CBMS861-Laboratory Quality Systems

Learning Outcomes

This assessment task relates to the following Learning Outcomes:

1.Analyse the requirements of international standards ISO/IEC 17025, ISO 15189, ISO 9000 and the OECD Principles of Good Laboratory Practice.

2.Prepare and maintain quality documentation.

3.Develop a quality management system.

4.Critically analyse/evaluate an existing quality management system for the purpose of quality improvement.

5.Understand, at an advanced level, technical management concepts including test methods, method selection, verification of methods, validation of methods, uncertainty of measurement, calibration and traceability.

6.Enhance customer service and the experience of interested parties through the use of quality improvement techniques and processes. 

Assignment Guide and Submission

Your assignment responses must be completed in the assignment template provided in the unit’s iLearn page. Students must answer both Part 1 and Part 2. There is one compulsory question in Part 1. Students must also select two questions from the optional task bank 1-4 in Part 2. Please indicate which questions you are answering in your submission for Part 2. 

Part 1:

Dr W. Edwards Deming developed 14 Points for Quality Management. Amongst these were the following principles. 1. Create constancy of purpose for improving products and services. 2. Cease dependence on inspection to achieve quality. 3. Improve constantly and forever every process for planning, production and service.

In this unit, we have studied the ISO/IEC 17025 approach to quality management. Critically evaluate the requirements of ISO/IEC 17025 against the three principles above. You must carefully explain the meaning of each of the principles and analyse whether ISO/IEC 17025 approach to quality management has adopted these principles. Discuss whether, in your view, ISO/IEC 17025 is an improvement on the initial work of Dr Deming, using examples to justify your opinion.

Part 2: Choose two (2) from the following four (4) task options

Part 2: Task 1 ISO/IEC 17025 contains requirements for handling samples. Examine these requirements and discuss how you would implement all these requirements in a laboratory. Give specific details of processes and procedures you would expect a laboratory to have in place to meet the requirements. 

Part 2: Task 2 Compare the requirements for testing and personnel of ISO/IEC 17025 with the similar OECD Principles of Good Laboratory Practice. Discuss the similarities and differences between the two standards and evaluate whether one standard is better than the other in dealing with these areas of a laboratory operation. Use examples to justify your answer. 

Part 2: Task Case Study: The Assessment of a Biotechnology Laboratory The basis of this scenario is given in a case study involving an external assessment of a testing laboratory by a team of assessors from an accreditation body.

Consider the information and evidence presented in the case study and identify any non-compliances against the requirement of ISO/IEC 17025 revealed by the assessment.  

Your task is to consider the information and evidence presented in the case study, and identify:

a) aspects of the laboratory’s facilities or operations that have been shown by the assessment not to comply with the requirement of ISO/IEC 17025 (N/C), and

b) any aspects of the laboratory’s facilities or operations on which more investigation would be needed in order to confirm compliance or noncompliance (MIN). 

Part 2: Task 4

In this scenario, you will be given basic information about a laboratory and asked to develop an action plan to enable it to gain accreditation. You are the newly appointed quality manager of a well-established multi-section independent testing laboratory. You have been directed by the senior management to develop an action plan to enable the laboratory to gain NATA accreditation against ISO/IEC 17025 within six months and to present your proposal in the form of a report to the Board of Directors.

The basic facts about the laboratory are these:

a) It has been in operation for about 10 years and currently employs 22 people;

b) It consists of four sections – General Chemistry, Environmental Chemistry, Sample Preparation, and Administration;

c) “Management Meetings” involving the General Manager, the Laboratory Manager, and the four Section Heads are held monthly; you expect to participate in these meetings in future. 

From a preliminary appraisal of the laboratory’s facilities and operations, you are reasonably confident about the correctness of the results being generated, but you have found that a lot needs to be done to raise the laboratory to accreditation status; for example:

1.the laboratory does not have a quality manual

2.the test methods are well documented, but only a few of the management procedures have been documented, and most of the work tasks are based on word of mouth instruction

3.there is no central or coordinated calibration program, Although the Laboratory Manager has started working on this

4.no internal audits have been conducted, and

5.management and staff generally have little understanding of document control, corrective and preventive action, and quality improvement. 

Your task is to prepare a report to the Board which includes an action plan outlining the steps you have identified to ensure that the laboratory is ready for an accreditation assessment in six months’ time. In your report, list the key issues that will need to be examined and addressed, and indicate other personnel whom you may need to involve in your project. You may present your report in the form of a table if you wish.