internal Auditing as ISO 1900:2000

Welcome to ISO 9001:2000 version

Internal AuditingTraining Course

Internal Audit Cycle

Audit

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

Monitoring and Measurement tool of the Quality Management System

Auditing

Types First Party Audit

Second Party Audit

Third Party Audit

Why Auditing

The requirements of the ISO 9001:2000 under clause 8.2.2 To fulfill Regulatory Requirements Customer Requirements To find actual & Potential departure

from the defined system To get opportunities for continual

improvements

ISO 9001:2000 Audit Requirements

Planned Intervals Audit Programs Audit Criteria Audit Scope Frequency Methods Selection of Auditor Impartiality Documented Procedure Taking Corrective action with out Undue Delay Follow up & Reporting of Verification Results.

Internal Auditor

A person who has the qualification to perform quality audits

• A auditor must be authorized for each audit

• Persons selected as internal auditor shall be

Free from bias Independent

of the activity being audited

Free from influence

Process Activities+

Resources

Process Activities+

Resources

Controls(e.g. procedure)

OutputInput

Processes

Processes - interactions

Process A

Process B Process D

Process C

Process

Any activity that takes “inputs”and converts them to “outputs”

Process ApproachProcess Approach

The systematic identification and The systematic identification and management of these activities and the management of these activities and the

interaction between activities.interaction between activities.

How is a Process Managed?

ActivityInput Output

Right Resources:Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Desired Results:Quality ProductsQuality ServicesCustomer Satisfaction

Monitor & Measure the Processmake sure the inputs are right, the transformation

activities consistently work, and the desired results are achieved, then - improve the process as needed

How is a Process Measured?

ActivityInput Output

Right Resources:Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Desired Results:Quality ProductsQuality ServicesCustomer Satisfaction

EfficientNo Waste

EffectiveDesired Results Achieved

ISO 9001:2000ISO 9001:2000

Conducting Top Management Interviews

The expanded role of top management requires more time be spent with them during internal audits to collect evidence of their commitment to:

Communicating importance of meeting requirements,

Establishing quality policy and objectives,

Conducting management reviews, and

Ensuring availability of necessary resources.

Interviewing “Process Owners” Other managers (i.e. “Process Owners”) should be

interviewed to collect evidence that:

Processes and improvement objectives are documented and planned,

Processes and needed resources are deployed,

Processes are monitored and measured, and

Actions are taken, as warranted by analysis of process data.

Note: Auditors should look for evidence that processsequence and interrelationships are knownand interfaces are effectively managed toachieve the desired objectives.

Management Style

“Tell” This approach is where the team leader plans

and makes the decisions up front and then gives clear instructions - directing the team the way he or she wants the task to proceed

This style may well be welcomed by the less experienced team members, but may not always receive approval from those more experienced who feel they have something to contribute.

Management Style

“Consult” The consult approach is where the team leader

takes time to talk to the team members first, listen to their ideas and evaluate their capabilities before making a decision.

This is probably the preferred approach, but if time is a constraint and the team ia not available then this approach may not be possible.

Management Style

“Team” The team approach is when the team leader

acts more as a chairperson seeking concise opinions and allowing other team members to take an active role in the decision making process.

This approach is perhaps more useful when preparing for the final report. Giving the opportunity for the final report to be truly representative of the whole teams findings.

SECTION

Planning

AUDITEE AUDITORAUDITOR

Non-conformance StatementsNon-conformance Statements

Audit objectivesAudit objectives Audit ScheduleAudit Schedule Notification of AuditNotification of Audit

Selection of Audit TeamSelection of Audit Team Prepare ChecklistPrepare Checklist Audit PlanAudit Plan

Audit teamAudit team AuditeeAuditee

Audit teamAudit team

CAR (s) / Audit ReportCAR (s) / Audit Report

CAR Status LogCAR Status Log

Team LeaderTeam Leader

Team LeaderTeam Leader QMRQMR

PlanningPlanning

PreparationPreparation

Conduct AuditConduct Audit

Complete Audit /Complete Audit /Discuss FindingsDiscuss Findings

Audit Report Back Audit Report Back and Recordingand Recording

Follow - upFollow - up

Close - outClose - out

-investigate cause of -investigate cause of nonconformancenonconformance-return completed CAR -return completed CAR

-implement necessary-implement necessary corrective / preventivecorrective / preventive action and monitor foraction and monitor for effectiveness.effectiveness.

