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==Sandbox begins below==
==Sandbox begins below==
==1. Introduction to materials and materials testing laboratories==


==3. Gaining buy-in from management and other stakeholders==
What is a material? This question is surprisingly more complex for the layperson than may be expected. The definition of "material" has varied significantly over the years, dependent on the course of study, laboratory, author, etc. A 1974 definition by Richardson and Peterson that has seen some use in academic study defines a material as "any nonliving matter of academic, engineering, or commercial importance."<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Chapter 1: Introduction to Analytical Methods |series=Materials science series |publisher=Academic Press |place=New York |page=2 |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref> But recently biomaterials like biopolymers (as replacements for plastics)<ref>{{Cite journal |last=Das |first=Abinash |last2=Ringu |first2=Togam |last3=Ghosh |first3=Sampad |last4=Pramanik |first4=Nabakumar |date=2023-07 |title=A comprehensive review on recent advances in preparation, physicochemical characterization, and bioengineering applications of biopolymers |url=https://link.springer.com/10.1007/s00289-022-04443-4 |journal=Polymer Bulletin |language=en |volume=80 |issue=7 |pages=7247–7312 |doi=10.1007/s00289-022-04443-4 |issn=0170-0839 |pmc=PMC9409625 |pmid=36043186}}</ref> and even natural<ref>{{Cite journal |last=Kurniawan |first=Nicholas A. |last2=Bouten |first2=Carlijn V.C. |date=2018-04 |title=Mechanobiology of the cell–matrix interplay: Catching a glimpse of complexity via minimalistic models |url=https://linkinghub.elsevier.com/retrieve/pii/S2352431617301864 |journal=Extreme Mechanics Letters |language=en |volume=20 |pages=59–64 |doi=10.1016/j.eml.2018.01.004}}</ref> and engineered biological tissues<ref>{{Cite journal |last=Kim |first=Hyun S. |last2=Kumbar |first2=Sangamesh G. |last3=Nukavarapu |first3=Syam P. |date=2021-03 |title=Biomaterial-directed cell behavior for tissue engineering |url=https://linkinghub.elsevier.com/retrieve/pii/S246845112030057X |journal=Current Opinion in Biomedical Engineering |language=en |volume=17 |pages=100260 |doi=10.1016/j.cobme.2020.100260 |pmc=PMC7839921 |pmid=33521410}}</ref> may be referenced as "materials." (And to Richardson and Peterson's credit, they do add in the preface of their 1974 work that "[a]lthough the volumes are directed toward the physical sciences, they can also be of value for the biological scientist with materials problems."<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Preface |series=Materials science series |publisher=Academic Press |place=New York |page=xiii |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref> A modern example would be biodegradable materials research for tissue and medical implant engineering.<ref>{{Cite journal |last=Modrák |first=Marcel |last2=Trebuňová |first2=Marianna |last3=Balogová |first3=Alena Findrik |last4=Hudák |first4=Radovan |last5=Živčák |first5=Jozef |date=2023-03-16 |title=Biodegradable Materials for Tissue Engineering: Development, Classification and Current Applications |url=https://www.mdpi.com/2079-4983/14/3/159 |journal=Journal of Functional Biomaterials |language=en |volume=14 |issue=3 |pages=159 |doi=10.3390/jfb14030159 |issn=2079-4983 |pmc=PMC10051288 |pmid=36976083}}</ref>) Yet today more questions arise. what of matter that doesn't have "academic, engineering, or commercial importance"; can it now be called a "material" in 2023? What if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists? Indeed, the definition of "material" today is no easy task. This isn't made easier when even modern textbooks introduce the topic of materials science without aptly defining what a material actually is<ref>{{Cite book |last=Callister |first=William D. |last2=Rethwisch |first2=David G. |date= |year=2021 |title=Fundamentals of materials science and engineering: An integrated approach |url=https://books.google.com/books?id=NC09EAAAQBAJ&newbks=1&newbks_redir=0&printsec=frontcover |chapter=Chapter 1. Introduction |publisher=Wiley |place=Hoboken |pages=2–18 |isbn=978-1-119-74773-4}}</ref>, let alone what materials science is.<ref>{{Cite book |last=Sutton |first=Adrian P. |date=2021 |title=Concepts of materials science |edition=First edition |publisher=Oxford University Oress |place=Oxford [England] ; New York, NY |isbn=978-0-19-284683-9}}</ref> Perhaps the writers of said textbooks assume that the definitions of "material" and "materials science" have a "well duh" response.
[[Laboratory]]-based organizations have projects, which ideally align with organizational goals. These projects may be small and simple (e.g., acquire new hot plates and stirrers as ours are currently failing) or large and complex (e.g., combine our [[data lake]]s, reduce IT requirements, and acquire software tools to better manage the data). In all cases, these projects inevitably have some impact on organizational stakeholders, and they often require some soft of approval before they begin. This means gaining buy-in from upper management or some other set of stakeholders.


