Quality: The Basic Tool Kit Quality: The Basic Tool Kit ASQ Section 1213 and Calumet College of St. ASQ Section 1213 and Calumet College of St.

JosephJoseph

Presented by Presented by Chuck RichardsonChuck Richardson

Performance Quality Systems, Inc.Performance Quality Systems, Inc.502-491-0313502-491-0313

chuck@performancequalitysystems.comchuck@performancequalitysystems.comwww.performancequalitysystems.comwww.performancequalitysystems.com

January 21, 2011January 21, 2011

Quality Management Quality Management Standards:Standards:

ISO 9001 and ISO/TS 16949 ISO 9001 and ISO/TS 16949

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Session topicsSession topics• Background of ISO 9001 and ISO/TS 16949Background of ISO 9001 and ISO/TS 16949• The registration process and growthThe registration process and growth• Quality management principlesQuality management principles• Steps to meeting the requirementsSteps to meeting the requirements• Internal auditingInternal auditing• Quality management system requirements Quality management system requirements

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What is ISO?What is ISO?• It’s the International Organization for It’s the International Organization for

Standardization.Standardization.• An organization based in Geneva, An organization based in Geneva,

Switzerland with representation from 163 Switzerland with representation from 163 countries.countries.

• ISO develops many standards most of which ISO develops many standards most of which are very specific to a product or process.are very specific to a product or process.

• ISO is not an acronym. "ISO", derived from ISO is not an acronym. "ISO", derived from the Greek the Greek isosisos, meaning "equal"., meaning "equal".

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What is ISO 9001 and its What is ISO 9001 and its purpose?purpose?

• It’s an quality management standard It’s an quality management standard embraced by about 1 million organizations embraced by about 1 million organizations worldwide. worldwide.

• It is probably the best known ISO standard. It is probably the best known ISO standard. • Its purpose is to define good business Its purpose is to define good business

practices so an organization can:practices so an organization can:– Consistently meets customer requirements. Consistently meets customer requirements. – Continually improves its operations & customer Continually improves its operations & customer

satisfaction.satisfaction.

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History of ISO History of ISO 90019001

• During World War II, manufacturing problems in During World War II, manufacturing problems in Britain led to development of BS 5750, a standard Britain led to development of BS 5750, a standard for managing manufacturing processes. for managing manufacturing processes.

• With BS 5750 as its foundation, ISO 9001 was first With BS 5750 as its foundation, ISO 9001 was first published in 1987.published in 1987.

• Revised in 1994, 2000, and amended in 2008.Revised in 1994, 2000, and amended in 2008.• Since 1987, manufacturers have taken the lead in Since 1987, manufacturers have taken the lead in

applying ISO 9001, but many service businesses applying ISO 9001, but many service businesses and government agencies and have also and government agencies and have also implemented ISO 9001 based management implemented ISO 9001 based management systems.systems.

• The year 2000 revision shifted the emphasis from The year 2000 revision shifted the emphasis from documentation to planning, performance, and documentation to planning, performance, and improvement.improvement.

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ISO/TS 16949ISO/TS 16949• Issued in 1999, revised in 2002 and 2009Issued in 1999, revised in 2002 and 2009• Developed by the International Automotive Developed by the International Automotive

Task Force (IATF) with support form ISO/TC Task Force (IATF) with support form ISO/TC 176 176 – IATF members include: BMW, Daimler AG, IATF members include: BMW, Daimler AG,

Chrysler, Fiat, Ford, GM, PSA Puegeot-Citroen, Chrysler, Fiat, Ford, GM, PSA Puegeot-Citroen, Renault SA, and VolkswagenRenault SA, and Volkswagen

• Includes all the ISO 9001 requirements plus Includes all the ISO 9001 requirements plus additions required by the automotive industryadditions required by the automotive industry

• Replaced QS-9000 in 2006 Replaced QS-9000 in 2006

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ApplicabilityApplicability• ISO 9001 applies to anyISO 9001 applies to any operation seeking to operation seeking to

consistently meet customer requirements consistently meet customer requirements and enhance customer satisfaction. and enhance customer satisfaction.

• ISO/TS 16949 applies only to sites where ISO/TS 16949 applies only to sites where automotive-related production and/or service automotive-related production and/or service parts are manufactured.(includes assembly, parts are manufactured.(includes assembly, welding, heat treating, plating, paintingwelding, heat treating, plating, painting, , or or other finishing services)other finishing services)

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What is certification? What is certification? What is registration?What is registration?

