Auditor Training Program

7/31/2019 Auditor Training Program

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INTERNAL AUDITORS

TRAINING PROGRAM


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OBJECTIVES :

UNDERSTANDQUALITY MANAGEMENT PRINCIPLES

ISO 9001 REQUIREMENTS

QUALITY SYSTEM DOCUMENTATION

AUDIT PROCESS AND CONDUCT

HAVE PRACTISEDPLANNING / PREPARING FOR AN AUDIT

CONDUCTING AN AUDIT INTERVIEW

RAISING NON-CONFORMITIESREPORTING AUDIT FINDINGS

HAVE RECEIVEDCONTINUOUS ASSESSMENT

PERFORMANCE RATING / CERTIFICATION


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COURSE EXAMINATION

Duration - 90 Minutes

Objective Type - 30 x 1.5 = 45

Audit Test - 3 x 10 = 30

Continual Assessment - = 25

Total = 100

Minimum marks for Pass = 80


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WHAT IS QUALITY ?


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FITNESS FOR PURPOSECONFORMANCE TO SPECIFICATION

VALUE FOR MONEY

CUSTOMER SATISFACTION / CUSTOMER DELIGHT

DOING IT RIGHT THE FIRST TIME AND EVERY TIME

JUST IN TIME

REDUCTION OF VARIABILITY


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The degree to which a set of inherent characteristics

(distinguishing feature) fulfils requirements. (need or

expectation that is stated, generally implied or obligatory).

( AS PER ISO 9000-2000)


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INSPECTION

Conformity evaluation by observation and judgementaccompanied as appropriate by measurement, testing or

gauging.

QUALITY CONTROL (QC)

Part of Quality Management focused on fulfilling Quality

requirements.

QUALITY ASSURANCE (QA)

Part of Quality Management focused on providing confidence

that the Quality requirements will be fulfilled.


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QC QA QMS

DETECTION PREVENTION DIRECTION

CODES &

STANDARDS ISO 9001/2/31987 - 2000

ISO9001 -2000


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Standardization originated in US during the II World war.

MIL-Q-9858 - Quality system specification.

MIL-I-45208 - Inspection system requirements.

NATO uses MIL standards as basis to form AQAP ( Allied Quality

Assurance Publication

AQAP-1 - Quality system specification.

AQAP-4 - Mfg. , Inspection & Test specification

AQAP-9 - Final Inspection specification


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UK does not accept AQAP and develops DEFSTAN (DefenceStandards) on its own.

Later, AQAP were aligned with DEFSTAN. DEFSTAN turns obsolete.AQAPs were very militaristic in their content. Within industry atlarge, there was need for common Quality standards. As a result

BS4891 & BS 5179 were born. These spelt out the codes of

practice, but had no application of contractual situations.

In 1979, BS 5750 was made. The First version of BS 5750 was notonly used in a contractual sense between buyer and seller but

BS introduced a third party registration scheme whereby they,

as an independent organization, registered companiescomplying with the requirements of the standard on behalf of

the customers.

Contd.


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As the need for such standardization was felt throughout theworld, an International committee was formed under the

chairmanship of Canada, to produce an International Qualitystandard. This committee was called International Organizationfor Standardization.

They considered many national inputs and in 1987 produced a

series of standards and this standards were called ISO 9000.

International Organization for standardization (ISO) located atGeneva, Switzerland is the approved body for issue andguidance of international standards today.


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Requirement for Global export / tender.

Requirement for supplies to large indigenouscompanies.

Decisive edge over competition.

Is an effective marketing strategy.Formal bench mark to improve effectiveness

Acquire new customers

Improved overall productivity & profit

Less Field failures, reduction in scrap and rework.

Employee Job satisfaction.


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ISO 9000 describes fundamentals of QualityManagement systems and specifies the terminology forQMS.

ISO 9001 specifies requirements for a QMS where an

organization needs to demonstrate its ability to provideproducts that fulfill customer and applicable regulatoryrequirements and aims to enhance customersatisfaction.

ISO 9004 provides guidelines that consider both theeffectiveness and efficiency of the QMS.

