iqa training_tuv sud psb

8/10/2019 Iqa Training_tuv Sud Psb

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TV SD PSB Philippines

Using ISO 19011:2011 Guidelines

Resource Speaker: Mr. Edison Yap Pike


Internal Quality Audit Training


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NO mobile phones switched on during training

sessions (or turn to silent mode) please

House Rules


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Delegate Introductions

Name (introduce the person to your right)

Involvement in QMS

Hobbies, interest

Expectation


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Course Objectives

Interpret the requirements of QMS in the context of an

audit;

Describe the roles and responsibilities of auditors and lead

auditors;

Understand the concept of an audit and its purpose as amanagement tool;

Plan and conduct an audit (in accordance with ISO 19011);

Understand the benefits of conducting an audit.


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Course Overview

Tutorial

Group Work

Presentation


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Course Outline

I. Introduction to Auditing

II. ISO 19011:2011 Updates

III. Audit Objectives, Principles, and Concepts

IV. Audit Planning

V. Conducting On-site Audit

VI. Audit Reporting

VII. Auditor Selection and Evaluation


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Introduction to Auditing


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Why do we Audit?

Certification or internal audit Assess effectiveness, doubtful performance

Verify compliance

Regulatory or contractual requirements

After significant changes

Needs from supplier evaluation

Identify opportunities for improvement


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Internal Auditing

Audits must be at planned intervals

Audits check that QMS

Is being followed

Is effective

Meets requirements of ISO 9001:2008 Audits must be objective


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Audit Types

Your ownOrganization

Subcontractoror Supplier

CertificationBody

1st Party

2nd Party

3rd Party

Audits carried out by a

company on its own systems.

Audits carried out by one organization on another prior to

or after contract placement.

Audits carried out by

independent accredited

organizations.


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Difference Between 1stand 2ndand 3rdParty Audits

Elements First Party (Internal Audit) 2ndand 3rdParty

Offers of advice

Audit Style

Opening meeting

Closing meeting

Auditee Reaction

Usually expected

Can be relaxed althoughSometimes inhibiting if

auditee is senior mgt.

Optional

Optional

Depends on culture

Never in 3rdParty, rarelyIn 2ndParty

Much formal

Required

Required

Usually taken very seriouslyDue to implications of auditResult.


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3.1 AUDIT

Systematic, independent and documented process forobtaining audit evidence (3.3) and evaluating itobjectively to determine the extent to which the auditcriteria (3.2) are fulfilled.

3.2 AUDIT CRITERIA

Set of policies, procedures or requirements used as a

reference against which audit evidence (3.2) iscompared

3.0 Terms and definitions


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3.3 AUDIT EVIDENCE

Records, statement of facts or other information whichare relevant to the audit criteria (3.3) and verifiable

3.4 AUDIT FINDINGS

Results of the audit evaluation of the collected auditevidence (3.3) against audit criteria (3.2)

3.5 AUDIT CONCLUSION

Outcome of an audit, after consideration of the auditobjectives and audit findings (3.4)



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3.6 AUDIT CLIENT

Organization or person requesting an audit (3.1)Note 1: In the case of the internal audit, the audit client

can also be the auditee (3.7)

3.7 AUDITEEOrganization being audited

3.8 AUDITOR

Person conducting the audit(3.1)



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3.9 AUDIT TEAM

One or more auditors (3.8) conducting an audit (3.1),supported if needed by technical experts (3.10)

Note 1: One auditor of the audit team is appointed as

audit team leader.

Note 2: The audit team may include auditors-in-training.

3.10 TECHNICAL EXPERT

Person who provides specific knowledge or expertise to

the audit team (3.9)Note 1: Specific knowledge or expertise is that which

relates to the organization, process or activity to be

audited, or language and culture.



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3.11 OBSERVER

Person who accompanies the audit team but doesnot audit.

Note 1: Not part of the audit team and does not

influence or interfere with the conduct of the audit

Note 2: Can be from the auditee, a regulator or

other interested party who witnesses the audit.

3.12 GUIDEPerson appointed by the auditee to assist the audit

team



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3.13 AUDIT PROGRAMME

Arrangements for a set of one or more audits planned for aspecific time frame and directed towards a specific purpose.

