In December 2021, Ford released their updated Customer Specific Requirements (CSR). A significant “first” in requiring their suppliers to manage Failure Mode & Effects Analysis (FMEA) in software. The potential for other OEMs to follow suit is likely high and could permeate into sub-tier suppliers. This is a major departure from the past. The biggest problem with FMEA as it exists today is the use of Excel spreadsheets. These copious, non-linked and editable records are used to manage, control and plan for every eventuality for some of today’s most sophisticated automotive manufacturing plants the world over.
When Microsoft first released Excel, they likely did not consult with Automotive OEMs on how it would be used to manage the failure mitigation of safety-critical components, and yet this is exactly what it is being used for as well as other unanticipated uses. Just imagine if an update was to come over that inadvertently affected the data in some way, or was accidentally deleted. Or even worse, changes were made and either not saved (loss of data) or saved by overwriting (lost historical intent).
Then comes the issue with linkages. Those sections within the FMEA:
- How are they linked to the Control Plans?
- Do I have any specifications that are not controlled, and how do I check?
- How can we see who is currently trained to do these tasks?
- How do you make sure that data is not changed without approval? and lastly,
- How easy is it to verify ratings, like Severity, Occurrence & Detection when each is managed in a different solution.
This is why a FMEA only solution just won’t cut it. When looking at a software solution to support FMEA, it’s easy to ignore the many other requirements within Ford’s CSR. Unless these are supported by existing applications, it could force the quality department to create or procure point solutions in order to maintain compliance. This is where an Enterprise-level Quality Management System (EQMS) can differentiate; it would not only support compliance of using software to manage FMEA but also complete the end-to-end loop of quality management for the whole business to leverage.
So that’s why I need an EQMS system!
What Ford has done, following significant evaluation, has taken IATF 16949:2016 and the more recent AIAG & VDA FMEA Handbook and produced their Customer Specific Requirements, which takes each section of 16949 and overlays Ford’s specific enhancements. Those requirements include:
- For forward model programs, which have not yet completed Job 1 by July 1, 2022, Foundation and Part FMEAs must be available in the FMEA software starting July 1, 2022.
- All Foundation PFMEAs for all manufacturing processes (current and forward model) and subsequent updates to all FMEAs must be available in the FMEA software starting December 31, 2022.
- Evidence of Reverse FMEA events must be available starting July 1, 2022 for forward model programs which have not yet completed Job 1.
In QAD terms, Foundation PFMEA are what we call our “Libraries,” or “Family Templates,” and in conjunction with the Foundation DFMEA are used together to create the part-specific FMEA. To differentiate and explain this, let’s use the example of a male-threaded fastener. E.g. M6 x 20mm Hex Bolt Grade 10.9 Zinc coated. The Design, Processes, Machinery, Skills and Tooling that go into producing this part are identical regardless of whether it is a M6 x 20, an M10 x 100 or 3/16 UNF x ½ inch and so on. So the effects of the failure and the failure modes will be common to that family of parts (i.e. male-threaded fasteners). Part-specific FMEA comes in when numerical tolerances, cosmetic appearance and additional physical/mechanical requirements are included.
Some say FMEA is “easier to do in Excel”. That is great for the individual working on a specific part, but it doesn’t help improve the foundational FMEA or drive standardization, efficiency and consistency in FMEAs. To compete with Excel’s ease of use, QAD EQMS has a hierarchical treeview FMEA editor that lets the user find, add, and manipulate FMEA much faster without losing context of where they are in a FMEA chain, which is the leading complaint against FMEA software.
Ford’s intent is to get the supply chain to improve their quality and therefore business’ efficiency. The use of foundational FMEA will not only improve their overall quality, but also allow the team to focus on unique features/requirements and their associated failures for a specific part, because the foundation is already in place and established.
Using the example above, a machine is set to produce male threaded fasteners M6 x 20, and at the end of the run, the machine is changed over to produce 3/16 UNF x ½ inch. This is where the highest risk of Part Failures will occur and focus on detection can be given priority at this time. The modes & effects of the failures from foundational FMEA need to be built into the part and process and should be 100% preventable.
What has changed with FMEA?
In this requirement, the fundamental change is in the application of the FMEA. Meaning, instead of thinking of a FMEA as a stand-alone process or as an excel sheet that you open up every now and again, Ford’s intention is to use software so FMEA not only becomes a living process but a way of working that is always aligned, feeds from data within other areas of Quality Management Solution and is grouped foundationally by families, by process and/or product and allows reporting (i.e. PFMEA report) to be a simple by-product of using the solution.
