Juggling Multiple Standards: Too Many Standards? Learn to Too Many Standards? Learn to Integrate Them! Chad Kymal – CTO and Founder, Omnex, Inc What We Do APQP/PPAP Standards New Product Development •ISO/TS 16949:2002 •ISO 9001:2000 •QOS Q1 APQP/PPAP FMEA/Control Plan Program Management SPC/DOE/ MSA QOS, Q1 •ISO 14000 •TL9000 Semicond ctor S pplement RABQSA certified Lead A ditor Auditor Training Tools SPC/DOE/ MSA Lean Manufacturing 5S T P bl Sli •Semiconductor Supplement •ISO 13485:2003 •ISO 17025:2005 RABQSA-certified Lead Auditor RABQSA-certified Internal Auditor Layered Process Audit Management T eam Problem Solving 7 Tools •AS 9100 TQM – Continuous Improvement QOS/Balanced Scorecard Mfg. Process Audit •Team Based •Hands-On Management Copyright 2008 Omnex. All Rights Reserved. Lean & Six Sigma •How To •Excellence-Based 2
Transcript
Juggling Multiple Standards: Too Many Standards? Learn toToo Many Standards? Learn to
Integrate Them!
Chad Kymal – CTO and Founder,
Omnex, Inc
What We Do
APQP/PPAPStandards New Product Development•ISO/TS 16949:2002•ISO 9001:2000•QOS Q1
APQP/PPAPFMEA/Control Plan
Program Management
SPC/DOE/ MSA
QOS, Q1•ISO 14000•TL9000Semicond ctor S pplementRABQSA certified Lead A ditor
– Juggling Multiple Standards: Save Time and Money by Integrating Your Various Management Systemsg g g y
• Upcoming Classes – Open Enrollment– Integrated Management System Understanding,
Documenting and Implementation (ISO 9000 ISO 14001Documenting and Implementation (ISO 9000, ISO 14001, OHSAS 18001)
• November 3-5, 2008 – Ann Arbor, MI
Integrated ISO 9001:2000 ISO/TS 16949:2002 ISO– Integrated ISO 9001:2000, ISO/TS 16949:2002, ISO 14001:2004 and OHSAS 18001:2007 Lead Auditor Training
• October 13-17, 2008 – Ann Arbor, MI
• December 1-5, 2008 – San Jose, CADecember 1 5, 2008 San Jose, CA
Copyright 2008 Omnex. All Rights Reserved.4
Resources Available From Omnex –On siteOn-site
• Class Available for On-site Trainingg– Integrated Management System Understanding,
Documenting and Implementation (ISO 9000, ISO 14001 OHSAS 18001)14001, OHSAS 18001)
– Integrated ISO 9001:2000, ISO/TS 16949:2002, ISO 14001:2004 and OHSAS 18001:2007 Lead Auditor Training
Copyright 2008 Omnex. All Rights Reserved.5
Chad Kymal – Omnex Inc.y
Chad Kymal is Chief Technical Officer and Founder of Omnex Inc. He recently published a book, The ISO/TS 16949:2002 Implementation Guide, available through Paton Press. His , p , gthird book, Conducting Effective Process Based Audits—An Auditor Handbook for ISO/TS 16949:2002 and ISO 9001:2000, will be available through Paton Press. His broad experience includes TQM, setup reduction, technology assessment and inventory analysis, statistical process control, and quality function deployment. After graduating from the General Motors Institute Chad spent a number of years working at General Motors andGeneral Motors Institute, Chad spent a number of years working at General Motors and KPMG. Over Chad's successful career, he has served on the Malcolm Baldrige Board of Examiners and has received numerous quality achievement awards, including the Quality Professional of the Year award by the American Society of Quality Automotive Division in 2005.
As CTO for Omnex, Chad is instrumental in determining the strategic direction of the consulting and training, as well as the product strategy for Omnex Systems. Chad personally led the Omnex team that helped Ford Motor Co. rewrite the QOS methodology. He also is the founder of AQSR a respected registrar that conducts audits worldwide HeHe also is the founder of AQSR, a respected registrar that conducts audits worldwide. He has a Bachelor's degree in Mechanical Engineering from General Motors Institute, a Master's degree in Industrial and Operations Engineering from the University of Michigan, and an MBA from the University of Michigan. He can be reached at [email protected].