According to the International Organization for Standardization (ISO):According to the International Organization for Standardization (ISO):

• “ “Certification” refers to the issuing of written assurance (the Certification” refers to the issuing of written assurance (the certificate) by an independent external body that it has audited a certificate) by an independent external body that it has audited a management system and verified that it conforms to the management system and verified that it conforms to the requirements specified in the standard. requirements specified in the standard.

• ““Registration” means that the auditing body then records the Registration” means that the auditing body then records the certification in its client register. So, the organization’s certification in its client register. So, the organization’s management system has been both certified and registered. management system has been both certified and registered.

• Therefore, in the ISO 9001 context, the difference between the two Therefore, in the ISO 9001 context, the difference between the two terms is not significant and both are acceptable for general use. terms is not significant and both are acceptable for general use. “Certification” is the term most widely used worldwide, although “Certification” is the term most widely used worldwide, although registration is often preferred in North America, and the two are registration is often preferred in North America, and the two are used interchangeably.used interchangeably.

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The registration processThe registration process

Accreditation Bodies (ANAB,

RvA, etc.)

ISO 9001

Certification Bodies

(Registrars) Auditors

Organization seeking

registration

International Automotive Task Force

International Automotive Oversight

Bureau (IAOB)Certification

Bodies (Registrars)

Auditors

Organization seeking

registration

ISO/TS 16949

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Growth in worldwide Growth in worldwide certificationscertifications

Source: ISO Survey of Certifications 2009

8% increase

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Top five industrial sectors for ISO 9001 certificates 2009

1 Construction 1166722 Basic metal & fabricated

metal products107253

3 Electrical and optical equipment

85357

44 Machinery and equipment 635235 Wholesale & retail trade;

repairs of motor vehicles, motorcycles & personal &

household goods

63015

Source: ISO Survey of Certifications 2009

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If aggregated services is the number one industrial sector with 302,108 certificates  

• Services includes: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 Quality management principlesprinciples• Customer focusCustomer focus

• LeadershipLeadership

• Involvement of peopleInvolvement of people

• Process approachProcess approach

• System approach to System approach to managementmanagement

• Continual Continual improvementimprovement

• Factual approach to Factual approach to decision makingdecision making

• Mutually beneficial Mutually beneficial supplier supplier relationshipsrelationships

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Where to begin? Where to begin? Commit to continual improvementCommit to continual improvement

“ “Ongoing activity to increase the ability to fulfill requirements.”Ongoing activity to increase the ability to fulfill requirements.”

• True commitment to continual True commitment to continual improvement should lead to:improvement should lead to:– Planning of processes so Planning of processes so problems are problems are

prevented.prevented.– Planning of new jobs so Planning of new jobs so problems are problems are

prevented.prevented.– Effective corrective action so Effective corrective action so problems are problems are

solvedsolved, and don’t keep happening. , and don’t keep happening.

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Identify your business Identify your business processesprocesses

Customer Inquiry

Customer receives the product

Examples include: Estimating, Human Resources, Project Planning, Purchasing, Product Design,

Production, Warehousing, Shipping, Installation, Servicing

Process: “Set of interrelated or interacting activities

which transforms inputs into outputs”

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What are your processes? What are your processes?

Customer Inquiry

Customer receives the product

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Take the Plan-Do-Check-Act Take the Plan-Do-Check-Act approachapproach• Plan:Plan: “Establish the objectives and processes “Establish the objectives and processes

necessary to deliver results in accordance with necessary to deliver results in accordance with customer requirements and the customer requirements and the organization's policies.” organization's policies.”

• Do:Do: “Implement the processes.” “Implement the processes.”

• Check:Check: “Monitor and measure processes and product “Monitor and measure processes and product against policies, objectives and requirements for the against policies, objectives and requirements for the product and report the results.” product and report the results.”

• Act:Act: “Take actions to continually improve process “Take actions to continually improve process performance.” performance.”

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Procedure(Specified way to carry

out an activity or a process – may be

documented or not)

Process(Set of interrelated

or interacting activities)

Monitoring & Measurement opportunities

(Before, during, and after the process)

Examples include:•Materials•Products•Information•Equipment•Resources

Input Output

Plan and implement what Plan and implement what is needed for each processis needed for each process

Examples include:•Materials•Products•Information•Equipment•Resources

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Manage processes Manage processes effectively, typically this effectively, typically this

means: means: • There is a process There is a process owner.owner.• The process is The process is defined.defined. • The process is The process is documenteddocumented as appropriate. as appropriate. • Process Process linkageslinkages (or handoffs) of the process (or handoffs) of the process

are established. are established. • The process is The process is monitored, analyzed, and monitored, analyzed, and

improved.improved.• RecordsRecords are maintained. are maintained.