3.14 AUDIT SCOPE

Extent and boundaries of an auditNote 1: The audit scope generally includes a description of

the physical locations, organizational units, activities and

processes, as well as time period covered.

3.15 AUDIT PLAN

Description of the activities and arrangements for an audit



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3.16 RISK

Effect of uncertainty on objectives

3.17 COMPETENCE

Ability to apply knowledge and skills to achieveintended results.

Note 1: Ability implies the appropriate application of

personal behavior during the audit process



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3.18 CONFORMITY

Fulfillment of a requirement

3.19 NONCONFORMITY

Non-fulfillment of a requirement

3.20 MANAGEMENT SYSTEM

System to establish policy and objectives, and to

achieve those objectives



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ISO 19011:2011 Updates


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Topic Changes

Terms and definitions Added definition for Observer, Guide, Risk

Revised definition for Competence

Principles of auditing Replaced Ethical conduct with Integrity

Added Confidentiality

5.0 Managing an audit

programme

Expanded and structured to follow a process flow:

5.1 General

5.2 Establishing the audit programme objectives

5.3 Establishing the audit programme

5.4 Implementing the audit programme

5.5 Monitoring the audit programme5.6 Reviewing the audit programme

6.0 Performing an audit No longer includes appointment of audit team and

audit team leader, defining audit objectives, scope

and criteria (transferred to 5.0 Managing an audit

programme)

6.0 Performing an audit Combined Conducting document review and

Preparing for the on-site audit activities to one

sectionPreparing audit activities


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Topic Changes

6.0 Performing an audit Conducting audit activities includes Performing

document review while conducting the audit

7.0 Competence and

evaluation of auditors

Added 7.2.3.3 Discipline and sector specific

knowledge and skills of management systemsauditorto cover knowledge and skills for auditing

different management systems (instead of Quality

and Environmental Management Systems only in

2002 version). Refers to Annex A

New section: Annex A

Illustrative examples of

discipline-specific

knowledge and skills of

auditors

Guidance on how to support the development of

auditor competence criteria and auditor selection

New section: Annex B

Additional guidance for

auditors planning and

conducting audits

Describes different audit methods and guidance on

how to conduct sampling audits, what to consider

when conducting document reviews, different

methods to gather information, considerations for

recording nonconformities, etc.


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Auditing Objectives, Principles, and

Concepts


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4.0 Principles of Auditing

PRINCIPLES DETAILS

Integrity Foundation of professionalism:

Honesty, diligence, responsibility,

demonstration of competence,

impartiality

Fair presentation Obligation to report truthfully andaccurately:

Significant obstacles and unresolved

diverging opinions between auditor

and auditee are reported and

disclosed


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PRINCIPLES DETAILS

Due professional

care

Diligence and judgment in auditing

Exercise due care in accordance with

the importance of task performed.

Have the necessary competence

Confidentiality Security of information

Exercise discretion in the use andprotection of information acquired

Info should not be used

inappropriately for personal gain or in

a manner detrimental to the legitimate

interest of the auditee



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PRINCIPLES DETAILS

Independence Impartiality and objectivity of auditconclusions

Free from bias and conflict of interest.

Maintain objectivity in the conduct of audit.

Evidence-

basedapproach

Reaching a reliable and

reproducible audit conclusions ina systematic process

Audit evidence is verifiable

Based on samples of information available

Use of appropriate sampling that is closelyrelated to confidence of audit conclusions



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5.0 Management of Audit Programme

Establishing the audit programme objectives

Establishing the audit programme

Assignment roles and responsibilities Competence of person managing the audit programme

Extent of the audit programme

Identify and evaluate audit programme risks

Procedures for the audit programme

Identify audit programme resources

0 M f A di P


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Implementing the audit programmeDefine the objectives, scope, and criteria for the audit

Selecting audit methods

Selecting team members

Assigning responsibilities to audit team leader

Managing the audit programme outcome

Managing and maintaining audit programme records

Monitoring the audit programme

Reviewing and improving the audit programme

Competenceand evaluation

of auditors

Performing an

audit

5.0 Management of Audit Programme

6 0 P f i A di A di A i i i


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6.0 Performing an AuditAudit Activities

INITIATING THE AUDIT (6.2)

PREPARING AUDIT ACTIVITIES (6.3)

CONDUCTING THE ON-SITE AUDIT (6.4)

