Internal Quality Auditing

to
IQA TO ISO 9000:2000

ISO 9000:2000

Pakistan Institute of Quality Control

 CONTENTS
IQA TO ISO 9000:2000

AUDITING ISO 9000:2000

1 ISO 9000 New Family of Standards

2 What’s New in ISO 9000:2000 (Outline)
3 ISO 9001:2000 New/Modified Requirements
4 Audit Terms and Definitions
5 Principles of Auditing
6 Competence of Auditors
7 Managing an Audit Program
 1
IQA TO ISO 9000:2000

ISO 9000 NEW FAMILY OF

STANDARDS
ISO 9000:2000 Family of
Standards

• CORE STANDARDS
– ISO 9000:2000 Fundamentals and Vocabulary
– ISO 9001:2000 QMS Requirements
– ISO 9004:2000 Guidelines for Performance Improvement

• SUPPORTING STANDARDS
– ISO 10005:1995 Guidelines for Quality Plans
– ISO 10006:1997 Guidelines for Project Management
– ISO 10007:1995 Guidelines for Configuration Mgt
– ISO 10011-1, -2, -3 on Auditing
– ISO 10012-1 & -2, Quality Assurance for Measuring
Eqpt.
– ISO 10013:1995 Guidelines for Quality manuals
– ISO/TR 10014:1998 Guidelines for managing economics
of quality
– ISO 10015 Guidelines for Training
– ISO/TR 10017:1999 Guidelines on Statistical techniques
 2
IQA TO ISO 9000:2000

WHAT’S NEW IN

ISO 9000:2000
Compared to ISO
9000:1994
ISO 9000:2000 vs 9000:1994

• Cancels and replaces second edition of 1994

• revised title which no more uses the term QA, instead
just QMS (QA + Customer Satisfaction)
• Released on 15 Dec 2000
• up-graded in contents, effectiveness, and logical
implementation
• 9000- and 9004- series guidelines eliminated and 9004
to serve as a general purpose guidelines
• Many guidelines available in the form of TR (Technical
Reports)
• compatibility with ISO 14001
• Scope (modified):
• to demonstrate its ability to provide
consistently product that meets customer
and applicable regulatory requirements, and
• to address customer satisfaction through
the effective application of the system,
including processes for continual
improvement and the prevention of
nonconformity
• ISO 9001, 9002, & 9003 merged into a
single 9001:2000
• ISO 8402 and ISO 9000-1 merged into a
new ISO 9000:2000
• ISO 10011 will be merged with ISO 14010
into a new ISO 19001 Quality &
Environmental Auditing
• 3 years for co-existence
What’s New?

1. The Standard
2. The Structure
3. The Definitions
4. The Emphasis
5. The Requirements
6. The Flexibility
7. The Approach
1. New Standard
• ISO 9002 and 9003 dropped
• ISO 9001 modified

2. New Structure
• 20 clauses abandoned
• Now 5 sections
3. New Definitions
• Supplier: Vendors, subcontractors, etc.
• Organization: The company implementing QMS
• Product Realization: The interconnected processes
that are used to bring products into being. When you start
out with an idea and end up with a product, you’ve gone
through the process of product realization

4. New Emphasis
• Customer Focused
• Continual Improvement
• Integration of Processes with the QMS
5. New Requirements
1. Communication with customers
2. Identify customer needs and expectations
3. Meet customer needs and expectations
4. Measure and monitor customer needs and expectations
5. Meet legal and regulatory requirements
6. Internal Communication
7. Provide necessary facilities and work environment
8. Evaluate the effectiveness of training
9. Measure and monitor realization processes
10.Evaluate the effectiveness and suitability of quality system
11.Identify QMS improvements
12.Improve QMS regularly
6. New Flexibility
1. Permissible Exclusions from Section 7 if
a. it doesn’t apply
b. customer’s requirements make it reasonable to exclude
c. regulatory requirements make it reasonable to exclude

