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NREL 2014- Photovoltaic Module Reliability Workshop Golden, Colorado
Overview of the Proposed PV Quality Management System
Task Group 1- Govind Ramu
SunPower Corporation, San Jose, CA
2© 2014 SunPower Corporation
About the presenter
 Director of Global Quality Management Systems, SunPower Corporation
 Has over 25 years of experience implementing quality management systems in various
global locations from various industry sectors
 US TAG TC 176/SC2 participating member for ISO 9001:2015 standards
 Expert on IEC TC 82 WG 2- Solar photovoltaic energy systems- Modules- non
concentrating
 A licensed professional engineer in the province of Ontario, Canada, mechanical
engineering degree from Bangalore University, India
 An ASQ Fellow, holds six ASQ certifications: quality manager, quality engineer, Six
Sigma Black Belt, quality auditor, software quality engineer and reliability engineer
 Registered QMS ISO 9001:2008 principal auditor from IRCA (UK)
 Has coauthored ASQ’s Certified Six Sigma Green Belt Handbook, one of the major
contributing authors for The Lean Certification Handbook
 Served as an examiner in 2006, 2011, and 2012 for the California Awards for
Performance Excellence (CAPE) and as an Examiner for the Malcolm Baldrige
National Quality Award in 2010
3© 2014 SunPower Corporation
Table of contents
 Why Quality Management System (QMS)?
 Introduction to ISO 9001
 ISO 9001 perceptions and fact
 Audits and Certification
 PV QMS Task group
 Why Industry standard?
 Comparison of ISO 9001 Vs PV QMS
 ISO 9001-What next?
 PV QMS- Future possibilities
 Appendix
4© 2014 SunPower Corporation
What customer needs?
Source: Unknown
Quality Management System= Business Management System
5© 2014 SunPower Corporation
ISO 9001 Quality Management System
Requirements
 Over 25 years of evolution since its inception in 1987.
Subsequently revised in 1994, 2000 and amended in 2008
 Covers general and foundational quality management
requirements applicable to any industry or service sectors
 Most widely used standard. Over 1 million organizations
worldwide are registered to this standard
 Hundreds of registration bodies worldwide are accredited to
issue certification for client organizations
 ISO 9001 is now a contractual requirement for many
organizations worldwide, often prerequisite for bidding new
tenders
ISO 9001 is implemented in various industries, countries worldwide
6© 2014 SunPower Corporation
ISO 9001 Myth
Perception: ISO 9001 certification does not help improve
quality of products and services. Only helps with consistent
product/services.
Fact: There are 16 instances in the ISO 9001: 2008
requirements that call out improvement of product/service,
process, effectiveness.
Why this perception?
Back in 1990s consultants and quality practitioners
summarized ISO 9001 implementation in a nut shell for
simplicity as:
“Say what you do, Do what you say”.
In the year 2000, ISO 9001 was significantly updated to change
this perception. Customer focus, Improvement and effectiveness
became a common theme throughout the standard.
ISO 9001 is more than just consistent product/services.
7© 2014 SunPower Corporation
PDCA Cycle*- ISO 9001 framework
*Also popularly known as Deming Wheel/Cycle
ISO 9001 requirements follow PDCA improvement model.
