SBS - The Best Value in QMS software

AS9102B - 3.6 Design Characteristics and form 3

#1
Hi,

We are electronic boards assembly company, dealing with components assemblies and integration. We perform FAI for following customers requests. I would like to understand if Form 3 is applicable for us, because we are not dealing with design characteristic and we are not inspecting dimensions and tolerances.

thanks
 
Elsmar Forum Sponsor

John Predmore

Trusted Information Resource
#2
The instructions for AS9102B for item 3.6 Design Characteristics describes these as "dimensional, visual, function, mechanical and material features or properties ... as specified by drawing or other requirements." You say you are not inspecting dimensions and tolerances on your electronic boards, but any requirement in your customer's specification, whether you design it or not, whether there is a dimensional drawing or not, should be listed on Form 3 in order to be thorough. Paragraph 3..6 goes on to say "Material features or properties include processing variables and sequences... that could not be otherwise" verified in the final assembly.

I listed the customer's requirements, verbatim, for packaging and labeling on my FAIR, as pass/fail requirements. Because I made a thorough list, that is my assurance that we don't overlook or misinterpret even a mundane requirement, like which corner of the box the label goes on.

I told one supplier I worked with, they had to first article inspect Diode orientation. They asked why, the diodes come from the manufacturer oriented in trays and are inserted automatically, untouched by human hands. I explained a First Article Inspection Report is a one-time check, and that is our assurance against somebody somewhere making a mistake designing the trays or writing the work instructions or programming the robot, which would result in every assembly built with the diode reversed. It might take weeks before that dumb error was discovered, depending on the function of the diode. First Article Inspection is a Risk Reduction activity, and for some design characteristics, there is no more economical hedge against human error. The good news is, I only do the thorough inspection once, until the process changes.
 

outdoorsNW

Quite Involved in Discussions
#4
Print notes often contain inspectable information and should be on form 3. For instance, I sometimes see a note along the lines of Conformal coat with Humiseal XXX except for hatched areas(typically connectors and test points). The AS9102 inspector should verify that the board is coated and that any keep out areas were not coated. On form 3 the result should be compliant, pass, or similar (assuming no problems).

Also, if the boards arrive in an array and then you depanel them, customers expect you to check any dimension the depaneling could affect. Sometimes the score or mousebites were improperly located, sized, etc, and the single board will be dimensionally out of spec.
 
Thread starter Similar threads Forum Replies Date
M AS9102B Detail Part/Assembly FAI Form 1 box 13; AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R AS9102B - Do I need a new FAIR? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Design Traceability - Labelling / Instructions for Use ISO 13485:2016 - Medical Device Quality Management Systems 5
B How to exclude empty rows in full factorial design analysis? Using Minitab Software 0
M Handling design changes with use-as-is inventory disposition Quality Manager and Management Related Issues 6
M Design Control - Management of Electronic CAD files Design and Development of Products and Processes 11
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Significant change related to design and intended use EU Medical Device Regulations 3
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
U NOC - What is considered a "design change" EU Medical Device Regulations 5
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
L Design & Development of a SERVICE Service Industry Specific Topics 13
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
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
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom