Verification of a conformity assessment institution by a third body (DAkkS)
In Germany, the "Deutsche Akkreditierungsstelle" (DAkkS) is responsible for the acceptance in the field of quality and environmental management systems. The DAkkS examines, monitors and confirms conformity assessment institutions (e.g. certification companies) their conformity with the applicable requirements. In short, the DAkkS audits the auditors.
- Action group
Group of actions (or measures, controls) assigned to a failure (cause)
The action group contains the attributes Occurrence O and Detection D.
- Action priority Standardized evaluation of single causes through the factors S, O and D according to AIAG and VDA
- Action state
Group of actions to a specific state
All actions (or measures, controls) relating to a date are listed under one action state which can be e.g. "initial" or "revision".
- Action status
Status of the actions
- decision pending
- implementation pending
- not implemented
Automotive Industry Action Group
The Automotive Industry Action Group (AIAG) is a not-for profit association founded in 1982 and based in Southfield, Michigan. It was originally created to develop recommendations and a framework for the improvement of quality in the North American automotive industry.
A professional but nevertheless relative assessment of the prioritization of the measures is only useful because of the three separate factors B, A and E. In order to provide a value for this, the Action Priority (AP) was designed.
There are now only three AP classes: High (H), Middle (M) and Low (L).
- High - Top priority for action: The team must either identify an appropriate action to improve the occurrence and / or detection, or justify and document why action taken is appropriate.
- Middle - Medium priority for action: The team should identify appropriate actions to improve the occurrence and / or detection, or at the company's discretion, justify and document why action is appropriate.
- Low - Low priority for action: The team can identify actions to improve occurrence or detection.
It is recommended that at least the meanings of the consequences of errors from 9 to 10 and the task priority high or medium, a review including the measures taken is carried out by management. Thus, the decision-making level has recently been given responsibility and finally informed well-founded and properly.
The action priorities are not used to prioritize a high, medium or lower risk, but rather to prioritize the need for measures to reduce the risk.
This evaluation approach has already been successfully tested in several practical projects. As a result, the following additional advantages were recognized:
- It is assessed more honestly, which leads to a more realistic risk landscape and thus the benefits of these analyzes are better perceived by all those involved.
- Customers, auditors and decision-makers get a better overview and can make more informed decisions.
- Confidence in the method increases.
As a current conclusion, it can be said that the AIAG and VDA working groups have achieved a great success here. Above all against the background that this procedure, thanks to the harmonization of the American and German automotive sectors, is now more or less valid worldwide.
- APQP (Advanced Product Quality Planning)
Systematic and qualitative project- and development planning
APQP is a defined and structured procedure for failure prevention, which is already used in the planning and development phase of a product. Measures are defined, executed and documented. This should ensure that a product meets customer expectations. Errors should be avoided and not corrected!
Automotive Safety Integrity Level
The ASIL automotive safety integrity levels are defined in ISO 26262 and are a measure of the extent to which a system should be designed or monitored more reliably. The ASIL assessments are determined in the hazard and risk analysis (HARA) and can assume the values QM, ASIL A, ASIL B, ASIL C and ASIL D. These are derived from the individual factors S Severity (severity of the failure), E Exposure (frequency or duration of the operating mode) and C Controllability (controllability of the failure).
- BBB (BigBlueButton)
Our preferred video conferencing platform (DDPR)
BigBlueButton is a license-free video conferencing system that can be seamlessly integrated into Moodle events via the Meetings plug-in and via direct access via Greenlight. The participants can hear and see each other and work with one another while they are using it. Slides can be presented and queries can be carried out. A window in the user interface of your own computer can be made visible to others, for example to show the participants certain websites or applications. The event can also be recorded and made available to interested parties. BigBlueButton offers the following functions
- Audio and video conferencing
- Record of meetings
- Screen sharing
- shared whiteboard
- smaller spaces for teamwork
- Chat Survey
- Firefox Chrome
- Current Edge (from Jan 2020 as it is based on Chrome)
- Android Moodle APP
- Neither Internet Explorer (completely out of date) nor the old MS Edge support BBB.
