pma apsc 042617 cathy · pdf file · 2017-04-26and vda 6.1 in 1990s...
TRANSCRIPT
International QMS StandardISO 9001:2008 ISO 9001:2015
Automotive QMS StandardISO/TS 16949:2009 IATF 16949:2016
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Transition deadline:September 14, 2018
(only 70 weeks!)
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» Audit nonconformances» More complex &
confusing QMS» Dis-satisfied customers
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Your QMS Transition was:» Fast» Worry-free» Made your business
money, and» Kept your
customers happy!
Your Automotive QMS Expert:Cathy Fisher
Ø Over 30 years Automotive industry QMS expertise
Ø Automotive QMS involvement since introduction of QS 9000 and VDA 6.1 in 1990s
Ø 1st ISO/TS 16949 QMS 3rd party auditor in US
Ø 1st to learn about new IATF 16949:2016 requirements in September, 2016
Ø Leader of “Future of Automotive Core Tools” initiative
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» Your organization is currently registered to ISO 9001:2008?
» Your organization is currently registered to ISO/TS 16949:2009?
» Your organization must transition your QMS to maintain business with your Automotive customers?
» You want information on how to accomplish your QMS transition efficiently and effectively?
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» Share as much as I can in the short time we have together today
» Answer all your questions about your QMS transition
» Provide you with additional resources to support your organization’s QMS transition effort
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Knowledge + Action = Results ©2017 Quistem, LLC www.Quistem.com
1.How to $capitalize$ on your QMS transition2. Critical QMS requirements changes3. Where to start your QMS transition4. What to expect from your Automotive customers
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1.How to $capitalize$ on your QMS transition2. Critical QMS requirements changes3. Where to start your QMS transition4. What to expect from your Automotive customers
» Routine review of ISO standards every 5 years
» Significant changes in QMS application, (especially in Automotive)
» Technology changes impacting organization’s operations, (the way we do business!)
» Quality as a strategic driver for business14
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Business Ladder
System Processes = Policies, Objectives & Practices(how an organization does business)
Planning Processes apply Systemto fulfill customer requirements
(how do we meet customer requirements?)
Producing Processes to accomplish Plans(are we making the product correctly?)
Products/Services = output of producing Processes(does product meet customer requirements?)
Satisfied Customers!
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Innovation & Opportunity
QMS = Strong Foundation/Roots
» Renumbering your QMS documentation to align with the ISO 9001/IATF 16949 standards
» Re-writing your Quality Manual to regurgitate the ISO 9001/IATF 16949 standards
» Creating QMS documentation for every individual requirement, (or “shall”), of the ISO 9001/IATF 16949 standards
» Generating more paperwork to show the auditor that does not directly support your organization’s processes 18
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» Assessing what is currently working well in your organization’s QMS
» Recognizing business processes essential to fulfilling customer requirements and enhancing customer satisfaction
» Determining where opportunity exists to enhance your current QMS to better support your organization’s strategic direction
» Involving everyone in your business in creating a proactive Quality culture using your QMS 19
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Knowledge + Action = Results ©2017 Quistem, LLC www.Quistem.com
1.How to $capitalize$ on your QMS transition2. Critical QMS requirements changes3. Where to start your QMS transition4. What to expect from your Automotive customers
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ISO 9001:2015» Context of
Organization» Leadership » Risk-based thinking» Externally-provided
products, processes and services
» Change management
IATF 16949:2016» Corporate responsibility» Auditor competencies» Embedded software» Product
safety/traceability» Control of external
provision» Manufacturing feasibility» Warranty management» Customer-specific
requirements
» Interrelation of sections 4, 5, 6 requirements» External provider requirements, (8.4)» Product safety & traceability, (4.4.1.2, 8.5.2.1)» Embedded software, (8.3.2.3, 8.4.2.3.1)» Process changes, (6.3, 8.1, 8.5.6, 8.5.6.1,
8.5.6.1.1)» Auditing: 1st & 2nd party, (7.2.3, 7.2.4,
8.4.2.4.1, 9.2.2.1, 9.2.2.2, 9.2.2.3, 9.2.2.4)» Nonconformance, (8.7.1.1, 8.7.1.4, 8.7.1.5,
8.7.1.7, 10.2.5)» Requirements: CSRs, statutory/regulatory 22
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» Avoid viewing new/modified requirements in isolation
» Process-approach emphasizes recognition of process interactions
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$$$
Customer Requirements
Business Planning
Resources
Evaluation
Improvement
Money-Making Process
Strategic
Planning/Improvement
Efficiency
On-Going Improvement
Customer Feedback
Effectiveness
!
