In the Quality Auditing qualification you’ll learn that when preparing for an audit, you will need to ascertain the initial parameters of the audit first. Often the Lead Auditor will source copies of all necessary documentation and parameters.
The initial parameters of an audit should consist of the following:
The audit scope: the extent and boundaries of the audit.
The audit scope generally includes a description of the physical locations, organisational units, activities, processes and or the criteria of the audit.
Auditee details: the main persons of contact throughout the audit within the area of audit.
You will need to obtain any necessary contact details, position titles and names of the people you will need to make contact with to confirm the scheduled audit.
Auditee team: the team of people conducting the audit.
You will need to select auditors according to their audit experience, areas of experience and background and necessary strengths required for the audit.
Auditee team meeting: initial planning discussion with all audit team members.
The Lead Auditor will lead the meeting/discussions required for the audit team members to prepare and plan their responsibilities throughout the audit. Typically the Lead Auditor will assign such responsibilities based on the skills and experience of each auditor.
This is the information required to ensure you know what you will be auditing, where and with whom.
What is an audit criteria?
As defined in 3.2 of AS/NZS ISO 19011:2003: ‘set of policies, procedures or requirements’.
Put simply, audit criteria are the set of requirements that the area being audited should be complying with. Requirements and control points are usually defined in policies, procedures, standards or regulations. As such these policies, procedures, standards or regulations form the criteria (or benchmark) with which the auditor is evaluating the area against.
Policies and procedures may be used as audit criteria typically during internal audits. Through external audit often the audit criteria is based on a Management System standard. Some examples of Standards are as follows:
ISO 9001: Quality Management Systems – Requirements
ISO/TS 16949: Quality Management Systems – Particular requirements for the application of ISO 9001:2008 for automotive production and service part organizations.
ISO 14001: Environmental Management Systems – Specification with guidance for use.
HACCP: Hazard Analysis Critical Control Point – Food manufacture.
ISO 13485: Quality Systems – Medical devices.
AS4360: Risk Management.
AS4801: Occupational health and safety management systems – Specification
with guidance for use
SafetyMAP: Work Safe Victoria (Victorian WorkCover Authority.
ACHS: Australian Council on Health Care.
TGA: Therapeutic Goods Administration.
Solo auditing or team?
In some cases a Lead Auditor will require extra auditors to assist in the carrying out of an audit. This may be due to a number of reasons.
The audit may be lengthy and extra auditors may be included to reduce the time needed to complete the audit.
There may be specific areas where expertise is required and so extra auditors with the specific expertise are required. For example, a lead auditor is required to audit a pharmaceutical company. If the Lead Auditor’s background in pharmaceuticals isn’t very strong, an auditor with a background in chemistry may be sourced to assist in the audit.
The scope and objectives of the audit will usually dictate the auditors required for the audit.
- Lead Auditor:
The Lead Auditor is typically an auditor with extensive experience. Registered third party auditors must meet criteria as described in ISO 19011:2003. Selection of a Lead Auditor for an audit is typically done based on their auditing experience and area of expertise.
- Other auditors
Other auditors are typically selected by complementing the Lead Auditor’s experience and background.
For example, an audit may be required in a construction and engineering firm.
The Lead Auditor was selected based on their extensive experience auditing constructions firms. The Lead Auditor was previously a Construction Manager for 10 years. However, the Lead Auditor doesn’t have a background in Engineering, nor have they audited many Engineering firms. So, another Auditor who is a qualified Engineer and has 15 years of experience in engineering is selected for the audit.
The Lead Auditor and Auditor will complement each other with their backgrounds and experience and ensure that the auditee experience is a value-added audit.
Audit team planning
Following the selection of the audit team members; the next step is to determine roles and responsibilities of each member throughout the audit.
Typically (although not always possible) the audit team will attend a meeting/discussion to develop an audit plan as doing this together ensures that roles and responsibilities of the audit team members are allocated at the same time and best use of audit time can be planned.
Read More: Auditing Team Roles and Responsibilities
Published by: LMIT