Transcript No Slide Title

Quality: The Basic Tool Kit
ASQ Section 1213 and Calumet College of St. Joseph
Quality Management Standards:
ISO 9001 and ISO/TS 16949
Presented by
Chuck Richardson
Performance Quality Systems, Inc.
502-491-0313
[email protected]
www.performancequalitysystems.com
January 21, 2011
Session topics
• Background of ISO 9001 and ISO/TS 16949
• The registration process and growth
• Quality management principles
• Steps to meeting the requirements
• Internal auditing
• Quality management system requirements
2
What is ISO?
• It’s the International Organization for
Standardization.
• An organization based in Geneva, Switzerland
with representation from 163 countries.
• ISO develops many standards most of which are
very specific to a product or process.
• ISO is not an acronym. "ISO", derived from the
Greek isos, meaning "equal".
3
What is ISO 9001 and its purpose?
• It’s an quality management standard embraced
by about 1 million organizations worldwide.
• It is probably the best known ISO standard.
• Its purpose is to define good business practices
so an organization can:
– Consistently meets customer requirements.
– Continually improves its operations & customer
satisfaction.
4
History of ISO 9001
• During World War II, manufacturing problems in Britain
led to development of BS 5750, a standard for
managing manufacturing processes.
• With BS 5750 as its foundation, ISO 9001 was first
published in 1987.
• Revised in 1994, 2000, and amended in 2008.
• Since 1987, manufacturers have taken the lead in
applying ISO 9001, but many service businesses and
government agencies and have also implemented ISO
9001 based management systems.
• The year 2000 revision shifted the emphasis from
documentation to planning, performance, and
improvement.
5
ISO/TS 16949
• Issued in 1999, revised in 2002 and 2009
• Developed by the International Automotive Task
Force (IATF) with support form ISO/TC 176
– IATF members include: BMW, Daimler AG, Chrysler,
Fiat, Ford, GM, PSA Puegeot-Citroen, Renault SA, and
Volkswagen
• Includes all the ISO 9001 requirements plus
additions required by the automotive industry
• Replaced QS-9000 in 2006
6
Applicability
• ISO 9001 applies to any operation seeking to
consistently meet customer requirements and
enhance customer satisfaction.
• ISO/TS 16949 applies only to sites where
automotive-related production and/or service parts
are manufactured.(includes assembly, welding,
heat treating, plating, painting, or other finishing
services)
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What is certification?
What is registration?
According to the International Organization for Standardization (ISO):
• “Certification” refers to the issuing of written assurance (the
certificate) by an independent external body that it has audited a
management system and verified that it conforms to the requirements
specified in the standard.
• “Registration” means that the auditing body then records the
certification in its client register. So, the organization’s management
system has been both certified and registered.
• Therefore, in the ISO 9001 context, the difference between the two
terms is not significant and both are acceptable for general use.
“Certification” is the term most widely used worldwide, although
registration is often preferred in North America, and the two are used
interchangeably.
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The registration process
ISO 9001
Accreditation Bodies
(ANAB, RvA, etc.)
Certification Bodies
(Registrars)
Auditors
ISO/TS 16949
International Automotive
Task Force
International Automotive
Oversight Bureau (IAOB)
Certification Bodies
(Registrars)
Auditors
Organization seeking
registration
Organization seeking
registration
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Growth in worldwide certifications
8% increase
Source: ISO Survey of Certifications 2009
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Top five industrial sectors for ISO 9001
certificates 2009
1
2
3
4
5
Construction
Basic metal & fabricated metal
products
Electrical and optical
equipment
Machinery and equipment
116672
107253
Wholesale & retail trade;
repairs of motor vehicles,
motorcycles & personal &
household goods
63015
Source: ISO Survey of Certifications 2009
85357
63523
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If aggregated services is the number one
industrial sector with 302,108 certificates
• Services includes:
•
•
•
•
•
•
•
•
•
•
Publishing companies
Printing companies
Electricity supply
Gas supply
Water supply
Wholesale & retail trade;
repairs of motor vehicles,
motorcycles & personal &
household goods
Hotels and restaurants
Transport, storage and
communication
Financial intermediation,
real estate, rental
Information technology
• Wholesale & retail trade;
repairs of motor vehicles,
motorcycles & personal &
household goods
• Hotels and restaurants
• Transport, storage and
communication
• Financial intermediation, real
estate, rental
• Information technology
• Other Services
• Engineering Services
• Education
• Public administration
• Health and social work
• Other social services
Source: ISO Survey of Certifications 2009
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Quality management principles
• Customer focus
• Continual
improvement
• Leadership
• Involvement of
• Factual approach to
decision making
people
• Process approach
• Mutually beneficial
supplier relationships
• System approach to
management
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Where to begin?
