WO2008139036A1

WO2008139036A1 - Method and arrangement at quality control

Info

Publication number: WO2008139036A1
Application number: PCT/FI2008/050263
Authority: WO
Inventors: Birgitta Dahl; Tore STÅHL; Lars Lundsten; Johan Lund
Original assignee: Stiftelsen Arcada
Priority date: 2007-05-14
Filing date: 2008-05-13
Publication date: 2008-11-20
Also published as: FI20075349L; FI20075349A0; WO2008139036A4

Abstract

The present invention relates to a method for quality control where database information including relevant base information, standard or rule related information and dynamically updated response information regarding authentic applications is compiled and relevant fictive typical cases are generated for a fictive administration, the outcome of which being evaluated as a comparison against said database information and returned as feed-back. The invention also relates to an arrangement for quality consolidation, which arrangement includes a general database (1) including basic information (2), information (3) regarding regulative functional description and responsive feed back (4, 10) which at least partially reflects a result of at least one authentic administration of the respective partial function. The arrangement further includes means (5) for generating varying typical cases, means (6, 8) for presenting selected typical cases, means (7) for processing response from a fictive administration of these presented typical cases, and means for presenting (6, 8) a comparison between the fictive administration and regulative administration of said typical case. Finally, the invention relates to a use of the method and, respectively, the arrangement in the administration of medicines, the handling of explosives or in some other distribution of substances.

Description

METHOD AND ARRANGEMENT AT QUALITY CONTROL

The present invention relates to a method according to the preamble of claim 1. The present invention also relates to an arrangement according to the preamble of claim 5 as well as to a use according to claim 10.

Quality as a concept constitutes a measure of, on one hand, a technical or economical expediency, and, on the other hand, a product stability, i.e. the fact that any variance is kept within pre-defined acceptable limits and that, for example, a product thus can be expected to fulfill certain pre-defined criteria. Normally, the word quality is also connected to a positive subjective judgement, but strictly spoken this is only a consequence thereof that the above described conditions generally can be considered as desirable.

Thus, every form of quality control will aim to processes where the properties of a product, in the widest interpretation of the word, can be supposed to correspond each occasion to expectations set at the time. Thus, a high quality can usually be defined as an even quality which, additionally excludes variations beyond acceptable limits.

In producing industry the quality control normally includes guiding measures by means of which the production is controlled so that the set demands are met, and further such control measures by means of which possible changes in the product are monitored, usually by statistical means. If such changes show that the production should be adjusted the quality control guides the production into a desired direction in order to counteract undesired changes. Shortly, the quality control acts so that the actual values correspond to predefined desired values.

Especially, for data related processes or processes which otherwise are controlled on the basis of regularization with a feed back connection to desired values which vary depending on a time factor, the quality control process will be more complicated, since the desired end result, on one hand, should eliminate all unacceptable variations but, on the other hand, at the same time should dynamically consider an acceptable variability. The question becomes especially complicated if this acceptable variability constitutes a result of a changed practice, changed applications of the product, a changed pattern of behavior or some other factor which cannot quite be foreseen or influenced. Thus, for a product to be able to meet, for example, the demands of a market the quality control must be able to flexibly meet these changes.

An old fashioned turning could be given as a concrete simplified example of such a problem, where a lathed piece, on one hand, must fulfill certain maximal measures in order to adapt the ends thereof to a ball bearing, while a central portion thereof should be turned as thin as possible though thick enough to be loaded with a transversal load without breaking. With the development of material technology said central portion can be made even thinner in order to save valuable material. Alternatively, one could, on the other hand, use a cheaper material if the central portion would be made thicker. A quality control which only considers the situation at the time when the turned piece originally was constructed would inevitably, as time goes by, lead to unappropriate products.

