Internal Quality Audit for ISO 9001_2008

Internal Quality AuditInternal Quality AuditFOR ISO 9001 : 2008FOR ISO 9001 : 2008

الداخليين المراجعين تأهيل الداخليين دورة المراجعين تأهيل دورةISO 9001 : 2008ISO 9001 : 2008

Nov, 14-16, 2009Nov, 14-16, 2009

Prepared ByPrepared By::

Ashraf S. Youssef, Ph. DAshraf S. Youssef, Ph. D..

QA & Ind. Methods ManagerQA & Ind. Methods Manager

S.M. ASQ, L.A. BSI, M. ELI, M. EMSS.M. ASQ, L.A. BSI, M. ELI, M. EMS

Course Structure

• Tutorial Sessions

• Case Studies

• Role Play

• Games

Learning Objectives

• To understand:Purpose, benefits and typical structure of a

Quality Management System (QMS)Plan-Do-Check Act (PDCA) methodology,

and the process approach to Quality Management

The 8 principles of Quality Management and how they relate to the QMS and ISO 9001

Purpose, scope and uses of the ISO 9000 series standards

Auditing ProcessRoles, responsibilities and competence

requirements of auditors and lead auditors with reference to ISO 19011

4

1. Purpose and structure of o a QMS, PDCA o and the 8 principles of quality management

2. ISOM 9001 Explored & Understood2. ISOM 9001 Explored & Understood

3. Internal Quality Audit Steps3. Internal Quality Audit Steps

4. Auditor’s Skills & Responsibility4. Auditor’s Skills & Responsibility

AgendaAgenda

Course assessment

• Continual assessmentYou will be informed of progress as we goThe exam

• Exam Pass Criteria70% pass markOpen book

• Ask questionsIt’s your tutors job to make problems go away

Session 1

Purpose and structure of a QMS, PDCA and the 8 principles of quality management

What is Quality?

• Q is fitness for use.

• Q is conformance to requirements.

• Q is conformance to customer/user requirements.Meet/satisfy customer/user requirements,

needs, and expectations.

• Degree to which a set of inherent characteristics fulfills requirements.

(ISO 9000 : 2005)

What is Audit?

• Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled

What is Audit Evidence?

• Records, statements of fact or other information, which are relevant to the audit criteria and verifiable

What is Audit Findings?

• Results of the evaluation of the collected audit evidence against audit criteria.

What is Audit Client?

• organization or person requesting an audit.

What is Auditee?

• Organization being audited

What is Auditor?

• Person with the competence to conduct Person with the competence to conduct an audit. an audit.

What is Technical Expert?

• person who provides specific knowledge or expertise to the audit team.

What is Audit Plan?

• Description of the activities and Description of the activities and arrangements for an arrangements for an audit.audit.

What is Audit Scope?

• extent and boundaries of an audit.

What is Nonconformance?

Non-fulfillment of a requirement

What is Correction, and C & P Actions?

Correction:Action to eliminate a detected nonconformity

Corrective Action:Action to eliminate the cause of a detected nonconformity

Preventive Action:Action to eliminate the cause of a potential nonconformity or other undesirable potential situation

What is Ident., Trac. And Status?

Identification:

To describe product/ raw material/ semi finish

product etc. Example Batch #, Lot #, Code etc

Traceability:

Ability to trace the history, application or location ofthat which is under consideration

Status:

To identify the current status of product/ raw material with regard

to inspection and test results. Tag/ sticker of HOLD, REWORK,

SCRAP Identified areas.

Types of Audits

• First-party

• Second-party

• Third-party

The purpose of an audit is ...

to collect objective evidence to permit an informed judgment about the status of the

quality management system

Objectivity of Auditing

AUDIT FINDINGS

AUDIT CRITERIA

AUDIT EVIDENCE

AUDIT CONCLUSION

RECOMMENDATION FOR AUDIT

Conformance Non-Conformance

Major Minor

Improvement

Audit Methods & Techniques

FORWARD TRACEFORWARD TRACE

BACKWARDS TRACEBACKWARDS TRACE

RECEIVEGOODS INSPECT STORES

What is ISO 9000:2008 QMS?

