Difference between revisions of "User:Shawndouglas/sandbox/sublevel1"

From LIMSWiki
Jump to navigationJump to search
 
(147 intermediate revisions by the same user not shown)
Line 1: Line 1:
===6.1 Conduct initial research into a specification document===
{{Saved book
A specification is "a detailed precise presentation of something or of a plan or proposal for something."<ref name="MWSpec">{{cite web |url=https://www.merriam-webster.com/dictionary/specification |title=specification |work=Merriam-Webster |publisher=Merriam-Webster, Inc |accessdate=18 November 2021}}</ref> This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they "present" their use case with the help of a requirements specification, and the vendor "presents" their ability (or inability) to comply through documentation and demonstration (more on that later). However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. This is where initial specification research comes into play for the lab.
|title=Introduction to Quality and Quality Management Systems
|subtitle=
|cover-image=Time-Quality-Money.png
|cover-color=#fffccc
| setting-papersize = A4
| setting-showtoc = 1
| setting-columns = 1
}}


Your lab's requirements specification document will eventually be a critical component for effectively selecting a laboratory informatics solution. There are numerous ways to approach the overall development of such a document. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your lab accomplish its goals. LIMSpec makes for one of the more thorough starting points to use, though you could also use other structured documents that have been developed by others. For the purposes of this guide, we'll look at LIMSpec.
==''Introduction to Quality and Quality Management Systems''==
{{ombox
| type      = content
| style    = width: 500px;
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
}}
The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.


The version of LIMSpec included in Appendix 1 of this guide is a slightly tweaked version of the original [[Book:LIMSpec 2019 R1|LIMSpec 2019]] document, omitting a few of the specialty laboratory functions that aren't applicable to clinical diagnostic and research laboratories. You'll note that it's divided into five distinct sections, with numerous subsections in each:
;1. What is quality?
:''Key terms''
:[[Quality (business)|Quality]]
:[[Quality assurance]]
:[[Quality control]]
:''The rest''
:[[Data quality]]
:[[Information quality]]
:[[Nonconformity (quality)|Nonconformity]]
:[[Service quality]]
;2. Processes and improvement
:[[Business process]]
:[[Process capability]]
:[[Risk management]]
:[[Workflow]]
;3. Mechanisms for quality
:[[Acceptance testing]]
:[[Conformance testing]]
:[[Clinical quality management system]]
:[[Continual improvement process]]
:[[Corrective and preventive action]]
:[[Good manufacturing practice]]
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
:[[Quality management]]
:[[Quality management system]]
:[[Total quality management]]
;4. Quality standards
:[[ISO 9000]]
:[[ISO 13485]]
:[[ISO 14000|ISO 14001]]
:[[ISO 15189]]
:[[ISO/IEC 17025]]
:[[ISO/TS 16949]]
;5. Quality in software
:[[Software quality]]
:[[Software quality assurance]]
:[[Software quality management]]


* Primary Laboratory Workflow
<!--Place all category tags here-->
** 1. Sample and experiment registration
** 2. Sample management
** 3. Core laboratory testing and experiments
** 4. Results review and verification
** 5. Sample, experiment, and study approval and verification
** 6. Reporting
* Maintaining Laboratory Workflow and Operations
** 7. Document management
** 8. Resource management
** 9. Compliance management
** 10. Instrument and equipment management
** 11. Batch and lot management
** 12. Scheduled event management
** 13. Instrument data capture and control
** 14. Standard and reagent management
** 15. Inventory management
** 16. Investigation and quality management
* Specialty Laboratory Functions (minus non-relevant industries)
** 18. Statistical trending and control charts
** 21. Forensic case and data management
** 22. Public health data management
** 23. Veterinary data management
** 24. Scientific data management
** 25. Health information technology
* Technology and Performance Improvements
** 26. Instrument data systems functions
** 27. Systems integration
** 28. Laboratory scheduling and capacity planning
** 29. Lean laboratory and continuous improvement
** 30. Artificial intelligence and smart systems
* Security and Integrity of Systems and Operations
** 31. Data integrity
** 32. Configuration management
** 33. System validation and commission
** 34. System administration
** 35. Cybersecurity
** 36. Information privacy
 
These sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements.
 
During the initial research towards your URS, you won't have to include every requirement for when you approach potential vendors. Most vendors appreciate a more inviting approach that doesn't overwhelm, at least initially. You will want to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. In fact, you'll want to wait until after participating in several software demonstrations before even considering your URS to be complete. (More on that in 6.3.1.) This naturally leads us to a discussion about the RFI process.
 
==References==
{{Reflist}}

Latest revision as of 19:46, 9 February 2022

Introduction to Quality and Quality Management Systems
Time-Quality-Money.png
This user book is a user-generated collection of LIMSWiki articles that can be easily saved, rendered electronically, and ordered as a printed book.
If you are the creator of this book and need help, see Help:Books.
Edit this book: Book Creator · Wikitext
Select format to download:

PDF (A4) · PDF (Letter)

Order a printed copy from these publishers: PediaPress
[ Start ] [ FAQ ] [ Basic help ] [ Advanced help ] [ Feedback ] [ Recent Changes ]


Introduction to Quality and Quality Management Systems

This book should not be considered complete until this message box has been removed. This is a work in progress.

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management


Retrieved from "https://www.limswiki.org/index.php?title=User:Shawndouglas/sandbox/sublevel1&oldid=46244"