However, no part can be excluded, if doing so will undermine the

organization’s abilities or performance
7. New Approach
PROCESS APPROACH TO QMS
QMS can now be considered as a single large process with many sub-
processes. Each of these sub-processes uses inputs and outputs.
These are:
1. Resource Management Process 10. Internal Communication Process
2. Regulatory Research Process 11. Document Control
Process
3. Market Research Process 12. Record Keeping Process
4. Product Design Process 13. Planning Process
5. Purchasing Process 14. Training Process
6. Service Process 15. Internal Audit Process
7. Product Protection Process 16. Management Review Process
8. Customer Needs Assessment Process 17. Measurement Processes
9. Customer Communication Process 18. Nonconformance Mgt
19. Continual Improvement P.
 3
IQA TO ISO 9000:2000

ISO 9001:2000

NEW/MODIFIED
REQUIREMENTS
Process Approach Model

CONTINUAL IMPROVEMENT OF THE

QUALITY MANAGEMENT SYSTEM

C R
e Management C S
a
U q
responsibility U
t
i
u
S i
S s
r Measurement, f
T e Resource
analysis and T a
c
O m management improvement
e O t
i
M n
t M o
Input
E s Product Output
E
n

R realization Product
R
Contents

1 Scope 1.1 General

1.2 Application

2 Normative Reference

3 Terms and Definitions

Contents (cont.)

4 Quality Management
System 4.1 General Requirements
4.2 Documentation Requirements

5 Management 5.1 Management Commitment

Responsibility 5.2 Customer focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management Review

6 Resource Management 6.1 Provision of resources

6.2 Human resources
6.3 Infrastructure
6.4 Work environment

7 Product Realization 7.1 Planning of product realization

7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring devices
Contents (cont.)

8 Measurement, Analysis
and Improvement 8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
1. Scope (applicability)
1.1 General

• Product meets customer and applicable regulatory

requirements

• to enhance customer satisfaction, including continual

improvement of the system and assurance of conformity to
customer and applicable regulatory requirements
1.2 Application

• Generic requirements; applicable

to all organizations, regardless of
type, size and product provided

• exclusion can be considered if

certain requirements not applicable

• Exclusion only allowed from

Clause 7
2. Normative Reference

• ISO 9000:2000 Fundamentals and vocabulary

(ISO 8402 is now obsolete)
Terms and definitions

• As given in ISO 9000

• Product also means services
• supply chain
supplier
organization
customer
4.1 Quality Management
System

INTEGRATION?
4.1 Quality Management System

Fully
Integrated!
4.2 Documentation
Requirements
4.2.1 General
• Documented statements of a
quality policy and quality
objectives
• a quality manual
• documented procedures required
by ISO 9000:2000
• documents needed by the
organization to ensure the
effective planning, operation and
control of its processes, and
• quality records required by this
standard
Documentation Structure
(Example)

What How

Applicable Dept A Relevant

QUALITY Clauses Procedures Records
MANUAL
(SUMMARY) Applicable Dept B Relevant
Clauses Procedures Records

Applicable Dept C Relevant

Clauses Procedures Records
Applicable Dept D Relevant
Clauses Procedures Records

Applicable Dept E Relevant

Clauses Procedures Records

Supporting Documents
e.g. standards, Manuals, GMP’s
Exercise

• What are the applicable Quality Processes

(sections/sub-sections) in Production Dept.?