• ISO = International Organization for

Standards

• 9000 = code to denote QMS Family

• 2008 = year of last revision

• Is a family of standards for implementing a

Quality Management System (QMS)

ISO 9000:2008 Family

ISO 9000

ISO 9001

ISO 9004

ISO/DIS 19011

Only ISO 9001 can be used forcertification purposes

The ISO 9001:2008 Model

Continual Improvement of the QMSContinual Improvement of the QMS

Input Outputvalue adding

activities

info. flow

info. flow

CU

ST

OM

ER

RE

QU

IRE

ME

NT

S

CU

ST

OM

ER

SA

TIS

FA

CT

ION

managementresponsibility

managementresponsibility

productrealization

productrealization

resourcemanagement

resourcemanagement

meas, analysisimprovement

meas, analysisimprovement

productproduct

clause 4

clause 5clause 6 clause 8

clause 7

value adding

activities

Clauses/Requirements

Clause 4. Quality Management System

Clause 5. Management Responsibility

Clause 6. Resource Management

Clause 7. Product Realization

Clause 8. Measurement, Analysis and

Improvement

Count the number of requirement categories.

Quality Management Principles

Customer Focus

Leadership

Involvement of People

Process Approach

System Approach to Management

Continual Improvement

Factual Approach to Decision Making

Mutually Beneficial Supplier Relationships

1. Customer Focus

• Organizations depend on their customers;

therefore they shouldKnow their current and future needs

Meet their requirements

Exceed their expectations

Get their feedback

CU

ST

OM

ER

SA

TIS

FA

CT

ION

CU

ST

OM

ER

SA

TIS

FA

CT

ION

CU

ST

OM

ER

RE

QU

IRE

ME

NT

SC

US

TO

ME

R R

EQ

UIR

EM

EN

TS

2. Leadership

• Leaders create common purpose

and direction; therefore they

shouldMaintain a healthy internal

environment

Inspire workforce to excel

managementmanagementresponsibilityresponsibility


3. Involvement of People

• People are the essence of an

organization; thereforeThey should be fully involved

Their abilities should be used for

organization benefits

resourceresourcemanagementmanagement


4.4. Process ApproachProcess Approach

Manage activities and related Manage activities and related

resources as a PROCESSresources as a PROCESS

OrderOrder ProductProduct

ReviewReviewPurchasePurchase DesignDesign MakeMake DeliverDeliver

“Turtle” Approach

PROCESSPROCESS

WITH WHAT?

INPUTS

HOW? OBJECTIVES/MEASURES?

OUTPUTS

WITH WHO?(Materials /

Equipment)

(Support Processes, Procedures & Methods)

(Performance Indicators)

(Competence / Skills / Training)

Example: Management, Responsibility

Management responsibility

& objective setting

with whatManagement Review

forumPrevious year’s results

inputsInternal audits

Customer satisfaction trends

Process/Product measures

Faults/Complaints data

measuresResults vs plan

Customer surveysMilestones

with whoManagement teamQuality manager

Team leaders

outputsAnnual plan

Improvement objectives

howImplementation planResource allocation

Roles & responsibilitiesCommunications

support processes

IT systemsPurchasingHR, Training

5. System Approach to Management

• Managing interrelated processes as a system helps the organization in achieving its objectives in an effective and efficient manner



productproductrealizationrealization




meas., analysismeas., analysisimprovementimprovement


PlanPlan

DoDo

ActAct

CheckCheck

6.6. Continual Improvement:Continual Improvement: PDCA CyclePDCA Cycle

Continual Improvement of the QMSContinual Improvement of the QMSContinual Improvement of the QMSContinual Improvement of the QMS

7. Factual Approach to Decision-Making

• Effective decisions are based on the analysis of data and information

info. flowinfo. flow

CU

ST

OM

ER

RE

QU

IRE

ME

NT

SC

US

TO

ME

R R

EQ

UIR

EM

EN

TS

CU

ST

OM

ER

SA

TIS

FA

CT

ION

CU

ST

OM

ER

SA

TIS

FA

CT

ION





info. flowinfo. flow



8. Mutually Beneficial Supplier Relationship

• Interrelated

• Win-Win


productproductrealizationrealizationSupplierSupplier

Session 2

ISO 9000 series explored and understood

Structure of ISO 9001:2008

• 0.1 General• 0.2 Process Approach• 0.3 Relationship with ISO 9004• 0.4 Compatibility with other standards• 1 Scope• 2Normative References• 3 Terms & Definitions• 4. Quality Management system• 5. Management Responsibility• 6. Resource Management• 7. Product Realization• 8. Measurement, Analysis & Improvement

