Using a process-centered approach to minimize the effort of compliance

 The complexity of different quality standards can, in principle, be covered by different approaches and strategies. In-depth process mapping of quality control (QC) work streams was used by the analytical laboratories of Lonza AG to show up the principle differences in being compliant to different quality systems. The results identified two main drivers for all necessary actions: process-related activities and infrastructure-related activities. In addition, a clear indication of the economic impact of these driving forces was gained, which led the laboratories to decide on a process-oriented approach. This approach has the advantage of being able to reflect the different demands of different quality assurance (QA) regulations within the same QC organizational structure. Following the process helps avoid unnecessary efforts in analytical work and represents a very economical approach, at the same time, providing high flexibility to react to different QA or customer demands. Received: 5 July 2002 Accepted: 12 November 2002 Acknowledgements The process-oriented approach resulted from many, very challenging discussions for which I would like to thank the staff of my organization (Analytics & QC), especially, the QA staff and the LIMS team. Presented at Analytica Conference, 23–26 April 2002, Munich, Germany Correspondence to B. Ciommer     

Summary of ISO/TC 201 Standard: ISO 22415—Surface chemical analysis—Secondary ion mass spectrometry—Method for determining yield volume in argon cluster sputter depth profiling of organic materials

The International Standard ISO 22415 provides methods to measure sputtering yield volumes of organic test materials using argon cluster ions. The test materials should consist of thin films of known thicknesses between 50 and 1000 nm. The format of the test materials, the measurement of sputtering ion dose, sputtered depth, and reporting requirements for sputtering yield volumes are described.     

False Detection of Cyanide Ion in Photographic Processing Waste Solutions Using Standardized Reference Methods

Abstract

Although cyanide compounds are not incorporated in photographic processing solutions, false detection of cyanide ion is often encountered during the determination of total cyanide by various standardized methods such as ISO, ANSI and JIS. Various organic compounds and nitrogen compounds in the processing solutions were examined because of this false detection. The results suggest that hydrogen cyanide is formed by a reaction between these compounds during the distillation process for the separation of total cyanide, even though ISO, ANSI and JIS were used. The results support the following three mechanisms of cyanide formation involved in the process: (1) Hydroxylammonium salts reacts with another ingredient, formaldehyde, to form formaldoxime, which then decomposes to HCN. (2) Hydroxylammonium is oxidized by air to form nitrite ion, which subsequently reacts with organic compounds such as aminocarboxylic acids and aromatic amines (the colour-developing agent) to form HCN. (3) Potassium permanganate oxidizes aromatic amines to form HCN.     

Dimensional considerations on the mechanical properties of 3D printed polymer parts

Additive manufacturing offers a useful and accessible tool for prototyping and manufacturing small volume functional parts. Polylactic acid (PLA) and thermoplastic polyurethane (TPU) are amongst the most commonly used materials. Characterising 3D printed PLA and TPU is potentially important for both designing and finite element modelling of functional parts. This work explores the mechanical properties of additively manufactured PLA/TPU specimens with consideration to design parameters including size, and infill percentage. PLA/TPU specimens are 3D-printed in selected ISO standard geometries with 20%, 60%, 100% infill percentage. Tensile and compression test results suggest that traditional ISO testing standards might be insufficient in characterising 3D printed materials for finite element modelling or application purposes. Infill percentage in combination to design size, may significantly affect the mechanical performance of 3D printed parts. Dimensional variation may cause inhomogeneity in mechanical properties between large and small cross section areas of the same part. The effect was reduced in small cross section parts where reducing the nominal infill had less effect on the resulting specimens. The results suggest that for 3D printed functional parts with significant dimensional differences between sections, the material properties are not necessarily homogeneous. This consideration may be significant for designers using 3D printing for applications, which include mechanical loading.     

