Lesson 6: Data Analysis

Question 1

Verifying the _________ or _________ is the key to conducting a sound and thorough quality audit.

Answer 1

process / system

Question 2

T or F

Prior to an audit, docs are evaluated to determine the adequacy of the quality management system, and further used to develop checklist questions.

Answer 2

T

Question 3

Verify process or system docs are _______ and being _______.

Answer 3

adequate / followed

Question 4

Verify records are being _________ and ________ for evidence of conformity and effective management control.

Answer 4

completed / sufficient

Question 5

Documents and records, physical exam, observations, and interviews are used to obtain __________.

Answer 5

evidence

Question 6

T or F

Interview info to be used in an audit report need not be corroborated

Answer 6

F

Question 7

What is the most effective interview format?

Answer 7

One on one

Interviewing more than one may lead to loss of control, whereas a greater number of interviewers is more of an interrogation.

Question 8

Dennis Arter’s Interview method: Make PEAASE? with your interviewee

Answer 8

Put at ease
Explain your purpose
Ask what they do
Analyze what they said
State your conclusions
Explain your next step

Question 9

Some processes are complex, with too many variables to quantify and document every step. The general procedure surrounding this is abbreviated as _________.

Answer 9

PDCA

Plan
Do
Check
Act

Question 10

Auditors can use PDCA to verify _________ of processes that have no documented procedures.

Answer 10

consistency

Question 11

According to ISO 19011, the three methods of collecting info are:
1.
2.
3.

Answer 11

1. Interviews
2. Review Doc’s
3. Observe Activities

Question 12

T or F

Records are considered to be very reliable evidence.

Answer 12

T

Question 13

What is the difficulty that stems from variability attributed to different users of the same gauge or equipment.

Answer 13

Reproducibility

Question 14

During an audit when test data of Auditee is to be relied upon, the Auditor should first ensure an effective ______ system is in place.

Answer 14

calibration

Question 15

Audit findings are always based on _______ evidence.

Answer 15

objective

Question 16

An isolated event in an unimportant area or a condition that meets minimum requirements, but is deteriorating, should be written up in the final report as an ________.

Answer 16

observation/concern

Note: A concern has a greater potential of becoming a non-compliance.

Question 17

What does judgmental sampling allow companies to do?

Answer 17

Allows focus on specific improvements rather than general assessments during audits.

Question 18

During the audit, what are the two primary means of acquiring objective evidence?

Answer 18

1. Auditor observation

2. Controlled records