Conducting opening meeting

Performing document review while

conducting the audit

Communicating during audit

Assigning roles and responsibilities of guides

& observers Collecting and verifying information

Generating audit findings

Preparing audit conclusions

Conducting closing meeting

Establish initial contact with auditee

Determine feasibility of audit

Review documents of mgt. systems to

prepare for audit

Preparing the audit plan

Assigning the audit team

Preparing work documents

6 0 P f i A dit A dit A ti iti


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PREPARING AND DISTRIBUTING

AUDIT REPORT (6.5)

COMPLETE AUDIT (6.6)

Verification of effectiveness of

corrective action

CONDUCTING

AUDIT FOLLOW-UP (6.7)

Prepare the audit report

Distribute the audit report

Documents pertaining to audit may be

retained or destroyed as agreed upon Confidentiality must be observed

6.0 Performing an AuditAudit Activities


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Audit Planning

Audit Team Leaders Responsibilities


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Audit Team Leaders Responsibilities

Prepare an Audit Plan and working

documents Protect the health and safety of the audit

team

Represent Audit team to Management

Organize and direct the audit team

Provide direction and guidance totrainees

Resolve conflict

Lead the team to reach audit conclusions

Prepare and complete the audit report

Auditors Responsibilities


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Auditor s Responsibilities

Comply with the audit requirement

Plan/carry out responsibility effectively Remain within audit scope

Be able to identify availability and adequacy ofDocumented System

Verify understanding and implementation of

Documented System Gather, check and analyze evidence

Remain alert to further information/evidence

Auditors Responsibilities


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Act in ethical manner

Documents audit findings Report audit results

Require corrective and preventive action

Verify implementation and effectiveness of

Corrective and Preventive Action

Retain/safeguard audit documents

Support Audit Team Leader

Auditor s Responsibilities

Responsibilities of Auditees


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Responsibilities of Auditees

Cooperate with lead auditor/team to ensure

that audit is conducted smoothly Establish communication channels

Confirm the audit authority

Ensure staff availability for interview and

meetings

Arrange logistics and necessary support

Audit Preparation


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Audit Preparation

Time and Resources Auditors Contacts Dept heads

Prepare audit plan

Prepare checklist

Review documentation

(Quality Manual and 6 Mandatory Documented Procedures)

Control of documents

Control of records

Internal audit

Control of nonconforming

product

Corrective action

Preventive action

Advantages of Audit Plan


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Clarifies Purpose of Audit

Use Time More Effectively

Ensure Important Elements Covered

Shows Open Approach if Copied Before Audit Gives Framework of Audit

Gives Professional Impression

Provides Records of What Covered

Advantages of Audit Plan

Preparing An Audit Plan


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Preparing An Audit Plan

Audit objectives, criteria and scope Dates and places

Time required

Roles and responsibilities of audit

team and accompanying persons

Allocation of appropriate resources to

critical areas of audits

Audit Plan - Sample


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Audit Plan SampleDate Time Organizational

unit/LocationProcess/Event/

ElementAuditors

01/12/12 ISO 9001 (Audit criteria)

9:009:30 Conference Room Opening Meeting AB

9:3010:30 Facility Tour AB

10:3012:00 Office of the Top Mgt 4.1, 4.2, 5.1, 5.2, 5.3,5.4.1, 5.4.2, 5.5.1, 5.5.2,

5.5.3, 5.6, 6.1, 8.2.1,

8.2.2, 8.5.1

AB

12:001:00 Lunch

1:003:00 Technical/ DesignSection

7.5.1, 7.5.2, 7.5.3, 7.5.4,7.5.5, 7.6, 8.2.3, 8.2.4, 8.3,

8.4, 8.5.2, 8.5.3

AB

Preparing Work Documents


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Auditor Toolkit

Clipboard

Logbook

Checklist

Audit plan Report Forms

ISO 9001:2008 standard

Preparing Work Documents

Sources for the Creation of Checklist


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ISO Standard (ISO 9001:2008) Requirements

Key elements of QMS Documentation

Known or Classic Problems of Organization

Ideas from Auditors

Knowledge of Industry

Previous Checklist

Sources for the Creation of Checklist

Sample Checklist for Auditing Warehouse


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1. How are damaged goods dealt with upon receipt?

