Whether you are new to FMEA or a seasoned professional, the requirements given to you by your customer may leave you with some additional questions. Plexus International experts have gathered some of the most common FMEA and Customer Specific Requirements (CSR) and addressed them in the fields below. Take a scroll for information that may surprise you:
We are producing a product that has the same process for all part numbers, with the same process flow. Therefore, our Foundation PFMEA, Family PFMEA, and Part PFMEA could be equal. How do you manage this?
Don’t get held up on the terms of Foundation, Family, and Part number… it is all a conceptual framework. Instead focus on fundamentals of the concept. The goal is always to have a baseline that you can take into a new development and explore the DIFFERENCES. So, if your process is the same by part number, then don’t try and split it for the sake of meeting an arbitrary term…. focus on the intent.
When starting a new project ask yourself: “What fundamental process or product design does this most closely resemble?”, and then pull the Foundation or Family FMEA that is most representative as the starting point for the new project.
Yes, Process FMEA and Design FMEA are separate items and while there are places that they reference one another, it is not exclusive that you can only do one with the other. It will create a more robust process / product design relationship if you have both, but it is not necessary to have one to generate the other.
Update the Foundation FMEA as new information comes in that is relevant to the Foundation FMEA; this can come from many sources like new purchasing information, warranty data, financial data or customer issues. There is no defined time frame, all information received needs to be compared against the Foundation FMEA to determine if it is relevant. If yes, it is relevant then update the Foundation FMEA.
There is no difference in being a bulk material supplier over a parts supplier, you still make a product like a grease, which is composed of chemicals instead of hard parts. As far as process goes there is no difference either, you have technologies like mixing , curing etc….so it exactly the same.
Yes, there is constantly new information that is flowing into your organization that changes your risk profiles etc.; so, the foundational is not static. As an example, if you learn your cutting operation is prone to vibration from the machine shaking the clamp loose, then the foundation may add another failure cause as this is universal to every product you place on that piece of equipment.
What portions of the FMEA should be submitted for audit?
We all like to think that companies will share all information, but the reality is that this question comes down to a contractual question. It is not uncommon if there are contractual items around proprietary information that you may not be allowed to see parts of it…or sometimes even see it at all. This is common in processes where process controls are key to the product like heat treating or plating (customers with low integrity will often take the settings and then shop the recipes to lower cost vendors…thus sharing the vendors secret to making their product). Therefore, it is becoming common place to restrict information especially from second party audits. Additionally, DFMEA on proprietary designs and high severity components frequently are not shared due to liability risk and legal concerns
This is not as large an issue in 3rd party audits as the registrars have no vested interest in the company being audited and much higher confidentiality thresholds based on their relationships in the hierarchy.
You do not control the FMEA of an outsourced product, you are responsible for that product in your product. So, the question is a higher level, if the FMEA is an expression of the risk their product / process poses in your product……how you are UTILIZING IT …. NOT CONTROLLING IT. Lets be honest, you do not control anything another company does, and you cannot be responsible for their FMEA, but you are responsible for your product to function as intended, and that you can control.
Realize when a vendor gives you an FMEA they are giving you a risk profile for their product in your product, and so it is on you to work with the vendor to manage risk to an acceptable level, what that is depends on your company.
Ask them “How does your organization manage their Reverse FMEA’s” it will differ from company to company, and all companies can implement it differently so it will be on case-by-case basis.
At the end of the day the responsibility to meet YOUR organization’s CSR’s you signed up to rests with your company, not the sub tier… you signed the PO. The answer is not to explore the expectation but to ask how at the tier we are at we can have the tier directly below us most effectively support the CSR’s we signed up to.
As an example, a tier 5 will never meet an OEM’s CSR (given resources and structure just are not there at that level) so pushing a blanket statement down to the sub tier leads to ineffective controls. However, as their customer, if you look at what you are being asked to do and craft your CSRs for your vendors to support your journey to fulfill your CSR’s then we should have effective flow up rather than an ineffective push down.
So the short answer is yes, however it is in how you approach it that will make the difference as to whether or not it is successful.
Case studies require 2 things… the utilization of the methodology and the willingness of an organization to share the information in the case study; so, case studies in industry are rarely available, as companies will rarely open their business and allow competitors a look under the hood at the workings of their business. In academia it is more common, but academia has shown surprisingly little interest in FMEA in a general sense.
A better question on this is “How can I utilize the FMEA in my functionality and is it right for my company, this question allows you not evaluate the success of another vs your endeavor, but allows you to know your needs at a deeper level.
Reverse FMEA is an activity where you begin out on the line…at the actual point of work ….and work
your way backward to validate the FMEA. This is a bottom-up event that provides VALIDATION and real-world applicability to the FMEA
Think of the Reverse FMEA as a process audit that begins at the floor level and compares what you see against the theory on the FMEA….so it is a separate event and does not show up anywhere directly on the FMEA. However, the actions from the reverse FMEA may result in modifications to the FMEA
No, all companies are allowed to do their own version of Reverse FMEA. Remember it is not about the form, it is about the Fundamentals….is it driving improvement, is it working. A Reverse FMEA can be different for all companies and one universal version will not suit all companies, so find the version of Reverse FMEA that works for your company that makes the activity value added
No, the reverse FMEA is primarily geared toward process. However, in a very broad sense you could review warranty data, ongoing test data and make modifications to the DFMEA based off that, but that is not quite the same…that is simply FMEA revision. So, for a simple answer, lets keep it only to Process FMEA.
No each company can and will do it differently.
If you do not document it …. how do you prove it occurred? Somehow documents of at least the frequencies, times and results need to show up somewhere. Now this can appear in a variety of places depending on where the company thinks the Reverse FMEA fists in the systems, so do not assume it must show up in a particular place, or in a particular form
It is possible a company could include the Reverse FMEA in its process audits, remember though in terms of frequency we are trying to be effective, so balance accordingly
Reverse FMEA allows for validation of the theoretical risk profile and augments it with what is happening on the floor. The real benefit is a sanity check around how you THINK the process works, and what is happening on the floor to uncover new failure modes, causes and places your prevention and detections maybe have slipped.
Yes, these are 2 different things.
It depends on the risk, remember the RFMEA is looking at variance and augmentation from the FMEA, and that variance is present on DAY 1 after you start the process, so I would aggressively perform RFMEA on launch and after and then adjust frequency as the process matures.
It depends on the changes you discover, and your performance. If the performance is lacking, then there are most likely causes and modes with occurrences you need to adjust. However, if the process is mature, functioning well and the previous activities have not yielded any deviations…. then you can do it less frequently.
Whatever comes out of the Reverse FMEA needs to be compared up to determine where it applies, if the modification ONLY affects the part #, then adjust that one, but if it affects the Foundation FMEA you may have to adjust that.
No, refer to the Ford CSR for the definition of what the software has to do, Excel will not do what has to happen
No, there is no list of software, there is a list of functionalities – it is up to the organization to choose a software with that functionality that meets their needs
If your software meets the interconnectivity requirements called out in the CSR, refer to the Ford CSR for guidance on required functionality
Refer to the CSR from Ford for a list of functionalities
Import functions vary from software to software so you will have to contact each company
Yes
This will become a contractual discussion with your customer and needs to be handled through that channel.
Subscribe to our newsletter.
This eLearning course provides you with a clear understanding of the principles and values driving the new AIAG & VDA FMEA approach.
This course will assist you in the execution of Process FMEAs using the new AIAG & VDA FMEA Handbook.
This course will assist you in transitioning from the AIAG FMEA 4th Edition to the AIAG & VDA FMEA Handbook.
Subscribe to our newsletter.