Difference between revisions of "User:Shawndouglas/sandbox/sublevel8"

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==Sandbox begins below==
==Sandbox begins below==
Material testing can focus on specific industries (e.g., automotive, construction, and pharmaceutical), products (e.g., car seats, asphalt, and medical devices), or raw materials (e.g., steel, gravel, and zirconia ceramic).


==1. Introduction to LIMS and LIMS acquisition==
About chemical testing of raw materials https://a2la.org/accreditation/chemical-testing/
Your [[laboratory]] was created to carry out specific tasks, to do work that its parent organization needed to conduct its work and reach its business goals. The lab's biggest output is analytical results of tests it conducts, and it's imperative those analytical results are accurate, timely, and unaltered. Today, lab's more than ever depend on a [[laboratory information management system]] (LIMS) to better meet those requirements.


The point of this guide is to give you the background you need to better make a case to your organization's management and key stakeholders for acquiring and deploying a LIMS. While pursuing this topic, we're going to make a couple of simple assumptions. We'll assume that your organization's senior management may not understand what goes on in your lab and how it carries out its work. We'll also assume they have a lot of things to contend with in their roles, giving them limited time to fully understand your lab's needs and the tools required to help it succeed. You want to make the explanation and justification for LIMS acquisition and deployment as easy and succinct as possible while at the same time demonstrating that this is the right decision.
Material testing domains:
* Aerospace
**Adhesives
**Composites
**Fasteners
**Paints and primers
**Sealants
**Etc.
*Automotive
**Adhesives
**Coatings
**Foams
**Lighting and high-visibility solutions
**Plastics
**Seating
**Etc.
*Carbon
**Activated carbon
**Coal tar
**Etc.
*Coatings, linings, and sealants
**Ceramic coatings
**Metal coatings
**Pipe linings
**Thermal sprays
**Etc.
*Construction and engineering
**Asphalt
**Brick and tile
**Fasteners
**Fenestration and glazing products (i.e., windows, doors, glass)
**Geosynthetics
**Plumbing
**Soil
**Etc.
* Insulation, foam, and composites
**Fiberglass
**Flexible and laminate urethane foam composite
**Polyester resins
**Etc.
*Lubricants and thickeners
**Metallic stearates
**Powdered metal
**Pre-formed grease thickeners
**Etc.
* Medical devices
**Ceramics
**Metals
**Screws
**Etc.
*Metals
**Aluminum
**Castings
**Copper
**Rebar
**Steel
**Tubing
**Welds
**Zinc
**Etc.
* Packaging and labeling
**Cardboard
**Label adhesives
**Pharmaceutical packaging
**Sterile barrier materials
**Etc.
* Paints and oils
**Interior/Exterior paints
**Organic coatings
**Paint on parts
**Transformer oil
**Etc.
* Paper
**Cellulose paper tape
**Crepe paper and tubes
**Kraft paper
**Pressboard
**Etc.
*Polymers and plastics
**Biopolymers
**Condoms and gloves
**Payment cards
**O-rings
**[https://www.sciencedirect.com/science/article/pii/S1751616121005105 Silicone-based biological tissue mimics]
**Thermoplastic resins
**Etc.
* Raw materials
**Food and beverage ingredients
**Elemental material
**Pharmaceutical ingredients
**Etc.
* Reference materials
**Cannabinoids
**Coals and cokes
**Elemental gasses
**Isotope reference material
**Organic analytical reference material
**Pesticides
**Etc.
*Rubbers
**Bump stops
**Gloves
**Neoprene
**Silicone
**Tires
**Etc.
*Electronics and energy devices
**Batteries
**Semiconductors
**Solar panels
**Transformers
**Etc.
*Textiles
**Carpet
**Drapery
**Non-woven fabrics
**Upholstery
**Etc.
*Wood
**Dowel
**Flooring
**Lumber
**Medium-density fibreboard (MDF)
**Etc.