ISO 19011 provides guidance on auditing Quality andenvironmental management system.


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Quality Loop involves all phases right from initial identification to

customer satisfaction.

Product Quality is the resultant of the work of all the functional

departments

Each department has to carryout certain Quality related activities along withthe function.

Business Development

Contracts

Engineering Design

Procurement

Planning

Inspection &TestingExecution

Installation

Commissioning

Servicing

Customer Satisfaction


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Triple Role Concept

Customer

Processor

Supplier

Our activities must be customer driven. All of our

people must understand who their customers are andwhat their customers expect, regardless of whether

those customers are internal are external

- John Creedon, President, Metropolitan life

Supplier

Processor of

the

operation

Customer

Processor of

the Design

Customer Supplier

Processor of the

Construction

Supplier Customer

Requirements

Facility


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PROCESS :

CONTROLSe.g. Specs , Standards , Training

S

UP

P

L

I

E

R

I

N

P

U

T

INSTRUCTIONS

INFORMATION

MATERIALS

VALUE

ADDITION

PAYMENT

SALES

REPORT

O

U

T

P

U

T

C

US

T

O

M

E

RMECHANISMPEOPLE,TIME,EQUIPMENT,CONSUMABLES


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ACT PLAN

CHECK DO

Take corrective action,standardize & feed forward

to the next plan

Verify results of the

plan

Prepare Plan

Progress

Implement the plan ona small scale


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CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

MANAGEMANT

RESPONSIBILITY

RESOURCE

MANAGEMENT

MEASUREMENT

ANALYSIS

IMPROVEMENT

PRODUCT

REALIZATION PRODUCT

PLAN

DO CHECK

ACT

PROCESS-BASED QUALITY MANAGEMENT SYSTEM

OUTPUT

VALUEADDING

ACTIVITIES INFORMATIONFLOW

CONTINUAL IMPROVEMENT OF QMS


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Quality

Manual

I

Quality

Procedures

II

WorkInstructions

III

Quality

Records

IV

Marke-

ting

Design Procur-

ement

Execu-

tion

QA Commi-

ssioning

Servici-

ng

Management / Customer Describes the Quality system inaccordance to Quality Policy

and ISO 9000 standards

Functional heads of

organization

Supervisors and

operators

Quality Assurance

Department

Describes the activities of

individual functional units

Describes the detail how a

specific activity is performed

Demonstrates the

performance of activity as

per the requirements of

standards

ISO QUALITY SYSTEM TRIANGLE


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ISO 9001-2000 PRINCIPLES &

REQUIREMENTS


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QMS :

MANAGEMENT SYSTEM ( COORDINATED ACTIVITIES )

TO DIRECT & CONTROL AN ORGANISATION WITHREGARDS TO QUALITY.


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1 . CUSTOMER FOCUS : UNDERSTAND CURRENT & FUTURE CUSTOMER NEEDS & MEET REQUIREMNTS

TRY TO EXCEED CUSTOMER EXPECTATIONS.

2 . LEADERSHIP LEADERS SHOULD CREATE & MAINTAIN INTERNAL ENVIRONMENT WHERE

PEOPLE INVOLVE FULLY & TRY TO ACHIVE ORGANISATIONS OBJECTIVES.

3. INVOLVEMENT OF PEOPLE PEOPLES FULL INVOLVEMENT ENABLES THEIR ABILITIES TO BE USED FOR THE

ORGANIASATIONS BENEFITS.

4 . PROCESS APPROACHMANAGE ACTIVITIES & RELATED RESOURCES AS PROCESS TO ACHIEVE

DESIRED RESULTS EFFICIENTLY.


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5. SYSTEM APPROACH TO MANAGEMENTACHIEVE EFFECTIVENESS & EFFICIENCY BY IDENTIFYING , UNDERSTANDING &

MANAGING INTERRELATED PROCESSES AS A SYSTEM.

