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
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 4
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 3
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 3
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
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
K Problems with process equipment ISO 13485:2016 - Medical Device Quality Management Systems 4
W Need for current design or process control FMEA and Control Plans 2
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 6
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C OEE and In-process Inspection Manufacturing and Related Processes 2
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
V Informational SMMT IATF Oversight - OEM KPI Process IATF 16949 - Automotive Quality Systems Standard 4
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16

Similar threads

Top Bottom