Quality Control & Process Improvement Flashcards

Which type of process improvement methodology uses Define, Measure, Analyze, Improve, and Control phases to reduce defects?

Answer: Six Sigma DMAIC

Six Sigma DMAIC is a structured data-driven methodology aimed at improving processes by eliminating defects and reducing variability.

Third-party certification by organizations like NSF International or USP for dietary supplements primarily verifies which quality attribute?

Answer: That the product contains what the label states and is free of harmful contaminants

Third-party certifications confirm ingredient identity, potency, purity, and absence of contaminants, adding consumer trust beyond manufacturer claims.

Which corrective action is most appropriate when a root cause analysis reveals that employee training gaps caused repeated labeling errors?

Answer: Implement revised standard operating procedures and mandatory retraining

Addressing root causes through updated SOPs and retraining prevents recurrence, which is the goal of corrective action in a quality system.

In dietary supplement quality control, what is the minimum shelf life testing requirement that manufacturers must establish?

Answer: Stability data supporting the expiration date on the label

cGMP regulations require that manufacturers establish product shelf life through stability testing that supports the labeled expiration date.

A food safety auditor finds that a supplement facility lacks written procedures for cleaning equipment between production runs. Under cGMP, this is classified as a:

Answer: Non-conformance that must be addressed in a corrective action plan

Absence of written cleaning procedures is a cGMP non-conformance that requires documented corrective and preventive actions.

Which principle of Lean manufacturing focuses on eliminating waste by ensuring product flows through each production step without interruption or delay?

Answer: Continuous flow

Continuous flow in Lean manufacturing aims to move product through each step without queuing or delay, reducing lead time and waste.

When a nutritionist evaluates a sports supplement for a client, which quality indicator suggests the product undergoes rigorous quality control?

Answer: The product carries an NSF Certified for Sport seal

NSF Certified for Sport indicates the product has been tested for banned substances and label accuracy by an independent third party.