2. What are the packaging / storage criteria used?

3. How is it decided where items should be stored?

4. Is storage environment suitable, ex. Temperature, humidity & dust control?

5. Are there any items with limited shelf life, if so, how are they controlled?

6. Are there any items requiring special protection, ex. from electrostaticdamage?

7. How are items routinely checked for deterioration?

8. How are defective items identified & segregated?

9. Is there any evidence of poor product house keeping, handling or storage?

10.What training do Warehouse Personnel get?

Sample Checklist for Auditing Warehouse


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Conducting On-Site Audit

Audit Communications


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With Auditee

Opening meeting Daily review

Informal communications

Closing meeting

Within Audit team

Regular communications (normally

each half day)

Internal meeting

Opening Meeting


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p g g

Participants (attendance record)

Confirm agreement of all parties to the audit plan Introduce audit team

Methods and procedures to conduct the audit

Communication channel and language used

Relevant safety, emergency and security procedures

Roles of a guide and observers

Methods and grading of nonconformities

Condition to terminate the audit

State the disclaimer

Appeal system Invite questions

What do we Audit Against?


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g

Conformance to the Documented System /Quality Manual

Conformance to ISO 9001:2008

Effectiveness and appropriateness of system?

Environment, Health and Safety?

Company Rules?

?

Evidence


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Results of interview with employees/others

Observation of activities, work environment, etc.

Review of documents and records

Review of physical samples, photos taken, etc.

Could be positive or negative

?

The Audit Triangle


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Question( ask them what they do)

Observe( see what they actually do) Check( what the process saysthey should do)

Interviewing Process


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Identify individual to be audited Introduce yourself

Explain why you are there

Ask open question(s)

Do show me please

Check facts and make notes

Thank auditee

Identify next auditee on trail

?

Interview Technique


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Avoid sitting in an opposing manner

Develop rapport with a small talk, eye contact

Explain the reason why you are here, take taking

Spend more time listening

Good idea to have an audit at the auditees office

?

Open Questions


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Encourage Auditee to talk freely

ex. set the scene

Use what, where, why, who, when & how?

Take care to prevent Auditee from talking to much

?

Probing Questions


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Follow-up or Focusing questions

Search for information in greater depth

Cornerstone of audit techniques

?

Closed Questions


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Used to established specific factsex. Do you?

Normally receives a yes / no answer

Do not use too often

?

Counter Productive Questions


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Type of questions to be avoided

Moves away from purpose of audit

Examples includes:

Tricky questions Leading questions

Ambiguous questions

Multiple questions

?

Nonconformity


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Non-fulfillment of a requirement, e.g.

Customer requirements

Statutory and regulatory requirements

System requirements

Nonconformity Classification


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NONCONFORMANCE (NC):

A nonconformance relates to the absence, or totalfailure, of a process to meet the internal requirementsresulting in an actual or potential adverse effect oncustomer satisfaction and quality of the product orservice.

A number of lapses against one clause of guidelineswhen acting together reduce the effectiveness of aprocess to the extent that there are actual adverseeffectson customer satisfaction and product quality

which can represent a nonconformance.

Nonconformity Classification


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OBSERVATION (O):

Single observed lapseor failure to comply with arequirement of the guidelines or an internalrequirement which however, as based on objectiveevidence, does not jeopardize product quality.

HINTS FOR IMPROVEMENT (H):

Findings which is a best practice observed by theauditor which the organization may or may not

consider them. This practices are sort ofrecommendation in improving the quality systemof theorganization.

Nonconformities Must


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Be factual / objective

Be clear and concise

Give clause number of Quality Standard /

Company Document

Be locatable by the Auditors

Define the exact instance

Be given a unique identifier

Be categorized (ex. NC / O / I)

Be accepted / signed by the audited

company

Nonconformity Format


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Clause No.

Criteria statement

However

Factual description (Audit Evidence)

When

Where

Who

What

Generating audit findings / Audit conclusions


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NONCONFORMANCE REPORT

Company: XYZ Co. Classification: NCArea: Warehouse ISO Clause:Reference:

Detail of Nonconformance:

Auditor:

Corrective Action:

By:

Remarks:

Verified by:

Element Specific Objective Evidences


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Element -Specific Objective Evidences4 Quality Management System

4.1 General Requirements

Determination of processes for QMS and their applicationthroughout the organization,

Determination of sequence of these processes,

Determination of criteria and methods for the effectivenessof these processes,

Availability of resources,

Process monitoring, measurement and analysis,

Actions for continuous improvement,

Control of outsourced processes as part of QMS.