$$$ DOING
PLANNING
CUSTOMER REQUIREMENTS4.2 Needs & expectations of interested parties
5.1.2 Customer focus8.2 Requirements for products/services
BUSINESS PLANNING: (Management)4 Context of the Organization
4.1, 4.2, 4.3 scope, 4.4 QMS processes5 Leadership: 5.1, 5.2, 5.3
6 Planning6.1 Risks & Opportunities
6.2 Quality Objectives6.3 Planning of changes
7.1 Resources
RESOURCE PROVISION: (Management)7 Support
7.1 Resources7.2 Competence7.3 Awareness
7.4 Communication7.5 Document information
CHECKINGEVALUATION: (Management)
4.4.1 g) evaluate QMS processes6.2.1 e) monitor quality objectives
7.2 c) evaluate effectiveness of actions taken8.5.1 c) Control of production and service
provision8.7 Control of nonconforming outputs
9 Performance evaluation9.1 Monitoring, measurement, analysis and
evaluation9.2 Internal audit
ACTINGIMPROVEMENT: (Management)
10 Improvement10.1 Opportunities for improvement
10.2 Nonconformity & corrective action10.3 Continual improvement
PRODUCT REALIZATION8 Operation
8.1 Operational planning and control8.2 Requirements for products & services
8.3 Design & development of products & services8.4 Control of Externally provided processes,
products, services8.5 Production & service provision
8.6 Release of products and services
Strategic
Planning/Improvement
Continual Planning
Measures of Efficiency
On-Going Improvement
ISO 9001:2015Managed Activities/Process System
9.3 Management Review
Customer Feedback8.2.1 c) obtain customer feedback
9.1.2 Customer satisfaction
Measures of Effectiveness
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Customer-oriented, (COPs) (product
realization)» Market analysis» Bid/tender» Order/request» Product/process design» Product/process
verification/validation» Product production» Delivery» Payment» Warranty/service» Post sales/customer
feedback
Support» Document control» Record control» Alignment of
process/output goals with organization quality objectives
» Training/competency requirements
» Communication with interfaces
» Methods used for analyzing process/output performance
» Application of improvement action processes
» ISO 9001:2015 does not specify name or nature of your organization’s QMS processes, (you decide!)
» IATF 16949:2016 supplements ISO 9001:2015 with additional QMS requirements where processes must be defined
» IATF 16949:2016 even indicates which of these processes must be documented! 28
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QMS Processes Required in IATF 16949 ISO 9001
IATF 16949
Requirement Your Process
4.4.1 Processes of QMS
4.4.1.2 Documented process for
management of product-safety
related products and
manufacturing processes
5.1.1.2 Product realization and support
processes
6.1.2.2 Process to lessen impact of
negative effects of risk
6.1.2.3d) Notification process to customer
7.1.5.2.1 Documented process for
managing
calibration/verification records
7.2.1 Documented process for
identifying training needs,
achieving competence of
personnel
7.2.3 Documented process to verify
internal auditors are competent
7.3.2 Documented process to
motivate employees to achieve
quality objectives, etc.
7.5.1.1b) Documented processes for
QMS
7.5.1.1c) Organization’s processes
7.5.3.2.2 Documented process
describing review, distribution
and implementation of all
customer engineering
standards/specs
ØISO 9001:2015 +ØIATF 16949:2016 automotive sector
supplemental requirements +ØCustomer-specific requirements +ØPart & process approval, (PPAP) +ØAutomotive Core Tools, (APQP,
FMEA, Control Plan, SPC, MSA) Ø (NOTE: these are all separate documents)
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1.How to $capitalize$ on your QMS transition2. Critical QMS requirements changes3. Where to start your QMS transition4. What to expect from your Automotive customers
» QMS Scope» QMS processes» Organizational
QMS Gap Analysis» Schedule QMS
Transition audit with your registrar
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» ISO 9001:2015 4.3» IATF 16949:2016
4.3.1, 4.3.2» Must be documented
information, (4.3)» Included in your
Quality Manual, (7.5.1.1)
» More than just the Scope statement on your QMS registration certificate! 34
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QMS Scope Review
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Current QMS scope: (can be found on QMS registration certificate or your organization’s quality manual) *Your organization’s products/services: Primary activities/processes of your business: (e.g. design, manufacture, assembly, processing, warehousing, distribution, delivery, servicing, etc.)
