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Robere & Associates 2004 Auditing Upgrade to ISO19011 1

Auditing Skills Update

Conformance to

ISO19011

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Agenda:

Day One: ISO19011: 2002

Principles of auditing Managing an Audit programme

Audit Activities (Part 1)

Day Two:

Audit Activities (Part 2)

Competence and evaluation of auditors

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Robere & Associates 2004 Auditing Upgrade to ISO19011

TutorIntroductions

Who we are

Our background

Our qualifications

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Name Job Title/Responsibility

Knowledge of ISO Standards and Auditing

Reasons/Objectives for Attending

Delegate Introductions

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What are your objectives? 15 min

This training program is yours. It is

important to determine what your objectivesare for this course, and what questions you

may want to address.

In the space below, indicate your teams

objectives and/or questions to be answeredduring this two day course.

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There is a need for a

good standard..and goodauditors

1.1. New standards requires newNew standards requires new

approachesapproaches2.2. Auditors have a realAuditors have a real

opportunity to add value to theopportunity to add value to the

organizationorganization

3.3. Demands for professionalismDemands for professionalism

have never been greaterhave never been greater4.4. Continual ProfessionalContinual Professional

Development (CPD) is the keyDevelopment (CPD) is the key

to continued success.to continued success.

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ISO9000:2000 is not the only new

standard!!

ISO10011ISO10011

QMS AuditingQMS AuditingISO14011ISO14011

EMS AuditingEMS Auditing

ISO19011

System Auditing

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ISO 19011

Auditing Standard

The new structure of ISO 9001:2000

follows in philosophy that of ISO14001

Identifies the requirements of QMSauditing and combines with EMS

auditing

Principles of Auditing

Managing an audit program

Audit Activities Competence of auditors

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3.0 Terms and definitions 15 min

Audit Criteria

Audit evidence Audit findings

Audit conclusion

Audit client

Auditee

Auditor

Audit team Technical expert

Audit programme

Audit plan

Audit scope Competence

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4.0 Principles of auditing

Ethical Conduct: the foundation of professionalism

Fair

Presentation: the obligation to report truthfullyand accurately

Due professional care: the application andjudgment in auditing.

Independence: the basis for the impartiality of the

audit and objectivity of the audit conclusions Evidence-based approach: the rational method for

reaching reliable and reproducible Audit conclusionsin a systematic audit process

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5.0 Managing

an auditprogramme

The organizations top

management should

grant authority for theaudit. Those assigned

for the audit should:

1.Identify the necessary

resources and ensure

they are provided.

2.Establish, implement,

monitor, review and

improve the audit

programme, and

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Audit programme objectives andextent

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5.2.1 Objectives of an auditprogramme

a) management priorities,

b) commercial intentions,c) management system requirements,

d) statutory, regulatory and contractual requirements,

e) need for supplier evaluation,

f) customer requirements,g) needs of other interested parties, and

h) risks to the organization

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5.2.2 Extent of an audit programme

The extent of an audit programme can vary and will be influenced by the size,nature and complexity of the organization to be audited, as well as by thefollowing:

a) the scope, objective and duration of each audit to be conducted;

b) the frequency of audits to be conducted;

c) the number, importance, complexity, similarity and locations of the activities tobe audited;

d) standards, statutory, regulatory and contractual requirements and other auditcriteria;

e) the need for accreditation or registration/certification;

f) conclusions of previous audits or results of a previous audit programme review;

g) any language, cultural and social issues;

h) the concerns of interested parties;

i) significant changes to an organization or its operations.

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Audit programme responsibilities,resources and procedures

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5.3.1 Audit programme responsibilities

Those assigned the responsibility for managing theaudit programme should

a) establish the objectives and extent of the auditprogramme,

b) establish the responsibilities and procedures, andensure resources are provided,

c) ensure the implementation of the audit programme,d) ensure that appropriate audit programme records

are maintained, and

e) monitor, review and improve the audit programme.

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5.3.2 Audit programme resources

When identifying resources for the audit programme, considerationshould be given to

a) financial resources necessary to develop, implement, manageand improve audit activities,

b) audit techniques,

c) processes to achieve and maintain the competence of auditors,and to improve auditor performance,

d) the availability of auditors and technical experts having

competence appropriate to the particular audit programmeobjectives,

e) the extent of the audit programme, and

f) traveling time, accommodation and other auditing needs.