Initial Planning

Decide who shall carry out the audit Identify the relevant quality

specification or requirements Plan the date/time Gather information

Detailed Planning

Prepare program - send copy to auditee Decide team composition Arrange team briefing Team prepare checklists

IDENTIFYING PROCEDURES TO AUDITIDENTIFYING PROCEDURES TO AUDIT

ISO ElementsISO Elements

AreaArea

Stores x x x x o x x x x x x

Product line 1 x x x x x x x x x x x x x

Q.A.

Legend: X = Direct Relationship

O = In-direct Relationship

EXAMPLE OF AN AUDIT PLANEXAMPLE OF AN AUDIT PLAN

AUDIT PLAN

Procedure/Department

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

AUDIT KEYP - PLANNEDP/D - PLANNED & DONEU - UNSCHEDULED AUDIT PERFORMEDF - FOLLOW-UP AUDIT PLANNEDF/D - FOLLOW-UP COMPLETED

AUDIT ITINERARYAUDIT ITINERARYTime Team A (PM) Team B (WL)09:00-09:15 Opening Meeting09:15-12:00 Sales Department Engineering Department

- Contract Review - Document & Data control- Customer Complaint - Product Design & Development- Sample Control - Control of Production Fixture & ToolsPMC Department - Control of Inspection, Measuring- Production Planning & Text Equipment- Material Planning

12:00-13:)0 Lunch13:00-13:30 Auditor’s Meeting13:30-16:45 Store Production

- Material Store - Process Control- Finished Store - In-process InspectionQuality Department - Control of Non-conforming Products- Incoming Inspection & Testing Personnel Department- Final Inspection & Testing - Training- Corrective & Preventive General Manager Action - Internal Audit

- Management Review16:45-17:30 Auditors’ Meeting17:30-18:00 Closing Meeting

SECTION

Preparation




Selection of Audit TeamSelection of Audit Team Prepare ChecklistPrepare Checklist Audit PlanAudit Plan

Audit teamAudit team AuditeeAuditee


CAR (s) / Audit ReportCAR (s) / Audit Report

CAR Status LogCAR Status Log

Team LeaderTeam Leader

Team LeaderTeam Leader QMRQMR

PlanningPlanning







-investigate cause of -investigate cause of nonconformancenonconformance-return completed CAR -return completed CAR

-implement necessary-implement necessary corrective / preventivecorrective / preventive action and monitor foraction and monitor for effectiveness.effectiveness.

Document review The audit plan Work documents Audit checklist

Preparing for the on-site audit

Documents: relevant QMS documentation and records to verify the requirements of ISO 9001:2000

are

addressed.

Purpose: to acquaint auditors with the processes to be

audited devise an audit plan develop a checklist

Document review

the processes taking places

relevant procedures

documents in use

records

requirements of ISO 9001

requirements of the quality management system

Preparing a checklist

AUDIT PREPARATIONAUDIT PREPARATIONAUDIT PREPARATIONAUDIT PREPARATION

Checklist - Preparation

WHAT WHAT the auditor wants to look for

WHOMWHOM the auditor wants to speak to

WHATWHAT the auditor wants to speak about

AUDIT PREPARATIONAUDIT PREPARATIONAUDIT PREPARATIONAUDIT PREPARATION

Checklist Questions

Based on Quality Documentation used by the Dept.to be Audited.

From the documentation Identify all thekey things involved / to be done

Record the key things on the checklistas things to be checked.

Include references to all forms and otherdocumentation, i.e. other procedures / W.I.

AUDIT CHECKLIST

Job Ref : NDB Procedure: QP008 / Issue B / Rev.1 Auditor : P.C. Chan

Sheet No. 1 of 4

Item No.

