DfR in Huntsville, AL and Atlanta, GA (February 16)
DfR Solutions will be visiting companies in Huntsville, AL and Atlanta, GA in mid-Febuary. If you and your associates are interested in an onsite visit and/or presentation, please contact Carrie Sharik-Ernest at csharik@dfrsolutions.com or Vaughn Carlson at vaughanc@valueeng.com.
Sunday, January 31, 2010
Wednesday, January 27, 2010
DfR at RAMS and Chesapeake, MD iMAPS This Week
RAMS (San Jose, CA: January 25-27)
Jim McLeish, CRE, will be in San Jose, CA, at the Reliability and Maintainability Symposium (RAMS) in late January. Jim will be presenting a paper entitled, " Enhancing MIL-HDBK-217 Reliability Predictions with Physics of Failure (PoF) Methods," in which he will discuss potential enhancements to the handbook using Physics of Failure methods.
IMAPS Chesapeake Conference Meeting (Columbia, MD: January 27)
Dr. Craig Hillman will be presenting " Manufacturing and Reliability Challenges with QFN Packages in Pb and Pb-Free Environments,” at the upcoming IMAPS conference. For more information on this topic, please contact Craig Hillman at chillman@dfrsolutions.com
Jim McLeish, CRE, will be in San Jose, CA, at the Reliability and Maintainability Symposium (RAMS) in late January. Jim will be presenting a paper entitled, " Enhancing MIL-HDBK-217 Reliability Predictions with Physics of Failure (PoF) Methods," in which he will discuss potential enhancements to the handbook using Physics of Failure methods.
IMAPS Chesapeake Conference Meeting (Columbia, MD: January 27)
Dr. Craig Hillman will be presenting " Manufacturing and Reliability Challenges with QFN Packages in Pb and Pb-Free Environments,” at the upcoming IMAPS conference. For more information on this topic, please contact Craig Hillman at chillman@dfrsolutions.com
Tuesday, January 26, 2010
DfR Solutions Welcomes Dr. Randy Kong
DfR Solutions is proud to announce the hiring of Dr. Randy Kong, an industry renowned expert in the fields of process reliability qualification, component engineering, and meeting OEM reliability requirements. Prior to joining DfR Solutions, Dr. Kong was responsible for establishing a failure analysis lab through his work at Hewlett-Packard. Most recently at Microsoft, Randy co-founded the reliability engineering group for the hardware division, led the development of a component engineering database which captured application-specific requirements, and established quality/reliability processes which emphasized DfX principals. Randy holds a BS in Electrical Engineering from Tsinghua University and has a Ph.D. in Physics from the Graduate Center of City University of New York.
For more information or to schedule an onsite visit at your facility, please contact Dr. Kong at rkong@dfrsolutions.com.
For more information or to schedule an onsite visit at your facility, please contact Dr. Kong at rkong@dfrsolutions.com.
Monday, January 25, 2010
Cheryl Tulkoff appears in Advancing Microelectronics 2009, Issue 6 November/December
On page 35, a photo of me giving a presentation to the Central Texas Chapter on "Manufacturability and Reliability Challenges with QFN" made it into the new iMAPS Advancing Microelectronics magazine.
The November/December 2009 issue features 4 technical articles on: NanoBond Assembly - A Rapid, Room Temperature Soldering Process; Can Current EDA Packaging Tools Meet the Demands of Ever-Changing 3D Packaging Technologies?; Thermal Management for LED Pico Projectors; and Conformal 3D Electronics: the Future of Consumer and Medical Products.
A link to the magazine can be found by clicking here.
For more information of future Central Texas events, please click HERE.
The November/December 2009 issue features 4 technical articles on: NanoBond Assembly - A Rapid, Room Temperature Soldering Process; Can Current EDA Packaging Tools Meet the Demands of Ever-Changing 3D Packaging Technologies?; Thermal Management for LED Pico Projectors; and Conformal 3D Electronics: the Future of Consumer and Medical Products.
A link to the magazine can be found by clicking here.
For more information of future Central Texas events, please click HERE.
Sunday, January 24, 2010
DfR QFN articles ranked as "Most Popular Articles of 2009" in SMT Week!