So why the change?
Great question. The answer lies in the current, legacy and stand-alone solutions and their inability to provide integrated visibility across the business. For example:
- Can your current system for CAPA predetermine the response times of the 8D inline with Ford’s requirements and send escalation notifications if a date was missed?
- Can you pull from your FMEA to populate Root Cause Analysis within your CAPA solution?
- In the event of a failure, can the operator/inspector access the part and process specific reaction plans within a few clicks?
- Can actions taken during a Non-conformance or CAPA link and update foundation, family and/or part specific FMEA?
- When an inspection event is created, can your system automatically pull the sampling criteria, specifications, tolerances, gauges, visual aids and work instructions etc. from your control plan?
- Does your Document Change system automatically provide you with a Risk Assessment?
- At the Process, Item, Document (SOP/WI), APQP (DFMEA, Process Flow, PFMEA, Control Plan, etc.) level, can you see the Skills needed and competent employees?
- If any of the above change, does it automatically trigger training events and notifications?
- Can it provide all of your reports (8D, DFMEA, PFMEA, Control Plan, etc.) as a by-product?
- Does it enable bundling all PPAP requirements into a single PDF and automate notifications and cadence for re-submission?
- Can you get an auditable history for all changes and approvals by e-signature for all critical decision points?
- Does it allow key metrics and reporting to be visible in real time on fully customisable dashboards with drill-down capability?
- Can it provide all of the above by access on any web enabled device?
What is QAD doing about it?
QAD EQMS at its core was developed to meet APQP requirements for Automotive and Industrial customers, and has done so for over 20 years. Most of what Ford is now requiring has its basis in the AIAG & VDA FMEA harmonization that came out in June 2019. But even before then, QAD was at the forefront of this change by continuously improving our product to make sure our customers were able to keep up to date with changing requirements. QAD had foundational FMEA consistently in the QMS product line back in the early 2000s in its first generation product. That commitment to foundational FMEA has continued. When the AIAG & VDA FMEA Handbook Draft version was released in 2018, QAD invested in being at the forefront, Hans-Joachim Pfeufer from VDA went through all of the proposed changes to what has now become the new requirement…that’s Jim in the red top below.
QAD EQMS is firmly aligned with AIAG 4th edition FMEA and also the AIAG & VDA FMEA Handbook, giving you access to both formats as an output from the same record. More importantly, if you were to go back to this article and reread the bullet points in the above section “So why the change?”, these are the core capabilities built within QAD EQMS that allows businesses to produce outputs or reports your customers ask for as a byproduct of using the solution. These capabilities are what using software to manage your FMEA will provide and can drive these practices into your supply chain.
So where do we go from here?
Before we answer the “where do we go” question, we need to understand the “where do we need to be” first, this will determine the path of least resistance we need to take.
Where we need to be is in a position where variations and failures are reduced to the lowest possible level. This is the whole purpose of APQP and the ultimate goal of OEMs as they try to improve reliability and reduce the effect from variations in products that ultimately lead to failure, vehicle breakdowns, warranty claims and the associated effect on their market standing.
Now add to that the need for OEMs and their suppliers to increase automation driven by recent disruptions, which will force the increase for higher toleranced quality parts. This is because automation of processes like pick and place, welding and assembly have less capacity in dealing with variations, which will also force the reduction of components’ acceptable limits for failure (PPM) to drop to single figures and to the ultimate goal of zero PPM.
Manufacturers looking for a solution to support them in meeting Ford’s new requirements have a fantastic opportunity to do a reset on current processes and how they are supported, documented and controlled. It’s a great time to really look at them in detail to validate steps, flows, processes, controls, etc. to make sure they are properly aligned, supported and to remove unnecessary bloat that gets accumulated over time, like knee jerk prevention or detection steps that are no longer needed (e.g. do you have an op 26 or 38, in between your 10, 20, 30, 40). Taking this data and inputting it into a solution that not only provides standardization in its application, flexibility into access of data from linked modules but also comfort that the solution is adaptive to the changing future that will allow your business to become more agile and support your compliance as a by-product. That’s why choosing the right EQMS is essential.
This article was co-written by Brian Brooks, Senior Product Manager at QAD.
