Quality Management

Based on a control system that follows our operating flow, staff are constantly aware of quality control, providing highly accurate, high-quality genotyping data.

DNA Checking

At RIKEN GENESIS we are constantly implementing improvements to enable us to continue to produce good results in a reliable and sustainable manner. We perform quality checks on the DNA sent to us by clients in accordance with our operating flow.
DNA concentration is measured by using a fluorometric DNA quantitative assay, and DNA quality (degree of degradation) is also confirmed by using electrophoresis.

DNA Storage

The DNA storage room is subject to access control by means of fingerprint authentication, with only staff whose fingerprints are registered being permitted to enter. Daily temperature and humidity measurements are taken inside the room, and the showcases and freezers used for DNA storage are validated yearly, with the temperature inside them recorded morning and evening to ensure stringent temperature control. DNA for different projects is stored in separate boxes as a measure to prevent mishandling during storage. To prevent DNA from deteriorating because of repeated melting, it is kept in showcases, except for long-term storage.

Standard Operating Procedures (SOPs)

Standard operating procedures (SOPs) have been produced for every process involved in testing, including machinery, apparatus, facilities management, operating methods for testing, and records. SOPs are placed at the locations where they are used in each process and are checked constantly to ensure operational uniformity. Staffs are constantly aware of quality control and perform operations with the greatest of care. SOPs are also updated with optimal methods and when points for improvement arise.

Reagent Lot Management

Reagents used in experiments are all managed by bar codes in an independently developed reagent control system. As this reagent control system is coordinated with the LIMS (laboratory infotmation management system), information can be searched not only by delivery date and individual number but also by parameters such as current stock, reagent lot, and which reagent was used for which sample. Once delivered, reagents are arranged according to type, lot, and storage temperature, and are stored under stringent temperature and humidity controls until use.

This system not only enables reagents to be managed in terms of order of use, but also makes it easy to identify whether or not any problems during experiments were caused by reagents.

Troubleshooting

We have developed a troubleshooting system to enable a swift, accurate response should a problem arise during an experiment. As RIKEN GENESIS uses an automated dispensing experimental system with robots managed by computer, there are very few problems with the experimental process itself.

When a problem does occur, it is categorized in accordance with previous occurrences or data, dealt with, and the cause determined. The course of events from occurrence to response is summarized in a report, which is provided to clients. The status of problems is also reported at meetings held as required, and information on how they have been dealt with is shared among all employees within our genotyping section in an effort to prevent any reoccurrence.

Quality Control (QC)

In order to enable high-throughput, high-quality genotyping, we use independently developed QC tools.
These QC tools enable the acquisition of all parameters (photographs) concerning experimental result determinations for all samples in an experiment as a single batch. In addition, abnormality determination is partially automated to prevent abnormal results being overlooked.

These tools enable the swift, accurate determination of experimental results.

Data Checking

Data obtained from experiments is checked from a variety of perspectives. These checks are carried out by several members of staff, combining the results of DNA quality assessments with experimental data that has undergone QC checking.

Chips for which genotyping has been completed are stored for a specified time, and are managed in order to enable repeated genotyping.

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