Our two QFN articles ranked as the "Most Popular Articles of 2009" in SMT Week. To read them or to read any of the other popular articles you may have missed, check out the following link:
SMT Weekly Newsletter
SMT Weekly Newsletter
Monday, December 21, 2009
The Tin Commandments - Just in Time for the Holidays!
The Tin Commandments
Copyright © DfR Solutions, College Park, MD, 2009 All Rights Reserved.
1. Thou shalt have no Lead (Pb) in the solder for EU (among other) applications.
The European Union, the USA, most industrialized Asian nations, etc., all require that all commercial products to be sold in their Countries must have hazardous materials (like Mercury and Lead) removed from PC Boards. The deadline for compliance was 2006 with elimination of some exemptions forthcoming. The most common Pb-free solder alloys consist mostly of tin with small additions of silver an copper. Some question why the electronics industry, which accounts for less than 0.1% of the lead in land-fills, was targeted by the EU. It matters not, since the train has now left the station. Even exempt industries such as telecommunications, medical, and the military are finding it increasingly difficult to continue using Pb.
2. Thou shalt not make Tin (Sn) whiskers that will cause short circuits.
Pure Tin tends to make “whiskers”, a short growth from the main body of Tin, and small Tin lands make the whiskers grow the most. Historically 1-2% Lead (Pb) was used to prevent whiskering in tin coatings. Various methods are used to mitigate whisker growth without use of Pb but the only way to prevent it is use coatings such as Pd or Au.
3. Thou shalt not take Pb-free ball grid array components and solder them onto a Pb-based solder pad.
Though it is not impossible to achieve a reliable mixed solder joint, the component must reach 230°C to do so. The PCB and other components must be designed to survive the higher temperature.
4. Remember the Sabbath Day (and 2nd and 3rd shift workers).
Building high quality products with Pb-free solder requires consistently hitting a much more narrow process window. Your off hour workers must be trained just as well as the 1st shift workers.
5. Honor thy supplier qualification and process control requirements.
In order to ensure that you get the materials you specify, trust the documentation from your suppliers.
6. Thou shalt not kill your boards with the higher temperatures in reflow ovens in a Lead-free application.
Notice that the temperature difference in most SMT re-flow ovens between a Leaded Solder and a Lead-free Solder is about 35 degrees C. Specifying the appropriate board properties is critical to prevent delamination, warping, cracked vias, or worse. Components must also be specified to survive reflow conditions (JST-020C should be followed religiously).
7. Thou shalt not mate female Gold connectors with male Tin connectors (or vice versa).
The reason for this is because of the inter-metallic that is made between Gold and Tin (or a solder Tin alloy) when they are repeatedly rubbed together. Build up of this inter-metallic can cause an open connection. If you need a good connection, use gold with gold. Tin with tin is also acceptable for applications where fretting is not a concern.
8. Thou shalt not steal published quality and reliability data.
Since your environment is unique to you, don’t expect to get similar results when you application differs from that of published reports.
9. Thou shalt not bear with the same rework standards after going Lead-free.
Experience shows that the re-work stations in most PC Board manufacturing facilities are often overlooked as an essential area that must be controlled. Hitting the small process window requires well controlled rework profiles and often new equipment. “Touch up” areas are becoming extinct because of the extra heat of the solder iron that’s required in a Lead-free process. The quality of all rework processes should be validated with close inspection.
10. Thou shalt not covet the Tin mines in China, Indonesia, and South America.
It’s true that our planet’s main resources for Tin are in China (40%), Indonesia (20%) and South America (20%) and yet it seems that Chinese companies are buying up another Tin mine every week. Tin is available in mines across our world, but the best mines are not in the Americas or Europe.
Copyright 2009 by DfR Solutions and VALUE Engrafting. All Rights Reserved.
Copyright © DfR Solutions, College Park, MD, 2009 All Rights Reserved.
1. Thou shalt have no Lead (Pb) in the solder for EU (among other) applications.
The European Union, the USA, most industrialized Asian nations, etc., all require that all commercial products to be sold in their Countries must have hazardous materials (like Mercury and Lead) removed from PC Boards. The deadline for compliance was 2006 with elimination of some exemptions forthcoming. The most common Pb-free solder alloys consist mostly of tin with small additions of silver an copper. Some question why the electronics industry, which accounts for less than 0.1% of the lead in land-fills, was targeted by the EU. It matters not, since the train has now left the station. Even exempt industries such as telecommunications, medical, and the military are finding it increasingly difficult to continue using Pb.
