ISO 4259-4:2021
Petroleum and related products — Precision of measurement methods and results — Part 4: Use of statistical control charts to validate 'in-statistical-control' status for the execution of a standard test method in a single laboratory
Petroleum and related products — Precision of measurement methods and results — Part 4: Use of statistical control charts to validate 'in-statistical-control' status for the execution of a standard test method in a single laboratory
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 36
- Дата публикации:
- 3 декабря 2021 г.
- Издание:
- ISO IS 4259 edition 1 version 1
- ICS:
- 75.080
This document specifies the process and methodology for the construction, operation, and maintenance of statistical control charts to assess if a laboratory's execution of a standard test method is in-statistical-control and how to establish and validate the 'in-statistical-control' status. It specifies control charts that are most appropriate for ISO/TC 28 test methods where the dominant common cause variation is associated with the long term, multiple operator conditions. The control charts specified for determination of in-statistical-control are: individual (I), moving range of 2 (MR2), and either the exponentially weighted moving average (EWMA) or zone-based run rules [similar to Western Electric (WE) run rules[3]] as sensitivity enhancement strategy to support the I-chart. The procedures in this document have been primarily designed for numerical results obtained from testing of control samples prepared from a homogenous source of petroleum and related products in a manner that preserves the homogeneity of properties of interest between control samples. If the test method permits, a certified reference material (CRM) sample is used as a control sample provided the sample composition is representative of the material being tested and is not a pure compound; if this is done then the laboratory best establishes its own mean for the CRM sample. This document is applicable to properties of interest that are (known to be) stable over time, and for data sets with sufficient resolution to support validation of the assumption that the data distribution can be approximately represented by the normal (Gaussian) model. Mitigating strategies are suggested for situations where the assumption cannot be validated.
Abstract
Overview
ISO 4259-4:2021 - Petroleum and related products - Precision of measurement methods and results - Part 4 - provides a standardized process for using statistical control charts to validate that a laboratory’s execution of a standard test method is in-statistical-control. Intended for petroleum and related product testing, this part of the ISO 4259 series specifies how to construct, operate and maintain control charts so that single laboratories can demonstrate long‑term stability and produce trustworthy, fit‑for‑use measurement data.
Key technical topics and requirements
- Control chart selection: Specifies the use of the Individual (I) chart and Moving Range of 2 (MR2) chart as the primary monitoring tools, with either EWMA (exponentially weighted moving average) or zone‑based run rules (Western‑Electric style) as sensitivity enhancements for the I‑chart.
- Scope of applicability: Designed for numerical results from homogeneous QC samples (including appropriate CRMs where representative), for properties that are stable over time, and for data approximating a normal (Gaussian) distribution.
- Work process and stages: Defines a multi‑step control chart work process (stage 1 and stage 2) for establishing and validating in‑statistical‑control status, including procedures for chart construction, interpretation and maintenance.
- QC material management: Provides procedures for QC material batch change transition (concurrent testing, Q‑chart, or dynamically updated charts).
- Dealing with non‑ideal data: Offers mitigating strategies and guidance for insufficient variation or non‑normal data when normality or resolution assumptions cannot be validated.
- Reference and provenance: Aligned with ISO/TC 28 test methods and informed by practices such as ASTM D6299; normative cross‑reference to ISO 4259‑1:2017.
Practical applications - who should use it
- Laboratory QC and QA managers in petroleum testing labs seeking to demonstrate method stability and precision.
- Analytical chemists and bench analysts who need procedures for routine monitoring and retest rules.
- Accreditation bodies and auditors evaluating laboratory statistical quality control (SQC) practices.
- Proficiency testing organizers and technical committees (ISO/TC 28) creating standardized evaluation frameworks.
- Regulatory bodies and customers requiring documented evidence that test results are produced under statistically controlled conditions.
Benefits and real‑world value
- Establishes consistent, repeatable procedures to increase data trustworthiness and reduce false alarms.
- Helps detect shifts due to long‑term, multiple‑operator common‑cause variation (environment, operator, equipment, procedure, reagent).
- Supports harmonized application across labs, improving comparability of precision assessments in petroleum testing.
Related standards
- ISO 4259‑1:2017 - Determination of precision data in relation to methods of test.
- Other parts of the ISO 4259 series and industry guidance such as ASTM D6299 (informative basis).
Keywords: ISO 4259-4:2021, statistical control charts, in‑statistical‑control, petroleum testing, I‑chart, MR2, EWMA, QC sample, laboratory quality assurance, precision of measurement.
Технические детали
- Технический комитет
- ISO/TC 28 - Petroleum and related products, fuels and lubricants from natural or synthetic sources
- SKU
- ISO 4259-4:2021
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