In the above example the turner could be compared to a presumptive administrator who must administrate his process, i.e. the setting of the lathe, in accordance with the individual requirements of different customers while observing material standards relevant at the time, as well as good turning practice. In this case a quality control includes that the turner in advance should be able to evaluate whether the product will fulfill the set requirements. Until now this has requested either separate calculations for each individual case, or merely experience related considerations where only the skill of the turner could guarantee the result. The object of the present invention is to eliminate this problem and provide a model by means of which quality related functions can be handled in a systematic manner in the form of a control and managing of the process administration. According to the present invention this is achieved by means of what is defined in the characterizing portions of the appended claims 1 and 5, respectively, while dependent claims 2 to 4 and 6 to 9 disclose especially favorable embodiments and claim 10 defines a favorable use of the present invention.

On a general plane the present invention is based on an interactive process where into a database is compiled valid relevant basic information, in the turner case information regarding the material and the dimensions of the bearing surfaces, valid standard or regularized information, in the turning case information regarding available materials and their strength, as well as dynamically updated response information regarding practical applications, in the turner case information regarding which kinds of pieces the market generally would use and which kind of pieces other turners have produced earlier. On the basis of these data relevant fictive typical cases are generated, which the presumptive administrator, in the above case the turner, can administrate in a fictive manner, in the turner case evaluate the lathing possibilities, whereafter the result of this fictive administration is compared to the database information and the result is used for the quality control, in the turner case the standards which should be considered valid for the respective individual lathing.

Below the invention is disclosed in more detail with reference to some slightly more complicated examples, where in the enclosed drawings

Figure 1 discloses a general schematic view of some central elements according to one embodiment of the present invention, and Figure 2 discloses a schematic view of an especially favorable embodiment of the present invention, more exactly a quality control process in connection with pharmaceutical administration where the quality control can be used in order to have an influence on, for example, the concrete dosing of medicines to patients in accordance with the properties of the products, given standards as well as in practice effected medications taking the fact that practice changes continuously into consideration.

In accordance with the principle drawing disclosed in Fig 1 an arrangement in accordance with the present invention primarily comprises a general database 1 including a number of structurally separate portions. A first portion includes basic information related to partial functions, which is physically and/or administratively located . in, or as, one or more separate databases 2 which in the embodiment according to Fig 2 also, for example, could be constituted as external databases 2, 2a. Said databases 2, 2a include, for example, product facts, relevant at the time. Said database 1 further includes at least one regulation database 3 including functional specifications, divergence standards or other marginal terms valid for the base information included in said database 2, 2a when applied within each respective partial function. In some cases the regulation database 3 can be included as an element in the basic database 2, 2a, for example as overlayed metadata. As a third element said database 1 includes a database element hereafter referred to as the process database 4 including registered authentic information regarding how the respective partial function has been administrated in practice, in actual situations. This registration of authentic situations in the form of process information can be implemented as verbal process descriptions, video recordings, recorded case descriptions, conventional text, biological data or other information describing how the basic information included in said database 2, 2a has been utilized in practice, taking the facts included in the regulation database 3 into consideration.

The arrangement according to the present invention further includes means 5 for generating relevant typical cases on the basis of the information included in database 1, suitably said basic data and said regularized information. These typical cases are presented for presumptive administrators which, in turn, in a fictive manner administrate the respective typical cases and feed subjective information back to the arrangement, suitably through a user interface 6 which favorably also is used for presenting the typical case. This interface 6 is then favorably used also for presenting a favorably numerical or verbal indication of the correlation between the authentic and the fictive administration, in the form of a an analysis 7 of the difference between the result of the fictive administration and a corresponding real administration as disclosed in the registered authentic process information. As disclosed in Fig 1 said interface 6 is favorably connected to said presumptive administrators by one or more networks 8, while especially said process database 4 but favorably also said regulation database 3 and said basic information database 2, 2a in a corresponding manner are connected to respective input functions (not disclosed in Fig 1) .