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5.3.3 Audit programme procedures

Audit programme procedures should address the following:

a) planning and scheduling audits;

b) assuring the competence of auditors and audit team leaders;c) selecting appropriate audit teams and assigning their roles and

responsibilities;

d) conducting audits;

e) conducting audit follow-up, if applicable;

f) maintaining audit programme records;

g) monitoring the performance and effectiveness of the auditprogramme;

h) reporting to top management on the overall achievements of theaudit programme.

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Audit programme implementation

Element 5.4

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Implementation points

a) communicating the audit programme to relevant parties;

b) coordinating and scheduling audits and other activities relevant to theaudit programme;

c) establishing and maintaining a process for the evaluation of theauditors and their continual professional development, in accordancewith respectively 7.6 and 7.5;

d) ensuring the selection of audit teams;

e) providing necessary resources to the audit teams;

f) ensuring the conduct of audits according to the audit programme;

g) ensuring the control of records of the audit activities;h) ensuring review and approval of audit reports, and ensuring their

distribution to the audit client and other specified parties;

i) ensuring audit follow-up, if applicable.

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5.5 Audit programme records

a) records related to individual audits, such as

audit plans,

audit reports, nonconformity reports,

corrective and preventive action reports, and

audit follow-up reports, if applicable;

b) results of audit programme review;

c) records related to audit personnel covering subjects such as

auditor competence and performance evaluation,

audit team selection, and

maintenance and improvement of competence.

Records should be retained and suitably safeguarded.

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5.6 Audit programme monitoring and

reviewing

The implementation of the audit programme

should be monitored and, at appropriateintervals, reviewed to assess whether its

objectives have been met and to identify

opportunities for improvement. The results

should be reported to top management.

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Performance Indicators

Performance indicators should be used to

monitor characteristics such as the ability of the audit teams to implement the

audit plan,

conformity with audit programmes and schedules,

and feedback from audit clients, auditees and

auditors.

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Audit Programme Review

a) results and trends from monitoring,

b) conformity with procedures,c) evolving needs and expectations of

interested parties,

d) audit programme records,

e) alternative or new auditing practices, andf) consistency in performance between audit

teams in similar situations.

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Audit Activities

Clause 6.0

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General Requirements

This clause contains guidance on planning and

conducting audit activities as part of an auditprogramme. The figure below provides an

overview of typical audit activities. The extent

to which the provisions of this clause are

applicable depends on the scope andcomplexity of the specific audit and the

intended use of the audit conclusions.

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Initiating the Audit

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Appointing the audit team leader

Those assigned the responsibility for managing the audit

programme should appoint t

he audit team leader for t

hespecific audit.

Where a joint audit is conducted, it is important to reach

agreement among the auditing organizations before the

audit commences on the specific responsibilities of each

organization, particularly with regard to the authority of theteam leader appointed for the audit.

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6.2.2 Defining audit objectives, scope and

criteria

Within the overall objectives of an audit

programme, an individual audit should bebased on documented objectives, scope and

criteria.

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Team Exercise

Determining and Writing a Scope of an

Audit. Time 10 minutes, feedback: 10 minutes)

Your team has been given a Quality Manual,

use the information in Quality Manual to

write-up the scope on the flip chart and beprepared to present to the rest of the class.

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6.2.3Determining the feasibility of theaudit

The feasibility of the audit should be determined,

taking into consideration such factors as the

availability of

sufficient and appropriate information for planning the audit,

adequate cooperation from the auditee, and

adequate time and resources.

Where the audit is not feasible, an alternative shouldbe proposed to the audit client, in consultation with

the auditee.

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6.2.4 Selecting the audit team

When the audit has been declared feasible,

an audit team should be selected, taking intoaccount the competence needed to achieve

the objectives of the audit. If there is only oneauditor, the auditor should perform allapplicable duties of an audit team leader.

Clause 7 contains guidance on determiningthe competence needed and describesprocesses for evaluating auditors.