4: Quality Management System

• General requirements (4.1)– General requirements for approach & content of the

QMS (e.g. for the adoption of the process approach)– Outsourcing

• Documentation requirements (4.2)– Mandatory procedures– Manual, Policy & Objectives– General sufficiency of documentation and records– System for Document Control– System for Control of Records

5: Management Responsibility

• The areas where direct Top Management involvement is mandatory– Demonstrating commitment– Demonstrating customer focus– Input into policy development & review– Identification of objectives and input into the planning

process– Defining responsibilities, providing resources– Ensuring internal communications are effective– Involvement in management review

6: Resources

• Human ResourcesEnsuring adequacy particularly in respect of training

• InfrastructureBuildings, work space, equipment, vehicles,

information systems etc

• Environmental controls (Aligned with ISO14000)Heat, light, humidity, temperature, clean roomsIn fact any controls that are applicable

7: Product Realisation

• Think of this as “Production” or “Service Delivery”Control of the core day to day operationsOperational planning (7.1)Handling contracts, enquiries & customer

communication systems (7.2)Design (7.3)Management of supplies and suppliers (7.4)Operational controls (7.5)Calibration (7.6)

• Exclusions may apply

8: Measurement, Analysis & Improvement

• The collection and constructive use of data– Measuring product (conformity checks and inspection) – Measuring process (efficiency measures)– Customer satisfaction (Survey, Feedback, Complaint)– Internal audit– Control of quarantine/isolation activities– Analysis of data (you must do something with data)– Continual improvement (the standard encourages the

application of the process approach to improvement)– Corrective action (Correction + Corrective Action)– Preventive action

Session 3

Internal Quality Audit Steps


Initiation

Preparation

Evaluation

Reporting

Fixing

Initiation STEPS RESPONSIBILITY1. Request Audit Program

Manager 2. Identify Lead Auditor Program

Manager 3. Define Audit Scope Program Manager

& Lead Auditor

STEPS RESPONSIBILITY1. Request Audit Program

Manager 2. Identify Lead Auditor Program

Manager 3. Define Audit Scope Program Manager

& Lead Auditor


Importance of Preparation

Exercise: Initiation

• Who is responsible for scheduling the audits?

• When are internal audits scheduled?

• How often are audits performed?

• Who is responsible for selecting the auditors?

• What criteria are important for selecting auditors?

Annual Audit Plan

• Considerations

• Approvals

Exercise: Auditing the Training Activity

• Why is the audit performed?

• What is being audited?

• Which requirements?

SOLUTION:

• Purpose:To verify compliance with Quality Manual

and ISO 9001:2000

• Audit Scope:Training Activity

• Requirements:As specified in

ISO 9001:2008EEICQM-01EEICHR-P-01

STEPS RESPONSIBILITY4. Select Audit Team Lead Auditor5. Understand Org. Audit Team6. Review Documentation Audit Team7. Plan the Audit Lead Auditor8. Prepare Checklist &

Working Papers Audit Team

STEPS RESPONSIBILITY4. Select Audit Team Lead Auditor5. Understand Org. Audit Team6. Review Documentation Audit Team7. Plan the Audit Lead Auditor8. Prepare Checklist &

Working Papers Audit Team

Initiation

Preparation


Audit Team

• Consider team member qualifications

• Consider activities being audited

• Consider type and degree of experience of the auditors

• Create a balanced team

Preparation Steps

initiationinitiation reviewdocuments

reviewdocuments

planaudit

planaudit

getapprovals

getapprovals

Exercise: Review Documentation

For the Training activity, which specific documents would you request to prepare your team for the audit?