8© 2014 SunPower Corporation
Types of System audits
 First party audit: Organization use the standard to verify
compliance. Also known as Internal quality systems audit
 Second party audit: Organization use the standard to
verify compliance of their suppliers quality systems
 Third party audit: An independent organization (registrar)
verify compliance to the standard to issue ISO 9001
certificate for a client
 An accreditation body audits the registrars to verify their
ability to issue ISO 9001 certificates
Audit verify compliance to standard, organization’s QMS, and its effectiveness
9© 2014 SunPower Corporation
Certification Process
 Stage 1 audit- Registrar auditors verify compliance to the
standard as a desk audit and review overall QMS
framework
 Stage 2 audit- Registrar auditors verify compliance to the
standard by auditing processes covered in the scope of
registration
 Once certificate is issued, registrars conduct periodic
surveillance audit annually, conduct recertification audit
every 3 years
Due diligence all the way
Highlights of QMS requirements for
PV Module Manufacturing- Task group 1
11© 2014 SunPower Corporation
Task group1Participants
Govind Ramu
SunPower
Paul Norum
Amonix
Ivan Sinicco
Tokyo Electron
Sumanth Lokanath
First Solar
Yoshihito Eguchi
Japan Electrical Safety
and Environment
Technology Laboratories
(JET)
Masaaki Yamamichi
National Institute of
Advanced Industrial
Science and
Technology (AIST)
Wei Zhou
Trina Solar
Gunnar
Brueggemann
Tokyo Electron
Alex Mikonowicz
Powermark
Sarah Kurtz
National Renewable
Energy Laboratory
Partial group of Task group 1 participants
12© 2014 SunPower Corporation
Why Industry specific standard?
 ISO 9001 Guidance notes: The extent of the quality management
system documentation can differ from one organization to another
due to the size of the organization and type of activities, the
complexity of processes and their interactions, and the competence
of personnel
 However organizations that are superficially implementing the QMS
can unfortunately get certified due to:
 Generic nature of requirements, inappropriate use of “Exclusion” clause
 Lack of in-depth review by external auditors, auditor competency
 Organization’s ability to prepare ahead of audit
 Impress auditors with pockets of good practices and compliance
 Supplementing Industry requirements on top of the foundational ISO
9001 requirements provides organization specific expectations
relevant to the industry
ISO 9001 alone may not be adequate to address industry specific requirements
13© 2014 SunPower Corporation
Industry specific QMS standards
Started from mid 1990s
 TS 16949- Automotive
 AS9100- Aerospace
 ISO 13485- Biomedical
 TL 9000- Telecommunication
 Service sectors are also developing QMS standards to address
specific requirements.
 Some interesting standards currently under development:
 Guidelines for the application of ISO 9001:2008 in local
government
 requirements for the application of ISO 9001:2008 for electoral
organizations at all levels of government
Other industry sectors are very successful in development and deployment of standards
14© 2014 SunPower Corporation
PV QMS Standard Development timeline
July
2011
July
2011
Sep
2011
Oct
2013
Feb
2014
International PV
Module QA
Forum
San Francisco
Highlighted the need to
strengthen the QM
program used by the PV
module manufacturer,
conclusion was to adopt
the two primary goals and
form the five Task Groups
The International PV
Module Quality Assurance
Task Force was formed –
5 Task groups formed,
Task Group 1-
Responsible for PV QMS.
Task Group #1
began to write a
PV-specific version
of ISO 9001
supplementary
requirements .
National
Committees of
IEC TC82 WG2
as the New Work
Item Proposal
82/800/NP.
PV Module
Reliability
Workshop
Golden, Denver
Dec
2010
METI
approaches
DOE toward
international PV
QA effort
Sep 2010- Govind
sends out a mail to
NREL web contact
about a possible
Solar QMS standard.
15© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• Inputs relating to product
requirements shall be determined
and shall include functional and
performance requirements
• The organization shall determine
requirements specified by the
customer, including the
requirements for delivery and
post-delivery activities (Warranty)
PV QMS Requirement
• Focus on the organization’s
control of the PV module’s
design to align the expected
lifetime with its relationship to
the organization’s warranty
• Controls:
– Design FMEA
– Reliability testing
– Lessons learned
16© 2014 SunPower Corporation
Design at the Source:
Factor of 10 thumb rule
The cost of addressing reliability issues increases tenfold as you move
through the development process
Courtesy: SunPower Corporation – New Employee Orientation material
17© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• Inputs relating to product
requirements shall be determined
and shall include applicable
statutory and regulatory
requirements
PV QMS Requirement
• A product realization that
includes appropriate
certification (e.g. IEC
qualification, including both type
approval and safety testing), a
design lifetime that enables
compliance with warranty, and
recycling provisions
• Controls:
– Internal/external qualification
– Certification
– Design FMEA/ Risk assessment
18© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• Where traceability is a
requirement, the organization
shall control the unique
identification of the product and
maintain records
PV QMS Requirement
• Requirement to improve
product traceability through the
entire supply and delivery chain
to enact positive control of the
product for recalls and warranty
claims.
