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Using ISO 19011:2011 Guidelines
Resource Speaker: Mr. Edison Yap Pike
TV SD PSB Philippines
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)
3.0 Terms and definitions
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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)
3.0 Terms and definitions
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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.
3.0 Terms and definitions
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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
3.0 Terms and definitions
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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
3.0 Terms and definitions
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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
3.0 Terms and definitions
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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
3.0 Terms and definitions
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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
4.0 Principles of Auditing
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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
4.0 Principles of Auditing
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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 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.
4 Quality Management System
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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.
4 Quality Management System
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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;
4 Quality Management System
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4 Quality Management System
4.2 Documentation Requirements
4.2.3 Control of documentscont.
Identification and controlled distribution of external
documents relevant to QMS;
Suitable identification of obsolete documents.
4 Quality Management System
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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.
4 Quality Management System
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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.
5 Management Responsibility
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5 Management Responsibility
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.
5 Management Responsibility
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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 continualimprovement
Reviewed for continuing suitability
Framework for establishing/reviewing quality objectives
Communication and understanding with in the organization.
5 Management Responsibility
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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
5 Management Responsibility
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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 organizations own management.
5.5.3 Internal Communication- Established suitable communication processes within the organization
- Communication on QMS effectiveness.
5 Management Responsibility
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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.
5 Management Responsibility
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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.
6 Resource Management
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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.
6 Resource Management
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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.
6 Resource Management
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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.
7 Product Realization
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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 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.
7 Product Realization7 5 P d ti d i i i
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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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7.5 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
8 Measurement, Analysis & Improvement8 2 Monitoring and Measurement
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8.2 Monitoring and Measurement
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.
8 Measurement, Analysis & Improvement8 2 Monitoring and Measurement
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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.
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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p
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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p pp g
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
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