• What are the applicable Quality Processes

(sections/sub-sections) in Purchasing Dept.?
5.2 Customer Focus
• Top management shall ensure
that customer requirements are
determined and fulfilled with the
aim of enhancing customer
satisfaction (7.2.1 and 8.2.1)
Examples
• Customer needs
identification
procedure?
(e.g. surveys, focus
groups, contracts)
• Top management
verification (through
1st, 2nd, 3rd party
tests etc., that such
requirements are
fulfilled
5.3 Quality Policy
What broad Quality aspects
Top management shall ensure that the should be Covered in the
quality policy: Quality Policy?
• is appropriate to the purpose of the
organization 1. Fulfillment of Customer
needs
• includes a commitment to comply with
2. Fulfillment of applicable
the requirements and continually national laws and
improve the effectiveness of the QMS regulations
• provides a framework for establishing 3. Minimization of
and reviewing quality objectives waste,errors and
• communicated and understood in the nonconforming
organization 4. Continual improvement
• is reviewed for continuing suitability 5. Employees quality and
organizational culture
5.4 Planning
• Quality Objectives: • What does Quality
– are established at relevant functions objectives for each
and levels, and are measurable and function means?
consistent with the quality policy
• What does Quality
• QMS Planning: objectives for each
– Each applicable process/dept. is level means?
addressed under the PDCA model;
– planning at changes is carried out
5.5 Responsibility, Authority and Communication
• Responsibility and Authority: Examples
– defined and communicated within • Job Descriptions
the organization • QMR’s clear role
• Management Representative:
appoint a QMS Coordination role to a
management member
– ensure QMS is established,
implemented and maintained
– report the performance and the
need for improvement
– promote awareness
– liaison with external parties
• Internal Communication: Examples
ensure effective communication • Team briefing and
regarding the effectiveness of the meetings
QMS • notice boards
• newsletter
• intranet
• employees surveys
 5.6 Management Review

INPUTS
QUALITY
PROCESS OUTPUTS
QUALITY REPORT
covering Improvements in QM
•Audit results
•Customer feedback Management Improvements in
•process performance Reviews
•product conformity Products/Processes
•C/P Action
•follow-ups Resource Needs
•changes / follow-ups
•recommendations
for improvements
6.2 Human Resources

6.2.1 General

Right person for the right job

qualified managers? Qualified /

qualified supervisors? Appropriate means
appropriate workers? 1. Education
2. Training
3. Skills
4. Experience
6.3 Infrastructure
• Provide necessary infrastructure Examples
for the QA program, e.g. • suitable machines,
workspaces,
software, hardware,
– building, workspace, utilities
information
– process equipment (hardware/
software)
– supporting services, e.g. transport,
communication,
6.4 Work Environment
• The organization shall determine Examples
and manage the work
environment needed to achieve • work space
conformity to product • heat, humidity, light
airflow,
requirements
• hygiene, cleanliness,
noise, vibration and
pollution, etc.
7. Product Realization

7.1
7.6 Planning 7.2
Monitoring & Customer
Measuring Related
Devices PRODUCTProcesses

7.5 REALIZATION
7.3
Production &
Design &
Service
Development
Provision 7.4
Purchasing
7.1 Planning of Product
Realization

• Quality objectives and • Product Quality

requirements for the product Plans?
• Guidance ISO 10005
• establish processes, documents,
and provide resources specific to
the product
• required verification, validation,
monitoring, inspection and test
activities specific to the product
and the criteria for product
acceptance
• identification of relevant records
7.2 Customer-related Processes

7.2.1 Determination of requirements related to the Product

• Determine: Examples
– customer’s requirements • contracts
– unstated but necessary requirements • customer surveys,
– statutory and regulatory product req’t focus groups
– • applicable national
any additional requirement
determined by the organization regulations
7.2 Customer-related Processes

7.2.2 Review of requirements related to the Product

Examples
• • Contract review
review contract before acceptance
• review of results of
• ensure product reqts are defined surveys and focus
• resolve issues before acceptance groups, etc.
• confirm organization capability
• maintain records
• ensure amendments properly
7.2 Customer-related Processes

7.2.3 Customer Communication

• Make effective arrangements for Examples
communicating with customers in • printing of product
relation to: information on
packaging
– product information
• internet
– inquiries, contracts or order handling,
• catalogs and service
including amendments, and
manuals, etc.
– customer feedback, including
customer complaints
7.3 Design and Development

Design Review

Customer
Regulatory
Professional Inputs Review Designing Output
Reqts.