• Controls:
– constituent key materials and
components
– lot/batch level
– Traceable to supplier, date, Mfg.
location
– Traceable to Internal processes
– Reworked/repaired products
19© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• The organization shall monitor
and measure the characteristics
of the product to verify that
product requirements have been
met.
• This shall be carried out at
appropriate stages of the product
realization process in accordance
with the planned arrangements
PV QMS Requirement
• An ongoing, periodic monitoring
program to ensure consistency
of aspects of manufacturing that
may affect safety, performance,
and reliability
• Controls:
– Reliability Monitoring Program
(RMP)
20© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• The organization shall validate any
processes for production and
service provision where the
resulting output cannot be verified
by subsequent monitoring or
measurement
• The analysis of data shall provide
information relating to conformity to
product requirements
PV QMS Requirement
• Special processes such as
control of solder connections
• Control of processes for ESD
protection
• Assignment of PV module power
rating with allowed tolerance
including measurement
uncertainty
• Controls:
– Software validation
– ESD Program effectiveness
– determine parameter sets for the
acceptance tolerance
– Determine measurement
uncertainty.
21© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• The organization shall determine
and provide the resources needed
to enhance customer satisfaction
by meeting customer
requirements
• No requirement on Succession
planning for key functions
• The organization shall determine
and manage the work
environment needed to achieve
conformity to product
requirements
PV QMS Requirement
• Resources needed to maintain
the product warranty system,
product reliability
measurements, provision of
after-sales service
• Succession planning for key
functions that affect customer,
quality reliability, safety and
performance
• ESD- Electrostatic Discharge
(ESD) safe environment at the
raw material storage,
processing, assembly areas, as
appropriate
22© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• Inputs relating to product
requirements shall be determined.
These inputs shall include where
applicable, information derived
from previous similar designs
PV QMS Requirement
• Previous failure information
incorporated into the
requirements of the QMS
• Controls:
– Failure information database
management
– Design Review
23© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• The organization shall evaluate and select
suppliers based on their ability to supply
product in accordance with the
organization's requirements. Criteria for
selection, evaluation and re-evaluation
shall be established.
• The organization shall establish and
implement the inspection or other activities
necessary for ensuring that purchased
product meets specified purchase
requirements.
PV QMS Requirement
• A method for selection of vendors that
can provide quality materials or
products
• Receiving inspection and/or testing
such as statistical sampling based on
performance.
• Ensure that the supplier maintains
product quality consistently, and will
notify and seek approval when there is
any change of products, process,
manufacturing location or significant
process excursion that may affect form,
fit, function, reliability or performance.
• Controls:
– Periodic supplier audits.
– Performance monitoring.
– Traceability requirements.
.
24© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• The organization shall monitor and
measure the characteristics of the
product to verify that product
requirements have been met. This
shall be carried out at appropriate
stages of the product realization
process
• The organization shall review the
requirements related to the
organization’s ability to meet the
defined requirements
• The organization shall plan under
controlled conditions shall include
the availability and use of
monitoring and measuring
equipment
PV QMS Requirement
• Routine tests on 100% of product
to ensure consistency of initial
quality
• Manufacturing feasibility at the
necessary scale, including risk
analysis
• Control plan for solar simulators
and how they are used in the
performance rating of modules
• Controls:
– Process FMEA
– Control Plan
– Measurement System Analysis –
uncertainty calculations
25© 2014 SunPower Corporation
9001 Vs PV QMS- Product- Process- System audits
Product Audit
(PV QMS)
Process Audit
(PV QMS)
System Audit (E.g. ISO 9001)
26© 2014 SunPower Corporation
Cost of Poor Quality (COPQ)
Rework / Re-grade
Inspection
Warranty
Rejects / Scrap
Lost sales / opportunities
Late delivery
Engineering change orders
Long cycle times
Expediting costs
Excess inventory
Hidden Costs
Visible Costs
Lost Customer Loyalty
More Set-ups
Time value of money
Working Capital allocations
Excessive Material
Orders/Planning
Field Service
Degraded Brand Image
RMA
Yield
(less obvious)
Gross Margin Erosion
COPQ ranges 15-20% of total cost! Hidden costs can be up to 4 times the visible costs!
