1 MALAYSIA PROGRAM TRAINING

AUDIT QUALITY STANDARD

By : Nor Arniza Binti Jamil Language : Malay & English Date : 29th MAY 2011

Course Objective
To teach delegates how to be effective internal auditors through :
Formal training Discussion Group exercises Practical work Case study (over 50% of course is practical)

AN OVERVIEW OF AUDITING

DEFINITION OF QUALITY AUDITING

A systematic and independent examination to determine whether the quality activities and related results comply with planned arrangements and whether the arrangements are implemented effectively and is suitable to achieve objectives

Typical Internal Audit Life Cycle

AUDIT PROGRAMME MADE BY QUALITY MANAGER TRAINED AUDITOR(S) ASSIGNED TO INDIVICUAL AUDIT

PLANNING DONE e.g. Talk to manager Read documentation Create Audit Plan Create trails Create checklists
HOLD OPENING MEETING Set the scene ACTUAL AUDIT Follow trail Talk to staff concerned (check previous nonconformities/findings cleared) AGREE FONDINGS THEN WRITE UP What is good Nonconformities/findings Observations/improvement Follow up action CLOSING MEETING Present the findings Follow up correction and corrective action performed and checked

Audit Preparation

Conducting An Audit

Reporting Findings and Follow Up

Role of Internal Quality Audits

Why do we audit? - To take an independent and accurate snapshot to see what an organization or department looks like at a point in time
Other advantages/objectives : 1. Check conformance 2. Check effectiveness 3. Highlights problems 4. Opportunity to improve 5. Helps maintain the business 6. To share best practice around the business 7. To investigate new ideas 8. To find the underlying cause of problems 9. Keeps staff on their toes 10. Helps develop auditor interpersonal and management skills 11. Helps auditors to understand the company 12. Can emulate external audit 13. Meets ISO 9001 requirement 14. A management tool

AUDIT TYPE AND REASON FOR AUDITING

1ST PARTY

2ND PARTY

3RD PARTY

AUDIT TYPE

ST 1

PARTY AUDIT

1st Party Audits are audits done internally. They are a management tool with the emphasis on continuous improvement. The auditor(s) must be independent of the audit area. The audit should be aligned with the company goals and metrics.

ND 2

PARTY AUDIT

2nd Party Audit are Audits from those who have a deep interest in the final outcome. This could be you auditing your suppliers, or your customers auditing you. The audit could be called a survey or an assessment.

RD 3

PARTY AUDIT

3rd Party Audit are done by an outside independent audit organization. In case of an ISO 9001 audit the independent organization is the registrar. They normally do not have an interest in the final outcome. The 3rd party could be a registrar, government employee, or a firm hired by the company. The result of the audit could be a certification, license, acceptance, or an award.

SUMMARY OF INTERNAL AUDITING ISO 9001 : 2008

Audits must be at planned intervals Audits check that QMS :
Conforms to the planned arrangement ( clause 7.1 Planning of product realization) Conforms to ISO 9001 : 2008 QMS requirement Conforms QMS requirements established by the organization is effectively implemented and maintained (Audits should identify improvements)

More critical, or problem areas, audited more than others Must be a procedure for internal audits You cant audit your own work Audits must be objective Maintain records of the audit and their results

QUALITY AUDIT PROCEDURE

COMMON DEFINITIONS RELATING TO AUDITS

Audit Auditee Auditor Nonconformity Major conformity Minor conformity Observation/OFI (opportunities for improvement) Objective Evidence

QUALITY DEFINITIONS FROM ISO 9000 : 2005

Review (meninjau kembali) Activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives. Nonconformity Non-fulfillment of a requirement Correction (pembetulan) action Action to eliminate the cause of a detected nonconformity or other undesirable situation Preventive (pencegah) action Action to eliminate the cause of a potential nonconformity or other undesirable potential situation

THE IDEAL AUDITOR

Relaxed and friendly Good listener/communicator Interested Objective and logical Positive attitude Explains the process Gives good feedback Excellent interpersonal skills Should motivate and facilitate Enquiring mind and persistent Can communicate at all levels of the organization Understands the technology

ISO 9000 FUNDAMENTALS

WHAT IS THE INTERNATIONAL STANDARDS OF ISO 9000 SERIES ABOUT?

