Internal Quality Audit For ISO 9001 - 2008
Internal Quality Audit For ISO 9001 - 2008
Internal Quality Audit For ISO 9001 - 2008
• To understand:
Purpose, benefits and typical structure of a
Quality Management System (QMS)
Plan-Do-Check Act (PDCA) methodology,
and the process approach to Quality
Management
The 8 principles of Quality Management and
how they relate to the QMS and ISO 9001
Purpose, scope and uses of the ISO 9000
series standards
Auditing Process
Roles, responsibilities and competence
requirements of auditors and lead auditors
with reference to ISO 19011
Agenda
1. Purpose and structure of
o a QMS, PDCA
o and the 8 principles of quality management
2. ISOM 9001 Explored & Understood
3. Internal Quality Audit Steps
4. Auditor’s Skills & Responsibility
4
Course assessment
• Continual assessment
You will be informed of progress as we go
The exam
• Exam Pass Criteria
70% pass mark
Open book
• Ask questions
It’s your tutors job to make problems go away
Session 1
Non-fulfillment of a
requirement
What is Correction, and C & P Actions?
Correction:
Action to eliminate a detected
nonconformity
Corrective Action:
Action to eliminate the cause of a detected
nonconformity
Preventive Action:
Action to eliminate the cause of a potential
nonconformity or other undesirable
potential situation
What is Ident., Trac. And Status?
Identification:
To describe product/ raw material/ semi finish
product etc. Example Batch #, Lot #, Code etc
Traceability:
Ability to trace the history, application or location of
that which is under consideration
Status:
To identify the current status of product/ raw material with regard
to inspection and test results. Tag/ sticker of HOLD, REWORK,
SCRAP Identified areas.
Types of Audits
• First-party
• Second-party
• Third-party
The purpose of an audit is ...
AUDIT FINDINGS
Major Minor
AUDIT CONCLUSION
RECOMMENDATION
FOR AUDIT
Audit Methods & Techniques
FORWARD TRACE
RECEIVE
INSPECT STORES
GOODS
BACKWARDS TRACE
What is ISO 9000:2008 QMS?
ISO 9000
ISO 9001
ISO 9004
ISO/DIS 19011
clause 4
CUSTOMER SATISFACTION
info. flow management
management
responsibility
responsibility
clause 5
clause 6 clause 8
resource
resource meas,
meas,analysis
analysis info. flow
management
management improvement
improvement
clause 7
Input product
product Output
realization product
product
value adding realization value
activities adding activities
Clauses/Requirements
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to Management
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships
1. Customer Focus
CUSTOMER SATISFACTION
Know their current and future needs
Meet their requirements
Exceed their expectations
Get their feedback
2. Leadership
management
management
• Leaders create common purpose responsibility
responsibility
Order Product
“Turtle” Approach
?WITH WHAT ?WITH WHO
Materials /(
)Equipment Competence / Skills /(
)Training
PROCESS
OUTPUTS
INPUTS
?HOW ?OBJECTIVES/MEASURES
Support Processes,( )Performance Indicators(
)Procedures & Methods
Example: Management, Responsibility
inputs
Internal audits Management
Customer satisfaction responsibility & outputs
trends objective Annual plan
Process/Product setting Improvement objectives
measures
Faults/Complaints data
how
measures support Implementation plan
Results vs plan
Customer surveys
processes Resource allocation
Roles & responsibilities
Milestones IT systems
Communications
Purchasing
HR, Training
5. System Approach to Management
Continual
Continual Improvement
Improvement of
of the
the QMS
QMS
management
management
responsibility
responsibility
Plan Act
resource
resource meas.,
meas.,analysis
analysis
management
management improvement
improvement
Do Check
product
product
realization
realization
7. Factual Approach to Decision-
Making
• Effective decisions are based on the
analysis of data and information
CUSTOMER REQUIREMENTS
CUSTOMER SATISFACTION
info. flow management
management
responsibility
responsibility
meas.,
meas.,analysis
analysis info. flow
improvement
improvement
product
product
realization
realization
8. Mutually Beneficial Supplier Relationship
• Interrelated
• Win-Win
product
product
Supplier realization
realization
Session 2
• Human Resources
Ensuring adequacy particularly in respect of training
• Infrastructure
Buildings, work space, equipment, vehicles, information
systems etc
• Environmental controls (Aligned with ISO14000)
Heat, light, humidity, temperature, clean rooms
In fact any controls that are applicable
7: Product Realisation
Initiation
Preparation
Evaluation
Reporting
Fixing
Internal Quality Audit Steps
• Considerations
• Approvals
