FMEA networking

Consistency of DFMEA, PFMEA and Control Plan

Every company is keen to keep the costs of a product development process as low as possible. An often unrecognized cost factor is the expenditure that the company has to accept if the manufacturing process is disrupted - or in the worst case paralyzed - due to errors.

Companies that use solution-oriented software for FMEA (fault detection and avoidance) can gain an invaluable competitive advantage. In addition to the solutions that FMEA offers the user, errors can also be identified and eliminated more quickly with a structured analysis process.

FMEA training provides participants with comprehensive knowledge which they can use to network FMEAs.

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Networking of FMEAs

The creation of a consistent Design- or Process-FMEA is already quite an art. But what does it look like if these two are to be interlinked or even if a matching Control Plan is to be created?

The webinar recording contains an illustrative example of how e1ns promotes exactly this consistency between Design-FMEA, Process-FMEA and the CP and helps to avoid inconsistencies.

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Aim of a structured FMEA analysis

The aim of the FMEA analysis is to detect errors in a timely manner or, at best, to avoid them. The user of the FMEA software achieves this through a stringency of design FMEA and product FMEA, which is reflected in the production control plan.

It starts with the following three elements:

  • Design FMEA (DFMEA for short)
  • Process FMEA (PFMEA for short)
  • Control plan (CP for short)

Those who take part in FMEA training benefit from a detailed presentation of these three elements.

Performing an FMEA analysis

Every FMEA analysis procedure starts with the requirements that must be fulfilled at the end of every product development process. On the one hand, these requirements come from the customers who will later purchase the product. On the other hand, internal company instructions or legal requirements must also be taken into account.

The design FMEA is created from the information about the requirements. The structure of the design FMEA provides for at least three levels, as the errors, the consequences and the causes of the error are presented here. For more extensive projects, the user can also structure the FMEA analysis into several levels. The result is to develop product characteristics that fulfill the product requirements and are included in the process FMEA. The structure of the product FMEA therefore corresponds to the structure of the design FMEA. The three levels include the process steps, the machines and the P-specifications (process specifications).

The specifications developed from the D-FMEA and the structure of the process FMEA are summarized in thecontrol plan. This is also the subject of FMEA training.

Example of an FMEA analysis using e1ns software

The FMEA analysis is used, for example, in the production of a disposable syringe. If we assume that the design FMEA has already been completed, the next step is to define the P-FMEA. This results in the development of a control plan.

For the analysis, the product is divided into different elements in e1ns. The disposable syringe consists of the disposable syringe product, which is made up of the housing and the plunger. The packaging is also included in the analysis procedure.

The process FMEA is divided into the production of the individual elements. The user defines an individual process step for the housing, the plunger and the packaging. The elements that must be used for a product creation process are also taken into account. These are, for example, an injection molding machine and the plastic granulate, which is used as a raw material in the new product. The entire manufacturing process is displayed graphically in a flowchart in the e1ns.flow module. e1ns also automatically creates a corresponding tabular flowchart in the background, in which M-elements can then be defined.

The housing and piston are produced in parallel in the P-FMEA. Once the individual parts have been completed, the assembly process step takes place. The analysis also takes into account the fact that the disposable syringe must be packed in sterile packaging.

The user has then created the fundamental basis for networking the FMEAs. These are the design FMEA and the process FMEA. The results of the two analysis procedures can now be combined in the control plan. In addition to the desired output quantity and the reject rate, the user of the FMEA software also takes into account other quality characteristics that have arisen from the customer requirements.

Errors in the production process are indicated, for example, by the fact that the output quantity is greater or certain quality requirements have not been met.

Networking of DFMEA und PFMEA

Software screen for networking D-FMEA and P-FMEA

Before the process FMEA can be created on the basis of the design and the manufacturing process, they must be linked. In the e1ns.architect module, requirements are supplied that do not result from the design but from the process. The requirements, such as output or quality indicators, apply to the individual process steps and can also be defined in more detail in the software. These values can then be used to identify potential sources of error.

The packaging process can now be referenced to the sterile-packed disposable syringe by simple drag & drop, whereby it receives requests from the syringe itself. The same can be done with the assembly process, etc.

Once the FMEA has been completed on the design side, with functions, features etc. and the sources of error have been defined, these elements can be linked.

The Control Plan

With the control plan, the user creates the basis for a trouble-free product development process. It is therefore important that both the DFMEA and the PFMEA are error-free. To ensure this, the FMEAs are analyzed for errors before being summarized in the control plan.

For the FMEA analysis, it is necessary that the elements of the product creation process are examined with regard to their function. For example, what should the injection molding machine do, what/how is my assumption? How should the plastic granulate be used? In this step, the user determines in the e1ns.methods module which temperature should be used for melting the plastic granulate. Furthermore, more than one specification can be assigned to the individual functions here.

The work steps (functions) that ensure a smooth production process are also specified to the worker during the analysis. He must fill in the granulate and set the corresponding program for the machine. Here too, several specifications can be added to each function in e1ns.methods.

If you now take a step back into the e1ns.architect module, you can see clearly that the housing and the injection molding process have been linked. If the user of the FMEA software now checks in which work step errors can occur, he must not ignore the function of the injection molding machine. This could be, for example, that an incorrect temperature has been entered for the melting of the granulate. The worker may also assume an incorrect value when setting the cooling time. All these possible errors can be linked here accordingly.

A major advantage offered by e1ns is the creation of template copies. This means that the process steps that have already been considered for one component can be copied for the process of another component, provided that the failure modes and causes are similar.

You can now go to the FMEA and see the following in the overview:

  • Higher and lower-level functions
  • Design specifications
  • Process specifications
  • Failure consequences and causes incl. B values from design FMEA

Once the errors have been identified, the prevention measures for eliminating errors can now be developed and stored in the overview together with individual detection measures.

In doing so, he can benefit from the advantages of the FMEA software solution e1ns. To create the control plan (CP), the user uses the process configurator, which compiles all process characteristics, process elements, machines and product elements in the correct order. At this point, it is possible to decide which elements should be included in the CP and PFC (per step).


Your Benefits

How do you benefit from the FMEA software?

Good failure detection is based on the requirements that FMEA places on a product development process. Systematic failure analysis is supported by a software solution for FMEA.

Users benefit from the fact that the individual steps of the design FMEA and the process FMEA are not only displayed graphically. Users can gain an additional overview with a tabular representation of the analysis procedure. The software also ensures that the DFMEA and the PFMEA are created, which makes all errors recognizable and can be eliminated before they are included in the control plan.

If you would like to use a software solution for FMEA in your company, you will receive all the necessary information in a corresponding FMEA training course.

Conclusion: A systematic failure analysis is the best basis for any production process that should not be hindered by malfunctions. The control plan is used to steer the process in the right direction. To ensure that the control plan no longer contains any errors, the user must create a flawless design FMEA and a flawless process FMEA.

The e1ns software solution supports in this task by detecting errors. The user benefits from being able to create an error-free control plan for the production process. Companies benefit from enormous cost savings.


Discover all e1ns methods

Tailored methods set to your development process with the associated forms - simple, intuitive, in the web browser.

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Creation of FMEAs: Worldwide, easily and in a team.

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Inspection Plan

Quality assurance measurements during production.

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Process Flow

Process flows for identifying the causes of possible malfunctions.

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Change management with DRBFM: Success with methods.

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Functional Safety

Functional safety (ISO 26262) and FMEDA.

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Complaints & 8D

Permanent complaints resolution.

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Special characteristics

Ensure consistency of special characteristics.

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