TOTAL QUALITY

MANAGEMENT

QUALITY AUDIT
QUALITY AUDIT:DEFINITION
• It is a Periodic, independent, and
documented examination and verification
of activities, records, processes, and
other elements of a quality system to
determine their conformity with
the requirements of a quality standard such
as ISO 9000.
Any failure in their proper implementation
may be published publicly and may lead to
a revocation of quality certification.
Also called conformity assessment or
quality system audit.
Quality

Quality Standard
audits ensure
quality
standards
are being met
• ISO – International Standard
Organization
• SIX SIGMA Quality Standard
• ASQ –American Society for Quality
• ANSI – American National
Standard Institute.
• MILSPEC – Military Specifications.
Quality audits
help ensure
customer safety
and satisfaction. Audit Classification
Audits can be classified based on what
is being audited
* the Product
* the Process
* the System
• Internal Audit –(first party audit)
• External Audit-(Second & Third Party
Audit)
• Process Audit
• Product Audit
• System Audit
Internal Audit
• Internal audits ensure that an organization
is meeting its own quality standards or
contractually required standards.
• Internal audits may be done by auditors
who work for the company being reviewed.
They may also be hired by the company to
audit its own functions.
• However, auditors must be independent of
the function they are auditing.
External Audits
• Second Party Audits
External audits done by a company that has a contract
with the audited firm.

• Third Party Audits

External quality audits done by an organization that has no
contract with the company it is auditing is called a third party
audit.
A third party external audit can be done to attain or maintain
certification in a quality standard. A third party audit can also
be mandated by law to qualify for government contracts.
It can also be done at the request of a supplier or customer
who would be considered a second party audit if they
performed the quality audit themselves.
• PROCESS AUDIT:
Verifies that a documented process meets quality standards.
This process could be a manufacturing process or service
process.
• PRODUCT AUDIT:
Verifies that a physical product meets design specifications
and other quality measurements.
Product audits may require measuring physical dimensions,
product testing etc.
A product audit can involve checking the calibration and test
equipment used to verify that the product meets quality
standards.
• SYSTEM AUDIT:
A system audit is a review of the quality system used by a
company.
It is a review of how quality standards are measured and met
by the company.
It verifies the procedures used to measure the quality of the
product, how defects are recorded, and how the company
ensures that failed product is not passed
 • To evaluate a supplier where
there is a desire to establish a
contractual relationship.
• To verify that an organization´s
own quality system continues

QUALITY to meet specified requirements

and is being implemented.
AUDITS • To verify that the supplier´s
FEATURES quality system continous to
meet specific requirements
and is being implemented.
• To evaluate an organization´s
own quality system against a
quality system standard.
Objectives
• General objectives
– Conformity
– Effectiveness
– Improvement
• Specific objectives
– Audit should be initiated:
1. Within a contractual framework
2. For the purpose of an internal
organization audit
 PROCESS FLOW FOR AUDIT
PROGRAMME
Authority

Plan
Establishing
the audit

Competence &
Act

Improving the Evaluation of

audit auditors

Do
Implementing
the audit
Audit activities

Monitoring &

Check
Reviewing the
audit
PURPOSE OF AUDIT
• Establish the adequacy & suitability of the system
• Determine the effectiveness of the system
• Afford opportunities for system analysis
• Aid problem-solving
• Facilitate decision-making
• Aid employee involvement
• Help in establishing the capability of process &
equipment
• Ensure meeting legal and statutory requirements
• Aid communication and facilitate training
THE QUALITY AUDITOR
• Personal Attributes
– Communication, Power of Observation,
Flexibility, Perseverance, Objectivity,
Decisiveness
• Professional Attributes
– Independence, Appearance, Punctuality,
Preparedness, Fairness, Integrity
• Technical Ability
– Knowledge of Technical Standards &
Regulations, Quality & Cost Analysis, Statistical
& Diagnostic Techniques
• Professional Status
– Accreditation, Code of Ethics, Professional
Expertise
How to Conduct a Quality Audit
Review documentation regarding the process
being audited.

Create a quality audit plan. Be sure to include

a time line and the location of the audit. Also,
provide a list of the documents needed to
conduct the audit.

Define the scope of the audit. Identify the

specific groups to be audited.

Objectives of the audit should be clear and

aligned to the audit plan.
Create a checklist of quality requirements to
use in the evaluation.

Introduce auditors to auditees. Auditees will

be tasked with helping the auditor to research
information about the quality requirements to
be audited.

Provide senior management with a list of

meeting times and dates.

Begin the audit. Have a kickoff meeting to

mark the start of the audit. The meeting
should have audit team members in
attendance; clarify scope, goals and schedule;
review how the audit will be conducted; and
confirm the readiness of the Auditee.
Interview designated groups and study
records. After analyzing the data, try to verify
or substantiate through more objective
means. Any quality system outliers or
nonconformities should be investigated and
thoroughly documented.

Draw conclusions, discuss results with

management and prepare the audit report.
The report should include recommendations
and observations along with the audit plan, a
review of all evidence found, conclusions and
a rating of the quality of the system.
QUALITY AUDITING
REPORT
AUDIT REPORT
IT SHOULD BE DATED AND SIGNED BY THE LEAD AUDITOR

IT SHOULD CONTAIN THE

Details Of The Audit Plan, The
The Scope And Objectives Of The Identification Of Audit Team Members,
Audit Dates, Identification Of The Specific
Organization Audited
AUDIT CHECKLIST

Area audited : ______________ Date:__________________

Checklist Questions Response

1. Does the company have a work

instruction to operate the machine?
2. How is the machine being cleaned and
maintained?
3. Are personnel trained to use the
machine?
4. How often is the equipment being
calibrated and cleaned?

5. When is the last breakdown of the

machine?
Are there any product being affected?
 AUDIT REPORT: AN EXAMPLE :CANON
No Date Findings of IA Grading Location Audite Auditor
e

1. 1.12.2013 Production Critical Human Hema Narayanan

and QC Resources
departments
are headed
by the same
person

2. 15.12.2013 Monitoring of Appu Muthu

temperature
in a Major or
warehouse Minor Warehouse

3 26.12.2013 Inadequate Major or Production Kausik Arun

control over Minor
sub-
contractor
Do not Report these
Proprietary or confidential information

Subjective statements not substantiated

by objective evidence/individual opinion

Unrelated recommendations

Minor non-conformities already corrected

Trivial matters

Statements reflecting emotions, prejudices

or arguments

Aspects neither discussed nor mentioned

during the closing meeting
VANATHI

PREMNATH