Professional Documents
Culture Documents
Internal Audit
Internal Audit
Internal Audit
INTERNAL AUDIT
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What is Quality ??
Fitness for use
Conformance to requirements
Accuracy
Perfection
Zero Defect
Adequacy
Cost Effectiveness
NEEDS “
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Quality
Best-in-Class Quality
World-Class Company
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ISO International Organization for Standardization
"ISO", derived from the Greek. ISO, meaning "equal". Whatever the
ISO 9001:2000
ISO - International Organization for Standardization
EXPECTED PLANNED
QUALITY QUALITY
by the Customer by the Company
PERCEIVED PRODUCED
QUALITY QUALITY
by the Customer by the Company
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The 8 principles of QMS …
• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Decisions based on facts
• Relationship with suppliers mutually beneficiary
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The 8 principles of QMS …
Customer Focus
Customer satisfaction
Principle 1
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The 8 principles of QMS …
Leadership
Principle 2
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The 8 principles of QMS …
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The 8 principles of QMS …
Involvement of people
Must encourage the involvement of people at
all level
Principle 3
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The 8 principles of QMS …
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The 8 principles of QMS …
Process Approach
Control
Principle 4
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The 8 principles of QMS …
Process A Process C
Process B Process D
Input
Output
Control
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The 8 principles of QMS …
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The 8 principles of QMS …
Principle 5
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The 8 principles of QMS …
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The 8 principles of QMS …
Continual Improvement
Customer Focus
Deming’s
wheel PLAN DO
(P.D.C.A.)
CHECK Continual
ACT Improvement
ISO
Principle 6 9000
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The 8 principles of QMS …
Principle 7
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The 8 principles of QMS …
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The 8 principles of QMS …
Principle 8
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The 8 principles of QMS …
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ISO 9000:2000 Family
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ISO 9000:2000 Support Documents
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The ISO 9000:2000 requirements
Five Operating Elements
4- QUALITY MANAGEMENT SYSTEMS
(QMS, documentation requirements)
5- MANAGEMENT RESPONSIBILITY
(Management commitment, Customer focus, Quality Policy, Planning,
Responsibility, Authority and Communication, Management Review)
6- RESOURCE MANAGEMENT
(Provision of Resources, Human Resources, Infrastructure, Work
Environment)
7- PRODUCT REALIZATION
(Planning, Customer Related Processes, Design and Development),
Purchasing, Service Provision, Control of Measuring Devices)
8- MEASUREMENT, ANALYSIS AND IMPROVEMENT
(Monitoring and Measurement, Control of Non-conforming Product,
Analysis of Data, Improvement)
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The ISO 9000:2000 requirements
Continual improvement of the
Quality Management System
Management
Responsibility
Satisfaction
CUSTOMERS
CUSTOMERS
Measurement,
Resource
Analysis and
Management
Improvement
Requirements
Product /
Input Output Product
Service
Data Data Service
Realization
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QUALITY MANAGEMENT SYSTEM
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QUALITY MANAGEMENT SYSTEM
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QUALITY MANAGEMENT SYSTEM
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QUALITY MANAGEMENT SYSTEM
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QUALITY MANAGEMENT SYSTEM
4.2.1 General
Basis of Auditing ( Auditor may look for )
Availability of
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QUALITY MANAGEMENT SYSTEM
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QUALITY MANAGEMENT SYSTEM
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MANAGEMENT RESPONSIBILITY
5 . Management Responsibility
5.1 Management 5.5 Responsibility , authority
commitment and communication
5.5.1 Responsibility , authority
5.2 Customer focus
5.5.2 Management
representative
5.3 Quality policy 5.5.3 Internal communication
5.4 Planning
5.6 Management review
5.4.1 Quality objectives
5.6.1General
5.4.2 QMS planning
5.6.2 Review input
5.6.3 Review output
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MANAGEMENT RESPONSIBILITY
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MANAGEMENT RESPONSIBILITY
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MANAGEMENT RESPONSIBILITY
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MANAGEMENT RESPONSIBILITY
• Organizational chart
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MANAGEMENT RESPONSIBILITY
Ensuring that processes needed for the QMS are established , implemented and
maintained
Note : Responsibility may include liaison with external parties in relation to QMS
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MANAGEMENT RESPONSIBILITY
within the organization , and that communication takes place regarding the
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MANAGEMENT RESPONSIBILITY
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MANAGEMENT RESPONSIBILITY
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MANAGEMENT RESPONSIBILITY
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QUALITY MANAGEMENT SYSTEM
Availability of
6. RESOURCE MANAGEMENT
6.1 Provision of resource
6.2 Human resource
6.2.1 General
6.2.2 Competence , awareness and training
6.3 Infrastructure
6.4 Work environment
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RESOURCE MANAGEMENT
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RESOURCE MANAGEMENT
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RESOURCE MANAGEMENT
Competence needed
Skill gap analysis
Identification of training needs
Provision of training
Evaluation of training effectiveness
Job descriptions
Related records
Employee’s awareness about relevance and importance of their work
Analyses of labor turnover or staff absenteeism
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RESOURCE MANAGEMENT
6.3 Infrastructure
The organization shall Identify ,provide & maintain the
infrastructure needed to achieve product conformity .
