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Internal Quality Audit Training

Using ISO 19011:2011 Guidelines

Resource Speaker: Mr. Edison Yap Pike

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House Rules

NO mobile phones switched on during training


sessions (or turn to silent mode) please

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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 a
management 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
Audits carried out by a
company on its own systems.

Your own Audits carried out by


Organization independent accredited
organizations.
1st Party
Certification
Body
3rd Party
Subcontractor
or Supplier
2nd Party
Audits carried out by one organization on another prior to
or after contract placement.
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Difference Between 1st and 2nd and 3rd Party Audits

Elements First Party (Internal Audit) 2nd and 3rd Party

Offers of advice Usually expected Never in 3rd Party, rarely


In 2nd Party

Audit Style Can be relaxed although Much formal


Sometimes inhibiting if
auditee is senior mgt.

Opening meeting Optional Required

Closing meeting Optional Required

Auditee Reaction Depends on culture Usually taken very seriously


Due to implications of audit
Result.
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3.0 Terms and definitions

3.1 AUDIT
Systematic, independent and documented process for
obtaining audit evidence (3.3) and evaluating it
objectively to determine the extent to which the audit
criteria (3.2) are fulfilled.

3.2 AUDIT CRITERIA


Set of policies, procedures or requirements used as a
reference against which audit evidence (3.2) is
compared

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3.0 Terms and definitions

3.3 AUDIT EVIDENCE


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

3.4 AUDIT FINDINGS


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

3.5 AUDIT CONCLUSION


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

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3.0 Terms and definitions

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 AUDITEE
Organization being audited

3.8 AUDITOR
Person conducting the audit (3.1)

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3.0 Terms and definitions

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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3.0 Terms and definitions

3.11 OBSERVER
Person who accompanies the audit team but does
not 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 GUIDE
Person appointed by the auditee to assist the audit
team
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3.0 Terms and definitions

3.13 AUDIT PROGRAMME


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

3.14 AUDIT SCOPE


Extent and boundaries of an audit
Note 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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3.0 Terms and definitions

3.16 RISK
Effect of uncertainty on objectives

3.17 COMPETENCE
Ability to apply knowledge and skills to achieve
intended results.
Note 1: Ability implies the appropriate application of
personal behavior during the audit process

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3.0 Terms and definitions

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 Expanded and structured to follow a process flow:
programme 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 programme
5.6 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
section – “Preparing 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 Added “7.2.3.3 Discipline and sector specific
evaluation of auditors knowledge and skills of management systems
auditor” to 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 Guidance on how to support the development of
Illustrative examples of auditor competence criteria and auditor selection
discipline-specific
knowledge and skills of
auditors

New section: Annex B Describes different audit methods and guidance on


Additional guidance for how to conduct sampling audits, what to consider
auditors planning and when conducting document reviews, different
conducting audits 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 and
accurately:
 Significant obstacles and unresolved
diverging opinions between auditor
and auditee are reported and
disclosed

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4.0 Principles of Auditing
PRINCIPLES DETAILS
Due professional Diligence and judgment in auditing
care  Exercise due care in accordance with
the importance of task performed.
 Have the necessary competence

Confidentiality Security of information


 Exercise discretion in the use and
protection 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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4.0 Principles of Auditing
PRINCIPLES DETAILS
Independence Impartiality and objectivity of audit
conclusions
 Free from bias and conflict of interest.

 Maintain objectivity in the conduct of audit.

Evidence- Reaching a reliable and


based reproducible audit conclusions in
approach a systematic process
 Audit evidence is verifiable

 Based on samples of information available

 Use of appropriate sampling that is closely


related 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

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5.0 Management of Audit Programme

Implementing the audit programme


Define the objectives, scope, and criteria for the audit Competence
and evaluation
Selecting audit methods
of auditors
Selecting team members
Assigning responsibilities to audit team leader
Managing the audit programme outcome Performing an
Managing and maintaining audit programme records audit

Monitoring the audit programme

Reviewing and improving the audit programme

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6.0 Performing an Audit – Audit Activities

• Establish initial contact with auditee


INITIATING THE AUDIT (6.2)
• Determine feasibility of audit

• Review documents of mgt. systems to


PREPARING AUDIT ACTIVITIES (6.3) prepare for audit
• Preparing the audit plan
• Assigning the audit team
• Preparing work documents

• Conducting opening meeting


• Performing document review while
conducting the audit
• Communicating during audit
CONDUCTING THE ON-SITE AUDIT (6.4)
• Assigning roles and responsibilities of guides
& observers
• Collecting and verifying information
• Generating audit findings
• Preparing audit conclusions
• Conducting closing meeting
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6.0 Performing an Audit – Audit Activities