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International Accreditation Forum (IAF)

Guide

Certificated entity:Certificated entity:

Number ofNumber ofemployeesemployees

Initial assessmentInitial assessment

(AuditorDays)(AuditorDays)

Annual surveillanceAnnual surveillance

visits (AuditorDays)visits (AuditorDays)

ReRe--assessment visitsassessment visits

(AuditorDays)(AuditorDays)

TotalTotal OnOn--sitesiteminimumminimum



less than 5less than 5 22 11 11 0.5*0.5* 1.51.5 1155--99 2.52.5 1.51.5 11 0.5*0.5* 1.51.5 11

1010--1919 33 22 11 11 22 112020--2929 44 2.52.5 1.51.5 11 33 223030--5959 66 4.54.5 22 11 44 2.52.5

6060--9999 77 55 22 1.51.5 44 33100100--249249 88 66 2.52.5 22 55 33250250--499499 1010 77 33 22 66 4.54.5

500500--999999 1212 99 44 33 88 5.55.51,0001,000--1,9991,999 1515 1212 55 44 1010 6.56.52,0002,000--3,9993,999 1818 1414 66 55 1212 884,0004,000--7,9997,999 2121 1717 77 55 1414 99

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EXERCISE: Selecting the Audit Team

Part 1 0f 2

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EXERCISE: Selecting the Audit Team

Part 2 0f 2

Time: 30 min preparation; 15 min

presentation

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6.2.5 Establishing initial contact with

the auditee

The initial contact for the audit with the

auditee may be informal or formal, but shouldbe made by those assigned responsibility for

managing the audit programme or the audit

team leader.

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6.3 Conducting document review

Prior to the on-site audit activities the

auditees documentation should be reviewedto determine the conformity of the system, as

documented, with audit criteria.

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6.4 Preparing for the on-site auditactivities

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6.4.1 Preparing the audit plan

The audit team leader should prepare an audit plan

to provide the basis for the agreement among the

audit client, audit team and the auditee regarding the

conduct of the audit. The plan should facilitate

scheduling and coordination of the audit activities.

The amount of detail provided in the audit planshould reflect the scope and complexity of the audit.

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6.4.2 Assigning work to the audit team

The audit team leader, in consultation with the auditteam, should assign to each team member

responsibility for auditing specific processes,functions, sites, areas or activities. Suchassignments should take into account the need forthe independence and competence of auditors andthe effective use of resources, as well as different

roles and responsibilities of auditors, auditors-in-training and technical experts. Changes to the workassignments may be made as the audit progressesto ensure the achievement of the audit objectives.

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Date Paul J. Robere Nithisit M. Srinuan S.

1st Jun 01 Opening MtgOverview of QMS

EngineeringLunchEngineering (cont.)Team Review

Opening MtgOverview of QMS

South shopLunchSouth shop (cont.)Team Review

2nd Jun 01 PurchasingContracts/SalesLunchProduct Support

Write-up & closingMeeting

CalibrationChemical/Met Laps

Lunch

Personnel /TrainingCustomer ServiceWrite-up & closingMeeting

MaintenanceDoc/Date contol

Lunch

Internal AuditCA/PAWrite-up & closingMeeting

Start times 09:00, finish times 17:00. Lunch to be determined. This is only an outline plan and may besubject to change. A wash up meeting will be held on the evening of the first day. Each Assessorshould have a guide to accompany them at all times. This will help facilitate the audit and ensure thesafety of the team.

Sample Audit ScheduleS.C. Lap Limited

Lead Auditor : Paul J. Robere

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Sample Audit Sch

eduleproPrint Bureau ServicesproPrint Bureau ServicesEaling SiteEaling SiteLEAD AUDITOR: PAUL ROBERELEAD AUDITOR: PAUL ROBERE SECOND AUDITOR: KHUN ONTEERASECOND AUDITOR: KHUN ONTEERA

DAY ONEDAY ONE

OPENING MEETING Overview of QMS MtgOPENING MEETING Overview of QMS Mtg 9.009.00

PurchasingPurchasing P280P280 10.0010.00 PrePre--Sales TeamSales Team P470P470 10.0010.00

Contractor ServicesContractor Services PP291291 11.0011.00 Design TeamDesign Team P465P465 10.4510.45

MarketingMarketing PP310310 11.3011.30 Tech. ServicesTech. Services P468P468 11.3011.30

LUNCHLUNCH

EstimatingEstimating P312P312 13.3013.30 Operator TeamOperator Team PP420420 13.3013.30