Infrastructure includes as applicable
Building ,workspace & associated utilities
Process equipments (hardware & software )
Supporting services ( Transport , communication )
7 Product Realization
7.4 Purchasing
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PRODUCT REALIZATION
Customer inquiries
Orders
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Records on discussion with customers
PRODUCT REALIZATION
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PRODUCT REALIZATION
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PRODUCT REALIZATION
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PRODUCT REALIZATION
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PRODUCT REALIZATION
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PRODUCT REALIZATION
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PRODUCT REALIZATION
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PRODUCT REALIZATION
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PRODUCT REALIZATION
Drawing
Quality Plans
Test records
Validation approval
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PRODUCT REALIZATION
7.4 Purchasing
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PRODUCT REALIZATION
7.4 Purchasing
7.4.1 Purchasing process
Ensure that purchased product meets requirements
Evaluate and selects suppliers based on their ability to
supply conforming product
Establish criteria for selection , evaluation and re-
evaluation of suppliers
Results of evaluation and any necessary actions must be
recorded
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PRODUCT REALIZATION
7.4 Purchasing
7.4.2 Purchasing information
Purchasing information must describe the product to be
purchased including where appropriate :
* requirements for approval of product , procedures
processes and equipment
* requirements for qualification of personnel
* quality management system requirements
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PRODUCT REALIZATION
7.4 Purchasing
Basis of Auditing ( Auditor may look for )
Purchase specification
Evaluation Criteria
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PRODUCT REALIZATION
7.4 Purchasing
7.4.3 Verification of Purchased product
Establish & implement inspection or other activities
needed to ensure purchased product conformity
Verification plan
Acceptance criteria
Test records of suppliers
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PRODUCT REALIZATION
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PRODUCT REALIZATION
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PRODUCT REALIZATION
Maintenance schedule
Service Contracts
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PRODUCT REALIZATION
Product identification
Routing tag
segregation slips
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PRODUCT REALIZATION
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PRODUCT REALIZATION
Inventory list
Dispatch methods
regulation on packing , storage , preservation and delivery
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PRODUCT REALIZATION
Identification of Equipments
Calibration standards and Records
Acceptance Criteria
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Calibration instruction
PRODUCT REALIZATION
Identification of Equipments
Calibration standards and Records
Acceptance Criteria
Calibration instruction 85
MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
Audit reports
Nonconformity report
Corrective actions 90
MEASUREMENT , ANALYSIS AND IMPROVEMENT
Process parameters
Statistical Techniques
KPI / Performance indicators
Are the KPI in line with functional objectives 91
MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
identified
Inspection reports
authorities
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
product is detected
repair
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
- Customer satisfaction
- Suppliers
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
SPC
Benchmarking
Quality Circles
Risk Assessment
Teamwork for Quali
Quality Function Deployme
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
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MEASUREMENT , ANALYSIS AND IMPROVEMENT
Complaints analysis
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QMS DOCUMENTATION
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QMS DOCUMENTATION
Quality Manual
Quality Manual: Document specifying the QMS of an
organization
Documented Procedure
Documented Procedure : Specified way to carry out an activity
or process
Record
Record : Document stating result achieved or providing
evidence of activities performance
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QMS DOCUMENTATION
Document
Document : Information and its supporting medium
Documentation can be in any format or medium
Document provides guidelines
Information Medium
- Procedure Paper
- Specification Electronic
- Drawing Photographic
- Standard Magnetic
Examples Examples
- Procedure for production - Production Report
planning - Inspection Results
- Drawing
- Part Quality Standard
- Work Instruction for
Printing
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QMS DOCUMENTATION
WHY
Define WHAT will be
Stated Once done
Policy ,
Manual
WHO
WHEN
Procedures
WHERE
HOW Work Instructions
Or
Practices
Evidence
Records
Or
Proof
Documentation Pyramid
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What is Audit