6.CONTINUAL IMPROVEMENT : IMPROVING ORGANISATIONS OVERALL PERFORMANCE IS AN PERMANENT OBJECTIVE

7. FACTUAL APPROACH TO DECISION MAKING :ANALYSE DATA & INFORMATION TO MAKE EFFECTIVE DECISION

8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP ; BOTH ARE INTERDEPENDANT & CORDIAL RELATION BENEFITS BOTH


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ISO 9001 - 2000

1. SCOPE

2. NORMATIVE REFERENCE

3. TERMS & DEFINITIONS

4 . QUALITY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS

4.2 DOCUMENTATION REQUIREMENTS

5 . MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT5.2 CUSTOMER FOCUS

5.3 QUALITY POLICY

5.4 PLANNING

5.5 RESPONSIBILITY , AUTHORITY&

COMMUNICATION5.6 MANAGEMENT REVIEW

6 . RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURSES

6.2 HUMAN RESOURSES

6.3 INFRASTRUCTURE

6.4 WORK ENVIRONMENT


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ISO 9001 - 2000 ( Contd )7 . PRODUCT REALISATION :

8. MEASUREMENT ANALYSIS &IMPROVEMENT


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AUDIT


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AUDIT

DEFINITION:

A SYSTEMATIC , INDEPENDENT & DOCUMENTED PROCESS FOROBTAINING EVIDENCE & EVALUATING IT OBJECTIVELY TO

DETERMINE THE EXTENT TO WHICH AGREED CRITERIA ARE

FULFILLED ( AS PER ISO 9000:2000 ).


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FIRST PARTY AUDIT

Conducted by, or on behalf of, the organization itself forinternal purposes.

SECOND PARTY AUDIT

Conducted by customers of the organization or by otherpersons on behalf of the Customer.

THIRD PARTY AUDIT

Conducted by external independent organizations,

usually accredited, provide certification or registration of

conformity with requirements such as ISO 9001.


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WHY INTERNAL AUDITS ?

WHAT ARE THE BENEFITS ?


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WHY TO AUDIT ?

Mandatory requirement of ISO 9000

Determining System conformity against aQuality System standard / procedures.

To determine the System effectiveness to

meet the objectives. To provide the Auditee with information to

use in improving the system.


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BENEFITS OF AUDITING

BUILDS CONFIDENCE IN MANAGEMENT

CONFIRMS QUALITY POLICY IS UNDERSTOOD & IMPLEMENTED IDENTIFIES SYSTEM DEFICIENCIES

ENABLE TO HIGHLIGHT SYSTEM WEAKNESS BEFORE POTENTIALPROBLEMS OCCURS

CONVENIENT FRAME WORK FOR INVESTIGATING PROBLEMS INPARTICULAR AREAS

ALLOW PERSONNEL FROM OTHER Depts AS AUDITORS TOKNOW HOW THEIR WORK AFFECTS OTHERS

CREATE OPPURTUNITY FOR INTERCHANGE OF IDEAS CREATES OPPURTUNITY FOR EXPRESSING NEW IDEAS FORIMPROVEMENT OF PROCESS IN COST EFFECTIVE MANNER

INCREASED COMMITMENT & MOTIVATION


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INTERNAL AUDIT

ISO 9001-2000 REQUIREMENTS

1 ) AUDITS ARE CONDUCTED AT PLANNED INTERVALS TO :* DETERMINE QUALITY MANAGEMENT SYSTEM

Conformity With PLANNED ARRANGEMENTS,

ISO 9001

POLICY & OBJECTIVES

EFFECTIVELY IMPLEMENTED

MAINTAINED

2 ) PLAN A PROGRAMME OF AUDITS , COVERING :

PROCESSES / AREAS TO BE AUDITED , CONSIDERING STATUS & IMPORTANCE

AUDIT HISTORY

3 ) DEFINE :

AUDIT CRITERIA & SCOPE

FREQUENCY & METHODS


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INTERNAL AUDIT

ISO 9001-2000 REQUIREMENTS

4 ) SELECT AUDITORS : OBJECTIVE

IMPARTIALTRAINED

5 ) DOCUMENTED PROCEDURE DEFINING :

PLANNING CONDUCTING AUDITS REPORTING

RECORDS

6 ) MANAGEMENT RESPONSIBILITY :

TAKE ACTIONS ( WITHOUT DELAY )

ELIMINATE NON CONFORMITY & THEIR CAUSES

7 ) FOLLOWUP ACTIVITIES SHALL :

VERIFY ACTION TAKEN ; REPORTING RESULTS


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ISO 19011 Guidance on auditing Quality and

environmental management system.

