Small Laboratory TNI Standard

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.

 

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Programmer/Developer needed!

Programmer/Developer – LIMS

Job Description:

Full-time position for an established IT professional to support and improve its Best-In-Class software product marketed as Omega LIMS (Laboratory Information Management System).  This product is used by commercial and government laboratories to handle all phases of lab operations such as sample management, scheduling, analytical results, QA/QC, reporting and invoicing among others. This position entails design, development, testing and implementation of new features and functionalities as well as fixing issues reported by clients.  The physical location of this job is in Livonia, Michigan and cannot work remotely.

Job Requirements:

The ideal candidate would be:

  • Experienced in all phases of product development lifecycle
  • Motivated by growing and mentoring people
  • A critical thinker, an effective coach and team builder
  • Translates strategy into action and ultimately into realized business value
  • Is passionate about problem solving in a most efficient manner
  • Is passionate about sharing knowledge with others and vice versa
  • Skillful in engaging when sharing knowledge and experience to solve problems
  • Focuses on the success of others to add value to the enterprise
  • Promotes collaboration in challenging executive and team circumstances
  • Open minded with a learning/teaching attitude
  • Encourages creativity, guiding and coaching staff in a non-controlling manner
  • A high sense of urgency to respond to client issues and meeting deadlines
  • Ability to work with and manage legacy code
  • Understand and follow good programming practices including the use of reusable code

Must have:

  • A degree in computer science, business information systems, or a related field
  • 5 plus years of strong experience in software design, development and implementation
  • Expert level knowledge and experience with MS Access, VBA, Visual Studio, ASP.NET, C#, VB.NET, MS SQL Server, SSRS, and Web Services
  • Expertise in windows environment on a client server platform and browser based architecture
  • Excellent verbal and written communication skills
  • Excellent organization and time management skills to solve customer problems at remote locations

Responsibilities:

  • Responsible for design, development, testing and implementation of software solutions
  • Work closely with internal staff and outside consultants to solve complex problems and create value for our clients
  • Participate in code review and unit testing to ensure acceptable performance
  • Respond to client issues in a timely manner
  • Coach or mentor team members, specifically around the development of technical skills and practices
  • Act as a role model and encourage professionalism and honesty
  • Be prepared to work long and flexible hours to meet client schedules and deadlines
  • Prepare reference materials for users by writing operating instructions
  • Maintain historical records by documenting program development and revisions
  • Maintain client confidence and protect operations by keeping information confidential.

How To Apply:  Send resume to hr@khemia.com

About Khemia Software:

Khemia Software is a premier provider of Laboratory Information Management Systems (LIMS) for the environmental, water/wastewater, food & beverage, manufacturing and chemical industries. Founded in 1995, the company has successfully implemented its LIMS in numerous laboratories across the United States and internationally. Our professionals have extensive experience working within laboratories and understand the challenges that clients face. Combining this background with over 20 years of product development has culminated in Omega 11, our most feature-rich and configurable LIMS to date.

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A hidden benefit within a LIMS: Human Resource information for laboratory personnel

By Robert Benz, Sales & Marketing Director for Khemia Software

Many of the broader laboratory based benefits of LIMS are well known: LIMS track samples from entry into the laboratory (in some cases even the field data and collection) to final analysis and disposal; LIMS track and document reagent and standards usage within the laboratory; LIMS generate reports and electronic data deliverables (EDDs).  However, one important and often overlooked feature is that LIMS can also track and record human resource (HR) information.

First and foremost, laboratories must keep some basic personal information in regards to their employees both for business and regulatory reasons.  Within the security blanket of a LIMS, storing personal information while keeping it private to only those with the proper rights to view this information is a simple and well vetted process.  As can be seen from the example below, hire/left date, social security number (if required), a copy of the employee’s signature and whether they are active or inactive may be set, as well as assigning a password:

khemia article 2-15-17

In addition, database roles may be set to allow staff access to different sections of the LIMS.  For example, analysts typically do not have EDD administration rights and often do not need to mind the pricing of analyses to clients, however, many laboratories find it useful for their analyst to see vendor pricing and have access to linked files.  Similarly, office staffs that have little to do with the actual validation of data can have this restricted from their roles.  HR is often best utilized when first applied before an accidental overstep occurs.

