DQM Core Units
Quality Assurance flashcards
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Complete Flashcard Reference
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What does quality assurance build confidence in, and where does it start?
Confidence that requirements will be met before and during production. It starts with defining exactly what is being assured and against what criteria.
What is the difference between a quality parameter and a critical limit?
Parameter: the specific, measurable characteristic being controlled, such as the fill volume of a 500 ml bottle. Critical limit: the maximum and/or minimum acceptable value for that parameter, such as 495 to 505 ml. Beyond it the product is non-conforming.
How does verification of a measuring instrument differ from calibration?
Verification confirms the instrument is still functioning correctly. Calibration adjusts it against a known reference standard where it has drifted.
What is the difference between destructive and non-destructive testing?
Destructive: the unit tested is damaged or consumed by the test itself. Non-destructive: the unit remains usable after the test, allowing 100% inspection where needed.
What is Pareto analysis used for when evaluating quality control?
To prioritise which quality issues to address first.
What are the four elements of the Quality Assurance unit?
1. Establish quality assurance criteria. 2. Determine the resources for monitoring and measuring. 3. Perform quality control. 4. Evaluate the quality control process.
What four items answer every control point?
Criterion: what is acceptable. Method: how and how often it is checked, with what instrument. Record: where the result is written. Action on a failure: hold, rework, reject or escalate.
What does a monitoring schedule fix, and what two concerns does it balance?
How often each parameter is checked, and by whom. It balances the cost of monitoring against the risk of a non-conformance going undetected between checks.
What are performance reports, and what are they used for?
The results of monitoring and testing, compiled together. They are the raw input for evaluating quality control and the evidence base a quality audit checks against.
How does a one-off cause of a non-conformance differ from a systemic problem?
One-off: an isolated event unlikely to recur, addressed by a correction. Systemic: a persistent, root-cause issue that will keep recurring unless corrective action addresses it, feeding into quality improvement.
Name four quality assurance tools and deployment methods.
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What does FMEA do, and when is it applied?
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What must quality assurance criteria be set against, and what does that require first?
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Give examples of quality parameters, and say why a parameter is chosen.
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How do critical limits differ from a control chart's upper and lower control limits?
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A bakery sets a critical limit of 495 to 505 grams for a loaf but never says who checks it or how often. What is missing?
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Name three kinds of process monitoring and measurement tools.
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Why must measuring instruments themselves be checked on a schedule?
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What two factors drive how often an instrument is verified and calibrated?
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List four items of quality control documentation for monitoring equipment.
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A gauge is found reading 2 mm high during a routine check and is adjusted back to the reference standard. Verification or calibration?
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How is calibration defined as a full point in a written answer?
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Why is quality control the point where planned quality assurance becomes actual practice?
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What does functional testing confirm?
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Why does destructive testing make sampling necessary?
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A component's safety is tested by crushing it to find its breaking point. What type of test is this, and what follows for the samples?
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What does collating performance data involve?
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Name four quality control tools used to evaluate performance data, with the purpose of each.
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What is a cause-and-effect diagram used for in evaluating quality control?
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What is trend analysis for?
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What three judgements does analysis of performance data make?
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A measurement drifts upward over several weeks but has not yet breached a control limit. What should happen?
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How does evaluating quality control close the loop?
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Which ISO 9001 clauses does the Quality Assurance unit map onto?
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How is the Quality Assurance unit assessed?
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How is quality assurance distinguished from quality control in a written answer?
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How is competence in the Quality Assurance unit shown?
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What headings does a set of acceptance criteria carry?
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What headings does a resource list for monitoring and measuring carry?
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What headings does an inspection and test plan carry?
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What headings does a nonconformity report carry, and what dispositions can it record?
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What does an evaluation report contain?
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Name three performance indicators used when evaluating the quality control process.
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What four things must happen to nonconforming product?
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A batch of 400-gram loaves is found under weight. How is it handled?
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How is a bakery's weighing scale kept fit for checking loaf weights?
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Which common errors cost marks in Quality Assurance answers?
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How to revise with these cards
- Answer out loud or on paper before you turn the card: recalling is what fixes it.
- Go through the deck in short sessions of ten to fifteen minutes, every day.
- Shuffle once you know the order, so you are not answering from memory of the sequence.
- When a card catches you out, read the chapter it links to, then try the topic in a past paper.