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• 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.

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Quality Standard

• ISO – International Standard Organization

• SIX SIGMA Quality Standard• ASQ –American Society for Quality• ANSI – American National

Standard Institute.• MILSPEC – Military Specifications.

Quality audits ensure quality standards are being met

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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

Quality audits help ensure customer safety and satisfaction.

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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.

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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.

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• 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

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• To evaluate a supplier where

there is a desire to establish a

contractual relationship.

• 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.



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• 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

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Establishing the audit

Implementing the audit

Monitoring & Reviewing the


Competence & Evaluation of


Audit activities

Improving the audit






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• 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

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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


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How to Conduct a Quality AuditReview 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.

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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.

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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.

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• 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?


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AUDIT REPORT: AN EXAMPLE :CANONNo Date Findings of IA Grading Location Audit


1. 1.12.2013 Production and QC departments are headed by the same person

Critical Human Resources

Hema Narayanan

2. 15.12.2013 Monitoring of temperature in a warehouse

Major or Minor


Appu Muthu

3 26.12.2013 Inadequate control over sub-contractor

Major or Minor




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Do not Report theseProprietary 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

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