Lesson 2: Audit Initiation

Question 1

Audit preparation ranges from when to when?

Answer 1

Audit prep begins when the client decides there needs to be an audit and ends with audit performance initiation.

Question 2

Prior to when an auditor starts planning, certain management actions to initialize the audit are known as the __________ ___________.

Answer 2

initiation phase

Question 3

What are the two keys to a professional and efficient audit?

Answer 3

Good planning and preparation

Question 4

T or F

The Preparation Phase has not been specifically quantified by any standards organization or professional society.

Answer 4

T

Question 5

The Preparation Phase, according to ASQ, is based on whose process, and made up of how many steps?

Answer 5

Dennis Arter’s (Quality Audits for Improved Performance) defines 9 steps, plus 1 additional ASQ step.

10 Prep Steps

Question 6

What are the first three preparation steps?

Answer 6

1. Define the Purpose
2. Define the Scope
3. Define Resources Required

Question 7

Step 1, Defining the Purpose is the “why” of the audit, thus determining if the controls are:

1. ____________
2. ____________ and ____________
3. ____________ and ____________

Answer 7

1. adequate
2. implemented and maintained
3. effective and efficient

AIMEE

Question 8

Within “Define the Purpose”, adequate controls means what?

Answer 8

The designed controls are adequate to meet higher level standard requirements of ISO 9001, FAA, etc.

Question 9

When are management systems audited for conformity with standards and what are the consequences of non-conformity?

Answer 9

Regulated Industries

Suspension of registration, supplier disapproval, or product rejection

Question 10

____________ auditing techniques should be used when auditing a group of processes with a singular, overall objective or function.

Answer 10

Process

Question 11

T or F

Processes, when grouped together, form a system.

Answer 11

T

Question 12

T or F

When audits discover problems beyond their scope, the auditor need not be concerned with those particular findings.

Answer 12

F

Question 13

What is determined by the size (scope) of an audit?

Answer 13

of auditors req’d.

Question 14

Audits of an entire management system are common for _________ ________ _________.

Answer 14

3rd party audits

Question 15

T or F

One of the main differences between process and system audits is scope definition and expansion.

Answer 15

T

Question 16

Who normally selects audit team members?

Answer 16

Auditing Org.

Question 17

Who is responsible for ensuring adequate audit team resources?

Answer 17

Audit Team Leader

Question 18

T or F

The number of audit days for 3rd party audits are always estimated by the lead auditor or audit program manager.

Answer 18

F - Some 3rd Party Audit days are specified or suggested by an Authority.

Example: QS9000 or TL9000 Audit day guidelines are based on the standard being audit against and the number of employees.

Question 19

Process auditors must be knowledgeable of both the _________ process and the __________ being audited

Answer 19

audit, process

Question 20

For all audits, the Lead Auditor (aka: Audit Process Mgr.) is responsible for what four steps?

Answer 20

1. Preparing the audit plan
2. Conducting the opening and closing meetings
3. Analyzing findings to be reported
4. Preparing and submitting the final report

Question 21

T or F

System audits are less labor intensive than process or product audits.

Answer 21

F

System audits have two to six members, whereas product or process audits may only have one auditor.

Question 22

Which Standard provides guidance on auditor competency and team member selection?

Answer 22

ISO 19011

Question 23

When conducting system audits of process based quality management systems, the audit team should be comprised of auditors that have _________ and __________ system knowledge.

Answer 23

technical, management

Question 24

What is the main purpose of an audit checklist?

Answer 24

Gather information

Question 25

T or F

A collection plan may be a list of items that will be required to be seen during an audit.

Answer 25

T

Question 26

Document reviews (desk audits) are acceptable as part of on-site activities unless ________ to audit effectiveness.

Answer 26

detrimental

Question 27

Are specialists (SMEs) required when conducting highly technical audits?

Answer 27

Yes

Question 28

Auditors with both technical and management system knowledge are required for ________ audits of a ________ based ________ system

Answer 28

system / process / management