The justification process for LIMS has a long history, and a lot has changed since the 1980s when the technology was first introduced. Therefore, we need to examine what a LIMS is, what alternatives people commonly turn to, how the technology has evolved, what the history of LIMS justification is, what practical and economic considerations surround LIMS adoption, and how to address any concerns management may raise during the justification process. This guide will attempt to address these things and more.
Test method developers:
 
* Aerospace Industries Association (AIA/NAS/NASM)
===1.1 What is a laboratory information management system (LIMS)?===
* American Architectural Manufacturers Association (AAMA)
A LIMS is a specialized, software-based [[information management]] solution that offers a set of key features that support a modern laboratory's operations. Introduced in the late 1970s and early 1980s<ref name="LIMSHistory">{{cite journal |title=A brief history of LIMS |journal=Laboratory Automation and Information Management |author=Gibbon, G.A. |volume=32 |issue=1 |pages=1–5 |year=1996 |doi=10.1016/1381-141X(95)00024-K}}</ref>, the design and functionality of this software has changed significantly over the years, such that today a majority of a laboratory's processes can benefit from the LIMS' implementation and use. A LIMS has functionality that addresses most of the [[workflow]] phases of a laboratory, including<ref name="MT5310">{{cite journal |title=Laboratory information management systems in the work of the analytic laboratory |journal=Measurement Techniques |author=Skobelev, D.O.; Zaytseva, T.M.; Kozlov, A.D. et al. |volume=53 |issue=10 |pages=1182–1189 |year=2011 |doi=10.1007/s11018-011-9638-7}}</ref>:
* American Association of State Highway and Transportation Officials (AASHTO)
 
* American Association of Textile Chemists and Colorists (AATCC)
* the reception and log in of a [[Sample (material)|sample]] and its associated customer data;
* American Institute of Timber Construction (AITC)
* the assignment, scheduling, and tracking of the sample and the associated analytical workload;
* American National Standards Institute (ANSI)
* the processing and [[quality control]] (QC) associated with the sample and the utilized equipment and inventory;
* American Petroleum Institute (API)
* the storage and access management of data associated with the sample analysis; and
* American Society of Mechanical Engineers (ASME)
* the inspection, approval, and compilation of the sample data for reporting and/or further analysis.
* American Welding Society (AWS)
 
* American Wood Protection Association (AWPA)
Related is the [[laboratory information system]] (LIS), which is tailored to the workflow of a [[clinical laboratory]]. That said, the distinction between the LIMS and LIS has blurred over time, with some LIMS having the same clinical information management features of an LIS. In both cases, the software—when developed, implemented, and maintained well—can improve laboratory workflows and workloads while enhancing safety, quality, and compliance. A well-implemented LIMS can reduce the silos of information and data in a laboratory, while at the same time make that information and data more secure, readily accessible, and actionable. Additionally, many modern LIMS are able to be pre-configured out of the box with analytical and quality control workflow support tools that can be further optimized to a lab's unique industry-based workflow. When integrated with instruments and other software systems, fewer transcription errors occur and traceability becomes easier, while monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. This also means that the lab can react more rapidly to issues that compromise compliance with certification to the [[ISO/IEC 17025]] standard, as is necessary in, for example, the food and beverage industry.<ref name="SmithInteg19">{{cite web |url=https://foodsafetytech.com/feature_article/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain/ |title=Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain |author=Smith, K. |work=Food Safety Tech |date=02 July 2019 |accessdate=04 July 2023}}</ref><ref name="ApteIsYour20">{{cite web |url=https://foodsafetytech.com/column/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit/ |title=Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit? |author=Apte, A. |work=Food Safety Tech |date=20 October 2020 |accessdate=04 July 2023}}</ref><ref name="McDermottHowDig18">{{cite web |url=https://foodsafetytech.com/column/how-digital-solutions-support-supply-chain-transparency-and-traceability/ |title=How Digital Solutions Support Supply Chain Transparency and Traceability |author=McDermott, P. |work=Food Safety Tech |date=31 July 2018 |accessdate=04 July 2023}}</ref>
* AOAC International (Association of Official Agricultural Chemists; AOAC)
 
