I agree with John. FMEAs are most helpful for determining Diagnostic Coverage or β-factor when doing the functional safety analysis. Risk assessments, when done correctly, are intended to help make decisions about risk control measures, including assessing the effectiveness of existing mitigations like certified components. ISO 12100 classes component certifications in the inherently safe design group of mitigations, as is electrical design to the relevant standard(s). Doug Nix [email protected]
"Life is like riding a bicycle. To keep your balance you must keep moving." ~Albert Einstein > On Aug 30, 2023, at 09:36, John Allen <[email protected]> wrote: > > Hi Ronan, > > I think you are doing the DFMEA correct, maybe a little too much > unforeseeable misuse. > > For us, Certification Standards are the minimum level of safety for end > products and components. We often rely on Certified components being the > assurance/mitigating factor in the design regarding the particular hazard. > However, there are cases where Certification is not enough. Also, a HARA > does not call out all the components. It’s a top down approach vs FMEA > bottom up, and starts with the hazards associated with the product, then > looks at what in the design mitigates against the hazard, then you confirm > what testing can be done to prove the mitigating factor works. The method is > quicker and gets right to the hazard and mitigating factors vs FMEAs. > > Best Regards and Be Safe, > > John > > John Allen | President & CEO | Product Safety Consulting, Inc. > Your Outsourced Compliance Department® > 630-238-0188, Cell: 630-330-3145 > <image001.jpg><image002.png> > <http://www.facebook.com/pages/Product-Safety-Consulting-Inc/97306850917><image003.png> > <http://twitter.com/SafetyTesting><image004.png> > <http://www.linkedin.com/in/productsafetyconsultinginc> > https://www.youtube.com/channel/UCVSzENmSoWeNFSBQcOYN7-A > www.productsafetyinc.com <http://www.productsafetyinc.com/> > > IEEE Product Safety Engineering Society > President Elect 2023, President 2024-2025, Past President 2026 > President 2016-2019 > Compliance 101 Technical Committee Chairman > IEEE Senior Member > > <image005.png> > Keeping our members informed and educated on Product Safety and Compliance > > https://ewh.ieee.org/soc/pses/index.html > > Although PSC maintains the highest level of virus protection, this e-mail and > any attachments should be scanned by your virus protection software. It is > the responsibility of the recipient to check that it is virus free. PSC does > not accept any responsibility for data loss or systems damage arising in any > way from its use. This message is confidential and intended only for the > individual to whom or entity to which it is addressed. If you are not the > intended recipient or addressee, or an employee or agent responsible for > delivering this message to the addressee, you are hereby notified that any > dissemination, distribution, or copying, in whole or part, of this message is > strictly prohibited. If you believe that you have been sent this message in > error, please do not read it. Please immediately reply to sender that you > have received this message in error. Then permanently delete all copies of > the message. > Thank you. > > From: Ronan Shanley <[email protected] > <mailto:[email protected]>> > Sent: Wednesday, August 30, 2023 8:27 AM > To: [email protected] <mailto:[email protected]> > Subject: Re: [PSES] DFMEA Component Selection > > [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the > sender and know the content is safe. > > Thanks All for Your Input, > > My takeaway from the discussion is that all items should be listed but only > the failure modes that fall outside of the normal scope of the relevant > standards should be focused on. We had problems with the DFMEA reviews taking > too long because we were considering every component and every failure mode > physically possible even if it was essentially unheard of. It sounds like we > can truncate the process by listing components that are being used according > to industry standards and say that the failure modes are accounted by the > fact that they are UL listed. Does that makes sense? > > Best, > > Ronan > > From: James Pawson (U3C) <[email protected] > <mailto:[email protected]>> > Sent: Wednesday, August 30, 2023 3:11 AM > To: [email protected] <mailto:[email protected]> > Subject: Re: [PSES] DFMEA Component Selection > > [EXTERNAL] > > Doug, > > Thanks for highlighting the differences between the IPC standards and the > safety standards. > > There are differences in approaches across standards as well. We recently saw > an IEC 60335-1 class product for some EMC testing that had six earth crimp > lugs on a single M4 bolt including the main earthing terminal. OK under > 60335-1, not OK for 61010-1. > > All the best > James > > James Pawson > Managing Director & EMC Problem Solver > > Unit 3 Compliance Ltd > EMC : Environmental & Vibration : Electrical Safety : CE & UKCA : Consultancy > > www.unit3compliance.co.uk > <https://urldefense.proofpoint.com/v2/url?u=http-3A__www.unit3compliance.co.uk_&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=9ACtYdEkYWQJ9uRTho4bmshIDsybGVOHLSWCYiBJ7bY&e=> > | [email