Quality Analysis News: News

2014 conference on Human Errors

Mon, 09 Dec 2013 12:00:00 AM

Dealing with the human element and potential for human errors in a laboratory is an important, yet difficult, task. The following conference is an excellent resource for tools and techniques to be successful in managing the human element. The 2013 workshop on human errors in Israel was very successful and productive. In the 2014 conference they plan to continue the discussion on human errors in analytical chemistry: 18–20 November 2014 Tel Aviv, Israel The 20th International Conference of the Israel Society for Quality including session "Metrology: measurement, chemical analysis & testing" e-mail: confer@isas.co.il http://www.isas.co.il/quality2014/

Article on Lifecycle Management of Analytical Procedures

Sun, 22 Sep 2013 12:00:00 AM

There is a lot happening in the world of analytical chemistry. Many groups and associations are discussing the lifecycle approach to analytical procedures using target measurement uncertainty and decision rules. You can read about the lifecycle approach at the following link on the USP website. Although this article is directed to the pharmaceutical industry, it is pertinent to all industries. Stimuli Article on Lifecycle Management of Analytical Procedures Posted for Comment at http://www.usp.org/usp-nf/notices/stimuli-article-lifecycle-management-analytical-procedures-posted-comment Jane recently spoke at the 6th Annual Joint Chinese Pharmacopoeia-USP Science and Standards Symposium/10th Annual USP Science and Standards Symposiumin Baltimore about this article. The talk was well received, generating a lot of interest and comments.

Webinar on Method Validation

Mon, 29 Jul 2013 12:00:00 AM

Sign up to learn about the new Quality by Design approach to Method Validation using Target Measurement Uncertainty. The webinar objectives are How to use validation to prove a method is fit-for-use Describe use of Design of Experiments (DOE) in method validation Employ statistical tools to characterize precision and bias Judge and prove a method is fit for its intended purpose Explain how the lifecycle approach to method validation saves money and resources The webinar is August 8; sign up today.

Webinar on New QbD Approach to Analytical Methods

Mon, 15 Apr 2013 04:15:00 PM

A new, improved approach to your analytical methods is coming. It simply and quantitatively links the performance of your method to its intended use. The very thing analytical people have been searching for! Join the webinar on May 9 at 1:00 PM ET to learn the details. You won’t want to miss this webinar. DESCRIPTION OF SESSION: Quality by Design, Lifecycle of a method, Target Measurement Uncertainty, Decision rules, Analytical Target Profile, Fit-for-Intended-Use,–what do all the new buzzwords mean and how do you use them in your laboratory? Science is now being applied throughout the entire lifecycle of the method. An approach parallel to that of ICH Q8, Q9 & Q 10 is being taken to analytical methods which includes a parallel terminology, system and process. This session will introduce the new concepts, explain their origin and meaning, and explain how to use them. See the attached flier for details.

Book on Method Validation and Target Uncertainty now for sale!

Tue, 19 Mar 2013 05:51:00 PM

The long awaited book on Method Validation that introduces the concept of Target Measurement Uncertainty is now for sale. You can buy it from: http://www.friesenpress.com/bookstore/title/119734000004601536

Preview of Book on Method Validation Now Available!

Tue, 05 Mar 2013 12:00:00 AM

The book on method validation includes extivensive information about Target Measurement Uncertainty. What it is and how to use it. You don't want to miss new, vital information. Visit this website to see the preview of the book: Http://friesenpress-accounts.appspot.com/bookstore/title/119734000004601536

Jane Weitzel receives Fellow of AOAC award

Mon, 08 Oct 2012 12:00:00 AM

Jane Weitzel received the Fellow of AOAC International award from AOACI at the AOAC annual meeting last week. This award was established in 1963 to provide a means for recognizing meritorious service to the Association. The Fellow of AOAC INTERNATIONAL Award recognizes the dedication and commitment of those volunteers who serve the Association. As the "Association of Analytical Communities,” AOAC INTERNATIONAL is committed to being a proactive, worldwide provider and facilitator in the development, use, and harmonization of validated analytical methods and laboratory quality assurance programs and services. AOAC also serves as the primary resource for timely knowledge exchange, networking, and high-quality laboratory information for its members and customers.

Check out the upcoming workshop and new guide on OOS from IUPAC/CITAC

Tue, 31 Jul 2012 12:00:00 AM

Just published, the IUPAC/CITAC Guide: Investigating out-of-specification test results of chemical composition based on metrological concepts (IUPAC Technical Report) is worth checking out. In addition there will be a workshop discussing the guide. The Chairman’s invitation letter describes the workshop: Out-of-specification (OOS) test results of chemical composition are results that fall outside the specifications of acceptance criteria established in the pharmaceutical industry, or do not comply with regulatory, legislation or specification limits in other industries and fields such as environmental and food analysis. Investigation of OOS test results is described in FDA Guidance 2006. The guidance established an empirical organizational approach to investigation and decisions which can be accepted at its different stages. When an OOS test result is identified, it is important to determine the root causes of the event and to avoid reoccurrence of such results. An investigation of the causes based on metrological concepts is proposed in the corresponding IUPAC/CITAC Guide 2012. This approach allows distinguishing between OOS test results which indicate an actual change in chemical composition of an analyzed object, and OOS test results which are metrologically-related with a certain confidence probability, i.e. caused by measurement problems. However, it is known that human activity is never free from errors: about 70 % of incidents and accidents are caused by human errors. There is an extensive literature on investigating and quantification of a human error in aviation, engineering, medicine, accident analysis and other fields. In analytical chemistry there are only some detached publications on the topic. Even those publications point to human error as the dominant cause of OOS test results. Reducing the error probability starts from study and classification of the errors, education and training. Therefore, your participation in the Workshop is important to share experiences and provide common human error models. The website for the workshop is http://www.bioforumconf.com/workshop-on-human-errors

On Target: Fitness-for-Purpose and Target Measurement Uncertainty

Fri, 15 Jun 2012 05:48:47 PM

Our article Using target measurement uncertainty to determine fitness for purpose has just been published and is available as 'Online First' on SpringerLink: http://www.springerlink.com/openurl.asp?genre=article&id=doi:10.1007/s00769-012-0899-x Now you can link the purpose of your method to quantitative acceptance criteria in your method validation. What a powerful tool! If you want more information on how this works, contact us today.

Eurachem has posted the new Quantifying Measurement Uncertainty in Analytical Measurement, 3rd Edition (2012)

Thu, 24 May 2012 01:35:02 PM

The just released Eurachem guide is now on the Eurachem website. Click here to see the guide. Last year we gave two presentations at the workshop hosted by the Eurachem/CITAC measurement uncertainty and traceability working group focused on the new MU guide held in Lisbon in June 2011. You can see the presentations at the website Eurachem 2011. Jane's paper is titled "Use of measurement uncertainty in testing a drug substance". Wes's paper is titled "The use of measurement uncertainty in an operating mine".

News - March 2012

Thu, 22 Mar 2012 11:28:00 AM

Quality Analysis Consultants published a paper on how to estimate measurement uncertainty from method validation data in the October 2011 issue of the Journal of Accreditation and Quality Assurance. Another paper on using measurement uncertainty to define “fit for purpose” has been submitted to the same journal. Wes just returned from a successful consulting trip to Peru helping a laboratory prepare for an ISO/IEC 17025 accreditation visit.