ISO 10011-1 AUDITING

ISO 10011-2 QUALIFICATION CRITERIA FOR AUDITORS

ISO 10011-3 MANAGING AN AUDIT PROGRAMME


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SCHEDULE

AUDIT

NOTIFY

PREPARE

ANALYSE

REPORT

FOLLOWUP

CORRECTIVE

ACTION


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SAMPLE FORMAT

PROJECT:

Month

Audited Area Date 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Audit No.

PLANNING

SURVEY

FABRICATION

PROCESS CONTROL

REINF. YARD

STORES

QC LAB

MR

Date Legend

Prepared by Next Rev. Holidays

QM-Dept. Audit Planned

Approved by MR Latest Rev. Audit performed

AUDIT CALENDAR

Jul-02

SAMPLE AUDIT NOTIFICATION


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SAMPLE AUDIT NOTIFICATIONLocation: CNRO Date: Sl No:

To: Section:

cc:

This notification is to advise that an Audit is scheduled to take place in your Site/Dept asdetailed below.

Please acknowledge receipt of this notification by signing and returning a copy of this form tothe MR ( R ).

AUDIT DETAILS:

Audit Number:

Date Planned:

Time:

Proposed Audit Scope:

The Auditor / Audit Team will be:The following personnel will be required to be available during the audit:

Approved by

Management Representative:(Region)

Signed:

Date:

Received by

(Title):

Signed:

Date:

Scope proposed Accepted by Auditee


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AUDIT PLANNING

IDENTIFY AUDIT SCOPE

Examine Relevant Documentation :

Manual / Procedures

Legislation / Specifications

Existing ChecklistsCorrective Action History

Prepare Itinerary Program :

Starting Time

Duration

Timetable

Closeout meeting

PREPARE

CHECK LISTS


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AUDIT CHECKLIST

PREPARE AUDIT CHECK LIST CONTAINING

THE QUESTIONS ON THE UNDERSTANDING OF

PROCESS

PROCESS STEPS

PROCESS CONTROLS

METHODS OF VERIFYING CONFORMANCE & EFFECTIVENESS

QUESTIONS

RECORDS

ACTIVITIES

DETAILS OF AUDIT TRAILS

AUDIT CHECKLIST


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Company : ABC Limited Dept : PURCHASING AUDITOR : XYZ Date : 23.04.02

QUESTION / TOPIC PROC. REF ADDRESSEE RESPONSE EVIDENCE

What is Purchasing department function Purchasing Mgr.

Where are relevant procedures are held? -do-

(check)

Review of requisitions Proc. WP 4.3.1 -do-

-Method

-Responsibility

What records are kept ? (Check) 3.1 -do-

Requistion log (Check) 3.2 -do-

Who maintains the preferred suppliers list? 3.3 -do-

(View and check issue)

-Method

Assessment of suppliers 3.4 -do-

-Method

-Frequency

Sample purchase orders (check against 3.5

requistions, log and supplier listing)


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AUDITORS - ROLE & RESPONSIBILITIES

REMAIN WITHIN THE SCOPE EXERCISE OBJECTIVITY

COLLECT & ANALYSE EVIDENCE

REMAIN ALERT FOR ANY INDICATIONS OF EVIDENCE THAT

INFLUENCE AUDIT RESULTS PREPARE FOR ANSWERING :

WHETHER THE PROCEDURES , DOCUMENTS DESCRIBING THE QSYSTEM KNOWN , AVAILABLE , UNDERSTOOD & USED BY

AUDITEE ?

WHETHER DOCUMENTS & OTHER INFO ARE ADEQUATE TOACHIEVE Q OBJECTIVES ?


