Quality Matters Column

Quality Matters addresses the ever-increasing importance, and complexity, of ensuring that our analyses are correct. Chris Burgess, John Hammond and Peter Jenks guide readers through the minefield of ISO standards and how they affect the spectroscopic community.

Chris-Burgess 

Chris Burgess is an internationally recognised expert in the qualification and validation of instrumentation and systems, analytical method development & validation and the statistical interpretation of data. In addition he has extensive experience in quality systems design and development for the whole supply chain and has acted as a Qualified Person within the EU for more than 25 years.

John-HammondJohn Hammond is an experienced analytical scientist, spectroscopist and technical marketing professional. John is internationally recognised in the field of Reference Material production and certification for use in the field of UV-Visible-NIR spectroscopy, currently Chair of ASTM International committee E13 on Molecular Spectroscopy and Separation Science, Convenor of Working Group 6—Information Services for ISO/REMCO, and a member of the USP General Chapters—Chemical Analysis Expert Committee.

Peter Jenks has over 30 years experience in analytical, environmental and pharmaceutical businesses. During this time he has promoted the use of Certified Reference Materials (CRMs) in support in of ISO 17025 Accredited Laboratories and worked with suppliers to improve both availability of CRMs and their proper use. He has set up new businesses to produce and distribute CRMs and consulted for key industry stakeholders.

 

Uncertain about uncertainty? There really is nothing to fear!

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Peter J. Jenks
the Jenks Partnership, Newhaven House, Junction Road, Alderbury, Salisbury, Wiltshire SP5 3AZ, UK. E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

At the beginning of October 2008 I took part in an International Symposium on Pharmaceutical Reference Standards, organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and held between 9 and 10 October 2008 in Strasbourg, France. For those interested, the proceedings can be found on the EDQM Website (http://www.edqm.eu/site/Download-527.html). They are a number of pdf files towards the bottom of the very long page...

Read more: Uncertain about uncertainty? There really is nothing to fear!

 

Standards for the 21st century; establishing trust in measurement

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Christopher Burgess
Burgess Analytical Consultancy Limited, “Rose Rae”, The Lendings, Startforth, Barnard Castle, Co. Durham DL12 9AB, UK
John Hammond
Starna Scientific Ltd, 52–54 Fowler Road, Hainault Business Park, Hainault, Essex IG6 3UT, UK

Spectroscopy and spectrometry have been around for a long time. In the “modern” era, spectroscopic instruments have been with us in one form or another for over 70 years. This is particularly true for those old “workhorse” techniques, UV-visible and infrared. So by now it might be reasonable to think that we would enjoy a standardisation and calibration environment that would make the assurance of our spectral data quality a matter of routine. Perhaps or perhaps not! Nothing stands still in the application of analytical science to assuring quality. As the column title rightly suggests Quality does Matter.

The rate of change of instrumentation and its application base accelerated during the 1980s with the availability of substantial data processing power and new technologies being incorporated into the humble spectrometer. Suddenly some of the reference materials we relied upon for qualifying and calibrating our spectrometers were no longer “fit for purpose”. Not only were end users in the laboratory faced with these issues but also the instrument manufacturers. At the same time as these technological changes were occurring so too were regulators. Regulatory bodies in a variety of fields, pharmaceuticals, medical devices, environmental, food to name but a few were becoming increasingly interested in the quality of the data coming from our laboratories to ensure compliance with national and international standards.

When discussing the need and role of standards, we need to consider the major changes that have taken place over the last 50 years in four key areas: The National Metrology Institutes (NMIs), the instrument manufacturers, the user base and the globalisation of regulation through international regulatory bodies.

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REACH....... into the future?

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Possible consequences of the EU REACH Directive on the analytical laboratory

Peter J. Jenks
the Jenks Partnership, Newhaven House, Junction Road, Alderbury, Salisbury, Wiltshire SP5 3AZ, UK

National laws, implementing the REACH Directive, came into force across the EU on 1 June 2007. The Directive aims to ensure that all chemicals used commercially in Europe shall be registered and the toxicity, bio-toxicity and persistence properly documented. In some cases, based on this registration process, the use of certain chemicals may be either severely restricted or completely prohibited. A new EU Chemicals Agency (ECHA, www.echa.europa.eu) has been established in Helsinki, Finland, to be responsible for this work.

Read more: REACH....... into the future?

   

The international role of ISO-REMCO—guiding reference materials

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John Hammond
Starna Scientific Ltd, 52–54 Fowler Road, Hainault, Essex IG6 3UT, UK

In the first of our new Quality Matters columns (Issue 20/1), I introduced the new team of contributors and mentioned that John Hammond would be writing, from his position as the UK Industrial Delegate to the ISO-REMCO Committee, about the workings of that important body and looking to the future following some important decisions taken at the June 2007 meeting in Japan. This is his first of what will be a regular series of reports on the workings of REMCO.
Peter Jenks

Read more: The international role of ISO-REMCO—guiding reference materials

   

Introducing the New Team

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Peter J. Jenks
the Jenks Partnership, Newhaven House, Junction Road, Alderbury, Salisbury, Wiltshire SP5 3AZ, UK.

