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QUALITY POLICY

“We measure our worth by the satisfaction of the customers we serve”


Through:
Strategic Decisions
Effectiveness
Responsiveness
Value Adding
Integrity
Citizen Focus
Efficiency

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Auditing Objectives, Principles, and
Concepts

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Objectives:
To determine whether
1. The QMS conforms to the planned
arrangements, requirements of ISO
9001:2008 and to the established
quality management system; and
2. The QMS is effectively implemented
and maintained.
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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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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
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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

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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
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Possible Evaluation Methods
EVALUATION OBJECTIVES EXAMPLES
METHODS
Review of To verify the background of Analysis of records of
records the auditor education, training,
employment and audit
experience
Positive and To provide information about Surveys, questionnaires,
negative how the performance of the personal references,
feedback auditor is perceived testimonials,
complaints,
performance
evaluation, peer review
Interview To evaluate personal Face to face and
attributes and communication telephone interviews
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skills, to verify information
Possible Evaluation Methods

EVALUATION OBJECTIVES EXAMPLES


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

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