Ref: The Tip of the Iceberg- Quality Progress, ASQ Quality Press, May 2001.
27© 2014 SunPower Corporation
9001 Vs PV QMS
ISO 9001 QMS requirement
• The organization shall determine,
collect and analyze appropriate data to
demonstrate the suitability and
effectiveness of the quality
management system
• The organization shall apply suitable
methods for monitoring of processes
• The organization shall continually
improve the effectiveness of the quality
management system through the use of
analysis of data, corrective and
preventive actions
PV QMS Requirement
• Use appropriate statistical tools and
statistically significant sample sizes to
make decisions that affect quality of
process and products at all stages of
the lifecycle
• Use of error proofing, Statistical
process Control, control plan, Failure
mode effects analysis, and 8
Discipline methodology to build PV
modules with consistent quality and
reliability
• Controls:
– Process FMEA
– Poke Yoke
– Control Plan
– SPC
– 8D methodology
28© 2014 SunPower Corporation
What is next in ISO 9001 (2015)?
 Standard becoming more generic to cater all industry types including service
sector. Mandatory documentation requirements for some process go away
(Even more so why we need PV Industry specific QMS!)
 Risk management-leveraged with leadership managing risks when making
organizational decisions. (adding good foundation)
 Specific requirements for adopting the process approach*. (adding good
foundation)
(Standard currently at the Committee draft stage. Draft standard expected by
April 2014)
PV QMS Standard expected timeline – June 2015
*See appendix
29© 2014 SunPower Corporation
PV QMS future Possibilities
(Brainstorm ideas)
 PV design, manufacturing and service metrics periodic submission to
a vetted third party for analysis and publication of Best in class, top
decile, median values (with anonymity- double blind process) for
industry benchmarking
 PV QMS extended to suppliers of “key materials”
 PV QMS transition to PV IMS “Integrated Management system” to
include Environmental, occupation health and safety requirements for
PV manufacturing
 Graded approach to PV QMS audit outcome based on maturity
levels. Audits go beyond compliance
 Exchange of epidemic failure information by PV technology
 Benchmark QMS practices with other well established industry
sectors (e.g. Automotive, Telecom, Aerospace)
Appendix
31© 2014 SunPower Corporation
References, Bibliography & Acknowledgements
 References:
 ISO 9001:2008 Quality Management System requirements
 82/800/NP- Guideline for increased confidence in PV module design qualification
and type approval.