The key to gaining buy-in for a project lies in "understanding"; if organizational leadership and other critical stakeholders understand why a proposed project is important to the organization, they are more likely to do what they can to support your project and ensure the project goals are met.<ref name="MillsGetting21">{{cite web |url=https://gathercontent.com/blog/getting-stakeholder-buy-in-across-a-siloed-organisation |title=Getting stakeholder buy-in across a siloed organization |author=Mills, R. |work=GatherContent |date=20 December 2021 |accessdate=11 July 2023}}</ref> Is there still a possibility a proposed [[laboratory information management system]] (LIMS) acquisition and deployment may get rejected by management despite understanding the potential benefits to the organization? Of course there is, particularly if the organizational budget is tight or some other external factor is influencing the decision. But those factors are largely out of your control; you can only focus on prompting greater understanding of the organizational and personnel benefits that can be realized and taking the time to better understand any resistance made to the proposed changes. That's what the previous two chapters of this guide have helped you prepare for.  
To complicate things further, a material can be defined based upon the context of use. Take for example the ISO 10303-45 standard by the [[International Organization for Standardization]] (ISO), which addresses the representation and exchange of material and product manufacturing information in a standardized way, specifically describing how material and other engineering properties can be described in the model/framework.<ref name="ISO10303-45">{{cite web |url=https://www.iso.org/standard/78581.html |title=ISO 10303-45:2019 ''Industrial automation systems and integration — Product data representation and exchange — Part 45: Integrated generic resource: Material and other engineering properties'' |publisher=International Organization for Standardization |date=November 2019 |accessdate=20 September 2023}}</ref><ref name=":0">{{Cite journal |last=Swindells |first=Norman |date=2009 |title=The Representation and Exchange of Material and Other Engineering Properties |url=http://datascience.codata.org/articles/abstract/10.2481/dsj.008-007/ |journal=Data Science Journal |language=en |volume=8 |pages=190–200 |doi=10.2481/dsj.008-007 |issn=1683-1470}}</ref> The context here is "standardized data transfer of material- and product-related data," which in turn involves [[Ontology (information science)|ontologies]] that limit the complexity of materials science discourse and help better organize materials and product data into information and knowledge. As such, the ISO 10303 set of standards must define "material," and 10303-45 complicates matters further in this regard (though it will be helpful for this guide in the end).


This third chapter will, ideally, help you put what you've learned from the prior two chapters together to pitch a LIMS acquisition and deployment proposal to not only upper management but also any other critical stakeholders that should be involved with the decision. It will also help you better understand stakeholder engagement and address resistance to the proposal.
In reviewing ISO 10303-45 in 2009, Swindells notes the following about the standard<ref name=":0" />:


<blockquote>The first edition of ISO 10303-45 was derived from experience of the testing of, so-called, "materials" properties, and the terminology used in the standard reflects this experience. However, the information modelling of an engineering material, such as alloyed steel or high density polyethylene, is no different from the information modelling of a "product." The "material" properties are therefore one of the characteristics of a product, just as its shape and other characteristics are. Therefore all "materials" are products, and the information model in ISO 10303-45 can be used for any property of any product.</blockquote>


===3.1 The importance of manager (and stakeholder) buy-in===
Put in other words, for the purposes of defining "material" for a broader, more standardized ontology, materials and products can be viewed as interchangeable. Mies puts this another way, stating that based on ISO 10303-45, a material can be defined as "a manufactured object with associated properties in the context of its use environment."<ref>{{Cite book |last=Mies, D. |date=2002 |editor-last=Kutz |editor-first=Myer |title=Handbook of materials selection |url=https://books.google.com/books?id=gWg-rchM700C&pg=PA499 |chapter=Chapter 17. Managing Materials Data |publisher=J. Wiley |place=New York |page=499 |isbn=978-0-471-35924-1}}</ref> But this representation only causes more confusion as we ask "does a material have to be manufactured?" After all, we have the term "raw material," which the Oxford English Dictionary defines as "the basic material from which a product is manufactured or made; unprocessed material."<ref name="OEDRawMat">{{cite web |url=https://www.oed.com/search/dictionary/?scope=Entries&q=raw+material |title=raw material |work=Oxford English Dictionary |accessdate=20 September 2023}}</ref> Additionally, chemical elements are defined as "the fundamental materials of which all matter is composed."<ref>{{Cite web |last=Lagowski, J.J.; Mason, B.H.; Tayler, R.J. |date=16 August 2023 |title=chemical element |work=Encyclopedia Britannica |url=https://www.britannica.com/science/chemical-element |accessdate=20 September 2023}}</ref> Taking into account the works of Richardson and Peterson, Mies, and Swindells, as well as ISO 10303-45, the concepts of "raw materials" and "chemical elements," and modern trends towards the inclusion of biomaterials (though discussion of biomaterials will be limited here) in materials science, we can land on the following definition for the purposes of this guide:
-- Write an into to this section about management buy-in here --


Management may raise one or more concerns about [[laboratory information management system]] (LIMS) acquisition. Some of their perceptions might be rooted in past experiences or comments about computerized systems from the late twentieth century. Among those concerns could be:
:A material is discrete matter that is elementally raw (e.g., native metallic and non-metallic elements), fundamentally processed (e.g., calcium oxide), or fully manufactured (by human, automation, or both; e.g., a fastener) that has an inherent set of properties that a human or automation-driven solution (e.g., an [[artificial intelligence]] [AI] algorithm) has identified for a potential or realized use environment.