International consensus on good management practice Looks for repeatability and enhancing customer satisfaction by meeting customer requirements Distilled into standard requirements Generic and applicable to all organizations-regardless of type, size and product category ISO 9001 defines what you have to meet-activities, nature of organization, products and processes in order to meet customer, statutory and regulatory requirements.

8 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 relationship

ISO 9001 : 2008 REQUIREMENTS

CLAUSE 4
Refer to the handout Summary of ISO 9001 : 2008

TYPES OF DOCUMENT USED IN QMS

Documented statements of quality policy and objectives Quality manual Procedures Work Instructions Quality Plans Specifications, drawing, standards Guidelines Record

STRUCTURE OF QMS DOCUMENTATION

Vision Mission Policy Objectives Responsibilities Quality Policy Scope of QMS Exclusion Process Descriptions Reference to procedures Who What When Where

QUALITY MANUAL

PROCEDURES

WORK INSTRUCTIONS

How

SUPPORT DOCUMENTATION

CLAUSE 5
Refer to the handout Summary of ISO 9001 : 2008.

CLAUSE 6
Refer to the handout Summary of ISO 9001 : 2008.

CLAUSE 6
Refer to the handout Summary of ISO 9001 : 2008.

CLAUSE 7
Refer to the handout Summary of ISO 9001 : 2008.

CLAUSE 8
Refer to the handout Summary of ISO 9001 : 2008.

PRE-AUDIT PREPARATION

Typical Internal Audit Life Cycle

AUDIT PROGRAMME MADE BY QUALITY MANAGER TRAINED AUDITOR(S) ASSIGNED TO INDIVICUAL AUDIT

PLANNING DONE e.g. Talk to manager Read documentation Create Audit Plan Create trails Create checklists
HOLD OPENING MEETING Set the scene ACTUAL AUDIT Follow trail Talk to staff concerned (check previous nonconformities/findings cleared) AGREE FONDINGS THEN WRITE UP What is good Nonconformities/findings Observations/improvement Follow up action CLOSING MEETING Present the findings Follow up correction and corrective action performed and checked

Audit Preparation

Conducting An Audit

Reporting Findings and Follow Up

AUDIT SCOPE
Extent and boundaries of an audit :
What is within the audit What outside the audit
Best practice is to look at a process including all the interfaces to other processes. To include any exclusion from Clause 7 of ISO 9001.

KEY PROCESSES IN MATERIAL CONTROL

PRODUCTION AND MATERIAL PLANNING

PURCHASING VENDOR EVALUATION RECEIVING CHECK

SUPPLIER

STOCK

RETURN OF PART ISSUE OF PART

MANUFACTURING

REVIEW OF DOCUMENTATION
Auditor obtains representative procedures Conduct review to help :
Understand Department Create audit plan Create checklists

STRUCTURE OF A TYPICAL DOCUMENTED QUALITY MANAGEMENT SYSTEM

TYPES Quality Manual DESCRIPTIONS Document that provide consistent information, both internally and externally, about the organizations quality management system Document that describe how the quality management system is applied to a specific product, project or contract Documents stating requirements Documents stating recommendation or suggestions Documents that provide information about how to perform activities and processes consistently Documents that provide objective evidence of activities performed or results achieved

Quality Plan

Specifications Guidelines Documented procedures, work instructions and drawings Records

TYPICAL DESIGN/MANUFACTURING BUSINESS PROCESS MAP

CUSTOMER REQUIREMENT BUSINESS PLANS/OBJECTIVE

SALES

PRODUCTION AND MATERIAL PLANNING

MATERIAL CONTROL MANUFACTURING

PRODUCT DESIGN AND RESOURCE PLANNING

ENGINEERING

QUALITY ASSURANCE

CUSTOMER

REVIEW AND IMPROVEMENT FINANCE AND ADMIN SUPPORT

HUMAN RESOURCE SUPPORT

IT SUPPORT

TYPICAL DESIGN/MANUFACTURING BUSINESS PROCESS MAP WITH ISO 9001 CLAUSES

CUSTOMER REQUIREMENT
7.2.1,7.2.1 5.1

BUSINESS PLANS/OBJECTIVE
7.1,7.3

SALES
7.4

7.4

PRODUCTION AND MATERIAL PLANNING MATERIAL CONTROL

6.4,7.1,7.5.1

PRODUCT DESIGN AND RESOURCE PLANNING

6.3,7.6

MANUFACTURING
8.2.3,8.2.4,8.3 8.2.3,8.2.4,8.3

ENGINEERING

QUALITY ASSURANCE

CUSTOMER
4.2,5.6,8.4,8.5

REVIEW AND IMPROVEMENT FINANCE AND ADMIN SUPPORT

6.2 6.3

HUMAN RESOURCE SUPPORT

IT SUPPORT

AREAS/PROCESSES TO BE AUDITED AND THE RELEVANT ISO 9001 CLAUSES ( IDENTIFIED FROM THE EARLIER BUSINESS PROCESS MAP )