环境监测实验室管理系统的开发与应用

基于2005版《计量认证/审查认可(验收)评审准则》要求,为满足环境监测实验室业务流程而设计开发了信息管理系统。该系统主要用于环境监测实验室的资源管理和日常自动化办公。系统采用B/S架构,实现全球化办公运作,能对监测样品的受理、分发、分析、原始记录、监测报告、数据三级审核、报告签发实现全程自动流转,并运用工作流和智能表单设计实现实验室程序文件中各类程序和日常办公事务流程的执行;原始记录和监测报告全部实现自动归档及智能查询;同时根据2005版准则中的要求,对人员、设备、材料、环境要素、记录、质量控制等所有要素全面实施网络化管理。     

Comparison of test methods for oxygen permeability: Optical method versus carrier gas method

The oxygen permeability of films is relevant for packaging related and technical applications. An increasingly used test method for the measurement of oxygen permeability is the optical test method, because it allows a simple and cost-efficient measurement setup. This method is based on optical chemical sensors. However, not much is known about its validity. Therefore, method validation is necessary which is subject of this study. The optical method is compared with the carrier gas method for a variety of film samples. In the tested permeability range of 0.5–2500 cm³ (STP)·(m² d bar)⁻¹ both methods deviated less than 20% for zero and 50% relative humidity.     

Evaluation of the quality of clinical laboratories in the Slovak Republic: conceptual and contextual remarks

The paper demonstrates conceptual parallels and relationships between intellectual capital measurement methods and the evaluation of quality in clinical laboratories in the Slovak Republic. It explores further the contextual links of those parallels with the tangibility (or intangibility) of quality indicators of laboratory diagnostics. It also highlights the problems which laboratory staff in Slovakia are confronted with. Presented at the conference Quality in the Spotlight, March 2007, Antwerp, Belgium.     

The process of management review

Management review of the quality-management system is an item in many quality standards and a requirement of the ISO 9001:2000 standard and of laboratory standards ISO 15189 and ISO 17125, and others. These reviews are conducted to ensure that the top management is informed and involved in the quality-management system with respect to continuing adequacy and effectiveness, and opportunities for improvement of the system. The management review is a process that should be conducted and audited utilizing the process approach. A process approach is defined as “An activity using resources and managed in order to enable the transformation of inputs into outputs” (ISO 9001:2000). All identified main processes in the quality system should be monitored through data collection by appropriate methods, assuring that data are valid, representative, and adequate. For management review data must be collected and presented in an accessible form so that processes can be evaluated according to objectives, goals, resources, etc. On the basis of this information the laboratory management makes the necessary decisions and ensure that actions are taken that improve the effectiveness of the quality-management system. As output from the management review process, there should be evidence of decisions regarding: change of quality policy and objectives; plans and possible actions for improvements; corrective actions as appropriate; increased customer satisfaction; and planning of resources needs. Identification of the processes involved and using the process approach in the management review ensures the continual improvement of the quality system. Presented at the conference Quality in the Spotlight, March 2006, Antwerp, Belgium.     

Twenty-five years of international collaboration in reference materials via ISO/REMCO

This paper looks back on a quarter century of history of the Council Committee on Reference Materials of the International Organization for Standardization – REMCO. It begins however with the period before its formation in 1976 to describe how the Committee came into being as a response to a growing need by the analytical community for the number and variety of reference materials (RMs) as well as a need for the assurance of the quality of RMs and ends with a view of REMCO activities in the near future. This is not intended as a detailed history but instead to describe the evolution of REMCO by identifying major activities and accomplishments of REMCO. Received: 21 January 2002 Accepted: 22 January 2002     

Development of standards for reliable surface analyses by ISO technical committee 201 on surface chemical analysis

The need for reliable surface analyses together with quality‐management requirements for analytical laboratories led the International Organization for Standardization (ISO) to form its Technical Committee (TC) 201 on Surface Chemical Analysis in 1991. This article describes the organization of TC 201, the strategies that have been found useful for identifying and assessing possible projects for new international standards, and the 57 international standards and other documents prepared to date by TC 201. Standards have now been developed for Auger‐electron spectroscopy, glow‐discharge spectroscopy, various types of scanning probe microscopy, secondary‐ion mass spectrometry, sputter‐depth profiling, total‐reflection X‐ray fluorescence spectroscopy, X‐ray photoelectron spectroscopy, and X‐ray reflectometry. In addition, standards have been developed with definitions of terms used in surface chemical analysis; the handling, preparation of specimens for surface analysis; information and data‐transfer formats; and methods for determining the lateral resolution of beam‐based methods of surface analysis. Copyright © 2014 John Wiley & Sons, Ltd.