2. Thou shalt not make Tin (Sn) whiskers that will cause short circuits.
Pure Tin tends to make “whiskers”, a short growth from the main body of Tin, and small Tin lands make the whiskers grow the most. Historically 1-2% Lead (Pb) was used to prevent whiskering in tin coatings. Various methods are used to mitigate whisker growth without use of Pb but the only way to prevent it is use coatings such as Pd or Au.
3. Thou shalt not take Pb-free ball grid array components and solder them onto a Pb-based solder pad.
Though it is not impossible to achieve a reliable mixed solder joint, the component must reach 230°C to do so. The PCB and other components must be designed to survive the higher temperature.
4. Remember the Sabbath Day (and 2nd and 3rd shift workers).
Building high quality products with Pb-free solder requires consistently hitting a much more narrow process window. Your off hour workers must be trained just as well as the 1st shift workers.
5. Honor thy supplier qualification and process control requirements.
In order to ensure that you get the materials you specify, trust the documentation from your suppliers.
6. Thou shalt not kill your boards with the higher temperatures in reflow ovens in a Lead-free application.
Notice that the temperature difference in most SMT re-flow ovens between a Leaded Solder and a Lead-free Solder is about 35 degrees C. Specifying the appropriate board properties is critical to prevent delamination, warping, cracked vias, or worse. Components must also be specified to survive reflow conditions (JST-020C should be followed religiously).
7. Thou shalt not mate female Gold connectors with male Tin connectors (or vice versa).
The reason for this is because of the inter-metallic that is made between Gold and Tin (or a solder Tin alloy) when they are repeatedly rubbed together. Build up of this inter-metallic can cause an open connection. If you need a good connection, use gold with gold. Tin with tin is also acceptable for applications where fretting is not a concern.
8. Thou shalt not steal published quality and reliability data.
Since your environment is unique to you, don’t expect to get similar results when you application differs from that of published reports.
9. Thou shalt not bear with the same rework standards after going Lead-free.
Experience shows that the re-work stations in most PC Board manufacturing facilities are often overlooked as an essential area that must be controlled. Hitting the small process window requires well controlled rework profiles and often new equipment. “Touch up” areas are becoming extinct because of the extra heat of the solder iron that’s required in a Lead-free process. The quality of all rework processes should be validated with close inspection.
10. Thou shalt not covet the Tin mines in China, Indonesia, and South America.
It’s true that our planet’s main resources for Tin are in China (40%), Indonesia (20%) and South America (20%) and yet it seems that Chinese companies are buying up another Tin mine every week. Tin is available in mines across our world, but the best mines are not in the Americas or Europe.
Copyright 2009 by DfR Solutions and VALUE Engrafting. All Rights Reserved.
Thursday, November 12, 2009
Quality & Regulatory Environment in Medical Device Industry
I attended this ASQ presentation in Austin on Thursday, November 11th. I found the presentation very informative and quite illuminating. Some highlights are outlined in the next few bullets.
Description of Event:Speaker: Evangeline Loh, Ph.D., RAC (US, EU), Emergo Group
The medical device industry is estimated to be a $210 billon dollar industry, (1). The definition of a medical device varies slightly around the world. The US is the largest market in both consumption and production (40% total market consumption). Japan is the next largest, and then Germany. This presentation will provide a brief overview of the global regulations for medical devices. In particular, the following countries/markets will be included: US, EU, Japan, Australia, China, and Canada. The quality system required for manufacturers will be discussed as well as medical device definitions and classifications. Harmonization has become a recent objective of the medical device industry and information on these endeavors will be provided.
(1) Acmite Market Intelligence, Study: World Medical Device Market
Key Takeaways:
Surprisingly, there is not a good, uniform definition of what exactly a medical device is. There is also an increasing overlap in technologies combining medical devices with biologics or drugs. Example: Stent coated with antibiotics. How the device is regulated depends upon the primary function of the product. In the example above, since the stent is performing the primary function of holding a blood vessel open, it is regulated in the US a a medical device. If the primary function was to deliver medication, it would be regulated as a drug. This is becoming an extremely complex area of regulation.