*They may have investigated the subject of LIMS, seen it as another software project, and been concerned about opening a financial black hole.
First, this definition more clearly defines the types of matter that can be included, recognizing that manufactured products may still be considered materials. Initially this may seem troublesome, however, in the scope of complex manufactured products such as automobiles and satellites; is anyone really referring to those types of products as "materials"? As such, the word "discrete" is included, which in manufacturing parlance refers to distinct components such as brackets and microchips that can be assembled into a greater, more complex finished product. This means that while both a bolt and an automobile are manufactured "products," the bolt, as a discrete type of matter, can be justified as a material, whereas the automobile can't. Second—answering the question of "what if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists?"—the definition recognizes that the material needs at a minimum recognition of a potential use case. This turns out to be OK, because if no use case has been identified, the matter still can be classified as an element, compound, or substance. It also insinuates that that element, compound, or substance with no use case isn't going to be used in the manufacturing of any material or product. Third, the definition also recognizes the recent phenomena of autonomous systems discovering new materials and whether or not those autonomous systems should be credited with inventorship.<ref>{{Cite journal |last=Ishizuki |first=Naoya |last2=Shimizu |first2=Ryota |last3=Hitosugi |first3=Taro |date=2023-12-31 |title=Autonomous experimental systems in materials science |url=https://www.tandfonline.com/doi/full/10.1080/27660400.2023.2197519 |journal=Science and Technology of Advanced Materials: Methods |language=en |volume=3 |issue=1 |pages=2197519 |doi=10.1080/27660400.2023.2197519 |issn=2766-0400}}</ref> The question of inventorship is certainly worth discussion, though it is beyond the scope of this guide. Regardless, the use of automated systems to match a set of properties of a particular matter to a real-world use case isn't likely to go away, and this definition accepts that likelihood.
*They may be concerned about adding more stress to an already overloaded IT organization.
*They may ask if the implementation can be done in a reasonable amount of time, and if the organization has the financial resources and expertise needed to get the job done.
*They may ask if there are alternatives to LIMS that might be less costly and easier to implement.


Don't be put off by these concerns, or most any other rejection or resistance; trying to change people or an organization naturally leads to resistance, as people typically don't care much for change itself. This fact is vital to understand in the scope of acquiring buy-in for your LIMS acquisition project, which will require involving the right stakeholders from the very beginning. In her book ''Leading Business Change: A Practical Guide to Transforming Your Organization'', author Karin Stumpf highlights this fact as such<ref name=":0">{{Cite book |last=Stumpf, K. |year=2015 |title=Leading Business Change: A Practical Guide to Transforming Your Organization |url=https://books.google.com/books?id=Lu35CQAAQBAJ&pg=PA80 |publisher=CRC Press |pages=80–82 |isbn=978-1-4987-2662-7}}</ref>:
Finally, this leads us to the realization that materials, by definition, are inherently linked to the act of intentional human- or automation-driven creation, i.e., manufacturing and construction.


<blockquote>When you try to change people or an organization, you will encounter a multitude of rejections. If you do not deliberately and successfully extend your circle of influence to include the right people and stakeholder groups, you will undoubtedly encounter major resistance—from critical gatekeepers, from peers, from subordinates, and from all those affected by the changes. Some issues might just be individual ones, linked to power, social hierarchy, or self-interest. However, some resisteance might be well-founded and, if addressed adequately, can help you avoid major pitfalls.<br />&nbsp;<br />I have seen change leaders wait until the populating phase of a project before reaching out to an affected stakeholder group for the first time. By then, the rumors had spread and resistance had taken a foothold.</blockquote>


Even if the attempt to gain upper management's buy-in is made early on, resistance is natural, whether it's emotionally based or a rational response to the proposal. This is where the "understanding" mentioned in the introduction comes into play; in both emotional and rational rejection, a lack of understanding from the stakeholders, and even the project proposer, is often the root cause. In some cases, an actual need may not be met from the proposal, requiring further dialogue. Stumpf further highlights these issues<ref name=":0" />:
===1.1 Materials testing labs, then and now===


