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ASQ CMDA Exam Questions and Answers, Medical Device Auditor Certification | SPOTO

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Question #1
Monitoring of which elements is crucial in a controlled environment? (Multiple correct answers)
A. Bioburden
B. Endotoxins
C. Employee mood
D. Color of the walls
View answer
Correct Answer: AB
Question #2
In preparing for an audit, which aspects are crucial? (Choose two)
A. Deciding on the lunch menu
B. Choosing the color of the audit report cover
C. Establishing the audit type
D. Verifying audit authority
View answer
Correct Answer: CD
Question #3
What are the benefits of including graphic presentation in an audit report? (Select two)
A. Simplifies complex data for better understanding
B. Enhances the visual appeal of the report
C. Replaces the need for written content
D. Assists in highlighting key findings
View answer
Correct Answer: AD
Question #4
When applying the elements of CAPA, which of the following is critical in ensuring the effectiveness of corrective actions?
A. Prioritizing actions based on financial impact
B. Focusing on actions with the easiest implementation
C. Prioritizing actions based on risk
D. Assigning responsibility based on department seniority
View answer
Correct Answer: C
Question #5
Effective auditors should possess which of the following skills? (Choose two)
A. Ability to play a musical instrument
B. Attention to detail
C. Problem-solving skills
D. Proficiency in video editing
View answer
Correct Answer: BC
Question #6
For products that require traceability under 21 CFR 820, which of the following is essential?
A. Tracking the product through its entire life cycle
B. Maintaining a customer database
C. Ensuring the product is cost-effective
D. Prioritizing product aesthetics
View answer
Correct Answer: A
Question #7
Auditor independence ensures that the audit is free from ________ bias.
A. Technical
B. Financial
C. Personal
D. Educational
View answer
Correct Answer: C
Question #8
Under the RoHS directive, which of the following substances is restricted?
A. Water
B. Lead
C. Sugar
D. Plastic
View answer
Correct Answer: B
Question #9
The impact of nonconformances in an audit report is significant. What is the primary purpose of detailing these impacts?
A. To allocate blame to specific individuals
B. To highlight areas for improvement
C. To assess the financial loss only
D. To promote alternative products
View answer
Correct Answer: B
Question #10
FDA CPG 7382.845 is critical for understanding the FDA's criteria for _______ based on quality system audit results.
A. regulatory action
B. market approval
C. financial penalties
D. product recalls
View answer
Correct Answer: A

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