Module 6, Special Aspects of EN 14065:
Risk-Analysis, microbiological hazard and controlling measures, determination of control points, target limiting values, monitoring systems, corrective action, documentation (fundamentals for the quality-management-system and hygiene-management respectively, for the conversion of EN 140659)
In this module the possibility of learning the fundamentals of the implementation of EN 14065 is given. It contains special aspects of EN 14065; this means in the way they are described and required in the standard.
The basic terms of understanding this 6th module concerning hygiene, microbiology, laundry-; process-engineering as well as detergents and disinfectants you will find in the modules 1-5.
It is strongly recommended, to learn the first 5 modules before this one, in order to be able to allow an appropriate conversion of EN 14065
Learning this 6th module, you should take some more time than for the other modules (perhaps three working days) and try to understand the contents and not, by any means, to commit it to memory. If problems of understanding arise in the 6th module, it is important to look at the first five modules or look at the EN 14065 respectively, in order to acquire the essential fundamentals. While in the power-point-presentation of this module you find a detailed overview to the topic “special aspects of EN 14065”, in this present chapter basic items are explained in order to assure a better understanding of the formal background of EN 14065.
The EN 14065 does not contain working instructions for laundries in order to obtain a clean, less-germ-containing plant nor limiting values-, warning- or benchmarks concerning the microbiological quality are delivered. The RABC-System is a hygiene- quality-management-system respectively, with riskanalysis, comparable to the HACCP-Concept for the food area. According to the worldwide and very approved HACCP-Concept (developed 1959 and published 1971) by the way, the EN 14065 was developed.
Microbiological limiting values (if existing) could be defined according to the customer’s requirements or might be taken from national or international recommendations or instructions. This guarantees, that the EN 14065 is applicable very flexibly in all areas (e.g. health-care or food industry) with regard to microbiological requirements for textiles.
The principle of the RABC-System is to analyse and understand the processingprocedure of a laundry beginning with the collection of the soiled textiles at the customer up to the delivery of the processed textiles to the customer with regard to biocontamination. After the according analysis, the potential hazard (which means the mischief, that might appear), shall be identified in order to estimate and, if necessary, define remedial measures.
In the standard EN 14065 for instance it is suggested, that the risk is classified in “negligible risk”, “average risk”, “high risk” and “very high risk”.
The following steps are necessary in order to carry out an adequate risk-analysis:
Monitoring-Systems may as well be automated, if possible. At the control-point „disinfecting washing procedure” for instance when temperature or dosage of disinfections is not correct, alarm-systems which create acoustic and/or visual warning may be installed. Systems of such kind cannot replace monitorings but constitute additional safety for the control point.
A validation of the control points according to EN 14065 has to take place at least once a year. (Validation means the application of bio-monitors for testing the disinfecting washing procedures)
For the successful conversion of EN 14065 internal audits are vital. The management shall conduct periodic internal audits to determine whether the RABC-System conforms to the requirements of this European standard and has been effectively implemented and maintained.