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<div class="nonumtoc">__TOC__</div>
{{Saved book
These addendums to the [[User:Shawndouglas/sandbox#System questionnaire|primary system questionnaire]] cover industry-specific laboratory requirements not common to other labs.  
|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
}}


==1.6 Industry-specific==
==''Introduction to Quality and Quality Management Systems''==
{|  
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| type      = content
===1.6a Agriculture industry===
| style    = width: 500px;
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
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  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6a.1 '''Compliance and support'''
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.
|-
 
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
;1. What is quality?
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
:''Key terms''
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
:[[Quality (business)|Quality]]
|-
:[[Quality assurance]]
  | style="padding:5px; width:500px;" |'''a.''' Does your system support the Food and Drug Administration's (FDA) and the United States Department of Agriculture's (USDA) mandatory hazard analysis and critical control points (HACCP) programs for seafood, juice, and meat?
:[[Quality control]]
  | style="background-color:white; padding:5px;" |
:''The rest''
  | style="background-color:white;" |
:[[Data quality]]
|-
:[[Information quality]]
  | style="padding:5px; width:500px;" |'''b.''' Does your system support the USDA organic regulations of 7 CFR Section 205? Please explain how.
:[[Nonconformity (quality)|Nonconformity]]
  | style="background-color:white; padding:5px;" |
:[[Service quality]]
  | style="background-color:white;" |
;2. Processes and improvement
|-
:[[Business process]]
  | style="padding:5px; width:500px;" |'''c.''' Can your system manage the activities necessary to support the USDA's Pesticide Data Program?
:[[Process capability]]
  | style="background-color:white; padding:5px;" |
:[[Risk management]]
  | style="background-color:white;" |
:[[Workflow]]
|-
;3. Mechanisms for quality
|}
:[[Acceptance testing]]
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
:[[Conformance testing]]
|-
:[[Clinical quality management system]]
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6a.2 '''Pre-analysis and testing'''
:[[Continual improvement process]]
|-
:[[Corrective and preventive action]]
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
:[[Good manufacturing practice]]
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
:[[Quality management]]
|-  
:[[Quality management system]]
  | style="padding:5px; width:500px;" |'''a.''' Can your system efficiently receive and process data captured by remote inspectors? If so, how?
:[[Total quality management]]
  | style="background-color:white; padding:5px;" |
;4. Quality standards
  | style="background-color:white;" |
:[[ISO 9000]]
|-
:[[ISO 13485]]
  | style="padding:5px; width:500px;" |'''b.''' Does your system provide a transport and routing management module?
:[[ISO 14000|ISO 14001]]
  | style="background-color:white; padding:5px;" |
:[[ISO 15189]]
  | style="background-color:white;" |
:[[ISO/IEC 17025]]
|-
:[[ISO/TS 16949]]
  | style="padding:5px; width:500px;" |'''c.''' Does your system permit input and query of information such as (but not limited to) client ID numbers, animal species, animal breed, animal sex, animal diagnostic test performed, animal diagnostic test result, client or bill to zip code, program or funding codes, date ranges, lab department, case coordinator, and lab technician? Please provide details.
;5. Quality in software
  | style="background-color:white; padding:5px;" |
:[[Software quality]]
  | style="background-color:white;" |
:[[Software quality assurance]]
|-
:[[Software quality management]]
  | style="padding:5px; width:500px;" |'''d.''' Does your system allow users to group soil and water samples, including test results, by location and depth?
 
