Test Method Validation

Attribute Agreement Analysis (Go/No Go Gage or Pass/Fail Test Systems)

Learn how to perform an Attribute Agreement Analysis (Go/No Go Gage or Pass/Fail Test System). You'll understand why false acceptance is more important than false rejection, what double sampling is, and how to select a sampling plan, design, and execute an Attribute Agreement Analysis.

Simon Föger

Aug 06
5 min.

In this blog post we discuss the validation approach of a Pass/Fail Test System aka Attribute Agreement Analysis or Go/No Go Gage.

An Attribute Agreement Analysis is based on attribute test data – data we cannot use to calculate parameters like averages, standard deviations are anything else.

A Pass/Fail Test System can make two types of errors: either passing a nonconforming part or failing a conforming part.

However, this is true for just about any test method, whether variable or attribute, destructive or non-destructive.

Why is False Acceptance More Important Than False Rejection?

The introduction briefly framed the two types of errors a Pass/Fail Test System can make.

Passing a nonconforming part which is considered a false acceptance, or failing a conforming part which is considered a false rejection.

While false rejection is strictly a business concern, false acceptance means products on the market do not meet specifications.

Hence, the false acceptance must be acceptably low [1].

Selecting the Sampling Plan for an Attribute Agreement Analysis (Go/No-Go Gage)

So, when false acceptance is the key, we need to define the sampling plan based on the probability of detecting precisely that.

The table below provides different sampling plans (single and double) based on the product risk/harm.

Study Design of an Attribute Agreement Analysis

The sampling plans provided in Table 1 are to be interpreted as follows:

  1. Perform 124 inspections of nonconforming units
  2. Accept if 2 or fewer nonconforming units are missed

124 nonconforming units do not mean one has to have 124 defective products but instead 124 readings.

This can be achieved by having 5 operators inspecting 10 nonconforming products 2 to 3 times each.

The idea is to have the nonconforming products among a larger number of conforming products.

For the study design, one must decide on the following numbers:

  • Nonconforming units to use
  • Conforming units to use
  • Inspectors
  • Repetitions

NOTE: The nonconformities can either be selected from production units or may need to be made. The nonconformities should include borderline samples that are expected to be detected [1].

How to Execute an Attribute Agreement Analysis?

Now that we decided on the study numbers and selected/prepared the samples to be inspected, we can execute the study.

Assuming we use a single sampling plan, the acceptance criteria is characterized by two parameters:

  • n = sample size
  • a = accept number

Inspect n defective units and count the number of missed defective units.

If the number of missed defective units is less or equal to the acceptance number a, you have passed the test – otherwise, you have not.

What is Double Sampling?

Double sampling is used to give a questionable batch another chance.

Double sampling is more complex than single sampling.

It is characterized by 5 parameters as opposed to two for single sampling.

An advantage of double sampling is the reduced average number of units to be tested which comes in handy for expensive, destructive testing [1].

Join Our Free Webinars

Why Your Visual Inspection Fails the Audit

Live Webinar incl. Q&A on July 1, 2026 at 17:00 (CEST)

The 6 steps that turn visual inspection into evidence that holds up – learn what auditors expect to see, the gaps they keep finding, and the framework that closes them.

Register for Free
Supplier Documentation
On-Demand | Originally aired May 20, 2026 

Stop Relying on Certificates – Learn the 5 Non-Negotiables Every Auditor Actually Probes 

In this webinar, you'll learn the 5 Non-Negotiables that decide every ISO 13485 audit – and how to satisfy them without dragging your team onto the audit-prep treadmill.

Close the gaps. Pass the audit. Stay qualified.

Watch Webinar
Risk-Based Samples Sizes
On-Demand | Originally aired April 22, 2026

Learn how to justify sample sizes using a clear, risk-based and statistically sound approach that reduces validation effort and cost.

Gain a practical framework you can confidently defend in audits across TMV, design verification, packaging, and process validation.

Watch Webinar
The 7 Deadly Sins of TMV
On-Demand | Originally aired January 21, 2026

Stop reacting to audit findings – start leading.  

Learn where MedTech companies repeatedly fail, what regulators truly expect, and how to set the right priorities – before inspections force your hand.

Join our free live webinar and walk away with:

  • - Clear insights of the 7 most common mistakes in TMV
  • - Practical principles you can apply immediately
  • - Confidence to lead TMV decisions instead of firefighting them

Get audit-ready. Gain clarity. Take the lead. Secure your seat now!

Watch Webinar

Further helpful links and resources: 

Do you need support in performing an Attribute Agreement Analysis in your company? Contact us today at office@sifo-medical.com, and we'll gladly provide hands-on support with your projects.

References

[1] W. Taylor, Statistical Procedures for the Medical Device Industry. Libertyville, IL, USA: Taylor Enterprises, Inc., 2017. [Online]. Available: https://www.variation.com