4 Quality Management System


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4.2 Documentation Requirements

4.2.1 General Documented statements of Quality Policy and Quality

Objectives

Quality Manual

Documented procedures and records required by the

standard

Documents and records required by the organizational

process control.



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4.2.2 Quality Manual

Scope of the system including justification of

exclusions;

Documented procedures or reference there to;

Organizational charts;

QMS process descriptions and interactions.



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4 Quality ManagementSystem4.2 Documentation Requirements

4.2.3 Control of documents

Documented procedure for control of documents;

Approval for adequacy prior to issue;

Review, update and re-approval;

Identification of changes and current revision status; Relevant applicable documents are available at point of

use;

Legible and readily identifiable;



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4.2.3 Control of documentscont.

Identification and controlled distribution of external

documents relevant to QMS;

Suitable identification of obsolete documents.



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4 Quality Management System4.2 Documentation Requirements

4.2.4 Control of records Documented procedure for control of records

Identification

Storage

Protection Retrieval

Retention

Disposition

Methods of control.



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4.2.4 Control of records cont.

Shall remain:

Legible

Readily identifiable

Easily retrievable.

5 Management Responsibility


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5.1 Management Commitment

Evidence of quality system effectiveness and continualimprovement by:

Communication on meeting customer, statutory and

regulatory requirements;

Established quality policy and quality objectives; Management reviews;

Availability of resources.



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5.2 Customer Focus

Customer requirements determined and met

Enhancing customer satisfaction.

5.3 Quality Policy

Commitment to comply w/ requirements and continualimprovement

Reviewed for continuing suitability

Framework for establishing/reviewing quality objectives

Communication and understanding with in the organization.



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5 Management Responsibility5.4 Planning

5.4.1 Quality objectives- Aligned with quality policy

- Aligned with requirements

- Established at relevant functions and levels

- Measurable.

5.4.2 Quality management system planning

- Business Planning, Strategic Planning, Project plans,

quality assurance agreements

- Quality planning



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5.5 Responsibility, Authority & Communication

5.5.1 Responsibility and Authority- Job/function/requirement profiles

- Responsibilities & authorities communicated

5.5.2 Management Representative

- Level of authority

- Appointment letter

- Job/Function profile

- Must be a member of the organizations own management.

5.5.3 Internal Communication- Established suitable communication processes within the organization

- Communication on QMS effectiveness.



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5 Management Responsibility5.6 Management Review

5.6.1 General- Regular review of quality system

5.6.2 Review Input

- Audit results

- Customer feedback- Process performance & product conformity

- Status of corrective and preventive action

- Follow-up action from previous management reviews

- Changes that could affect the QMS- Recommendations for improvement.



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g p y

5.6 Management Review

5.6.3 Review Output- Improvement of the effectiveness of the QMS and the

processes

- Product improvement

- Resource needs.

6 Resource Management

6.1 Provision of Resources

- Implement, maintain for continually improvement

- Ensure customer satisfaction.



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g6.2 Human Resources

6.2.1 GeneralMust be competent on the basis of:

- Education

- Training

- Skills- Experience

- Competence requirements are relevant for any personnel

involved in QMS.



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g6.2 Human Resources

6.2.2 Competence, Awareness and Training- Define training needs;

- Provide appropriate training/training program;

- Evaluation of training effectiveness;

- Awareness of personnel on their activities and contributionon the quality objectives achievement;

- Maintain relevant records.



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g6.3 Infrastructure

- Determination, provision and maintenance of infrastructure- Buildings, workplace and associated utilities

- Process equipment hardware and software

- Support services

- Information systems.

6.4 Work Environment

- Determine and control work-environment and other factors for

product conformity such as physical, environmental, noise,

temperature, humidity, lighting or weather.

7 Product Realization


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7.1 Planning of Product Realization

- Planning of the quality objectives and productrequirements including resources;

- Quality planning;

- Project development plans;

- Maintain records.



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7.2 Customer- Related Processes

7.2.1 Determination of product requirements

- Product requirements including delivery and post delivery

activities such as warranty provisions, maintenance services

and supplementary services (recycling)

- Statutory & regulatory requirements applicable to theproducts.



