Tolerance Interval Limits With Technical Cutoff Transformation

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Solution Overview

Problem

Existing methods for determining tolerance intervals in production processes do not adequately consider technical limits, leading to potentially questionable results and high computational demands.

Innovation Solution

A method for determining tolerance intervals that incorporates technical limits by using a transformed probability content, allowing for efficient calculation of tolerance intervals without complex algorithms or iterative processes, suitable for manufacturing drug delivery devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing methods for determining tolerance intervals are used, then the calculation can be performed, but the results are questionable and computational demands are high when technical limits are not adequately considered

Engineering Contradiction:
Improvereliability of tolerance interval resultsVSAvoidcomplexity of calculation method
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent transforms the probability content parameter to account for technical limits. By applying a transformation to the probability content based on the technical limit value, the method adjusts the statistical calculation to reflect the constrained parameter space, thereby improving reliability without requiring complex iterative algorithms

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces a cutoff value as an intermediary element that represents the technical limit in the probability distribution function. This cutoff value serves as a mediator between the technical constraint and the statistical calculation, allowing the tolerance interval determination to respect technical limits while maintaining computational efficiency

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If standard probability distribution functions are used without technical limits, then calculations are simpler, but the tolerance intervals do not reflect actual technical constraints

Engineering Contradiction:
Improveease of calculationVSAvoidaccuracy of tolerance interval
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The method maintains computational simplicity by using standard probability distribution functions but transforms the probability content parameter to incorporate technical limits. This parameter transformation allows the use of straightforward calculations while achieving accurate tolerance intervals that reflect actual technical constraints

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3977318B1Methods for determining a limit of a tolerance interval, method for evaluating a production process and corresponding calculation device
Publication Date: 2025.09.17 SANOFI SA(FR)
  • EP3977318B1 patent drawingFigure 1~2
  • EP3977318B1 patent drawingFigure 3~4
  • EP3977318B1 patent drawingFigure 5~6

AI summary

Disclosed is a method for determining a limit of a tolerance interval (TI), comprising: - providing a plurality of sample values (x), wherein the sample values (x) fluctuate and define a sample value distribution (306, 602), the sample values (x) being values of a technical parameter related to sampled items of a sample, wherein the sample items are parts of drug delivery devices (100), assemblies for drug delivery devices (100) or drug delivery devices (100), wherein the sample items are of the same construction, and wherein the technical parameter is limited by at least one technical limit value, - depending on the technical parameter and/or the sample values (x), choosing a probability distribution function (306, 602), - using the technical limit value (308) to determine a cutoff value (ξL, ξR) for the probability distribution function (306, 602), - specifying a probability content (pc) for the tolerance interval (TI), and - providing the limit (UTBL, LTBL) of the tolerance interval (TI) for the technical parameter based on a transformed probability content <image>, wherein said transformed probability content <image> is based on the cutoff value (ξL, ξR) and based on the specified probability content (pc).