Assignment Question
Select one of the scenarios provided.
Write a laboratory test method providing all information essential to the proper performance of the selected method. You will have to find and read the standard method referenced in the scenario and your submitted method must reflect the requirements of both ISO/IEC 17025/ ISO 15189 and the relevant standard method.
Scenario 1
You are the Laboratory Manager for Enviroanalysis Laboratories Pty Ltd. EnviroanalysisLaboratories has been testing soil samples for clients for several years and has decided to seek NATA accreditation for this work to ISO 17025. As the head of the Chemical Analysis Department, you have been asked to oversee the development of the required documentation for the Department. One of the tests your Department performs is the analysis of pH of soilsin accordance with AS 1289 Part 4.3.1
Write a test method for use in the laboratory for the analysis of samples for pH in accordance with AS 1289 Part 4.3.1 Ensure your method includes the following details.
- Scope of the method
- Apparatus and reagents
- Step-by-step sequence of testing operations, including any sample preparation and analysis
- Records to be kept
- Calculation of results
- Quality control activities, including criteria for acceptance/ rejection of results
- A description of any method validation and verification work your laboratory will need to complete to meet accreditation requirements
- Reporting requirements
Scenario 2
You are a medical scientist in the Microbiologylaboratory of Biopath Limited. The laboratory performs testing of ear swab samples for Pseudomonas spp. and the government now requires the laboratory to have NATA accreditation for this work to ISO 15189. The laboratory performs this testing in accordance with AS 5013 Part 21 and has modified this method so that it can test ear swabs instead of food. Instead of preparation of the samples as described in ISO 6887-1 and 6887-2, the laboratory places received swabs into a McCartney bottle containing sterile peptone and uses this solution as the basis of creating its dilutions for testing.
The Department Head has asked you to write a test method for use in the laboratory for the analysis of ear swab samples. Include details of the following.
- Scope of the method
- Apparatus and reagents
- Step-by-step sequence of testing operations, including any sample preparation and analysis
- Records to be kept
- Calculation of results
- Quality control activities, including criteria for acceptance/ rejection of results
- A description of any method validation and verification work your laboratory will need to complete to meet accreditation requirements
- Reporting requirements
Scenario 3
You are a Chemist in a radiopharmaceutical manufacturing firm, Alpharay Pharma. The QC laboratory analyses production samples for radiopharmaceutical purityin accordance with the International Pharmacopoeia. Alpharay Pharma has just commenced production of Technetium (99mTc) bicisate complex injection and the laboratory needs to seek NATA accreditation to ISO 17025 for testing this material. The Laboratory Manager has asked you to assist with this project by preparing the necessary documentation.
Write a test method for use in the laboratory for the analysis of production samples of Technetium (99mTc) bicisate complex injection in accordance with the International Pharmacopoeia. Ensure your method includes the following details.
- Scope of the method
- Apparatus and reagents
- Step-by-step sequence of testing operations, including any sample preparation and analysis
- Records to be kept
- Calculation of results
- Quality control activities, including criteria for acceptance/ rejection of results
- A description of any method validation and verification work your laboratory will need to complete to meet accreditation requirements
- Reporting requirements