QUALITY SYSTEM
Organizational Structure Procedures,
Processes and Resources needed to
implement Quality Management
ISO 9001 : 2000
WHAT IS IT ? WHAT DOES IT DO ?
A Model for Quality Management Systems
Defines Minimum Requirements for QM Systems
Provides a base line for Assessment and Certification
COMMON SENSE MANAGEMENT
ISO 9001 : 2000 - SCOPE
General
Needs to demonstrate consistency
Aims to enhance Customer Satisfaction
Application
Generic and intended to be applicable to all
Organizations, Type, Size and Product
Requirements that are not applicable can be
considered for exclusion
THE FOUR ABSOLUTES OF
QUALITY
1.
2.
3.
4.
QUALITY IS CONFORMANCE TO REQUIREMENTS
Do What you said you would do
THE SYSTEM FOR PRODUCING QUALITY IS
PREVENTION NOT APPRAISAL
Solve Problems permanently
THE PERFORMANCE STANDARD IS ZERO DEFECTS
Right First Time and Every Time
QUALITY IS MEASURED BY THE COST OF NONCONFORMANCE
Repair / Rework is paid for out of Profits
QUALITY CONTROL
QUALITY ASSURANCE
Quality Control is REACTIVE whereas
Quality Assurance is PROACTIVE
Quality Control deals with DETECTION
Quality Assurance deals with PREVENTION
i.e. All the planned and systematic actions
necessary to prevent problems and ensure
confidence that the product will satisfy the
requirements for quality
QUALITY ASSESSMENT
Comparison of a Quality Management
System with the requirement system with
the requirements of a standard or standards
to determine the degree of compliance with
the specified requirements
QUALITY ASSURANCE
Part of Quality Management, focused on
providing
confidence
that
Quality
requirements will be fulfilled
ISO 9000 : 2000
QUALITY MANAGEMENT
SYSTEMS
Management System to direct and control
an Organization with regard to Quality
ISO 9000 : 2000
QUALITY AUDIT
systematic, independent and documented
process for obtaining audit evidence and
evaluating it objectively to determine the
extent to which the audit criteria are
fulfilled
ISO 19011 : 2002
AUDIT CRITERIA
Set of policies, procedures or requirements
AUDIT EVIDENCE
Records, statements of fact or other
information, which are relevant to the audit
criteria and verifiable
AUDITS
Objectives
Determination of Compliance with specified
Requirements
Identification of Weakness
Management Tool for Improvement
Planned and Independent
Defined Standards and / or Procedures
AUDIT OBJECTIVES
To determine Compliance or NonConformity of the Quality System elements
with specified requirements
To determine the effectiveness of the
implemented Quality System in meeting
Quality objectives
To afford an opportunity to improve the
Quality System
Cont
AUDIT OBJECTIVES
To meet regulatory Requirements
To Permit the listing of the Audited
Organization in the Register of Audited
Companies
AUDITS
1st PARTY
2nd PARTY
3rd PARTY
PRODUCT
SERVICE
QUALITY
INTERNAL
EXTERNAL
EXTRINSIC
PROCESS
SYSTEM
FINANCIAL
ENVIRONMENTAL
AUDITS
1st PARTY
INTERNAL
Required by ISO and Other Standards
Any Trained personnel can be used
Documentation Awareness
Timing / Timescales easily adjusted to suit
individuals
Advice / Assistance with corrective actions
Must not replace responsibility for Quality
AUDITS
2nd PARTY EXTERNAL
Supplier or Sub-Contractor approval
Quality Personnel-Role
Choice of Standards
Timing / Timescales more important
Team Leaders Authority
The power of the contract
AUDITS
3rd PARTY
Totally Independent
International / National Standards
Qualified or Registered Assessors
Timing / Timescales very important
Team Leader only Recommends
EXTRINSIC
CONDUCT OF THE AUDIT
Enter the area
Introductions by guide
Explain what you want to see
Investigate to the depth necessary
No problems found, move on
Dont keep on auditing until problems are
found
SPECIFIED REQUIREMENTS
Customer requirements
Quality system requirements
Manuals
Procedures / work instructions
Quality standard
Legal requirements statutory, regulatory or
industry body
Regulations of registration body
AUDIT PROGRAMME
RESPONSIBILITIES
Those assigned the responsibility for managing the audit
programme should
Establish the objective and extent of the audit
programme
Establish the responsibilities and procedures, and
ensure resources are provided
Ensure the implementation of the audit programme
Ensure that appropriate audit programme records are
maintained, and
Monitor, review and improve the audit programme
AUDIT PROGRAMME
RESOURCES
When identifying resources for the audit
programme, consideration should be given