- Cause (of failure)
potential cause of failure
Causes in an FMEA are failure modes of a hierarchically subordinated system.
- Controling Methods
actions that ensure the manufacture of a product feature.
The control methods must ensure the production of a product feature under controlled and reproducible conditions.
- Controls (or Measures or Actions)
Prevention and Detection Controls to Failure Causes
The types of controls (measures, actions) in an FMEA are subdivided into prevention and detection controls to failure causes. The action includes the attributes deadline, responsibility and status.
The control plan is a requirement of the APQP. The CP is a document for the respective workplace in production. In general, all special characteristics in the drawing, the process FMEA, in the CP as well as in the test plan are 100% consistent and 100% subject to labeling. The CP provides the employee with four essential pieces of information:
- Product characteristics from the drawing or from the P-FMEA. However, not all characteristics have to be derived from the drawing or the FMEA. Also the contents of the column "Detection measures" are not always 1: 1 unseen in the CP.
- Process characteristics, which ensure product characteristics, from the P-FMEA.
- Tests that are necessary for control. These are the actual control measures.
- Instructions on how the employee should behave in the event of non-achievment of the above product or process characteristics (reaction plan = closing the control loop).
Requirement from IATF 16949: The organization shall prepare control plans (as defined in Annex A) for the relevant production site and for all products to be supplied at the system, sub-system, component and/or material levels. The organization shall include the following in the control plan:
- Measures used to control and monitor the manufacturing process, including the verification of set-up procedures,
- First/last part comparison, if applicable,
- Methods for monitoring the control of the special characteristics, both those specified by the client and those defined by the organization itself,
- Information requested by the customer, if applicable,
- Defined reaction plans in case defective products were detected or the process was judged to be statistically unstable (not controlled) or incapable
- Not to forget the scope and frequency of re-qualification examinations.
- Critical characteristics
Special characteristics leading to safety hazards or non-legal
Critical characteristics are characteristics which, depending on an individual risk assessment :
• may result in an immediate risk to life and limb from the product
• must be complied with, in accordance with legal regulations (such as emission limits).
Critical characteristics are a sub-division of the definition of the term "special characteristics", as used, for example, in ISO/TS 16949:2002.
- D (Detection)
Detection of a failure cause or its effects considering all detection actions
The detection assessment is an indication of the effectiveness of the detection measures to detect a failure before production release (D-FMEA) or before product delivery (P-FMEA) or before damage occurs (MSR-FMEA).
The detection is a relative classification within the framework of the respective FMEA and is determined without consideration of the Severity or Occurrence ratings.
The detection can be made on the basis of the criteria in the rating table. This rating table can be extended to include examples of common detection measures used by the organization. The FMEA project team should agree on uniform evaluation criteria, evaluation levels and evaluation systems, even if these are adapted for an individual product analysis.
The detection, which has not yet taken place, is initially a prediction of the effectiveness of a detection measure that has not yet been tested. Once the discovery measure has been implemented, its effectiveness must be reviewed and reassessed.
If possible, the detection measures should refer to the cause of failure. For technical, but mostly cost reasons, this is rarely used and is not enforceable. Therefore, the discovery of failures or their effects is the more practical way. This detection can therefore refer to the assumed cause of the failure, the failure itself or the effects of failure. The earlier the failure is detected, the more favourable is the effect on capacities and total costs (this loss of value is not included in the evaluation, however - although this is still being discussed in expert circles).
D=10 is chosen if it is impossible or unlikely to detect the failure at all or in time or if no detection measure is available.
D=1 is chosen if the failure is detected very reliably and in time and if it is determined reliably by the sum of all measures.
The Design-FMEA or simply D-FMEA is often also referred to as Construction-FMEA. This analysis is intended to identify weaknesses in the constructive design of a product at an early stage and to contribute to increasing system safety, reliability and availability through optimizing measures.