As described above the arrangement according to the present invention can easily take into consideration all such changes in practice that have been registered in the process database 4, and thus the system can function in fully real time, if necessary, and/or utilize all most recently available relevant information. This permits hitherto unknown dynamics which in combination with, for example, web-based user interfaces provide a tool with quite new possibilities for applications essentially independent of time and location. At the same time the inventive system provides a reliability which is outstanding compared to known arrangements. The arrangement according to the present invention handles a combination of analog information regarding action patterns and other human habit related processes as well as digital information regarding standards, classifications, physiological data and other measurable quantities . The dynamic function is a key factor, i.e. the fact that authentic processes are monitored and evaluated in order to provide regularized models for test situations which, in turn, indirectly change practice in the authentic reality.

Generally the functional principle is based on the reading of occasional authentic situations which are evaluated in relation to given standards and transformed to generally valid situations of interaction including relevant variants, i.e. the typical cases described above. These can then be utilized, for example, for a quality control of the behavior of monitored individuals into a desired direction as a function of a presentation and an analysis of a response.

Referring to the above Fig 2 now shows an embodiment which can be used, for example, in connection with a concrete administration of medicines, explosives or other substances or quantities the use of which being controlled by certain marginal terms, external standards and practices within a trade, whereby the arrangement according to the present invention constitutes an efficient instrument for monitoring and controlling the security in situations where professional users perform the practical administration. By defining clear qualitative marginal terms the arrangement then can be used for following up and steering, e.g., the behavior of nursing staff so that a correct practice is enforced, procedural weaknesses are identified and replaced by a correct behavior at an individual level. The instrument is dynamic in that it considers the specific context and reacts upon changes in practices in, e.g., care, blasting or even in the building of bridges . In the embodiment disclosed herein, comprising an application in the care field, the arrangement includes, besides the elements discussed above additionally the following components :

- a process registrator 9 by means of which and via a user interface 10 such authentic situations A are monitored and identified wherein a clinical medicinal treatment is effected;

- a relevance weighing device 11 for an evaluation of the accuracy, value and function of the registered situations;

- a case description managing means 12 by means of which a complex database 13 is administrated, said database 13 including regularized and standardized case descriptions;

- an example generator 14 which constructs a large number of simulated typical cases based on case descriptions generated in said case description managing means 12; a variant generator 15 which creates context relevant typical cases for measuring and guiding a response from an individual nurse B in individual situations which favorably are stored in a variant database 16; and finally an analyzing tool 7 monitoring the response from an individual presumptive administrator B to those typical cases presented through said user interface and following up changes in the response. If necessary, this response can be stored in a separate result database 17 which, according to one embodiment, also can be read by an external consumer D. Additionally, Fig 2 discloses that the whole arrangement favorably but not necessarily is administrated by a system operator or tool administrator C.

Said process registrator 9 identifies, registers and combines information which favorably in authentic administrative situations is collected, for example, by picture and sound recording, through statistical analysis of person related data (e.g., patient journals, human resource systems), by reading physiologic and biologic data (e.g., body functions, response to medication) and semi or fully standardized reporting via interviews, web-based forms and other interactive interfaces. The reading of the authentic situations, for example concrete actions in a certain physical environment, but also work internal regulations and pure biological data, favorably takes place as large scale operations and is suitably administrated by means of small mobile terminals (not shown) . The registration of the read authentic medicine administration situations is effected in one or several process databases 4 which handle the different technical kinds of materials and which are capable of processing them synchronously by means of guiding metadata.

