Quality assurance

Aims

The aims of the component are to: Provide background in basic fundamentals of Quality Assurance, such as statistics, uncertainty and traceability, which are applicable to all types of measurements, through specific guidance on method validation, use of reference materials and control charts. Provide basic knowledge, principles and methodologies in total quality management, certification and accreditation. Focus on the importance of quality assurance of chemical measurements on the global trade and the global society in the domain of food. Describe the contents of ISO 9000 (used for the certification of companies) and ISO 17025 (used for the accreditation of testing laboratories

Prerequisites

1. Analytical Chemistry I and II  
 2. Biostatistics
 
  

Learning Outcomes

 After completing the component, attendees will able to: Understand the meaning and importance of Quality Assurance for Food Industries and Quality Control Laboratories. Use statistics to treat and evaluate analytical results Know how to validate an analytical method used for the quality control of food Know how to estimate the uncertainty of an analytical result Understand the principles and requirements of ISO 9000 and how to work in a company certified according to this ISO standard Understand the principles and requirements of ISO 17025 and how to operate in a testing laboratory accredited according to this ISO standard Understand the meaning and how to use the “Quality Manual” Understand the meaning and how to use a Standard Operation Procedure (SOP) Understand the meaning of the Calibration of an Analytical Method and an Analytical Instrument Know how to carry out research work according to Good Laboratory Practice Know how to perform internal quality control and construct control charts Understand the meaning of External Quality Control and how to evaluate the results of the participation in such a scheme Understand the meaning and use correctly the Reference Materials Know how to write correctly a Certification of an  Analysis          

Syllabus

Glossary of Analytical Chemistry Terms ·         Accreditation – ISO/IEC 17025 ·         ISO 9000 Quality Systems ·        Accreditation vs Certification ·         Good Laboratory Practice ·         Total Quality Management and Cost of Quality ·         Quality Manual ·         Basic Statistics ·         Calibration ·        Metrology in Chemistry and Traceability of Analytical Measurement Results · Validation of Analytical Methods – to be Fit for the Purpose ·         Measurement Uncertainty ·         Control Charts ·         (Certified) Reference Materials ·         Interlaboratory Tests  

Content Delivery

This component is delivered through lectures (mainly) and the presentation of examples of calculations.  

Coursework And Assignment Details

Final written examination consisting of:   Multiple Choice  Questions (16 x 4 =  64 points). Wrong answer : -0.5 points Correct – Wrong Statements – Justification of the answer-Writing the correct one if the statement is wrong (22 x 2 = 44 points). Finding the exact clause (paragraph) in the ISO 17025 standard to support findings during the audit of a laboratory (10 x 4 = 40 points) 148 points = 100%