 JIS Q 8901:2012- Terrestrial photovoltaic (PV) modules -- Requirement for
reliability assurance system (design, production and product warranty)
 Bibliography:
 ISO 19011:2011 Guidelines for auditing management systems
 Tip of the iceberg- Quality Progress article, May 2001
 Acknowledgement:
 Ms. Sarah Kurtz, Reliability Group Manager, Principal Scientist, PhD, National
Renewable Energy Laboratory, Golden, CO 80401
 Task Group 1 International team members
 SunPower Corporation, San Jose, CA USA Quality, Reliability & Management
32© 2014 SunPower Corporation
BACK UP SLIDES
33© 2014 SunPower Corporation
Nuggets in the ISO 9001 notes
(Items gets pushed to notes during standards review)
 Ensuring control over outsourced processes does not absolve the organization of
the responsibility of conformity to all customer, statutory and regulatory
requirements
 The extent of the quality management system documentation can differ from one
organization to another due to the size of the organization and type of activities,
the complexity of processes and their interactions, and the competence of
personnel
 Conformity to product requirements can be affected directly or indirectly by
personnel performing any task
 Design and development review, verification and validation have distinct
purposes
 Customer property can include intellectual property and personal data
 Confirmation of the ability of computer software to satisfy the intended application
would typically include its verification and configuration management to maintain
its suitability for use
 In some industry sectors, configuration management is a means by which
identification and traceability are maintained
34© 2014 SunPower Corporation
*Process Approach
Systems / Processes
Inputs Outputs
Outcomes
Product
or
Service
End-userSupplier
Machines Methods
MaterialPeople Environment
Reference : Elsmar.com Audit guide PPT
Overview of the proposed Photovoltaic Solar Quality Management System standard

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Overview of the proposed Photovoltaic Solar Quality Management System standard

  • 1. NREL 2014- Photovoltaic Module Reliability Workshop Golden, Colorado Overview of the Proposed PV Quality Management System Task Group 1- Govind Ramu SunPower Corporation, San Jose, CA
  • 2. 2© 2014 SunPower Corporation About the presenter  Director of Global Quality Management Systems, SunPower Corporation  Has over 25 years of experience implementing quality management systems in various global locations from various industry sectors  US TAG TC 176/SC2 participating member for ISO 9001:2015 standards  Expert on IEC TC 82 WG 2- Solar photovoltaic energy systems- Modules- non concentrating  A licensed professional engineer in the province of Ontario, Canada, mechanical engineering degree from Bangalore University, India  An ASQ Fellow, holds six ASQ certifications: quality manager, quality engineer, Six Sigma Black Belt, quality auditor, software quality engineer and reliability engineer  Registered QMS ISO 9001:2008 principal auditor from IRCA (UK)  Has coauthored ASQ’s Certified Six Sigma Green Belt Handbook, one of the major contributing authors for The Lean Certification Handbook  Served as an examiner in 2006, 2011, and 2012 for the California Awards for Performance Excellence (CAPE) and as an Examiner for the Malcolm Baldrige National Quality Award in 2010
  • 3. 3© 2014 SunPower Corporation Table of contents  Why Quality Management System (QMS)?  Introduction to ISO 9001  ISO 9001 perceptions and fact  Audits and Certification  PV QMS Task group  Why Industry standard?  Comparison of ISO 9001 Vs PV QMS  ISO 9001-What next?  PV QMS- Future possibilities  Appendix
  • 4. 4© 2014 SunPower Corporation What customer needs? Source: Unknown Quality Management System= Business Management System
  • 5. 5© 2014 SunPower Corporation ISO 9001 Quality Management System Requirements  Over 25 years of evolution since its inception in 1987. Subsequently revised in 1994, 2000 and amended in 2008  Covers general and foundational quality management requirements applicable to any industry or service sectors  Most widely used standard. Over 1 million organizations worldwide are registered to this standard  Hundreds of registration bodies worldwide are accredited to issue certification for client organizations  ISO 9001 is now a contractual requirement for many organizations worldwide, often prerequisite for bidding new tenders ISO 9001 is implemented in various industries, countries worldwide
  • 6. 6© 2014 SunPower Corporation ISO 9001 Myth Perception: ISO 9001 certification does not help improve quality of products and services. Only helps with consistent product/services. Fact: There are 16 instances in the ISO 9001: 2008 requirements that call out improvement of product/service, process, effectiveness. Why this perception? Back in 1990s consultants and quality practitioners summarized ISO 9001 implementation in a nut shell for simplicity as: “Say what you do, Do what you say”. In the year 2000, ISO 9001 was significantly updated to change this perception. Customer focus, Improvement and effectiveness became a common theme throughout the standard. ISO 9001 is more than just consistent product/services.
