**Possible reasons**

**Possible coping strategy**

*Risk Management and Assessment*

**4.2 Operational risks**

*4.2.1 Infrastructural risks*

**Possible reasons**

**Possible consequences**

duration of breakdown)

**Possible coping strategy**

• Installation of backup systems

• Installation of monitoring systems

personnel

**86**

• Infrastructural, technical reasons

• Missing backup devices and strategies

• Define responsible staff and representatives

biobank.

• Continuing research market analysis

strategies to close the gap (if applicable)

• High priority of congress and conference participation

*4.2.1.1 Breakdown of cooling systems for low-temperature sample storage*

• Tissue or blood samples can be damaged (depends on temperature and

• In a worst case (duration of breakdown and period until detection of the problem), the samples are not useable any more (loss of samples)

• Staff training in accordance to validated Standard Operation Procedures

• Development of an "emergency plan" for the weekend and public holidays

• Current maintenance of cooling systems through qualified technical

• Evaluation of the requests that are not processed and implementation of

Not only strategic risks need to have awareness, but it is important to have an insight to "the bottom" of the organizations, e.g., if infrastructure is disturbed or key staff is leaving because of dissatisfaction, then operating the biobank may run into trouble before all new plans can be implemented. These are operational risks—risks connected with internal resources, systems, processes, and employees of the organization. The following section describes some operational risks of a

• Electric spark, dust, no or defective smoke detector

### **Possible consequences**


#### **Possible coping strategy**


### **Possible reasons**

• Technical failure

#### **Possible consequences**


#### **Possible coping strategy**


#### *4.2.1.4 Breakdown of backup systems*

Natural disasters such as super-storms, droughts and earthquakes must also be taken into consideration by developing the risk management plan of a biobank but also it is important to have a breakdown plan—if the case arises. Among others, the recovery after disasters can be one of the most challenging tasks of biobank management and staff. There are several examples in the literature that show the challenges of such situations. It is important to note that the staff of the given biobank have to monitor the whole infrastructure in a way that does not harm them directly, e.g., the freezers, tanks, and other storage capacities. If the breakdown

#### *Risk Management and Assessment*

affects also the electricity supply, there must also be a plan "B" for this supply, as a variety of technicians, engineers and scientists, who are usually quite familiar with standard infrastructure must act together as a team and need the electricity supply for disaster management.

• Installation error

*Risk Management in Biobanks*

• Image loss

• Lack of maintenance

**Possible consequences**

**Possible coping strategies**

• Demand-oriented staff training

• Regular process monitoring

*4.2.2 Process-related risks*

**Possible reasons**

• Image loss

**Possible reasons**

**89**

**Possible consequences**

**Possible coping strategy**

worst case is the loss of sample-related data

• Continuous improvement of the database system

• Implementing testing periods before launching

therefore is stored as valid in the system

• Staff training (staff who is scanning documents)

• Wrong documentation in the clinical subsystem

*4.2.2.2 Collecting wrong clinical data through biobank delegates*

• Biobank delegate gets the wrong patient identification from the biobank

• Follow-up of stored documents is possible

• Samples cannot be used for projects

• Samples cannot be used for projects

*DOI: http://dx.doi.org/10.5772/intechopen.91463*

• Faulty documentation of samples ! sample-related data are difficult to find;

• Structured evaluation and procurement (requirement specification)

*4.2.2.1 Informed consent is invalid although it is stored as valid in the system*

• Invalidity of the IC cannot be detected during scanning and monitoring and