PREPARING AND DISTRIBUTING


• Prepare the audit report
AUDIT REPORT (6.5)
• Distribute the audit report

• Documents pertaining to audit may be


COMPLETE AUDIT (6.6) retained or destroyed as agreed upon
• Confidentiality must be observed

CONDUCTING • Verification of effectiveness of


AUDIT FOLLOW-UP (6.7) corrective action

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Audit Planning

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Audit Team Leader’s 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 to
trainees
• Resolve conflict
• Lead the team to reach audit conclusions
• Prepare and complete the audit report

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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 of
Documented System
• Verify understanding and implementation of
Documented System
• Gather, check and analyze evidence
• Remain alert to further information/evidence

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Auditor’s Responsibilities

• 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

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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

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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 nonconforming
• Control of records product
• Internal audit • Corrective action
• Preventive action

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Advantages of Audit Plan

• 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

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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

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Audit Plan - Sample
Date Time Organizational Process/Event/ Auditors
unit/Location Element

01/12/12 ISO 9001 (Audit criteria)


9:00 – 9:30 Conference Room Opening Meeting AB

9:30 – 10:30 Facility Tour AB


10:30 – 12:00 Office of the Top Mgt 4.1, 4.2, 5.1, 5.2, 5.3, AB
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

12:00 – 1:00 Lunch


1:00 – 3:00 Technical/ Design 7.5.1, 7.5.2, 7.5.3, 7.5.4, AB
Section 7.5.5, 7.6, 8.2.3, 8.2.4, 8.3,
8.4, 8.5.2, 8.5.3

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Preparing Work Documents

Auditor Toolkit
• Clipboard
• Logbook
• Checklist
• Audit plan
• Report Forms
• ISO 9001:2008 standard

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Sources for the Creation of Checklist

• 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

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Sample Checklist for Auditing Warehouse

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 electrostatic
damage?
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?

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Conducting On-Site Audit

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Audit Communications

• With Auditee
– Opening meeting
– Daily review
– Informal communications
– Closing meeting
• Within Audit team
– Regular communications (normally
each half day)
– Internal meeting

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Opening Meeting

• 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

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What do we Audit Against?

• Conformance to the Documented System /


Quality Manual
• Conformance to ISO 9001:2008
• Effectiveness and appropriateness of system?
• Environment, Health and Safety?
• Company Rules?
?

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Evidence

• 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

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The Audit Triangle

Question
( ask them what they do)

Observe Check
( see what they actually do) ( what the process says
they should do)
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Interviewing Process

• 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

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Interview Technique

• 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 auditee’s office

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Open Questions

• 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

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Probing Questions

• “Follow-up” or “Focusing” questions

• Search for information in greater depth

• Cornerstone of audit techniques

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Closed Questions

• Used to established specific facts


ex. “Do you…?”

• Normally receives a yes / no answer

• Do not use too often

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Counter Productive Questions

• Type of questions to be avoided


• Moves away from purpose of audit
• Examples includes:
– Tricky questions
– Leading questions
– Ambiguous questions ?
– Multiple questions

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Nonconformity

Non-fulfillment of a requirement, e.g.


• Customer requirements
• Statutory and regulatory requirements
• System requirements

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Nonconformity Classification

NONCONFORMANCE (NC):
A nonconformance relates to the absence, or total
failure, of a process to meet the internal requirements
resulting in an actual or potential adverse effect on
customer satisfaction and quality of the product or
service.
A number of lapses against one clause of guidelines
when acting together reduce the effectiveness of a
process to the extent that there are actual adverse
effects on customer satisfaction and product quality
which can represent a nonconformance.

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Nonconformity Classification

OBSERVATION (O):
Single observed lapse or failure to comply with a
requirement of the guidelines or an internal
requirement which however, as based on objective
evidence, does not jeopardize product quality.

HINTS FOR IMPROVEMENT (H):


Findings which is a best practice observed by the
auditor which the organization may or may not
consider them. This practices are sort of
recommendation in improving the quality system of the
organization.
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Nonconformities Must

• 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

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Nonconformity Format

• Clause No.
• Criteria statement
• However…
• Factual description (Audit Evidence)
– When
– Where
– Who
– What

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Generating audit findings / Audit conclusions

NONCONFORMANCE REPORT
Company: XYZ Co. Classification: NC
Area: Warehouse ISO Clause:
Reference:

Detail of Nonconformance:

Auditor:
Corrective Action: Remarks:

By: Verified by:


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Element -Specific Objective Evidences
4 Quality Management System
4.1 General Requirements
– Determination of processes for QMS and their application
throughout the organization,
– Determination of sequence of these processes,
– Determination of criteria and methods for the effectiveness
of these processes,
– Availability of resources,
– Process monitoring, measurement and analysis,
– Actions for continuous improvement,
– Control of outsourced processes as part of QMS.