* ASTM International (ASTM)
===1.2 What are the alternatives to a LIMS?===
* Automakers (Ford, GM, Honda, PACCAR, Peugeot, Subaru, Tesla, Toyota, Volvo, etc.)
Introducing new technologies and products often causes people to balk because it represents a change to current operations and an expense, even if the change is beneficial. As such, some may view the acquisition, use, and maintenance of a LIMS to be too daunting. The organization may even see the value in a LIMS but finds several questions arise:
* Canadian Standards Association (CSA)
 
* Chemical Fabrics & Film Association (CFFA)
* What happens if we don’t make the change to a LIMS?
* Consumer Product Safety Commission (CPSC)
* Is there an alternative technology that is less costly?
* Deutsches Institut für Normung (DIN)
 
* Electronic Components Industry Association (ECIA/EIA)
The answer to the first question is straightforward: lab costs continue to increase, operations stagnate, sample backlogs increase, and lab personnel—including management—become increasingly frustrated. This in turn means the lab may fail to achieve its goals. That second question is politically charged, however, particularly in medium to larger organizations. There are two frequently encountered answers, both involving internal software development: let's use a spreadsheet, or let's use an [[enterprise resource planning]] (ERP) system as a solution with similar characteristics to a LIMS. The latter often occurs if a company has recently invested in an ERP solution with the idea that it will take care of all of the company’s needs (i.e., they may not have checked with the labs to see if actually will).
* European Telecommunications Standards Institute (ETSI)
 
* Federal Motor Vehicle Safety Standard (FMVSS)
Before we get into a response to that second question, I'd like to ask you one. What business is your company in? Is it a software development organization, or does it want to become one? I ask this because what often happens is someone in the organization proposes custom software development as an alternative. Suppose you are seriously considering developing a LIMS alternative in-house or through a consulting firm. In that case, that is something you have to think through, taking on all the issues that plague large software development projects, including ongoing maintenance and support once the project is completed.
* FM Approvals (FM)
 
* GE Aerospace (GE)
Software development projects are fraught with issues. Reasons for software project failure include<ref name="DACD5Reasons22">{{cite web |url=https://dac.digital/why-software-projects-fail-and-how-to-make-them-succeed/ |title=5 reasons why software projects fail and how to make them succeed |work=DAC.digital Blog |publisher=DAC.digital |date=19 April 2022 |accessdate=30 June 2023}}</ref><ref name="Singh23Reas22">{{cite web |url=https://www.netsolutions.com/insights/23-reasons-why-software-projects-fail-with-solutions/ |title=23 Reasons Why Software Projects Fail (with Solutions) |author=Singh, S. |work=Net Solutions Insights |publisher=Net Solutions |date=15 June 2022 |accessdate=30 June 2023}}</ref><ref name="Forbes14Comm20">{{cite web |url=https://www.forbes.com/sites/forbestechcouncil/2020/03/31/14-common-reasons-software-projects-fail-and-how-to-avoid-them/amp/ |title=14 Common Reasons Software Projects Fail (And How To Avoid Them) |author=Forbes Technology Council |publisher=Forbes |date=31 March 2020 |accessdate=30 June 2023}}</ref>:
* Government and military (MIL, [https://fedspecs.gsa.gov/s/federal-standards Fed], Consumer Product Safety Commission, CSFA, EPA, FDA, MMM, NAVSEA, United Nations Economic Commission for Europe, etc.)
 
* Industrial Fasteners Institute (IFI)
* insufficient organizational leadership
* Institute of Electrical and Electronics Engineers (IEEE)
* insufficient understanding of business and department problems and requirements, even as they evolve during development
* International Atomic Energy Agency (IAEA) ([https://www.iaea.org/topics/material-analysis 1], [https://www.iaea.org/topics/other-non-destructive-testing 2], [https://www.iaea.org/topics/materials 3])
* inadequate planning and project management
* International Code Council (ICC-ES)
* undefined project roles and responsibilities
* International Electrotechnical Commission (IEC)
* inaccurate time and cost projections
* International Maritime Organization (IMO)
* inadequate use of available resources
* International Organization for Standardization (ISO)
* insufficient understanding of changing software development practices
* International Safe Transit Association (ISTA)
* poor or mismanaged communication methods
* IPC International (Institute for Interconnecting and Packaging Electronic Circuits; IPC)
* poor response to project challenges that inevitably arise
* Japanese Standards Association (JAS/JIS)
* lack of focus on project success
* NACE International (National Association of Corrosion Engineers; NACE)
* lack of focus on soft skills such as training and team building
* National Fire Protection Association (NFPA)
* scope creep
* [https://www.dot.ny.gov/divisions/engineering/structures/manuals/scm/repository/SCM_4th_Edition_1-2018.pdf New York State Steel Construction Manual (NNSSCM/SCM)]
 