AREAS/PROCESS
TOP MANAGEMENT (BUSINESS PLANS/OBJECTIVES) SALES PRODUCT DESIGN AND RESOURCES PLANNING PRODUCTION AND MATERIAL PLANNING MATERIAL CONTROL QUALITY ASSURANCE MANUFACTURING ENGINEERING REVIEW AND IMPROVEMENT HUMAN RESOURCE IT

ISO 9001 CLAUSES

5.1 7.2.1, 7.2.2 7.1, 7.3 7.4 7.4 8.2.3, 8.2.4, 8.3 6.4, 7.1, 7.5 6.3, 7.6 4.2, 5.6, 8.4, 8.5 6.2 6.3

EXAMPLE OF THE AUDIT PROGRAMME ABC SDN BHD AUDIT PROGRAMME FOR THE YEAR 2011

AREAS/PROCE5SS
TOP MANAGEMENT SALES PRODUCT DESIGN AND RESOURCES PLANNING PRODUCTION AND MATERIAL PLANNING

ISO CLAUSES
5.1 7.2.1 7.1, 7.3

M1

M2

M3

M4

M5

M6

M7

M8

M 9

M 10

M 11

M 12

AUDIT OR

X X X

AB LYC MHA

7.1

LTN

MATERIAL CONTROL
QUALITY ASSURANCE MANUFACTURING ENGINEERING REVIEW AND IMPROVEMENT HUMAN RESOURCE

7.4.1
8.2.3,8.2.4,8.3 7.5.1,8.2.3,8.2.4 6.3,7.6 8.5 6.2

X
X X X X X

AB
KW LYC MHA LTN AB

AUDIT PLAN CONTENTS

Audit objectives Audit scope Audit criteria and any reference documents Dates and places Expected time and duration Roles and responsibilities of the audit team members Personnel to be interviewed e.g. Human Resource Manager, Procurement Executive, Production Supervisor etc.

TIME AND RESOURCES

Audits usually 0.5 or 1 working day Duration decided by Quality /Audit Manager (usually half a day) Usually conducted by one auditor Preparation time is as important as audit time

PRE-AUDIT COMMUNICATION
Auditor contacts Department Manager Explains the process if required Confirms date/time audit Obtains representative documents Sets up opening meeting Checks if protective clothing needed Checks on outstanding nonconformities Explain the planning of audit and confirm the audit plan Answer any questions

PURPOSE OF CHECKLISTS
To provide a framework for the audit To ensure all aspects are addressed To act as a prompt for the auditor To act as an aide memoir

CHECKLIST WHAT? WHERE? WHEN? WHY? HOW? WHO?

SOURCES FOR CHECKLIST ITEMS

ISO 9000 series Company Documented Quality Management System (DQMS) Known or classic problems Ideas from others Knowledge of industry Previous checklist

CHECKLIST CREATION
Identify if any procedures or work instruction or flow-charts, etc do exist LOOK at :
Objectives Interfaces Inputs Outputs Measures

EXAMPLE OF CHECKLIST CREATION

Key Process Audited Process Audited Area Audited Procedure Audited ISO 9001 : 2008 clause : Material Control : Purchasing : Purchasing Department : Purchasing Procedure : 7.4 Purchasing

KEY ITEMS Objectives

WHAT TO LOOK FOR? Quality Policy, Quality Objective for Purchasing Department. Performance of Purchasing relate to Purchasing Department quality Objective Overall processes for purchasing, process sequences and their interrelationship with other processes. Trail of the processes. Purchasing Procedure (if available) will be checked during the audit. Personnel involved (competency), clarity of responsibility and authority. Machinery/equipment, methods used, materials used, measurement used (refer back to the quality objectives). ISO 9001 Clause 7.4 Purchasing. Note : For audit of top management, availability of resources (human resources, infrastructure and work environment) is also checked.

