Quality Assurance & Improvement Flashcards
7 cards from real CPP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Assurance & Improvement flashcards as text
In the context of packaging QA, what is the primary purpose of a Gauge R&R study?
Answer: To quantify measurement system variation due to operators and equipment
Gauge R&R (Repeatability and Reproducibility) assesses how much of the total variation in measurement data comes from the measurement system versus the process.
A packaging company implements FMEA before launching a new blister pack line. At what stage is FMEA most valuable?
Answer: During product and process design, before production begins
FMEA is a proactive tool most effective when applied in the design phase to identify and mitigate potential failure modes before they occur.
Which lean quality concept focuses on stopping production when a defect is detected to prevent further defective output?
Answer: Jidoka (autonomation)
Jidoka empowers machines or operators to stop a line immediately upon detecting a defect, embedding quality at the source.
When a packaging process has a Cpk value of 0.85, this indicates that:
Answer: The process is not centered and/or is producing output outside specification limits
A Cpk below 1.0 means the process is not capable of consistently meeting specifications, either due to excess variation or off-center mean.
ISO 15378 is a quality management standard specifically developed for:
Answer: Primary packaging materials for medicinal products
ISO 15378 applies GMP requirements to manufacturers of primary packaging materials for pharmaceuticals, based on ISO 9001.
In statistical process control, an 'assignable cause' of variation is one that:
Answer: Can be identified and eliminated through investigation
Assignable (special) causes produce non-random signals on control charts and represent specific, identifiable sources of variation that can be corrected.
A packaging quality team uses a 'fishbone diagram' during a root cause analysis session. The six typical 'bones' or categories in this tool are:
Answer: Man, Machine, Material, Method, Measurement, Environment
The Ishikawa (fishbone) diagram organizes potential causes into six standard categories: Man, Machine, Material, Method, Measurement, and Environment (the 6 Ms).