While much of the personal information may need to be private, contacting various members of staff might be vital in certain situations – i.e. I still remember getting the call that a parr bomb had exploded in one of the ovens in inorganics at the laboratory as I was sitting down for dinner one evening.  While fortunately no one was hurt, as the inorganics manager, it was vital for me to know immediately upon its happening and return to the laboratory quickly.  Having a set of contact information readily accessible in the LIMS is ideal for this type of situation.  An example of viewable laboratory personnel details may be seen below:

khemia article 2 2-15-17

LIMS can also function as a great resource for recording training information. Training with proper documentation continues to grow in importance and within any good laboratory there are generally some training programs in place, whether internal or external.  What the training was about, when it was offered (date/time) and who attended is important to document and note for both the employee themselves and the laboratory.  The training course’s organizer/presenter, duration and frequency should at a minimum be recorded.  Ideally, any handouts or information provided should be linked to the training so that it may be accessed be staff as needed and documented by the laboratory.  An example of a page dedicated to logging this information may be seen below:

khemia article 3 2-15-17

In addition to training records, OSHA record keeping requirements for injury and illness, etc. may also be met simply by recording the vital information within the LIMS and linking/attaching the proper files.  This information is important for employers, employees and OSHA in evaluating the safety of a workplace, understanding industry hazards and implementing worker protections to reduce and eliminate hazards.

On a lighter and simpler note, holiday schedules for laboratories are also extremely important. Laboratories routinely have to schedule short-hold time analyses and sampling events.  Many laboratories have to run around the clock with multiple shifts all year long.  Simply by making a record of the holidays upfront and apparent, as seen below, and by properly scheduling people to be in place can avoid much heartache and confusion.  I do remember some improperly scheduled events ruining my social plans as an analyst as well as ruining a number of employees’ plans as a department manager.  Most definitely a case of “a little planning goes a long way” towards employee happiness.

khemia article 4 2-15-17

Another major advantage within a LIMS for HR is employee evaluation.  Obviously an employee’s worth is not wholly tied to production, but it does certainly play a hand.  As many laboratory managers can vouch for, pulling old log books and seeing how many analyses and batches an employee ran is often a matter of making a good guess with some backing.  Within a LIMS, this can be done with a handful of keystrokes to give a true performance evaluation as all data going into and linked to the LIMS is linked to the employee via their log in credentials.

khemia article 5 2-15-17

Key performance metrics by department and by analyst may be pulled under a wide variety of time scales and other criteria from this management dashboard.  Often, from a management perspective, departments can be looked at based on total work completed, work completed late and work by an individual analyst to best judge what or what might not need to happen within a certain group.  Again, often with a little HR pre-intervention, HR issues can be laid to rest before they become realities that a laboratory has to deal with.

While HR in any organization is not necessarily straightforward, it does have some unique challenges in the laboratory world.  By simply using tools that already exist in a mature LIMS, HR’s grasp on the needs and needed controls may be largely gained without going well outside the box.

For any additional information, please contact Robert Benz (rbenz@khemia.com) at Khemia Software, Inc. (www.khemia.com).  This article may also be seen at on LIMSFinder (www.limsfinder.com) at http://www.limsfinder.com/BlogDetail.aspx?id=42315_0_2_0_C.

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TNI Education & Training

See the following link to the TNI courses being offered in March 2017:  http://us14.campaign-archive1.com/?u=52d1e20b54514b5888bddd9dd&id=758d3dbfe8&e=a1218e022a

Basic Environmental Laboratory
Assessor Training Course

Environmental Laboratory Refresher
Assessor Training Course

NEFAP Assessor Training Course

More details on this course can be found at the TNI Educational Delivery System home page at: http://nelac-institute.org/content/load_eds.php?id=98.

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