Although the QM module is widely known, the FMEA application already integrated into it remains largely unused in many places. However, its functions are in no way inferior to the standard FMEA tools from other providers. SAP provides a powerful tool for both S/4HANA and its predecessor systems that easily meets the requirements of the ISO 9001 standard, among others. CONSILIO supports you in the creation or optimization of such an FMEA system.
What is an FMEA and why are risk analyses important?
Risk analyses are essential for manufacturing companies in order to identify potential quality losses at an early stage and take targeted countermeasures. Depending on the severity of the identified risk and the economic and regulatory consequences, suitable countermeasures can be taken in advance. This ultimately helps to avoid high costs due to rework, rejects, recalls or reputational damage.
A proven method for carrying out such analyses for processes or products (design) is the common "Failure Mode and Effects Analysis" (FMEA). This evaluates the risk potential based on three criteria:
- Significance/severity of the failure (S)
- Probability of occurrence of the error (A)
- Probability of detection of the defect (E)
Each criterion is given a numerical value (usually from 1 to 10). Based on these values, either the risk priority number (RPN) or the now more established task priority (TPP) can be calculated.
As the multitude of possible risks in production processes and products can quickly become confusing, a professional software solution is required for structuring and documentation. This is precisely where SAP's FMEA tool offers decisive advantages: It supports companies in systematically recording, categorizing and efficiently managing risks of all kinds. Corresponding follow-up measures to minimize risks can also be recorded transparently.
With this tool, you not only optimize your risk structuring, but also create a basis for sustainable quality assurance and cost efficiency.
Advantages of using FMEA in SAP
- No additional costs: In most cases, the FMEA application is already included in the existing SAP license for the QM module. Since the 2022 release, FMEA has also been available in Quality Management in the SAP S/4HANA Cloud.
- Library function: previously documented and evaluated detection and avoidance measures as well as failure sequences can be reused for future analyses using saved templates. This prevents redundancies and ensures a uniform evaluation.
- Traceability and integration: SAP processes and objects such as production control plans or complaint management can be directly linked to relevant FMEA content.
- Standardized procedure: Individually defined question lists and predefined fields for evaluating criteria such as function, defects or consequences ensure a structured and consistent analysis - even when used by different users.
- Compliance with standards: The systematic structure of the FMEA fulfills the requirements of ISO 9001 and (ISO/TS) IATF 16949.
These advantages enable systematic, transparent and cost-efficient risk assessment and management within the SAP system.
Structure and visualization
The standardized structure of an FMEA in GUI and Fiori is illustrated in the following figure using the example of the "water sterilization" process:
In addition, Fiori offers the option of visualizing causal chains by showing the relationships between functions and possible errors.
With the help of (individually customizable) risk matrices, the urgency of risk mitigation or avoidance measures can be clearly identified according to task priority (AP).
An FMEA can be printed out at any time. SAP provides the form in accordance with VDA 96 and QS9000 as a stored standard.
The FMEA tool in SAP QM is powerful, audit-compliant and requires no additional license costs.
Summary
Why incur additional costs for external FMEA software when SAP already provides a powerful FMEA tool in the QM module? As the FMEA is directly integrated into SAP, interfaces to other system areas can be optimally utilized. This not only seamlessly guarantees the traceability often required in audits, but also provides a stable and user-friendly system for everyday use.
