Thanks for your imput Malcom. What you say makes sense, although I think there has to be some consistency set.. Would you recommend submitting to the laboratory manager documentation of all variances that have occurred in the blood bank, regardless of FDA reportability? What would you think of a monthly report to the manager listing the nature of the variances and what corrective action was initially taken. If the manager wants more then they can get back to you and ask you for further follow up. This way the supervisor is not taking the sole responsibility for what happens in the department and the laboratory manager is fully informed and this is documented. If they don't respond back then this is documented also. Also, would you submit the FDA reportable issues to management and let them perform the root cause analysis using the supervisor as the resource for whatever information is needed? Then when they have finished and given you their report you can file this with the FDA. Do you think this process has validity and helps support the supervisor when policies are not too clear?