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RoHS Technical Documentation File

December 08, 2022 • Intertek • Season 5 • Episode 23

0:00 | 18:14

Technical documentation describes the design, manufacture, and operation of a product and must include all details necessary to demonstrate that the product complies with all applicable requirements.

Join our guests Robert Trimble, Program Manager, and Jasmin Durkut, Operations Manager from Intertek Assuris to learn more about RoHS Technical Documentation File services.

0:12
Refaya Priya Intertek
Hello and welcome to Assurance and Action Intertek podcast that discusses key assurance topics and trends. My name is Refaya Priya and our episode today features two of our colleagues from our GRS and Assuris Team Robert Trimble, program Manager and Jasmine Durkat, operations manager. Today they're here to talk about RoHS technical documentation file services. Thank you so much, Robert and Jasmine for joining us today. It's a pleasure. Can you both share with us your experience in the industry? And what do you do with Intertek?

0:49
Robert Trimble Intertek
Here, I'll. I'll let Jasmine give first. Cause she's younger. Yeah.

0:53
Jasmin Durkut Intertek
Thank. Thanks Bob.

0:56
Jasmin Durkut Intertek
So I've been working with Intertek for almost. Nine years? Yes, almost. Almost a decade. And since have supported companies in complying with various requirement mainly in the EU. However, also with yeah, like more, more and more legislations popping up worldwide also with global legislations specifically you know implementation of highs for different industries. So the 1st big implementation deadline that I was part of was for the medical devices to become RoHS compliant in 2014.

1:41
Jasmin Durkut Intertek
Over to you, Bob.

1:42
Robert Trimble Intertek
Ohh, thank you. Appreciate that. So Bob Trimble I'm. A little bit outside Philadelphia, kind of in between Philadelphia and New York City. So based in in North America and primarily working with North American companies that are selling product into the European Union concerning RoHS , but also now going forward with all the global regulations, whether it's Saudi Arabia as the rest of the world, China, RoHS , whatever it might be, add some additional requirements or EU RoHS technical documentation files, services kind of leverage themselves going forward.

2:17
Robert Trimble Intertek
So I'm I been with Intertek over 10 years, been working in a compliance domain and quality for over 15 plus years and haven't been on sites and worked with customers. You know sitting down at a table with them and building their technical documentation file as well as you know one of the things we did was review technical education, technical documentation files and we have a template that kind of starts this whole process off so that customers kind of they have a head start, right. So that's how I got into the whole TDF thing and now working with Jasmin you know we. We have a we have boots on the ground as we say it Intertek all over the world. So we leverage that. So it's not just some guy in North America going. Yeah, we think this works. We have people in Europe that are review and the technical documentation file and keeping up with the the regulations and the authorities and stuff like that. That's where I'm coming from on this.

3:07
Refaya Priya Intertek
Awesome. Thank you so much for sharing your experiences with us. It's great to hear everything you do for Intertek and all your experiences. Thank you so much. So I guess my first question for you would be, I know the technical documentation. It provides information on the design, manufacture and operation of a product and must contain all the details necessary to demonstrate that the product confirms to the applicable requirements.

3:35
Refaya Priya Intertek
What information do you frequently see missed?

3:40
Robert Trimble Intertek
Yeah. So. So I'll kind of kick that one off. One of the things that we don't see a lot of companies right from the get go references, any type of standards to evaluate the information that's going into their technical documentation. So that the RoHS technical documentation that we're Speaking of today sits under the bigger picture CE technical documentation. And when it comes down to the RoHS part of it frequently, I don't see a standard referenced and I can go on about this below Jasmin kind of kind of jump in here if you might see something different. It might kind of agree with me, but that there's there's not a lot of basis on a standard or on a any type of even an internal standard or reference as to what information they need and why they're accepting the information they're getting.

4:28
Jasmin Durkut Intertek
Yeah, and and to add to that, I think especially in well recent months, you would find a lot of document well technical documentations to if they reference standards to reference outdated, expired standards. Yeah, which mainly comes from the replacement of the EN50 By 6/1.

4:48
Robert Trimble Intertek
50581

4:48
Jasmin Durkut Intertek
Exactly.

4:52
Robert Trimble Intertek
50581 Yeah 50581 replaced by IEC 63,000.

4:53
Jasmin Durkut Intertek
Exactly. I agree with you. So it was only only just replaced, um, last year. Yeah. So a lot of companies, especially since there's not been a huge and massive change in well the requirements, yeah, of of the technical documentation. Yeah, companies just seem to have missed the change.

5:16
Robert Trimble Intertek
Yeah, I'll, I'll agree. And that that kind of jumps us ahead to the one of the other points we were gonna talk about, right. And that is one of the requirements to to maintain this documentation, to review it, to keep it current. So if we're doing an audit or we're reviewing technical documentation and we see old standards referenced or the last time this document was reviewed and signed was 2016, that's like a red flag. It's it's not a one and done. It needs to be maintained, it needs to be current. So that that's something else that flies under the radar. Once this initial work gets completed by our clients.

