Study Guide - Biomedical Auditor Certification - CBA

Study Guide

Directions: Each of the questions or incomplete statements below is followed by four suggested answers or completions. Select the one that is best in each case and then fill in the corresponding space on the answer sheet.

Please note: The Food and Drug Administration is referred to as "FDA," and the Food, Drug, and Cosmetic Act is referred to as "FD&C Act." All other abbreviations (e.g., ISO, GHTF) are expected to be understood by the candidate and are associated with their numeric standard, guideline title, etc.

1. The FDA will issue a warning letter under which of the following circumstances?
   1. The manufacturer is unable to fix an intermittent problem.
   2. There is evidence of the company’s intent to violate federal law.
   3. A classification of “official action indicated” is determined.
   4. Samples of defective product have been discovered.
      
      
2. An auditor should use a histogram in a quality audit to do which of the following?
   1. Provide objective evidence that the auditee uses statistical process control (SPC)
   2. Expose patterns that are normally difficult to detect
   3. Interpret data for a trend chart
   4. Create a stratified tally diagram
      
      
3. According to ANSI/ASQC D1160, a design review is NOT required to include which of the following input data?
   1. Agenda items and a list of participants
   2. Specifications and drawings
   3. Engineering proposals and alternative controls
   4. Quality control analyses of processes and supplies
      
      
4. Comparing how a process is actually performed against the documented work instruction for that process is an example of which of the following techniques?
   1. Quantitative
   2. Qualitative
   3. Statistical
   4. Random sampling
      
      
5. An auditee has initiated the corrective action process for the nonconformities identified during an audit even before the closing meeting occurs. How could the lead auditor best handle this at the closing meeting?
   1. Require corrective action plans only for the outstanding items.
   2. Recommend that the auditee wait until the report is issued to begin corrective action.
   3. Document only the items that have not been corrected because those that have been corrected are no longer findings.
   4. Report all nonconformities as well as corrective actions already taken.
      
      
6. Which of the following should be included in a trend analysis of corrective and preventive actions?
   1. Customer complaints
   2. Supplier audits
   3. Internal audits
   4. Internal nonconforming material
      
      
   1. I and IV only
   2. II and III only
   3. I, III, IV only
   4. I, II, III, and IV
      
      
7. The distribution of radiation throughout a product load can be determined by using which of the following methods?
   1. Fraction negative
   2. Survivor curve
   3. Dose mapping
   4. Half-cycle
      
      
8. The use of interviews to compare the responses of two different groups of people who interface with each other on the job is an efficient way for an auditor to
   1. improve interpersonal dynamics within and between the groups
   2. verify information and detect differences or exceptions
   3. determine the effectiveness of internal control
   4. involve more people in the audit process
      
      
9. According to the Medical Device Directive, a custom-made device must be built on the basis of
   1. design validity tests in human validity trials
   2. mass production methods adapted to meet the needs of individual physicians
   3. a written request from a physician for use on a single patient
   4. marketing input that describes the needs of individual physicians
      
      
10. Which of the following body systems uses surface-contacting devices?
    1. Mucosal membranes
    2. Respiratory tract
    3. Circulating blood
    4. Tissue and bone
       
       
11. What type of audit is appropriate for goods that are ready for shipment?
    1. A process audit
    2. A systems audit
    3. A shipping audit
    4. A product audit
       
       
12. The primary purpose of collecting data during an audit is to
    1. provide the basis for drawing correct conclusions about items audited
    2. develop a statistical confidence level in the audit findings
    3. prove the validity of nonconformances
    4. identify the root cause of nonconformances.
       
       
13. FDA inspectors use the Quality System Inspection Technique (QSIT) to do which of the following?
    1. Standardize a company’s quality system evaluations
    2. Evaluate a company’s quality system
    3. Document a company’s departures from the QSIT plan
    4. Determine a company’s compliance to the QSIT plan
       
       
14. A document change record must include which of the following information?
    1. A copy of the previous version of the document
    2. A review of the regulatory impact the change will have
    3. Evidence of training the appropriate personnel
    4. Effective date
       
       

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