  • 7. 7© 2014 SunPower Corporation PDCA Cycle*- ISO 9001 framework *Also popularly known as Deming Wheel/Cycle ISO 9001 requirements follow PDCA improvement model.
  • 8. 8© 2014 SunPower Corporation Types of System audits  First party audit: Organization use the standard to verify compliance. Also known as Internal quality systems audit  Second party audit: Organization use the standard to verify compliance of their suppliers quality systems  Third party audit: An independent organization (registrar) verify compliance to the standard to issue ISO 9001 certificate for a client  An accreditation body audits the registrars to verify their ability to issue ISO 9001 certificates Audit verify compliance to standard, organization’s QMS, and its effectiveness
  • 9. 9© 2014 SunPower Corporation Certification Process  Stage 1 audit- Registrar auditors verify compliance to the standard as a desk audit and review overall QMS framework  Stage 2 audit- Registrar auditors verify compliance to the standard by auditing processes covered in the scope of registration  Once certificate is issued, registrars conduct periodic surveillance audit annually, conduct recertification audit every 3 years Due diligence all the way
  • 10. Highlights of QMS requirements for PV Module Manufacturing- Task group 1
  • 11. 11© 2014 SunPower Corporation Task group1Participants Govind Ramu SunPower Paul Norum Amonix Ivan Sinicco Tokyo Electron Sumanth Lokanath First Solar Yoshihito Eguchi Japan Electrical Safety and Environment Technology Laboratories (JET) Masaaki Yamamichi National Institute of Advanced Industrial Science and Technology (AIST) Wei Zhou Trina Solar Gunnar Brueggemann Tokyo Electron Alex Mikonowicz Powermark Sarah Kurtz National Renewable Energy Laboratory Partial group of Task group 1 participants
  • 12. 12© 2014 SunPower Corporation Why Industry specific standard?  ISO 9001 Guidance notes: The extent of the quality management system documentation can differ from one organization to another due to the size of the organization and type of activities, the complexity of processes and their interactions, and the competence of personnel  However organizations that are superficially implementing the QMS can unfortunately get certified due to:  Generic nature of requirements, inappropriate use of “Exclusion” clause  Lack of in-depth review by external auditors, auditor competency  Organization’s ability to prepare ahead of audit  Impress auditors with pockets of good practices and compliance  Supplementing Industry requirements on top of the foundational ISO 9001 requirements provides organization specific expectations relevant to the industry ISO 9001 alone may not be adequate to address industry specific requirements
  • 13. 13© 2014 SunPower Corporation Industry specific QMS standards Started from mid 1990s  TS 16949- Automotive  AS9100- Aerospace  ISO 13485- Biomedical  TL 9000- Telecommunication  Service sectors are also developing QMS standards to address specific requirements.  Some interesting standards currently under development:  Guidelines for the application of ISO 9001:2008 in local government  requirements for the application of ISO 9001:2008 for electoral organizations at all levels of government Other industry sectors are very successful in development and deployment of standards
  • 14. 14© 2014 SunPower Corporation PV QMS Standard Development timeline July 2011 July 2011 Sep 2011 Oct 2013 Feb 2014 International PV Module QA Forum San Francisco Highlighted the need to strengthen the QM program used by the PV module manufacturer, conclusion was to adopt the two primary goals and form the five Task Groups The International PV Module Quality Assurance Task Force was formed – 5 Task groups formed, Task Group 1- Responsible for PV QMS. Task Group #1 began to write a PV-specific version of ISO 9001 supplementary requirements . National Committees of IEC TC82 WG2 as the New Work Item Proposal 82/800/NP. PV Module Reliability Workshop Golden, Denver Dec 2010 METI approaches DOE toward international PV QA effort Sep 2010- Govind sends out a mail to NREL web contact about a possible Solar QMS standard.
