00:00 – Greetings, introducing Andrew and the topic.

Businesses and entrepreneurs bringing a new product to market often don’t realise the scale of the tasks needed in order to do so with fewer quality and reliability risks. This episode serves as an introduction to the process and Andrew shares the one thing you MUST do.

02:25 – What’s the difference between validation and verification?

Validation is, basically, testing for different things that can affect the product negatively, so it might, for example, be drop testing, vibration testing, testing electronics, and FDA-level tests for food safety.

Verification is the conclusion and approval process you go through to analyze the data from the testing.

05:59 – What MUST you do before you go into mass production?

Qualification of the product is your must-do activity before you go into mass production. The NPI process includes:

• Qualifying design
• Qualifying suppliers and analyzing components
• Qualifying your product through different prototype builds
• Qualifying that the manufacturing line (including production processes) is able to produce the product quickly and properly
• Qualifying that the product complies with market regulations

Tests like drop tests will be done to validate whether the design meets the minimum operating conditions and what its limits are, assuring you that it’s reliable and good enough quality. Designers will use the test data to verify the design and fix issues that occur. After this, the design is considered ready and mature enough to move to the next step of the NPI process.

Validating and verifying suppliers and components by doing on-site audits is an important step in order to assure that what goes into the product is quality and reliable, such as components being able to handle heat if your product is meant for use in high temperatures. If you have validated and verified your components and suppliers you have also improved your design.

13:00 – Is a qualified design and prototype a golden sample?

A golden sample is a perfect demonstration of the product or component’s desired specification and performance that is used for reference by stakeholders (production operators, QC inspectors, etc), but to make 100% of production at that level would be very expensive. In fact, production units may on be able to deviate slightly from the golden sample specifications and still be acceptable because the tolerances involved won’t affect the look, quality, and usability of the product.

16:28 – Product qualification.

Product validation is where the validated design and components come together and you do different tests on the product builds, such as UX testing, reliability testing, assembly-level testing, software testing, etc, and then verify them.

18:05 – Manufacturing line qualification.

An NPI production line is set up and dedicated to new products and includes the more experienced team members (assembly, manufacturing and quality engineers, etc) who are expecting to find different problems. They will check that the line is set up properly and balanced, that jigs and automation required are used, timing the assembly process, etc. All of these tasks enable them to validate the line, finding bottlenecks and other issues which will then be resolved. The final result is a manufacturing line and production processes that are ready and it’s verified by timing the output and confirming that its quality and speed are acceptable.

21:02 – Compliance and regulatory qualification.

Products will have different regulatory and compliance requirements. Consumer electronics are likely to need to be compliant with FCC, Bluetooth, Prop 65, RoHS, etc, depending on which country they’re meant to be sold in. Not qualifying the product to comply could prevent you from being able to sell the product completely. It’s also better to do the validation testing after the Bill of Materials and design are fixed, as if something changes the compliance testing needs to be redone which could prove costly and slow you down.

24: 33 – How to get started with product qualification?

You need expertise in each area, reliability, software, etc. The teams work on the qualification of the product design and components throughout the development process. One issue occurs when the teams are in the West but the product development is happening in China or elsewhere in Asia, so it makes the process hard to manage. Staff will need to keep flying to Asia to work with the supplier on different aspects, but this can be costly and time-consuming (also difficult in China due to Covid restrictions). Another option is to work with a local third-party company there, like our contract manufacturing subsidiary Agilian, who will take over the entire process and manage it for you, devise and conduct testing, communicate results, etc. This is particularly helpful when a business lacks expertise in bringing new products to market and where access to China is limited.

27:40 – In summary. 

In order to go into mass production successfully, you need to qualify design, components, product, manufacturing, and compliance. Following a repeatable NPI process provides you with the structure to get it right and not miss any important qualification steps.