Your benefit is an early assessment and improvement of your product design and documents your expert knowledge.
Availability of the of the product functions
Collective term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance and maintenance support performance.
from DIN EN ISO 9000:2005
- Detection distance
Distance between the point in time between the occurrence and discovery of an error
Evaluation of detection (E) according to the new AIAG-VDA standard (detection distance has also been evaluated since 2019)
So far, we have always used the E-evaluation in the process FMEA to evaluate the ability of a detection measure to discover a cause or its effects in good time. From our point of view, this also made sense in order to be able to assess the risk in the process.
The exact location of the discovery was irrelevant to the quality of the discovery. According to the new standard, a further criterion for the e-rating is the place or time of discovery. The loss of added value is thus taken into account in the assessment with regard to the detection distance. So the later an error is discovered, the higher the costs in terms of rework or scrap costs and the higher the e-rating. (The costs of the discovery measure are not considered separately for this)
The aspect of the loss of added value and also the costs of the measures are important and not negligible in our opinion. We are of the opinion that the central goal of the P-FMEA must prevent or minimize the slip of defective or faulty products to the customer. This slip through could be perfectly represented in the ExA matrix.
Due to the new evaluation criterion, this evaluation is no longer meaningful and the informative value of the e-evaluation is no longer unambiguous and clear, since in practice many teams still evaluate the effective discoverability, as it offers more advantages in the analysis. Thus, the results of FMEAs become heterogeneous to the discovery.
We would like to incorporate the loss of added value and the costs of the measures into the FMEA through one or two of our own assessment factors or in the form of comments, remarks or notes and to continue to focus on the ability of the detection measure in the e-assessment. However, this request does not conform to the AIAG-VDA evaluation tables, but will certainly cause discussions in specialist circles in the next few years.
Design of Experiments
The objective of this method is to optimize processes and systems as efficiently as possible. In several planned experiments, influencing variables on the process or system are varied in a targeted manner in order to search for an optimum with respect to one or more defined target variables (e.g. optimum combination of injection nozzle, mixture, etc. in order to achieve the most fuel-efficient combustion possible). The method is based on statistical procedures for maximizing the use of information from tests, which are used for the targeted planning of a sequence of tests and their evaluation.
Design Review Based on Failure Mode
The table-based DRBFM method was developed by Toyota and is based on the FMEA methodology.
Since changes usually contain the highest potential for error, the design changes are assessed in an unpredictable manner in brainstorming team meetings. Since it is important to know the risks / types of errors in the previous design for the evaluation of the newly added error potential, it is advantageous if an FMEA has already been carried out for the product or the process before starting a DRBFM.
- Effect of failure
potential effect of a failure mode
Bezeichnung der möglichen Folgen (Wirkung in einer hierarisch höheren Ebene), die durch das Auftreten des Fehlers/das eintreten könnte.
1. Jeder Fehler kann mehrere mögliche Folgen auf mehreren übergeordneten Ebenen hervorrufen.
2. Folgen sind Fehler eines übergeordneten Systems.
3. Jede mögliche Top-Folge wird separat bewertet.
Vorsicht: Verwechslung mit Signalpfad-Folgen (Blockdiagramm) sind sehr leicht möglich aber nicht zielführend.
- F (Frequency)
Frequency of failure cause in relevant operating situations during planned operation time of vehicle or system
The frequency F is an evaluation factor in the MSR-FMEA and replaces or supplements the occurrence O from the design FMEA. The frequency describes the estimated or expected frequency of a cause of failure in relevant operating situations during the planned operating time of the vehicle or system. The frequency can also assume values from 1 (very low) to 10 (very high). The reason for the frequency can be: Results of D-FMEAs Results of P-FMEAs Field data on returns and rejected parts customer complaints Data on guarantee and goodwill costs Catalogs with failure rates of components
Failure mode in the considered system element (focus element)
Nonconformity Non - fulilment of a requirement.
from ISO 9000:2005
Reference Volume (and volume-specific, additional or differing definitions to the standard):
VDA Volume 6 Part 2 and
- Definition from standardized process for handling customers complaints
Synonymous with and often used instead of "problem“ or "defect". If the deviation (q.v.) exceeds the permitted/specified/agreed limits for quantitative characteristics, this represents a failure. In the case of qualitative characteristics, if the parts do not meet requirements in terms of specified limits or characteristics which may tacitly be expected, this is also a failure.