Review Documentation

• Quality manual• Procedures• Forms• Organization chart• Facility floor plan

• Past audit performance• Customer feedback• Number of employees• Working hours

Plan Audit

• Confer with audit team members

• Don’t forget the approvals

Audit Plan: December 22-23, 2001

Purpose: To verify compliance with Quality Manual and ISO 9001:2000Audit Scope: TrainingRequirements: As specified in

- ISO 9001:2008- Quality Manual, - HR Procedure

Overall Schedule:December 22, 2001 December 23, 20018:00-8:30 Opening Meeting 8:00-11:00 Field Activities8:30-9:00 Audit Team Meeting 11:00-12:00 Audit Team Meeting9:00-12:00 Field Activities 12:00-1:00 Exit Meeting12:00-1:00 Audit Team Meeting1:00-3:00 Field Activities3:00-3:30 Daily Auditee Briefing

Audit Team Members: Ms. Ashraf Youssef, Lead AuditorMr. Wissam Toumeh, AuditorMr. Nelson Tenorio, Auditor

Approved: ________________ Approved: ________________ Mr. Ashraf Youssef Mr. Muntaser Kalahji.

STEPS RESPONSIBILITY9. Conduct Opening Meeting Lead Auditor10. Meet with Management Audit Team11. Interview & Observe Audit Team12. Assess Evidence Audit Team

STEPS RESPONSIBILITY9. Conduct Opening Meeting Lead Auditor10. Meet with Management Audit Team11. Interview & Observe Audit Team12. Assess Evidence Audit Team

Initiation

Preparation

Evaluation


An auditor’s memory isas sharp as his pencil.

An auditor’s memory isas sharp as his pencil.

Focus of the Audit

To collect objective evidence to permit an informed judgment about the status

of the quality management system.

Objective evidence may be ...

• documented

• based on interview

• based on observation

• quantitative

• qualitative

• verifiable

Checklists & Working Papers

Checklists

Audit Questions

Audit Investigation

Audit Findings

Checklists

Checklists plan the flow of questions

Checklists plan the flow of questions

Checklists

Checklists guide the course

of the audit

Checklists guide the course

of the audit

Checklists

Checklists define

the sample

Checklists define

the sample

Checklists

Checklists help in writing

the report

Checklists help in writing

the report

Checklist should …

• Be based on information available before the audit

• Be modified when necessary

• Allow follow-up

• Be balanced to cover priority areas

• Be created by individual auditors

Checklist should NOT …

• Restrict auditor’s inquiry

• Be completely generic

• Be yes/no lists

To Create a Checklist

Who do I want to talk to?

Who do I want to talk to?

What am I looking for?


What will I ask?What will I ask?

IndividualIndividual

DocumentsDocuments

Questions on checklistQuestions on checklist


RECORDS ARE THE MOST RELIABLE SOURCE OF

INFORMATION


Sample should be representative, although not necessarily statistically valid

Who do I talk to?

• Talk to the right peopleThose responsible for the activity

Those doing the activity

Audit Team Meeting

• Informal briefings• Opportunity to share

information • Discuss necessary

adjustments to plan• Develop report• Helps keep communication

lines open among audit team members

Opening Meeting

• Conduct before start of field activities

• Audit team members must be present

• Auditee contacts should be present

• Creates an atmosphere of cooperation between auditors and auditee

Opening Meeting

• Sign-in sheet

• Distribute detailed audit schedule

• Address any auditee scheduling concerns

• Revise schedule, if necessary

Daily Auditee Briefing

• Review potential findings regularly with auditee

• Opportunity for auditee to close a finding before the end of the audit

• Helps strengthen communications

• Audit becomes constructive

Interview & Observe

• Asking questions

• Observing activities

• Examining documents & records

• Examining facilities

Observing Activities

Confirm that procedures are being followed

howhow??howhow??


Look for undocumented activities

whatwhat??whatwhat??


Confirm answers

whowho??whowho??


• Auditee ReactionsTake over conversationsPlay “show & tell”Blame someone Act defensivelyWaste timeInterruptProvokeBribe!

Interviewing

Interviewing

• Introduce yourself

• Explain why you are there

• Investigate to depth necessary

• Ask, Listen, Verify

• Interview the right peopleThose responsible for the

activity

Those doing the activity

• Hearsay is not evidence

Interviewing

• Interview for:

elaboration

corroboration

perspective

basis for evidence

Interviewing

• Two eyes• Two ears• One mouth

• Ratio of use:One of speaking

to four receiving

Interviewing

whatwhatwhatwhat

whywhywhywhy

whowhowhowho wherewherewherewhere

howhowhowhow

whenwhenwhenwhen

When Something Seems Wrong

When Something Seems Wrong

• Is it really wrong?