<blockquote>Sometimes resistance is emotionally based. Perhaps a person fears getting out of their comfort zone or resents being given more work. Often, though, resistance is a rational response. If someone does not see the need for change or disagrees with the solution, they may try to block the project. Also, if an employee does not not know how to effectively interact with a new toold or how to be productive in the process, the employee may resist. Last but not least, people may resist because there is a real problem—your plan may have not addressed a real need, the tools may be substantially flawed, or the structure may leave a serious gap in operations. It could be that some people see that you do not have the requisite budget or buy-in from upper management. Because they believe your project will ultimately fail, why should they invest their time and energy?</blockquote>
====1.1.1 Materials testing 2.0====


Stumpf's statements emphasize the importance of upper management and critical stakeholder buy-in, as without it, an under-funded, under-supported LIMS project hindered by lack of understanding and lack of stakeholder engagement has cascading effects. This means taking your LIMS acquisition proposal seriously, involving upper management and other stakeholders, helping them understand the implications of the project, addressing their concerns and resistance, and conducting the necessary research to make the most relevant and convincing proposal as possible.
*https://onlinelibrary.wiley.com/doi/full/10.1111/str.12434
*https://onlinelibrary.wiley.com/doi/full/10.1111/str.12370


So far we've talked about primarily winning over upper management for a proposed LIMS acquisition and deployment project, but it's not always that simple, especially within larger organizations. While management is often a stakeholder in an organizational project, there often are other stakeholders inside and outside the organization. A "stakeholder," as defined by ISO 26000 ''Social responsibility'', is defined as an "individual or group that has an interest in any decision or activity of an organization."<ref name="ASQStake">{{cite web |url=https://asq.org/quality-resources/stakeholders |title=Stakeholders |work=Quality Resources |publisher=American Society for Quality |accessdate=07 July 2023}}</ref> As such, identified stakeholders of the decision to acquire and deploy a LIMS could be anyone from IT personnel to the laboratory's clients, and anything in between. In some cases the number of apparent stakeholders, at first glance, may become daunting, requiring a formal stakeholder identification process that asks questions such as "who can help the organization address specific impacts?" or "who would be disadvantaged if excluded from stakeholder engagement?" Once identified, those stakeholders may be further separated into those most directly impacted by the LIMS decision vs. those who are only indirectly impacted.<ref name="ASQStake" /> From there, more refined decisions can be made as to who will be included in the LIMS justification process.


Conducting relations (i.e., interacting) with these stakeholders—management and otherwise—can be seen as stakeholder engagement. Involving management and other stakeholders demonstrates a commitment to the engagement process, as well to its importance. Kujala ''et al.'' define "stakeholder engagement" as "the aims, activities, and impacts of stakeholder relations in a moral, strategic, and/or pragmatic manner."<ref name="KujalaStake22">{{Cite journal |last=Kujala |first=Johanna |last2=Sachs |first2=Sybille |last3=Leinonen |first3=Heta |last4=Heikkinen |first4=Anna |last5=Laude |first5=Daniel |date=2022-05 |title=Stakeholder Engagement: Past, Present, and Future |url=http://journals.sagepub.com/doi/10.1177/00076503211066595 |journal=Business & Society |language=en |volume=61 |issue=5 |pages=1136–1196 |doi=10.1177/00076503211066595 |issn=0007-6503}}</ref> Their definition, based on a literature review and descriptive analysis of academic literature, provides a wide level of applicability to organizations of many types, and it highlights the benefits of engagement, as well as why it's valuable in particular to gaining buy-in of LIMS acquisition.
===1.2 Industries, products, and raw materials===


Table 9 shows an adapted version of the work of Kujala ''et al.'', highlighting how the different components of stakeholder engagement can benefit the organization. From this chart, we can see how a stakeholder my be more likely to buy into LIMS acquisition (or any other organizational decision) through a stakeholder engagement process that takes into account multiple aspects. If, for example, a stakeholder is involved with determining the potential strategic impacts (from Table 9, find the Strategic row and move right to the Impacts column) of a LIMS, the potential end result of that stakeholder engagement could yield improved efficiency, a greater competitive advantage, greater innovation, and an enhanced reputation for the organization overall.