Worldwide, the two most commonly accepted medical device standards are ISO 13485 (EU) – Medical Devices, Quality Management Systems and FDA 21 CFR Part 820 (US) – Good Manufacturing Practices for Medical Devices. The ISO standard is the most widely accepted worldwide but is not currently recognized by the US. The two standards are ~ 95% equivalent.
There is a Global Harmonization Task Force (GHTF) currently issuing guidelines for a common worldwide structure for regulating medical devices.
Worldwide, there are two basic regulatory schemes for medical devices.
US Model:
Basic classes of devices identified
Specific letter codes to identify products very specifically
May hinder innovation since new/novel products require a longer process to have a letter code created for the device in addition to the other regulatory devices
Quality management system and registration required
Good Management Practices (GMR)
Ongoing compliance mandatory, FDA 21 CFR Part 820
Frequency of audits based on classification
CAPA feedback
Design controls
EU Model
CE marking is the ultimate goal
De facto expectation to annually certify to ISO 13845
Basic classes of devices identified
Broad letter codes that are more functional than specific in nature, generic rules not prescribed categories
Thought to allow more rapid approval of new/novel devices
Risk management required
Essential requirements identified
Labeling + Language requirements
Technical files
Design Controls
Clinical evaluation
Traditionally easier/faster to get certified in Europe than in the US
In the US, there are three broad classes of medical devices – Class I, Class II, and Class III. A class I device example is a toothbrush. Class II – stent, infusion pump. Class III – implantable heart pump
Compliance to the FDA standard is managed by:
Device submission material
FDA audits/inspections
Form 483 / warning letters
Adverse Event reporting system
Typical new approval process takes 1 year or more but is considered relatively efficient by worldwide standards.
Even the highest risk Class III device manufacturers only get audited by the FDA once every 2 years on average. The FDA can issue warning letters or non-compliance letters based on severity of issues found.
Device changes require FDA notification. There is an FDA flowchart detailing change requirements based on device type and significance of change made.
Reliability is never explicitly mentioned.
Design requirements are as follows:
Design Input, Design Output, Design review, Design verification, Design validation, design transfer, design changes, design history file. No specific testing recommendations or requirements are identified (types of tests, # of units tested, success rates, etc.).
Quality is handled via the Quality Management System requirements. Again. there are no hard and fast rules only general guidelines.
Statistics / sampling plans / CAPA feedback are required but no goals or requirements or set. The system seems to encourage setting a low bar on quality since the audits are keyed on attaining goals that were set.
Although there is some recognition of risk versus reward in the US, Europe gives greater consideration to this aspect. Example: All medical devices pose an inherent risk to the patient. Even relatively simple ones like catheters can cause death due to blood stream infection. For more complex cases like heart pumps, the device risk may be higher but the patient’s risk of non action is also higher. This is giver greater consideration in Europe than in the US.
Interestingly, ISO 13485 does not seem to require continuous improvement like ISO 9001. It does require implementation and maintenance of a quality management system.
The end result is a product CE marking followed by 4 digits with identify the notified body.
Classes I, II, and II with codes MDD (medical), VDD (in vitro), and AIMDD (active implantable, implantable)
EU makes a distinction between “cosmetic” and “medical” devices. Toothbrushes, wrinkle creams, etc are considered cosmetic and not regulated in the same manner.
ISO 13485 is specific to medical devices. It contains the elements of ISO 9001 plus:
Cleanliness requirements
Risk management
Post market surveillance requirements
Implantable requirements
Description of Event:Speaker: Evangeline Loh, Ph.D., RAC (US, EU), Emergo Group
The medical device industry is estimated to be a $210 billon dollar industry, (1). The definition of a medical device varies slightly around the world. The US is the largest market in both consumption and production (40% total market consumption). Japan is the next largest, and then Germany. This presentation will provide a brief overview of the global regulations for medical devices. In particular, the following countries/markets will be included: US, EU, Japan, Australia, China, and Canada. The quality system required for manufacturers will be discussed as well as medical device definitions and classifications. Harmonization has become a recent objective of the medical device industry and information on these endeavors will be provided.