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7.2.2 Review of product requirements

- Capability checked- Agreement before acceptance

- Statutory and regulatory requirements

- Differences resolved

- Amendments documented and communicated

- Determine requirements not specified by the customer but

necessary for use

- Maintain records.

7 Product Realization cont.


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7.2.3 Customer Communication

- Define and implement communication with customerson:

Product information

Inquiries, contracts or order handling including

amendments Customer feedback, customer complaints

7 Product Realization cont.


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7.3 Design and Development

7.3.1 Design and Development Plan- Review, verification and validation

- Interfaces and effective communication

- Clarity of responsibilities and authorities

7.3.2 Design and Development Inputs- Customer/market performance requirements

- Statutory and regulatory requirements

- Previous design and development results obtained

- Other requirements

- Adequate, clear-cut requirements

7 Product Realizationcont.


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7.3.3 Design and Development Outputs

- Meet input requirements

- Provide information for purchasing, production and

service provision

- Product acceptance criteria

- Specify product characteristics essential for its safe and

proper use

- Preservation of product

- Approve before release.

7 Product Realizationcont.


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7.3.4 Design and Development Review

- Evaluate capability at suitable stages- Identify problem, prepare necessary actions

- Document review results & the necessary actions

7.3.5 Design and Development Verification

- Plan and perform to ensure that output satisfy inputrequirements

- Follow-up action is defined

- Document verification results.



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7.3 Design and development

7.3.6 Design and Development Validation- Ensure fitness for use

- Validation prior to product delivery

- Partial Validation, if applicable

7.3.7 Control of Design and Development Changes- Review, identify and document changes

- Review, verification, validation and approval prior to

implementation

- Review the effect of changes

- Review follow-up action on the product

- Document review results.



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7.4 Purchasing

7.4.1 Purchasing Process- Criteria for supplier selection, evaluation and re-evaluation

- Regular evaluation and re-evaluation of suppliers

- Documentation of evaluation

- List of approved suppliers.


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7 Product Realization7 5 Production and service provision


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7.5 Production and service provision

7.5.1 Control of production & service provision- Define product characteristics

- Available work instructions

- Suitable equipment and environment

- Comply with reference standards- Control/ monitor process parameters and product

characteristics

- Approve & maintain process & equipment

- Workmanship criteria clearly stipulated

- Post-delivery activities must be implemented.

7 Product Realization7 5 P d ti d i i i


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7.5.2 Validation of Processes for production and service provision- Criteria for review and approval

- Approval of equipment and personnel qualification

- Process control data

- Validation specification.

7 Product Realization7 5 P d ti d i i i


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7.5.3 Product identification and traceability

- Identified product at all stages

- Identified status with respect to measurement and

verification activities

- Traceability for critical items recorded

- Applied to component and parts.



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7.5 production and service provision

7.5.4 Customer property- Identification, verification, protection and maintenance

- Procedure and documentation in cases involving damage or loss

(notification to customer)

- Inventory of customer property- Organization exercise care for customer property

- Intellectual property

- Personal data.

7 Product Realization7 5 Production and Service Provision


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7.5 Production and Service Provision

7.5.5 Preservation of productHandling methods to prevent damage or deterioration

Stipulate methods of receipt and dispatch to/from stock

Regularly assess condition of product in stock

Packing, packaging and marking

Preservation and segregation

Protect product after final inspection and test

Apply to parts and components

Product release and/or service delivery

Activities satisfactorily completed

Documentation available and authorized

7 Product Realization7 6 Control of monitoring & measuring equipment


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7.6 Control of monitoring & measuring equipment Determine required monitoring and measuring equipment and its ability

Calibrate and adjust at regular intervals

Traceability to recognized standards

Define calibration process -acceptance criteria and action for

unsatisfactory results

Identification of calibration status

Out of calibration-assess & document affected products Test software or comparative references check to prove capability of

verifying the acceptability of product

Software validation

Suitable environmental conditions

Safeguard from adjustments.


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8 Measurement, Analysis & Improvement8 2 Monitoring and measurement


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8.2 Monitoring and measurement

8.2.1 Customer Satisfaction- Customer satisfaction survey

- User opinion surveys,

- Customer on product delivery,

- Lost business analysis,

- Compliments,- Warranty claims and

- Dealer reports.