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4 Quality Management System
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 Quality Management System
4.2 Documentation Requirements
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 Management System
4.2 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 Quality Management System
4.2 Documentation Requirements
4.2.3 Control of documents…cont.
• Identification and controlled distribution of external
documents relevant to QMS;
• Suitable identification of obsolete documents.

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4 Quality Management System
4.2 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 Quality Management System
4.2 Documentation Requirements
4.2.4 Control of records… cont.
Shall remain:
• Legible
• Readily identifiable
• Easily retrievable.

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5 Management Responsibility
5.1 Management Commitment
Evidence of quality system effectiveness and continual
improvement 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 Management Responsibility
5.2 Customer Focus
• Customer requirements determined and met
• Enhancing customer satisfaction.

5.3 Quality Policy


 Commitment to comply w/ requirements and continual
improvement
 Reviewed for continuing suitability
 Framework for establishing/reviewing quality objectives
 Communication and understanding with in the organization.

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5 Management Responsibility
5.4 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 Management Responsibility
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 organization’s own management.
5.5.3 Internal Communication
- Established suitable communication processes within the organization
- Communication on QMS effectiveness.

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5 Management Responsibility
5.6 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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5 Management Responsibility
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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6 Resource Management
6.2 Human Resources
6.2.1 General
Must be competent on the basis of:
- Education
- Training
- Skills
- Experience
- Competence requirements are relevant for any personnel
involved in QMS.

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6 Resource Management
6.2 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 contribution
on the quality objectives achievement;
- Maintain relevant records.

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6 Resource Management
6.3 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.

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7 Product Realization
7.1 Planning of Product Realization
- Planning of the quality objectives and product
requirements including resources;
- Quality planning;
- Project development plans;
- Maintain records.

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7 Product Realization
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 the
products.

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7 Product Realization
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.

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7 Product Realization… cont.
7.2.3 Customer Communication
- Define and implement communication with customers
on:
• Product information
• Inquiries, contracts or order handling including
amendments
• Customer feedback, customer complaints

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7 Product Realization… cont.
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
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7 Product Realization…cont.
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.

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7 Product Realization…cont.
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 input
requirements
- Follow-up action is defined
- Document verification results.

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7 Product Realization
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 Product Realization
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 Realization
7.4 Purchasing
7.4.2 Purchasing information
- Ensure adequacy of the requirements prior to communication to
supplier
- Product approval, procedures, facilities and equipment.

7.4.3 Verification of purchased products


- Supplier verification
- Verification plans
- Incoming inspection

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7 Product Realization
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.

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7 Product Realization
7.5 Production and service provision
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.

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7 Product Realization
7.5 Production and service provision
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 Product Realization
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.

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7 Product Realization
7.5 Production and Service Provision
7.5.5 Preservation of product
 Handling 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
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7 Product Realization
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 & Improvement
8.1 General
- Determination, planning and implementation of measurement,
monitoring, analysis & improvement processes
- Type, location, timing and frequency of measurements
- Periodically review effectiveness of measures
- Use of suitable statistical techniques
- The results of analysis and improvements shall be an input to the
management review
- Determine, establish process for measurement of QMS
performance.

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8 Measurement, Analysis & Improvement
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.

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8 Measurement, Analysis & Improvement
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
- Auditor’s qualification
- Independence
- Record and report findings

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8 Measurement, Analysis & Improvement
8.2 Monitoring and Measurement
8.2.2 Internal Audit…cont.
- Follow-up audit -verify implementation and effectiveness
- Auditor’s 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.

TÜV SÜD PSB Philippines


8 Measurement, Analysis & Improvement
8.2 Monitoring and Measurement
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.

TÜV SÜD PSB Philippines


8 Measurement, Analysis & Improvement
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

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8 Measurement, Analysis & Improvement
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

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8 Measurement, Analysis & Improvement
8.4 Analysis of Data
• 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

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8 Measurement, Analysis & Improvement
8.5 Improvement
8.5.1 Continual Improvement
Continual Improvement through:
- Quality policy
- Quality objectives
- Audit results
- Data analysis
- Corrective and preventive action
- Management review

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8 Measurement, Analysis & Improvement
8.5.2 Corrective action
- 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.

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8 Measurement, Analysis & Improvement
8.5.3 Preventive Action
- 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.