(1) Acmite Market Intelligence, Study: World Medical Device Market
Key Takeaways:
Surprisingly, there is not a good, uniform definition of what exactly a medical device is. There is also an increasing overlap in technologies combining medical devices with biologics or drugs. Example: Stent coated with antibiotics. How the device is regulated depends upon the primary function of the product. In the example above, since the stent is performing the primary function of holding a blood vessel open, it is regulated in the US a a medical device. If the primary function was to deliver medication, it would be regulated as a drug. This is becoming an extremely complex area of regulation.
Worldwide, the two most commonly accepted medical device standards are ISO 13485 (EU) – Medical Devices, Quality Management Systems and FDA 21 CFR Part 820 (US) – Good Manufacturing Practices for Medical Devices. The ISO standard is the most widely accepted worldwide but is not currently recognized by the US. The two standards are ~ 95% equivalent.
There is a Global Harmonization Task Force (GHTF) currently issuing guidelines for a common worldwide structure for regulating medical devices.
Worldwide, there are two basic regulatory schemes for medical devices.
US Model:
Basic classes of devices identified
Specific letter codes to identify products very specifically
May hinder innovation since new/novel products require a longer process to have a letter code created for the device in addition to the other regulatory devices
Quality management system and registration required
Good Management Practices (GMR)
Ongoing compliance mandatory, FDA 21 CFR Part 820
Frequency of audits based on classification
CAPA feedback
Design controls
EU Model
CE marking is the ultimate goal
De facto expectation to annually certify to ISO 13845
Basic classes of devices identified
Broad letter codes that are more functional than specific in nature, generic rules not prescribed categories
Thought to allow more rapid approval of new/novel devices
Risk management required
Essential requirements identified
Labeling + Language requirements
Technical files
Design Controls
Clinical evaluation
Traditionally easier/faster to get certified in Europe than in the US
In the US, there are three broad classes of medical devices – Class I, Class II, and Class III. A class I device example is a toothbrush. Class II – stent, infusion pump. Class III – implantable heart pump
Compliance to the FDA standard is managed by:
Device submission material
FDA audits/inspections
Form 483 / warning letters
Adverse Event reporting system
Typical new approval process takes 1 year or more but is considered relatively efficient by worldwide standards.
Even the highest risk Class III device manufacturers only get audited by the FDA once every 2 years on average. The FDA can issue warning letters or non-compliance letters based on severity of issues found.
Device changes require FDA notification. There is an FDA flowchart detailing change requirements based on device type and significance of change made.
Reliability is never explicitly mentioned.
Design requirements are as follows:
Design Input, Design Output, Design review, Design verification, Design validation, design transfer, design changes, design history file. No specific testing recommendations or requirements are identified (types of tests, # of units tested, success rates, etc.).
Quality is handled via the Quality Management System requirements. Again. there are no hard and fast rules only general guidelines.
Statistics / sampling plans / CAPA feedback are required but no goals or requirements or set. The system seems to encourage setting a low bar on quality since the audits are keyed on attaining goals that were set.
Although there is some recognition of risk versus reward in the US, Europe gives greater consideration to this aspect. Example: All medical devices pose an inherent risk to the patient. Even relatively simple ones like catheters can cause death due to blood stream infection. For more complex cases like heart pumps, the device risk may be higher but the patient’s risk of non action is also higher. This is giver greater consideration in Europe than in the US.
Interestingly, ISO 13485 does not seem to require continuous improvement like ISO 9001. It does require implementation and maintenance of a quality management system.
The end result is a product CE marking followed by 4 digits with identify the notified body.
Classes I, II, and II with codes MDD (medical), VDD (in vitro), and AIMDD (active implantable, implantable)
EU makes a distinction between “cosmetic” and “medical” devices. Toothbrushes, wrinkle creams, etc are considered cosmetic and not regulated in the same manner.
ISO 13485 is specific to medical devices. It contains the elements of ISO 9001 plus:
Cleanliness requirements
Risk management
Post market surveillance requirements
Implantable requirements
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