QA for hardware
I have noticed that all of the threads here relate to testing of e-liquid. I thought it might be interesting to start one for hardware. I would be interested to hear from manufacturers of any physical products in the electronic cigarette industry relating to the quality control procedures that your company has in place. I have written out some sample questions below, but feel free to add anything that you feel might be of interest.
Is your organization accredited to a particular quality system. (ex. ISO9001)?
Do you perform first article or final inspections?
Do you implement AQL sampling plans or any sort of statistical process controls (SPC)?
Do you have a designated quality department?
What sort of tolerances do you normally work to?
If your product is electronic in nature, do you perform any electrical testing? If so, what tests exactly?
May want to consider this:
In the USA if you put your name (company or personal) on the device, even though manufactured in another country you are still considered the "manufacturer" and will need to have the appropriate documents in check.
Came direct from an FDA inspector whilst inspecting my med device lab a few years ago. I am glad my suppliers were OK and had their documents in order.
I don't think I follow you. I recognize that if you are a U.S. based company then anything that is branded as being a product of that company is subject to whatever regulatory provisions might be applicable regardless of where the product is actually manufactured. However, I don't quite understand how that ties into quality control for ecig related hardware. I keep re-reading your post though and I can't help but feel that you might be making a really good point that I'm just not picking up on. Could you please clarify/elaborate?
I have noted that nearly all products manufactured in China advertise CE and ROHS registrations. CE is a quality registration, similar to ISO 9001. ROHS is the quasi-environmental system to track what materials are used in the manufacture of the product. These registrations do not necessarily mean that there is extensive quality management/control, but are indicators that something is in place. I have not found any domestic manufacturers that are registered to ISO 9001. Registration is a complicated and expensive proposition, and most small companies cannot afford it. I have worked in the Med Device field for a while, and know how much time and effort it takes to get registered. However, your original questions are good ones! That list is very similar to the first survey I send to potential suppliers. If they are ISO registered, I can get a clear picture of their Quality Management System by reviewing their most recent audit report, which has to be performed (by their Registrar) annually. Not that it guarantees good quality, but it does provide evidence that they are aware of what they need to do. And in partial response to your last question, e-cig related hardware is by definition NOT an FDA regulated product (yet) so the FDA comments are not particularly relevant. In the medical device world, who actually makes a product (and where) doesn't matter to the FDA: as soon as it says "Janusxvii" on it, you are the manufacturer.
You bring up good points about the CE and ROHS certifications being indicative of some sort of level of quality standards. I don't know if it is just a rumor or not, but I have heard of a "fake" CE logo that some Chinese manufacturers use so that might be worth looking into. Yeah, ISO 9001 certification is expensive and can be difficult at first.If you don't mind me asking, is your work related to quality of medical devices? I'm asking because you obviously know about quality management. I'm not too familiar with the med device world as my QA/QC experience is all related to aerospace electronics (EMI/RFI filtered connectors). I'm sure hardware manufacturers have to be working to some sort of quality standards , even if it is only their own internal specs. Still, I would be interested in seeing someone step forward and say "this is the the level of quality that we work to and we maintain objective evidence on file to support this claim."
I am a Quality Engineer, currently working with life support equipment (ventilators, gas mixers, hyperbaric chambers). Medical devices are highly regulated, as is Aerospace. We are covered primarily by 21 CFR part 820. We are also registered to ISO 13485, the medical device version of the ISO 9000 series. We sell globally, so we also have CE marks to deal with. As a QE, I am primarily a statistician. I don't design products, I analyze data dealing with all aspects of them. My primary function is to ensure our products are safe and effective, as well as to control and improve the processes involved in production. So yes, I am intimately involved in the quality of the devices.
Yes, it is possible to fake a CE mark. However, if you care, they are easy to trace and determine if they are genuine. I am far more concerned with the build quality, which is why my primary tool is a ProVari.
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