Verification

Validation
7.4 Purchasing

Pu
ss
ce

rch
o
Pr

asi
ng
ing

In
as

for
ch

ma
PUR CH ASI NG
r
Pu

tio
n
Verification of
Purchased Product
7.5 Production and Service
Provision

7.5.1
Control of 7.5.4
Production & Customer
Service Property 7.5.6
Provision 7.5.3
Control of
Identification
Monitoring and
and
Measuring
Traceability 7.5.5
7.5.2 Devices
Preservation
Validation of of Product
Processes
8. Measurement, Analysis and
Improvement

8.1 8.4
General Analysis of
Data
8.3
Control of
non-conforming
product
8.2 8.5
Monitoring & Improvement
Measurement
8 Measurement, Analysis and
Improvement
8.1 General
• Ensure conformity of the product
• ensure conformity of the QMS
• ensure effectiveness and
continually improving the QMS
• This section is about
Quality Control (QC)
• Conformity to customer
needs, contracts, and
national regulation must
be ensured before
product is dispatched
• Validation of measuring
procedures
• Regularly up-grade
accuracy and
effectiveness of QC
8 Measurement, Analysis and
Improvement

8.2 Monitoring and Measurement Examples of CS:

• Direct interfaces
• Customer Satisfaction
• focus groups
– device a method to measure and
monitor customer satisfaction from • surveys
customer perception point of view • sector and industry
studies
• Internal Audit Examples of IA:
– regularly carry out internal audit to • Main objective is to
check conformity and check the correctness
effectiveness of the QMS and performance of
– design an effective audit program functions and
and plan, criteria processes; not
– competent auditors documentation of
– audit results and records processes
– follow-ups and timely C/A
8 Measurement, Analysis and
Improvement

8.2 Monitoring and Measurement

Examples
• Processes • use of SPC,
– apply suitable monitoring of especially control
processes where required charts
– C/A when deviation occurs • monitoring and
supervision of
process parameters
• Products • daily morning reviews
– measure product characteristics to of quality by workers
confirm fulfillment of quality and their supervisors
– at appropriate stages in accordance • Appropriate product
with the quality plans measurement scheme
– define acceptance criteria
– authorize release and records
8 Measurement, Analysis and
Improvement
8.4 Analysis of Data
• Determine, collect and analyze
appropriate data from
measurement sources to check
conformance and analysis for
improvement in:
– customer satisfaction
– product conformance
– process
– suppliers
• Analysis is not
compiling of data
• Analysis is after
compiling of quality
data
• Analysis is part of
Quality Report
• Sources of data?
8 Measurement, Analysis and
Improvement

8.5 Improvement
• Continual Improvement • Clear evidence of
– identify opportunities of improvement improvement
from quality policy, objectives, audit processes
results, analysis of data, C/P actions, • Clear evidence of
and management reviews improvements
– mobilize improvement programs
8 Measurement, Analysis and
Improvement

8.5 Improvement
• Corrective Action • What is the
– take timely action to eliminate the difference between
cause of nonconformities. Correction,
Corrective Action
– Review nonconformities
and Preventive
– determine causes Action?
– evaluate • Corrective Action
– determine and implement action Form
– records of results • Control of Corrective
– review and confirm results Actions
8 Measurement, Analysis and
Improvement

8.5 Improvement
• Preventive Action • Outputs of
– determine potential nonconformities management
current mistakes and future planning reviews or corrective
actions
– determine their causes
– device actions
– implement actions
– record results
– review action taken
 4
IQA TO ISO 9000:2000

Audit Terms and

Definitions

Ref: ISO/CD.3 19011

• Audit: systematic, independent and documented
process for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit
criteria are fulfilled

• Audit Criteria: set of policies, procedures or

requirements used as a reference

• Audit Evidence: records, statements of fact or

other information, relevant to the audit criteria and
which are verifiable (can be quantitative or qualitative)
• Audit Finding(s): result(s) of the evaluation of
the collected audit evidence against audit criteria

• Audit Conclusion(s): outcome of an audit,

reached by the audit team after consideration of the
audit objectives and all audit findings

• Auditee: organization being audited

• Auditor: person with the competence to conduct

an audit
• Audit Team: one or more auditors conducting an
audit (one being appointed as audit team leader)