Requirement Comments/Remarks

Activity ComplianceYes/No

Receiving CheckFor small packet, By Foreman - Visual check- Identified & Marked off against the P.O.- Until required (what does it means?), unpacked/ inspected / put into storeFor Plant / Equipment, By Foreman- Quantity check against Engineers order- Damage check- For specialised equipment, need to sign DN, may be by Chargehand- Equipment Acceptance Cert send to Contract EngineerBy Foreman for all items:- Check DN about Order No., Quantity or Weight Supplier’s name & her Order No. Description

4.01

4.02

4.01

AUDIT CHECKLIST

Job Ref. : NDB Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan

Sheet No. 2 of 4

Item No.

Requirement Comments/Remarks

Activity ComplianceYes/No

- Check DN against PO- Send test Cert to site eng.If all Ok, sign Material Received Copy, send to Engg:Dept with D.N.

IF Non-conformity found

Inform Contract EngineerIndicated with Red Label with defect’s detail, separately locatedDisposition by Site EngineerFill Non-conforming item input sheet (Distribution required?)If found after stored, remedial work.Record on either one- Non-Conforming Item Report Sheet- Non-Conforming Workmanship Report Sheet

4.014.06

4.11

4.09

SECTION

AUDIT Conduction




Selection of Audit TeamSelection of Audit Team

Prepare ChecklistPrepare Checklist Audit PlanAudit Plan


AuditeeAuditee

Audit teamAudit teamCAR (s) / Audit ReportCAR (s) / Audit Report

CAR Status LogCAR Status Log Team LeaderTeam Leader Team LeaderTeam Leader

QMRQMR

PlanningPlanning







-investigate cause of non--investigate cause of non- conformanceconformance

-return complete CAR-return complete CAR

-implement necessary-implement necessary corrective / preventivecorrective / preventive action and monitor foraction and monitor foreffectiveness.effectiveness.

Auditor

Auditee

PERSONAL CONDUCT

positive, professional, constructive approach

co-operative, open, honest

People Processes Equipment / tools /

materials Documentation

AN AUDITOR "VERIFIES" BY OBTAINING OBJECTIVE EVIDENCE

Sampling

Scope Duration of Audit Requirements of

the standard Complexity of the

process

Considerations:

• Previous Problems

• Important aspects

• Auditor skills / knowledge

• Sample size and its significance

Support from management Trained auditors Independence of audit function Timely access to facilities,

documents, personnel Access to all levels of management Defined audit procedures

FUNDAMENTAL REQUIREMENTS FOR EFFECTIVE AUDITING

FUNDAMENTAL REQUIREMENTS FOR EFFECTIVE AUDITING

Record Past implementation

Examined / Observed Current implementation

Method Stated Staff knowledge &

understanding

OBJECTIVE EVIDENCEOBJECTIVE EVIDENCE

meet the area representative first

always talk to those performing the task

explain the purpose of the visit be calm, polite, reassuring never talk down speak clearly and carefully

THE AUDITOR'S APPROACH

examine objective evidence ask open-ended questions refer to checklists make notes consider impact on other

activities examine physical conditions

CONDUCTING THE AUDIT

ASK

LOOK

LISTEN

How Wher

e When What Why Who

QUESTIONING TECHNIQUES

6 important words

be side-tracked be led or misled get "bogged down" let the auditee dictate the

pace make assumptions or

presumptions

CONTROL THE AUDIT

DO NOT

aggressive auditees missing people missing documents pre-prepared samples (choose your

own !)

