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Your assignment for this module is to undertake the following tasks.
Choose two (2) activities in your laboratory that have been, or currently are, subject to errors, result in complaints or involve non-conformance to practice as outlined in your Operating Procedures and Quality manuals. Choose one issue that involves management processes and one that involves technical operations. Undertake a root cause analysis of each problem using a fish-bone, or cause and effort diagram, and the 5 whys approach mentioned in the document on non-conformance reporting. You will be assessed on the thoroughness of your investigation and the quality of your documentation.
As a guide this assignment should be between 8 and 10 pages in length.
The assignment must include the following: completed assignment coversheet as the first page, title page and a Table of Contents where appropriate. The assignment must have a footer indicating your name, assignment number/topic and page numbers eg. 1 of 5. Name your file using your initials or family name and then assignone eg. rebgassignone, would be my file name for the first assignment.
Adherence to the above requirements will be part of the assessment of your submitted work.
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Indicate what corrective action should be implemented, and how that should be done to ensure that the problem/s do not reoccur.
Briefly discuss (approx 500 words) the importance of non-conformance investigation in the overall operation of the laboratory and what the ISO15189 standards require in terms of identification and control of non-conformities
The activities mentioned in your assignment will be treated in strictest confidence and not communicated to any third party. Your assignment will be marked by the course coordinator or a tutor designated by the course coordinator who will observe the same confidentiality requirements outlined above.
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