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Audit Definition
Audit :
Systematic , documented verification process
of objectively obtaining and evaluating
evidence to determine whether specified
activities , events , conditions , management
systems or information about these matters
conform with audit criteria , and
communicating these results of this process
to the client
Audit Evidence :
A statement of facts or other information relevant
to audit criteria
- based on actual observation
- uninfluenced by emotion
- stated or documented
- verifiable 112
INTERNAL AUDIT
Definitions
Auditee :
Organization to be audited
Auditor :
A person qualified to perform audits
Lead Auditor :
A person qualified to manage and perform audits
Audit Scope :
Audit scope provides the extend and boundaries of
the audit
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Audit criteria
Audit Criteria :
Policies , practices , procedures or requirements
against which the auditor compares the collected
evidence about the subject matter
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Audit Objectives
Objectives of the audit are
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Audit Process
Audits are expensive
Audits must be well managed
Audits must not be carried out by surprise
Always agree mutually convenient dates well in
advance
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Audit Process
Audit Plan Preparation
Conduct Audit
Report preparation
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Audit Checklist
Audit checklists are used during the audit to collect the
information / evidence / notes
Benefits
To assist memory
Maintains continuity during the audit
To ensure depth & continuity of the audit
Help in time management
Part of audit report
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Time Management
Fact Finding
Audit Reporting
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Time Management
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Fact Finding
Collect Evidence
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Fact Finding
- Observations
- Reading
- Communication
- Interviews
- Listening
- Use of check lists
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Communication Skills
How do we communicate ?
- Verbal
- Using Body Language
- Through Facial Expressions
- Using different styles and sounds
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Physical Factors
Environment Factors
Intellectual Factors
Emotional Factors
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Communication barriers
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Communication - Interviewing
Hold interviews only during normal working
hours
Put the auditee at ease
Communicate the objective of the interview
Show an interest in what THEY do
Always start with open ended questions
Verify the facts and records is as finding
Avoid arguments
Explain your observations
Thank the auditee for participation and
opportunity for auditing
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Argumentative Inflexible
Opinionated Lazy
Over conclusive Impractical
Inconsistent Know it all
Inconsiderate Indecisive
Untrained Uncommunicative
Accepts things at Unprofessional
face value
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Auditor’s Qualities
Auditor must be a good listener . Listen and Listen
with full attention
Listen without your own judgment and conclusion
Do not start teaching
Active listening always assist auditee to give more
information
Generate questions from what auditee says – this
possible only when auditor listens carefully
Auditors should be situation manager
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Sampling
No time to check everything
Select representative sample
No sampling calculation
Sample should represent all activities
Should be on random basis
Spot checking
Take permission before asking / taking samples
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Observations
Keep observing the physical evidence
Non conformity
Non Conformity
- Non fulfillment of a requirement
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Timely Reporting
Report without delay
Don’t leave writing report till late
Time never becomes available
Prepare NCR’s on the spot
Timely reporting adds value
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G.M.Pens International Pvt Ltd
Non conformance
Signature of Auditee Signature of Auditor
Agreed corrective action Responsibility
Details
Corrective action
Preventive action
Responsibility Target Date
Verification of Corrective Action ( Follow up Audit)
details
Verification Audit
Signature of Auditee Signature of Auditor( followup audit)
Verified Corrective Actions is Effective / Not Effective
Details
NCR Closed Yes / No
Report Status
To be discussed in management review Yes / No
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Signature
INTERNAL AUDIT
Situation 1
The auditor enters the manufacturing area & identifies lots of filled
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Situation 2
new source.
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Situation 3
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Situation 4
When asked, the stores in-charge said that these are meant
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Thank You
sivasankaran2001@yahoo.com
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