  | style="background-color:white; padding:5px;" |
<!--Place all category tags here-->
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Does your system provide the standard tests associated with agricultural analysis?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' Does your system permit manual override of allowable test/species combinations for circumstances outside the norm? If so, to what extent?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6a.3 '''Post-analysis'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system offer a way to separately manage non-compliance records?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system make report output available online for external and internal web viewing?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
===1.6b Chemical and petrochemical industry===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6b.1 '''Compliance and support'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system support the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) requirements?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6b.2 '''Pre-analysis and testing'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system include multi-level product specification management?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system provide product and batch traceability?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system support statistical process control (SPC) quality control methodology and provide SPC charting tools?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system permit on-demand customization of instrument calibration and maintenance protocols?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Can your system interface with digital control systems (DCSs)?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' Can your system interface with [[laboratory execution system]]s (LESs)? If so, how?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' Does your system provide the standard tests associated with chemical analysis, including density, limit, melting point, and acid neutralization testing?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' Does your system integrate [[ELN feature#Chemical and/or mathematical drawing and calculation|chemical drawing and computational tools]]? If not, can it interface with third-party chemical drawing tools like ChemDraw, MarvinSketch, and Ketcher?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' Does your system allow the import of [[ELN feature#Chemical and spectrum file support|chemical structure and spectroscopic files]]?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' Does your system permit users to query by functional group or designed structure?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
===1.6c Environmental, water, and wastewater industry===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6c.1 '''Compliance and support'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system support the baseline requirements of the Department of Defense's (DoD) Quality Systems Manual (QSM) for Environmental Laboratories?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system support the electronic delivery of analytical data for environmental programs via the EPA's Staged Electronic Data Deliverable (SEDD) format?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system support the Cross Media Electronic Reporting Rule (CROMERR) of [[40 CFR Part 3|Title 40 CFR Part 3]]?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6c.2 '''Pre-analysis and testing'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Can your system generate permits, permit applications, directions for the application, and semi-annual report templates with fields like "name of industry," "mailing address," "SIC code," "permit number," and "contact name"?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Can your system generate correspondence letters for permit renewals and new permits?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system store permits for each industry?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system index all industries/companies by Standard Industrial Classification (SIC) code?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Does your system index all industries/companies by: categorical and non-categorical, exempt and non-exempt, alphabetical order, permit number, bar code, permit due dates, as well as daily, weekly, biweekly, monthly, quarterly, bi-annual, and annual?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' Does your system contain an address book for all industries and programs in environmental compliance that indexes alphabetically, by industry, by address, etc.?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' Does your system provide a flexible procedure for assigning location codes or sample types for each default sample point, including tests required, report types, invoice information, maximum holding time, project accounts, and location description; each location code has an upper and lower warning limit, target specification for every analyte assigned, and stored defaults for all user-defined universal fields, special project fields, and sample comments?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' Does your system store standard operating procedures (SOPs) for all pretreatment procedures?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' Does your system permit entering matrix duplicates for oil and grease samples?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' Does your system include tools to track and monitor nuclear-related sample and analysis data?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' Does your system include tools to track and monitor hazardous waste sample and analysis data?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6c.3 '''Post-analysis'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system allow for the electronic exportation of [[LIMS feature#Raw data management|raw]] quality control data?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system include tools to measure data against different quality objectives?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system link all lab results with the correct reporting test method?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Can your system generate and print industrial reports, sampling reports, inspection reports, fact sheets, citations, formal charges, correspondence letters, and industrial permits?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Can your system generate and print corresponding letters/templates for special and routine cases (e.g. industrial waste, permit renewals, semi-annual reports)?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' Can your system generate and print sampling cost reports for each industry, including the number of visits, types of analyses, calculated administrative cost, tubing cost, and duplicate sample cost, etc.?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' Can your system generate and print a biochemical oxygen demand (BOD) and total suspended solids (TSS) result report for industries?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' Can your system generate and print a special report for HAZMAT incidents, storm water violations, spills/slugs, and local limit violators?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' Can your system generate and print a report that determines if an industry is in significant non-compliance (SNC)?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' Does your system index and compile lists of businesses and industries that are in non-compliance/violation?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' Can your system generate notices of violation according to permit criteria and local limits?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' Does your system determine violation by either combined waste stream formula or local limits? If so, explain.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' Can your system generate documentation for filing charges?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' Can your system generate reminder notices for citation dates?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' Can your system link permit criteria with significantly non-compliant criteria?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' Does your system calculate surcharge fees for each industry?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''q.''' Does your system calculate surcharge from chain of custodies and data results?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''r.''' Can your system compile cost data for each industry?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