- Failure net
Graphical representation of hierarchical, causal failure chains
The failure network graphically represents the hierarchical failure chains along the system structure. The failure network is always viewed with a focus on a failure and shows its causal effects and causes. It consists of at least 3 hierarchical levels (effect - failure - cause), but can also consist of more levels depending on the system (e.g. top effect - direct effect - failure - direct cause - root cause). The maximum severity evaluation is inherited from left (effect) to right (cause) along the failure network.
Failure Mode and Effects Analysis
FMEA is an analytical method for improving the quality, reliability and safety of products and processes. Thus, FMEA supports teams in the development and manufacturing of failure-free products. In addition, a correctly performed FMEA also fulfils the due diligence as part of the responsibility in the product development process. Potential product or process failures are evaluated according to their Severity, Occurrence and Detection in order to determine the need for further control measures.
- FMEA Moderation
Efficiently lead an FMEA team with the goal of creating an effective FMEA.
Effective FMEA moderation is only possible if the trained FMEA moderator masters the methodology, the software and the communication rules.
Methodologically, the state of the art and science must be brought to the team. For this, the preparation, the team knowledge level, the organization and the software used are essential.
For a proper execution the number of participants should be limited to about 8 persons. The best results are achieved with 3-5 persons in cooperation with the respective specialists or product and process managers.
Failure Mode, Effects, and Criticality Analysis
The FMECA is an extended FMEA for the analysis and evaluation of the probability of failure and the expected damage. This is now 100% mapped in an FMEA and therefore no longer needs to be explicitly considered. In some cases, a quantitative probability for the failure effects is required. This means that only the evaluation of the Severity S is not sufficient.
Standards: FMECA (Military Aviation): MIL-STD 1629
Failure Mode Effects Diagnostic Analysis (for electrics/electronics only)
The FMEDA is a quantitative analysis for all electronic components or modules to determine the reliability of the product through metrics (random failures as a supplement to the systematic failures of an FMEA). The FMEDA also determines the Safe Failure Fraction (SFF) as an evaluation quantity for Functional Safety Management according to IEC 61508.
Failure Modes and Effects Summary
Is contained in a state-of-the-art FMEA. Mostly required in aviation: determination of the error rates on the error effect level. Standard: (civil aviation): SAE ARP-4761, ABD0100.1.3
Fault Tree Analysis
The FTA is a method for reliability analysis. Based on Boolean algebra, the FTA depicts adverse events of a system (system analysis) by means of a qualitative and quantitative analysis.
Based on the undesired event, a tree structure and the critical paths are developed (top-down procedure), in which the interaction of potential causes for the undesired event is logically represented. In addition to component faults, other influences such as situational aspects and environmental conditions are also considered as potential causes.
- NUREG – 0492 (Nuclear and NASA)
- SAE ARP 4761 (aviation)
- IEC 61025: 2006 (DIN EN 61025: 2007)
- DIN 25424 part 1 and 2
A function is a (clearly defined) activity, task or result to be performed within a larger context
- Understanding of the product / process
- Completeness of the functions as the basis for failure analysis
- Understanding and communicating system levels
- should be unambiguous, concrete, verifiable and validatable, and should be formed from a noun and a verb
- can be derived from technical and country-specific requirements as well as from design objectives
Functional descriptions implicitly contain the associated requirements (e.g. over service life, environmental conditions, ...) without having to mention them explicitly. This also includes:
- expressed expectations (specifications)
- naturally assumed expectations
- predictable misuse
Activities in the frame of functional analysis:
- Finding functions at the right system levels
- Analyze signal paths or hierarchical paths
- Assignment of requirements to functions
- Visualize hierarchical functional relationships
- Function net
Graphical representation of hierarchical, causal function contexts
The functional network graphically represents the functional relationships of the system elements hierarchically along the system structure. The functional network synchronizes the system knowledge of all team members and is the basis for the subsequent failure analysis. When creating and checking the plausibility of the function networks, the questions "How" (how is this function implemented by system elements of lower hierarchy levels?) can support top-down and "why" (why do we need this function?) bottom-up analysis.