{|
===1.3 Laboratory roles and activities in the industry===
| style="vertical-align:top;" |
:{| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="80%"
|-
  | colspan="4" style="background-color:white; padding-left:10px; padding-right:10px;" |'''Table 9.''' A tabular view of the benefits of stakeholder engagement, based on the definition by Kujala ''et al.'' and adapted from their research.<ref name="KujalaStake22" />
|-
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |''Component''
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |Aims
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |Activities
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |Impacts
|- 
  | style="background-color:white; padding-left:10px; padding-right:10px;" |'''Moral'''
  | style="background-color:white; padding-left:10px; padding-right:10px;" |
• Legitimacy, trust, and fairness<br />
• Corporate responsibility and sustainability<br />
• Stakeholder inclusion and accountability
  | style="background-color:white; padding-left:10px; padding-right:10px;" |
• Stakeholder empowerment<br />
• Democratic activities
  | style="background-color:white; padding-left:10px; padding-right:10px;" |
• Enhanced social and ecological well-being<br />
• Giving voice to stakeholders<br />
• Stakeholder value
|-
  | style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |'''Strategic'''
  | style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |
• Financial performance, risk management, and value creation<br />
• Knowledge creation and learning<br />
• Reputation building
  | style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |
• One-way and two-way communication activities<br />
• Co-creation<br />
• Supportive organizational structures
  | style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |
• Improved efficiency and competitive advantage<br />
• Innovation<br />
• Enhanced reputation
|- 
  | style="background-color:white; padding-left:10px; padding-right:10px;" |'''Pragmatic'''
  | style="background-color:white; padding-left:10px; padding-right:10px;" |
• Context-dependent problem-solving and decision-making<br />
• Organizational and societal development
  | style="background-color:white; padding-left:10px; padding-right:10px;" |
• Collaborative and dialogic activities<br />
• Relationship cultivation
  | style="background-color:white; padding-left:10px; padding-right:10px;" |
• Broad stakeholder involvement<br />
• Inclusive accountability and disclosure activities<br />
• Achieved resolutions
|-
|}
|}


Outside of upper-level organizational management, LIMS consultancy Third Wave Analytics breaks down a laboratory-based organization's LIMS stakeholders into five groups, while adding what value a LIMS adds for each group. When you seek buy-in from any of these stakeholder groups, it will be useful to keep these potential benefits in mind during justification processes<ref name="TWAHowEach22">{{cite web |url=https://thirdwaveanalytics.com/blog/how-each-lab-stakeholder-can-benefit-from-a-laboratory-information-management-system-lims/ |title=How Each Lab Stakeholder Can Benefit from a Laboratory Information Management System (LIMS) |author=Third Wave Analytics |publisher=Third Wave Analytics, Inc |date=14 September 2022 |accessdate=11 July 2023}}</ref>:
====1.3.1 R&D roles and activities====


*''Laboratory technicians and sample testing personnel'': These stakeholders realize improvements from knowing sample status and location, using sample processing protocols, having automated data capture and analysis, and managing training activities.
====1.3.2 Pre-manufacturing and manufacturing roles and activities====
*''Laboratory managers and supervisors'': These stakeholders realize improvements from having more granular sample management tools, tracking inventory, managing analytical test scheduling, and verifying regulatory training requirements are met.
*''Laboratory directors and clinical lab scientists'': These stakeholders realize improvement from having the tools to manage sample review and sign-out, identifying documents that require review and approval, and tracking quality control procedures for reagents and instruments.
*''Quality assurance and quality management services personnel'': These stakeholders realize improvement from ensuring the appropriate review and storage of all testing and quality control (QC) data, managing controlled documents, and auditing lab data and records.
*''Research personnel'': These stakeholders realize improvement from ensuring the difference between clinical and research samples, seeing which samples and data are associate with which studies/projects, and querying data from a single location.


Now that we've discussed why gaining buy-in from upper management and other critical stakeholders is important, let's take a closer look at the actual LIMS proposal process.
====1.3.3 Post-production quality control and regulatory roles and activities====
 
 
===3.2 Pitching the LIMS project===
-- General advice about pitching the project goes here --
 
 
===3.3 Developing a cheat sheet for management===
Pitching a LIMS acquisition project is no simple task, to be sure, but one can arguably make the proposal process more effective if they provide information and tools that help stakeholders more effectively and rapidly understand the value and costs associated with the proposed LIMS project. As such, you may want to consider making a "cheat sheet" of sorts for critical stakeholders who will be the recipients of your proposal.
 
This cheat sheet could take many forms, homogenous or varied, but in the end it should be readily accessible and organized such that it's easy for recipients to make sense of its contents. Those contents will also vary, based upon the level of familiarity stakeholders have with LIMS and [[laboratory informatics]] solutions. If management isn't familiar with a LIMS, you'll probably want to include a more broad list of bullet points as to how LIMS can benefit labs of all types. That list might look something like this:
 
'''A LIMS can...'''
 