The material in said process databases 4 are systematized by means of said relevance weighing device 11 where the cases are evaluated and categorized in relation to parameters such as, for example, statistic relevance (spontaneous frequency) , context specificity, deviation tendency both in authentic situations and in test situations, concordance with standards and degree of harmfulness, i.e. an evaluation of how much absolute harm an error can cause. The statistic deviations are extracted, on one hand, from a database belonging to the general database 1, in Figure 2 shown in the shape of an external deviation database 3a which indicates acceptable deviations within the borders of set standards, as well as favorably also taking relevant data from the internal result database 17 into consideration, whereby the arrangement thus also may include some kind of relevance feed-back, suitably controlled by said system operator C or in some other manner. Said relevance weighing device 11 weighs together the separate components but will also consider marginal terms for individual parameters (e.g., highly toxical substances are prioritized upwards although their frequency in authentic situations could be low) . Among the parameters may also be external circumstances such as visible patient symptoms, the exterior appearance of labels, the nature of packages, and mechanical properties for different instruments for the administration of medicines. The case description managing means 12 combines the relevancy weighed case descriptions with standardized data from the external basic database 2, favorably, for example, an official so called Vnr-database (a national Finnish medical database, translator ' s comment) which contains information regarding all practically available medical preparates, including all trade marks and packages, but sometimes also from one or more other databases 2a including relevant basic information. This way standardized but unique case descriptions are generated, which case descriptions constitute the dynamic description of the reality that the arrangement then utilizes in order to control the monitoring of the individual competence at a respective place of work. The standardized case descriptions are stored in a case database 13 which favorably handles both audiovisual material, measured data and texts. The case database is suitably organized in accordance with the parameters created in the relevance weighing device 11.

The example generator 14, in turn, synthesizes generic but empirically deduced definitions of relevant typical cases which are used as examples in a simulating environment. If the arrangement is used for practical testing of competence or for some other quality control concrete test situations can be mad up of a combination of given factors, i.e. constants, and open possibilities for a response, i.e. variables, as well as a key which indicates which response is a correct one. These generic examples are then processed in the variance generator 15 where concrete typical cases or test situations are generated by varying the given factors. The variance generator 15 then creates a large but limited number of practical situations for, in the present case, the administration of medicines, which situations are stored in the variant database 16. The variance generator 15 favorably cuts off such alternative^'s where the parameters for the given factors exceed or are below absolute marginal values, for example minimum or maximum human weight, or where there is a discontinuity at some dimension, for example tablets which cannot be divided or absolute maximal doses for some preparate .

When the arrangement according to the present invention is used for quality control purposes the analysis tool 7 can now be utilized as a testing tool for identifying and monitoring separate individuals so that the presumed competence of the individual in relation to a certain generic medicine administration situation can be tested at a given frequency and in accordance with pre-defined regulative values. The testing tool's simulation interface 6 towards the monitored individuals B reads the capability of these persons to respond in test situations and evaluates the response against current regulative values. The testing situation is repeated until the individual provides a desired response. The monitored individuals are guided towards a correct reaction to the test examples by providing the key to a correct response as a feedback. Since the test examples include a sufficiently high number of variants the monitored individuals will make corrections to their principles of behavior, e.g., calculating a dilution, while avoiding the individual's learning separate example situations by heart .

When the testing procedure has been realized the testing tool can save the results in a separate database, for example in said result database 17, which can deliver statistically relevant feed-back to the relevance weighing device 11. The result database 17 may also be used as a source for services to external consumers D which need information regarding the competence of the monitored individuals as a population or as individuals .

By using the arrangement according to the present invention a situation is attained where the actual competence of a nursing staff for performing administration of, for example, medicines at a specific place of work may be safeguarded at a very small error margin and in accordance with both pre-defined static quality demands, as well as through a continuous development dynamic ones. The instrument is built on the principle of dynamic real-time monitoring of the personnel's competence in relation to the actual nursing standards and the actual nursing practice prevailing at the individual place or work. By implementing the present invention in this manner it is easy to fulfill, for example, the official requirements set on efficiency and patient security at the dosing of medicines. An erroneous dosing due to, for example, a calculation error or other mistakes in the administration of medicines can thus be avoided to a higher degree than what has been possible until now, since a good practice for the administration of medicines is defined as a feed-back.