Contract ReviewContract Review P314P314 14.3014.30 Job ShipmentJob Shipment PP472472 14.3014.30

Requirements DefinitionRequirements Definition P315P315 15.3015.30 Customer SupportCustomer Support P500P500 15.3015.30

DAY ONE ROUND UPDAY ONE ROUND UP 17.0017.00 DAY ONE ROUND UPDAY ONE ROUND UP 17.0017.00

DAY TWODAY TWO

LEAD AUDITORLEAD AUDITOR SECOND AUDITOR SECOND AUDITOR

Project ManagementProject Management PP405405 09.0009.00 Web Development TeamWeb Development Team P410P410 09.0009.00

Development ControlDevelopment Control P420P420 11.3011.30 Admin ServicesAdmin Services P440P440 1010..3030

P490P490 12.0012.00

LUNCHLUNCH 12. 0012. 00 LUNCHLUNCH 1212..0000

Resource ManagementResource Management P200P200 14.0014.00 Design ControlDesign Control P400P400 14.0014.00

Quality ManagementQuality Management P250P250 14.3014.30 Configuration ManagementConfiguration Management P403P403 15.0015.00

Preparation for ClosingPreparation for Closing

MeetingMeeting

16.0016.00 Preparation for ClosingPreparation for Closing

MeetingMeeting

16.0016.00

CLOSING MEETINGCLOSING MEETING 17.0017.00 CLOSING MEETINGCLOSING MEETING 17.0017.00

12.0012.00 12.0012.00LUNCHLUNCH

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EXERCISE: Audit Schedule

Time: 45 minutes. Feedback: 30 Minutes

Imagine you are part of a team conducting an third party audit.

The lead auditor asks you to come up with an audit schedule detailinghow you might cover the core activities as indicated in the informationgiven in the Quality Manual

Include a daily programme for the auditor(s) involved, remembering toconsider: Opening and closing meetings

Logistics

Breaks

Contingency planning.

Be prepared to discuss the thinking behind your plan with the class.

The exercise is intended to make you think about the planningnecessary for an effective audit in a situation of real-world complexity.

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6.4.3Preparing work documents

The audit team members should review the

information relevant to their auditassignments and prepare work documents

as necessary for reference and for recording

audit proceedings.

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EXERCISE Checklists

Time: 60 minutes. Feedback: 30 minutes.

Produce a checklist on the templateprovided to cover the training process as

detail in the given quality manual.

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6.5 Conducting on-site audit activities

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6.5.1 Conducting the opening meeting

An opening meeting should be held with theauditees management or, where appropriate, those

responsible for the functions or processes to beaudited.

The purpose of an opening meeting is to confirm the audit plan,

to provide a short summary ofhow the audit activities will be

undertaken, to confirm communication channels, and

to provide an opportunity for the auditee to ask questions.

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Exercise Opening Meeting

Time: 60 minutes, feedback 30 minutes.

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6.5.2 Communication during the audit

Depending upon the scope and complexity ofthe audit, it can be necessary to make formalarrangements for communication within theaudit team and with the auditee during theaudit.

The audit team should confer periodically toexchange information, assess auditprogress, and to reassign work between theaudit team members as needed.

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6.5.3 Roles and responsibilities of

guides and observers

Guides and

observers mayaccompany the

audit team but are

not a part of it. They

should not influenceor interfere with the

conduct of the audit.

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Collection Methods

Methods to collect information include

interviews, observation of activities, and

review of documents.

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Practical help Conducting

interviews

Interviews are one of the important means ofcollecting information and should be carried

out in a manner adapted to the situation and

the person interviewed.

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6.5.5 Generating audit findings

Audit evidence should be evaluated

against the audit criteria to generatethe audit findings.

Audit findings can indicate either

conformity or nonconformity with

audit criteria.

When specified by the auditobjectives, audit findings can identify

an opportunity for improvement.

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EXERCISE Recording

Non-conformities

Time: 60 minutes. Feedback: 30 minutes

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EXERCISE: GRADING NCRs

Time : 45 minutes Feedback: 30 minutes.

