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ISO 14253-2:2011 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 14253-2:2011 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 14253-2:2011 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.
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Benefits
ISO 14253-2:2011 is intended to support ISO 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
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The problems and challenges associated with the ISO/TS 14253-2 are directly associated with its main principles, as follows:
ISO/TS 14253-2 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.
The problems and challenges associated with the ISO/TS 14253-2 are directly associated with its main principles, as follows:
ISO/TS 14253-2 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 14253-2, 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.
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SoftExpert Excellence Suite ensures compliance with many regulations including the ISO/TS 14253-2. The solution allows companies to increase efficiency for quality processes, minimize the high costs of compliance, and quickly bring new products to market.
Each SoftExpert module addresses key compliance issues as shown below:
| Module |
ISO/TS 14253 Requirements |
SE Action Plan
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- 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
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SE Asset
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- 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;
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SE Audit
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- 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
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SE Calibration
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- 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
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SE Competence
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- 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
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SE Document
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- 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
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SE FMEA
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- 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
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SE MSA
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- 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
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SE PDM
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- 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
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SE Process
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- 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
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SE Request
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- 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
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SE Risk
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- 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
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SE Training
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- 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
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