5:47
Refaya Priya Intertek
Oh, that's awesome. Like the the podcast is already getting really interesting. So my second question would be how does the technical documentation affect the affixing of CE marking to the product?

6:02
Robert Trimble Intertek
When you CE mark the product. You you are saying that you legally comply with all the directives that fall under the CE mark, so when it comes down to ROHS , when you CE mark your product and place it on the market, you are legally stating that you have all this technical documentation in place to back up that you comply with the director.

6:25
Refaya Priya Intertek
So now that you talked about the CE mark, can you talk a little bit about the risk assessment requirement?

6:33
Robert Trimble Intertek
Sure you wanna? You wanna lead off on that one? Jasmin. And you want me to?

6:39
Jasmin Durkut Intertek
I'm know how how.

6:40
Robert Trimble Intertek
There's three, but so I don't. I don't want to monopolize.

6:41
Jasmin Durkut Intertek
No, I'm not. I'm I'm happy to. Uh, yes. Like the the risk assessment requirement, which is stated as as a requirement under the IEC 63,000 informally and 5581. I'm basically consists out of two different risk assessments, so one focusing on the actual direct suppliers. That supply components, materials, subcomponents to be used in the production of the final product and then secondly, the assessment of the actual materials, right. And then we always have to remember that the RoHS Directive requires compliance on the homogeneous level. So even if your suppliers. Supply your or if you saw us subcomponents. Yeah. Which are complex products just by itself, you will always have to. While determined, the risk of the homogeneous materials present and used in in that finished product, yeah.

7:42
Jasmin Durkut Intertek
Bob, I think now that I've sort of outlined the basic basic requirements. If you just want to go into a little bit more detail.

7:46
Robert Trimble Intertek
No, that's that's great.

7:50
Robert Trimble Intertek
Yeah. So we talked about this risk based process, which is, uh laid out by IEC 63,000. Um, which kind of takes us into the land of. I can't don't want to where it's not realistic to test at the homogeneous material level for everything that might be in this product, right? So we we take a risk based approach for the material where we say historically or because I know what's in plastics, what's in integrated circuits, what are what we use to plate metals, how how we assemble wiring harness was harnesses with solder and crimp connectors than things like that. As I look at all the different parts of product realization.

8:31
Robert Trimble Intertek
Where are the risks that these restricted substances are in my product? And then I address those risks according to a matrix, whether that's I'm just gonna require documentation or I'm gonna require documentation and a test report. Whatever your internal and external standards and processes require, as well as supplier risks, and not just monetarily. They're on the D&B, or I have a relationship with this company because they're right down the block and I've worked with them for 20 years. But but things that are typically missed, like did I evaluate this supplier for their capability to supply me? Materials, components, processes that comply with the directive, right, as well as why do I trust them? Do I audit them? Have I had questions on my supplier surveys that address restricted substances? If I go to their website or they are they ISO certified like we always like to see the ISO certified, right, right. Jasmin. Like that's a kind of a big deal when it comes to meeting all the requirements for this directive.

9:39
Jasmin Durkut Intertek
Yeah, exactly. So, yeah, I I just wanted to mention like especially talking about that risk based approach. This is also what what you see in like QMS systems, right? So the ISO 9001 since the last revision would also like focus very much on the risk based approach which which now fits very well also with the IEC 63,000 approach to determine compliance.

10:04
Robert Trimble Intertek
It does, yeah. 9001, 2015, please. Plays very well with IEC 63,000. I agree with you.

10:8
Jasmin Durkut Intertek
Exactly.

10:10
Refaya Priya Intertek
Well, so has there been any major changes to the TDF requirements? That you haven't mentioned yet.

10:19
Robert Trimble Intertek
Other than other than the update, the IEC 63,000, there have been no major changes in what we see technical documentation file wise for RoHS .

10:31
Refaya Priya Intertek
OK. And how does the additional legislation, such as Saudi the RoHS and UAE RoHS affect the TDF?

10:43
Robert Trimble Intertek
Yes, so the the EU RoHS TDF, which is based on that I E60 IEC 63,000 standard. Um gets you a long way towards being able to support and and apply for entry into other markets other than just the European Union and then includes KSA, UAE, RoHS there. There are some additional requirements. For global market access concerning restricted substances. But they're be very few instances where not having that information would benefit you.

11:20
Jasmin Durkut Intertek
Yeah, I think the the biggest well, the biggest difference to mention here really is that in the European Union, the requirement to have a technical documentation file really like refers to having one on file in case an authority asks for it. Whereas especially in the UAE, in order to get market access. A notified body actually has to attest the compliance of your technical documentation, yes, so they will physically. Review the technical documentation and in some cases like, depending on which compliance route companies choose, they would even audit your factories according to the IEC 63,000 standard, which obviously includes the documentation, but even more so focuses on whether what's written in your technical documentation is also well lived on a daily basis in your in your production.

