Quiz · QMSR 3/3

QMSR Risk Management and Risk-Based Decisions

10 questions80% to pass

Haven't watched this lesson yet? Watch it first (22:36).

1Which two dimensions combine in the presentation’s definition of risk?Choose one

Probability of harm and severity of harm Production volume and sales price Audit frequency and company age Number of procedures and number of employees

2What distinguishes a risk-based decision?Choose one

A general statement that quality is important A decision based only on financial return A specific decision using risk assessment and other relevant criteria A decision that requires no supporting information

3Where does the presentation place risk management?Choose one

Only in a design file before first release Only in complaint handling after an injury Only in the final product inspection Across the product lifecycle and relevant QMS processes

4A company sets controls for an outsourced process. What should influence their extent?Choose one

Only the size of the supplier’s organization The risk involved and the external party’s ability to meet requirements Only the length of the contract Only whether the supplier has been used before

5How should the evaluation of training effectiveness relate to the task?Choose one

It should be proportionate to the risk associated with the work It should always consist solely of reading a procedure It should always use an identical quiz for every role It can be omitted after a course attendance certificate

6How should supplier evaluation affect incoming verification?Choose one

Require the supplier to choose all acceptance criteria unilaterally Omit verification whenever the price is low Use the same checks regardless of the supplied product Use evaluation results and purchased-product risk to select verification

7A production software application can affect product conformity. What should guide its validation approach?Choose one

Only whether it is commercially available Only the total number of screens The risk associated with its use and effects on conformity Only the date of the latest software update

8Complaint data shows an increase in a known malfunction. What should happen?Choose one

Leave risk information unchanged because the hazard was already identified Review and update risk information as appropriate and assess needed controls Wait until a new device generation is designed Remove older complaints from the analysis

9Nonconforming product is discovered after delivery. What should guide the response?Choose one

Only the cost of retrieving the device Only the number of employees available Only whether the original production record was signed The effects or potential effects of the nonconformity

10Did QMSR’s incorporation of ISO 13485 automatically incorporate ISO 14971 as well?Choose one

Yes; every referenced standard automatically became incorporated No; FDA says ISO 14971 may help, but was not incorporated by that rulemaking Yes; every later ISO 14971 revision also becomes automatic law No; FDA prohibits using ISO 14971 as a resource