What would a QA program that you put in place to improve the quality, reliability, and compliance of new electro-mechanical products ideally include? Find out here!
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Why do you need a QA auditing and inspection program?
In a nutshell, you will implement a program of QA audits and inspections like this to ensure that your supplier will do a good job for you. If this is important, you need to be doing QA checks from the end of the product design phase and throughout as the new product is industrialized and goes into production.
If you’re working with a factory that has made very similar or the same types of products as yours, they’re used to your kind of quality standard and they have a proven ability to test and inspect the products correctly, maybe bringing in outside assistance, such as from Sofeast, isn’t as necessary as the risks of them making mistakes and doing a poor job are minimal, especially for simpler products. The experience effect is very strong in manufacturing, so if they have experience your risk of them doing a bad job is reduced.
However, a great many manufacturers in China, India, Vietnam, etc, are not very strong at industrializing (going from prototype to mass production while reaching your cost and quality expectations) an innovative new product that has never been made before and are more likely to make costly errors during the NPI process. Even larger manufacturers who work for big brands may not do a great job for you unless you’re placing very large orders, as their best people won’t be on your project. So for many listeners, putting in place a QA auditing and inspection program should occur when the final pre-production and pre-tooling prototype is being made. (01:37)
#1. A DFM review of some components (especially custom-designed).
Many electro-mechanical products include a custom-designed enclosure from injection molded plastic, for example. For parts like this if you do not follow production best practices you will face quality issues, and while your manufacturer may be informed about adding draft angles for easy removal, you also need to check the design files and anticipate manufacturing problems that might occur such as scratches, burns, warping of long parts, etc. For metal parts, it’s the same story when it comes to DFM reviews, too. Die-cast parts might need ribs, anodising, painting, specific tolerances, etc, and a review will check all of these. A proper DFM review will often prevent serious issues by pointing out risks and suggesting improvements at an early stage, and since product design tends to be responsible for a lot of issues, if these can be addressed before tooling is made it’s far cheaper and faster to fix them. (06:53)
#2. A quality system audit of suppliers’ factories.
Focus on your critical components here, such as battery, display, actuator, etc. They may need tight tolerances. What are the main risks and how can they be controlled and prevented if possible? If the suppliers have good quality systems and mature experience and processes, that’s a good sign. But if you send an auditor and they inform you that the supplier is working less professionally, with no real quality system, few inspectors, little documentation, and a lack of in-house equipment to do important testing, this means you will need to work more closely with your main assembly supplier to do incoming QC. Such as to ensure that they have the right checking processes, fixtures, and gauges, etc, to check the quality, because you can’t rely on the component supplier to do so. You may even want to place your own QC inspector at the key component supplier’s factory to catch issues before parts go out of the door. Without auditing the supplier’s factory you will not know that you need to take action.
Also for some components such as power supplies, you will want them to be pre-certified to certain regulatory compliance standards, but to ensure that they are you will need to run a check on the technical documentation as from product to product there can be key differences. One mistake here could be the difference between your product being compliant or being banned from sale in your market due to safety concerns, so getting experienced engineers to check the standards and documentation for the components to confirm compliance can be a lifesaver. The same for reliability, are there documented results demonstrating the components’ reliability testing success? If the suppliers can’t tell you anything about their components’ reliability you run the risk of unreliable products that fail when customers use them. (10:50)
Are market surveillance authorities scrutinising product compliance more than before?
In the EU there are more demands on compliance and sustainability than before, for example, the ecodesign regulation. In the USA there are also movements in that direction, for example, now there are moves afoot to make Amazon bear responsibility for the compliance of products sold on its platform there which will no doubt lead to them requiring their vendors (i.e. you if you sell there) to provide proof of compliant products (this is already the case for Amazon in the EU). So ensuring that you have a good understanding of your products’ compliance requirements is ever more important and you may need to seek expert help to ensure that you don’t run into trouble accidentally. (18:00)
#3. Production line preparation audit at the assembly factory.
Importers generally have a ‘main supplier’ who does assembly and maybe upstream processes like plastic injection molding and PCBA. This supplier will gather all of the components from various sources and have a plan to assemble the products in a way that will reach your expectations. There is a lot to get right before mass production, especially when you’re bringing a new product to market that they haven’t worked on before. So you need to know that they are ready for this challenge and have prepared accordingly, and this is where an audit on the production line at the factory comes in handy.
A rough checklist of activities for the assembly factory audit might include the following (although this can change per project and supplier):
- Document your requirements (quality standard) and specifications sent to custom component suppliers: anything obviously missing (tolerances, materials, type of finish…)?
- Incoming QC has been done appropriately? Do they have the right equipment and a clearly documented standard about the key topics to look for? Plan for testing stations and staff to start work?
- The physical layout of the assembly, testing, and inspection process is already prepared?
- Work instructions for the assembly, testing, and inspection process are ready?
- Product testing plan: is it ready?
- Is there a control plan? Does its content match the above-mentioned work instructions and testing plan?
- Is there a list of issues the factory encountered during the engineering build? Will the factory keep it up to date during the first production run?
- Is there a list of risks, and have the highest risks led to an action plan?
- Quality standard, approved samples: is it appropriate? Anything missing? Will production operators and quality inspectors have access to them? (21:13)
#4. A product inspection during the pilot run(s).
For new innovative products, you don’t go straight into mass production. There will be a pilot run or runs where production is tested and ramped up of both components and products. During this period there will be inspections, and they can happen at 2 levels:
- The pilot run of a custom component – the focus is on detecting quality issues but also counting first-time good parts and reworked/scrapped parts (to know the yield). The risk analysis of earlier factory audits on custom component suppliers will dictate whether this is necessary.
- The assembly factory – someone goes on-site with a focus on detecting issues and looking into the top 1 or top 2 issues in more detail. A first article inspection is especially helpful to thoroughly check the initial products and spur changes where necessary before large volumes come off the line. (28:46)
#5. Final product inspections during and after production.
The key here is to check the products coming off the line during mass production before shipment and detect any quality issues found by doing product inspections which can then be fed back to production rapidly for the problems to be worked on. Doing these inspections on random samples of packaged products in the factory before shipment is far cheaper than it would cost to solve the problem of defective products that have been shipped and delivered to you around the world.
Product reliability and consistency between batches, and traceability, are also key topics here for inspectors, and sending samples picked at random to testing labs for ORT (ongoing reliability testing) will help you confirm that there are no significant differences between the product and your requirements now that it’s in mass production. This is a safety net that can catch problems between batches. (33:12)
- Explore Sofeast factory audits and product inspections
- Documenting Your Company’s Quality Standard into the Details
- What Is A Quality Assurance Plan?
- Product Quality Checklist: How To Prepare It
- How To Choose Which Factory Audit You Need?
- How To Choose Which Product Quality Inspection You Need?
- Get help and advice from our testing lab