The arrangement according to the embodiment discussed above with reference to Fig 2 thus collects data regarding authentic medicine treatment situations, relates these to basic data regarding current medical and juridical standards, regarding available pharmacological preparates as well as statistics regarding diversions from secure medicine treatment. Based on this information the arrangement creates regulative descriptions of medicine administration situations. When the arrangement thus has defined the qualitative framing for the activity, the true competence of the separate individuals active within, for example, the care field may thereafter be monitored in relation to the relevant environments and the regulative situations, whereby the arrangement dynamically will allow all relevant variations in the real environment to influence upon the parameters for the monitoring.

The monitoring is then suitably effected by means of said testing tool which comprises a simulation environment where the individuals' response can be read and evaluated. The testing tool can easily be made integrity protected so that the monitored individuals can decide themselves which monitoring session will be registered. Since the arrangement makes it possible for the people responsible for the care to evaluate which ones in the staff fulfill the competence and quality requirements the security at, for example, a medicinal treatment in the above embodiment will be increased. The monitored individuals' personal responsibility for their own competence is increased since the individuals will get a better understanding of their own competence by means of the monitoring and, additionally, are able to utilize the testing tool as a training environment.

Since the arrangement is dynamic and context defined the present invention in the shown embodiment functions as an aid for regulating good practice within medicinal administration in all environments. The competence of the individual is monitored in relation to current practice and valid requirements at the place of work. In order to effectively maintain an operative benefit the arrangement is favorably connected to such an information system at separate nursing units which maintains the registration of the authorization for specific working tasks for individual workers .

Unlike, for example, known electronic simulation environments which function on the basis of a static idealized interpretation of the reality the arrangement according to the above discussed embodiment of the present invention is based on a dynamic set of test situations which are based on a continuous updating with respect to authentic situations. Thus the arrangement according to the present invention can provide, i.a., a dynamic tool which can be used to consolidate correct practice in specific working and functional environments of completely different kinds . An advantage of the tool is then, i.a., that it with respect to the substance content (parameters, cases, examples) is empty and context neutral. The tool reads the reality in the context where the monitoring takes place and which makes the dynamic effect maximal. The connection to external databases, for example said divergence database 3a and said official Vnr-database or, in practice, any other expedient database 2, 2a renders the content dynamic also in relation to relevant environment factors located outside the read and monitored environment.

Said interfaces 6, 8, 10 to said process registrator 9 and said testing tool 7, respectively, are favorably decentralized which implies that the arrangement can handle a multitude of environments in parallel where such data, cases, relevance criteria and feed-back that can be generalized can be used for the entity while the environment specific parameters can be used in order to constitute a difference between individual environments .

An especially favorable form of the present invention includes a multi medial representation of the reality, i.e. the situations managed are formed both intuitively/analogically and analytically/mathematically. The case descriptions and the test situations are then suitably provided by means of audiovisual depiction in combination with verbal and numeral documentation. This renders the above described tool adaptable so that the personal learning and understanding character of the monitored individuals can be taken into consideration. Verbally talented persons will not have an advantage on behalf of the tactile ones, and vice versa.

An additional advantage of the arrangement according to the present invention is that the dynamic function principle manifested in an extreme context sensibility renders the tool fully language and culture neutral, and this in spite of the fact that it can be used to control human behavior. The close connection between read authentic situations and created test situations makes variations in language and culture an automatically integrated part of the function of the instrument . Above the arrangement and the method according to the present invention have been discussed mainly with a general reference to turning and, respectively, to an embodiment which has been adapted for quality control at, for example, medicine or explosives administration, with a cursory reference that such faculties as bridge building could constitute conceivable fields of application. Thus, it would be clear for the person skilled in the art that the present invention can be used also at many other contexts, for example in other environments where a connection between, on one hand, regulative facts and, on the other hand, a changing practice causes a requirement for a more or less continuous update of current quality framings .