*''Increase efficiency'': LIMS can help laboratories manage data more efficiently by eliminating data silos, managing standard operating procedures (SOPs), generating custom reports, facilitating data interoperability and exchange, tracking reagent inventories, and managing staff training. This in turn can minimize wasted resources.
*''Improve process control'':  LIMS can help laboratories better manage test/sample status and workload evaluation, resulting in better customer support and smoother workflows. With a LIMS, these and other tasks are automated, so we can spend more time on what really matters: research and testing. As an added benefit, LIMS also reduces errors by automating manual processes and eliminating the potential for human error.
*''More rapidly disseminate business data and analytical results'': LIMS can help laboratories communicate test results more quickly and accurately. In research, this means faster project execution and better decision-making. In production, this means faster release of products, quicker evaluation of incoming raw materials, and prevention of wasted products.
*''Enable access to data anywhere, anytime'': Many LIMS can help laboratories access lab data from anywhere, particularly cloud-based LIMS. With cloud-based LIMS software, we can access lab data from anywhere with an internet connection. That access capability means we can work remotely or collaborate with team members across different locations, all with a high level of security.
*''Provide safer, more secure storage for critical lab data'': LIMS can help laboratories centralize and secure their various data and information. LIMS software provides a centralized location for all lab data, making it easy to access and share data with other team members. It also ensures that data is secure and protected from unauthorized access, especially when the LIMS is purpose-built to meet data- and information-related regulatory requirements.
*''Facilitate better results interpretation and retrieval'': LIMS can help laboratories interpret and retrieve results more quickly, increasing customer satisfaction and lab productivity.
*''Improve billing processes'': LIMS can help laboratories streamline their billing processes, improve record access, and provide greater insights into organizational financials.
*''Increase productivity'': LIMS can help laboratories realize 10-20% productivity benefits based on a reduction in clerical work alone. By automating manual processes and providing easy access to lab data, LIMS software frees up time for researchers and analysts to focus on their core work. Using automated reporting, and giving clients controlled access to the system—i.e., through a secure, administrator-controlled client portal—for sample logging, along with having automated instrument connections for worklist downloading and data entry, will greatly increase those productivity gains.
*''Facilitate collaboration'': LIMS can help laboratories share data and collaborate on tasks and projects, resulting in improved communication and streamlined workflows.
 
As Chapter 2 points out, you'll also want to address how the LIMS acquisition and deployment specifically addresses organization goals and challenges. At this point you've already linked tangible and intangible benefits to organizational goals and challenges as part of your proposal research, and you'll want to make these connections clear to stakeholders. This might be best visualized in an easily digestible table, for example. Table 10 provides a few representative examples of this effort; your table may be larger and more extensive, but remember to keep it succinct and easy-to-understand.
 
{|
| style="vertical-align:top;" |
{| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="70%"
|-
  | colspan="2" style="background-color:white; padding-left:10px; padding-right:10px;" |'''Table 10.''' An example of linking tangible and intangible benefits of LIMS acquisition and deployment to organizational goals and challenges.
|-
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |Organizational goal
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |Tangible/Intangible benefit
|- 
  | style="background-color:white; padding-left:10px; padding-right:10px;" |"Provide more timely results to clients..."
  | style="background-color:white; padding-left:10px; padding-right:10px;" |We can better meet this goal with a LIMS, as we can save up to 22% of the time we currently spend manually processing samples and preparing them for analytical testing. Automated tracking with barcodes and a client portal for accessing results provides greater gains in timeliness, improving client satisfaction and, by extension, improving client retention.
|- 
  | style="background-color:white; padding-left:10px; padding-right:10px;" |"Further expand into the environmental testing industry..."
  | style="background-color:white; padding-left:10px; padding-right:10px;" |We can better meet this goal with a LIMS, as our 22% time savings allows us to take on approximately 6% more workload. We estimate that through pre-loaded environmental workloads and LIMS integration with our environmental testing instruments, we could potentially take on up to another 5 to 6% without adding any additional personnel.
|-
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |Organizational challenge
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" |Tangible/Intangible benefit
|- 
  | style="background-color:white; padding-left:10px; padding-right:10px;" |"We have a bottleneck in sample entry and test scheduling, losing up to six hours of productivity a week."
  | style="background-color:white; padding-left:10px; padding-right:10px;" |A LIMS allows for more rapid, automated sample entry, tracking, and scheduling mechanisms, which could demonstrable recover that productivity loss plus an additional two hours. Adding a client portal where samples can be pre-registered before delivery can provide further efficiency to our lab workflow.
|- 
  | style="background-color:white; padding-left:10px; padding-right:10px;" |"Our clients are complaining about missing reports that we know we mailed."
  | style="background-color:white; padding-left:10px; padding-right:10px;" |Most LIMS provide an administrator-controlled client portal, as an add-on, that will empower clients to view reports wherever and whenever, improving lab-client relations.
|-
|}
|}
 
-- Talk more about a cheat sheet here --
 
Finally, Appendix 1 of this guide provides you with an Excel workbook containing many of the tools referenced in this guide. The LIMS Acquisition and Deployment Justification Workbook has five tabs addressing on-premises vs. cloud LIMS account costing and overall five-year costing, as well as the barcode benefits analysis tables and the tangible and intangible benefits of LIMS acquisition and deployment in tabular form, with value calculation fields. These tools can readily implemented in any cheat sheet you pass on to upper management and other critical stakeholders as part of streamling your overall proposal process.


