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

From LIMSWiki
Jump to navigationJump to search
 
(146 intermediate revisions by the same user not shown)
Line 1: Line 1:
In some cases—particularly if your organization is of significant size—it may make sense to issue a formal RFI or request for proposal (RFP) and have laboratory informatics vendors approach your lab with how they can meet its needs. The RFI and RFP are traditional means towards soliciting bidding interest in an organization's project, containing the organization's specific requirements and vital questions that the bidder should be able to effectively answer. However, even if your organization chooses to skip the RFI or RFP process and do most of the investigative work of researching and approaching informatics vendors, turning to a key set of questions typically found in an RFI is extremely valuable towards your fact finding.
{{Saved book
|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
}}


An RFI is an ideal means for learning more about a potential solution and how it can solve your problems, or for when you're not even sure how to solve your problem yet. However, the RFI should not be unduly long and tedious to complete for prospective vendors; it should be concise, direct, and honest. This means not only presenting a clear and humble vision of your own organization and its goals, but also asking just the right amount of questions to allow potential vendors to demonstrate their expertise and provide a clearer picture of who they are. Some take a technical approach to an RFI, using dense language and complicated spreadsheets for fact finding. However, as previously noted, you will want to limit the specified requirements in your RFI to those carefully chosen because they matter to you and your lab the most.<ref name="HolmesItsAMatch">{{cite web |url=https://allcloud.io/blog/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner/ |title=It's a Match: How to Run a Good RFI, RFP, or RFQ and Find the Right Partner |author=Holmes, T. |work=AllCloud Blog |accessdate=30 November 2021}}</ref>
==''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.


Remember, an RFI is not meant to answer all of your questions. The RFI is meant as a means to help narrow down your search to a few quality candidates while learning more about each other.<ref name="HolmesItsAMatch" /> Once the pool of potential software vendors is narrowed down, and you then participate in their demonstrations, you then can broadly add more requirements to the original collection of critical requirements from the RFI to ensure those providers meet all or most of your needs. That said, be cognizant that there may be no vendor that can meet each and every need of your lab. Your lab will have to make important decisions about which requirements are non-negotiable and which are more flexible. The vendors you engage with may be able to provide realistic advice in this regard, based upon your lab's requirements and their past experience with labs. As such, those vendors with real-world experience meeting the needs of clinical and research laboratories may have a strong leg up on other vendors.
;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]]


Again, Appendix 1 of this guide includes a comprehensive specifications document called LIMSpec, from which you can draw the requirements that are most critical to be addressed in an RFI. If you have zero experience developing an RFI, you may want to first seek out various example RFIs on the internet, as well as some basic advice articles on the topic. Some websites may provide templates to examine for further details. Broadly speaking, if you're conducting a full RFI or RFP, you're going to lead with the standard components of an RFI or RFP, including:
<!--Place all category tags here-->
 
* a table of contents;
* an honest introduction and overview of your organization, its goals and problems, and the services sought to solve them;
* details on how the RFI or RFP evaluation process will be conducted;
* basis for award (if an RFP);
* the calendar schedule (including times) for related events;
* how to submit the document and any related questions about it, including response format; and
* your organization's background, business requirements, and current technical environment.
 
Being honest about your organization, it's informatics requirements, and its current technical environment upfront in the RFI or RFP will also ensure that the time spent on the process is optimized for all involved parties. Before submitting any RFI, your lab will want to conduct thorough internal research ensuring everyone understands what the current technology and processes are, and how you all want to shape that with the introduction or updating of laboratory informatics systems. (If your lab has limited to no experience with adding automation and informatics elements to a laboratory, you may want to read through laboratory informatics veteran Joe Liscouski's [[LII:The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies|''The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies'']] for further insight.) You'll also want to answer critical questions such as "who will be responsible for maintaining the solution and its security?" and "how will our processes and procedures change with the introduction or updating of informatics systems?". These and other questions make up your business considerations, which should also address the:
 
* acquisition and long-term maintenance budget;
* diversity of laboratory services offered now and into the future;
* level of in-house knowledge and experience with informatics systems and automation;
* level of in-house, executive buy-in of informatics adoption; and
* need for additional vendor pre-planning.
 
One other note: make it clear in any issued RFI that it's strictly a request for information and not a guarantee to issue a contract with any respondent.
 
==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

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