Functional safety refers to that part of the safety of a system that depends on the correct functioning of the safety-related system and other risk-reducing measures. Functional safety does not include electrical safety, fire protection or radiation protection.
Safety can also be achieved by stopping the intended function and achieving a safe state if necessary.
The complexity of electronic systems, especially programmable systems, increases the variety of possible failures: Nowadays, microcomputers perform almost all safety functions. They ensure, for example, that the pressure in the steam boiler does not exceed the norm; they ensure the safety of chemical plants or direct trains to the right tracks at the right speed.
Accordingly, the IEC 61508 series of standards "Functional safety of safety-related electrical/electronic/programmable electronic systems" requires the use of various methods to control faults:
- avoidance of systematic failures in development, e.g. specification and implementation errors
- Monitoring during operation to detect random failures
- Safe control of detected failures and transition to a previously defined safe state.
(in the automotive industry refer to ISO 26262)
- Hazard / Gefahr
The potential cause of damage
Actual or potential threat/hazard to persons, property, circumstances, animals, or the environment.
- HW (Hardware)
General term for the physical components (electronics and mechanical parts) of a system.
- Hybrid network Graphic representation of hybrid function and failure nets for the MSR-FMEA
- M (Monitoring)
A measure of the ability to detect a failure during customer operation and to implement appropriate system reactions or conditions in time
The monitoring M is an evaluation factor in the MSR-FMEA and replaces or supplements the detection D from the design FMEA. Monitoring is a measure of the ability to detect a failure in customer operation and to implement appropriate system reactions or states (safe states) in good time. The monitoring can also have values from 1 (very good) to 10 (very bad). The following aspects must be taken into account in the assessment: Monitoring reliability (DC diagnostic coverage) System reaction automatically or manually Scatter with regard to failures or causes and the components used Range of human perception and speed of reaction Experience with the implementation and effectiveness from previous projects (degree of innovation)
- Mechatronical analysis Graphical representation in which error discoveries and reactions for critical causes are modelled.
Time of a special event in project management
A milestone is an event of particular importance. Milestones divide the course of the project into verifiable stages with intermediate goals, thus facilitating both project planning and monitoring of project progress.
Mean Time Between Faults
The average time between the occurrence of faults. In other words, the total running time of a machine divided by the total number of faults.
Mean Time To Repair
The average time that is necessary to bring the machine back to the specified condition.
- O (Occurrence)
Evaluation of the occurrence O of the failure cause considering all preventive actions.
The occurrence O of the cause of the failure is evaluated under consideration of all effective preventive measures during the service life under all operating conditions and other requirements. (This evaluation attribute is assigned in APIS to the action groups and to the action status in other SW).
The occurrence rating is the respective relative assessment by the technical experts according to the current state of knowledge and does not have to be proven by evaluations (with the exception of 1). It is not an absolute measure and the resulting risk assessment can therefore only be assumed to be relative.
The occurrence should be estimated using the criteria in the rating table. This table should be extended by product-specific examples.
Expert knowledge, data manuals, failure rates or other experiences from the field of comparable products can be used for this assessment. Tolerance calculations and simulations are also prevention measures that influence the occurrence.
- In some cases ppm data can be used for the evaluation of possible failures with experience in series production. The exact determination of the ppm numbers in new products or products of small quantities is not possible.
- The occurrence is a relative classification within the FMEA and may not reflect the actual occurrence.
- The occurrence describes the potential with which the cause of the failure occurs, according to the rating table, without taking into account the detection measures.