  • 15. 15© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • Inputs relating to product requirements shall be determined and shall include functional and performance requirements • The organization shall determine requirements specified by the customer, including the requirements for delivery and post-delivery activities (Warranty) PV QMS Requirement • Focus on the organization’s control of the PV module’s design to align the expected lifetime with its relationship to the organization’s warranty • Controls: – Design FMEA – Reliability testing – Lessons learned
  • 16. 16© 2014 SunPower Corporation Design at the Source: Factor of 10 thumb rule The cost of addressing reliability issues increases tenfold as you move through the development process Courtesy: SunPower Corporation – New Employee Orientation material
  • 17. 17© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • Inputs relating to product requirements shall be determined and shall include applicable statutory and regulatory requirements PV QMS Requirement • A product realization that includes appropriate certification (e.g. IEC qualification, including both type approval and safety testing), a design lifetime that enables compliance with warranty, and recycling provisions • Controls: – Internal/external qualification – Certification – Design FMEA/ Risk assessment
  • 18. 18© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records PV QMS Requirement • Requirement to improve product traceability through the entire supply and delivery chain to enact positive control of the product for recalls and warranty claims. • Controls: – constituent key materials and components – lot/batch level – Traceable to supplier, date, Mfg. location – Traceable to Internal processes – Reworked/repaired products
  • 19. 19© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. • This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements PV QMS Requirement • An ongoing, periodic monitoring program to ensure consistency of aspects of manufacturing that may affect safety, performance, and reliability • Controls: – Reliability Monitoring Program (RMP)
  • 20. 20© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement • The analysis of data shall provide information relating to conformity to product requirements PV QMS Requirement • Special processes such as control of solder connections • Control of processes for ESD protection • Assignment of PV module power rating with allowed tolerance including measurement uncertainty • Controls: – Software validation – ESD Program effectiveness – determine parameter sets for the acceptance tolerance – Determine measurement uncertainty.
  • 21. 21© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • The organization shall determine and provide the resources needed to enhance customer satisfaction by meeting customer requirements • No requirement on Succession planning for key functions • The organization shall determine and manage the work environment needed to achieve conformity to product requirements PV QMS Requirement • Resources needed to maintain the product warranty system, product reliability measurements, provision of after-sales service • Succession planning for key functions that affect customer, quality reliability, safety and performance • ESD- Electrostatic Discharge (ESD) safe environment at the raw material storage, processing, assembly areas, as appropriate
  • 22. 22© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • Inputs relating to product requirements shall be determined. These inputs shall include where applicable, information derived from previous similar designs PV QMS Requirement • Previous failure information incorporated into the requirements of the QMS • Controls: – Failure information database management – Design Review
  • 23. 23© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. • The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. PV QMS Requirement • A method for selection of vendors that can provide quality materials or products • Receiving inspection and/or testing such as statistical sampling based on performance. • Ensure that the supplier maintains product quality consistently, and will notify and seek approval when there is any change of products, process, manufacturing location or significant process excursion that may affect form, fit, function, reliability or performance. • Controls: – Periodic supplier audits. – Performance monitoring. – Traceability requirements. .
  • 24. 24© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process • The organization shall review the requirements related to the organization’s ability to meet the defined requirements • The organization shall plan under controlled conditions shall include the availability and use of monitoring and measuring equipment PV QMS Requirement • Routine tests on 100% of product to ensure consistency of initial quality • Manufacturing feasibility at the necessary scale, including risk analysis • Control plan for solar simulators and how they are used in the performance rating of modules • Controls: – Process FMEA – Control Plan – Measurement System Analysis – uncertainty calculations
  • 25. 25© 2014 SunPower Corporation 9001 Vs PV QMS- Product- Process- System audits Product Audit (PV QMS) Process Audit (PV QMS) System Audit (E.g. ISO 9001)
  • 26. 26© 2014 SunPower Corporation Cost of Poor Quality (COPQ) Rework / Re-grade Inspection Warranty Rejects / Scrap Lost sales / opportunities Late delivery Engineering change orders Long cycle times Expediting costs Excess inventory Hidden Costs Visible Costs Lost Customer Loyalty More Set-ups Time value of money Working Capital allocations Excessive Material Orders/Planning Field Service Degraded Brand Image RMA Yield (less obvious) Gross Margin Erosion COPQ ranges 15-20% of total cost! Hidden costs can be up to 4 times the visible costs! Ref: The Tip of the Iceberg- Quality Progress, ASQ Quality Press, May 2001.