to
Financial resources necessary to develop,
implement, manage and improve audit
activities
Audit techniques
Cont
AUDIT PROGRAMME
RESOURCES
Process to achieve and maintain the competence of
auditors, and to improve auditor performance
The availability of auditors and technical experts
having competence appropriate to the particular
audit programme objectives
The extent of the audit programme and
Travelling time, accommodation and other
auditing needs
AUDIT PROGRAMME
PROCEDURES
Audit programme procedures should address
the following
Planning and scheduling audits
Assuring the competence of auditors and
audit team leaders
Selecting appropriate audit teams and
assigning their roles and responsibilities
Cont
AUDIT PROGRAMME
PROCEDURES
Conducting audits
Conducting audit follow-up, if applicable
Maintaining audit programme records
Monitoring the performance and
effectiveness of the audit programme
Reporting to top management on the overall
achievements of the audit programme
AUDIT PROGRAMME
IMPLEMENTATION
The implementation of an audit programme should
address the following:
Communicating the audit programme to relevant
parties
Coordinating and scheduling audits and other
activities relevant to the audit programme
Establishing and maintaining a process for the
evaluation of the auditors and their continual
professional development
Cont
AUDIT PROGRAMME
IMPLEMENTATION
Ensuring the selection of audit teams
Providing necessary resources to the audit teams
Ensuring the conduct of audits according to the
audit programme
Ensuring the control of records of the audit activities
Ensuring review and approval of the audit reports,
and ensuring their distribution to the audit client and
other specified parties
Ensuring audit follow-up, if applicable
AUDIT PROGRAMME RECORDS
Records should be maintained to demonstrate the
implementation of the audit programme and
should include the following:
Records related to individual audits, such as
Audit plans
Audit reports
Nonconformity reports
Corrective and preventive action reports, and
Audit follow-up reports, if applicable
Cont
AUDIT PROGRAMME RECORDS
Results of audit programme review
Records related to audit personnel covering
subjects such as
Auditor competence and performance
evaluation
Audit team selection, and
Maintenance and improvement of competence
AUDIT PROGRAMME
MONITORING AND REVIEWING
The audit programme review should consider, for
example
Results and trends from monitoring
Conformity with procedures
Evolving needs and expectations of interested parties
Audit programme records
Alternative or new auditing practices, and
Consistency in performance between audit teams in
similar situations
AUDITOR ATTRIBUTES
Must be proficient in sector
Proficient in auditing Top Management
Proficient in legal requirements
Understand the process
Understand the interaction of process
Team player
Cont
AUDITOR ATTRIBUTES
Local Requirements
Culture
Practices
Approach
Cont
AUDITOR ATTRIBUTES
Auditors must be flexible to Changing situations
Differing Management styles
Differing Management / Employee levels
Auditors must be competent in Reasoning of Non-Conformities
Evaluating effectiveness of corrective action
Cont
AUDITOR ATTRIBUTES
Open minded
Tenacious
Diplomatic
Decisive
Observant
Self reliant
Perceptive
Ethical
AUDITORS RESPONSIBILITIES
Developing the audit schedule
Ensure team is always punctual
The agreed programme is adhered to
Valid restrictions are observed
Team members complete designated tasks
Confidentiality is preserved
Cont
AUDITORS RESPONSIBILITIES
Arguments are avoided
No criticism is levelled at individuals
Chairs all meetings:- opening, review, team
and closing
Summarise findings
Makes recommendation
Files audit report
AUDITOR DUTIES
Support the team leader
Prepare checklist
Arrive on time
Participate at opening meeting
Carry out assigned tasks
AUDITOR DUTIES
Keep to the timetable
Document all findings
Keep auditee informed
Assist team leader with reports
Safeguard all documents
Maintain confidentiality
AUDITOR TRAINING
Auditor Training should consider the following:
Knowledge & Understanding of the standards
used to Audit Quality Systems
Audit Techniques such as Examining,
Questioning, Evaluating and Reporting
Additional skills needed to manage an audit
E.g.: Planning, Organizing, Communicating and
Directing
COMMUNICATION
The imparting, conveying or exchanging of ideas,
knowledge etc. whether by speech, writing or sings.