- Expert knowledge, manuals, warranty databases or other experience, for example from comparable products, can be used to evaluate the occurrence.
- If causes of failure are classified according to occurrence, the effectiveness of the ongoing preventive measure is taken into account. The accuracy of this evaluation depends on how well the prevention measure has been described.
O=10 is entered if the considered cause of the failure occurs with a high probability, no prevention measure is available or its effectiveness is unknown.
O=1 is entered if it is almost impossible for the considered cause of failure to occur.
The Parameter-Diagram or P-diagram is a useful tool for determining, documenting and visualizing influencing factors (parameters) on a system, a system function, or a manufacturing process. The visual representation is based on the central position of the system/function/process.
Every system, function and process has input factors, the inputs. The central element converts the inputs into output results. So input - function - output. In addition to the desired output, there are usually undesired side effects. These are called "Undesired Output, Side Effects, Undesired Output in the P-diagram.
In the following step, two further important influencing factors are identified and documented. Disturbance variables and control variables provide probably the most essential information about the selectable control variables and the all-around disturbance variables. Let us start with the disturbance variables. These are influences that constantly affect the system due to systematic dispersion in production, the environment and customer use. The term disturbance variable is based on the fact that these disturb and/or negatively influence the ideal system function.
The control variables are opposed to these non-adjustable influencing parameters. These are parameters to be selected, with the help of which the system / the system function is made robust against the disturbance.
Process FMEA or simply P-FMEA includes all types of FMEA that deal with the analysis of processes, i.e. manufacturing FMEA, production FMEA, logistics FMEA, etc. The purpose of this analysis is to identify weaknesses in production planning at an early stage and to contribute to increasing process reliability, availability and robustness through optimizing measures.
Your benefit is an early assessment and improvement of your process design and documents your expert knowledge.
- PDP Product Development Process
Der Prüfplan wird auf der Grundlage des Prozesslenkungsplans aufgebaut (ohne die geschlossenen Regelkreise). Hier werden die Prüfabläufe für die Sicherstellung der Qualität und für die Überwachung der Produktion aufgezeigt.
Einstellblätter entsprechen hinsichtlich ihres Inhalts und ihrer Intention einem Teil des Betrachtungsumfangs des PLP. Sie sind für sich allein aber hinsichtlich der zwingend vorgegebenen Inhalte (Spalten) des PLP (s. Anhang A der IATF 16949) sicherlich nicht vollständig.
Wenn die Mitarbeiter gut qualifiziert sind, fällt es oft schwer, den Sinn des PLP zu verstehen. Die Mitarbeiter erfahren typischerweise mittels Arbeitsanweisungen oder Fertigungsaufträgen, was man von ihnen erwartet. Ihnen ist normalerweise auch klar, dass sie den Vorgesetzten informieren müssen, wenn zu überwachende Merkmale oder Parameter aus dem Ruder laufen.
Es müssen nicht alle Produkt- und Prozessmerkmale, die im Fertigungsprozess überwacht und geprüft werden, per se im Produktionslenkungsplan enthalten sein, sondern nur die, mit denen die Qualitätseigenschaften des Produkts gelenkt werden – egal, ob mittels direkter Prüfung des Qualitätsmerkmals am Produkt oder Überwachung eines damit korrelierenden Prozessparameters. Manche Unternehmen nehmen auch einzelne Arbeitsschritte in den PLP auf und ersetzen damit die Arbeitsanweisungen für die betreffenden Arbeitsplätze.
- PPAP Production Part Approval Process
parts per million
1 ppm = 10^-6
- Process characteristics Causal parameters that affect the product features to be manufactured
- Product characteristics
Specifiable product properties (drawing specifications), which are designed in development (D-FMEA) and produced in process (P-FMEA)
The process characteristics are usually noted in the causes (mostly in the machine).
Examples: feed, speed, temperature, pressure, ...
Quality Function Deployment
QFD (Quality Function Deployment) is a quality tool developed in Japan at the beginning of the 1970s. It is used to elicit customer requirements and translate them directly into the necessary technical specifications. The methodical approach is based on a separation of the customer requirements (WAS) from the technical product features and functions (WIE).
