Part II Flashcards
Statistically valid sampling plans are used
Product process and compliance audits when gathering info they don’t have to be statistically valid.
Page 73
Working papers are an ____ should not restrict the ——— of audit. They are used
To facilitate investigation and record and report results.
Audit Observations have to be
They have to be recorded and traceable. Confirmed prior to the exit meeting.
Documents vs records
What should be done
What has been done
Reasons for examining documents and records 1 each
Ensure alignment with higher tier documents
Objective evidence to demonstrate acceptability and implementation.
Data patterns
You have to analyze if something is a _____ or ____ issue.
Just because something is ——- doesn’t mean it is a bigger use.
Isolated
95
What is interviewing?
The process of gathering data from
Another person. -95
During interviewing before ending it, make sure to _____. This will allow the interveee to —-
Preliminary conclusion. Clarify
Even though sampling results are factual there is an element of uncertainty regarding conclusions. The conclusions are only as good
As the degree to which the samples represent performance.
A nonconformity is a ——-
Could be
No fulfillment of requirement.
Isolated systemic major or minor
A finding has the following characteristics (3)
Negative
Violation of requirements
It is a big deal
ISO 19011 supports that findings can be both
negative and positive
Audit findings with significant risk should be reported —- to who
Immediately auditee and audit client
New International standard say that
Auditee should grade NC
Audit conclusion.
Lead auditor should report the overall degree ——/——
The audit conclusion should also match the audit _____.
Conformance to requirements were met
Complaint or not compliant.
The exit meeting is the ending of
The performance stage of the process.
The exit meeting is a ______. Who is involved here? When does it take place?
Presentation of the audit results to the auditee organization and in some cases the client.
Top management to ensure that results are clearly understood.
The exit meeting takes place after the interviews and final team meeting.
Usually the same people who attended the opening meeting attend the
Exit meeting
during the exit meeting
Besides non conformities there May be _____.
However the audit should not.
Recommendations or opportunities for improvement. They are generally not binding
Recommending what corrective actions to take.
102
Findings non conformances and audit reports should be marked as
Draft or preliminary since they have not been approved by the client and May need to be edited fir language or grammar
102
Audit observation=
Objective evidence
