New processes and products are being developed and then brought to market in ever shorter periods of time. The faster a company’s progress is planned, the higher the probability that errors occur. This can affect not only the product quality, but z. B. also internal processes, project management or decision-making with a lack of preparation and data processing. There may be errors that occur with a relatively high probability, but have hardly any consequences for the user.
An example from reality: Can an electric sphygmomanometer If the blood pressure is not recorded correctly (error), it will inflate the arm loop again in order to be able to record correct values (avoidance measure). A possible cause lies with the user, who usually ties the arm loop around himself and may not have tied it tightly enough. This can occur with a high probability, but has negligible consequences for the user.
FMEA for timely detection and avoidance of errors
A very frequently used tool for detecting and minimizing possible risks is the Failure Mode and Effects Analysis (FMEA). The FMEA has several Goals:
- cost-effective ways to improve the design of a unit or process by influencing it early in development
- Product and process optimization through early detection and avoidance of errors
- Identify risks related to non-compliance with requirements (e.g. security)
- Compliance with legal and corporate requirements through traceability and evidence that risks have been managed and accepted
Error functions are analyzed, which are made up of errors, error consequences and error causes. The effects, avoidance and detection measures of the respective errors can then be derived. Another building block of the FMEA is the risk assessment. It is used to estimate the frequency and probability of the error that occurs, whether it can be noticed by the customer and determined before delivery. FMEA are used in many areas. These are, for example, in development, construction, production, quality management, purchasing and sales. Nevertheless, the principle of the FMEA can be extended to all areas of the company and makes sense for one structured and objective approach.
FMEA when creating a business plan
As soon as entrepreneurs have developed their product idea or their range of services, they usually need capital for implementation and establishment in the market. A business plan must be drawn up for this. One of the contents of such a business plan is financial planning for at least the next three years. Development banks and investors, for example, look very closely at this part. Is the financial plan as a whole plausible? Is the number of employees realistic and is there growth over the years? Is the turnover calculation plausible in relation to the market situation? Are all costs incurred to implement the content of the business plan drawn up taken into account? Have financial buffers been set up to cushion unexpected events due to risks that have arisen?
For example, when start-ups do their own financial planning, financial buffers are often neglected. But also the consequences of the costs due to errors is significantly underestimated. If a product or software defect is discovered early in development, the cost of the impact is all the less. The later in the product cycle an error has to be fixed, the more difficult it is to implement preventive measures and the more expensive the error correction becomes. Recalls are the last resort and indicate insufficient error prevention measures.
Analysis of possible errors, consequences and causes on the object to be examined
At the beginning, the creator of an FMEA must describe the system or function that is to be analyzed in the further course. Then the answer helps following questions:
- Where could an error occur?
- How would the error be noticeable or how does it occur?
- What kind of error could this cause?
- Why can the error or the error sequence occur
It should be all sorts error causes be documented briefly and fully. It is helpful to document these points in a list.
The assessment of the significance of the possible error is to be made from the point of view of the user or employee and refers to each cause of the error. The scale goes from 1 (no noticeable effect) to 10 (extremely severe).
Discover and avoid mistakes
When it occurs, the scale goes from 1 to 10. 1 means that an error has been effectively eliminated by the avoidance measures. With a value of 10, the probability of occurrence is extremely high and cannot get through preventive measures be reduced or none have been provided.
With the discovery, the Effectiveness of detection measures rated. The scale goes from 1 to 10, with 1 being very high detection ability and 10 being very low, so no test procedure or method has yet been developed.
Finally, the individual assessments are summarized as a product in the risk priority number (RPN) and serve as a subjective risk ranking. An RPN (external link) between 1-125 indicates low risk, 126-250 medium risk and 251-1000 high risk. However, the RPN alone is not suitable for assessing risk potential.
After measures have been taken to avoid and detect errors, these must be checked afterwards. This is done taking into account self-defined control measuresResponsibility, and Target Date, as well as the re-implementation of the Importance, Occurrence, Detection, and Risk Priority Number ratings.
Risks can never be completely ruled out. Overlooking opportunities for error can be huge effects to have. This not only applies to product development, but also e.g. financial planning for at least three years, project planning by when something should be completed, or threats from the competition based on a target market analysis. When designing a business idea, founders must know the risks of their company or business area in advance. A prerequisite for creating a business plan is knowledge of the entrepreneurial strengths and opportunities, but also weaknesses and risks. It is therefore particularly important to integrate avoidance measures that reduce the probability of occurrence and the effects of risks.
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