Verification and RM Flashcards

1
Q

Validation

Verification

A

Confirmation by examination and provision of evidence that the particular requirements for a specific intended usehave been met

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2
Q

Robustness

A

Insensitivity against changes of known operational paramaeters

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3
Q

Fit for purpose evaluation

A

What’s the question
What analytical technique
What’s the analyte

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4
Q

What is type 1 error and type 2?

A

False positive result

Null hypo rejected even though it’s true

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5
Q

The lower the p value the lower the what?

Lower the statistical power, the lower the what

A

False positive

False negative

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6
Q

What to look for in cert?

A

Analyte and matrix
Analytical method, traceability to SI
Uncertainty and coverage factor

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7
Q

Who produces CRM?

A

National institutes of standard and tech

Institute of reference material and measurement

NMI

Private companies

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8
Q

What are the types of reference materials?

A

Reference mat:
Primary, secondary, control samples

Measurement standards
Working, reference, National, international

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9
Q

How to produce CRM

A
Base materials
Homogenize
Stability
Assignment of reference value
Uncertainty statement
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10
Q

How do u use CRM?

A

Avoid contamination,
Follow instructions
Choose according to what u need it for

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11
Q

How do u choose CRM?

A
Best possible match
Correct uncert range
ISO accreditation 
Traceability
Cost
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12
Q

What is a RM?

A

Homogenous and stable. Fit for purpose

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13
Q

What is a CRM?

A
RM with a certificate issued by
Specified property values 
Uncertainty
Traceability
Using valid procedures
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