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ISO/TS 14253-2

Overview

ISO/TS 14253-1

This part of ISO/TS 14253 establishes the rules for determining when the characteristics of a specific workpiece or measuring equipment are in conformance or non-conformance with a given tolerance, for a workpiece, or limits of maximum permissible errors, for measuring equipment, taking into account the uncertainty of measurement.

It also gives rules on how to deal with cases where a clear decision, conformance or non-conformance with specification, cannot be taken, i.e. when the measurement result falls within the uncertainty range that exists around the specification limits.

The part 1 of ISO/TS 14253 does not apply to inspection using limit gauges. Inspection with limit gauges is covered by ISO/R 1938.

Published in the March of 2002, the document "Guidelines for Decision Rules: Considering Measurement Uncertainty in Determining Conformance to Specifications" specifically addresses the issue of applying measurement uncertainty in industrial settings. A decision rule is a prescription for the acceptance or rejection of products based on the measurement result of a characteristic of the product, the permissible variation associated with that characteristic, and the uncertainty of the measurement result. For workpieces the permissible variation is commonly called the tolerance; for instruments it is often given by the specification limits or a maximum permissible error (MPE).

Some measurements, particularly at NMIs, state a description of the measurement, its result, and its uncertainty; decision rules are not involved since there are no product specifications.

However, most industrial measurements are performed to determine if a product is in accordance with some specification, e.g., if a workpiece is within its specified tolerance. In this situation, the measurement value is usually used in a binary decision that the product is acceptable or not acceptable. This general class of problems, determining if a measurement result yields an acceptable product when clouded by measurement uncertainty, is not addressed by the GUM and represents an important economic (and potentially conflict prone) application of measurement uncertainty.

The goals of the document are to establish a set of requirements for a decision rule, define a terminology that allows unambiguous communication of what decision rule is being used, and provide some well-documented decision rules that can be referenced.

ISO/TS 14253-2

ISO/TS 14253-2 shows the implementation of the "Guide to the estimation of uncertainty in measurement" concept (in short GUM) to be applied in the industry for calibration (measurement) standards, and for measuring equipment in the field of GPS, and the measurement of work piece GPS characteristics. The goal is to promote full information on how to achieve uncertainty statements and provide the basis for international comparison of measurement results and their uncertainties (relationship between purchaser and supplier).

ISO/TS 14253-2 introduces the Procedure for Uncertainty Management (PUMA), which is a practical, iterative procedure based on the GUM for estimating uncertainty of measurement without changing the basic concepts of the GUM. It is intended to be used generally for estimating uncertainty of measurement and giving statements of uncertainty for: single measurement results; the comparison between two or more measurement results; the comparison of measurement results from one or more work pieces or pieces of measurement equipment with given specifications, i.e. maximum permissible errors (MPEs) for a metrological characteristic of a measurement instrument or measurement standard, and tolerance limits for a work piece characteristic, etc., for proving the conformance or non-conformance with the specification.

The iterative method is based basically on an upper bound strategy, that is overestimation of the uncertainty at all levels, but the iterations control the amount of overestimation. Intentional overestimation and not underestimation is necessary to prevent wrong decisions based on measurement results. The amount of overestimation is controlled by economical assessment of the situation.

ISO/TS 14253-3

Geometrical Product Specifications (GPS) -- Inspection by measurement of workpieces and measuring equipment - Part 3: Guidelines for achieving agreements on measurement uncertainty statements.

ISO/TS 14253-3 provides guidelines and defines procedures for assisting the customer and supplier to reach amicable agreements on disputed measurement uncertainty statements regulated in accordance with ISO/TS 14253-1, and so avoid costly and time-consuming disputes.

Basically the part 3 is a report designed to allow parties avoid potential, or resolve actual, disagreements over the magnitude of a stated measurement uncertainty, particularly when that uncertainty is part of determining the conformance of a product to dimensional specification.

With significant economic interests at stake, it is not surprising that customers and suppliers might disagree over the magnitude of the measurement uncertainty statement. Applying these guidelines can assist businesses in avoiding disagreements about measurement uncertainty statements between customers and suppliers and in resolving such disagreements should they occur. Disagreements over uncertainty statements involving a single measurement system and multiple measurement systems, each having its own uncertainty statement, are considered.

Guidance is provided for examining uncertainty budgets as the primary method of assessing their reliability. Additionally, resolution by direct measurement of the measurand is also discussed.