==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}
==Citation information for this chapter==
'''Chapter''': 3. Gaining buy-in from management and other stakeholders
'''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''':
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Latest revision as of 23:51, 20 September 2023

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1. Introduction to materials and materials testing laboratories

What is a material? This question is surprisingly more complex for the layperson than may be expected. The definition of "material" has varied significantly over the years, dependent on the course of study, laboratory, author, etc. A 1974 definition by Richardson and Peterson that has seen some use in academic study defines a material as "any nonliving matter of academic, engineering, or commercial importance."[1] But recently biomaterials like biopolymers (as replacements for plastics)[2] and even natural[3] and engineered biological tissues[4] may be referenced as "materials." (And to Richardson and Peterson's credit, they do add in the preface of their 1974 work that "[a]lthough the volumes are directed toward the physical sciences, they can also be of value for the biological scientist with materials problems."[5] A modern example would be biodegradable materials research for tissue and medical implant engineering.[6]) Yet today more questions arise. what of matter that doesn't have "academic, engineering, or commercial importance"; can it now be called a "material" in 2023? What if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists? Indeed, the definition of "material" today is no easy task. This isn't made easier when even modern textbooks introduce the topic of materials science without aptly defining what a material actually is[7], let alone what materials science is.[8] Perhaps the writers of said textbooks assume that the definitions of "material" and "materials science" have a "well duh" response.

To complicate things further, a material can be defined based upon the context of use. Take for example the ISO 10303-45 standard by the International Organization for Standardization (ISO), which addresses the representation and exchange of material and product manufacturing information in a standardized way, specifically describing how material and other engineering properties can be described in the model/framework.[9][10] The context here is "standardized data transfer of material- and product-related data," which in turn involves ontologies that limit the complexity of materials science discourse and help better organize materials and product data into information and knowledge. As such, the ISO 10303 set of standards must define "material," and 10303-45 complicates matters further in this regard (though it will be helpful for this guide in the end).

In reviewing ISO 10303-45 in 2009, Swindells notes the following about the standard[10]:

The first edition of ISO 10303-45 was derived from experience of the testing of, so-called, "materials" properties, and the terminology used in the standard reflects this experience. However, the information modelling of an engineering material, such as alloyed steel or high density polyethylene, is no different from the information modelling of a "product." The "material" properties are therefore one of the characteristics of a product, just as its shape and other characteristics are. Therefore all "materials" are products, and the information model in ISO 10303-45 can be used for any property of any product.

Put in other words, for the purposes of defining "material" for a broader, more standardized ontology, materials and products can be viewed as interchangeable. Mies puts this another way, stating that based on ISO 10303-45, a material can be defined as "a manufactured object with associated properties in the context of its use environment."[11] But this representation only causes more confusion as we ask "does a material have to be manufactured?" After all, we have the term "raw material," which the Oxford English Dictionary defines as "the basic material from which a product is manufactured or made; unprocessed material."[12] Additionally, chemical elements are defined as "the fundamental materials of which all matter is composed."[13] Taking into account the works of Richardson and Peterson, Mies, and Swindells, as well as ISO 10303-45, the concepts of "raw materials" and "chemical elements," and modern trends towards the inclusion of biomaterials (though discussion of biomaterials will be limited here) in materials science, we can land on the following definition for the purposes of this guide:

A material is discrete matter that is elementally raw (e.g., native metallic and non-metallic elements), fundamentally processed (e.g., calcium oxide), or fully manufactured (by human, automation, or both; e.g., a fastener) that has an inherent set of properties that a human or automation-driven solution (e.g., an artificial intelligence [AI] algorithm) has identified for a potential or realized use environment.

First, this definition more clearly defines the types of matter that can be included, recognizing that manufactured products may still be considered materials. Initially this may seem troublesome, however, in the scope of complex manufactured products such as automobiles and satellites; is anyone really referring to those types of products as "materials"? As such, the word "discrete" is included, which in manufacturing parlance refers to distinct components such as brackets and microchips that can be assembled into a greater, more complex finished product. This means that while both a bolt and an automobile are manufactured "products," the bolt, as a discrete type of matter, can be justified as a material, whereas the automobile can't. Second—answering the question of "what if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists?"—the definition recognizes that the material needs at a minimum recognition of a potential use case. This turns out to be OK, because if no use case has been identified, the matter still can be classified as an element, compound, or substance. It also insinuates that that element, compound, or substance with no use case isn't going to be used in the manufacturing of any material or product. Third, the definition also recognizes the recent phenomena of autonomous systems discovering new materials and whether or not those autonomous systems should be credited with inventorship.[14] The question of inventorship is certainly worth discussion, though it is beyond the scope of this guide. Regardless, the use of automated systems to match a set of properties of a particular matter to a real-world use case isn't likely to go away, and this definition accepts that likelihood.

Finally, this leads us to the realization that materials, by definition, are inherently linked to the act of intentional human- or automation-driven creation, i.e., manufacturing and construction.