BE AWARE OF

Be prepared Be punctual Insist on auditee answering questions As little talking as possible Avoid misunderstandings Keep questions clear and concise Polite and calm

CONTROL THE AUDITDO

good listener open-minded diplomatic unbiased honest patient self-disciplined

SELECTING AUDITORSDESIRABLE TRAITS

SELECTING AUDITORSDESIRABLE TRAITS

opinionated self-important lazy argumentative shy

SELECTING AUDITORSUNDESIRABLE TRAITS

SELECTING AUDITORSUNDESIRABLE TRAITS

stay within audit scope communicate audit requirements collate objective evidence document CARs report audit findings verify effectiveness of corrective

actions retain and safeguard documents

AUDITORS SHOULDAUDITORS SHOULD

Audit Techniques

Forward Trace Background Trace Vertical Audit Horizantal Audit

comply with the Standard implement quality manual,

procedures or other documented requirements

implement a code of practice, regulation or contract

_______________

no requirement = no nonconformance

A NONCONFORMANCE MAY BE A FAILURE TO:

A NONCONFORMANCE MAY BE A FAILURE TO:

Noncompliance Reporting

What is the Problem ?describe clearly, concisely and factually

Why is it a noncompliance ?i.e. against what requirement

Where did it occur ?i.e. which department or activity

Who ? - avoid apportioning blame(i.e. naming individuals)

Noncompliance ReportingNoncompliance Reporting

Information to be recorded Identification /Serial number The nature of the noncompliance Where,

What,Why Reference numbers of Documents/ Materials etc. Auditee/ contact Clause of the standard or specification applicable Category of noncompliance (if applicable) Agreed corrective action and timescale Follow up action See Noncompliance Report Form

Standard: ISO 9001:2000

Procedure: QP6 Issue 2

Area: Purchasing Dept.

1. The procedure is not being implemented in full in

that not all purchase orders are being fully

completed. For example; Pos 1234 and 1235

do not contain prices or delivery dates.

2. All Purchase Orders must be completed in

accordance with Procedure QP6.

EXAMPLE OF NON-COMPLIANCE STATEMENTEXAMPLE OF NON-COMPLIANCE STATEMENT

LAC 09.08 / 05

EXAMPLE OF CORRECTIVE ACTION REQUESTEXAMPLE OF CORRECTIVE ACTION REQUEST

Company:

Job No:

Assessor:

Company Representative:

Procedure No:Issue:

Details of Non-Conformance:

Signed:CompanyRepresentative:

Corrective Action taken to prevent recurrence:

Signed:Company Representative

Acceptance of Corrective Action/Comments

Visit No:

Assessment Date:

Area/Dept/Function:

CAR No.: of

ISO 9001/2/3/REFClause

Major CARProposedClose out date:

Signed:Assessor:

Date:

:

NON-CONFORMANCE NON-CONFORMANCE STATEMENTSSTATEMENTS

L/C 341-6787 for a customer under credit grade of # L/C 341-6787 for a customer under credit grade of # 8 for the amount of USD 400,000 FOB, there was no 8 for the amount of USD 400,000 FOB, there was no evidence of any insurance provided.evidence of any insurance provided.The procedure requires that for the issue of L/C’s to The procedure requires that for the issue of L/C’s to customers under credit grade 7-10 over USD 325,000 customers under credit grade 7-10 over USD 325,000 under FOB and C&F terms evidence of insurance is under FOB and C&F terms evidence of insurance is required.required.

NON-CONFORMANCE STATEMENTSNON-CONFORMANCE STATEMENTS

Customer complaint from the ABC company had not Customer complaint from the ABC company had not been followed up and no action had been carried out been followed up and no action had been carried out whatsoever. whatsoever.

According to the procedure QP 13 paragraph 4.6 all According to the procedure QP 13 paragraph 4.6 all customer complaints are to be followed up in the customer complaints are to be followed up in the Quality Improvement Committee.Quality Improvement Committee.

SECTION

Audit Follow Up & Close Out




Selection of Audit TeamSelection of Audit Team

Prepare ChecklistPrepare Checklist Audit PlanAudit Plan


AuditeeAuditee

Audit teamAudit teamCAR (s) / Audit ReportCAR (s) / Audit Report

CAR Status LogCAR Status Log Team LeaderTeam Leader Team LeaderTeam Leader

QMRQMR

PlanningPlanning







-investigate cause of non--investigate cause of non- conformanceconformance

-return complete CAR-return complete CAR

-implement necessary-implement necessary corrective / preventivecorrective / preventive action and monitor foraction and monitor foreffectiveness.effectiveness.