Automotive Customers served: Other interested parties/requirements: Physical boundaries, (sites, locations): Primary: Support:
Outsourced processes: *IATF 16949:2016 reqs. Not Applicable + Justification: Updated QMS Scope statement: Reviewed with registrar by: Date: (NOTE: * items must be reflected in QMS Scope statement)
» Recognize shared QMS processes, (especially with corporate/sister divisions and other “interested parties”)
» Supporting functions, (both on-site or remote); e.g. design centers, corporate headquarters, distribution centers, etc.
» Customer-specific requirements, (need to name your automotive customers!)
» Identify ALL Outsourced processes, (and consider as part of 8.4 External Provision)
» Determine what new IATF 16949:2016 requirements do not apply to your organization’s QMS
» Get clear on product design ownership; exclusion for product design limited to specific IATF 16949 sub-requirements 35
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» Evaluation of current processes and evidence in your organization related to general QMS requirement topics
» Top-level view of your QMS
» Set of open-ended questions related to QMS topics
» Designed to promote dialogue about QMS
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Organizational QMS Gap Analysis
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ISO Ref Question Process Owner Response Process Evidence 4.1 How is your QMS
considered during business planning?
Top Management
4.2 What groups of interested parties
does your organization interact
with?
Top Management
4.3 What activities of your business directly impact satisfying
customers?
Top Management
4.4 How are processes of your organization
identified?
Top Management
5.1 How does your organization
demonstrate customer focus?
Top Management
5.2 How is success of your business
measured?
Top Management
» Highlights what your organization already has in place that is working
» Prevents overwhelm of trying to fit interpretations of new ISO 9001:2015 & IATF 16949:2016 requirements into your business
» Avoids prescribing specific solutions» Involves process owners across your
organization» Gets people talking about your QMS from a
strategic perspective 38
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» Confirm transition audit dates
» Auditor availability!» QMS Scope review» Documentation review» Structure for QMS
transition audit» Registrar requirements» Duration same as re-
registration audit 39
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» October 1, 2016: IATF 16949:2016 release» January 1, 2017: IATF 16949:2016 3rd party
Transition audits begin» January 1 thru September 30, 2017: Voluntary
IATF 16949:2016 QMS Transition audit at regularly scheduled surveillance/re-certification audit
» October 1, 2017 thru September 14, 2018: Mandatory IATF 16949:2016 QMS Transition audit at regularly scheduled surveillance/re-certification audit
» Up to May 15, 2018: “safe window” for transition to allow 120 days to clear potential audit nonconformances
» September 14, 2018: ISO/TS 16949:2009, (and ISO 9001:2008) expires!
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IATF 16949:2016 QMS Transition Plan Action Responsible Date Status
Determine transition date Schedule transition audit with
registrar
Get copy of ISO 9001:2015, IATF 16949:2016, (optional:
IATF Rules 5th, ISO 9000:2015)
Review QMS scope Conduct Organizational QMS
Gap Analysis
Confirm QMS processes to IATF 16949:2016
requirements
Identify new/revised QMS processes & process owners
Define detailed QMS Transition time & action plan
Update internal auditor competencies
Management briefing on IATF 16949:2016
All-employee awareness training of IATF 16949:2016
Conduct internal audits of updated QMS
Management review of updated QMS
Prepare QMS vs. IATF 16949:2016 mapping
QMS Transition audit prep
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1.How to $capitalize$ on your QMS transition2. Critical QMS requirements changes3. Where to start your QMS transition4. What to expect from your Automotive customers
Operational consistency!
PredictableSuccess
Preventive/detectiverisk control strategy
Stable/capable processes
0-4 dppm (internal) No customer complaints
Never Recalls!
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Get certified to IATF 16949:2016!
1. Compliance to ISO 9001 through 2nd party audits2. Certification to ISO 9001 through 3rd party audits;
maintain 3rd party certification issued by an IAF accredited member where accreditation body’s main scope includes management systems certification to ISO/IEC 17021
3. Certification to ISO 9001 with compliance to other customer-defined QMS requirements, (e.g. AIAG CQI-19), through 2nd party audits
4. Certification to ISO 9001 with compliance to IATF 16949 through 2nd party audits
5. Certification to IATF 16949 through 3rd party audits, (by IATF-recognized certification body)”
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This is a progression to accomplish over time!
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Knowledge + Action = Results ©2017 Quistem, LLC www.Quistem.com
1.How to $capitalize$ on your QMS transition2. Critical QMS requirements changes3. Where to start your QMS transition4. What to expect from your Automotive customers
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QMS Transition Resources» QMS cross-reference» QMS scope worksheet» QMS Transition plan» Cathy’s book
“Worry-Free QMS Transition”