Lesson 2: Audit Initiation Flashcards
Audit preparation ranges from when to when?
Audit prep begins when the client decides there needs to be an audit and ends with audit performance initiation.
Prior to when an auditor starts planning, certain management actions to initialize the audit are known as the __________ ___________.
initiation phase
What are the two keys to a professional and efficient audit?
Good planning and preparation
T or F
The Preparation Phase has not been specifically quantified by any standards organization or professional society.
T
The Preparation Phase, according to ASQ, is based on whose process, and made up of how many steps?
Dennis Arter’s (Quality Audits for Improved Performance) defines 9 steps, plus 1 additional ASQ step.
10 Prep Steps
What are the first three preparation steps?
- Define the Purpose
- Define the Scope
- Define Resources Required
Step 1, Defining the Purpose is the “why” of the audit, thus determining if the controls are:
- ____________
- ____________ and ____________
- ____________ and ____________
- adequate
- implemented and maintained
- effective and efficient
AIMEE
Within “Define the Purpose”, adequate controls means what?
The designed controls are adequate to meet higher level standard requirements of ISO 9001, FAA, etc.
When are management systems audited for conformity with standards and what are the consequences of non-conformity?
Regulated Industries
Suspension of registration, supplier disapproval, or product rejection
____________ auditing techniques should be used when auditing a group of processes with a singular, overall objective or function.
Process
T or F
Processes, when grouped together, form a system.
T
T or F
When audits discover problems beyond their scope, the auditor need not be concerned with those particular findings.
F
What is determined by the size (scope) of an audit?
of auditors req’d.
Audits of an entire management system are common for _________ ________ _________.
3rd party audits
T or F
One of the main differences between process and system audits is scope definition and expansion.
T
Who normally selects audit team members?
Auditing Org.
Who is responsible for ensuring adequate audit team resources?
Audit Team Leader
T or F
The number of audit days for 3rd party audits are always estimated by the lead auditor or audit program manager.
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.
Process auditors must be knowledgeable of both the _________ process and the __________ being audited
audit, process
For all audits, the Lead Auditor (aka: Audit Process Mgr.) is responsible for what four steps?
- Preparing the audit plan
- Conducting the opening and closing meetings
- Analyzing findings to be reported
- Preparing and submitting the final report
T or F
System audits are less labor intensive than process or product audits.
F
System audits have two to six members, whereas product or process audits may only have one auditor.
Which Standard provides guidance on auditor competency and team member selection?
ISO 19011
When conducting system audits of process based quality management systems, the audit team should be comprised of auditors that have _________ and __________ system knowledge.
technical, management
What is the main purpose of an audit checklist?
Gather information
T or F
A collection plan may be a list of items that will be required to be seen during an audit.
T
Document reviews (desk audits) are acceptable as part of on-site activities unless ________ to audit effectiveness.
detrimental
Are specialists (SMEs) required when conducting highly technical audits?
Yes
Auditors with both technical and management system knowledge are required for ________ audits of a ________ based ________ system
system / process / management
