SBS - The best value in QMS software

Process, component or full product re-qualification: leaded to unleaded solder

#1
I was wondering whether you have any experience with moving a Printed Circuit Board Assembly (PCA) from a lead based soldering standard to a lead free soldering standard. Is it possible to do a process based re-qualification of the soldering process only or would you recommend to focus on the PCA as one part of the product? The third option we see is to re-qualify the product as a whole. Each of these appear to demand different types of tests.

At the moment I am looking at it from a form, fit and function consideration (reliability element). As form and fit appear not to be impacted we consider that potentially reliability considerations come into play here. Do you have any experience or are aware of any case studies, standards or suggestions on how to approach this in a concise way?
 
Elsmar Forum Sponsor

Miner

Forum Moderator
Staff member
Admin
#2
I cannot speak to the FDA regulatory aspects of your questions, but have gone through a conversion to lead free in order to comply with RoHS.

This conversion is a MAJOR issue. It is not easy, and a lot of unexpected problems WILL arise. The temperatures required to process lead free are higher, and some components (LEDs) are borderline in the ability to handle these temperatures. Lead free components and processing are less forgiving than leaded. This results in higher levels of defects and reliability problems until you get your process and product design dialed in.

In summary, do not try to minimize your re-qualification testing.
 
#3
Thank you very much. This is really helpful. The RoHS route is what we are looking into.
We have done a review of the components that are used on the PCA. The max. temperature of the components appear to work well with the higher temperatures of the lead free soldering. It appears on paper that we should be fine.
The main thing we are trying to get our head around is the reliability issue that appears to be always associated with the change. How do we qualify this as we couldn't do a multi year test to see whether certain chemical formations occur, which impact on reliability. Next to the higher soldering temperature is this the second most important thing to look into or are we missing anything here?
 

outdoorsNW

Quite Involved in Discussions
#4
In addition to the components, you need to check the max temperature and number of thermal cycles the PCB material can withstand. There still are a few materials available that are not suitable for typical lead free temperatures.
 

Miner

Forum Moderator
Staff member
Admin
#5
I am going from memory because I am not as close to that process as I once was. You may have to redesign your board layout to prevent tin whiskers. Some of the board finishes have a shorter shelf life due to oxidation in which to process them through the soldering operations. Be very careful in the selection and use of fluxes. Lead free does not wet as easily as lead solder and may cause components to shift or tombstone.
 

Jim Wynne

Staff member
Admin
#6
In addition to the issue of tin whiskers, when you're experimenting with different fluxes, be on the lookout for solder balls.
 

outdoorsNW

Quite Involved in Discussions
#7
Since you are switching solder, you will switching fluxes. For a high reliability application, no clean fluxes are higher risk because certain types can be reactivated if the device is ever exposed to condensation or other some other conditions. I read an article about this but can't find it right now. There are low activity water soluble fluxes (often low activity is why no clean is used in high reliability applications), but they are less common.
 
Thread starter Similar threads Forum Replies Date
A Is a Manufacturing Process Sheet required for each Component? Manufacturing and Related Processes 4
A Design FMEA, Process FMEA, Component FMEA --> FDA requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
R Process FMEA Applicability for an Electronic Component FMEA and Control Plans 2
B Toyota PPAP Process - Three Questions APQP and PPAP 3
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
V Laser Welding Process - Impact on Electrical Properties Reliability Analysis - Predictions, Testing and Standards 4
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
N Riveting - special process Manufacturing and Related Processes 11
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 15
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
D Measurables for Plastic Injection molding process Manufacturing and Related Processes 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
R Inspection and Work order process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Two excellent examples of process capability analysis from Quality Magazine Capability, Accuracy and Stability - Processes, Machines, etc. 5
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Error Proofing Label process Manufacturing and Related Processes 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 6
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3

Similar threads

Top Bottom