2020

How can you measure How can you measure or monitor your processes?or monitor your processes?

ProcessProcess Method of Method of MonitorinMonitorin

gg

ProcessProcess Method of Method of MonitoringMonitoring

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Train and empower Train and empower your internal auditorsyour internal auditors

• An audit is a systematic, independent, and An audit is a systematic, independent, and documented process to evaluate the extent to documented process to evaluate the extent to which policies, procedures, or requirements are which policies, procedures, or requirements are fulfilled.fulfilled.

• An excellent tool for evaluating your quality An excellent tool for evaluating your quality management system’s implementation and management system’s implementation and effectiveness.effectiveness.

• Auditors must be trained and have the qualities to Auditors must be trained and have the qualities to be successful auditors.be successful auditors.– DesireDesire– Able to “Think on your feet”Able to “Think on your feet”– Good communication skills (speaking and listening)Good communication skills (speaking and listening)– ObservantObservant– Able to analyze and assess situationsAble to analyze and assess situations

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ISO 9001 & ISO/TS 16949 ISO 9001 & ISO/TS 16949 requirementsrequirements

• Quality management systemQuality management system– Quality manualQuality manual– Control of documentsControl of documents– Control of quality recordsControl of quality records

• Management ResponsibilityManagement Responsibility– Management commitmentManagement commitment– Quality policyQuality policy– Customer focusCustomer focus– Management reviewManagement review

• Resource managementResource management– Human resourcesHuman resources– InfrastructureInfrastructure– Work environmentWork environment

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ISO 9001 & ISO/TS 16949 ISO 9001 & ISO/TS 16949 requirementsrequirements

(continued)(continued)

• Product realizationProduct realization– Customer related Customer related

processesprocesses– Design & developmentDesign & development– PurchasingPurchasing– Production and service Production and service

provisionprovision– Control of monitoring Control of monitoring

and measuring devicesand measuring devices

• Measurement, analysis Measurement, analysis and improvementand improvement– Customer satisfactionCustomer satisfaction– Internal auditInternal audit– Monitoring and Monitoring and

measuring product & measuring product & processesprocesses

– Control of nonconforming Control of nonconforming productproduct

– Analysis of dataAnalysis of data– Continual improvementContinual improvement– Corrective actionCorrective action– Preventive actionPreventive action

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Management

responsibility

Measurement, analysis, &

improvementResource

management

Product realization

Customer

Requirements

Product

Continual improvement of the quality management system

Value adding activities Information flowModel of a process-based quality management system

Output

Customer

Satisfaction

Plan

DoCheck

Act

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• Has the goals of defect prevention, reduction in Has the goals of defect prevention, reduction in variation, and wastevariation, and waste

• Expanded training requirementsExpanded training requirements– Process for motivating employees and measuring Process for motivating employees and measuring

awareness of impact on qualityawareness of impact on quality• Expanded quality planning requirements Expanded quality planning requirements

– Core tools: APQP, PPAP, FMEA, SPC, MSACore tools: APQP, PPAP, FMEA, SPC, MSA• The only exclusion is product design, not The only exclusion is product design, not

manufacturing process designmanufacturing process design• Supplier development requirements Supplier development requirements • Requires evaluating manufacturing process capabilityRequires evaluating manufacturing process capability• Requires use of error-proofing methodsRequires use of error-proofing methods

ISO/TS 16949 additionsISO/TS 16949 additions

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Quality planning toolsQuality planning tools

• APQP – Advanced Product Quality PlanningAPQP – Advanced Product Quality Planning• PPAP – Production Part Approval ProcessPPAP – Production Part Approval Process• FMEA – Failure Mode and Effects AnalysisFMEA – Failure Mode and Effects Analysis• SPC – Statistical Process ControlSPC – Statistical Process Control• MSA – Measurement Systems AnalysisMSA – Measurement Systems Analysis

ISO/TS 16949

Automotive

APQP/PPAP

FMEA SPC MSA

Core Tools

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• Must be understood in light of additional documentsMust be understood in light of additional documents• ISO/TS 16949 Automotive Certification Scheme-Rules ISO/TS 16949 Automotive Certification Scheme-Rules

for Achieving IATF Recognitionfor Achieving IATF Recognition• Customer specific requirements (CSR)Customer specific requirements (CSR)

• Companies must demonstrate readiness for the Companies must demonstrate readiness for the registration audit by presenting dataregistration audit by presenting data• 12 months of audit results, management review 12 months of audit results, management review

results, and performance dataresults, and performance data

ISO/TS 16949 additions ISO/TS 16949 additions continuedcontinued