Interfaces

Inputs

Cont..

KEY ITEMS Outputs Measure

WHAT TO LOOK FOR? Identify related records Identify the measurement made, data collection and data analysis and how quality objectives are achieved or not being achieved and evidence of continual improvement, any correction and/or corrective actions taken.

EXAMPLE OF PURCHASING CHECKLIST

Auditor Process Audited Area Audited Procedure Audited ISO 9001 : 2008 clause
No.

: : Purchasing : Purchasing Department : Purchasing Procedure : 7.4 Purchasing

ITEMS

Auditee

Date
COMPLIANCE STATUS YES : / NO : X

:
FINDINGS CONCLUSION (SEE NOTE 1)

1. 2.

Quality Policy of the company and the relevant Quality Objective for Purchasing Explanation of the overall process of purchasing including processes before purchasing and after purchasing Purchasing Procedure available. Take a sample of PR and PO and follow the trail of the processes. Select product/item and services which have effect on subsequent product realization or final product Competency of personnel performing the processes. Identify training required

3.

4.

Cont..
No. ITEMS COMPLIANCE STATUS YES : / NO : X FINDINGS CONCLUSION (SEE NOTE 1)

5. 6.

Conformance to specified purchase requirements Verify record used : PR, PO, authority list, purchaser/material specification, purchase contract, list of materials and services, productions and material plan, approved vendor list Check data collection, data analysis, whether quality objectives is met Evidence of continual improvement Any collection and/or corrective action taken

7. 8. 9.

AUDIT TRAILS
Follow process from start to finish You see what really happens
Not what procedure says should happen

EXAMPLE TRAIL
Receive Purchase Requisition Check purchase Requisition Prepare Purchase Order Approve Purchase Order Sent PO to supplier

You keep on track Less likely to miss stages Audit is more systematic/logical

AUDITOR TOOLKIT
Clipboard Logbook Checklist Audit Plan Report Forms ISO 9001

CONDUCTING THE AUDIT

Typical Internal Audit Life Cycle

AUDIT PROGRAMME MADE BY QUALITY MANAGER TRAINED AUDITOR(S) ASSIGNED TO INDIVICUAL AUDIT

PLANNING DONE e.g. Talk to manager Read documentation Create Audit Plan Create trails Create checklists
HOLD OPENING MEETING Set the scene ACTUAL AUDIT Follow trail Talk to staff concerned (check previous nonconformities/findings cleared) AGREE FONDINGS THEN WRITE UP What is good Nonconformities/findings Observations/improvement Follow up action CLOSING MEETING Present the findings Follow up correction and corrective action performed and checked

Audit Preparation

Conducting An Audit (Opening Meeting)

Reporting Findings and Follow Up

OPENING MEETING
Opening Meeting Agenda :
1. 2. 3. 4. 5. 6. 7. 8. Introduction Purpose and scope Plan for the day Explanation of Value Added Process Nonconformity/Findings definitions (Role of Guide) Reporting method Any Questions

ROLE OF THE GUIDE (OPTIONAL)

Takes Auditor to where s/he wants to go Introduces Auditor to Auditee Acts as witness Overcomes problems Provides missing answer (Not always needed) Usually keep quiet

Typical Internal Audit Life Cycle

AUDIT PROGRAMME MADE BY QUALITY MANAGER TRAINED AUDITOR(S) ASSIGNED TO INDIVICUAL AUDIT

PLANNING DONE e.g. Talk to manager Read documentation Create Audit Plan Create trails Create checklists
HOLD OPENING MEETING Set the scene ACTUAL AUDIT Follow trail Talk to staff concerned (check previous nonconformities/findings cleared) AGREE FONDINGS THEN WRITE UP What is good Nonconformities/findings Observations/improvement Follow up action CLOSING MEETING Present the findings Follow up correction and corrective action performed and checked

Audit Preparation

Conducting An Audit (Actual Audit)

Reporting Findings and Follow Up

CHECKING CONFORMANCE, IMPROVEMENT & EFFECTIVENESS

Conformance Do audit results show topics such as procedures, ISO 9001 and Quality Management System are being followed. Improvement :
Check : Conformance to increasing goals Can a task be done efficiently? Use Process-Based Auditing

Effectiveness Checking conformance to pre-defined goals which show process is working correctly.

