Monthly Archives: March 2017

Keeping a LIMS up to date with State and Federal EPA regulations

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A LIMS is a great and almost necessary tool in any modern day environmental laboratory, whether commercial, state or municipal.  In a highly regulated community, the LIMS, like everything else in the laboratory, must evolve.  Some evolutions are complex, however, 99% of them are very simple and in many ways, mostly a matter of proper record keeping.

Changes in regulatory limits, methods (calculations, limits, method variations, etc.), recording keeping criteria (HR and training records, instrument validation studies, case narratives) and countless other changes occur.  All of these changes may be easily and effectively recorded in the LIMS and, most importantly, documented with a time and date stamp.  In the case of changes to an actual method, as soon as they are entered by a user with proper authority and published, the new limits and variations go into immediate effect.

How to best stay on top of changes within the environmental laboratory community?  One, your LIMS vendor should actively participate in various conferences and be a bit proactive.  As a LIMS vendor, I can honestly say we do what we can but are far from perfect.  Our clients are an invaluable source of information as well; particularly on the state level.  Two, stay informed.  There are numerous state level conferences as well as national conference such as the TNI Conference (www.nelac-institute.org) and NEMC (www.nemc.us).  An easy, third way is subscribe to a newsletter such as Calibrate put out by Catalyst Information Resources, LLC (www.catalystinforesources.com).  In the case of Calibrate, a new newsletter appears in your inbox every Monday morning by the time you have your first cup of coffee at your desk.

Keeping up to date in our current regulatory environment is typically not complex, it just take a bit of effort and forethought and possibly an easy tool or two.  Keeping the LIMS up to date far more often than not simply requires putting the information you have gained through various sources to use in the LIMS.

For more information contact:

Robert Benz, [email protected]  or see www.khemia.com.

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Small Laboratory TNI Standard

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Small Laboratory TNI Standard

Implementation Series

Course Description:

The NELAC Institute, in cooperation with Advanced Systems, Inc., will provide a series of (10) 2-hour webinars that show how to implement the Standard. All size laboratories can implement the TNI Environmental Laboratory Standard. The key is understanding the Standard and documenting what you do in your everyday work.

Running a laboratory is more than just performing the method. There are other operations that require management such as buying supplies, handling customer inquiries, receiving and disposing of samples, ensuring the competency of personnel, and keeping equipment running, plus others. What is needed and how these operations are performed is up to you.

Do you want to make sure you have considered all parts of the operation? Then use the TNI Environmental Laboratory Standard as your road map.

Small Laboratory TNI Standard Implementation Series
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Small Laboratory TNI Standard Implementation Series
  

Course Description:

The NELAC Institute, in cooperation with Advanced Systems, Inc., will provide a series of (10) 2-hour webinars that show how to implement the Standard. All size laboratories can implement the TNI Environmental Laboratory Standard. The key is understanding the Standard and documenting what you do in your everyday work.

Running a laboratory is more than just performing the method. There are other operations that require management such as buying supplies, handling customer inquiries, receiving and disposing of samples, ensuring the competency of personnel, and keeping equipment running, plus others. What is needed and how these operations are performed is up to you.

Do you want to make sure you have considered all parts of the operation? Then use the TNI Environmental Laboratory Standard as your road map.

You may choose to register for individual courses or all 10 at a discount. Click the webinar title, or the Register Now button below to sign up.

Part 1 – You Can Do It!  4/18/2017
A small laboratory can meet the TNI Environmental Laboratory requirements without hiring a full-time consultant. Working in the laboratory is more than just following the method. The laboratory staff knows how to manage the work, but does not always think about what is involved in performing the method. The TNI Standard provides one place to find the requirements and think about how to manage the work. Whether required or not, the Standard is developed by laboratory personnel. These are not requirements developed and interpreted by solely government personnel. This is a consensus process to develop requirements for not only laboratories, but also for assessors and accreditation bodies.Part 2 – The Management Requirements  4/25/2017
The second part of the series will review what the Standard requires for policies and procedures to support running the method. These requirements manage feedback mechanisms from staff, clients and others. These items require the laboratory to describe the organization and management of the operation, how to purchase from suppliers and contract with clients, and control work when it does not meet regulatory or method requirements.Part 3 – Management of Ethics  5/9/2017
The third part of the series will review how to manage the work environment to ensure work is done in an ethical manner. It starts with a policy, but the climate or culture of the laboratory has more influence and can often make the policy ineffective. The management defines the culture. Management must have open discussions of technical and non-technical matters. It must encourage understanding of the requirements and communicate in a documented manner so miscommunication is minimized. When an inappropriate practice is suspected, how the management investigates the activity and handles the matter establishes the climate.

