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Quality Manual

Taking the concept of “quality comes from design”, Tomums has established complete quality management processes, and has established strict standard operating procedures for each process:

1.    Testing flows

1)    Label

Labels are important media and means to indicate product information. Thus, we have established a scientific label management system. Tomums divides labels into three colors: respectively green, yellow and red.

Yellow label: Used to identify products that have not been tested or are being tested or that have questionable testing results.

Green label: Used to identify products that have been tested and that have been qualified and released.

Red label: Used to identify products that have been tested but have nonconforming testing results.

The label referred to here refers to the label of the internal quality management of Tomums, and does not include the label affixed to the products sold to users.

2)    Management before storage

The raw materials that have just been purchased or the products that have just been produced are in the “to-be-inspected” state, and are marked with yellow labels. For such materials and products, product files and records that are linked up with the procurement or production processes are maintained, which clearly indicate the procurement/production in-charge person, procurement/production date, product batch number, and testing status. Testing requests are sent to QC for such materials and products. After the products pass the sampling test conducted by QC and are reviewed and released by QA, warehouse personnel change their labels to green ones and place them into the warehouse together with their certificate of analysis (COA). If the products fail to pass the test, warehouse personnel change their labels to red ones and hand over them to procurement or production department for change, return, rework or other appropriate treatment.

3)    QC

After QC department receives the testing request from the warehouse, relevant QC personnel go to the warehouse to take samples, test the samples strictly in accordance with corresponding product testing standards of Tomums, record the testing process and results, and issue a test report to QA department for review.

4)    QA

After receiving the request for review from QC, QA decides to reject or release the products according to the corresponding quality standards, and submits the result to the warehouse for further operation.

2.     Instruments

Instrument is a tool used for testing. The accuracy and sensitivity of the instrument directly affect the test results. Thus, Tomums has developed a comprehensive instrument management system, and appointed dedicated personnel to regularly check and calibrate the instruments.

3.    Batch number and date

1)     Batch number

Batch number is a code specified by Tomums for each batch of products according to some rules. The batch number is unique, and can be used to check all the product information such as product name, production date, and information on production, inspection, storage and delivery.

2)     Retesting date

Retesting date refers to the date of the next testing of products after storage under specified conditions. After a product reaches its retesting date, the product needs to be re-tested, and its continued use is allowed only if the test results meet corresponding standards. The fact that a product reaches its retesting date does not mean the product is nonconforming, and its continued use is allowed so long as it passes the retesting.

3)     Expiry date

Expiry date refers to the last date for conformity of a product under specified storage conditions. After the expiry date, the product can be no longer used, and Tomums will not be liable for any adverse consequences arising from use of the product after its expiry date.

4)     Batch number and expiry date of a product are marked on its package label and COA; retesting date of a product is indicated on its COA.

4.    Storage conditions

1)     In view of the high quality requirements for reagents in life science experiments, storage conditions are very important to ensure the quality of products. To this end, Tomums stores most of the products in a dry and sealed place at the temperature below 0 °C, and stores some special products under the temperature of -20 °C or -80 °C.

2)     The product label indicates the storage conditions of the product. After receiving the product, the user needs to keep the product under the required conditions. Otherwise, Tomums will not be liable for any quality nonconformity caused by improper storage.

3)     The product storage conditions indicated on the package label refer to the conditions for long-term storage, which are not necessarily the same as the transport conditions of the products, as transport is a short-term process. Tomums determines storage conditions respectively for product transport and long-term keeping according to the specific nature of the product.