1) What is qualification and why is it important? (1 point) 2) What is the diffe

1) What is qualification and why is it important? (1 point)
2) What is the difference between qualification and validation? (2 points)
3) Under “Equipment Records”, the reading states that records are required for equipment “which can influence laboratory activities”. Utilizing the Equipment Maintenance Log Template spreadsheet link below, create an equipment record, using fictitious information, for a laboratory analytical balance that was just returned to your laboratory following a repair. The balance was sent to a vendor for repair due to several failed attempts you made to calibrate it with test weights. In addition to the other equipment record information you include, add an entry to this record that discusses the importance of the repair and how this might have affected the lab’s activities. (4 points) Equipment Maintenance Log Template.xlsx Download Equipment Maintenance Log Template.xlsx
Additionally, here is a link to an analytical balance to assist with this question: Mettler Analytical; Balance
Note: To utilize this spreadsheet, click on the link and then select “download”. You can then open it, add your entries, and save the spreadsheet. Submit this spreadsheet together with your response to the remainder of the assignment.
4) Locate the Certificate of Analysis for a certified reference material (CRM) that might be used during forensic toxicology drug analysis. This question is asking specifically for a CRM versus SRM (standard reference material). The certificate you locate and draw information from should state “Certified Reference Material”. Please select a drug other than cocaine, which was presented in Module 4’s reading.
a) Include a direct link to the Certificate of Analysis for full credit. (1 point)
b) Locate and then list the drug’s certified concentration to include the units, the measurement uncertainty, the coverage factor, and the associated confidence level used for determining the reported measurement uncertainty, expressed as an expanded uncertainty. (1 point)
c) In considering sources of measurement uncertainty, as discussed at the end of module 4, would this certificate’s uncertainty information be considered as part of a Type A or a Type B evaluation? (1 point)
d) Discuss your answer to (b) further. If you were going to explain the confidence level to a jury, how would you do that? What would you tell them?(1 point)
e) What does it mean when a certified reference material (CRM) is considered to be “traceable to NIST? Discuss how this CRM is traceable to NIST. (1 point)
5) What is the goal of calibration in relationship to how a quantitative value or concentration is determined? (2 points)
6) Watch the following video on pipette calibration and then answer the following:

a) What parameters are determined from calibrating a pipette? (1 point)
b) The video discusses the importance of the equipment being used. Why is a balance used? (1 point)
c) The balance should be calibrated prior to this process. Briefly discuss the process used for calibrating a balance. (2 points)
d) If the balance fails during calibration, what should be the next step? (1 point)
e) If an outside vendor is needed for calibration, how would you evaluate that vendor? (1 point)