8 Measurement, Analysis & Improvement8 2 Monitoring and Measurement


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8.2 Monitoring and Measurement

8.2.2 Internal Audit- Documented procedure for Internal Audit

- Internal Audit shall be used as a tool for evaluating ongoing

system compliance

- Cover quality activities and related results

- Schedule-based on status and importance

-Auditors qualification

- Independence

- Record and report findings



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8.2.2 Internal Auditcont.- Follow-up audit -verify implementation and effectiveness

-Auditors performance evaluation- Determine if QMS is

effectively implemented and maintained

- Determine if QMS conform to relevant standard

- Correction and corrective action

- Identify potential opportunities for improvement

- Maintain records.



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8.2.3 Monitoring & Measurement of Process- Suitable methods for monitoring and measurement with impact to

the conformity of product and quality system processes

- Implementation of correction and corrective action for

nonconformity.

8 Measurement, Analysis & Improvement8.2.4 Monitoring & Measurement of Product


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8.2.4 Monitoring & Measurement of Product

- Product characteristics monitoring, measuring, verification and

documentation

- Responsible person identified for release of product

- Record evidence of implementation of required

measurement and monitoring and conformance with the acceptance

criteria

8 Measurement, Analysis & Improvement

8 3 Control of nonconforming Product


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8.3 Control of nonconforming Product

- Documented procedure for control of nonconformance- Identify, record and review the nature & extent of the non-conformity

- responsibility for disposition - defined and implemented

- Concerned functions notified

- Review in accordance with documented procedure

- Report use of non-conforming product to customer- Record description of accepted non-conformity

- Re-inspect repaired and/or reworked product

- Determine and implement verification requirements for repaired or

reworked product

8 Measurement, Analysis & Improvement8.4 Analysis of Data


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y

Determine, collect, analyze appropriate data to demonstrate

quality system suitability & effectiveness

Provide information on:

Customer satisfaction/dissatisfaction

Conformity of product requirements

Process and product characteristics Suppliers

8 Measurement, Analysis & Improvement8.5 Improvement


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8.5.1 Continual ImprovementContinual Improvement through:

- Quality policy

- Quality objectives

- Audit results

- Data analysis

- Corrective and preventive action

- Management review

8 Measurement, Analysis & Improvement8.5.2 Corrective action


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- Documented procedure for corrective action

- Review non-conformities (incl. Customer complaints)

- Determine the causes of non-conformities

- Required measures to prevent recurrence

- Corrective action

- Monitoring and evaluation of corrective action

- Documentation

- Submit for management review.

8 Measurement, Analysis & Improvement8.5.3 Preventive Action


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- Documented procedure for preventive action- Determine potential non-conformities

- Determine potential root cause

- Planning of preventive action

- Implementation of preventive action- Evaluation of preventive action taken

- Documentation

- Submit for management review.

Discuss and Agree Findings

Dont raise nonconformities / findings in front of staff


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Don t raise nonconformities / findings in front of staff,

if possible Raise, at first opportunity, with Guide/Dept Heads

Resolve problems by discussion

Agree corrective action timetable

Closing Meeting

Thanks for cooperation etc


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Thanks for cooperation, etc

Summary of good findings / points

Nonconformities / finding(s) and recommendation(s)

Corrective actions

Report details What happens next

Any questions


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Audit Reporting

Preparing Audit Report

Audit objectives

Audit Scope


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Audit Scope

Audit client

Audit team and auditees participants

Dates and locations of audit

Audit criteria Audit findings and relevant evidence

Audit conclusions

Statement on the degree on which the

audit criteria have been fulfilled

Corrective vs. Preventive Action


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Nonconformity Detected NC NOT YET Detected

Eliminate itself(fixing NC)

Preventrecurrence

Eliminate cause ofPotential NC

CORRECTION CORRECTIVE

ACTION

PREVENTIVE

ACTION

Corrective Action Steps

Confirm NC


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Confirm NC

Identify Root Cause/s

Identify Solution

Propose, review, accept

Implement , close

Followup Action

Report circulated


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Report circulated

Audit program updated

Checklist filed

Corrective action performed

Trends/findings fed to management review Corrective action verified


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Selecting Audit Team Members


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Identify knowledge and skills required based onaudit objectives

Ensure all necessary knowledge and skills arepresent in the audit team

Ensure impartiality and independence (not audit

own work) Experts may be appointed to support

competence

The Ideal Auditor?