TYPES OF INTERPERSONAL BEHAVIOUR Passive Aggressive Assertive

Express your needs, wants, views and feelings Stand up for your rights Direct and honest Respect rights of others Work towards satisfying all parties

PUT PEOPLE AT EASE

Find best place for interview Smile when appropriate Avoid barriers, e.g. across table Keep at same physical level as auditee Be assertive Dont infringe personal space Be open in speech and manner Use humour but only if appropriate Be calm, cool and objective Give feedback

FEEDBACK BY AUDITOR
Nod when appropriate Look interested Occasionally restate what they have said Gently steer them Generate questions from what they say

THE AUDIT TRIANGLE

QUESTION (ASK THEM WHAT THEY DO)

CHECK (WHAT THE PROCEDURE SAYS THEY SHOULD DO)

OBSERVE

(SEE WHAT THAY ACTUALLY DO)

DIFFERENT METHODS OF GATHERING DATA Interviews (talk about what happens) Observing Activities (see what happens) Examining :
Documents Records (see what has happened in the past) Data summaries/analysis Reports, e.g. on customer feedback, warranty claims, dealer reports etc

INTERVIEWING PROCESS
1. 2. 3. 4. 5. 6. 7. 8. 9. Identify individual to be audited Introduce yourself Explain why you are there & Break the ice Ask open question(s) Ask the detailed questions Do show me please Check facts and make notes Thank auditee Identify next Auditee on trail

QUESTIONING THE FILTER FUNNEL

Open questions :
Encourage Auditee to talk freely Use What, Where, When, Why, How and Who?

Probing questions :
Follow up or focusing on more precise detail

Closed questions :
Used where you want a clear Yes or No answer & dont forget the please Show me

TAKING NOTES
Try to keep flow of audit Be open Use clipboard and/or logbook Record :
Suspected nonconformities Observations Info to be provided later Items to be followed up Improvement ideas (Positive evidence of conformance)

WHAT TO DO IF AUDITING WHERE THERE IS NO DOCUMENTED PROCEDURE

Double-check whether documented procedure needed Check whether outputs of process are correct Check whether different people conduct task in the same way, (i.e. informal procedures) Check whether interfaces to other processes are OK Check performance measurements are correct Check any records Check how new staff are trained In summary, is it under control?

AUDITING OF ELECTRONIC BASED SYSTEMS & RECORDS ISO treats all types of media equally May have to do desktop audit in Department Get authorization/dont tamper Ideally get guide to operate terminal Follow through complete lifestyle Check back-ups, archiving & disaster recovery

AUDITING TOP MANAGEMENT

Dont be overawed Prepare properly e.g. good checklist Follow business cascade Look at objective & controls, etc. Ensure ISO 9001 requirements met Look at business process

AUDITORS SHOULD
Avoid nit-picking Take good points into account Be punctual Perform all tasks Avoid argument Audit against specification Respect confidentiality Audit system not individual Record objective evidence Usually audit at place of work for auditee

EXAMPLE OF NOTE TAKING ON PURCHASING USING CHECKLIST

Auditor Process Audited Area Audited Procedure Audited ISO 9001 : 2008 clause
No. ITEMS

: : Purchasing : Purchasing Department : Purchasing Procedure : 7.4 Purchasing

COMPLIANCE STATUS YES : / NO : X

Auditee

Date

:
FINDINGS CONCLUSION (SEE NOTE 1)

1.

Quality Policy of the company and the relevant Quality Objective for Purchasing Explanation of the overall process of purchasing including processes before purchasing and after purchasing

Quality Policy is well understood by the purchasing manager and two purchasing personnel. Quality objective to process purchase order in two days upon receiving of approved purchase requisition Purchasing processes-receive PR>check PR>prepare PO>approve PO>sent PO to supplier. Process before-production planning and material planning,aftermanufacturing.

Con

2.

Con

Cont..
No. ITEMS COMPLIANCE STATUS YES : / NO : X FINDINGS CONCLUSION (SEE NOTE 1)

3.

Purchasing Procedure available. Take a sample of PR and PO and follow the trail of the processes. Select product/item and services which have effect on subsequent product realization or final product Competency of personnel performing the processes. Identify training required

PO No. 1352A and 2391B for the purchase of raw material XY are purchased from non-approved supplier and are without proper approval from the authorized personnel-MD

NC No. HR-01

4.

