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Mohamed Ghorab
June 2010
Introduce yourself
Toilets.
Break.
Material provided.
Certification
Inspection & Verification
Outsourcing
In the areas of: Risk Management
Technical Consulting
Testing & Analysis
Trainings ®:
ISO 9000: 2000 Series
Awareness & Internal
Auditor Certification Course
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Course Objectives:
• Continual improvement
• Emphasizing defect prevention and
• The reduction of variation and waste in
the supply chain.
Course Outline:
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Comprises:
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2.0 Fundamentals of
quality management systems
process approach
documentation
Written definitions
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Example definition
Specification:
document (3.7.2) stating requirements (3.1.2)
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ISO 9004
• provides guidance for improvement
• not for implementation of ISO 9001 or
certification/contractual use
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Identification of processes
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A process
Establish objectives
Take actions to continually necessary to deliver
improve process performance – results in accordance
effectiveness and efficiency with customer
Act Plan requirements
• What to do
• How to improve • How to do it
and the organisation's
next time? policies
Check Do
• Do what was
• Did things happen planned
according to plan?
Monitor and measure Implement the
processes and product processes
against policies, objectives
and requirements
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Process approach
Management
Management
responsibility
responsibility
Customers Customers
Requirements Measurement
Measurement Satisfaction
Resource
Resource analysis
management analysisand
and
management improvement
improvement
Input Output
Product
Product Product
realisation
realisation
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6 4 8
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Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to management
Continual Improvement
Factual Approach to decision making
Mutually beneficial supplier relationship
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Process Improvement
(Shewart Cycle)
Plan
• What and why?
Act Plan
Do
• How, when, and how much? Check Do
Check
• How will you know it worked?
Act
• How do you plan to fully adopt?
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Blame someone
else for Make wild guess
catastrophe at what is wrong
ACT
Adopt unproven
process or
technology
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Plan-Do-Check-Act diagram
Requirement
Requirement
Yes
Product /
Plan
Plan Do Check Conforms?
Service
No
Corrective Feedback
Action Loop
Continual Improvement
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Process (7.5)
How?
Control plans (7.5.1) What Results?
Work instructions (7.5.1) Analysis of data (8.4.1)
(Support Processes) Customer satisfaction (8.2.1)
Preventive maintenance (7.5.1)
IT Other Organizational objectives (5.4.1)
SPC (8.1.1)
Human resource Maintenance objectives (7.5.1)
Nonconforming product procedure (8.3)
Logistics Cost of poor quality (5.6.1)
Dispatch process (7.5.1)
Sales Process capability (8.2.3)
Contingency plan (6.3.2)
Quality Management review (5.6.1)
Document control/ records (4.2.3/4)
Preventive maintenance Continual improvement results (8.5) 31
Audit records (8.2.2)
Session 2:
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• Documentation requirements
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Comprises 8 clauses:
Scope
Normative reference
Terms and definitions
Quality management system
Management responsibility
Resource management
Product realization
Measure, analysis and improvement
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generic
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Exclusions:
may be due to:
- nature of the product
- customer requirements
- applicable regulatory requirements
must be justified
may not be requirements which affect the ability
or responsibility to provide product that meets
customer and regulatory requirements
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4
Quality Management System
4.1 4.2
General requirements Documentation requirements
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Mohamed Ghorab
Mohamed.ghorab@sgs.com
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Management commitment
Customer focus
Quality Policy
Planning
Responsibility, authority and communication
Management review
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5
Management responsibility
5.1
Management commitment
5.2
Customer focus
5.3
Quality policy
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5
Management responsibility
5.5
5.4 5.6
Responsibility, authority
Planning Management review
and communication
5.5.1 5.6.1
5.4.1 Responsibility and General
Quality objectives authority
5.5.2 5.6.2
Management Review input
5.4.2 representative
Quality management
system planning 5.6.3
5.5.3 Review output
Internal communication
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Provision of resources
Human resources
Infrastructure
Work environment
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Resource management
6.1 6.2
6.3
Provision of Human
Infrastructure
resources resources
6.2.2
6.2.1
Competence, awareness
General
and training
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Session 4:
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Product realization
7.1 7.2
Planning of Customer–related
Product realization processes
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7.4 Purchasing
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7.5.1
Control of production and service provision
7.5.2
Validation of processes for production
and service provision
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General
Monitoring and measurement
Control on nonconforming product
Analysis of data
Continual improvement
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8.1 General
8.2.1
Customer satisfaction
8.2.2
Internal audit
8.2.3
Monitoring and measurement of processes
8.2.4
Monitoring and measurement of product
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8.5 Improvement
8.5.1
Continual improvement
8.5.2
Corrective action
8.5.3
Preventive action
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Mohamed Ghorab
Mohamed.ghorab@sgs.com
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Session 5:
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ISO 19011
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Quality Environment
Generic
system Knowledge System
knowledge knowledge
Personnel attributes
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Personnel Attributes
Ethical: Fair, truthful, sincere, honest, discreet
Open minded: Willing to consider other points of view
Diplomatic: Tactful in dealing with people
Observant: Actively aware of physical surroundings and
activities
Perceptive: Instinctively aware of and able to understand
situations
Versatile: Adjusts readily to different situations
Tenacious: Persistent, focused on achieving objectives
Decisive: Reaches timely conclusions based upon logical
reasoning and analysis
Self – reliant: Acts and functions independently while
interacting effectively with others
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Education
Training in ISO 9001: 2008
Work Experience
Quality management experience
Demonstrated ability to apply knowledge and
skills
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S O
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U 3rd p 3rd p R U
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P A S
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2nd p
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Phases of an audit
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Conformity:
Fulfillment of requirement
Nonconformity:
Non fulfillment of a requirement
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Reporting Findings
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THANKS
Mohamed Ghorab
Mohamed.ghorab@sgs.com
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