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Use of FMEA

KZK Solutions /kzoli62/
Published by Z. Kovács in Quality · 15 October 2021
Tags: QAFMEA
Here, however, I have to note that although the majority of the companies are responsible for quality assurance for the FMEA and the Control Plan, there are some, where the first belongs to the engineering.
You can also look at the thematics, this area is also closely linked to the production, it deals with the possible problems.

1. Summary Failure Mode and Effects Analysis: FMEA

On the advanced western markets, only the companies are able to live for a long time, which are economically a good quality product was produced.

The competitive corporate strategy must be taken into account in designing the following principles:

The business processes (business, production) for a permanent repair, development:

  • First good manufactured!
  • "Zero-error" strategy
  • Decimal failure costs rule.

Rule:
The decimal failure costs usefully applied to the error increases exponentially with time.


The decimal rule table

2. What is FMEA?

2.1 FMEA is a consistent process order, the object of which is:

  • To recognize and evaluate the product development and manufacture of all the possible problem arising in their causes and consequences.
  • For specifics on the occurrence of faults, which take alehetséges or reduce,
  • Document the development, manufacturing process.

2.2. Types of FMEA

  • Construction, the design (design): the product construction always vaguely planning and never taking off for analysis, the errors arising from breakdowns and exploring, before the product is released. (DFMEA)
  • Process and manufacturing (process): production and assembly processes in the production process, analyze problems, identify and eliminate errors. (PFMEA)

The FMEA analysis it is necessary to carry out successful a responsible person, who is held in control the whole process, but the analysis is actually collaboration result.


Recommended composition of the team:

  • The team will be led by a responsible person
  • Members of the team:
    • Design/development (only than Design FMEA necessary)
    • Production
    • Quality Assurance
    • Logistics (acquisition, storage, and logistics)
    • Engineering (technology)
    • Person responsible for education
    • Supplier (if possible)

An analysis of a pre-made form, the table shall be recorded. The FMEA is characterized by a "never-ending" process. The analysis must be carried out while the errors they cease the value-at-risk or low enough value.


2.3. Documents

The following table should be used in the FMEA



2.3.1. Interpretation of the terms

The receiver: the receiver FMEA analysis is not only the end user (external customer) we mean, but also in the so-called internal receiver (e.g., working for the next operation, or to another engineer, who the product is intended for use by an etc. ).

Possible problems (failure mode): is a phenomenon, when the component functions, the operation does not meet the requirements for him. It is also assumed that the error may occur, but the action is not a requirement.

Effect: the errors by customer request influence the buyer, what are the effects of that fault. What do you notice about the receiver?

Possible cause: the facility is the weakness or process, which causes(weekly) the problem.

Current checks: they are the examinations, tests, which is used for a long time already, processes or similar products are currently used for the particular failure or error cause prevent, detect. They may be, for example, labor controls, audits, inspections, tests, etc.

2.3.2. Severity measures are:

Severity: will assess that the errors occur, the consequences of any errors, taking into account how problem the receiver. Usually, 1 to 10 says. (QS-9000-es recommendation)



Occurrence: the probability that a given fault cause brain, and cause a malfunction occurs. Usually, 1 to 10 says. (QS-9000-es recommendation)



Likelihood of survival has armed (hidden), detectability: an assessment of the current control measures how effectively is. The likelihood is estimated, that the test procedure is not filtering out the causes and failures. Usually, 1 to 10 says. (QS-9000-es recommendation)



Class (special order Department): if the customer specific requirements, there are certain criteria for process features, process steps, it must be shown in this field. This provided for by the buyer shall be marked symbol in the FMEA. This could involve specific requirements: e.g. SPC, and 100% inspection, etc.

FMEA risk index: output the risk index, the Risk Priority Number (RPN).  We value the RPN factor of the test facility and process. The RPN showing a complex, which includes both the buyer and the manufacturer of. Three scores of severity, occurrence, detectability.

RPN= severity * occurrence * detectability

Sorted by the RPN values (as in the Pareto analysis) to get the product/process, the order of risk, i.e. the remedial measures, received the highest score we concentrate on problems. Irrespective of the value of the RPN in practice in the special attention shall be given to the defect severity score, and high.

Another solution is to define a before each FMEA RPN limit. After the analysis is primarily with the issues that should be addressed to the limit has been exceeded. This may be as long as it should be increased to some companies, an internal RPN value, and then the limit is used for FMEA. The JCI W/C, the RPN target 70, which means 70 is above RPN remedial measures must be taken. If the RPN number is below 70, it is not necessary disciplinary action be taken.

Continue the form, the repair plan: after we sorted the failure arts the RPN, the basis for the rest of this form to determine remedial measures must be the highest value errors and/or the critical characteristics. The remedial purpose of the measures to reduce the RPN factor value. One time a repair measures shall identify the person responsible for implementing the action and shall set a time limit. After the introduction of the remedial measures must be re-evaluated, and the threescore the RPN value. We will re-order the RPN numbers, remedial measures are recommended….. and so on. The FMEA a permanent process, it is only when there is no end of the fault in ours.

2.4. Flowchart for the FMEA:



As any process, it can also be described in a flowchart. In my training lessons, I already showed simple and complex ones. This figure shows quite simply, how this process takes place.
There are special programs that can bring FMEA, Control Plan (CP) and product flow charts together. Such programs eg. the IQRM. Later on, I may also present this program.


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