While the document was initially designed for resolving disagreements over measurement uncertainty, the report discusses many factors of formulating uncertainty budgets that will be useful to anyone responsible for this task.

The ISO/TS 14253-3 document, is concerned with resolving disagreements between two parties over a dispute of a measurement uncertainty statement. The main goal of ISO/TS 14253-3 is achieving agreement between the parties whereas emphasizes the metrological issues seeking to achieve agreement through education.

ISO/TS 14253-4

Geometrical product specifications (GPS) -- Inspection by measurement of workpieces and measuring equipment -- Part 4: Background on functional limits and specification limits in decision rules

ISO/TS 14253-4 outlines the main assumptions behind the theoretically ideal decision rules established in ISO/TS 14253-1. It discusses why these rules have to be the default rules and what considerations should be taken into account before applying different decision rules.

ISO/TS 14253-4 applies to all specifications defined in general GPS standards, i.e. standards prepared by ISO/TC 213, including workpiece specifications, usually given as specification limits, and measuring equipment specifications, usually given as maximum permissible errors.

Benefits

ISO/TS 14253 is intended to support ISO/TS 14253-1. Both parts are beneficial to all technical functions in a company in the interpretation of GPS specifications, i.e. tolerances of work piece characteristics and values of maximum permissible errors (MPEs) for metrological characteristics of measuring equipment.

The iterative method is a tool to maximize profit and minimize cost in metrological activities of a company. The iterative method/procedure is economically self-adjusting and is also a tool to change/reduce existing uncertainty in measurement with the aim of reducing cost in metrology (manufacture). The iterative method makes it possible to compromise between risk, effort and cost in uncertainty estimation and budgeting.

The Challenge

The problems and challenges associated with the ISO/TS 14253 are directly associated with its main principles, as follows:

ISO/TS 14253 also give detailed instructions how to make uncertainty budgets. This instruction is aiming at as simple assessment methods for uncertainty contributors as possible, and is really taking into account an uncertainty on the contributor's measurement uncertainty. In the real life (industry), the knowledge about the uncertainty contributor is often very limited because of the costs to establish good estimates.

Measurement uncertainty is not only the interest of metrologists. Even designers and manufacturing people shall be able to understand and use the concept due to conformance/non-conformance. Specifications shall be decided on a new and other basis, knowing that specification limits shall no longer be violated as in the past, where measurement uncertainty was ignored. Manufacturing processes can no longer use the full tolerance, because the measurement uncertainty is taking its share in advance.

In GPS area, it is obvious that the specification uncertainty – today – is a much bigger problem than the measurement uncertainty, and that measurements performed with small measurement uncertainty, in many cases, are too expensive and it is not used if the specification uncertainty is not drastically reduced.

In practice, the experience shows that the most frequent and the biggest mistakes related to uncertainty estimation come from the fact that major contributors are ignored or not discovered as present in the actual situation. The biggest mistakes are not coming from the mathematical methods used. A mistake even more frequent is that the measurand is not defined properly before all the calculations and number-tricks starts. In many cases, uncertainty estimation and resulting value have no connection with the current measurement method. That is the reason why ISO/TS 14253, in its instruction, makes this initial part of uncertainty estimation very detailed.

SoftExpert Excellence Suite offers tools for a complete implementation and maintenance of the processes of estimation of uncertainty in measurement in compliance with the ISO/TS 14253. All of this in a collaborative and integrated environment that guarantees the standardized and correct use of information to ensures corporative excellence.


  • MenegottiOur productivity and reliability increased greatly. The software helped us to meet the ISO/TS 16949 standard requirements, providing security in the daily routine of the Engineering area and auditing, while easily proving full compliance with the standard and customer requirements.

    Jeferson R. F. dos Santos – MENFUND Unit Manager

  • CoinduThe SoftExpert facilitates and speeds up activities, and the system was considered highly suitable for the renewal of ISO/TS 16949 and ISO 14001.

    Cristina Pereira – Gerente adjunta de Informática

  • Mitsubishi MotorsWe have achieved improved dependability as well as standardization in our processes to assure measurement consistency and the required monitoring to verify conformity in our products. This adds enhanced safety and quality to our customers.

    Helton Calaça – SPC Technical Support

  • Laboratório GloboThe SE Project was implemented quickly and the time required for the adoption of the solution by the users was quite natural, considering that the pharmaceutical segment is legally required to work with reliable and secure records that guarantee the quality of products and do not represent risks to the population.