• Does he know it is wrong?

• What is his explanation?

• Is it an isolated event, or a symptom of a deeper problem?

• Why didn’t quality system detect it?

• What lapse in the quality system allows this to happen?

Nonconformity

Nonconformity refers to a failure to meet a specified requirement:Quality Manual PoliciesProceduresISO 9001:2000 req.Government Regulations

90% or more of processes can be improved

by modifying organizational systems

(a management responsibility )rather

than attempting to modify an

individual employee’s performance.

W. Edwards Deming

• No problems …

don’t panic

• Move on

• Don’t keep looking

for something wrong

What if nothing seems to be wrong?

ROLE PLAY:

•Auditing role play

STEPS RESPONSIBILITY13. Write Nonconformities Audit Team14. Conduct Closing Meeting Audit Team 15. Write a Summary Report Lead Auditor

STEPS RESPONSIBILITY13. Write Nonconformities Audit Team14. Conduct Closing Meeting Audit Team 15. Write a Summary Report Lead Auditor

Initiation

Preparation

Evaluation

Reporting


Do I have a Nonconformity?

YES

if you have objective evidence that:

• A requirement is not addressed

• Practice differs from defined system

• System is not effective

Major or Minor Nonconformity

• MajorSystem element is missingSystem element is not implementedSystem element is not effective

• MinorA single/isolated lapse in the system

EXERCISE: Nonconformity or Not

• For each situation, identify whether major nonconformity, Minor nonconformity, ornothing.

Nonconformity Statement

• State the evidenceWhat is it?

• State the requirementWhat is it against?

Writing a Nonconformity: The 4 C’s

• Clear … Simple language

• Correct … Objective

• Complete … Traceable

• ConciseWhat happened?What should happen?

Writing Nonconformity: Steps

1. Write )informally( the nonconformity on the spot.

2. Explain to auditee manager promptly.

3. Review with team members.

4. Write nonconformity statement on the NCR.

5. Get auditee manager signature.

Closing Meeting Keys

• Informal setting

• Report the results to management

• Agree on follow-up

• Entertain questions

Agenda of Closing Meeting

1. Introduction & purpose of meeting

2. Thanks for cooperation

3. Distribute list of attendees

4. Review audit purpose and scope

5. Explain nature of sampling

6. Summarize results: Good observations, no. of NCRs, overall weakness, recommendations, repeat good observations

7. Summary from each auditor

8. When to expect written report

9. Agreement on follow-up

10. Questions & Clarifications

Audit Summary Report• Prepared by Lead Auditor• Sent promptly to MR• Sent promptly to Heads of audited area

Audit Report Content• Audited area• Lead Auditor and members• Audit date• Audit scope• Audit criteria (list of key documents)• Summary of findings

• Good practices• Total number of nonconformities• Descriptions and discussion of nonconformities

• Conclusion

STEPS RESPONSIBILITY16. Take Corrective Actions Auditee17. Verify Corrective ActionsAudit Team

STEPS RESPONSIBILITY16. Take Corrective Actions Auditee17. Verify Corrective ActionsAudit Team

Initiation

Preparation

Evaluation

Reporting

Fixing


Follow-Up Flowchart

Agree?Agree?

OK

not OK

Identify NC, issue NCR

Identify NC, issue NCR

Agree on need for CA, sign it

Agree on need for CA, sign it

Propose CAplan

Propose CAplan

ImplementCA

ImplementCA

Verify CA&

Close NCR

Verify CA&

Close NCR

Session 4

Auditor’s Skills & Responsibilities

Auditor’s Responsibilities

• Communicating

• Planning and executing

• Documenting

• Reporting

• Verifying

• Safeguarding

• Cooperating

Auditor’s Qualifications

• Education

• Training

• Experience

• Personal Attributes

• Management Skills

Auditor Skills

• Communication skills

• Interpersonal skills

• Analytic skills

Auditor Ethics

“I will inform each client or employer of any

business connections, interests, or

affiliations that might influence my

judgment or impair the equitable character

of my services.”

ASQ Code of Ethics

Internal Auditor

• Acts as a consultant

115

� �شــــكرًا شــــكرًا

Internal Quality Audit for ISO 9001_2008

Documents

Transcript of Internal Quality Audit for ISO 9001_2008