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Discuss and Agree Findings

• 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

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Closing Meeting

• 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

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Preparing Audit Report

• Audit objectives
• Audit Scope
• Audit client
• Audit team and auditee’s 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
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Corrective vs. Preventive Action

Nonconformity Detected NC NOT YET Detected

Eliminate itself Prevent Eliminate cause of


(fixing NC) recurrence Potential NC

CORRECTION CORRECTIVE PREVENTIVE


ACTION ACTION

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Corrective Action Steps

Confirm NC

Identify Root Cause/s

Identify Solution

Propose, review, accept

Implement , close

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Follow –up Action

• Report circulated
• Audit program updated
• Checklist filed
• Corrective action performed
• Trends/findings fed to management review
• Corrective action verified

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Auditor Selection and Evaluation

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Selecting Audit Team Members

• Identify knowledge and skills required based on


audit objectives
• Ensure all necessary knowledge and skills are
present in the audit team
• Ensure impartiality and independence (not audit
own work)
• Experts may be appointed to support
competence

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The “Ideal” Auditor?
• Relaxed and Friendly
• Good Listener/Communicator
• Interested, Objective and
Logical
• Positive attitude and Enquiring
Mind
• Explains the process and
Understand the Technicality.
• Gives good feedback
• Excellent Interpersonal Skills
• Can communicate at all levels
of the organization
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Personal Behavior
• Ethical – fair, truthful, sincere, honest, discreet
• Open minded – willing to consider alternative ideas
• Diplomatic – tactful in dealing with people
• Observant – actively observing surroundings and activities
• Perceptive – aware and able to understand situations
• Versatile – able to readily adapt to situations
• Tenacious – persistent and focused on achieving objectives
• Decisive – able to reach timely logical conclusions
• Self-reliant – able to act and function independently

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Personal Behavior

• Acting with fortitude – able to act responsible and


ethically even though this actions may not always be
popular / may result in disagreement or confrontation
• Open to improvement – willing to learn from
situations and striving for better audit results
• Culturally sensitive – observant and respectful to the
auditee’s culture
• Collaborative – effectively interacting with others
(auditee and audit team)

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Auditor Knowledge
Generic Knowledge
Audit principles, Must know how to collect information, use
procedures and methods work documents to support audit findings
and conclusions, document audit findings,
communicate effectively, etc.

Management System Must be able to audit within the audit scope


requirements and and apply audit criteria using ISO standards,
reference documents procedure manuals, etc.

Organizational context Must understand auditee’s structure, and


business and management practices

Applicable legal, Must know applicable laws and regulations


contractual, and other related to the business
requirements
TÜV SÜD PSB Philippines
Auditor Knowledge

Discipline and Sector Specific Knowledge

Discipline Specific Ex. ISO 9001 requirements, terminologies


Knowledge relating to QMS

Sector Specific Knowledge Ex. Transportation/ Education / Construction


sector – terminologies, processes and
practices

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Achieving Auditor Competence

Education
Auditor’s should have:
Formal education / training
contributing to development of
knowledge and skills in the
management system discipline /
sector that the auditor intends to
audit

TÜV SÜD PSB Philippines


Achieving Auditor Competence
Training
Auditor’s training should cover:
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
TÜV SÜD PSB Philippines
Possible Evaluation Methods
EVALUATION OBJECTIVES EXAMPLES
METHODS
Review of To verify the background of the Analysis of records of
records auditor education, training,
employment and audit
experience
Positive and To provide information about Surveys, questionnaires,
negative feedback how the performance of the personal references,
auditor is perceived testimonials, complaints,
performance evaluation,
peer review
Interview To evaluate personal attributes Face to face and
and communication skills, to telephone interviews
verify information and test
knowledge and to acquire
additional information
TÜV SÜD PSB Philippines
Possible Evaluation Methods

EVALUATION OBJECTIVES EXAMPLES


METHODS
Observation To evaluate personal Role-playing, witnessed audits,
attributes and the ability to on-the-job performance
apply knowledge and skills
Testing To evaluate personal Oral and written exams,
attributes and knowledge psychometric testing
and skills and their
application
Post-audit review To provide information Review of the audit report
where direct observation and discussion with the audit
may not be possible or client, auditee, colleagues and
appropriate with the auditor

TÜV SÜD PSB Philippines


TÜV SÜD 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
For inquiries on Certification, please contact:
MARLON PALISOC – Account Consultant (South Luzon)
THANK YOU
JAMES SABANDAL – Account Consultant (North Luzon)
!!!
MARK KHRIS SANTIAGO – Account Consultant (Metro Manila)
FAITH PEDRIGAL – Account Consultant (Cebu)
ANNA LIZA SAMORRO – Account Consultant (Davao)

For inquiries on Trainings, please contact:


ANN RINGOL – MCS Assistant

TÜV SÜD PSB Philippines