    Randel Moreira – IT Manager

  • CarrierSoftExpert Solution has streamlined data sharing for our quality system and has contributed to reducing impacts on the environment through doing away with the need for storing piles of original and obsolete paper documents for auditing purposes.

    Solange Amaral – Human Resource Analyst

  • Group RoullierSE Document completely meets our document control requirements, facilitates retrieval, and manages the entire document revision process.

    Janaina Salatti – Quality Supervisor

  • CTA-ContinentalSE Document has provided the means to streamline our document control, through excellent drilldown options for searching and registering documents, a systematic workflow
    tool for sending pending tasks to system users, as well as really cutting down on the need for printed copies.


    Ângela Fischer

  • Universal Leaf TabacosSE Document manages ISO standardization documentation to facilitate compliance, as well as all other document types. The workflow system provides great distribution copy control, approval, revision, printed copies, and document retrieval search capabilities. Currently, there are over 1,100 users and 3,500 registered documents.

    Carla Regina Schmitt

  • Coca-ColaThe implementation of SE Action streamlined our continuous improvement process for managing actions, especially through the workflow functionality. This facilitates the verification of occurrence causes and drafting correction actions.

    Gustavo Martins – Quality Department Assistant

  • OpetrecOnline access to wherever we offer services ensures us speedy responses, through reliable and updated information, which, in turn, facilitates decision making and customer satisfaction.

    José Andrade – Opetrec Manager

The Solution

Each SoftExpert component addresses key compliance issues as shown below:

Module ISO/TS 14253 Requirements
SE Action Plan
SE Action Plan
  • Helps organizations to coordinate and manage the entire workflow effectively, by maintaining team communication and improving collaboration through the centralized control of action plan and task planning, execution and monitoring, including corrective, preventive or predictive actions
SE Asset
SE Asset
  • Manages approval process before Assets become available for use
  • Changes to any asset log type are documented and controlled
  • Provides detailed calibration and maintenance log on each asset
  • Defines and enforces calibration and maintenance intervals for each asset, including automatic generation of work orders
  • Provides resources of asset's check-in and check-out ;
  • Knows exactly what assets are available and how they are used;
SE Audit
SE Audit
  • Programs audits, taking into consideration the scope, status and importance of the processes and/or areas to be audited
  • Defines criteria, methods, responsibilities and requirements to be audited
SE Calibration
SE Calibration
  • Identifies the monitoring and measuring that should be done.
  • Chooses devices that meet monitoring and measuring needs.
  • Develops monitoring and measuring procedures.
  • Calibrates your monitoring and measuring devices.
  • Safeguard your monitoring and measuring devices.
  • Automates scheduling of calibrations, maintenance and repairs
  • Supports Type A and Type B measurement uncertainties
  • Identifies if the gage is used as a calibration standard
  • Chooses calibration/maintenance based on frequency or usage
  • Automates calibration procedures
  • Maintains and retrieves master equipment, calibration history and measurement data logs
  • Traceability to in-house equipment calibration and Reference (or National) Standards
  • Logs electronic signatures for full traceability of stored
SE Competence
SE Competence
  • Determines necessary competence for the personnel performing work affecting conformity with measurement processes
  • Evaluate the effectiveness of the actions taken
  • Helps users to be aware of the relevance and worth of their activities and how they help to achieve the goals established by the organization
  • Maintains the appropriated log of education, skills and experience
SE Document
SE Document
  • Guarantees a constant log of all Calibration Plans and procedures
  • Allows for log retention, based on regulatory requirements
  • Automates forwarding, revision and approval, among other activities, boosting the team's efficiency
  • Guarantees that only the document's latest version is used, avoiding the use of obsolete documents
SE FMEA
SE FMEA
  • Displays the hierarchy of all FMEA structure – Including MFMEA – from the first level down to the lowest levels and automatically generates the FMEA form
  • Contains catalogs of assets, products and processes, functions, failure modes, effects, existing causes and controls, thus ensuring nomenclature standardization and agility to create FMEA
  • Automatically calculates risk priority (RPN) and both actual and revised criticism
  • Displays the ranking of failures for one or more FMEA using spreadsheets and Pareto, bar, pie, or area charts
  • Automatically sends preventive and corrective actions to respective users via email
  • Displays RPN through Pareto analysis, area chart, and distribution graphs
SE MSA
SE MSA
  • Provides guidance for developing a formal gauge management system
  • Classifies the equipment based on several criteria, such as laboratory, application, usage location, type of equipment, and more
  • Demonstrates how to find root causes measurement process problems and explores basic causes to investigate
  • Matches equipment with standard calibration procedures
  • Provides forms for collecting measurement data
  • Maintains procedures and instructions documented to perform studies
  • Defines a specific gauge in each type for a particular characteristic that needs to be analyzed
  • Provides fixed and variable calibrations
  • Schedules and tracks MSA studies
  • Documents, schedules, and performs Bias, Linearity, Stability and ANOVA Repeatability and Reproducibility studies
  • Compares the equipment performance before and after its repair
  • Establishes acceptability of manufacturing processes
  • Completes analysis using graph charts, such as average/range, errors, normalize individuals chart, whiskers chart, scatter, histogram, linearity, and others
SE PDM
SE PDM
  • Supports unlimited product types, product attributes and specs, categories and subcategories, product images, product relationships, and mainly Geometrical Product Specifications – GPS
  • Ensures product verification of the highest integrity and accuracy
  • Access to product/part information including change history, customers and suppliers definitions, authorized suppliers, and other product related information
  • Customizes data quality routines to meet your Company's inventory or product nomenclature and protocols
  • Provides information on standard components and facilitates reuse of design
  • Reduction in documentation re-work with more effective reviews and electronic sign offs
  • Tracks and manages all changes to product related data
  • Spends less time organizing and tracking design data
  • Workflow functions that enable users to become active participants in product development, design reviews, engineering change orders, approvals and other product related processes
  • Supports workflow and process management that controls procedures for handling product verification and provides a mechanism to drive a business with information
  • Maintains an extensive audit trail of all activities performed in the system, which is essential for regulatory compliance
SE Process
SE Process
  • Provides the development of the flow diagram
  • Creates a flow diagram showing all activities associated with the calibration processes
  • Tracks and manages all changes to the flow diagram
  • Guarantees verifying of the flow diagram by the defined approval team
  • Guarantees traceability
SE Request
SE Request
  • Automates the processes requests for Calibration Log and changing asset data
  • Manages deadlines and sending tasks to those responsible
  • Configures levels for calibration process satisfaction
  • Defines responsible teams for fulfilling the request
  • Optimizes productivity and quality optimization of requests through the use of checklists
SE Risk
SE Risk
  • Facilitates the identification of Calibration processes risks
  • Facilitates hazard analyses based on different risk assessment methods
  • Automates the application of risk assessments
  • Helps users to define prerequisite programs
  • Facilitates the identification and assessment of risk-related control measures
  • Identifies and monitors Critical Control Points (CCPs)
  • Facilitates the determination of CCPs through the use of flexible decision trees
  • Ensures the continuous monitoring and revision of the hazard management process
  • Determines the residual assessment risk, identifying the treatment options and their application
  • Guarantees communication with and easy access to assessments
SE Training
SE Training
  • Provides training or taking other actions to achieve the necessary competence
  • Evaluates effectiveness of the training
  • Helps on raising user awareness as to the relevance of the assigned activities and how they help to achieve the goals established by the organization
  • Maintains appropriated logs of training

About SoftExpert

SoftExpert is a market leader in software and services for enterprise-wide business process improvement and compliance management, providing the most comprehensive application suite to empower organizations to increase business performance at all levels and to maximize industry-mandated compliance and corporate governance programs.

Founded in 1995, SoftExpert has a rich history of innovation and growth as a true industry leader. More than 300,000 users from 2,000 organizations worldwide trust SoftExpert applications to ensure the highest standards of efficiency, quality and innovation for their products, services and processes.

By streamlining and integrating all levels and operations, SoftExpert applications also enable organizations to address an ever-increasing variety and number of international standards, laws and regulations that affect business operations by delivering enhanced compliance capabilities based on industry-specific best practices.

SoftExpert solutions are used by leading corporations in all kinds of industries, including consumer products, automotive, food and beverage, mining and metals, high tech and IT, energy and utilities, government and public sector, financial services, transportation and logistics, healthcare, education, medical devices and many others.

Along with its extensive network of resellers spread across all continents, SoftExpert also provides hosting, implementation, post-sales support, and validation services for its solutions to ensure that customers realize the maximum value from their investments.

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