- Rating catalogs
Rating catalogs help to understandably determine the meaning B, the occurrence A, the detectability E.
A qualified evaluation catalog should help the FMEA team to determine the meaning B, the occurrence A, the detectability E and the task priority AP as comprehensibly as possible. According to VDA, DGQ and AIAG, a product-specific evaluation catalog should therefore be used. In the above mentioned methodological documents, example catalogs are described, which tend to also apply to this company.
We recommend using the current AIAG / VDA tables and adding your own product or process-specific examples to the example column. The following catalogs are specifically adapted to the products and processes of this company (examples were defined by the competence team) and correspond to the standards proposed in the documents.
The evaluation catalogs are also applicable documents for project and product-related customer assignments.
- Requirement A requirement is a necessary condition or ability, a system or system parts have to fullfill or own in order to comply with a standard, a specification or other given documents
- Requirement specification
Total requirements from customer
All requirements specified by the client in a contract for all items (products including services) to be provided by the contractor.
Requirements from the user's standpoint, including all peripheral conditions must be described in the requirements specification. These requirements should be quantifiable and capable of being checked. The requirements specification defines what kind of task is to be carried out and why it is to be resolved.
- Response measures Measures to be taken if errors are found
- Risk analysis Systematic approach to identify and reduce potential hazards
- Risk Matrix A diagram to illustrate the Severity over the Occurrence
Risk-Matrix based Ranking
Designation of a prioritization indicator (from the APIS software), which is formed from the risk matrix combinations (SxO, SxD, OxD) of an FMEA.
- Root cause
Failure mode in lowest level of failures
There are no other causes below the root cause. So no further link (right end of the failure chain).
- Root element
Highest system element in a system tree
The root element is the highest system element (far left) in a system tree in the system analysis. The root element is where the potential effects of an FMEA are located. In most cases, the higher-level systems (law, OEM, vehicle, user) are contained here.
Risk Priority Number (former indicator for risk prioritization)
The risk priority number is the product of S x O x D. The RPN is described in the current regulations (VDA, AIAG, DGQ and others) as not recommendable with regard to a reliable statement or even completely rejected or prohibited. Threshold values are generally not recommended. (RPN=60 can be highly risky whereas RPN=300 does not cause any problems).
In 2019, AIAG and VDA have replaced the RPN by the action priority AP.
- S (Severity) Severity of the failure effect on a scale from 1 to 10
- Safe state State that the system or vehicle should adopt in the event of a failure in order to minimize the risks for people despite a failure
- SE System element (an element in the structure tree)
- SG Safety goal
- SGL Safety goal latent
- Six Sigma
Quality strategy with the aim of radically reducing defect costs
At the core of Six Sigma is a structured methodology for static problem solving based on the analysis of measurable process characteristics, resulting in a reduction of variation in the process under consideration.
- SOP Start of Production
- Special Characteristics
Characteristics whose considerations require special care
Special characteristics form a subset of the total of all characteristics and are divided into three categories according to the VDA approach.
"BM S": Related to safety requirement / product safety / safety related consequences
"BM Z": Related to legal and regulatory requirements
"BM F": related to special requirements and functions
- SW Software
- Tier 1, ..., n
Tier 1, …, n The term "tier 1,…, n" is used to refer to suppliers at various levels in the supply chain. Direct suppliers to the OEM are referred to as "tier 1", a supplier to a tier 1 supplier is referred to as a "tier 2", etc.
- Top effect potential effect at highest level (left end of the failure chain)
Are we creating the right product?
Validation Confirmation, through the pro-vision of objective evidence that the requirements for a specific intended use or application have been fulfilled.
from DIN EN ISO 9000:2005
- VDA German Association of the Automotive Industry
Are we creating the product right?
Confirmation, through the provision of objective evidence that specified requirements have been fulfilled.
from DIN EN ISO 9000:2005