Training needs of the purchasing personnel have been identified (Title : Effective Purchasing) but there is no plan when the training will be conductred

Obs

CONDUCTING THE AUDIT

Using process based auditing, the auditor should :
Check objectives, interfaces, inputs, outputs and measures Follow top down approach on objectives and measure Check any informal procedure ; Processes are implemented but no documented procedure. See slide on What to do if auditing where there is no documented procedure Take samples and follow through the trail to ensure all the processes are followed and complying to the requirements (e.g. Procedure and ISO requirements)

REPORTING THE AUDIT & FOLLOW UP

Typical Internal Audit Life Cycle

AUDIT PROGRAMME MADE BY QUALITY MANAGER TRAINED AUDITOR(S) ASSIGNED TO INDIVICUAL AUDIT

PLANNING DONE e.g. Talk to manager Read documentation Create Audit Plan Create trails Create checklists
HOLD OPENING MEETING Set the scene ACTUAL AUDIT Follow trail Talk to staff concerned (check previous nonconformities/findings cleared) AGREE FONDINGS THEN WRITE UP What is good Nonconformities/findings Observations/improvement Follow up action CLOSING MEETING Present the findings Follow up correction and corrective action performed and checked

Audit Preparation

Conducting An Audit (Actual Audit)

Reporting Findings and Follow Up

OUTPUT FROM AUDIT

Need to determine if objectives have been met, e.g. :
Check conformance e.g. to ISO 9001 : 2008 Check effectiveness ie. :
Do processes add value (do we need to do it at all) Achieving process measurement and quality objectives Do interfaces work properly To investigate problems

To identify improvements To share best practice

DISCUSS AND AGREE FINDINGS

Dont raise nonconformities/findings in front of staff, if possible Raise, at first opportunity, with Guide/Manager Resolve problems by discussion Do give feedback to auditee but in positive way

WRITING THE NONCONFORMITY REPORT (NCR)

Remember! NCR has to be clear Must have evidence Describe the nonconformity clearly State the requirement that it violates e.g. ISO 9001 standard or EVIDENCE the companys QMS Reader should be able to understand the nonconformity and able to locate it and same for the other auditors who will are going to follow up on the corrective action

PROBLEM STATEMENT

NC

REQUIREMENT

NON CONFORMITY REPORT

CORRECTION
Definition from ISO 9000 : 2005 Action to eliminate a detected nonconformity A correction can be made in conjunction with a corrective action A correction can be, for example rework or regrade

CORRECTIVE ACTION
Department Manager defines action and timescales Action may be in two stages :
Fix the symptoms (correction) Fix the root cause (causes of the nonconformity)

ACTION PLAN Actions Timescales Responsibilities

Timescales must be realistic

SAMPLE 1

Statement No evidence to show that the machine inspection & maintenance for hobbing machine were carried out in Jan 10 & Feb 10

Root Cause Due to forgotten to fill up this form, where is handle by new PE staff

Immediate Action Fill up form after completing servicing

Corrective Action After servicing and fill up completely, pass to prod supervisor for approval

SAMPLE 2

Statement of Non Conformance

It was found that in-process assembly part for BR-M445 kit pad assembly station before & after process part put inside same trolley & didnt have ID before & after process.

SAMPLE 2 cont..

Immediate Action : Put ID for indicate before & after process

SAMPLE 2 cont..

Root Cause : Forgot to put ID

Corrective Action : Give briefing & monitor operator always follow it all the time

CORRECTION AND CORRECTIVE ACTION

Must address nonconformity Must address root cause(s) Should prevent recurrence Should help to improve Quality Management System Must be timely corrected

CHECKING CORRECTIVE ACTION

Auditor will initially evaluate proposals to check if they are suitable/effective Must be timely corrected (not too long/short a time) Correction and corrective action must ensure problem is solved at root cause Minor nonconformities can initially be cleared by post/email, etc., or on next routine visit Major nonconformities may require a special visit to clear Objective evidence will always be required to clear a nonconformity

HOW TO GET THE MOST OUT OF INTERNAL AUDITS

Must be a no blame culture Auditor and auditee should work in partnership Staff should be encouraged to reveal problem areas Use process-based auditing Both Auditor and Auditee should look for improvements Audits must be seen as essential part of business Positive terms can be used (e.g. finding not nonconformity) Findings or nonconformities should be seen as opportunity to improve Must be adequate time and resources for Auditee/Auditor to perform audit

THANK YOU & HAPPY AUDITING!