Commit to continual improvement
“Ongoing activity to increase the ability to fulfill requirements.”
• True commitment to continual improvement
should lead to:
– Planning of processes so problems are prevented.
– Planning of new jobs so problems are prevented.
– Effective corrective action so problems are
solved, and don’t keep happening.
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Identify your business processes
Process: “Set of interrelated or interacting activities
which transforms inputs into outputs”
Customer
Inquiry
Customer
receives the
product
Examples include: Estimating, Human Resources, Project
Planning, Purchasing, Product Design, Production,
Warehousing, Shipping, Installation, Servicing
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What are your processes?
Customer
Inquiry
Customer
receives the
product
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Take the Plan-Do-Check-Act approach
• Plan: “Establish the objectives and processes necessary
to deliver results in accordance with customer
requirements and the organization's policies.”
• Do: “Implement the processes.”
• Check: “Monitor and measure processes and product
against policies, objectives and requirements for the
product and report the results.”
• Act: “Take actions to continually improve process
performance.”
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Plan and implement what
is needed for each process
Procedure
(Specified way to carry out an
activity or a process – may be
documented or not)
Input
Examples include:
•Materials
•Products
•Information
•Equipment
•Resources
Process
Output
(Set of interrelated or
interacting activities)
Monitoring & Measurement
opportunities
(Before, during, and after the
process)
Examples include:
•Materials
•Products
•Information
•Equipment
•Resources
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Manage processes
effectively, typically this means:
• There is a process owner.
• The process is defined.
• The process is documented as appropriate.
• Process linkages (or handoffs) of the
process are established.
• The process is monitored, analyzed, and
improved.
• Records are maintained.
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How can you measure
or monitor your processes?
Process
Method of
Monitoring
Process
Method of
Monitoring
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Train and empower
your internal auditors
• An audit is a systematic, independent, and
documented process to evaluate the extent to which
policies, procedures, or requirements are fulfilled.
• An excellent tool for evaluating your quality
management system’s implementation and
effectiveness.
• Auditors must be trained and have the qualities to
be successful auditors.
–
–
–
–
–
Desire
Able to “Think on your feet”
Good communication skills (speaking and listening)
Observant
Able to analyze and assess situations
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ISO 9001 & ISO/TS 16949 requirements
• Quality management system
– Quality manual
– Control of documents
– Control of quality records
• Management Responsibility
– Management commitment
– Quality policy
– Customer focus
– Management review
• Resource management
– Human resources
– Infrastructure
– Work environment
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ISO 9001 & ISO/TS 16949 requirements
(continued)
• Product realization
– Customer related processes
• Measurement, analysis
and improvement
– Design & development
– Customer satisfaction
– Purchasing
– Internal audit
– Production and service
provision
– Monitoring and measuring
product & processes
– Control of monitoring and
measuring devices
– Control of nonconforming
product
– Analysis of data
– Continual improvement
– Corrective action
– Preventive action
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Continual improvement of the
quality management system
Management
responsibility
Customer
Customer
Act
Plan
Measurement,
analysis, &
improvement
Resource
management
Satisfaction
Check
Do
Product
realization
Requirements
Value adding activities
Product
Output
Information flow
Model of a process-based quality management system
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ISO/TS 16949 additions
• Has the goals of defect prevention, reduction in
variation, and waste
• Expanded training requirements
– Process for motivating employees and measuring
awareness of impact on quality
• Expanded quality planning requirements
– Core tools: APQP, PPAP, FMEA, SPC, MSA
• The only exclusion is product design, not
manufacturing process design
• Supplier development requirements
• Requires evaluating manufacturing process capability
• Requires use of error-proofing methods
25
Quality planning tools
ISO/TS 16949
Core Tools
APQP/
Automotive
FMEA
SPC
MSA
PPAP
• APQP – Advanced Product Quality Planning
• PPAP – Production Part Approval Process
• FMEA – Failure Mode and Effects Analysis
• SPC – Statistical Process Control
• MSA – Measurement Systems Analysis
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ISO/TS 16949 additions
continued
• Must be understood in light of additional documents
• ISO/TS 16949 Automotive Certification Scheme-Rules
for Achieving IATF Recognition
• Customer specific requirements (CSR)
• Companies must demonstrate readiness for the
registration audit by presenting data
• 12 months of audit results, management review
results, and performance data
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