* NSF International (National Sanitation Foundation; NSF)
The bottom line is this: software projects develop issues, and while they may eventually succeed, they a may take a year or more to work through during development. Meanwhile, your lab is suffering
* Pressure Sensitive Tape Council (PSTC)
under whatever issues caused you to look for a LIMS in the first place. When you're done with developing the solution, will you have something better than commercial products or just the best you can settle for? Commercial products will be continually improved with new features and capabilities added; that's their business. Do you have the resources and commitment to make it yours?
* Radio Technical Commission for Aeronautics (RTCA)
 
* Suppliers of Advanced Composite Materials Association (SACMA)
We find that software development approaches have their own issues to address, but what about spreadsheets and ERP systems? Spreadsheet-based systems, while seemingly inexpensive, are costly in development time and use. Additionally, spreadsheets are single-user-at-a-time systems. Everyone else has to wait their turn if someone is working with the system. They are fraught with errors creeping in, especially through changes that may not be documented. They are also difficult to validate and keep under modification control. Those factors are red flags to regulatory inspectors, particularly regarding development documentation. As for ERPs, those systems may address some of the requirements of your lab, but they will have significant problems with instrument connections, a significant source of productivity gains in the laboratory. Do these and similar alternatives represent the most cost-effective way to manage risk and utilize your resources towards the goal of improving laboratory productivity and compliance?
* SAE International (SAE/AMS/AS)
 
* TAPPI (Technical Association of the Pulp and Paper Industry; TAPPI)
===1.3 LIMS acquisition then===
* Truss Plate Institute (TPI)
 
* UL Standards and Engagement (UL)
===1.4 LIMS acquisition today===
* United States Pharmacopeia Convention (USP)
 
===1.5 Why a LIMS matters===
 
==References==
{{Reflist|colwidth=30em}}
 
==Citation information for this chapter==
'''Chapter''': 1. Introduction to LIMS and LIMS acquisition
 
'''Title''': ''Justifying LIMS Acquisition and Deployment within Your Organization''
 
'''Edition''': First Edition
 
'''Author for citation''': Joe Liscouski, Shawn E. Douglas
 
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
 
'''Publication date''':
 
<!--Place all category tags here-->

Latest revision as of 18:07, 20 September 2023

This is sublevel8 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

Material testing can focus on specific industries (e.g., automotive, construction, and pharmaceutical), products (e.g., car seats, asphalt, and medical devices), or raw materials (e.g., steel, gravel, and zirconia ceramic).

About chemical testing of raw materials https://a2la.org/accreditation/chemical-testing/

Material testing domains:

  • Aerospace
    • Adhesives
    • Composites
    • Fasteners
    • Paints and primers
    • Sealants
    • Etc.
  • Automotive
    • Adhesives
    • Coatings
    • Foams
    • Lighting and high-visibility solutions
    • Plastics
    • Seating
    • Etc.
  • Carbon
    • Activated carbon
    • Coal tar
    • Etc.
  • Coatings, linings, and sealants
    • Ceramic coatings
    • Metal coatings
    • Pipe linings
    • Thermal sprays
    • Etc.
  • Construction and engineering
    • Asphalt
    • Brick and tile
    • Fasteners
    • Fenestration and glazing products (i.e., windows, doors, glass)
    • Geosynthetics
    • Plumbing
    • Soil
    • Etc.
  • Insulation, foam, and composites
    • Fiberglass
    • Flexible and laminate urethane foam composite
    • Polyester resins
    • Etc.
  • Lubricants and thickeners
    • Metallic stearates
    • Powdered metal
    • Pre-formed grease thickeners
    • Etc.
  • Medical devices
    • Ceramics
    • Metals
    • Screws
    • Etc.
  • Metals
    • Aluminum
    • Castings
    • Copper
    • Rebar
    • Steel
    • Tubing
    • Welds
    • Zinc
    • Etc.
  • Packaging and labeling
    • Cardboard
    • Label adhesives
    • Pharmaceutical packaging
    • Sterile barrier materials
    • Etc.
  • Paints and oils
    • Interior/Exterior paints
    • Organic coatings
    • Paint on parts
    • Transformer oil
    • Etc.
  • Paper
    • Cellulose paper tape
    • Crepe paper and tubes
    • Kraft paper
    • Pressboard
    • Etc.
  • Polymers and plastics
  • Raw materials
    • Food and beverage ingredients
    • Elemental material
    • Pharmaceutical ingredients
    • Etc.
  • Reference materials
    • Cannabinoids
    • Coals and cokes
    • Elemental gasses
    • Isotope reference material
    • Organic analytical reference material
    • Pesticides
    • Etc.
  • Rubbers
    • Bump stops
    • Gloves
    • Neoprene
    • Silicone
    • Tires
    • Etc.
  • Electronics and energy devices
    • Batteries
    • Semiconductors
    • Solar panels
    • Transformers
    • Etc.
  • Textiles
    • Carpet
    • Drapery
    • Non-woven fabrics
    • Upholstery
    • Etc.
  • Wood
    • Dowel
    • Flooring
    • Lumber
    • Medium-density fibreboard (MDF)
    • Etc.

Test method developers:

  • Aerospace Industries Association (AIA/NAS/NASM)
  • American Architectural Manufacturers Association (AAMA)
  • American Association of State Highway and Transportation Officials (AASHTO)
  • American Association of Textile Chemists and Colorists (AATCC)
  • American Institute of Timber Construction (AITC)
  • American National Standards Institute (ANSI)
  • American Petroleum Institute (API)
  • American Society of Mechanical Engineers (ASME)
  • American Welding Society (AWS)
  • American Wood Protection Association (AWPA)
  • AOAC International (Association of Official Agricultural Chemists; AOAC)
  • ASTM International (ASTM)
  • Automakers (Ford, GM, Honda, PACCAR, Peugeot, Subaru, Tesla, Toyota, Volvo, etc.)
  • Canadian Standards Association (CSA)
  • Chemical Fabrics & Film Association (CFFA)
  • Consumer Product Safety Commission (CPSC)
  • Deutsches Institut für Normung (DIN)
  • Electronic Components Industry Association (ECIA/EIA)
  • European Telecommunications Standards Institute (ETSI)
  • Federal Motor Vehicle Safety Standard (FMVSS)
  • FM Approvals (FM)
  • GE Aerospace (GE)
  • Government and military (MIL, Fed, Consumer Product Safety Commission, CSFA, EPA, FDA, MMM, NAVSEA, United Nations Economic Commission for Europe, etc.)
  • Industrial Fasteners Institute (IFI)
  • Institute of Electrical and Electronics Engineers (IEEE)
  • International Atomic Energy Agency (IAEA) (1, 2, 3)
  • International Code Council (ICC-ES)
  • International Electrotechnical Commission (IEC)
  • International Maritime Organization (IMO)
  • International Organization for Standardization (ISO)
  • International Safe Transit Association (ISTA)
  • IPC International (Institute for Interconnecting and Packaging Electronic Circuits; IPC)
  • Japanese Standards Association (JAS/JIS)
  • NACE International (National Association of Corrosion Engineers; NACE)
  • National Fire Protection Association (NFPA)
  • New York State Steel Construction Manual (NNSSCM/SCM)
  • NSF International (National Sanitation Foundation; NSF)
  • Pressure Sensitive Tape Council (PSTC)
  • Radio Technical Commission for Aeronautics (RTCA)
  • Suppliers of Advanced Composite Materials Association (SACMA)
  • SAE International (SAE/AMS/AS)
  • TAPPI (Technical Association of the Pulp and Paper Industry; TAPPI)
  • Truss Plate Institute (TPI)
  • UL Standards and Engagement (UL)
  • United States Pharmacopeia Convention (USP)
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