Ensure that the message given is received. and
understood
Message content
Words spoken
Verbal style and sound
Non-verbal
Facial expression
Body language
OPEN QUESTIONS
Tell me:
Who (does it)
What (is done)
Where (is it done)
Why (is it done)
When (does it get done)
How (is it done; often is it done)
Show me
THE AUDIT CYCLE
PREPARATIONS
Documentation Review
Preliminary visit
Audit Planning
PERFORMANCE
Opening Meeting
Gathering Information
Cont
THE AUDIT CYCLE
Team Meetings
Non-Conformity Reporting
Closing Meeting
FOLLOW-UP ACTIONS
Audit Report
Corrective Action Verification
Surveillance
THE OPENING MEETING
Introductions
Confirm Standard, Scope and Audit Authority
Confirm Audit Plan and Other arrangements
Outline Audit Method
Confirm Guides and their Authority
Confirm Confidentiality
Staff / Employee Issues
Any Relevant Questions
Close Meeting
TEAM MEETINGS
Discuss the Findings of Team
Team Leader Agrefs:
Non-Conformities
Wording
Categorization
Resolve any Issues
Identify any modifications to the programme as a result of the
findings to Date
OBJECTIVE
Ensure that the Team presents a unified
response at the wash-up meeting
WASH-UP MEETINGS
Presentation of findings to Date
Resolution of any issues
Agree Non-Conformity Categorization
Obtain signatures and possible corrective action
completion dates
Monitor Audit Progress
Monitor Auditor / Company interrelationships
Keep everyone informed. No surprises at the
closing meeting
CLOSING MEETING AGENDA
Thank Company and Guides
Confirm Standard and Scope
Disclaimer
Confirm Confidentiality
Define Categories of Non-Conformities
Questions Deferred
Cont
CLOSING MEETING AGENDA
Findings Presented
Team Leaders Summary
Recommendations
Questions Answered
Corrective Action Dates Agreed
Close Meeting
RECOMMENDATIONS
The Companys Quality System:
Meets the Requirements of ISO 9001:2000
Registration to the agreed scope will be recommended
Will meet the requirements of ISO 9001:2000
Registration will be deferred until the completion and
verification of the necessary corrective actions
Does not meet the requirements of ISO 9001: 2000
Registration cannot be recommended
FOLLOW-UP ACTIONS
Deferred Registration
Close out or Down rate all outstanding Major /
Hold point Non-Conformities. Clear as many
Minor / On-Going improvements as possible
Routine Surveillance visits
Re-Registration
AUDIT REPORT
Report Identification
Purpose, Objective and Scope of the Audit
Details of Auditors, Dates etc
Reference documents (e.g. Quality Manual, Procedures)
Summary of Audit Results as declared at the Closing
Meeting
Cont
AUDIT REPORT
Details of all Non-Conformities and Observations
Reference to any additional supporting Evidence
Recommendations
Conclusions
Distribution
NOTE TAKING
Recording the objective evidence:
Admissible statements
Document numbers and issue/revision
levels
Identifiers
Departments
Name of auditee
Cont
NOTE TAKING
Notes could be used as reference for:
Immediate investigation
Investigation later
Use by a colleague
Subsequent audits
Notes must therefore be:
Legible
Retrievable
Cont
NOTE TAKING
Notes taken during an audit are a
record of:
The audit sample taken
What was reported
What was observed
Notes may be referenced by subsequent
auditors
NONCONFORMITY
A situation where there is a likelihood that
nonconforming product or service will
occur, or where the benefits of the
management standard are not being
realized, because of the absence of, or lack
of adherence to a procedure
Cont
NONCONFORMITY
Non fulfillment of a requirement
Specified requirements
conditions of contract
quality standard
quality manual
