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©2013 Waters Corporation 1
Creating a Robust
and Sustainable
Quality Assurance Program
©2013 Waters Corporation 2
Moderator: Rick Persichitte
Senior Account Representative
ERA – A Waters Company
Presenter: Tom Widera
Product Line Manager - Inorganics
ERA – A Waters Company
©2013 Waters Corporation 3
Manufacturing reference
standards since 1977
25,000 sf dedicated laboratory
space
> 7,000 laboratories
> 80 countries
> 35 scientists on staff
About ERA
©2013 Waters Corporation 4
Air & emissions
Waste water
Drinking water
Soils
Microbiology
Radiochemistry
Custom standards
52 PT studies per year
About ERA
©2013 Waters Corporation 5
Agenda
Definition of Certified Reference Material
Basics of quality control
— Method development
— Staff training
— Ongoing performance
— Corrective action
Types and uses of CRMs
©2013 Waters Corporation 6
Definition of CRM
©2013 Waters Corporation 7
What are CRMs?
Reference Material*
— sufficiently homogeneous
— stable with respect to one or more specified properties
— fit for its intended use
Certified Reference Material*
— metrologically valid procedure
— one or more specified properties
— accompanied by certificate
o specified property
o associated uncertainty
o statement of metrological traceability
*Source: ISO Guide 34:2009, 3.4 and 3.5
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What are CRMs?
Characteristics of Certified Reference Materials:
— Known concentrations (assigned values)
— Known uncertainty, homogeneity and stability
— Assigned values are traceable to an independent reference
— Includes a certificate of analysis (CofA)
o Characteristics of the CRM
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Certificate of Analysis
Certified value Uncertainty Performance acceptance limits NIST traceability Accreditations and registration
©2013 Waters Corporation 10
Basics of Quality Assurance
©2013 Waters Corporation 11
Basics of quality assurance
Four basic laboratory functions
— Method development
— Staff training
— Ongoing performance
— Corrective action
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Basics of quality assurance
©2013 Waters Corporation 13
Method Development
Key areas of method development
— Precision
— Accuracy
— Analysis range
— Ruggedness
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Method Development
Precision
— “Degree of agreement between independent measurements under
controlled conditions”
— How close repeated measurements are to each other
— Represented by standard deviation
Accuracy
— “Degree of agreement of a measured value with the true or
expected value”
— How close measurements are to the “true” value
— Represented by the percent recovery
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Method Development
Precision and accuracy
Precise but not accurate Accurate but not precise
©2013 Waters Corporation 16
Method Development
Precision
— Short-term studies and long-term studies
o Short term variability = repeatability
• 1-3 days
• Same prep and analysis conditions
o Long term variability = reproducibility
• Extended time period
• Potentially different instrument or laboratory conditions
Accuracy
— How close should results be?
o Method-based criteria
o In-house QA/QC criteria
• Control charting
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Basics of quality control
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Staff Training
Initial training
— Communicating procedures
— Observe trained analysts
— Lab safety rules
— Importance of ethics
Ensure that the training was effective
— CRMs are effective tools
— Document precision and accuracy
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Basics of quality assurance
©2013 Waters Corporation 20
Ongoing Performance
Variables can affect an established method
— Analysts
— Instruments
— Laboratory environment
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Ongoing Performance
Routine use of CRMs
— Calibration
o Trusted source
o Traceable to a NIST standard reference material (SRM)
— Continuing calibration verification (CCV)
o Same source as calibration
o Analyzed at routine intervals
o Check for analytical drift
— Independent calibration verification (ICV)
o Independent of the calibration source
o Generally mid-calibration range
o Control chart the results of ICV analysis
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Ongoing Performance
Control charting
— Plot the percent recovery of a CRM
— Each analysis
— Analyzed with each analytical batch
— Use the same CRM provider
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Ongoing Performance
90
95
100
105
110
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Re
co
ve
ry (%
)
Analyte Control Chart
Recovery
LWL
UWL
LCL
UCL
Trend
Outside of control limits
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Ongoing Performance
Control charting
— Apply preventive action
— Implement corrective action
— Document the corrective action
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Basics of quality assurance
©2013 Waters Corporation 26
Corrective Action
Corrective action indicators
— Failed proficiency test
— Calibration failure
— Data outside control chart limits
Corrective action process
— Root cause analysis
— Implement corrections
— Confirm corrections are appropriate and effective
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Corrective Action
Root cause analysis
— Man
— Machine
— Material
— Method
Implement corrections
Confirm appropriate and effective
— Analyze CRM
— Long-term control charting
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Basics of quality assurance
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How CRMs can help your analyses
©2013 Waters Corporation 30
ERA’s CRMs
Waste Water
Effluent
Drinking Water
Clean Water
Soil
Air and Emissions
Microbiology
Radiochemistry
Organic Chemicals
Inorganic Chemicals
Physical Properties
Calibration
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ERA’s CRMs
Certified Reference Materials
— Known concentrations of various analytes
— Guide 34 accredited manufacturer of reference standards
— Analytically verified by ERA’s in-house laboratory
— Values for analytes are assigned based on weights and measures
— Manufactured using NIST traceable balances and calibrated class A
glassware
— Traceable to a NIST standard reference material
— Multiple lots in stock
— Certificate of analysis
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ERA’s CRMs
Uses
— Routine quality control
— Method development
— Control charting (ICV)
— Analyst demonstration of capability
— Corrective action
— Calibration
©2013 Waters Corporation 33
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