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MAKMAL KESIHATAN AWAM KOTA BHARU

                                                                Document Number         : MKAKB/BP/QP-14
                            QUALITY PROCEDURE
                                                                Issue Number            : 01
                      MANAGEMENT OF REAGENT AND                 Issue Date              : 03.04.2016
                                CONSUMABLES                     Page Number             : 2 of 5

                   6.0    PROCEDURE

                    NO.                           ACTIVITY                               RESPONSIBILITY

                    6.1.0  RECEPTION AND STORAGE

                    6.1.1  Check the quantity, quality, expiry date and other critical    SO/ MLT/ ASO
                           parameter. Acknowledge receipt.

                           Reject if requirement above is not fulfilled.

                    6.1.2  Store accepted reagents and consumables according to  SO/ MLT/ ASO/ PPK/ PA
                           the manufacturer’s instruction.

                           Information for storage condition  can  be  obtained  from
                           its leaflet or as stated on the packaging/box.
                    6.1.3  Record  received  of  reagents  and  consumables  in  the      SO/ MLT/ ASO
                           KEW.PS-4 (Appendix 1).

                           a. Items with expiry date: pink
                           b. Items without expiry date: green.

                    6.2.0  ACCEPTANCE TESTING
                    6.2.1  Perform  acceptance  test  for  new  examination  kit  when    SO/ MLT/ ASO
                           there  is  changes  in  procedures  or  new  lot/batch
                           received.

                    6.2.2  Verify the test performance of each lot of reagent before      SO/ MLT/ ASO
                           use in examination & consumable (if applicable). If test
                           failed, contact supplier for troubleshooting or new
                           supply.

                    6.3.0  INVENTORY MANAGEMENT
                    6.3.1  Record inventory of reagents and consumables in the            SO/ MLT/ ASO
                           Kad Petak KEW PS 4.

                    6.3.2  Keep reagents and consumables  in appropriate                  SO/ MLT/ ASO
                           condition. If the reagents are required to be kept in cold
                           temperature, ensure the temperature is monitored.

                    6.3.3  Use reagents and consumables with older expiry dates           SO/ MLT/ ASO
                           prior using a new batch.

                    6.4.0  INSTRUCTION FOR USE.

                    6.4.1  Use according to manufacturer’s instruction and/or work        SO/ MLT/ ASO
                           instruction.

                    6.5.0  ADVERSE INCIDENTS REPORTING.


                   Disease Sector                                                           Quality Procedure
                                                 CONTROLLED DOCUMENT
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