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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 : 3 of 5
NO. ACTIVITY RESPONSIBILITY
6.5.1 Report any adverse incidents and accidents that can be SO/ MLT/ ASO
attributed directly to a particular reagent or consumables
to the OIC and Health Committee for investigation.
Report to the Safety and Health Committee if involving
injury, accident or near miss. Notify manufacturer when
necessary.
6.6.0 RECORDS.
6.6.1 Maintain the record of the reagents and consumable that SO/ MLT/ ASO
contribute the performance of examination in the
laboratory include but not limited to the following:
a) Identity of the reagent or consumable.
b) Manufacturer’s name and batch code or lot number.
c) Contact information for the supplier or the
manufacturer.
d) Date of receiving, the expiry date, date of entering
into service and, where applicable, the date the
material was taken out of service.
e) Record the condition when received.
f) Manufacturer’s instructions.
g) Records that confirmed the reagents or
consumables initial acceptance for use.
h) Record the ongoing acceptance performance of
reagents and consumables in use.
6.6.2 Create a record for reagent preparation in-house, SO/ MLT/ ASO
including the person or persons carrying on their
preparation and the date of preparation.
Disease Sector Quality Procedure
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