Relaxed and Friendly

Good Listener/Communicator


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Interested, Objective andLogical

Positive attitude and EnquiringMind

Explains the process andUnderstand the Technicality.

Gives good feedback

Excellent Interpersonal Skills

Can communicate at all levelsof the organization

Personal Behavior

Ethicalfair, truthful, sincere, honest, discreet

Open mindedwilling to consider alternative ideas


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Diplomatictactful in dealing with people Observantactively observing surroundings and activities

Perceptiveaware and able to understand situations

Versatileable to readily adapt to situations

Tenaciouspersistent and focused on achieving objectives Decisiveable to reach timely logical conclusions

Self-reliantable to act and function independently

Personal Behavior

Acting with fortitudeable to act responsible and

thi ll th h thi ti t l b


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ethically even though this actions may not always be

popular / may result in disagreement or confrontation

Open to improvementwilling to learn from

situations and striving for better audit results

Culturally sensitiveobservant and respectful to the

auditees culture

Collaborativeeffectively interacting with others

(auditee and audit team)

Auditor Knowledge

Generic Knowledge

Audit principles,

procedures and methods

Must know how to collect information, use

work documents to support audit findings


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and conclusions, document audit findings,communicate effectively, etc.

Management System

requirements and

reference documents

Must be able to audit within the audit scope

and apply audit criteria using ISO standards,

procedure manuals, etc.

Organizational context Must understand auditees structure, and

business and management practices

Applicable legal,contractual, and other

requirements

Must know applicable laws and regulationsrelated to the business

Auditor Knowledge

Discipline and Sector Specific Knowledge


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Discipline Specific

Knowledge

Ex. ISO 9001 requirements, terminologies

relating to QMS

Sector Specific Knowledge Ex. Transportation/ Education / Construction

sectorterminologies, processes andpractices

Education

Achieving Auditor Competence


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Auditors should have:

Formal education / training

contributing to development of

knowledge and skills in themanagement system discipline /

sector that the auditor intends to

audit

Training

Auditors training should cover:

Achieving Auditor Competence


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Knowledge and understanding of the standard

including legal and other requirements

Assessment techniques

Skills required for managing an audit

Experience

Should be in a position where the activities undertaken

helped develop skills and knowledge in MS.Audit experience gained as auditor trainee

EVALUATION

METHODS

OBJECTIVES EXAMPLES

Review of

records

To verify the background of the

auditor

Analysis of records of

education, training,

Possible Evaluation Methods


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, g,

employment and auditexperience

Positive and

negative

feedback

To provide information about how

the performance of the auditor is

perceived

Surveys, questionnaires,

personal references,

testimonials, complaints,

performance evaluation,

peer review

Interview To evaluate personal attributes

and communication skills, to

verify information and testknowledge and to acquire

additional information

Face to face and

telephone interviews

EVALUATION

METHODS

OBJECTIVES EXAMPLES

Observation To evaluate personal Role-playing, witnessed

Possible Evaluation Methods


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attributes and the ability toapply knowledge and skills

p y g,

audits, on-the-job performance

Testing To evaluate personal

attributes and knowledge

and skills and their

application

Oral and written exams,

psychometric testing

Post-audit review To provide information

where direct observation

may not be possible or

appropriate

Review of the audit report and

discussion with the audit

client, auditee, colleagues and

with the auditor

For inquiries on Certification please contact:

TV SD PSB Philippines Inc.

1808 The Orient Square, F. Ortigas Jr. Rd., Ortigas Center, Pasig City

Trunkline: +63 2 687 5673

Facsimile: +63 2 687 2651


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THANK YOU

! ! !

For inquiries on Certification, please contact:

MARLON PALISOCAccount Consultant (South Luzon)

JAMES SABANDALAccount Consultant (North Luzon)

MARK KHRIS SANTIAGOAccount Consultant (Metro Manila)

FAITH PEDRIGALAccount Consultant (Cebu)

ANNA LIZA SAMORROAccount Consultant (Davao)

For inquiries on Trainings, please contact:

ANN RINGOLMCS Assistant