• Technical Expert: person who provides specific

knowledge or expertise with respect to the subject
to be audited

• Audit Program: set of one or more audits

planned for a specific time frame and directed
toward a specific purpose
• Audit Plan: description of the on-site activities
and arrangements for an audit

• Audit Scope: extent and boundaries of an audit

(typically includes a description of physical
locations, organizational units, activities and
processes, as well as the time period covered

• Competence: demonstrated capability to apply

knowledge and skills
 5
IQA TO ISO 9000:2000

Principles of Auditing

Ref: ISO/CD.3 19011

 Five Principles of Auditing

Ethical Conduct
1
Trust, integrity,
the foundation of professionalism confidentiality, discretion

Fair Presentation
2
the obligation to report truthfully and accurately
Accurate and complete

Due Professional Care

3 Priorities of stakeholders
application of reasonable care in auditing
necessary competence

Independence
4 Free from bias and
impartiality and objectivity of the audit conclusion
conflict of interest

Evidence
5 Proper sampling
the rational basis for reaching audit conclusions
verifiable
 6
IQA TO ISO 9000:2000

Competence of Auditors

Ref: ISO/CD.3 19011

Elements of Competence

Work
Personal
Experience
Attributes

Auditor
Training

Audit
Education Experience
• There should be an evaluation process that should
first be used for initial evaluation of a person who
wishes to become an auditor
• Even in case where he/she doesn’t, the
development process of an auditor should be
clearly defined to ensure a sound and professional
function in the organization
• Providing competent auditors is only the first step
towards ensuring the reliability of the audit process
General Guidelines

• EDUCATION: minimum high school, preferably

graduation
• TOTAL WORK EXPERIENCE: minimum 5 years
• TOTAL QUALITY EXPERIENCE: at least 2 years
from the 5 years general
• AUDITOR TRAINING: two days for internal auditor,
5 days (Lead Auditor) for the External Auditors
• AUDIT EXPERIENCE: 4 complete audits or 20
days of audit
Auditor’s Personal Attributes

• Mature
• unbiased and fair
• ethical
• open minded
• diplomatic
• observant
• decisive
• self-reliant
 7
IQA TO ISO 9000:2000

Managing An Audit
Program
What is being Audited ?

Product Processes

Machinery
? People

Facilities Procedures
Why an organization is being
audited?

•
•
•
it is an ISO 9000’s requirement
independent review
check and balance is a human nature
?
• people tend to forget and/or neglect
• a sort of an external and internal
pressures to run systems
• or special needs
•Any audit will have the objectives to
review the intent, efficiency and
effectiveness of the system
How the extent of an audit
vary?

Large Textile Automobile Dental Clinic

Spinning Plant 3 person
1000 persons 400 person Many Complex
4 processes 3 5 processes Treatment
Processes
•Scope ?
•Objective?
•Duration?
•Expertise?
•Frequency of Audit?
•Complexity of Product and Processes?
•Legal Requirements?
•Standards?
•Audit Criteria?
•Social Environment?
•Educational Environment?
What resources are required to
audit?
Large Textile Automobile Dental Clinic
Spinning Plant 3 person
1000 persons 400 person Many Complex
4 processes 3 5 processes Treatment
Processes

•Number of Auditor(s)?
•Competence of Auditor(s)?
•Technical Expertise?
•Duration?
•Administration?
•Documentation?
•Stationary?
Can you identify company’s
Product /services?

• Shoe company
• Pharmacy
• Hospital
• Airline
• University
• Primary School
• Insurance Company
What does it mean to Audit a
Process Model ?

• to audit every process

• to audit departments in a certain sequence
• to audit people in a certain sequence
• to audit QMS in a certain sequence and logic
Discussion Exercise - Process
Model

• You are auditing a purchase dept. that buys

material for the company. How would you apply the
QMS Process Model on the activities of the
department? Identify the sequence of your check
points / from the requirements of ISO 9000:2000.
Audit Process

1
• Definition of scope, objective and
Initiating the Audit criteria
• Establish audit team and contacts

2
• Review the documents of the QMS and
Document Review establish their completeness and correct
ness (relevance to their processes)

3
Site Audit • Planning
• Team assignments
Preparation
• Preparing working documents
.
Audit Process (cont.)

4 Site Audit
• Opening Meeting
• Verification Process (collecting and
verifying information), audit findings,
. communicating findings, closing meeting.

