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.
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.
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.
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?
John Hammond updates us on news from the latest ISO/REMCO meeting and implementation of the new 17000 series standards.
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.
John Hammond updates us on recent developments with the ISO 17xxx series of standards. John continues with news of standards particularly relevant to readers.
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.
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.
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.
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.
“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.
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.
In the Quality Matters Column, Peter Jenks, Paul Boother and Annette Marshall are concerned about “The proper use of certified reference materials for analytical instrumentation qualification”. There are many aspects to consider in ensuring the validity of an analytical system, from before any instrumentation is installed, before it is used and during its use. Readers interested in the chemicals and reference material field may be interested in the news that, as this issue was being prepared, Merck completed its $17-billion acquisition of Sigma-Aldrich.
In the “The analysis of poly aromatic compounds: a never-ending story?”, Peter Jenks reports from the 25th International Symposium on Poly Aromatic Compounds. He concludes that “data from the academic and research community often acts as a stimulus for government concern and the data may ultimately result in legislation. It concerns me that legislation may be driven by bad data”.
John Hammond updates us on “Reference materials: what’s new?”. The 2015 meeting of the ISO Committee on Reference Materials (ISO/REMCO) was held in June and significant developments in a number of standards that will ultimately affect all users of reference materials have taken place.
In the Quality Matters Column, Peter Jenks reminds us about “BERM 14: it’s that time again!”. The latest in this line of conferences on Biological and Environmental Reference Materials is being held in the USA in October 2015.
C. Burgess and J.P. Hammond outline the work that has been undertaken to modernise the spectroscopic General Chapters in the United States Pharmacopeia (USP).
Peter Jenks seeks to show where it is important to check the CRM or RM you are using includes a clear statement of commutability, and when and where it can be largely ignored.
In the Quality Matters column, Peter Jenks and John Hammond look “Into the future: changes to ISO 17025 and ISO Guide 34”. There is a lot happening at present around ISO/IEC 17025 and ISO Guide 34, which together provide the framework for the development and use of certified reference materials in analytical laboratories around the world. John reports from the recent 37th meeting of the Reference Material Committee of ISO (ISO/REMCO) and provides an update on the topic of “commutability”.
Peter Jenks is off to a conference. He describes the history of the Biological and Environmental Reference Materials (BERM) series of conferences and concludes that they still are important for all of us 30 years after their start. He urges you to attend the next, in October 2015 in the USA.