FMEAs including Foundation, Family, Part Process FMEA:

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.

How do you formulate a Foundation FMEA when starting a new product?

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.

Can you develop a Process FMEA if you are not Design Responsible or do not have access to a Design FMEA? 

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.

How often should you review and update the Foundation FMEA?

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.

As a “bulk material” supplier, how should I apply the 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.

 Is your Foundation FMEA a living document? 

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.

Customer Specific Requirements:

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 3^rd 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.

Do we have to control FMEA of the outsourced process? How would one go about this? 

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.

If there is no specific template, how does the supplier show Reverse PFMEA activity has taken place? 

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.

Are we expected to flow-down FMEA Customer Specific Requirements (CSRs) to sub-tier suppliers? 

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.

Are there any case studies on the FMEA being used in every aspect of a company’s functionality (Hiring, Purchasing, etc.) that are successful with proven sustainability? 

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: