Quality Control & Process Improvement Flashcards

Which document in a quality management system outlines the specific steps employees must follow to perform a task consistently and correctly?

Answer: Standard Operating Procedure (SOP)

An SOP provides detailed, step-by-step instructions to ensure tasks are performed uniformly and in compliance with quality standards.

A supplement manufacturer's internal audit reveals that analytical equipment used for potency testing has not been calibrated for 18 months. What is the most immediate quality risk?

Answer: Product test results may be inaccurate and unreliable

Uncalibrated equipment produces unreliable data, meaning product potency determinations cannot be trusted and may lead to releasing out-of-specification products.

In the HACCP system applied to supplement manufacturing, what is a 'corrective action' specifically triggered by?

Answer: A deviation from a critical limit at a Critical Control Point

In HACCP, corrective actions are predefined responses that must occur whenever monitoring shows a CCP is not under control.

What is the primary purpose of a Master Manufacturing Record (MMR) in dietary supplement production?

Answer: To document the definitive formula, process, and specifications for each product

The MMR serves as the authoritative reference document defining every aspect of how a product should be manufactured to ensure reproducibility.

Which quality control concept involves sampling a statistically representative portion of a batch to make decisions about the entire batch without testing every unit?

Answer: Statistical sampling

Statistical sampling uses probability to select representative units, allowing batch-wide quality conclusions without testing each individual product.

A protein supplement is found to contain undeclared milk allergens due to inadequate equipment cleaning. Under FDA regulations, this most likely triggers:

Answer: A mandatory product recall and consumer notification

Undeclared allergens pose serious health risks to sensitive individuals and typically require an immediate product recall under FDA authority.

Which quality improvement tool is best suited for mapping the relationship between a problem (effect) and its potential contributing factors (causes)?

Answer: Cause-and-effect (Ishikawa) diagram

The Ishikawa (fishbone) diagram visually organizes potential causes of a problem into categories, facilitating root cause analysis.