Quiz · ISO 13485:2016 10/10

Nonconformances, Data and CAPA

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (8:26).

1What is the immediate objective when nonconforming product is found?Choose one

Close a CAPA before identifying affected product Release it if the delivery date is near Wait for a customer complaint before documenting it Prevent unintended use or delivery while the issue is evaluated

2Which example is containment?Choose one

Changing a process to eliminate a verified root cause Holding a potentially affected lot pending evaluation Preventing a potential failure before any occurrence Approving a redesigned product for future manufacture

3Which example is a correction?Choose one

Changing the underlying process to prevent recurrence Analyzing a trend before a nonconformity occurs Reworking a defective item to meet its requirement Defining a future audit schedule

4What distinguishes corrective action from correction?Choose one

Corrective action addresses the cause to prevent recurrence Corrective action is simply a longer repair record Correction always requires a regulatory submission Correction can only occur after shipment

5A risk trend suggests a failure that has not occurred. What kind of action may be appropriate?Choose one

Only correction of an already-existing defective unit Automatic closure because all results remain within limits A statement that CAPA applies only after harm Preventive action addressing the potential cause

6Must every isolated issue use the same extensive CAPA investigation?Choose one

Yes; identical investigation depth is always required No; small companies never need CAPA No; evaluate risk, significance and recurrence and document the basis Yes; the number of investigation pages determines compliance

7An investigation stops at operator error despite unclear instructions. What is the concern?Choose one

The investigation includes too much technical detail The underlying cause and system contributors may remain unaddressed The operator’s name should replace all other evidence Training records eliminate the need to review instructions

8A revised procedure has been issued. What would best demonstrate corrective-action effectiveness?Choose one

Follow-up evidence showing the targeted failure is controlled against defined criteria Only the approval date of the revised procedure Only the count of employees invited to training Only a status field marked closed

9What should rework controls include?Choose one

Only a verbal instruction from the most experienced operator Only repeating the failed step until it passes Approved instructions, adverse-effect consideration, verification and records Only relabeling the product as reworked

10The same receiving defect appears in several shipments. What does the pattern suggest?Choose one

Evaluate the cause and need for supplier corrective action beyond holding each shipment Treat every shipment as unrelated because each has a separate record Stop collecting data once the product is contained Close the issue when the next shipment happens to pass