SBS - The best value in QMS software

PCBA process validation

#1
Hi,
I work for a Medical Device Startup, and we are in the process of identifying our Process Validation Requirements.
I know that the FDA identified soldering as a "special process", but I wanted to see if anyone knows if this applies to PCBs assembly? If so, do we need to validate the assembly process for each of our PCBAs, or is it sufficient that the process at the Contract Manufacturer (who uses standard equipment for PCB assembly)?
Thanks
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Well, I was hoping someone would jump in but since nobody has yet, I'll give it a go.

Processes whose outputs are not 100% verified are expected to be validated. Is anything done to give assurance that each PCBA meets spec? Any scanning systems? Electrical tests? What about even later in the process where you might test the installed PCBA?

Stepping back a bit, how do you know the assembly process is set up correctly (e.g., maybe oven temperatures)? Just because you use standard equipment doesn't necessarily imply you're using it correctly!
 

outdoorsNW

Quite Involved in Discussions
#3
I work for a PCB assembly CM. Your PCB design and layout makes a big difference in how easily your finished PCB can be tested. A dedicated tester is best. A general purpose electrical tester is limited by the ability of its probes to touch the test points. The test probes we have are a bit smaller in diameter than a pencil and taper to a rounded point. Tall components can block access a lot of general purpose test equipment can't probe both sides at the same time. Of our three general purpose testers, only one has double side capability.

PCB design also impacts how difficult your board is to build. See the IPC-22xx Series for design guidelines. In a few cases, the IPC acceptance standards 600 and 610 apply different requirements to boards designed to 22xx series vs boards that are not.
 
Thread starter Similar threads Forum Replies Date
P SMT (Surface Mount Technology) and PCBA Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
U Validation of Wave Solder Process - PCBA for Medical Products Qualification and Validation (including 21 CFR Part 11) 7
D Would Design & Process FMEA (PCBA) be sufficient to fulfill requirement of Cl 7.1? ISO 13485:2016 - Medical Device Quality Management Systems 2
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
C PCBA Hardware Component different failure types - How to rate detection? FMEA and Control Plans 8
M PCBA Drawing Best Practices IPC Class 3 ISO 13485:2016 - Medical Device Quality Management Systems 1
alonFAI Determining PCBA Xray Test Sampling Size Statistical Analysis Tools, Techniques and SPC 1
S Who is doing BGA cross sectional analysis in assembled PCBA in INDIA? Reliability Analysis - Predictions, Testing and Standards 1
T Faulty PCBA - Our Testing Fails but Manufacturer's Testing Passes Supplier Quality Assurance and other Supplier Issues 2
D PCBA Lab Temperature & Humidity Requirements - Advice needed Manufacturing and Related Processes 7
N Off Shore Supplier PCBA REACH Reporting RoHS, REACH, ELV, IMDS and Restricted Substances 4
O PPAP Validation for Electronic Parts (PCBA) APQP and PPAP 6
T PCBA Verification and Testing Manufacturing and Related Processes 3
P Brightness Specification for PCBA Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Q Reliability of a Ferrite Inductor mounted on a PCBA Reliability Analysis - Predictions, Testing and Standards 1
Q PCBA Qualification Plan and Protocol example wanted Qualification and Validation (including 21 CFR Part 11) 1
H Basic questions about Installation, Operational & Performance Qualification - PCBA Qualification and Validation (including 21 CFR Part 11) 11
Q PCBA Visual Inspection Tools & Methods - discounting Optical Tools Manufacturing and Related Processes 11
N PCBA (Printed Circuit Board Assembly) Conformal Coating Material and Thickness? Reliability Analysis - Predictions, Testing and Standards 15
J Using Weibull to Calculate an Optimal PCBA Burn-In Test? Reliability Analysis - Predictions, Testing and Standards 4
P Can anyone help with ESD Protection (PCBA)? How is ESD generated? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
A When someone refuses to follow a process.... Misc. Quality Assurance and Business Systems Related Topics 17
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
R AS5553 Clause 3.1.7 f - "Implement a returns process....." AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
normhowe "The Problem with Quality Management: Process orientation, controllability and zero-defect processes as modern myths" Book, Video, Blog and Web Site Reviews and Recommendations 2
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Process mapping Process Maps, Process Mapping and Turtle Diagrams 1
R MDEL Process Canada Medical Device Regulations 4
optomist1 Rates Daily or Hourly Process Improvement Training Consultants and Consulting 2
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
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 17

Similar threads

Top Bottom