For our example, let us say that we are creating an IQCP for ammonia testing. We decided to do this after several incident reports were filed related to ammonia testing failures. In our example, we will be concentrating on the preanalytical phase of the testing process.
However you begin this process, it is important to not predetermine causes for failures or solutions to the problems. This will allow you to recognize issues or risk mitigations that you might not have previously considered.
In order to thoroughly understand the process, review test system manufacturer's instructions, the laboratory's own operational procedures, operational policies, and/or workflow charts. You may also want to interview individuals who are performing the tasks. This will assist you in filling in the vital pieces of information that are part of the process as it is currently being performed. Ask non-judgmental, open-ended questions during the interviews. For example, you could ask a phlebotomist who collects blood samples for ammonia testing,
"How do you know that an ammonia test has been ordered?"
"What supplies do you need to collect this sample?"
"Where would you look to find specimen collection instructions for this sample?"
Try to keep the atmosphere non-threatening so the individuals you are interviewing feel at ease and answer your questions freely and honestly.