INSTRUMENT SOP You are required to: 1.
prepare a Standard Operating Procedure (SOP) for the routine operation of an instrument which you will be allocated 2.
devise and check a performance qualification (PQ) test for that instrument 3.
perform PQ tests on other instruments, using SOPs developed by others in your class Instrument
Part 1 – Standard operating procedure Prepare an SOP for the following uses of the instrument:  start‐up  basic operation  shutdown The “basic operation” part would allow a user to do ANY analysis on the instrument, so must not include specific values, e.g. wavelengths. For example, a SOP for the UV/VIS would describe how you set the wavelength range, but not provide any actual values. Process Step 1. Locate and copy any relevant operational information available for the instrument. Read this and draw a diagram (or take photographs) of the instrument, so that you can clearly identify the important knobs, dials and others bits that you will need to be familiar with in the operation of the instrument. Step 2.
With teaching/technical staff assistance, begin the familiarisation process for setting up the instrument from before “power on” to after “power off”. Record each step in the process as you do it. DO NOT RELY ON MEMORY!!! Step 3.
Once you are confident in the process of set up, operation and shut down, you can write up the SOP. Step 4. Obtain a usage sheet to which you will need to add your instrument details. Part 2 – Performance qualification (PQ) Test A PQ test is one that measures a key aspect of the instrument’s performance, and can be done quickly (no more than 10 minutes including the initial set up of the equipment). The standard being measured should require little or no preparation, so that observed variations are not due to this. It is essential that the result of the PQ test is known, and any acceptable variation determined, e.g. the absorbance should be between 0.50 and 0.52. The only way to do this is by running the test material a number of times. Instrument SOP Process Step 1. Devise a suitable performance qualification test. Check with your teacher that it is appropriate. Step 2. Write an SOP for the PQ test that references your general SOP and specifies the appropriate settings. Step 3. Run this enough times so that you are confident about an acceptable range of values. Step 4. You will be provided with a PQ Results Sheet, which you will need to add the following information:  name of instrument being tested  a statement of the acceptable result range Part 3 – Using other people’s SOPs and PQ tests Once everyone has completed SOPs and PQ tests for their instrument, there will be a swapping of work, so that you will use other people’s SOPs and PQ tests to: 
check that what they have done is readily useable by another 
gain familiarity with other instrument types Changes and revisions When you are using someone else’s SOP, pay attention to whether the instructions make sense to you. If you feel that something isn’t clear, ask the author of the SOP, but also write comments/suggested changes on a copy of the SOP and include your name and the date. This will allow the SOP to be revised and a revision history to be maintained. You should retain all SOP copies for your instrument with suggested changes for your Folder. Logs Ensure that you complete all the necessary paperwork for the other SOPs that you use, and check that your usage sheet have been completed by the people using them. Signoff You will be given a signoff sheet which you get signed by the person whose instrument you have used. Assessment Each of these tasks require documentation, some more extensive than others, and you will be required to assemble a folder of work for submission at the end of the work. This task MUST be completed satisfactorily to allow you to pass the unit, regardless of other results. If any of these components are missing or unsatisfactory, you will be required to resubmit the folder. The folder must contain the following: 1.
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IM the final version of the Standard Operating Procedure you have written for your assigned instrument an Appendix with the revisions and suggested changes the Performance Qualification test you wrote for your instrument (written in SOP format) results of the PQ tests done on your instrument by you and others in the class completed Instrument Log for your instrument a signoff sheet to be completed by each instrument “owner” to indicate that you have used their SOP/PQ and completed the paperwork p2 INSTRUMENT MAINTENANCE Instrument SOP – Usage Log Instrument Author Date User Time Used Comments INSTRUMENT MAINTENANCE Instrument SOP – PQ Test Log Instrument Author Test Material Acceptable Test Value Date User Result Acceptable (Y/N) IM p2