12:20
Refaya Priya Intertek
Well, can you share some of the most common weaknesses you see in your clients technical documentation?

12:27
Robert Trimble Intertek
Sure, I'll, I'll. I'll eat off on that. Take two things kind of come to mind. One, they don't always have the written processes to reproduce the technical documentation file, so some somebody takes the ball on it and they reach out and they get all the documentation and they evaluate all the documentation and they build the technical file and they hand it off to whoever maintaining the CE technical documentation says OK, we're good to go on this product, but the the process basically can't be replicated because it's not written, it's not an SFP so that. The process is missing when we dig down and and the other thing that happened. I think I mentioned this earlier is, is they don't maintain the documentation. So as they're approved vendor list or is there supplier list changes and we update components on the circuit board or whatever the product might be we make changes it doesn't get. Doesn't get updated and placed in the current technical documentation file, so falls out of date. I would say that those would be the two biggest things that I said.

13:32
Refaya Priya Intertek
So what would be your number one advise to the companies who are facing the challenge of documenting their material compliance procedures?

13:41
Robert Trimble Intertek
Don't wait. Get get started on it. And I say that in the context of some people think when they get their test reports back or when they get all the documentation back from their suppliers, that they're done and they they kind of organize those those. Um, there's work streams so that they overlap, but they don't leave time before they plan the place. The product on the market to resolve any issues to to replace a component that may be noncompliant to, to go out and order the supplier where there may be a gap on. Hey, I didn't get anything back from this guy till I still want to place this on the market. This is kind of a big deal. So I would say get started early and if you need help like reach out to somebody because there's not a lot of this.

14:26
Robert Trimble Intertek
Like if you Google RoHS Technical documentation files you really don't find much right, Jasmin. There's. I'm not gonna say they're hidden, but it's not typically publicly available. Information companies spend a lot of time and effort. There's frequently intellectual property in the file, so they're not always easy to just find the template. And I think that that's one of the things that, like we have this template that we help people out with, like, it's just a great starting point. So I would say, like, don't wait.

14:54
Jasmin Durkut Intertek
Yeah, and and and and probably as important as stay up to date, yeah, because especially with with RHS. Are a lot of changes like frequently happening and so like in in the last what was it like 24, four months? The exemptions from Annex 3 had been reviewed. Yeah. Which will then also require companies to, like, go back to their processes to evaluate everything, like completely from scratch, really, on on their risk of not meeting the requirements and the set out in, in the legislation, there will be new changes coming, new substances pretty soon. So yeah, I think get started. Stay up to date.

15:39
Robert Trimble Intertek
Yeah, we can talk about. I think we, I think we have two substances on the list that are being evaluated now, right? Yeah. And so we can we can talk about that in another time for sure.

15:46
Jasmin Durkut Intertek
Yeah. There's always something to talk about when it comes to art, it's or material compliance generally.

15:52
Robert Trimble Intertek
It's not going away there.

15:54
Refaya Priya Intertek
Well, hopefully we'll have another episode only for this one, like a second episode. For this one, I would love to have you guys again.

16:04
Refaya Priya Intertek
So if if our listeners have a question and want to reach out to you directly, is there a contact information you would like to share for the team or how will they contact you?

16:14
Robert Trimble Intertek
Yes, if you're so for sure, we're we have a lot of presence on the Internet. So if you just, you know, whatever your search engine is put up Intertek a share this in there and restricted substances, ROHS technical documentation files that that'll take you right to your local regional global group that can help with that.

16:32
Refaya Priya Intertek
Awesome. So we're almost at the end of our podcast. Is there anything else we missed that you you would like to add before we finish our podcast today?

16:43
Robert Trimble Intertek
Now are we look forward to engaging with the customers one-on-one. So you know I know this is this is kind of general and and mean could just kind of be an overview and and you know have fun and have a discussion about it. But everybody has a different way of making products. Everybody has a different supply based supply chain. So we really like getting involved one-on-one with our customers helping them in the capacity of here's how they do business. So we can help with that. It's not a one solution, one template, one checklist fits all.

17:14
Jasmin Durkut Intertek
Agreed.

17:15
Refaya Priya Intertek
Well. Thank you so much, Robert and Jasmin, for joining with us today. These were some really great insights on Intertek’s ROHS Technical Documentation Services.

17:25
Refaya Priya Intertek
I hope that I hope our listeners will love our podcast and thank you to all our listeners for listening all the way through. Please follow us and like us on Twitter and LinkedIn, links to which are in the description of this podcast. With any questions, please feel free to reach out to us at business.assurance@intertek.com. This is your host Refaya and I hope you have a wonderful day. Thank you all and thank you so much, Jasmin and Robert.