5
• audit report preparation
Audit Reporting • report review, approval and distribution
• retention of documents

6
• confirmation of completion as per the
Audit Completion
audit plan

7
• Verification of Corrective, Preventive
Audit Follow-up
and/or Improvement Action
Key Points of the Audit Process

• Audit Objectives, scope, and criteria

– to be defined by the auditee
– Objectives: compliance to all applicable ISO 9001 QMS
requirements, legal obligations (illegality) for product
conformity, contractual obligations to clients, and
consumer protection (in general)
– scope: boundaries of audit, I.e. location, organizational
units, activities and processes to be audited
– criteria: applicable policies, procedures, standards, laws,
QMS requirements, contractual requirements, industry
codes,
Audit Team’s Requirement

• GENERAL
– independence, process familiarity, mature personality,
good communicator and analyzer, motivated, physically fit,
socially disciplined, free from conflict of interest, honest,
capable to write objective audit findings/reports, not
submissive, and interactive

• APPROPRIATE COMPETENCE
– relevant technical expertise or take assistance of technical
experts with appropriate technical knowledge, skills and
experience.
Auditee’s Right on acceptability
of Auditors

• Both the audit client and auditee have a right to

request the replacement of particular team
members on reasonable grounds, which should be
communicated to those responsible for managing
the audit program.
• Examples of reasonable grounds can be conflict of
interest situation (formal employees, consultant),
unethical behavior, lacking appropriate professional
background of the audit team, non-professional
behavior (e.g. violating confidentiality), etc.
Document Review

• A necessary step before site audit

• Should be reviewed in light of audit objectives,
scope and criteria
• A preliminary on-site visit may be necessary to be
able to carry out the document review
• Document Review should be done very carefully,
and is most effectively done with the support of
relevant records.
Planning for On-Site Audit

• Parameters of plan: auditor(s), departments /

sections, time (usually hours), applicable QMS
processes (clauses), applicable criteria (standards,
legal, contractual, etc.), locations / sites, logistics,
language limitations, technical expertise (doctors,
computer specialists, pharmacists, architecture,
etc.)
Working Documents

• Audit procedure
• audit checklist(s)
• sampling plan
• forms / papers for recording information and
supporting evidence
• NCR forms
On-Site Activities

• Opening Meeting
• Investigation
– Observation
– Interviews
– confirmations
– Communication
• Audit Findings
• Closing Meeting
Opening Meeting

• Establish an Audit Environment and

Communication links with the management
• Inform about the audit plan and methodology
• confirm the audit criteria (contractual, legal,
industrial, and company’s obligations and
standards)
• confirm the sampling plan (number of samples to
be used in the width and depth of audit)
• confirmation of relevant work safety, emergency
and security procedures for the audit team
Investigation

• Main objectives:
– what are the contractual and legal requirements
– Does the company products meets the contractual and
legal requirements
– Is consistency ensured in the standards
– Are company policies and procedures followed as a
routine activity
– Is the company following the standards and procedures
genuinely
– Is there any serious discrepancy between what is
produced and the test results
(cont.)

• Interviews:
– relevant people must be interviewed directly at all levels
– auditor should go to the relevant people to interview; they
should not be called to answer the auditor
– tone must be respectful and genuine
– objective of interview must be clarified to the interviewee
– Types of questions: Open-ended, Closed-ended, Leading-
questions, Personal -questions, Interrogative-questions,
taunting-questions. Certain types must be avoided.
– The results from the interview should be summarized and
reviewed with the interviewed person
– End must be with thanks
Exercise

• Break the group into teams

• Suppose you are auditing the (activity to be given
by the course facilitator)
• Prepare an audit program keeping in view the
requirement of relevant sections of the ISO-9001-
2000 and the objectives of the audit (intent,
efficiency and effectiveness)
• Present in the plenary session

(A)
(cont.)

