The A2LA Workplace Training blog is a resource for information related to international standards, quality systems, conformity assessment, and measurement training. Topics covered include helpful how-to’s and informational content, news related to A2LA WPT and the industry in general, spotlights on customers and examples of best practices, and other topics related to A2LA WPT courses and the industries they serve. Our writers and collaborators strive to provide content that is accurate, informative, consistent, and clear to best serve those seeking to learn. Do you have a special request or an idea for a topic? Please contact marketing@A2LAWPT.org.
Many of AWPT’s customers are required to adhere to The FDA’s Code of Federal Regulations (CFR) for their calibration activities. As a helpful exercise, AWPT collaborator Walter Nowocin, Life Sciences Product Manager at IndySoft Corporation, collected information from several real but anonymized FDA warning letters to better understand what circumstances led to these letters. Included are four excerpts from those FDA warning letters, with identifiable information redacted, accompanied by comments on how the problems cited in these warning letters can be avoided.
There are very few people in the world who enjoy auditing – whether they’re conducting or experiencing one, but a well-planned, well-executed audit provides incredibly valuable insight into an organization’s systems and functions. Part of that all-important planning and execution is accounting for the human factors involved: things like communication, trust, and teamwork. The value an organization gets from an audit will be much greater if there is a positive relationship between auditors and staff, and the overall experience will be more unifying and less disruptive. Make no mistake, the technical expertise of your auditor is crucial, but an auditor’s interpersonal skills are equally important and far more often overlooked.
The particulars of each organization’s document control system may vary, but the principles that inform the design of a consistent, effective, and logical system are universal. Whether you’re seeking conformance to a specific standard, like an ISO standard, or building a system to meet your own internal quality goals and culture, your development process should be driven by what you expect your document control system to achieve. Bear in mind that an effective document control system is not just a place for files to live when you’re not using them, but a set of processes for editing, labeling, retrieving, storing, and reviewing those documents in an orderly and consistent way to form a logical system.
Traditional public courses and highly individualized one-on-one training each have their own advantages and disadvantages, but one effective way that AWPT bridges the gap between classroom-style teaching and individualized needs is with contract training. Contract training is conducted by an AWPT instructor at a time and place chosen by the customer, or – as is currently the case – remotely via private Virtual Classroom sessions. Contract training is attractive to many organizations because they can set their own schedule for the courses, rather than attending public classes at fixed dates and times, but the benefits go beyond convenience.
AWPT recently began exploring a new media channel with our podcast “The Conformance Cast”, hosted by our team and featuring expert guests from fields related to accreditation, calibration, instructional technique, and more. Through The Conformance Cast, we hope to allow more people to access our educational topics in short, listener-friendly segments that are available on many different devices.
AWPT values its customers not only for their patronage, but for the insight they give us on our products and the opportunities they provide us for collaboration. Medtronic is a longtime AWPT client, and Medtronic’s now-retired Senior Engineering Manager Walter Nowocin was instrumental in the development of two of our current e-learning course options. Mr. Nowocin, whose career in calibration has spanned more than 40 years, advocated for the use of AWPT e-learning courses at Medtronic and over the course of many years provided feedback on what subjects he felt needed to be added to our course catalog.
The Certified Calibration Technician (CCT) program was created by the American Society for Quality (ASQ) and serves as a standardized way for calibration technicians to demonstrate their understanding of concepts related to their field. Although certification is not necessary to get an entry-level job in calibration, it can be a major advantage for those looking to advance in their careers.
The world of conformity assessment has its own specialized jargon that can make understanding requirements challenging, especially to organizations who are pursuing accreditation for the first time. We find that our customers often try to find information on ISO/IEC 17025 certification, only to learn that what they actually need is ISO/IEC 17025 accreditation, or may research product registration, but ultimately learn that in their region the process is called certification. In ordinary speech, the words accreditation, certification, and registration are often used interchangeably, but the International Organization for Standardization (ISO) has specific definitions for these terms that differ somewhat from their everyday use.
Food testing labs will soon see their regulatory environment change somewhat as part of the FDA’s Food Safety Modernization Act (FSMA), which seeks to implement its own laboratory accreditation program for food testing labs. The goal of this program is to ensure the safety of the U.S. food supply and protect U.S. consumers by helping ensure appropriate oversight of certain food testing that is relevant to public health. It will also ensure that the testing is done according to appropriate model standards which will help produce consistently reliable and valid test results.
A2LA WorkPlace Training (AWPT) has partnered with Qualtrax, a leading provider of custom quality management system (QMS) software, to create 17025 QMS QuickStart: a specialized software solution with preloaded content that helps small labs achieve ISO/IEC 17025 conformance.