procedures
legal regulatory requirements
Cont
NONCONFORMITY
Manual is not conforming with the quality
standard
(intent)
Practice is not in line with the intent
(implementation)
Practice is not effective
(effectiveness)
OBJECTIVE EVIDENCE
Data supporting the existence or verity of
something ISO 9000 : 2000
May be obtained through observation,
measurement, test or other means
May be stated or (preferably) documented
Can be verified
ESTABLISH THE FACTS
Get help form the auditee
Discuss concerns
Verify the findings
Record all the evidence:
exact observation
where, what, etc
Establish why a nonconformity or otherwise
State who (if relevant) preferably by job title
Cont
ESTABLISH THE FACTS
Use auditees terminology
Make it retrievable
Make it helpful
Make it concise
CONSIDER THE SERIOUSNESS
Two questions to be answered What could go wrong if the nonconformity
remains uncorrected
What is the likelihood of such a thing going
wrong
THE PURPOSE OF NCRS
To convey your findings to the company in a clear,
concise and accurate way so that they know
exactly what needs to be done
To provide a record that gives an accurate picture
which can subsequently be reviewed remotely
from the company
To ensure that another auditor can follow up the
corrective action on your findings just as easily as
you would yourself
NCR WORDING
Report exactly what you observed
Give a factual report, not a commentary or opinion
Write legibly If you cant then print
Choose your words with care for easy reading
Avoid the use of adjectives and adverbs
Try to use words and phrases taken from the
chosen paragraph of the standard
Cont
NCR WORDING
Choose the requirement paragraph with care as a
guide to corrective action
Establish TRACEABILITY in your report. Be
specific Quote Details
Report accurately But no personal criticism
Be sure that your report is based on
UNSHAKEABLE facts
CERTIFICATION
Audit against the Requirements of ISO 9000 : 2000
by an accredited certification body which approves
then registers or certifies the supplier resulting in:
Issue of a Certificate
Entry in the DTI Register
Use of LOGO on Literature
NOTE
CERTIFICATION BODIES DO NOT ACCREDITATE
SUPPLIERS
ACCREDITATION
The term Accreditation in the context of Quality
Systems is used to denote certification bodies
whos ability to audit against the requirements of
ISO 9000 has been independently audited by a
National Authority using agreed criteria
NOTE
Most people assume Accreditation and
Certification to be the same thing they are not
A SYSTEMATIC APPROACH TO
QUALITY AUDITING
SELECT
(1)
(1) A Process or an
element of Q. system
No
DOCUMENTED?
Repeat
cycle as
necessary
(2) 1st check only
DOCN
No
SATISFACTORY?
(2)
(3) Plus 2nd check
on documentation
PRACTICE
No
SATISFACTORY?
(3)
RAISE
NC FORM
COMPLETE?
Yes
END
NCR CORRECTIVE ACTION CYCLE
NCR IDENTIFIED
3rd PARTY AUDIT
NCR ISSUED
PROBLEM INVESTIGATED
CORRECTIVE ACTION PLANNED
CORRECTIVE ACTION
IMPLEMENTED
CORRECTIVE ACTION
VERIFIED BY AUDIT
NO
YES
NOTIFY
CERTIFICATION BODY
CORRECTIVE ACTION VERIFIED
BY CERTIFICATION BODY
YES
NO
OK
NCR ISSUED
FOR MAJOR NCR CORRECTIVE ACTION WILL BE VERIFIED BY AN
ADDITIONAL FOLLOW UP VISIT.
MINOR NCRs MAY BE VERIFIED AT A SUBSEQUENT SURVEILLANCE VISIT.
NON COMPLIANCE REPORT
NON-COMPLIANCE REPORT
STANDARD :
AREA :
NCR NO. :
NON COMPLIANCE : ( To be filled by Assessor )
PROPOSED CORRECTIVE ACTION : ( To be filled by Assessee )
Assessor
Assessee
MR
Date
MR
Date
IMPLEMENTED CORRECTIVE ACTION :
( To be filled by Assessor )
ROOT CAUSE ANALYSIS :
( To be filled by Assessee )
Assessor
Assessee
FOLLOW UP COMMENTS : ( To be filled by Assessor )