===1.6d Forensics industry===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6d.1 '''Compliance and support'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system meet [[The American Society of Crime Laboratory Directors/Laboratory Accreditation Board|ASCLD]] standards for certified lab evidence transfers?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system support [[ASTM International|ASTM]] standards, including evidence handling and numbering?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system permit analysis of evidence in support of intelligence activities, including dissemination of document intelligence, document analysis, and other technical information to the law enforcement community?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system facilitate sharing of information with federal, state, and local law enforcement agencies? Please explain how.
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6d.2 '''Pre-analysis and testing'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system provide functionality for each discipline, including latent prints, crime scene unit, multi-media lab, evidence control, ballistics, polygraph, forensic chemistry, and DNA?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system manage inventory of chemicals, ammo, supplies, etc.?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system maintain evidence inventory and include the ability to make a report from it?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system support open field numbering to create evidence packets?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Does your system support additional segmentation of evidence?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' Does your system provide complete, accurate, and timely processing and tracking of evidence, reports, and statistical information?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' Does your system use [[LIS feature#Barcode and/or RFID support|barcode or radio frequency]] (RFID) technology to identify and track property/evidence?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' Does your system make evidence associated with a case or submission searchable by defendant, victim, case number, etc.?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' Does your system record transaction date/time/persons associated with the movement of lab evidence?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''j.''' Does your system provide a complete reconciliation history for each evidence item stored in the system?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''k.''' Does your system implement security functions such as password, PIN, etc. for evidence transfers?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''l.''' Does your system list evidence currently or recently checked out by an analyst?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''m.''' Does your system initiate automatic flags and processing for evidence return?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''n.''' Does your system provide automated chain of custody for all items of evidence?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''o.''' Does your system permit a supervisor or assignee to review all pending cases before assignment to staff?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''p.''' Does your system internally manage [[LIMS feature#Case management|case workflow]], including case assignment, case forwarding, and notification?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''q.''' Does your system allow authorized users to configure case reports for location?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''r.''' Does your system support a statewide single case number?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''s.''' Does your system link system and lab case numbers or Z (database) numbers?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''t.''' Does your system make objects associated with a case or submission accessible only from within the application?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''u.''' Can your system capture data from external property management systems?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''v.''' Does your system support the documentation of expert witness and other court testimony in courts of law and other judicial proceedings?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''w.''' Does your system support submission of forensic analysis requests electronically via e-mail, the FDL intranet, or FTP server?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''x.''' Does your system permit authorized users to define analytical test parameters based on case and standard operation procedure (SOP)?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''y.''' Does your system support the analysis of document and fingerprint evidence?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6d.2 '''Post-analysis'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system require case notes, data, and reports to be previewed before approval?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system provide report templates with variable fields for things such as case, item results, and conclusion?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system collect data on and report on meeting forensic case requester and case return deadlines?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Does your system provide to external customers and staff automated, limited [[LIMS feature#External monitoring|remote access]] to the database for case status inquiries and to view case reports?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Does your system provide a record locate function by name, agency, ORI, etc.?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
===1.6e Medical, public health, and veterinary industry===
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6e.1 '''Compliance and support'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Can your system create reports for and route samples to the Centers for Disease Control and Prevention (CDC), Food and Drug Administrations (FDA), Environmental Protection Agency (EPA). and other contract laboratories?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Can your system record test results or map them to the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) and/or Logical Observation Identifiers Names and Codes (LOINC) standards?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Does your system record veterinary tests with results and map them to VeNom (Veterinary Nomenclature) Codes?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6e.2 '''Pre-analysis and testing'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Can your system differentiate among clinical, environmental, and other types of samples and their associated test requests?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''b.''' Does your system handle biobanking and blood banking activities and the data associated with them? If so, how?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''c.''' Can your system geographically organize clinical, environmental, and other types of samples and their associated tests for special analysis?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''d.''' Can your system capture and store patient demographics, risk factors, and exposure data included with third-party test requests?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''e.''' Can your system accept and process third-party epidemiology data associated with test requests?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''f.''' Does your system provide the tools for creating and maintaining licensing, proficiency testing, inspection, and regulatory records for other public health laboratories within jurisdiction?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''g.''' Does your system include an incident tracking system for recording, investigating, and managing safety and accident violations in the laboratory and other industries?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''h.''' Does your system include or integrate with an [[electronic medical record|electronic medical]] or [[electronic health record|health record]] system?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
  | style="padding:5px; width:500px;" |'''i.''' Does your system include an [[electronic medical record]] specifically for animal care?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="3" style="color:DarkSlateGray; text-align:left; padding-left:40px;"| 1.6e.3 '''Post-analysis'''
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Request for information
  ! style="color:brown; background-color:#ffffee; width:100px;"| Requirement code
  ! style="color:brown; background-color:#ffffee; width:700px;"| Vendor response
|-
  | style="padding:5px; width:500px;" |'''a.''' Does your system automatically report any diagnostic test results deemed "suspect" or "positive" for reportable diseases?
  | style="background-color:white; padding:5px;" |
  | style="background-color:white;" |
|-
|}
|}

Latest revision as of 19:46, 9 February 2022

Introduction to Quality and Quality Management Systems
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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


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