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6.5.6 Preparing audit conclusions

The audit team should confer prior to the closing meeting

a) to review the audit findings, and any other appropriateinformation collected during the audit, against the auditobjectives,

b) to agree on the audit conclusions, taking into account theuncertainty inherent in the audit process,

c) to prepare recommendations, if specified by the auditobjectives, and

d) to discuss audit follow-up, if included in the audit plan.

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6.5.7 Conducting the closing meeting

A closing meeting, chaired by the audit team

leader, should be

held to present t

he auditfindings and conclusions in such a manner

that they are understood and acknowledged

by the auditee, and to agree, if appropriate,

on the timeframe for t

he auditee to present acorrective and preventive action plan.

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Exercise Closing Meeting

Time: 60 minutes, feedback 30 minutes.

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6.6 Preparing, approving anddistributing the audit report

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6.6.1 Preparing the audit report

The audit team leader should

be responsible for thepreparation and contents of

the audit report.

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Findings Summary Part 1

This Company has a Quality Management System which is well documented

and generally in conformance with the requirements of ISO 9001:2000.

However,the systems and procedures have not been fully

implemented in the contract, project management and product

shipment areas.

The audit found 33 non-conformities and particular concern is felt for:

Lack of application of the system for review of the quality

requirements of contracts.

Evidence of a lack of disciplined control toward customercomplaints and related follow-up actions.

Lack of quality awareness on the part of project and senior

management personnel.

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Findings Summary Part 2

No significant problems were found in the activities of either the

Design or pre-sales teams.

There is a need for more frequent review of the Quality Manual and

project management procedures.

It will therefore be necessary for the company to undertake

corrective action on the deficiencies raised and for a further audit

to be carried out to verify that it has been taken before the

company can be awarded a certificate. Corrective action should

be effected with

in th

ree month

s from today.

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6.6.2 Approving and distributing the

audit report

The audit report should be issued within the agreed time period.If this is not possible, the reasons for the delay should be

communicated to the audit client and a new issue date s

houldbe agreed.

The audit report should be dated, reviewed and approved inaccordance with audit programme procedures.

The approved audit report should then be distributed torecipients designated by the audit client.

The audit report is the property of the audit client. The auditteam members and all report recipients should respect andmaintain the confidentiality of the report.

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6.7 Completing the audit

The audit is completed when all activities described

in the audit plan have been carried out and the

approved audit report has been distributed.

Documents pertaining to the audit should be retained

or destroyed by agreement between the participating

parties and in accordance with audit programme

procedures and applicable statutory, regulatory andcontractual requirements.

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6.8 Conducting audit follow-up

The conclusions of the audit may indicate the

need for corrective, preventive orimprovement actions, as applicable. Such

actions are usually decided and undertaken

by the auditee within an agreed timeframe

and are not considered to be part of theaudit. The auditee should keep the audit

client informed of the status of these actions.

C ti A ti PC ti A ti P

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ACCEPT

Corrective Actions ProcessCorrective Actions Process

Initiation of Non-conformity

Provide Programme of CA

Submit CA Programme to Auditor

Analysis of CAProgramme

Monitoring,Reviewing,Auditing

Verify and closing

Auditor

Auditee

Auditee

Auditee

Auditor

Auditor

Stage 1

Stage 5

Stage 2

Stage 6

Stage 3

Stage 4

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7 Competence and evaluation ofauditors

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7.1 General Requirements for

Competence and Evaluation

Confidence and reliance in the audit processdepends on the competence of thoseconducting the audit. This competence isbased on the demonstration of: the personal attributes described in 7.2, and

the ability to apply the knowledge and skills

described in 7.3 gained through the education,work experience, auditor training and auditexperience described in 7.4.

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7.2 Personal attributes

Auditors should possess

personal attributes to enablethem to act in accordance

with the principles of auditing

described in clause 4.

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7.3 Knowledge and skills

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7.3.1 Generic knowledge and skills of qualitymanagement system and environmental management

system auditors

Auditors should have knowledge and skills in

the following areas.1. Audit principles, procedures and techniques

2. Management system and reference documents

3. Organizational situations

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Audit principles, procedures and

techniques

Audit principles, procedures and techniques:

to enable the auditor to apply t

hoseappropriate to different audits and ensure

that audits are conducted in a consistent and

systematic manner

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Management system and reference

documents

1. to enable the auditor to comprehend the

scope of the audit and apply audit criteria.