Part 4 – Personnel  5/18/2017
The fourth part of the series will present management and staff responsibilities, training needs, skills, and demonstration of capability. Management must establish training goals and then attempt to meet these goals. The qualifications for the technical manager and the job descriptions for all staff are presented in the Additional Requirements section. In addition, the contents and what must be included in data integrity training is defined in this section.

Part 5 – Sample Handling  6/6/2017
The fifth part of the series will review the documentation for sample handling and provide ways to conform to the requirements. Any size laboratory must perform sample receipt, tracking and disposal. You can meet the standard requirements in many ways depending on the matrix, technologies and customer requirements for the analyte to be measured. The key is to be sure the laboratory can prove which sample was measured and if the sample has been changed either as part of the procedure or before analysis. We will review several ways that labs conform to the requirements, which most labs perform now, but they lack the documented procedure to prove what is done. How does your lab know when it changed the process and can you determine which samples were handled the old way and which the new way?

Part 6 – Equipment  6/15/2017
The sixth part of the series will present the equipment requirements for setting up, routinely using, and reporting results from various types of laboratory equipment. This includes traceability of measurements and maintenance of the equipment. Learn why it is more correct to indicate your traceability to the SI through a National Metrological Institute (NMI) such as NIST. This class will also present the definitions for reference standards and reference materials. The records requirements for calibration, understanding differing techniques for calibration, and calibration checks will be reviewed.

Part 7 – Methods  6/28/2017
The seventh part of the series will discuss the various types of methods, such as regulatory, non-regulatory and research methods. The reason a laboratory has to rewrite the method into a procedure and the contents of the procedure will be presented. An explanation of the differences will be provided, as well as when to write a work instruction, procedure, or use a form to record the data and provide the steps to perform the operation. Who and how to write a procedure is part of the training.

Part 8 – Quality Control  7/11/2017
The eighth part of the series will review the quality control used in routine testing, including the process to analyze quality control data. What does each quality control sample tell the lab about the data? The myths of perfect data will be explored and the interpretation for each type of quality control sample will be explained. When to reanalyze your data and evaluate short-term and long-term testing performance using statistical process control will be presented.

Part 9 – Reporting Results  7/20/2017
The ninth part of the series will present how to report results for regulatory and non-regulatory client needs. The report content will be reviewed as well as how to decide on what to include in the report. Reporting results with qualifiers and without qualifiers is based on the performance of the procedure and the regulator program or client request. Confidential reporting and having a process for changing and reissuing the report is reviewed.

Part 10 – It’s More Than Running the Right Method  8/1/2017
The tenth part of the series will pull together all the elements and show why they are needed to ensure that data are of known and documented quality. Many of the elements of the TNI and ISO standards are not considered relevant to small laboratories. All the elements are relevant, but how they are implemented is different for a small lab with 1 or 2 people, 3 to 20 people, 21 to 100 people, and more than 100 people in a single location or multiple locations. This training will explain how all the sections are relevant for a 1 to 20 person operation. Examples are provided on how to perform these activities with ease and understand why each are important to the laboratory operation.

Cost:$40 per webinar for TNI members
$50 per webinar for non-members
$350 for all 10 classes (the full series) for TNI members*
$450 for all 10 classes (the full series) for non-member*

Note: An additional $15 per person will be charged for anyone who desires a certificate of attendance for a course. If the series is purchased, a single certificate can be purchased to cover all 10 classes for $15.

*The full series option must be purchased to receive the discount.

Instructor:Marlene Moore founded Advanced Systems, Inc. in February 1992 as a consulting company specializing in quality systems for laboratory and sampling operations. She brings together the needs of quality system management, measurement operations and regulatory compliance.
Marlene Moore has worked and managed sampling and testing laboratories for over twenty years before providing her expertise to others. Current work includes assessing for laboratory accreditation programs to ISO/IEC 17025 and assessing to ISO/IEC 17065 for conformity assessment certification programs. Assessments are performed for A2LA, ANAB and ANSI. Additional assessor and auditor training was completed under the EPA Safe Drinking Water Program for State certification laboratory auditors for inorganic, organic and microbiology and as an ISO auditor for ISO 9000.  Formerly an RAB ASQ/ANSI registered auditor.
Copyright © 2017 The NELAC Institute, All rights reserved.
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www.nelac-institute.org

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