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• Statement from Dr. Igor Krotky, Porsche AG, Weissach, Germany

“The PLATO SCIO system allows project-specific processing and analysis of FMEAs and highly transparent action tracking. The clear linking of external and internal functions and their relation to system elements ensures the completeness of the FMEA. The checklists and options for linking various documents are a sensible way of supporting moderation and can be used as a knowledge base for subsequent projects.”

• Statement from Dr. Wolfgang Hehlein, Quality and Environmental Management Systems ISO, Merck KGaA, Darmstadt, Germany

“PLATO AG’s XERI document management system considerably reduced the work involved in managing and archiving our quality documentation. Because it ensures fast, complete distribution of the many guidelines and procedures to all the necessary people and places within our company, we can now be sure that they are always as up-to-date as the law and standards require. We see this as a significant contribution to the integrity and continuous improvement of our quality system.”

• Statement from Denis Nienhueser, Head of risk management, Berna Biotech, Switzerland

“As producers of a variety of biotech vaccines, we must adhere to the statutory requirements in the pharmaceutical industry (GMP), which often explicitly call for risk analysis. Other regulators (occupational safety, environmental protection, and biosafety) do not require this method but have so far reacted very favorably to the systematic analysis and comprehensible evaluations of the relevant risks.
In addition, more and more customers are requiring risk analyses. Since greater scope and detail are being required in all areas, any other kind of risk management than the existing database-supported FMEA is no longer imaginable for our company given our specific risk management needs.
Since we can easily draw on existing causal chains and their evaluations, we're achieving resource savings of around 80% when it comes to risk analysis!
For multiple-use buildings, plants, and systems (e.g. central ventilation or water supply), the savings potential is nearly 100%. As part of project management, the systematic approach based on experience from previous projects helps us streamline project planning considerably.
We have had no complaints related to risk management in the last inspections by authorities and customers – and even earned some compliments.”

• Statement from Jürgen Wandelt, Johnson Controls GmbH, Germany

“By systematically using knowledge-based quality planning tools from PLATO AG, JOHNSON CONTROLS is increasing the quality of its products and cutting time to market by building a centralized knowledge database. PLATO has proven to be a competent, reliable partner in design and implementation and played a constructive role in making the concept a reality.”

• Statement from Joachim Wasner, Quality Director at Dräger Medical ANSY GmbH

Software-aided risk management
Conformity assessment procedures for supply systems for medical gases

The Medical Device Directive [MDD], which applies across Europe, stipulates that medical devices must carry a CE mark before they can be placed on the market and/or put into service in the countries of the European Union. For medical devices with a risk class higher than 1, conformity assessment procedures (MDD Article 11) must be carried out prior to CE marking. These procedures entail an examination of the technical documentation and risk management performed. This requirement is aimed at fulfilling the essential requirements for medical devices as set forth in Annex I of EC Directive 93/42/EEC].

Supply systems for medical gases are Class IIb medical devices and must always undergo a conformity assessment procedure. The declaration of conformity is the "result" of the conformity assessment procedure, with which the legally responsible manufacturer certifies the product's conformity with the MDD - and thus fulfillment of the essential requirements for a medical product as set out in Annex I of EC Directive 93/42/EEC. The conformity assessment procedure comprises who parts:

1. Proof of the product’s technical conformity with the "general" essential requirements, e.g. through verification with the harmonized standards (e.g. EN 737-3, through records in the technical documentation) and

2. Fulfillment of the quality assurance requirements for the product, e.g. by having the manufacturer's quality system certified by a Notified Body, the result of which is the granting of an EC certificate in accordance with Annex II of EC Directive 93/42/EEC.

Manufacturers of supply systems for medical gases without an EC certificate can only produce these systems and place them on the market with the help of a Notified Body (as set forth in Annex III, IV, V or VI of the Directive) unless they are acting as an operating unit for a manufacturer that has an EC certificate. In this case, the operating unit must work strictly in accordance with the rules of the quality system of the company holding the EC certificate. The holder of the certificate thus becomes the legally responsible manufacturer for the installed system and draws up the declaration of conformity.
In Germany, failure to adhere to the legal requirements results in fines and punishment pursuant to Secs. 40–43 (criminal provisions and regulatory fining provisions) of the Act on Medical Devices [Medizinproduktegesetz].

Proposals, planning, and setup
The setup of the supply systems for medical gases is a critical step in production and is carried out by employees of the manufacturer or authorized operating units at the location where the system will be operated. The expertise and responsibility for the carrying out of a conformity assessment procedure lie with the manufacturer and not with the operating unit. The manufacturer must give the operating unit clear rules (processes within the quality system), which the operating unit must strictly adhere to when drawing up proposals and planning and setting up the systems. Only those components that have been approved for use in the systems can be used. If the customer wishes to use a component that deviates from this standard, e.g. a compressor from a different manufacturer, the corresponding risk analysis must be expanded to cover these special components.

Risk management
As a medical product, the installed supply system for medical gases must be assessed together with all of its individual components such as oxygen supply, air compressors with air filtration, pressure reduction stations, and piping systems. For risk management, DIN EN ISO 14971 (Medical Devices – Application of risk management to medical devices) suggests using FMEA (Failure Mode and Effects Analysis) methods.

Risk analysis using the FMEA method
To avoid potential failures in products and processes, the system elements and function structures are assessed as a preventive measure. The method makes it possible to systematically find potential weaknesses, their causes, and their effects on the system as a whole. The aim of this work is to prevent failures in the product design stages of design and planning. Suitable actions are taken to eliminate detected weaknesses early. A matrix analysis is done before the FMEA to systematically identify all relevant system elements and to ensure that no important ones are missed. The documented FMEA serves as proof that the essential requirements for medical devices have been fulfilled [see Annex I of EC Directive 93/42/EEC].

The use of suitable FMEA software (PLATO AG's SCIO) simplified the risk management process and considerably reduced the time required. The extensions of the risk assessment for special components that differ from the standard can be implemented quickly. This method ensures that system components that are not suitable for use as part of a supply system for medical gases are identified early on and not approved for use. The customer is then informed of the rejection and given reasons for the rejection as well as a suggestion for an approved alternative.

Dräger Medical ANSY GmbH develops, plans, and produces supply systems for medical gases. The company is certified in accordance with Annex II of EC Directive 93/42/EEC (EC certificate) and can carry out the required conformity assessment procedures without involving a Notified Body.