Copyright 2008 Omnex. All Rights Reserved.6
Objectivesj
• To discuss the integration of ISO 9001:2000, ISO/TS 16949:2002, ISO 14001:2004 and OHSAS 18001:2007 into a single integrated14001:2004 and OHSAS 18001:2007 into a single integrated management system
• This integrated approach will allow you to save both time and money by focusing on a single management system to fulfill all your managementfocusing on a single management system to fulfill all your management system requirements:
– many quality-oriented organizations adhere to multiple standards with overlapping requirements
i t ti ti d b idi th f i f lti l– integration saves time and money by avoiding the confusion of multiple standards, reducing costs for implementation and reducing auditing costs by 25%
– integration fails when different groups within the organization take responsibility for separate standards, when middle managers attempt to maintain control of isolated systems or when there's a general lack of understanding about specific standards
– integration succeeds when standards are aligned, when processes are g g , pimplemented accordingly, and when processes and requirements are audited together
Copyright 2008 Omnex. All Rights Reserved.7
Objectivesj
• Why did have you joined this webinar?y y j
• What specific questions would you like me to answer?
Use text client box to ask questions now
Continue asking questions as the seminarContinue asking questions as the seminar progresses
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Management Systems Todayg y y
• Organizations today adhere to multiple standards –some examples include:– ISO 9001:2000 – QMS Standard
– ISO/TS 16949:2002 – QMS StandardISO/TS 16949:2002 QMS Standard
– ISO 14001:2004 – EMS Standard
– OHSAS 18001:2007 – OH&S Standard
ISO 17025 2005 L b t St d d– ISO 17025:2005 – Laboratory Standard
– Sarbannes-Oxley (SOX) – Financial Controls
– Malcolm Baldrige – Excellence Standards
– JACHO – Medical Industry Quality Standard
– AS 9100 – Aerospace Standard
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Multiple Standards with Multiple IntentIntent
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Why Multiple Standards?y p
• Management wants to reduce risks– Quality
– Environmental
– Health & safetyHealth & safety
– Financial
• Market requires itMarket requires it
• Customer requires it
• Certification – requirement to be able to do work– Government
– Certification Body– Certification Body
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Implementation and Documentationp
ISO-based Non ISO-based
Documents
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How Companies Implement –Typically One Site ImplementationTypically One Site Implementation
Stand alone Systems
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Stand-alone Systems
Lack of Integration – Results In g
• Duplication of processesDuplication of processes
• Increased cost to implement and• Increased cost to implement and maintain
• Increased cost to audit
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Lack of Integration – Duplication of ProcessesProcesses
Confusion for Top Managementp g
• Management has four reviews – for example:1 ISO 9001 2000 (QMS)1. ISO 9001:2000 (QMS)
I really don’t have time for this! Do I need this??
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Do I need this??
Lack of Integration – Duplication of ProcessesProcesses
Confusion for the Engineerg
• When designing a product:St d lit d f FMEA d C t l– Study quality procedure for FMEA and Control Plan
– Study EMS planning procedure for aspects andStudy EMS planning procedure for aspects and impacts
– Study OH&S planning procedure for health and f t i ksafety risks
I don’t do QMS, EMS or OHSAS; I just do my job
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I don t do QMS, EMS or OHSAS; I just do my job
Lack of Integration – Duplication of ProcessesProcesses
Confusion for a Nurse Giving Care to a gPatient
• Procedure for JCHAO• Procedure for JCHAO
• Procedure for HIPPA
P d f i i• Procedure for insurance carrier
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Lack of Integration – Increased Cost to Implement and Maintainto Implement and Maintain
• Duplication of Documents– Multiple teams/personnel work on the same or similar
documents• For example: management review, document control, training
• More Costly to Maintain– It is costly for an organization to conduct four management
reviews or to have three document control proceduresreviews or to have three document control procedures
• We estimate that implementation costs reduce by half when they are integratedwhen they are integrated– The biggest savings are actually in maintaining duplicate
processes; costs of maintaining three separate processes to i t t d ill b 60% d ti i tone integrated process will be a 60% reduction in costs
Copyright 2008 Omnex. All Rights Reserved.18
Lack of Integration – Increased Cost to Auditto Audit
• External Audit Costs– Registrars use tables to estimate number of days
to audit
– Travel costs
– Preparation costs
I t l A dit C t• Internal Audit Costs
• The cost of an external audit, including travel , gcosts, will be reduced by 25% for a medium-sized organization with integrated standards
Copyright 2008 Omnex. All Rights Reserved.19
Lack of Integrationg
• Causes Confusion
• Increases Cost to Implement and Maintain
• Increases Audit Costs
Do We Agree?