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BE PATIENT

TRY TO KEEP TO YOUR PLAN

USE YOUR CHECKLIST

USE A NOTE BOOK AND TAKE GOOD NOTES

USE OTHER TEAM MEMBERS

EXPLAIN WHY YOU ARE THERE

BE AGGRESSIVE

CONDESCENDING

CLEVER IN HINDSIGHT

PASS INSTANT OPINIONS

BE LATE

BE SIDE TRACKED BY AUDITEE


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INTERVIEWING

SAMPLING

OBSERVATION

NOTE TAKING


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WHO - RESPONSIBILITIES

WHAT - INFORMATION

WHY - UNDERSTANDING

WHERE - LOCATIONS

WHEN - SEQUENCE

HOW - PROCESS

SHOW ME - COLLECT EVIDENCE

WHAT IF - TESTING THE SYSTEM


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OBSERVE CONSISTENTLY - DEVELOP AWARENESS HOUSE KEEPING

BODY LANGUAGE

FOLLOW VISUAL SIGNS LIKE SMILING , EYE CONTACT Etc.

BE A PEOPLE WATCHER COMMUNICATION CONSIST

WORDS WE USE 7 %

WORDS WE SAY 38 %

BODY LANGUAGE 55 %

COMMUNICATION SKILLS


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GENERAL SAMPLING METHODS

Auditors may sample

Departments

Procedures and work instructions

Processes / Equipment

People

Products & Records


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SAMPLING :

LET COMMONSENSE PREVAIL


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RECORD : ALL THE OBJECTIVE EVIDENCES

BE SELECTIVE IN RECORDING BOTH CONFORMANCES & NON

CONFORMANCES

NOTE RELEVANT TO AUDIT SCOPE DO IT OPENLY

DO NOT TRY TO REACH ON AGGREMENT ON INTERPRETATION

OF FACTS


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SIX STAGES OF AUDIT PROCESS

SET THE SCENE

CONFIRM BASICS

ESTABLISH THE PROCESS

CHECK BACK

CLOSEOUT

CHECK FOR

OBJECTIVE EVIDENCE

CYCLICAL

STAGES

COLLECT EVIDENCE BY

QUESTIONINGREVIEWING RECORDS

OBSERVING ACTIVITIESF

PUT THE AUDITEE AT EASE

HAVE SOME INFORMAL DISCUSSION

INFORM THE AUDITEE OF THE AUDIT PROCESS

DETERMINE :

ORGANISATION STRUCTURE

RESPONSIBILITIES

STATUS OF DOCUMENTATION

TRAINING & COMPETANCY OF PERSONEL

UNDERSTAND THE PROCESS BY:

IDENTIFYING PROCESS STEPS

By ASKING WHAT HAPPENS AT THE END

& VITAL WHEN DOCUMENTATION IS LIMITED

TO ESTABLISH HOW THE SYSTEM IS MANAGED ?

CONFIRM CONFORMANCE

ESTABLISH TRAILS

FOLLOW UP PREVIOUS TRAILS

EXPRESS APPRECIATION FOR COOPERATION

SUMMARISE FINDINGS

AGREE ON COMPLETION DATE


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NON CONFORMANCE

A NON FULFILMENT OF A REQUIREMENT

QUALITY MANAGEMENT SYSTEM

ISO 9001 : 2000

CUSTOMER SPECIFICATION

LEGISLATION

REGULATORY BODY


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GRADING OF NON CONFORMANCE

MAJOR

No evidence of adherence to a procedure or system

element

Or

Major risk to final product or service quality.

MINOR

Limited evidence of compliance with a procedure

Or

No appreciable risk to final product or service quality


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OBSERVATION

A STATEMENT OF FACT BASED ON EVIDENCE

INSTANCES OF BEST PRACTICES

INSIGNIFICANT PROBLEM SUSPISIOUS THAT NEED TRAILING

FEEDBACK TO THE AUDIT CONTROLLER


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NCR - REPORT REQUIREMENTS

NCR MUST CONTAIN

CLAUSE OF THE AUDIT STANDARD

PROCEDURE REFERENCE

LOCATIONACTIVITY

NATURE OF PROBLEM

EVIDENCE

SCALE OF PROBLEM ( MAJOR OR MINOR )

NON-CONFORMANCE REPORT (NCR)

LARSEN & TOUBRO LIMITEDRGEN 14 F 03-2


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Section Audited: MR FUNCTIONS

Auditor(s): Signature:

1 J Joseph Amalraj 1 -sd-

2 2

3 3

Audited Document:

Project Quality Plan No. VEC/PQP/025 Rev. 0 dtd. 07.01.02

Cl. 4.17 - Internal Audit

Non-conformance Statement:

INTERNAL AUDITS COMPLIANCE TO PLAN NOT EVIDENCED.

