ISSA Quality Control & Process Improvement 2

Question 1

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

Accepted Answer

FDA

Answer

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

Question 2

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

Accepted Answer

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

Answer

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

Question 3

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

Accepted Answer

Place the batch on quarantine hold pending further testing

Answer

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

Question 4

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

Accepted Answer

Pareto chart

Answer

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

Question 5

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

Accepted Answer

Certificate of Analysis (CoA)

Answer

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

(ISSA) International Sports Sciences Association Certified Nutritionist Practice Test

(ISSA) International Sports Sciences Association Certified Nutritionist Practice Test

ISSA Quality Control & Process Improvement 2