CPC CPC Quality Assurance & Standards 2

Question 1

Traceability of measurement results in a laboratory context means that results can be related to:

Accepted Answer

A stated reference through an unbroken chain of calibrations with stated uncertainties

Answer

Metrological traceability requires an unbroken chain of comparisons to higher-level standards (ultimately to SI units or accepted references) with stated uncertainties at each link.

Question 2

In Good Laboratory Practice (GLP), a study director is responsible for:

Accepted Answer

Overall conduct of the study and ensuring the study protocol is followed

Answer

Under GLP regulations (FDA 21 CFR Part 58, EPA TSCA/FIFRA), the study director is the single point of study control, responsible for overall scientific conduct and protocol compliance.

Question 3

A laboratory's proficiency testing (PT) result is evaluated using a z-score. A z-score of |z| > 3 indicates:

Accepted Answer

Unsatisfactory performance requiring corrective action

Answer

In PT evaluation, |z| ≤ 2 is satisfactory, 2 < |z| ≤ 3 is a warning, and |z| > 3 is unsatisfactory, indicating the laboratory result is more than 3 assigned standard deviations from the consensus value.

Question 4

Under 21 CFR Part 11 (FDA), electronic records are acceptable if they include:

Accepted Answer

Audit trails, access controls, and electronic signatures meeting specified requirements

Answer

21 CFR Part 11 requires electronic records to have audit trails capturing changes, controlled access, secure electronic signatures, and system validation to ensure authenticity and integrity.

Question 5

The purpose of running a method blank in environmental analysis is to:

Accepted Answer

Identify contamination introduced by the analytical process itself

Answer

A method blank contains all reagents processed through the complete analytical procedure without the sample, detecting contamination from reagents, glassware, or laboratory environment.

(CPC) Certified Professional Chemist Practice Test

(CPC) Certified Professional Chemist Practice Test

CPC CPC Quality Assurance & Standards 2