At the beginning of a development process, there are many unanswered questions relating to the project or product. The most commonly encountered disruptions during a project are:

• Changes to customer requirements
• Changes to project resources
• The discovery of errors during verification
• Changes to the design or manufacturing process

Risk management according to EN ISO 14971:2000 guides a product through the development process and into the manufacturing and application of the product.
Discussions and risk analyses often lead to changes in a variety of business processes and in different departments. Different actions are initiated at the same time and resources are allocated. To avoid repeated work and to promote communication between the departments, it is advisable to integrate the change process into the risk management process.

Recommended Procedure:

• Changes are entered into and triggered in the risk analysis
• Changes are reported automatically to the change process. There, they are discussed, assessed, and released.
• Released changes are reported back to the risk analysis where they are further tracked

1. Methods
1.1 FMEA as a supporting method in the risk management process

The Failure Mode and Effects Analysis (FMEA) is a method of risk analysis performed while the project is underway. The goal of the FMEA is the early detection of potential errors during the development of a product and even during the planning phase of a manufacturing process, as well as to prevent these errors by taking appropriate actions [1].




1.1 DRBFM as a supporting method in the change management process

The Design Review Based on Failure Mode (DRBFM) is a creativity method used during development and represents a philosophy of discussion-based design selection and design evaluation. This method is the application of a risk analysis specifically to the changes, as well as the functions and assemblies affected by these changes. DRBFM is a tool developed by Tatsuhiko Yoshimura. Yoshimura is a veteran employee at Toyota, who was responsible for reliability at this company for 32 years [2].

2 Implementation

In this chapter, a simple, practical example of a database-oriented software solution for the integration of change management and risk management is presented. The starting point is the initiation of the risk analysis for the product “Blood bag system for blood donors”

Fig.: Diagram of a blood bag system

2.1 Risk management: Determining proper use

The proper use and deliberate misuse of the product or its accessories has to be described. The goal is to create a list of all qualitative and quantitative characteristics that might affect the safety of the product. The FMEA supports this requirement by providing the system and function analysis (requirements analysis)

Procedure:

• Functional description of each system
• Determine how the functions interact, for example “the ability to sterilize the plastic bag” has a direct influence on the “sterility of the entire blood bag system” (see Fig. 5)
• Description of quantitative and qualitative characteristics of each function

2.2 Risk management: Determining known or foreseeable threats

A list of the known and foreseeable threats arising in connection with the product in the normal state or in the failure state is worked out, and possible effects that could lead to damage are listed. The FMEA supports these requirements by providing the failure analysis.

Procedure

• Functions are drawn directly from the requirements analysis
• The threat derives from a restriction/exceeding of the function or its non-existence
• The damage caused by the threat is physical injury or harm to the health of people or damage to materials or the environment
• The cause of the threat is the failure of individual parts or the incorrect use of the product

2.3 Risk management: Estimating and classifying the risks of each threat

The risk posed in the normal and error state has to be estimated for each threat, i.e. the probability of occurrence of the threat and the severity of the resulting damage has to be estimated. The risk is calculated by forming the product of these two figures. The FMEA supports these requirements by providing a risk evaluation of the current status.

Procedure:

• Estimate the severity of the damage “S” and the probability of occurrence “O”
• Risks are classified using the risk graphs
• Traffic light colors are displayed directly in the form

2.4 Risk management: Triggering changes

Due to a change in the law, the upper limit for the “germ-forming units” was reduced from 10^-6 to 10^-7 for the “Guarantee sterility” function in the “Blood bag system”. This change is then documented in the FMEA, and the person responsible has to decide at this point if a change process should be triggered.
All of the persons involved in the change process are automatically informed by email.

2.5 Change management: Communicating and discussing changes

After the DRBFM, an open discussion about the changes should be held with all participants, for example with the suppliers, review team, development, and process planners. This means that it should be possible to communicate creatively regarding possible concerns, ideas, or required actions. Making changes to the FMEA form here automatically creates a blog forum. It is possible to subscribe to the blog and receive information on new entries to the blog via RSS feeds.

2.6 Change management: Assessing and releasing changes

Each member of the change team adds entries for the DRBFM in the blog and provides an evaluation:

Fig.: Distribution of information and feedback in the blog

The blog is closed upon final release of the change and further analysis is performed in the FMEA.

2.7 Risk management: Analyzing risk reduction possibilities

Actions for reducing the risk are defined. Hereby, the following order should be applied:

• Ensuring safety directly within the design
• Implementing safeguards into the product or the manufacturing process
• Providing safety information

The FMEA supports these requirements by optimizing the risks.

Procedure:

• Definition of actions, responsible persons, deadlines, and expected improvements
• The traffic light colors for risk classification are displayed directly in the form

2.8 Risk management: Classifying residual risks

An overview of the residual risks after making the change as well as with or without taking any actions can be displayed and the residual risks classified by using the risk graphs.

3 Conclusions

The FMEA is a method that accompanies the project to help manage the risks within the company. It promotes and documents each decision made for a product or process. It always provides the current risk classification status and the current implementation status of actions.

To prevent repeated work and to overcome communication barriers, it is suggested to integrate changes to the design or manufacturing process into the risk management process as well, and to trigger and coordinate the changes using the FMEA.

In order to enable all participants to be informed about a change and work out creative suggestions for solutions on a decentralized basis, the somewhat rigid methodology used in the FMEA form should be left behind once in a while and the creative capabilities of the DRBFM utilized. The IT (in this case the blog) should create a framework that promotes a methodical change process and supplies well-founded reasons for releasing or rejecting the change at the end of the process.
The concerns (possible failures) and actions discussed in the DRBFM have then to flow back into the FMEA, so they can be documented and analyzed there in terms of their risks.

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