Exercise: Auditing the Training Activity
Initiation
STEPS RESPONSIBILITY
Preparation 4. Select Audit Team Lead Auditor
5. Understand Org. Audit Team
6. Review Documentation Audit Team
7. Plan the Audit Lead Auditor
8. Prepare Checklist &
Working Papers Audit Team
Audit Team
review
initiation
documents
get plan
approvals audit
Exercise: Review Documentation
Initiation
Preparation
STEPS RESPONSIBILITY
9. Conduct Opening Meeting Lead Auditor
Evaluation 10. Meet with Management Audit Team
11. Interview & Observe Audit Team
12. Assess Evidence Audit Team
An auditor’s memory is
.as sharp as his pencil
Focus of the Audit
Checklists
Audit Questions
Audit Investigation
Audit Findings
Checklists
Checklists plan
the flow of
questions
Checklists
Checklists
guide the course
of the audit
Checklists
Checklists
define
the sample
Checklists
Checklists
help in writing
the report
Checklist should …
What am I
Documents
?looking for
• Informal briefings
• Opportunity to share
information
• Discuss necessary
adjustments to plan
• Develop report
• Helps keep communication
lines open among audit team
members
Opening Meeting
• Conduct before start of field activities
• Audit team members must be present
• Auditee contacts should be present
• Creates an atmosphere of cooperation
between auditors and auditee
Opening Meeting
• Sign-in sheet
• Distribute detailed audit schedule
• Address any auditee scheduling
concerns
• Revise schedule, if necessary
Daily Auditee Briefing
• Asking questions
• Observing activities
• Examining documents & records
• Examining facilities
Observing Activities
Confirm that
procedures are being
followed
??how
how
Observing Activities
Look for
undocumented
activities
??what
what
Observing Activities
Confirm answers
??who
who
Observing Activities
• Auditee Reactions
Take over conversations
Play “show & tell”
Blame someone
Act defensively
Waste time
Interrupt
Provoke
Bribe!
Interviewing
Interviewing
• Introduce yourself
• Explain why you are there
• Investigate to depth
necessary
• Ask, Listen, Verify
• Interview the right people
Those responsible for the
activity
Those doing the activity
• Hearsay is not evidence
Interviewing
• Interview for:
elaboration
corroboration
perspective
basis for evidence
Interviewing
• Two eyes
• Two ears
• One mouth
• Ratio of use:
One of speaking
to four receiving
Interviewing
why
why
when
when
what
what how
how
who
who where
where
When Something Seems Wrong
When Something Seems Wrong
• Is it really wrong?
• Does he know it is wrong?
• What is his explanation?
• Is it an isolated event, or a
symptom of a deeper problem?
• Why didn’t quality system detect
it?
• What lapse in the quality system
allows this to happen?
Nonconformity
Nonconformity refers to a
failure to meet a specified
requirement:
Quality Manual Policies
Procedures
ISO 9001:2000 req.
Government Regulations
or more of processes can be improved 90%
by modifying organizational systems
a management responsibility) rather)
than attempting to modify an
.individual employee’s performance
W. Edwards Deming
What if nothing seems to be wrong?
• No problems …
don’t panic
• Move on
• Don’t keep looking
for something wrong
ROLE PLAY:
Initiation
Preparation
Evaluation
STEPS RESPONSIBILITY
13. Write Nonconformities Audit Team
Reporting 14. Conduct Closing Meeting Audit Team
15. Write a Summary Report Lead Auditor
Do I have a Nonconformity?
YES
if you have objective evidence that:
• A requirement is not addressed
• Practice differs from defined system
• System is not effective
Major or Minor Nonconformity
• Major
System element is missing
System element is not implemented
System element is not effective
• Minor
A single/isolated lapse in the system
EXERCISE: Nonconformity or Not
• Informal setting
• Report the results to management
• Agree on follow-up
• Entertain questions
Agenda of Closing Meeting
Initiation
Preparation
Evaluation
Reporting
STEPS RESPONSIBILITY
Fixing 16. Take Corrective Actions Auditee
17. Verify Corrective Actions Audit Team
Follow-Up Flowchart
Identify
Identify Agree
Agreeononneed
need
NC,
NC,issue
issueNCR
NCR for
forCA,
CA,sign
signitit
Propose
ProposeCACA
??Agree
Agree plan
plan
not OK
OK
Verify
VerifyCACA Implement
Implement
&&
CA
CA
Close
CloseNCRNCR
Session 4
• Communicating
• Planning and executing
• Documenting
• Reporting
• Verifying
• Safeguarding
• Cooperating
Auditor’s Qualifications
• Education
• Training
• Experience
• Personal Attributes
• Management Skills
Auditor Skills
• Communication skills
• Interpersonal skills
• Analytic skills
Auditor Ethics
• Acts as a consultant
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