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Organizational situations:

To enable the auditor to comprehend the

organization's operational context.

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Applicable laws, regulations and other

requirements relevant to the discipline:

to enable the auditor to work within, and be

aware of, th

e requirements th

at apply to th

eorganization being audited

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7.3.3 Specific knowledge and skills of

quality management system auditors

Quality management system auditors should have

knowledge and skills in the following areas.

a) Quality-related methods and techniques: to enable

the auditor to examine quality management systems

and to generate appropriate audit findings and

conclusions.

b) Processes and products, including services: toenable the auditor to comprehend the technological

context in which the audit is being conducted..

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7.3.4 Specific knowledge and skills of

environmental management system auditors

Environmental management system auditors

sh

ouldh

ave knowledge and skills in th

efollowing areas.

a) Environmental management methods and

techniques

b) Environmental science and technology

c) Technical and environmental aspects of

operations

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Environmental management methods

and techniques:

to enable the auditor to examine

environmental management systems and togenerate appropriate audit findings and

conclusions.

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Environmental science and technology

to enable the auditor to comprehend the

fundamental relationships between human

activities and the environment.

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Technical and environmental aspects

of operations:

to enable the auditor to comprehend the

interaction of the auditees activities,

products, services and operations with the

environment.

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7.4 Education, work experience,auditor training and audit experience

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7.4.1 Auditors Qualification

They should have completed an education

sufficient to acquire the knowledge and skills

They should have work experience

They should have completed auditor training

They should have audit experience

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7.4.2 Audit team leaders

An audit team leader should haveacquired additional audit experience to

develop the knowledge and skillsdescribed in 7.3.2. This additionalexperience should have been gainedwhile acting in the role of an audit team

leader under the direction and guidanceof another auditor who is competent asan audit team leader.

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7.4.3 Auditors who audit both quality and

environmental management systems

Must have training and

work experience and

Have conducted audits in

the second discipline under

direction of an auditor.

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7.4.4 Levels of education, work experience,

auditor training and audit experience

Organizations should establish the levels of

the education, work experience, auditor

training and audit experience an auditor

needs

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7.5 Maintenance and improvement ofcompetence

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7.5.1 Continual professional development

Continual professional development is

concerned with the maintenance and

improvement of knowledge, skills and

personal attributes.

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7.5.2 Maintenance of auditing ability

Auditors should maintain and demonstrate

their auditing ability through regular

participation in audits of quality and/or

environmental management systems.

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7.6 Auditor evaluation

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7.6.1 General

The evaluation of auditors and audit team

leaders should be planned, implemented andrecorded in accordance with audit

programme procedures to provide an

outcome that is objective, consistent, fair and

reliable. The evaluation process shouldidentify training and other skill enhancement

needs.

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7.6.2 Evaluation process

A four-step process:

1. Identify the personal attributes, and t

heknowledge and skills to meet the needs of

the audit programme

2. Set the evaluation criteria

3. Select the appropriate evaluation method

4. Conduct the evaluation

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An International Provider ofAuditor

Certification andAuditor Training Certification

Programmes

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A worldwide activity

60,000 a year

24,000 since 1984

100 countries 100 providers

London, UK

QMS 2000 & 1994

EMS

OH&S

FSMS

ISMS

SectorP

rogrammes

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Why become an

IRCA certified auditor?

Recognize your competenceIncrease your credibility

International recognition

Increase earning potential

Improve your CV / resume

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Which grade?

Internal Auditor

Provisional Auditor

Auditor

Lead Auditor

Principal Auditor

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What are the requirements?

AuditorTraining Course

Education & Qualifications

Work experience (general and specific)

Auditing experience

+

ContinuingP

rofessionalD

evelopment

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What now?

Contact IRCA to apply for auditor certification:

www.irca.org

or

[email protected]

Or

www.irca.co.th

[email protected]

telephone +66 (2) 661-9955

or

66 (2) 661-9957

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Evaluation Methods

D

O NOT

D

ELET

E

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TABLE 3

DO NO

TD

ELET

E

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Thank you for your participation

For additional information or support

Contact:Paul Robere, IRCA Certified Principle Auditor

at:

[email protected]

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Any Questions?Any Questions?Any Questions?Any Questions?