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) 12
D Would Design & Process FMEA (PCBA) be sufficient to fulfill requirement of Cl 7.1? ISO 13485:2016 - Medical Device Quality Management Systems 2
D PCBA was swollen after SMD Manufacturing and Related Processes 12
M REACH assessment of PCBA/finished product REACH and RoHS Conversations 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
C Handling in-Process Defect Repairs Nonconformance and Corrective Action 3
B How to satisfy clause 5.7.1.5 process validation for valve production API 6D Oil and Gas Industry Standards and Regulations 13
C Change Management Process ISO 14971 - Medical Device Risk Management 8
B Documents for production process IATF 16949 - Automotive Quality Systems Standard 8
J Process Capability - Determining the process capability of certain equipment Lean in Manufacturing and Service Industries 6
Z E-Coating process International Specifications? FMEA and Control Plans 3
W CQI-15 for new welding process IATF 16949 - Automotive Quality Systems Standard 3
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
M Process & Product Characteristic in Control Plan FMEA and Control Plans 17
S Consolidated Analysis Report for Moulding Process Manufacturing and Related Processes 1
P ISO 11607-2 Process Specification Other Medical Device Related Standards 1
Q Best off presentation of process flows Process Maps, Process Mapping and Turtle Diagrams 16
Q Logistics process flow ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Process FMEA for Laser Cutting/Press Brake/Welding FMEA and Control Plans 2
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
F Is this misuse of the MRB process? Manufacturing and Related Processes 7
L Product and process Deviation procedure Manufacturing and Related Processes 1
Ch00Ch00 How to evaluate a process ? Document Control Systems, Procedures, Forms and Templates 3
M Implants made by Additive Manufacturing process approved by USFDA Other Medical Device and Orthopedic Related Topics 1
Q Process Key figures and reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Ch00Ch00 Evaluate a process - Issue number Lean in Manufacturing and Service Industries 7
F Rules of process outsourcing in China China Medical Device Regulations 1
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
P Certification process for registered device China Medical Device Regulations 12
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Melissa Process Validation of Rotary Heat Sealer Speeds Design and Development of Products and Processes 4

Similar threads

Top Bottom