So What Do We Do To Integrate?
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Integration of Standardsg
We need to move towards the right, but how?
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We need to move towards the right, but how?
Steps to Integrationp g
1. Determine standards that need to be followed – which standards?
2. Align the requirements of the standard
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Steps to Integrationp g
Example of the li t falignment of
standards
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Steps to Integrationp g
1. Determine standards that need to be followed – which standards?
2. Integrate the requirements of the standard
3. Determine Process and Process Map– Choose process owner and place responsibility
for documentation and implementation with one person
Copyright 2008 Omnex. All Rights Reserved.24
Processes, Process Map and Process OwnerProcess Owner
• There should be only Product Realization Business Management Other Units(Out of Scope)y
one unique document control process or
ProductRoadmapping
New ProductCreation
BusinessPlanning
ManagementReview
StrategicPlanning
Purchasing
Business CreationPhilips Units
SV Site(Out of Scope)
training process – this procedure should address all current
System Definition
Study
Business Fulfillment(DDP) Corrective &
Preventive Action
Support
IT
Facilities
A ditiaddress all current requirements or change to address a future
Design
Development
HiringFinancialReporting
Training
Auditing
DocumentControl
TrainingPersonal
PerformanceImprovement
Control ofNonconforming
Product
Records Controlto address a future requirement
Qualification
Discontinuation
CustomerS t
Production
Operations (Out of Scope)
Improvement
Marketing &Sales
Units (Out of Scope)
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Support(Logistics)
Requirements and Processesq
• Requirements have the following impact on a q g pprocess:– Process satisfies the requirements
– Process needs to be changed to fulfill the requirement
The process does not accommodate the– The process does not accommodate the requirements and there is a need for a new process
Copyright 2008 Omnex. All Rights Reserved.26
What Do We Mean?
• Requirements or new t d d d t h
ProductRoadmapping
Product Realization
StrategicPlanning
Business Management Other Units(Out of Scope)
Business CreationPhilips Units
standards do not change what we do wholesale; what we do is essentially
pp g
New ProductCreation
System Definition
Business Fulfillment(DDP)
BusinessPlanning
ManagementReview
Corrective &Preventive Action
Purchasing
IT
Facilities
SV Site(Out of Scope)
what we do is essentially the same
• The organization and its
Study
Design
Development
HiringFinancialReporting
Training
SupportAuditing
DocumentControl
TrainingPersonal
Performance
Control ofNonconforming
Product
Records ControlThe organization and its processes evolve due to new requirements
Qualification
Discontinuation
CustomerSupport
(Logistics)
Production
Operations (Out of Scope)
PerformanceImprovement
Records Control
Marketing &Sales
Units (Out of Scope)
q
• Creating as entirely different management systems essentially means we are creating new processes, hence confusion costs arise
Copyright 2008 Omnex. All Rights Reserved.27
Steps to Integrationp g
1. Determine standards that need to be followed – which standards?
2. Integrate the requirements of the standard
3. Determine Process and Process Map
4. Document the processes and implement p pthem
Copyright 2008 Omnex. All Rights Reserved.28
Documenting and Implementing ProcessesProcesses
• Processes fulfill all the Product
Product Realization
StrategicPlanning
Business Management Other Units(Out of Scope)
Business CreationPhilips Units
requirements of the various standards
ProductRoadmapping
New ProductCreation
System Definition
Business Fulfillment(DDP)
BusinessPlanning
ManagementReview
Corrective &Preventive Action
Purchasing
IT
SV Site(Out of Scope)
• Processes will not be duplicated unless necessary
Study
Design
Development
HiringFinancialReporting
Training
Support
Facilities
Auditing
DocumentControl
TrainingP l
Control ofNonconforming
Product
• Processes will have only one process owner
Qualification
Discontinuation
CustomerSupport
(Logistics)
Production
Operations (Out of Scope)
PersonalPerformanceImprovement
Records Control
Marketing &Sales
Units (Out of Scope)
Copyright 2008 Omnex. All Rights Reserved.29
Steps to Integrationp g
1. Determine standards that need to be followed – which standards?
2. Align the requirements of the standard
3. Determine Process and Process Map
4. Document the processes and implement p pthem
5. Use web-based document management systems for integrated management systems
Copyright 2008 Omnex. All Rights Reserved.30
Web-based Document Management SystemsSystems
• Allows user to navigate system either in an i t t d f hi b t d dintegrated fashion or by standard