In the final RM Column, I concluded with the words “To cover this enhanced scope the editorial team will expand: there will be a couple of new names joining me in the preparation of the new column”. In this, the very first Spectroscopy Europe Quality Matters Column, I’m delighted to be able to announce our new columnists as Christopher Burgess and John Hammond.

Chris Burgess brings to the column a wealth experience gained over more than 30 years working in the pharmaceutical industry. Now an independent consultant he spent much of his working life within the Analytical Division of Glaxo Operations at Barnard Castle responsible for pharmaceutical Quality Assurance and Analytical R&D. In parallel he has been much involved with the Royal Society of Chemistry, indeed he is a Fellow of the Royal Society of Chemistry (RSC), a Qualified Person on the Indicative Register of Analytical Chemists of the RSC, a Chartered European Chemist and a qualified ISO 17025 assessor.

Chris started out as a research chemist, following his PhD at Loughborough with a post doctorial research posts at both the University of Hong Kong and at the University of Southampton. He has published more than 60 papers and books, including Standards in Absorption Spectrometry on behalf of the Ultraviolet Spectrometry Group. His interests include the automation and software control of analytical operations, the application of mathematics to analytical chemistry, and diode array spectrometry in analytical chemistry.

Chris brings a unique combination of skills and experiences to the column: his first contributions will focus on Quality Matters in the pharmaceutical industry and in particular the consequences of the growth of ISO 17025 within the analytical side of the pharmaceutical industry.

John Hammond is Technical Manager for Analytical Products at Starna Group, including Optiglass spectrophotometer cells. In the 1950s Optiglass developed a technique for fusing the parts of a spectrophotometer cell only by heat without distorting the optical surfaces. This led to the production of filled, sealed cells for use as optical property CRMs. The growing requirement for laboratory accreditation by a recognised quality standard such as GLP, ISO 17025 or ISO 9000 with “evidence of control” increased demand for all types of CRMs with a traceable path to internationally recognised primary materials or procedures. Starna was one of the very first CRM producers to achieve accreditation to ISO 17025 plus ISO Guide 34 as a RM producer.

John has been closely associated with the changes caused by ISO 17025: he recently was appointed the UK Industrial Representative on the ISO REMCO Committee, succeeding the late Peter Ridsdale. Like Chris he has been much involved with the Royal Society of Chemistry (RSC) and is a Fellow of the Royal Society of Chemistry, a Chartered Chemist and a Chartered Scientist. John also serves as chairman of ASTM Sub-committee E13.01 on UV-Visible Spectrophotometry, and is a member of the UK Reference Materials Working Group.

John’s first article will be “What’s ISO-REMCO all about”—a review of the 30th anniversary meeting in Tsukuba, Japan, in June 2007, will explain more about the aims and objectives of ISO REMCO. He will follow this with a report of the 31st REMCO meeting, which will take place in Rio, Brazil, during June 2008.

In addition to the two new contributors I will continue to write on the use and application of reference materials in analytical chemistry and how their role underpins the practical application of ISO 17025. Although it seems as though ISO 17025 has been around for many years, 17025 accreditation is very new and there are still many laboratories for whom ISO 17025 is a novel experience and the journey to accredited status filled with pitfalls. Many of the new wave of ISO 17025 accredited labs are to be found in academia: a very readable overview from one such laboratory was published last year in the journal Accreditation and Quality Assurance1 (better known as AQAL). The authors, D. Zapata-García, M. Llauradó and G. Rauret from the Analytical Chemistry Department, Faculty of Chemistry, University of Barcelona describe the experience of implementing a quality system on ISO 17025, and the accreditation of some tests for a university laboratory, in this case the Environmental Radiology Laboratory.

It was obvious that implementation in a university institution was a difficult task, since the setting and environment are both unfavourable when compared with industry. In particular the collaboration of many independent units of a university and the involvement of academics and researchers who have to coordinate all the different requirements of ISO 17025 especially as the number of people working is variable is a challenge. Some specific aspects of the system are discussed by the authors who conclude that implementation of an ISO 17025 quality system is completely achievable and desirable as the discipline, as they put it, “puts university members in touch with the real world and broadens their minds”—undoubtedly this can only have a positive impact on research studies and academic content.

Reference

  1. D. Zapata-García, M. Llauradó and G. Rauret, Accred. Qual. Assur. 6, 317–322 (2007).
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