John Hammond continues his journey through four generations of quality, this time focusing on some of the specific Quality “tools” in use in both the ISO and GxP environments; how they are defined, applied and used; and how they have evolved with time.
Quality Matters Columns
Editors: Chris Burgess, John Hammond and Peter Jenks
The Quality Matters column is dedicated to issues around reference materials and standards, including the underlying regulations that are of great importance to the majority of laboratories. Read more about the Column Editors.
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Issue 33/8 (2021)
John describes the similarities and differences between the two standards and likens their developments to a pair of parallel railway tracks that occasionally join through the points. John charts the history of GLP, GMP and GCP from before the 1940s, when, as far back as 1906, the US passed the Pure Food and Drug Act.
Issue 33/6 (2021)
John Hammond continues his series of Quality Matters Columns looking at Four Generations of Quality, with one on the developments of the ISO Technical Committee responsible for reference materials to its latest incarnation as a Technical Committee.
Issue 33/5 (2021)
John Hammond continues his journey through four generations of quality with “’Don’t risk it’. Accreditation standards and their role in quality assurance”. John reviews the two main ISO 17000 series accreditation standards—ISO/IEC 170251 and ISO 17034—their impact on quality assurance, testing or calibration laboratories, and how these standards have evolved and continue to be implemented.
Issue 33/4 (2021)
This article concentrates on the International Organization for Standardization (ISO) organisation, its standards and their place within the Quality environment. By definition, it discusses the role of ISO in the administration and control of these standards and their evolution and harmonisation into the standards currently in existence.
Issue 33/3 (2021)
John Hammond describes the start of a new mini-series of column articles and what you can look forward to in the next few issues.
Issue 33/2 (2021)
What can quality sustems tell us about PCR testing for COVID-19? Peter Jenks has some concerns.
Issue 33/1 (2021)
The Quality Matters Column highlights how the reference material industry has grown. Peter Jenks asks for your help in rerunning a 2001 survey with aim of establishing how users’ use of and experience with reference materials has changed. Whilst most questions are optional, such surveys are of the greatest value if most questions are answered. We hope you can spend a few minutes to complete the survey at https://www.spectroscopyeurope.com/reference-material-survey-2019.
Issue 31/5 (2019)
Some compliance requirements would seem to make impossible demands on the performance specification of “fitness for purpose” for ultraviolet spectrometers; Chris and John unravel what’s going on.
Issue 31/2 (2019)
Peter Jenks is thinking about the new definition of the kilo, and other SI units, in “The kilo, the mole and the commutability of a result to activity”. However, he is more concerned with maintaining accurate laboratory measurements over time, which is crucial to making data comparable.
Issue 30/6 (2018)
Peter Jenks makes a welcome return to the Quality Matters Column and raises the radical idea of secondary producers of certified reference materials paying for the use of the primary CRMs. How may this affect the supply and price of secondary CRMs?
Issue 30/5 (2018)
John Hammond updates us on news from the latest ISO/REMCO meeting and implementation of the new 17000 series standards.
Issue 30/2 (2018)
Chris Burgess and John Hammond are back with an “Update on the modernisation of the spectroscopic General Chapters in the United States Pharmacopeia (USP)”. They review progress over the last three years and particularly on the changes intended in the USP Review Cycle 2015 to 2020.
Issue 29/6 (2017)
John Hammond updates us on recent developments with the ISO 17xxx series of standards. John continues with news of standards particularly relevant to readers.
Issue 29/4 (2017)
Peter Jenks and Alan Nichols embark on “ISO/IEC 17025: a never-ending journey”. They describe what is behind this recent standard and give valuable advice as to what to expect from an audit. Newcomers may find the requirements daunting, but Peter and Alan’s guidance will prove most helpful.
Issue 29/3 (2017)
Chris Burgess and John Hammond look back 40 years to the start of GLP regulations and consider how closely qualification processes are aligned to quality by design principles.
Issue 29/2 (2017)
Peter Jenks and Alan Nichols plot a path through the accreditation jungle and decide that “Confidence: the key to quality”. With increasing numbers of readers’ labs requiring auditing, ensuring that the reference materials and standards you are using meet the requirements of the auditors is essential.
Issue 29/1 (2017)
Next year, a new version of ISO/IEC 17025 will be published, which is going to mean changes for all those involved in quality systems. Peter Jenks investigates.
Issue 28/6 (2016)
“Is your spectrometer in calibration?” ask Chris Burgess and John Hammond. The answer may not be as straightforward as you might think. However, Chris and John explain all.
Issue 28/2 (2016)
Peter Jenks looks back to the BERM 14 conference on biological and environmental reference materials in the Quality Matters Column. The next conference in the series returns to Europe: Berlin in June 2018.
Issue 28/1 (2016)