00:00 – Greetings, mentioning Renaud’s recent trip to India to check out component suppliers.

01:55 – Introducing the topic: Why Quality Assurance is particularly important for new electronics that have a lot of risks.

New electronic products almost always come with more risks, mechanical elements and parts that need to be dimensionally and aesthetically correct, electronic parts and firmware must work together, faulty components might make their way into the product, manufacturing processes might be defective causing delays, quality problems, and scrap, testing processes might have problems that make them miss non-conforming products, reliability testing may be deficient leading to breakdowns in the field, etc.

These risks need to be controlled, and there are many QA activities that need to happen to assure that your product gets produced with good quality, reliability, safety, etc. We base the following points on the QA program that we provide clients here at Sofeast.

Electronics QA Program

07:21 – Activities to do at the start of product development.

Many activities need to be taken when the product is being designed and early during its development to avoid problems caused by deficient design and testing much later on.

• Review the design files and confirm if the product can be manufactured, changes needed to reduce defect risks, scrap, for quality and reliability, component selection, etc
• Devise a relevant reliability and compliance testing plan for your product, for example, kitchen equipment might need to be compliant with food contact safety standards – to be documented so everyone understands what will happen
• Product design FMEA – discussed with the product designer to reduce risks in the product design
• Source components suppliers carefully, especially for critical components, to assure that they’re production-ready and of high enough quality – therefore suppliers need to be qualified with factory audits, background checks, etc
• Get quotes from testing labs for testing that cannot be done in-house, such as when a laboratory is needed for chemical analysis
• Develop custom plans where needed if specific standards are not applicable
• HALT testing on look like and work like prototypes

20:34 – Activities do when the design is frozen and we’re transferring to manufacturing.

If the product design is frozen and has been validated, our attention needs to turn to the manufacturing processes (of the manufacturer who does assembly, packing, and testing) to assure that problems won’t occur due to issues here either.

• Manufacturing risk analysis (FMEA) and process control plan need to be in place. Clear work instructions need to be made for the operators so they can be trained and do a good job
• Checking fixtures for assembly and PCBA functional test stations, and go no-go gauges need to be made and set up as early as possible
• Pilot runs need to be planned with objectives given and then conducted to validate that production and testing processes work and the components are as expected (essential before a lot of money is spent on large batches of components for mass production). The more complex the product, the more pilot runs are required for validation
• Create the technical file for proving product compliance – up-to-date versions of drawings with changes stemming from validation work need to be obtained by all parties, no one keeps them ‘secret’

27:49 – Activities to do during mass production.

As mass production starts and during the following is suggested to assure that the manufacturer is ready.

• A production readiness review can be done at the start to check component quality, assembly line and testing stations are ready, work instructions are up-to-date and operators are familiar with them, etc
• Check what kind of testing will be done and what defects are supposed to be found, does the manufacturer’s plan make sense?
• Check finished products starting with a first article inspection and correct any issues with the manufacturer before it’s too late and then perform regular random sampling inspections during production on the products and check the packaging
• Samples to be picked for performance and reliability testing in the lab
• Failure analysis can be conducted on defective samples to confirm exactly what is wrong and decide on countermeasures

31:08 – Wrapping up.