RESPONSIBILITY OF MANAGERSRESPONSIBILITY OF MANAGERS RECEIVING A CARRECEIVING A CAR

1. Investigate the problemInvestigate the problem

2. Determine the causeDetermine the cause

3. Decide on appropriate corrective actionDecide on appropriate corrective action and target date for implementationand target date for implementation..

4. Send the completed form to the CARSend the completed form to the CAR administratoradministrator

5. Implement corrective actionImplement corrective action

C.A.R. FLOWC.A.R. FLOW

C.A.R. Raised

Signed & Issued Accepted

Investigate & Analyze

Implemented

Corrective Action DocumentedReviewed

Reviewed

Reject Accept

Closed Out

RecordRecord

INTERNAL AUDIT REPORTINTERNAL AUDIT REPORT

INTERNAL QUALITY SYSTM AUDIT REPORT

AUDITOR’S NAME AUDIT REPORT NUMBER

DEPARTMENTAL REPRESENTATIVE DATE OF AUDIT

QUALITY FUNCTION or PREVIOUS AUDIT DATE AND RESULTSPROCEDURES(S) AUDITED

SUMMARY AUDIT:

SIGNED: _______________________(AUDITOR) DATE: _______________________

exists is complete operates correctly is effective

AIMS OF THE AUDIT

To verify that the quality system:

explain, support and justify findings

obtain agreement on CARs

ensure good points are mentioned

state overall degree of compliance

reinforce objectives and scope

PRESENTING THE FINDINGSPRESENTING THE FINDINGS

RREPORT BACK MEETINGEPORT BACK MEETING Have Your Reports Ready

Discuss Positive As Well As Negative Aspects

Make Sure Reports Are Agreed By All Parties

Procedure QP-10

F F O L L O W UPO L L O W UPSubsequent follow up should review:Subsequent follow up should review:

- audit file- audit file

c- corrective action file- corrective action file

Review should examine actions Review should examine actions required andrequired and whether completed andwhether completed andwhether the actions have been effectivewhether the actions have been effectiveto prevent recurrence.to prevent recurrence.

shows status of:

CARs

follow-up action

‘close-out’

CARs from second and third party

audits

CAR STATUS LOGCAR STATUS LOG

CAR STATUS LOG

CAR CAR DEFICIENCY AUDIT INITIALS DATE CORRECTIVE ACTION PROPOSED DATESERIAL ISSUED DATE OF REMINDER ACTION PREVENT FOLLOW- CARNO. TO AUDITOR SENT COMPLETION RECURRENCE UP DATE CLOSED

DATE

CORRECTIVE ACTION REQUEST (CAR) STATUS LOG

Why ??

FOLLOW-UPFOLLOW-UP OF OF THE CORRECTIVE ACTIONTHE CORRECTIVE ACTION

WHY?WHY?

To ensure corrective action has preventedTo ensure corrective action has prevented any recurrencesany recurrences

To determine whether corrective action hasTo determine whether corrective action has been effective?been effective?

CLOSE-OUT THE CLOSE-OUT THE CARCAR Each non-conformance is to be closed out Each non-conformance is to be closed out

individuallyindividually

Ensure that the corrective action hasEnsure that the corrective action has addressed theaddressed the root cause of the non-root cause of the non- conformanceconformance

Not treated the symptoms only butNot treated the symptoms only but prevented recurrence of the non conformity.prevented recurrence of the non conformity.

When the auditor is satisfied there is noWhen the auditor is satisfied there is no furtherfurther example of the non-conformanceexample of the non-conformance..

CLOSED-OUT

CLOSED-OUT

CAR

MANAGEMENT REVIEWMANAGEMENT REVIEW

internal audits reported

audit results analysed

status of corrective actions reported

preventive actions identified

INTERNAL AUDIT INTERNAL AUDIT -THE SYSTEMTHE SYSTEMManagementManagement

Management Review

Follow-up/Close out

Audit Schedule

Corrective/Preventive Action

Conduct Audit

CAR Requests

Thank you very Much

Cirin Pharmaceuticals (Pvt.) Ltd.