Creating a Robust and Sustainable Quality Assurance Program documents/Webinar_Robust_and_Sus… · Certified Reference Materials —Known concentrations of various analytes —Guide

©2013 Waters Corporation 1

Creating a Robust

and Sustainable

Quality Assurance Program


Moderator: Rick Persichitte

Senior Account Representative

ERA – A Waters Company

Presenter: Tom Widera

Product Line Manager - Inorganics

ERA – A Waters Company


Manufacturing reference

standards since 1977

25,000 sf dedicated laboratory

space

> 7,000 laboratories

> 80 countries

> 35 scientists on staff

About ERA


Air & emissions

Waste water

Drinking water

Soils

Microbiology

Radiochemistry

Custom standards

52 PT studies per year

About ERA


Agenda

Definition of Certified Reference Material

Basics of quality control

— Method development

— Staff training

— Ongoing performance

— Corrective action

Types and uses of CRMs


Definition of CRM


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


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


Certificate of Analysis

Certified value Uncertainty Performance acceptance limits NIST traceability Accreditations and registration


Basics of Quality Assurance


Basics of quality assurance

Four basic laboratory functions


— Staff training

— Ongoing performance





Method Development

Key areas of method development

— Precision

— Accuracy

— Analysis range

— Ruggedness


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


Method Development

Precision and accuracy

Precise but not accurate Accurate but not precise


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


Basics of quality control


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




Ongoing Performance

Variables can affect an established method

— Analysts

— Instruments

— Laboratory environment


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


Ongoing Performance

Control charting

— Plot the percent recovery of a CRM

— Each analysis

— Analyzed with each analytical batch

— Use the same CRM provider


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


Ongoing Performance

Control charting

— Apply preventive action

— Implement corrective action

— Document the corrective action




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


Corrective Action

Root cause analysis

— Man

— Machine

— Material

— Method

Implement corrections

Confirm appropriate and effective

— Analyze CRM

— Long-term control charting




How CRMs can help your analyses


ERA’s CRMs

Waste Water

Effluent

Drinking Water

Clean Water

Soil

Air and Emissions

Microbiology

Radiochemistry

Organic Chemicals

Inorganic Chemicals

Physical Properties

Calibration


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


ERA’s CRMs

Uses

— Routine quality control


— Control charting (ICV)

— Analyst demonstration of capability


— Calibration


Contact ERA

800.372.0122

303.431.8454

6:00 am – 6:00 pm Mon-Thu (MT)

6:00 am – 5:00 pm Fri (MT)

[email protected]

www.eraqc.com

www.facebook.com/eraqc

www.twitter.com/era_qc

www.youtube.com/eraqc

Documents

Creating a Robust and Sustainable Quality Assurance Program documents/Webinar_Robust_and_Sus… · Certified Reference Materials —Known concentrations of various analytes —Guide