against your real production rather than one nominal value.