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Medical Device Auditor

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Q_01 domain/d1 · medium multi discuss →

During data collection, an auditor finds a batch record where several entries were written in pencil days after the operation, and one signature is illegible. Applying ALCOA+ principles, which two attributes are MOST directly compromised?

A Legible
B Contemporaneous
C Available
D Attributable to a specific auditor's checklist

Q_02 domain/d1 · medium single discuss →

While conducting the exit/closing meeting, a lead auditor presents a finding that will likely lead to an adverse conclusion for the auditee. According to good audit performance practice, what should the lead auditor do before finalizing this finding?

A Obtain the auditee's concurrence on the evidence supporting the adverse conclusion
B Immediately notify the next level of management and re-issue a corrective action request
C Defer presenting the finding until the follow-up audit is scheduled
D Reassign the finding to another audit team member to avoid conflict of interest

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