quality assurance - state hygienic laboratory · quality control 40 cfr 136.7 the...
TRANSCRIPT
![Page 1: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/1.jpg)
Quality Assurance Key Practices for Your Lab
September 2017Iowa’s Environmental & Public Health Laboratory
Copyright the State Hygienic Laboratory at the University of Iowa 2017. All rights reserved. Images may be subject to copyright.
![Page 2: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/2.jpg)
Agenda
• Introduction• Pre-Quiz• Key Practices• Post-Quiz• Questions
![Page 3: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/3.jpg)
60 Minute Schedule
• Introduction 5 min• Pre-Quiz 5 min• Key Practices
– Standard Work 20 min– Quality Control 15 min
• Post-Quiz 5min• Questions ( 10 min float)
![Page 4: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/4.jpg)
Introduction
Mark Pendergast• 15 years as an analytical chemist
– GCMS, HPLC, Nutrients– Microscopist
• 2015 to Present – Manager, Quality Systems– Advisor to SHL Director
• Contact Information– [email protected]– 319.335-4236
![Page 5: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/5.jpg)
Standard Work
• Hand Out and Exercise
![Page 6: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/6.jpg)
Quality Control1. DOC2. MDL3. LRB4. LFB5. MS/MSD6. ISTD7. CCV8. Control Charts9. Corrective Action10. QC Acceptance Criteria11. Definitions12. Minimum Frequency for QC
![Page 7: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/7.jpg)
Quality Control1. DOC2. MDL3. LRB4. LFB5. MS/MSD6. ISTD7. CCV8. Control Charts9. Corrective Action10. QC Acceptance Criteria11. Definitions12. Minimum Frequency for QC
![Page 8: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/8.jpg)
Process
• Document Hierarchy
![Page 9: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/9.jpg)
Process
• Measurement Process
Quality Assurance of Chemical Measurements – John Keenan Taylor
![Page 10: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/10.jpg)
Quality Control
Meet the needs of the users• Satisfactory• Adequate• Dependable• Economic
![Page 11: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/11.jpg)
Quality Control40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with any part 136 chemical method or an alternative method specified by the permitting authority. These QA/QC procedures are generally included in the analytical method or may be part of the methods compendium for approved Part 136 methods from a consensus organization. For example, Standard Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The permittee/laboratory shall follow these QA/QC procedures, as described in the method or methods compendium. If the method lacks QA/QC procedures, the permittee/laboratory has the following options to comply with the QA/QC requirements:
12 Elements
![Page 12: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/12.jpg)
Quality Control40 CFR 136.7
• Use suitable QA/QC procedures • Standard Methods contains QA/QC procedures (part 1000)• The permittee/laboratory shall follow these QA/QC procedures, as described in
the method or methods compendium. • If the method lacks QA/QC procedures, the permittee/laboratory has the
following options to comply with the QA/QC requirements:– 12 Elements
![Page 13: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/13.jpg)
Quality ControlStandard Method 1020 B.
Include in each analytical method or SOP the minimum required QC for each analysis.
14 Elements
![Page 14: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/14.jpg)
Control Charts & QC Limits
1. Percent Recovery (unknown compared to known)
2. Relative Percent Difference (duplicate samples comparing two values)
3. X Control Chart
![Page 15: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/15.jpg)
Control Charts & QC Limits
X Control Chart 1. Mean (establish from 20 data points)2. Warning Limits (2 standard deviations)3. Control Limits (3 standard deviations)
![Page 16: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/16.jpg)
Control Charts & QC Limits
Control Limits– Control charts utilize a central line to define and
provide the best estimate of the variable plotted.
– Control limits define the bounds of virtually all values produced and in statistical control.
![Page 17: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/17.jpg)
Control Charts & QC Limits
Standard Deviation– Standard deviation is only an estimate based on
limited data. – Represents the spread around the mean. Is used
to establish control of a measurment.
![Page 18: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/18.jpg)
QC Frequency
• Follow your method requirements
• If in doubt contact lab certification program
![Page 19: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/19.jpg)
Corrective Action
Culture• Create a culture to discover and report
nonconforming events• Nonpunitive• link events to process improvement• provide education open communication
![Page 20: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/20.jpg)
Corrective Action
A Just Culture• Unintended, honest human error - error was
not intended but resulted from distractions and system problems; most common.
• At-risk behavior - employee thinks actions are sufficient, but are not (shortcutting)
• Reckless behavior - employee knows the risk but does it anyway
![Page 21: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/21.jpg)
Corrective Action
Nonconforming Event (NCE) Management• Detect and Discover • NCE Reporting Mechanism• Action to the NCE
![Page 22: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/22.jpg)
Corrective Action
Not all actions are the same• Remidial Action - action taken to rectify a
recongnized NCE• Corrective Action - action taken to remove the root
cause of the NCE• Preventive Action - action taken to eliminate the
cause of a potential NCE
![Page 23: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/23.jpg)
Corrective Action
InvestigateReview your lab's workflow• Pre-analytical• Analytical• Post-analytical
The what, how, and why
![Page 24: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/24.jpg)
Corrective Action
DocumentRecord of action relating to NCE
![Page 25: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/25.jpg)
Corrective Action
AssistanceForms and assistance available, just ask.
![Page 26: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/26.jpg)
Demonstration of Capability (DOC)
Initial Can the lab and the analyst perform the method and obtain acceptable results for each analyte?
What the SHL does for documenting initial DOCs:– Four Blind Spikes– Each analyst before performing testing
![Page 27: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/27.jpg)
Demonstration of Capability (DOC)
OngoingDemonstrates laboratory performance versus method performance (Also known as the laboratory control sample)
What the SHL does for documenting ongiong DOCs:One of the following is used:– Acceptable performance of a blind sample (PT)– Another initial DOC– Four consecutive analytical runs of acceptable control samples – Duplicate analyst analysis (when other options are unavailable)
![Page 28: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/28.jpg)
Next Steps
Plan, Do, Check, Analyze1. Review your policy, process, procedure, and
forms2. Improve and Repeat
![Page 29: Quality Assurance - State Hygienic Laboratory · Quality Control 40 CFR 136.7 The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with](https://reader034.vdocuments.net/reader034/viewer/2022042411/5f2919dbfc8b9f413c2a4091/html5/thumbnails/29.jpg)
QUESTIONS?
Acknowledgements• CFR• Standard Methods• Quality Assurance of Chemical Measurements –
John Keenan Taylor• CLSI – QMS11-A Management of Nonconforming
Laboratory Events; Approved Guideline• BD Medical and Life Sciences• Google