The role of Auditor and Auditee

During Quality Audit

Presented by:
Shahbaz ul Hassan Jafary
Food Technology
Basic types of audit
Internal (First Party, Self)
• This type includes audits by your company employees,
consultants and contractors.
° External
• Supplier Audit
Second Party
This is where:
1. Customer employee(s) audit your company or where
2. Your employee(s) audit a company which supplies
your company with a product or service.
• Independent Organization
Third Party - Registrar
• A customer wants an audit of your company but wants your company to pay for it.
• This type of audit is described as independent. In QS-9000 this is not really the case.
Audit Sub-Types
° Compliance (do we comply with the standard)
• Example: Desk audit of high level systems
°System (the theory)
• Example: Audit of Document Control
° Process (the practice)
• Example: Audit of an assembly or fabrication ‘station’ (note to service industries: you
DO have comparable processes)
° Product (the result)
• Example: Dock Audit
A breakdown of the final product. Verify paperwork trail,inspection and test results, for
each item of the product. Verify key characteristics meet dimensional requirements.
Audit Types
A Typical Audit System
Definitions: “Who”
° Auditor: A person who has the appropriate qualifications and performs audits.
° Client: A person or organization requesting the audit. For internal audits, this is
the Management Representative.
° Auditee: An organization, facility or person being audited.
Definitions: “What”
° Quality System: The organizational structure, responsibilities, procedures,
processes and resources for implementing quality management.
° Observation: A statement of fact made during an audit and substantiated by
objective evidence.
° Objective Evidence: Qualitative or quantitative information, records or
statements of fact pertaining to the quality of an item or service or to the existence
and implementation of a quality system element, which is based on observation,
measurement or test and which can be verified.
° Nonconformity: The no fulfillment of specified requirements.
Phases of Auditing
° Planning and Preparing for the audit
° Execution of the audit plan
° Reporting the audit results
° Close out of corrective actions
The ‘Standard’ Four Phases
The Part People See
° Opening Meeting
° Collection of Information
° Record and Grade Nonconformance's
° Evaluation of Number and Significance of
Nonconformance's
° Assessment of Compliance to Requirements
° Preparation of Findings
° Closing Meeting Review
Quality Audit
A systematic and independent examination to
determine whether quality activities and related
results comply with planned arrangements and
whether these arrangements are implemented
effectively and are suitable to achieve the stated
objectives.
Objective Evidence II
Reasons For Audits
One Purpose of Audits
Is To Remove Bear Traps
More Reasons For Audits
° ISO 9001 Requires Them (ISO 9001:2008 8.2.2)
° A Control Mechanism Used By Management
° Tool For Continuous Improvement
° Correct Nonconformities In Systems
° Helps Assure Ongoing Systems Operate As Intended
And Required
The Audit Must Be
Open, Honest, and Constructive
The Person or Activity Being Audited Always Gets the Benefit of
the Doubt.
Validation
° Random Basis
° Auditor Chosen
° Permission
° Factual Agreement
° Objectivity
° Be Polite
° Be Professional
Why A Formal Audit Program?
° To ensure the documented systems meet specified
requirements.
° To ensure the documented systems are practical,
understood, and followed throughout the business.
° To maintain records of audit activity including areas
audited, nonconformance's, and corrective and
preventive actions.
Internal Audits
The Internal Audit
The Systematic Investigation
of the Intent, Implementation, and Effectiveness
of Selected Aspects of the Systems
of an Organization
or One or More of It’s Departments
Definition according to the Institute of
Internal Auditors (IIA)
"Internal auditing is an independent, objective
assurance and consulting activity designed to add
value and improve an organization's operations.
. It helps an organization accomplish its objectives
by bringing a systematic, disciplined approach to
evaluate and improve the effectiveness of risk
management, control, and governance processes."
Internal

Audit System Base Requirements
° Documented system
• Remember 8.2.2 in ISO 9001:2008
° You must have a Schedule
• Preferably 1.5 year minimum
° Effective Corrective Element
• Including An Escalation ‘Trigger’
° Verification of Corrective Action
• You CAN NOT close an audit out until the effectiveness of the
corrective action is verified and validated!
° Input of results into Management Review
• This must include any specific problem areas as this is the highest
level in the escalation feature of your system.
Role of the Auditor
° A Catalyst
° An Interface Between Different Groups
° An Advisor
° A Reporter of Fact(s)
Internal Quality Auditing
° Is NOT a Police Force
° Is NOT an Inspection of Products
° Is NOT an Interrogation Task Force
ISO 9001:2008
Quality
 Management System
° Document What You Do
° Perform to Your Documentation
° Record the Performance as Evidence
° “Say what you do and do what you say”
What is a System?
° Collection of interacting parts functioning as a whole.
° Collection of subsystems that support the larger
system.
° Collection of processes oriented toward a common
goal.
° The organization as a system.
System vs. Process
System
 Definition A group of related things or parts that
function together as a whole.
Example The school system in your city.
Process
Definition A systematic sequence of actions used to
produce something or achieve an end.
Example An assembly-line process.
Auditor’s Responsibility
° Comply with applicable audit requirements
° Communicate and clarify audit requirements
° Plan the audit and carry out assigned responsibilities
effectively and efficiently
° Document the observations
° Report the audit results
° Verify the effectiveness of corrective actions taken as a
result of the audit
° Retain and safeguard documents pertaining to the
audit:
Auditee’s Responsibility
° Inform relevant employees about the objectives and scope of the
audit
° Appoint responsible members of staff to meet with members of
the audit team
° Provide all resources needed for the audit team in order to ensure
an effective and efficient audit process
° Provide access to the facilities and evidential material as
requested by the auditors
° Co-operate with the auditors to permit the audit objectives to be
achieved
° Determine and initiate corrective actions based on the audit
report
Effective Auditee
The Auditee has a major role in the audit process
The Auditee is responsible to a great extant for the
success and failure of the process.
The information provided by the Auditee must be
precise and accurate
Pre- Audit Stages
The Auditee must be familiar with the process and
specially with the following aspects:
1. Basic documents like standards, specifications,
regulations and contracts
2. Manual operating procedures and related documents
3. Audit schedule
4. Documents regarding the functional areas
5. Unnecessary materials should be removed
For example irrelevant or obsolete documents
6.Check list questions and their answers with evidence
Desired Qualities of an Auditee
Positive attitude
Patience
Knowledge of the audit process
Cooperation
Alertness
The Auditee has to take an active interest in the audit
and look at it as a fruitful activity.
He may ask for provisions in the contratct,
regulations,
What should an Auditee avoid
Misconduct
Stoppage or obstructing the auditor
Bribes
Absenteeism
Misuse of power
Time wasting tactics
 ROLE OF DIFFERENT
DEPARTMENTS DURING AUDIT
Administration
Over all arrangement of audit
Reception of auditors
Opening meeting
Availability of meeting requirements
Presence of all concerned personals
Hospitality
Discipline
MANAGEMENT
Commitment
Command over QMS and its requirements
Precision and accuracy
Avoiding the over efficiency
To the point answering
Active body language
Presence of mind
Pre audit preparation
Arrangement of documentation requirements
Training of the subordinates
Positive behavior during the audit
 N KS
TH A