CBA/CQA Comparison Chart - Ombu Enterprises LLC

CBA
CQA
CBA Text
Citation CQA Text
II. Auditing & Inspection Processes
Citation
II. Auditing & Inspection Processes
B. Audit performance
B. Audit performance
4. Objective evidence
5. Objective evidence
Identify and differentiate various characteristics of
Identify and differentiate various characteristics of
objective evidence, such as observed, measured, verified,
objective evidence, such as observed, measured, verified,
and documented. (Analyze)
and documented. (Evaluate)
II. Auditing & Inspection Processes
B. Audit performance
II.B.5 [NOTE: The definition of evidence is covered in I. A.] II.B.4
6. Observations
II. Auditing & Inspection Processes
Evaluate the significance of observations in terms of
B. Audit performance
positive, negative, chronic, isolated, and systemic.
5. Observations
(Evaluate)
Evaluate the significance of observations in terms of
[NOTE: This topic area includes general audit observation
positive, negative, chronic, isolated, and systemic.
classification only; FDA classification criteria are covered
(Evaluate)
in Body of Knowledge area II.E.3.] II.B.6 [NOTE: The definition of observation is covered in I. A.]
II. Auditing & Inspection Processes
B. Audit performance
II.B.5
II. Auditing & Inspection Processes
6. Nonconformances
B. Audit performance
Classify nonconformances in terms of significance,
7. Classifying nonconformances
severity, frequency, and level of risk. (Evaluate)
Classify nonconformances in terms of significance,
[NOTE: The definition of nonconformance is covered in
severity, frequency, and level of risk. (Analyze) II.B.7 I.A.] II.B.6
II. Auditing & Inspection Processes
II. Auditing & Inspection Processes
B. Audit performance
B. Audit performance
8. Audit process management
7. Audit process management
Define and apply elements of managing an audit,
Define and apply elements of managing an audit,
including coordinating team activities, reallocating
including coordinating team activities, re-allocating
resources, adjusting the audit plan, and communicating
resources, adjusting audit plan, and communicating with
with the auditee during the audit. (Apply) II.B.8 the auditee. (Analyze) II.B.7
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