Claims

1. A method for controlling and regulating processes at the administration of a multitude of quality related partial functions, which method comprises compiling database information including such relevant base information which at the time is valid for the respective partial function, standard or rule related information valid at the time as well as dynamically updated response information regarding practical applications of corresponding administration (A) ; generating, for a multitude of random selected partial functions, relevant fictive typical cases,- bringing respective typical cases to be administrated, in a fictive manner, by at least one presumptive administrator (B) ; evaluating an outcome of said fictive administration as a comparison against said database information; and feeding this comparison back as a response to said presumptive administrator (s) (B) and/or to some other consumer (D) .

2. A method as defined i claim 1, c h a r a c t e r i z e d by generating, suitably in semi real time, said updated response information as practical user experience provided by authentic administrators (A) as registered authentic application situations.

3. A method as defined in claim 1 or 2 , c h a r a c t e r i z e d by generating said fictive typical cases to correspond to standardized regulative situations which suitably are varied within acceptable variance limits, favorably so that partial functions of different relevance are given, respectively, a weighing portion which correspond to the relevance .

4. A method as defined in any one of claims 1 to 3 , c h a - r a c t e r i z e d by presenting respective typical cases for the presumptive administrator as a suitably automatically generated verbal description.

5. An arrangement for quality consolidation of essentially manually administrated partial functions, which arrangement includes at least one general database (1) comprising information regarding each respective partial function, c h a r a c t e r i z e d in that said database (1) , besides basic information (2, 2a) regarding each respective partial function, additionally includes information (3, 3a) regarding at least one regulative functional description and at least one responsive feed back (4, 7, 9, 10, 17) which at least partially reflects a result of at least one registered authentic administration (A) of the respective partial function, whereby the arrangement further includes means (5, 11, 12, 14) for generating, on the basis of the information included in said data base (1, 2, 2a, 3, 3a, 4), varying typical cases, means (6, 7, 8, 15) for presenting selected typical cases, means (7) for processing a fictive manual administration (B) of these presented typical cases, as well as means for presenting (6, 8, 17) a comparison between the result of said fictive administration (B) of the respective typical case and the result of a standardized administration of a partial function essentially corresponding to said typical case .

6. An arrangement as defined in claim 5, c h a r a c t e r i z e d in that the arrangement includes means (14) for generating, on the basis of said regulative functional description and said registered authentic manual administration (A) , an estimate for said standardized administration of the respective partial function.

7. An arrangement as defined in claim 5 or 6, c h a r a c t e r i z e d in that the arrangement includes means (11) for evaluating, in real time or on the basis of a predefined sampling, the relevance of updated registered authentic processes (A) at a manual administration of said partial functions, suitably further including at least a divergence database (3a) comprising predefined acceptable divergences from the respective regulative functional description for the respective partial function, as well as means (12) for feeding back a result of this evaluation at least at the generation of the respective typical case, as well as favorably means (17) which present information regarding a registered difference between said fictive manual administration and said acceptable divergence .

8. An arrangement as defined in any one of claims 5 to 7, c h a r a c t e r i z e d in that the arrangement further includes means (11, 15) for overlaying, at the generation of said typical cases, a relevance for registered authentic manual administrations (A) in the form of a suitably predefined weighing of an information distribution which constitutes the basis for the respective typical case, favorably so that each respective typical case represents a unique combination of the information which constitutes the elements of the respective typical case.

9. An arrangement as defined in any one of claims 5 to 8, c h a r a c t e r i z e d in that the arrangement additionally includes means (15) which removes such generated typical cases which do not correspond with given pre-defined parameters and saves, for a later presentation, the rest of the typical cases, and suitably also variables, regulative data and/or authentic administrative information related to the respective typical cases .

10. The use of the method as defined in any one of claims 1 to 4 or, respectively, the arrangement as defined in any one of claims 5 to 9 in order to improve the security in the administration of medicines, the handling of explosives or in some other distribution of substances where the amount of use, the manner of use or some other usage related condition is assumed to have an impact on the security of a third party.