  • 27. 27© 2014 SunPower Corporation 9001 Vs PV QMS ISO 9001 QMS requirement • The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system • The organization shall apply suitable methods for monitoring of processes • The organization shall continually improve the effectiveness of the quality management system through the use of analysis of data, corrective and preventive actions PV QMS Requirement • Use appropriate statistical tools and statistically significant sample sizes to make decisions that affect quality of process and products at all stages of the lifecycle • Use of error proofing, Statistical process Control, control plan, Failure mode effects analysis, and 8 Discipline methodology to build PV modules with consistent quality and reliability • Controls: – Process FMEA – Poke Yoke – Control Plan – SPC – 8D methodology
  • 28. 28© 2014 SunPower Corporation What is next in ISO 9001 (2015)?  Standard becoming more generic to cater all industry types including service sector. Mandatory documentation requirements for some process go away (Even more so why we need PV Industry specific QMS!)  Risk management-leveraged with leadership managing risks when making organizational decisions. (adding good foundation)  Specific requirements for adopting the process approach*. (adding good foundation) (Standard currently at the Committee draft stage. Draft standard expected by April 2014) PV QMS Standard expected timeline – June 2015 *See appendix
  • 29. 29© 2014 SunPower Corporation PV QMS future Possibilities (Brainstorm ideas)  PV design, manufacturing and service metrics periodic submission to a vetted third party for analysis and publication of Best in class, top decile, median values (with anonymity- double blind process) for industry benchmarking  PV QMS extended to suppliers of “key materials”  PV QMS transition to PV IMS “Integrated Management system” to include Environmental, occupation health and safety requirements for PV manufacturing  Graded approach to PV QMS audit outcome based on maturity levels. Audits go beyond compliance  Exchange of epidemic failure information by PV technology  Benchmark QMS practices with other well established industry sectors (e.g. Automotive, Telecom, Aerospace)
  • 31. 31© 2014 SunPower Corporation References, Bibliography & Acknowledgements  References:  ISO 9001:2008 Quality Management System requirements  82/800/NP- Guideline for increased confidence in PV module design qualification and type approval.  JIS Q 8901:2012- Terrestrial photovoltaic (PV) modules -- Requirement for reliability assurance system (design, production and product warranty)  Bibliography:  ISO 19011:2011 Guidelines for auditing management systems  Tip of the iceberg- Quality Progress article, May 2001  Acknowledgement:  Ms. Sarah Kurtz, Reliability Group Manager, Principal Scientist, PhD, National Renewable Energy Laboratory, Golden, CO 80401  Task Group 1 International team members  SunPower Corporation, San Jose, CA USA Quality, Reliability & Management
  • 32. 32© 2014 SunPower Corporation BACK UP SLIDES
  • 33. 33© 2014 SunPower Corporation Nuggets in the ISO 9001 notes (Items gets pushed to notes during standards review)  Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements  The extent of the quality management system documentation can differ from one organization to another due to the size of the organization and type of activities, the complexity of processes and their interactions, and the competence of personnel  Conformity to product requirements can be affected directly or indirectly by personnel performing any task  Design and development review, verification and validation have distinct purposes  Customer property can include intellectual property and personal data  Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use  In some industry sectors, configuration management is a means by which identification and traceability are maintained
  • 34. 34© 2014 SunPower Corporation *Process Approach Systems / Processes Inputs Outputs Outcomes Product or Service End-userSupplier Machines Methods MaterialPeople Environment Reference : Elsmar.com Audit guide PPT