Recommendation of the Quality Task Group (123): Quality assurance in the RUMED through well-targeted process monitoring

Recommendation of the Quality Task Group (123):

Quality assurance in the RUMED through well-targeted

Authors: T. Appel, D. Diedrich, M. Fažon, A. Hartwig, A. Jones, T. Gerasch, K. Mann, J. Metzing, A. Papadopoulos, C.
Schmid, A. van Waveren, U. Zimmermann; e-mail:

++You can also download the recommendation as pdf here ++


The focus of the first part of “Quality assurance in the RUMED” is on the structured and well-targeted development and maintenance of PERSONNEL QUALIFICATIONS. In the second part we would like to draw attention to the myriad OTHER FACTORS that in some cases can imperceptibly influence the process quality and jeopardise the outcome quality. In an efficient quality management system processes must be monitored. The PROCESS MONITORING measures must be planned and the outcomes documented. In that way discrepancies can be recognized at an early stage and remedial action taken (as per the PDCA cycle [1]).
The following quality assurance measures must be planned, implemented and monitored:

1. Maintenance plan

Maintenance includes servicing, inspection, repair and improvement and must be specified as such in a maintenance plan (Figure 1).

One way to IMPLEMENT THE MAINTENANCE PLAN is to enter into contractual agreements with external service providers (inspection contract, servicing contract, maintenance contract, etc.).
The following targets should be achieved:

  • Avoidance of disruptions and system breakdowns
  • Minimization of operating and maintenance costs
  • Value retention
  • Improvement of operating safety
  • Optimization of operating processes
  • Cost planning reliability.

2. Validation

Validation involves verification and evidence-based documentation of the process effectiveness. In addition, a process must always function as specified and in compliance with the normative requirements (reproducibility), e.g. as per DIN 58341 [3]. Any discrepancies must be quickly analysed, remedied and this must be documented. Repairs impacting the WD control system may warrant REQUALIFICATION for a particular reason. This is the case e.g. when switching to other process chemicals or in the event of deviation of process parameters requiring system repairs that result in a change to the process.

Meticulous preparations should be made by the RUMED and its teams for conduct of process validation. Plans should be made for the WORST CASE SCENARIO of having to decontaminate medical devices that are difficult to reprocess, while paying attention to the actual contamination load and the time lapses until the devices are reprocessed.

3. Routine tests

Each process step (e.g. cleaning and disinfection process, sealing seam process, etc.) is subject to routine tests to monitor each day, before equipment is placed in operation, whether the process is functioning as specified.
Furthermore, other ROUTINE TESTS are carried out at specified intervals to verify compliance with defined quality targets. One such example is verification of the cleaning results in accordance with DIN EN ISO 15883-1 [4]; the applicable intervals are specified at the time of validation.
Routine tests are a core element of quality assurance since they help to quickly identify any discrepancy in the process quality, paving the way for timely and well-targeted improvement measures. For example, equipment with faulty process sequences can be quickly shut down and remedial action taken. This helps to avoid more extensive DAMAGE and minimize downtimes and costs.
The operator is responsible for deciding how often routine tests are carried out (daily, weekly, periodically).  For equipment-based processes, the nature of the tests and their intervals will depend on the equipment features (WD manufacturer’s instructions, e.g. flow checks, conductivity test, temperature sensors, etc.) as well as on the process itself.

These tests ensure that

  • The validated process continues to function fault-free and faults are detected early on
  • The operating performance of equipment (WD, sterilizer, etc.) is demonstrated to be within specified limited values,
  • The media supply (demineralized water, process chemicals, etc.) complies with the specifications.

In the case of manual process steps (e.g. packing instructions, device assembly, packaging, loading patterns, etc.), SPOT CHECKS can help to ensure that these manual steps, too, are always carried out to assure the specified quality (in accordance with the in-house standard operating procedures [SOPs]).
All routine tests are set out in a plan and are an integral part of the quality management system. Documentation of the conduct and results of these tests serves as proof of compliance with all legal requirements, demonstrating that the processes continue to function as specified.


4. Complaints management

Complaints are not only an indicator of customer satisfaction but are also a key indicator of process quality. DAILY EVALUATION is recommended for timely identification and elimination of any discrepancies. This helps to avoid similar problems or escalation of customer dissatisfaction. Admittedly, the cause of an error does not always lie with the RUMED. The RUMED has many interfaces which should also be considered in error analysis.

Therefore, when carrying out fault analysis the cause, nature, incidence and responsible parties should always be identified and documented on the basis of the agreements in place with the various interfaces. Constructive collaboration between the RUMED and its clients helps to take well-targeted and timely MEASURES to avoid repeating such errors.
The effectiveness of the measures taken must be checked and the process adapted accordingly if necessary. The input of staff should be sought and members given regular training in all partial processes. Staff must always be BRIEFED again following any process adjustment.

Grading of complaints in terms of severity (e.g. minor, moderate, major, near incident, patient damage) gives insights into the nature of the errors. Personnel should be given regular FEEDBACK on individual mistakes as a learning exercise. A digital complaints’ management system contributes to transparent communication between the RUMED and user.

 5. Feedback management

It is recommended to get feedback from the team and evaluate this to gain a better understanding of one’s own processes and potential problems:

  • Team meetings
  • Staff meetings
  • Shift management meetings
  • Suggestion boxes
  • Ideas management.



  1. PDCA cycle: Plan – Do – Check – Act
  2. Guideline compiled by the German Society of Hospital Hygiene (DGKH), German Society of Sterile Supply (DGSV) and Working Group Instrument Preparation (AKI) for validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices, status 2017, page 63, Information 9
  3. DIN 58341:2020-07 Requirements for validation of cleaning and disinfection processes
  4. DIN EN ISO 15883-1:2014-10 Washer-disinfectors – Part 1: General requirements, definitions and test methods


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