Microbiological Laboratory Quality Assurance
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1 Microbiological Laboratory Quality Assurance
2 Laboratory quality assurance A group of activities proceeded in order to ensure the validity of test results
3 Laboratory quality assurance according to ISO/IEC17025 clause Internal quality control 2. External quality assessment
4 1. Internal quality control Internal quality control consists of all the procedures undertaken by a laboratory for the continuous evaluation of its work in order to ensure the consistency of results day-to-day and their conformity with defined criteria
5 1. Internal quality control 1.1 Personel On the job training Competency test Job assignment
6 1. Internal quality control 1.2 Environment Room temperature Air ventilation Air and work area cleanliness Humidity
7 1. Internal quality control 1.3 Equipment Equipment profile - installation - Repair and maintenance Manual and instruction Preventive maintenance program Calibration Performance check
8 1. Internal quality control 1.4 Reference culture Growth performance of culture media Method validation Quality control of test Competency test
9 1. Internal quality control 1.5 Culture media quality and water supplied Media assessment for new brand or new production lot Stock management and keeping of dehydrated media Production batch testing - ph - Performance growth - Sterility - Volume test - Color and texture
10 1. Internal quality control 1.6 Culture media quality and water supplied Media storage and shelf life Reagent-grade water quality - ph - Conductivity - Total metal - Residual chlorine - Total bacteria
11 1. Internal quality control 1.7 Glassware and laboratory apparatus Detergent and inhibitory residues Volume verification (Pipette, cylinder, micropipette, auto-dispenser) Sterility (For sterilized materials)
12 1. Internal quality control 1.8 Sample handling Sample identification Sample receiving and registration Sample storage Sample retention Sample disposal
13 1. Internal quality control 1.9 Quality control of test Positive and negative control Sterility control Replicate test
14 2. External quality assessment (Proficiency testing) Laboratory should regularly participate in proficiency testing to conduct performance evaluation studies among all participant laboratories. Results of such studies indicate the quality of analysis of each laboratory as compared to group performance
15 Quality assurance of temperature controled equipments
16 The main temperature controled equipments in microbiological laboratories Incubator Water bath Autoclave
17 Three requirements for equipment handling
18 Three requirements for equipment handling 1. Equipment maintenance Preventive maintenance plan by the rate of use Avoidance of cross-contamination - Clean and disinfect internal surfaces
19 Three requirements for equipment handling 2. Equipment calibration Calibration plan Uncertainty of measurement Temperature stability Temperature uniformity
20 Three requirements for equipment handling 3. Performance verification Maximum permissible error criteria (MPE) Time required to achieve equilibrium condition Monitor of the operating temperature with thermocouple or thermo data logger - Daily check - Each use check - Intermediate check
21 Three requirements for equipment handling 3. Performance verification Corrective action for non-conformity performance Validation after significant repair or modification
22 Case study of temperature controled equipment validation
23 Incubator Installed place : Bacteria lab Code No. : B IN 09 Objective : For pathogenic bacteria growth Temperature requirement : 37 c MPE : Temperature uncertainty : ±1 c Temperature uniformity : ±0.5 c Temperature stability : ±0.5 c
24 Result of calibration Incubator
25 Verification of incubator performance Instrument Name: Incubator Model: KB240 Serial No.: ID No.: B-IN-09 Manufacturer: Binder Calibration Date: May 3, 2011 Technology Promotion Association (Thailand- Calibration by: Japan) Temp Aecept: 37+1 o C (36-38) Verification parameter Position1 Position2 Position3 Position4 Position5 Position6 Position7 Position8 Position9 UUC reading temp Reference reading temp Error Uncertainty ± UUC reading - Error - Unc UUC reading - Error + Unc Maximum permissible error 37±1 c c Result of verification passed passed passed passed passed passed passed passed passed
26 Monitor of operating temperature (Daily check) 40 Incubator temperature daily check Code B-IN-09 Setting temperature 37±1 c C am pm date in Jul 2011
27 Water bath Installed place : Bacteria lab Code No. : B WB 04 Objective : For selective growth of E.coli at 44.5 c and Clostridium perfringens at 46 c Temperature requirement : 44.5 c and 46 c MPE : Temperature uncertainty at 44.5 c: ±0.2 c Temperature uncertainty at 46 c: ±0.5 c Temperature uniformity : ±0.5 c Temperature stability : ±0.5 c
28 Result of calibration Water bath
29 Result of calibration Water bath
30 Verification of water bath performance Instrument Name: Waterbath Model: E125 Serial No.: LCB ID No.: B-WB-04 Manufacturer: Luada Calibration Date: January 9, 2011 Calibration by: MIT Temp Aecept: o C ( ) Verification parameter Position1 Position2 Position3 Position4 Position5 UUC reading temp Reference reading temp Error Uncertainty ± UUC reading - Error - Unc UUC reading - Error + Unc Maximum permissible error 44.5±0.2 c c Result of verification passed passed passed passed passed
31 Monitor of operating temperature (In use check) c Water bath temperature in use check Code B-WB-04 Setting temperature 44.5±0.2 c am. Date in Jul 2011
32 Autoclave Installed place : Sterilizing room Code No. : B AU 05 Objective : For culture media sterilization Temperature requirement : 121 c MPE : Temperature uncertainty : ±3 c
33 Result of calibration Autoclave
34 Verification of sterilization
35 Monitor of sterilizing performance (In use check) Physical check Maximum thermometer Thermo data logger Chemical check Chemical indicator strip Biological check Bio indicator (Bacillus stearothermophilus)
36
37 Thank You
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