protected] <mailto:[email protected]> > +44(0)1274 911747 | +44(0)7811 139957 > 2 Wellington Business Park, New Lane, Bradford, BD4 8AL > Registered in England and Wales # 10574298 > > > > > From: Douglas Powell <[email protected] <mailto:[email protected]>> > Sent: Tuesday, August 29, 2023 10:45 PM > To: [email protected] <mailto:[email protected]> > Subject: Re: [PSES] DFMEA Component Selection > > Mike, > > When workmanship practices come into the discussion, I occaionally invoke IPC > standards to supplement what we are doing, specifically IPC 610 and IPC 620. > This takes opinion out of the discussion. A classic example was long ago > when I had a product under review and nearly a dozen crimped ring lugs with > GRN/YEL wire were all screwed to a single-point earthing terminal in a PCBA, > in a radial pattern. Additionally an extra-long screw was used thoguh the > lugs and into the top of a hexagonal standoff swaged into the PCB, which was > all very insecure. IPC had some things to say about the maximum number of > connections on screw terminals when the safety standard did not. > > For torque specs, I'll mark assembly documents calling out torque > specifications as an SCI, or "Safety Crtitical Item." > > As for the photo, I've had that one for years and use it in my presentations. > I wish I could give attribution, but I cannot find the source, and I've tried > several reverse image lookups too. > > -Doug > > > Douglas E Powell > Laporte, Colorado, USA > [email protected] <mailto:[email protected]> > LinkedIn > <https://urldefense.proofpoint.com/v2/url?u=https-3A__www.linkedin.com_in_coloradocomplianceguy_&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=TdOsycA1xXSfe2Y_S16q0pZItRVBCStkf1kC5-dgMF8&e=> > > (UTC-06:00, US-MDT) > > > On Tue, Aug 29, 2023 at 3:19 PM MIKE SHERMAN <[email protected] > <mailto:[email protected]>> wrote: > Doug speaks from experience similar to mine---the standards tend to do a good > job of addressing risks, so it's good to spend some time on things maybe not > explicitly covered in the standards. > > My pet peeve list includes workmanship issues, such as properly torquing all > terminal connections, especially those on components. Plus routing, bundling, > and securing the wiring correctly (e.g., properly segregating low voltage > wiring). And only stripping the specified length on line voltage conductors > where they enter components, to reduce the risk of touch shock. These are the > kind of details a good UL 508A panel shop will do for you if you contract it > out. Conversely, these are things you have to come up to speed on if you do > the work in house. > > Another thought: not only is the designer a good person to have in on the > analysis, but also bring in a field service technician for a reality check on > how things are actually used (I love Doug's photograph!). > > Mike Sherman > Sherman PSC LLC > On 08/29/2023 4:01 PM CDT John Allen <[email protected] > <mailto:[email protected]>> wrote: > > > Very good point on the Designer to be a part of it. You may consider a HARA > vs an FMEA to get to the bottom of your question. To Rich Nute’s point a > long time ago to me – what are the hazards we are concerned about?? > > A Hazard Analysis Risk Assessment is a top down approach of Hazards vs an > FMEA calling out each part and what can go wrong. HARA asks what are all the > Hazards associated with this product/system/event. What in the design > mitigates against those hazards? What tests can I do to prove those > mitigating factors work? and is that adequate? > > There are many ways to understand overall safety of a product/system/event – > FMEA, HARA, HAZOP, etc. We should work to a common way or even some guidance > in this area. The LVD says a “risk assessment shall be in the technical > documentation”. Thanks for the guidance!! > > If there are any leaders in this group regarding such I’d love to discuss > possible Hazard Analysis and Risk Assessment methodologies and Standard(s). > Along with a PSES Technical Committee and Track at ISPCE. > > Best Regards and Be Safe, > > John > > John Allen | President & CEO | Product Safety Consulting, Inc. > Your Outsourced Compliance Department® > 630-238-0188, Cell: 630-330-3145 > <image001.jpg><image002.png> > <https://urldefense.proofpoint.com/v2/url?u=http-3A__www.facebook.com_pages_Product-2DSafety-2DConsulting-2DInc_97306850917&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=kW3ZAUyuU_KJBzcOA6YiCKpYnuCRpfHhfWt9DJUTess&e=><image003.png> > > <https://urldefense.proofpoint.com/v2/url?u=http-3A__twitter.com_SafetyTesting&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=HRGylgUVYp2BBB11Sxr8xjDa5Iy_NvrUkq5-tBea4ZA&e=><image004.png> > > <https://urldefense.proofpoint.com/v2/url?u=http-3A__www.linkedin.com_in_productsafetyconsultinginc&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=Grk9nmlwC-5ESj3U52pZWWJPHm1fwemZcNs53d2wvrg&e=>https://www.youtube.com/channel/UCVSzENmSoWeNFSBQcOYN7-A > > <https://urldefense.proofpoint.com/v2/url?u=https-3A__www.youtube.com_channel_UCVSzENmSoWeNFSBQcOYN7-2DA&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=Fj4G5bMMLSQZPJ9PzBT74ybU5vpY4dV_xb3f6xMSyi0&e=> > www.productsafetyinc.com > <https://urldefense.proofpoint.com/v2/url?u=http-3A__www.productsafetyinc.com_&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=hyVDaeUEvKm73uXjyDxUGYDb32Ze1VYHe8lAafWVoEc&e=> > > IEEE Product Safety Engineering Society > President Elect 2023, President 2024-2025, Past President 2026 > President 2016-2019 > Compliance 101 Technical Committee Chairman > IEEE Senior Member > > <image005.png> > Keeping our members informed and educated on Product Safety and Compliance > > https://ewh.ieee.org/soc/pses/index.html > <https://urldefense.proofpoint.com/v2/url?u=https-3A__ewh.ieee.org_soc_pses_index.html&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=TVrW6lATl3Q3tLvLrfagJ-_SNWaBGd2IE2CZBhpvXkE&e=> > > Although PSC maintains the highest level of virus protection, this e-mail and > any attachments should be scanned by your virus protection software. It is > the responsibility of the recipient to check that it is virus free. PSC does > not accept any responsibility for data loss or systems damage arising in any > way from its use. This message is confidential and intended only for the > individual to whom or entity to which it is addressed. If you are not the > intended recipient or addressee, or an employee or agent responsible for > delivering this message to the addressee, you are hereby notified that any > dissemination, distribution, or copying, in whole or part, of this message is > strictly prohibited. If you believe that you have been sent this message in > error, please do not read it. Please immediately reply to sender that you > have received this message in error. Then permanently delete all copies of > the message. > Thank you. > > From: Douglas Powell <[email protected] <mailto:[email protected]>> > Sent: Tuesday, August 29, 2023 3:12 PM > To: [email protected] <mailto:[email protected]> > Subject: Re: [PSES] DFMEA Component Selection > > [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the > sender and know the content is safe. > > I have always considered that the design engineer, who is most familiar with > the product, needs to be involved in DFMEA and forthcoming about potential > difficulties. And it's not just about components but also various use models > ranging from manufacture to servicing to the end user. A hypothetical > example: a heavy module installed in a high location, requiring handling by > two people. > > And cases of foreseeable misuse are also part of this. My favorite example > is this photo of a man using the electrical panel of a pivot sprinkler to get > a view of something in the distance. The securement of that panel is > obviously not designed to carry that much weight. This is a photo I found > online, and I have no idea who it is. > > <image006.jpg> > > In general, certified components used within their ratings are not as big a > concern, but it is good practice to include them in any case. When performing > a DFMEA, you want to focus on identifying failure modes that are not > explicitly covered by existing safety standards. This involves looking beyond > the standard's prescriptive requirements and considering potential failure > scenarios that could arise due to the unique nature of the component, device, > or product and the way it is being used. Keep in mind that FMEA, of any > type, is generally a bottom-up approach, whereas FTA is top-down. Using the > two in conjunction has sometimes been referred to as a Bowtie Analysis. > > -Doug > > > Douglas E Powell > Laporte, Colorado, USA > [email protected] <mailto:[email protected]> > LinkedIn > <https://urldefense.proofpoint.com/v2/url?u=https-3A__www.linkedin.com_in_coloradocomplianceguy_&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=TdOsycA1xXSfe2Y_S16q0pZItRVBCStkf1kC5-dgMF8&e=> > > (UTC-06:00, US-MDT) > > > > > > > > > On Tue, Aug 29, 2023 at 1:30 PM Ronan Shanley > <[email protected] > <mailto:[email protected]>> wrote: > Hi All, > > We are going through a DFMEA process for an enclosure we have designed but > are having trouble determining which components to analyze. We know we want > all the safety rated components and likely the upstream components of those > as well. We’re unsure if we should include components related only to > functionality or how granular we should get with the components upstream of > the safety components. For example do we include the wire feeding the safety > controller or what about the terminal blocks? Is anyone familiar with where > the limit for component criticality usual falls for DFMEAs? > > Best, > > RONAN SHANLEY > EE > > <image007.png> > > ALERT INNOVATION > www.alertinnovation.com > <https://urldefense.proofpoint.com/v2/url?u=http-3A__www.alertinnovation.com_&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=8-usP8sOsXZ4gbjoJWW6HAPVHBAGyayh94Of0bVCjWEZwSUSWxst_sLBuQ4COzVW&m=N_fxw3_Pq2-5Zw5CiOL9UtPN5QmPH_8wzQJhjfe5HGeSLdEzY04lFH3fqetQkwer&s=Sn0gUJcu6RtelbhAnh1KihisG8E_5MzHTXRlPqnfwZQ&e=> > > > This message (including any attachments) may be confidential and privileged > communication to the intended addressee. If you are not the intended > addressee, you have received this message in error. 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