Académique Documents
Professionnel Documents
Culture Documents
House Rules
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Delegate Introductions
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Course Objectives
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Course Overview
Tutorial
Group Work
Presentation
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Course Outline
I.
II.
III.
IV.
V.
VI.
VII.
Introduction to Auditing
ISO 19011:2011 Updates
Audit Objectives, Principles, and Concepts
Audit Planning
Conducting On-site Audit
Audit Reporting
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
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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
Organization
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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Offers of advice
Usually expected
Audit Style
Much formal
Opening meeting
Optional
Required
Closing meeting
Optional
Required
Auditee Reaction
Depends on culture
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Topic
Changes
Principles of auditing
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Topic
Changes
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DETAILS
Integrity
Foundation of professionalism:
Honesty, diligence, responsibility,
demonstration of competence,
impartiality
Fair presentation
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DETAILS
Due professional
care
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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DETAILS
Independence
Evidencebased
approach
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Competence
and evaluation
of auditors
Performing an
audit
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CONDUCTING
AUDIT FOLLOW-UP (6.7)
Verification of effectiveness of
corrective action
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Audit Planning
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Auditors Responsibilities
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Auditors Responsibilities
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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
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Control of documents
Control of records
Internal audit
Control of nonconforming
product
Corrective action
Preventive action
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Time
Organizational
unit/Location
01/12/12
Process/Event/
Element
Auditors
Conference Room
9:30 10:30
Facility Tour
10:30 12:00
12:00 1:00
Lunch
1:00 3:00
Technical/ Design
Section
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Opening Meeting
AB
AB
AB
AB
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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
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Evidence
?
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Observe
Check
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Interviewing Process
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Interview Technique
?
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Open Questions
Encourage Auditee to talk freely
ex. set the scene
Use what, where, why, who, when & how?
?
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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
?
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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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NONCONFORMANCE REPORT
Company:
Area:
Reference:
XYZ Co.
Warehouse
Classification:
ISO Clause:
NC
Detail of Nonconformance:
Auditor:
Corrective Action:
Remarks:
By:
Verified by:
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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 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 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
- Ensure customer satisfaction.
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improvement
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
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Product information
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7 Product Realizationcont.
7.3.3 Design and Development Outputs
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7 Product Realizationcont.
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
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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.
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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
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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
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7 Product Realization
7.6 Control of monitoring & measuring equipment
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Customer satisfaction/dissatisfaction
Conformity of product requirements
Process and product characteristics
Suppliers
- Quality policy
- Quality objectives
- Audit results
- Data analysis
- Corrective and preventive action
- Management review
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Closing Meeting
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Audit Reporting
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Audit objectives
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
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Nonconformity Detected
Eliminate itself
(fixing NC)
CORRECTION
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Prevent
recurrence
CORRECTIVE
ACTION
PREVENTIVE
ACTION
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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Personal Behavior
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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
auditees culture
Collaborative effectively interacting with others
(auditee and audit team)
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Auditor Knowledge
Generic Knowledge
Audit principles,
procedures and methods
Management System
requirements and
reference documents
Organizational context
Applicable legal,
contractual, and other
requirements
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Auditor Knowledge
Discipline and Sector Specific Knowledge
Discipline Specific
Knowledge
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Education
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EVALUATION
METHODS
Review of
records
OBJECTIVES
EXAMPLES
Analysis of records of
education, training,
employment and audit
experience
Positive and
negative
feedback
Interview
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Testing
OBJECTIVES
EXAMPLES
To evaluate personal
attributes and the ability to
apply knowledge and skills
Role-playing, witnessed
audits, on-the-job performance
To evaluate personal
attributes and knowledge
and skills and their
application
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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)
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