A vertical audit of a test for analysing concentrations of progesterone found that the reagents are stored in a refrigerator although the protocol stated they should be stored between 2 to 8°C. The...

Extracted text: A vertical audit of a test for analysing concentrations of progesterone found that the reagents are stored in a refrigerator although the protocol stated they should be stored between 2 to 8°C. The temperature of the refrigerator was not monitored. A horizontal audit to measure the temperatures of refrigerators throughout the department showed none of them maintained temperatures between 2 to 8°C. The quality manager agreed with the departmental management team that the current storage of the reagents for this test was an unsafe practice and a critical non-compliance with CPA (Section 1.1) standards. (a) What are the implications of storing temperature critical reagents in this way? (b) What action is required to resolve this non-compliance? (c) How would you determine whether the problem has been rectified?