• 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.
• ISO – International Standard
• SIX SIGMA Quality Standard
• ASQ –American Society for Quality
• ANSI – American National
• MILSPEC – Military Specifications.
are being met
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
• Process Audit
• Product Audit
• System 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.
• 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
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
• 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
• SYSTEM AUDIT:
A system audit is a review of the quality system used by a
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
• To verify that an organization´s
own quality system continues
to meet specified requirements
and is being implemented.
• To verify that the supplier´s
quality system continous to
meet specific requirements
and is being implemented.
• To evaluate an organization´s
own quality system against a
quality system standard.
• General objectives
• Specific objectives
– Audit should be initiated:
1. Within a contractual framework
2. For the purpose of an internal
PROCESS FLOW FOR 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 &
• Ensure meeting legal and statutory requirements
• Aid communication and facilitate training
THE QUALITY AUDITOR
• Personal Attributes
– Communication, Power of Observation,
Flexibility, Perseverance, Objectivity,
• 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
How to Conduct a Quality Audit
Review documentation regarding the process
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
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
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.
IT SHOULD CONTAIN THE
The Scope And Objectives Of The
Details Of The Audit Plan, The
Identification Of Audit Team Members,
Dates, Identification Of The Specific
IT SHOULD BE DATED AND SIGNED BY THE LEAD AUDITOR
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
3. Are personnel trained to use the
4. How often is the equipment being
calibrated and cleaned?
5. When is the last breakdown of the
Are there any product being affected?
AUDIT REPORT: AN EXAMPLE :CANON
No Date Findings of IA Grading Location Audite
1. 1.12.2013 Production
by the same
2. 15.12.2013 Monitoring of
3 26.12.2013 Inadequate
Production Kausik Arun
Do not Report these
Proprietary or confidential information
Subjective statements not substantiated
by objective evidence/individual opinion
Minor non-conformities already corrected
Statements reflecting emotions, prejudices
Aspects neither discussed nor mentioned
during the closing meeting