Quality Control & Process Improvement Flashcards

Which federal agency is primarily responsible for regulating dietary supplement manufacturing under the Dietary Supplement Health and Education Act (DSHEA)?

Answer: FDA

The FDA oversees dietary supplement regulation and enforces Current Good Manufacturing Practice (cGMP) regulations under DSHEA.

In a Hazard Analysis and Critical Control Points (HACCP) system, what is the purpose of establishing critical limits?

Answer: To set the maximum or minimum values that control a hazard at a CCP

Critical limits define the boundary between safe and unsafe conditions at each Critical Control Point.

A nutrition supplement company discovers a batch of protein powder has moisture content exceeding specifications. What quality control action should be taken first?

Answer: Place the batch on quarantine hold pending further testing

Quarantining the affected batch prevents potentially non-conforming product from reaching consumers while investigation occurs.

Which statistical tool is used to identify the most frequent causes of defects in a quality control process, following the 80/20 principle?

Answer: Pareto chart

A Pareto chart ranks causes by frequency, highlighting the vital few defects that account for the majority of problems.

When evaluating a supplement supplier, which document confirms that raw materials meet specified quality standards before use in manufacturing?

Answer: Certificate of Analysis (CoA)

A Certificate of Analysis provides test results confirming raw material identity, purity, and potency against established specifications.

In the context of cGMP for dietary supplements, what does 'in-process testing' refer to?

Answer: Quality checks performed at defined stages during manufacturing

In-process testing involves sampling and testing at critical stages during production to detect deviations before the batch is completed.

A nutritionist reviewing a client's supplement label notices the serving size listed does not match the actual scoop provided. This discrepancy represents which type of quality issue?

Answer: Labeling non-conformance

A mismatch between labeled serving size and the physical measuring tool constitutes a labeling non-conformance under FDA regulations.