KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
12 j. Laboratory shall have documented verification or comparison of standards andor
reference materials before use and the protocol when non-conforming results are encountered.
k. Distilled or de-ionized water systems are monitored for conductivity, bacterial content, and total chlorine periodically. Heavy metals analysis, water quality test
and use test are performed annually on the water systems. l. Microbiology media preparation and sterilization areas are separated from work
areas to prevent contamination of clean media. m. Laboratories shall ensure that all reagents including stock solutions, media,
diluents, and other suspending fluids are adequately labeled to indicate, as appropriate, identity, concentration, storage conditions, preparation date, and
validated expiry date and or recommended storage periods.
7. REFERENCE MATERIAL AND REFERENCE CULTURE
a. Microbiology, standards and reference materials and cultures are stored separately from samples.
b. Reference cultures are required for establishing acceptable performance of media including test kits, for validating methods and for assessing evaluating on-going
performance. i. Traceability is necessary, when establishing media performance for test kit
and method validations. ii. To demonstrate traceability, laboratories must use reference strains of
microorganisms obtained directly from a recognized national or international collection, where these exist.
iii. Commercial derivatives for which all relevant properties have been shown by the laboratory to be equivalent at the point of use may be used as alternatively.
KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
13 iv. Reference strains may be sub-cultured once to provide reference stocks.
Purity and biochemical checks should be made in parallel as appropriate. v. It is recommended to store reference stocks in aliquots either deep-frozen or
lyophilized. vi. Working cultures for routine use should be primary subcultures from the
reference stock. If reference stocks have been thawed, they must not be re- frozen and re-used.
vii. Working stocks should not be sub-cultured unless it is required and defined by a standard method or laboratories can provide documentary evidence that
there has been no change in any relevant property. viii. Working stocks shall not be sub-cultured to replace reference stocks.
Commercial derivatives of reference strains may only be used as working cultures.
8. ASSURING THE QUALITY OF TEST RESULTS
a. Laboratory Quality Control is an essential aspect of ensuring that data released is fit for the purpose determined by the quality objectives.
b. Approach of quality control is the principal recourse available for ensuring that only quality data is released.
c. The Principe of the laboratory quality control program is its internal quality control to monitoring of analytical performance, and its external quality control based on
the laborator y’s performance in proficiency testing programs.
d. Laboratory Management is responsible for establishing a Laboratory Quality Control Program and ensures that quality control is performed and reviewed of
quality control data for acceptability. e. Analysts are responsible for conducting quality control analyses in accordance
with The Laboratory Quality Control Program.
KAN-TN-LP 02 Issue Number : 3
April 2016
Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded
14 f. Internal quality control is used to measure accuracy, precision, contamination, and
matrix effects. The laboratory determines, where feasible, the accuracy and precision of all analyses performed.
g. Quality Control Program for Media shall including: i. pH of medium checked after autoclaving,
ii. Positive control culture to reference culture performed per batch of media, iii. Negative control culture to reference culture performed per batch of media,
iv. Checked of sterility per batch of media, v. Media that used for quantitative methods, quality control program including
compare positive control cultures on selective media and nonselective media once per batch of media.
Bibliography:
1. Eurochem Guide 2013. Accreditation for Microbiological Laboratories 2. ISO 7218; 2007, Microbiology of food and animal feeding stuffs - General rules for
microbiological examinations. 3. ISO 11133; 2014, Microbiology of food and animal fedd and water
– Preparation, production, storage and performance testing of culture media