Objective Evidence:

SITE AUDITS FOR THE MONTHS MAY, JUNE, JULY HAVE

NO NCR'S / OBERVATIONS RECORD.

Auditee: Mr. N BALA MURUGAN

NCR Caegories(tick one) EN ISO 9002 Reference:

see reverse page Clause(s)

1 2 3 4 5 6

Signature: -sd- Date: 07.08.02

Remedial Action by auditee:

RECORDS OF SITE INTERNAL AUDITS WILL BEMAINTAINED FOR THE AUDITS CONDUCTED

Signature: -sd- completion target date:

13.08.02

Preventive action Proposed by auditee:

AUDIT PLAN Vs COMPLIANCE WILL BE REVIEWED DURING MANAGEMENT

REVIEW MEETING TO ENSURE COMPLIANCE

Auditee: Date:

Date:

Audit No: 05

NCR No: 30

Page 1of 2

4.17

Closing of NCR:

Auditor:

Signature:

Category Description

A A non-conformance situation that:

Can be easily corrected by auditee such as incorrect

1


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Can be easily corrected by auditee, such as incorrectcompletion of forms, or lack

of attention to detail in a number of occasions.

Generally does not require training of staff Can be corrected without cost to the Company

A nonconformance situation that;

Can be solved by the auditee, but may requireapproval from Manager

May necessitate training of staff Can be corrected without cost to the Company

A non-conformance situation that:

Can only be resolved through the issue of revisedprocedure text or content (not format) and associated

documents

Requires overview by QM Department (RO) tomaintain system integrity

May necessitate training of staff Can be solved with no or little cost to the Company


Can only be resolved through the issue of revisedand/or delegation of procedure text

or content (not format) and associated documents

Can be solved by Site Manager but resolution mayhave wider business impact.

Requires overview by QM Department (RO) tomaintain system integrity.

Requires training of staff. Corrective action involves cost to the Company.


Can only be resolved through the creation of anidentified procedure(s) and/or

associated documents

That can only be solved by Site Manager, butresolution may have wider business impact

Requires overview by RPM / RM to maintain systemintegrity

Requires the purchase of additional material orresources for its resolution

Requires training of staff Corrective action may cause significant costs to theCompany

A very serious non-conformance situation that:

Could affect the business and/or integrity of thesystem To be referred to RPM/ RM for further action.

5

6

2

3

4

CORRECTIVE ACTION


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CORRECTIVE ACTION

AUDITOR AUDITEENC IDENTIFIED

WRITE NCCONFIRM

NC

AGREE ON COMPLETION DATE

INVESTIGATE CAUSE

RECORD RESULTS

IDENTIFY CA

IMPLEMENTVERIFY

VERIFY CA TAKEN &

EFFECTIVENESSCLOSE NCR


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FOLLOW UP AUDITS

IT IS NECESSARY TO ENSURE THAT :

PROBLEM IS RECTIFIED & ELIMINATED COMPLETLY

EFFECTIVENESS IS DEMONSTRATED

CHECK BYASKING QUESTIONS

REVIEWING RECORDS

OBSERVING ACTIVITIES


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PERFORM AUDITINGPREPARE YOUR SELF FOR THE AUDITINGCONDUCT THE AUDIT AS PER THE GUIDELINES OF THE

TRAINEROTHERS OBSERVE THE AUDITINGDISCUSS WITH TRAINEE ON YOUR FINDINGS


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PREPARE NON CONFORMANCE REPORTS &SUMMARY OF AUDIT ON YOUR AUDIT

PRESENT YOUR FINDINGS ( EACH 10 MIN )DISCUSS WITH AUDIENCE


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COURSE REVIEW


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