Kinds of Audits/Audit Process
What are the three main roles in an audit?
Auditee, Auditor, Client
What are the three questions to determine if something is unethical?
Is this legal?
Is this balanced?
How will this make me feel about myself?
Define Misfeasance
Objective evidence can only be expressed via:
a. The lead auditor's credentials
b. Verifiable qualitative observations
c. Statements of fact
d. Verifiable quantitative observations
Objective evidence can only be expressed via:
c. Statements of fact
What are the three kinds of audits by method and their definitions?
System audit - concentrating on quality system interest
Process audit - concentrating on achieved results of the processing effort
Product audit - concentrating on one or more products or services
What are the 5 data integrity principles?
Physical integrity
Logical integrity
ALCOA-CCEA
Metadata
Audit Trails
Name three benefits of a process audit over a system audit
(Any three of the following)
Easier to verify conformance to standard, methods, procedures or other requirements
Require less planning than system audits
Require fewer auditors than system audits
Identified issues are more easily addressed
What are the three main things auditors must be competent with respect to?
Applicable regulatory, statutory, and safety requirements
Appropriate device technologies and processes
Auditing of medical device manufacturers' quality systems
What are the 5 steps of the audit process?
Managing
Planning
Conducting Audits
Reporting Results
Maintaining Records
What are the 3 fundamental principles of the ASQ code of ethics?
Honest and impartial in serving stakeholders
Strive to increase competence and prestige of the quality profession
Use knowledge and skill for enhancement of human welfare
It is found that several job aids slightly conflict with the quality manual. Management suspects a systemic issue, but funds are quite limited. Which of the below kinds of audit is the most appropriate?
a. Quality System Audit
b. Process audit
c. Management audit
d. Desk audit
It is found that several job aids slightly conflict with the quality manual. Management suspects a systemic issue, but funds are quite limited. Which of the below kinds of audit is the most appropriate?
d. Desk audit
What is the sequence of events necessary for legal consequence? (5 events)
Negligent
Owes company a duty
Breached the duty
Failed required standard of care
Breach of duty caused damages
Name each term in ALCOA-CCEA
Attributable, Legible, Contemporaneous, Original, Accurate
Complete, Consistent, Enduring, Available
An external auditor is engaged by the company owner to conduct an organization audit and to provide a report. The auditor should seriously consider which of the following liability issues:
a. Fraud, standard of care and negligence
b. Standard of care, negligence and liability damages
c. Negligence, liability damages and fraud
d. Liability damages, negligence and standard of care
An external auditor is engaged by the company owner to conduct an organization audit and to provide a report. The auditor should seriously consider which of the following liability issues:
a. Fraud, standard of care and negligence