1.1 Materials testing labs, then and now

1.1.1 Materials testing 2.0


1.2 Industries, products, and raw materials

1.3 Laboratory roles and activities in the industry

1.3.1 R&D roles and activities

1.3.2 Pre-manufacturing and manufacturing roles and activities

1.3.3 Post-production quality control and regulatory roles and activities

References

  1. ↑ Richardson, James H.; Peterson, Ronald V. (1974). "Chapter 1: Introduction to Analytical Methods". Systematic Materials Analysis, Part 1. Materials science series. New York: Academic Press. p. 2. doi:10.1016/B978-0-12-587801-2.X5001-0. ISBN 978-0-12-587801-2. https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false. 
  2. ↑ Das, Abinash; Ringu, Togam; Ghosh, Sampad; Pramanik, Nabakumar (1 July 2023). "A comprehensive review on recent advances in preparation, physicochemical characterization, and bioengineering applications of biopolymers" (in en). Polymer Bulletin 80 (7): 7247–7312. doi:10.1007/s00289-022-04443-4. ISSN 0170-0839. PMC PMC9409625. PMID 36043186. https://link.springer.com/10.1007/s00289-022-04443-4. 
  3. ↑ Kurniawan, Nicholas A.; Bouten, Carlijn V.C. (1 April 2018). "Mechanobiology of the cell–matrix interplay: Catching a glimpse of complexity via minimalistic models" (in en). Extreme Mechanics Letters 20: 59–64. doi:10.1016/j.eml.2018.01.004. https://linkinghub.elsevier.com/retrieve/pii/S2352431617301864. 
  4. ↑ Kim, Hyun S.; Kumbar, Sangamesh G.; Nukavarapu, Syam P. (1 March 2021). "Biomaterial-directed cell behavior for tissue engineering" (in en). Current Opinion in Biomedical Engineering 17: 100260. doi:10.1016/j.cobme.2020.100260. PMC PMC7839921. PMID 33521410. https://linkinghub.elsevier.com/retrieve/pii/S246845112030057X. 
  5. ↑ Richardson, James H.; Peterson, Ronald V. (1974). "Preface". Systematic Materials Analysis, Part 1. Materials science series. New York: Academic Press. p. xiii. doi:10.1016/B978-0-12-587801-2.X5001-0. ISBN 978-0-12-587801-2. https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false. 
  6. ↑ Modrák, Marcel; Trebuňová, Marianna; Balogová, Alena Findrik; Hudák, Radovan; Živčák, Jozef (16 March 2023). "Biodegradable Materials for Tissue Engineering: Development, Classification and Current Applications" (in en). Journal of Functional Biomaterials 14 (3): 159. doi:10.3390/jfb14030159. ISSN 2079-4983. PMC PMC10051288. PMID 36976083. https://www.mdpi.com/2079-4983/14/3/159. 
  7. ↑ Callister, William D.; Rethwisch, David G. (2021). "Chapter 1. Introduction". Fundamentals of materials science and engineering: An integrated approach. Hoboken: Wiley. pp. 2–18. ISBN 978-1-119-74773-4. https://books.google.com/books?id=NC09EAAAQBAJ&newbks=1&newbks_redir=0&printsec=frontcover. 
  8. ↑ Sutton, Adrian P. (2021). Concepts of materials science (First edition ed.). Oxford [England] ; New York, NY: Oxford University Oress. ISBN 978-0-19-284683-9. 
  9. ↑ "ISO 10303-45:2019 Industrial automation systems and integration — Product data representation and exchange — Part 45: Integrated generic resource: Material and other engineering properties". International Organization for Standardization. November 2019. https://www.iso.org/standard/78581.html. Retrieved 20 September 2023. 
  10. ↑ 10.0 10.1 Swindells, Norman (2009). "The Representation and Exchange of Material and Other Engineering Properties" (in en). Data Science Journal 8: 190–200. doi:10.2481/dsj.008-007. ISSN 1683-1470. http://datascience.codata.org/articles/abstract/10.2481/dsj.008-007/. 
  11. ↑ Mies, D. (2002). "Chapter 17. Managing Materials Data". In Kutz, Myer. Handbook of materials selection. New York: J. Wiley. p. 499. ISBN 978-0-471-35924-1. https://books.google.com/books?id=gWg-rchM700C&pg=PA499. 
  12. ↑ "raw material". Oxford English Dictionary. https://www.oed.com/search/dictionary/?scope=Entries&q=raw+material. Retrieved 20 September 2023. 
  13. ↑ Lagowski, J.J.; Mason, B.H.; Tayler, R.J. (16 August 2023). "chemical element". Encyclopedia Britannica. https://www.britannica.com/science/chemical-element. Retrieved 20 September 2023. 
  14. ↑ Ishizuki, Naoya; Shimizu, Ryota; Hitosugi, Taro (31 December 2023). "Autonomous experimental systems in materials science" (in en). Science and Technology of Advanced Materials: Methods 3 (1): 2197519. doi:10.1080/27660400.2023.2197519. ISSN 2766-0400. https://www.tandfonline.com/doi/full/10.1080/27660400.2023.2197519. 
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