• Observations and Confirmations

– actual products
– actual processes (operators, skill levels, equipment,
material)
– actual operators
– actual environment
– actual records
– external documents (customers’, vendors’, legal, and
referenced standards)
– computerized data bases
– effectiveness of procedures

(B)
Audit Findings

• Auditors should review all facts and the overall

situation
• Conformities should be summarized to at least
indicate locations, functions, processes, or
requirements that were audited, where no
nonconformities were observed
• Nonconformities should be recorded and supported
by audit evidence. It should be reviewed by the
auditee to ensure accuracy and understanding.
• Difference of opinions should be resolved before
finalizing
Nonconformity Statement -
a critical output of an Auditor

• Few auditors write accurate, clear, and complete

statements of non-conformity
• Example of a good non-conformity statement

“One of the voltmeters, number 389000, used for

the testing of generators at the final test bench of
the main assembly shop was not calibrated, as
required by the Quality Procedure No.
QSP4.11/2000. All test equipment which affect
product quality shall be calibrated to ensure
accuracy of results”
(cont.)

• Poor way of writing NC statements:

Rewrite the statements as audit findings and

discuss in the plenary session:
– quality objectives were not defined
– test equipment was not calibrated
– there were no training programs
– identifications were missing
– the procedure for SPC was wrong
(cont.)

• Statements blaming to wrong people !

“An operator was repairing the machine with wrong

method”
OR
“The operator was not properly trained to repair the
machines”

who is to be blamed in the same incident above?

Preparing for the Closing
Meeting

• Review the overall audit findings

• Prepare the list of audit findings
• reach consensus on the audit conclusions
• agree on the roles and tasks for the closing
meetings (for more than one auditors)
• prepare recommendations
• discuss subsequent audit follow-up
Closing Meeting

• Present overall conclusion and findings. Address

your summary of Conformity and Non-conformity,
both.
• Present non-conformities in order of priority (from
more important findings to less important)
• Provide direction to management on Corrective,
Preventive and Improvement actions. It is auditee's
responsibility to identify C/A or P/A; however they
normally do not understand the difference.
• Confirm follow-up audit
Auditor-Auditee Roles
AUDITOR

Audit Approve Verify

Audit Report C/A
C/A
AUDITEE

Identify
Rootcause & Take
C/A Improve-
Suggest
ment
C/A
Audit Report

• Should provide a complete, accurate, concise and

clear record of the audit and should contain audit
conclusions on the following issues:
– extent of conformance of the management system to the
audit criteria
– effective implementation and maintenance of the
management system, and
– the ability of management review process to ensure the
continuing suitability, adequacy, and effectiveness of the
management system
Contents of Audit Report

• The second/third party reports are formal, whereas,

first party audit can be less comprehensive and
may include just nonconformance reporting.
Audit Follow-up

• Focus should be on whether the auditee has gone

into the root cause of the nonconformance, and
whether solution provided by the auditee eliminate
the root cause(s)
• Auditee tend to neglect timely corrective actions.
Therefore, auditor should ensure timely corrective
actions. Appropriate time should be ensured, as
most often daily or weekly solutions are projected
into monthly tasks.
• Just recorded answers to solutions are not
sufficient. Physical verification of effectiveness of
the solution is necessary
Audit Completion

• An audit is completed when all activities in the audit

plan have been finalized and the approved audit
report has been distributed
Normal Problems in Audits

• Lack of Product Orientation

• Lack of Process Orientation
• Non-technical audits in technical areas
• Incomplete audits
– depth
– width
Final Words ...

• Audits driven by professional programs can be highly

valuable in improving the Quality of organizations. On
the other hand, if conducted unprofessionally, the same
can be damaging
• Auditors and audit programs should also be subject to
checking and improvements
• Progressive development of auditors is generally
neglected, resulting in poor value
• Technical competence and personal attributes are both
important parts of the auditors
• Announced audits can be mixed with unannounced ones
IQA TO ISO 9000:2000

THE END