QA line management
Reply to Thread
Can the head of GLP QA report to the Test Facility Manager in a large organisation or should the head of GLP QA be completely independent from all GLP, i.e. can the test facility manager be the line manager of the head of GLP qa?
RQA GLP Committee
The head of QA should report into the highest level of management responsible for GLP as possible, although it will be accepted that at some point, this management will have high-level authority over the Study Directors and QA there should be no direct reporting of the head of QA into a Study Director or direct Study Director Management. Therefore, the Test Facility Management can be the line manager of the head of QA assuming these criteria are met.
Please could you clarify what you mean by 'direct Study Director Management.' Until recently, I reported into an independant manager, as it was thought that QA reporting to the TFM wasn't allowed. Our department is part of a larger organisation but only our department is applying for GLP. The TFM has 2 study directors and approx. 9 technicians reporting to them. If the SDs directly report to TFM is it not a conflict of interest if QA also reports directly to the TFM. I know under GMP rules, head of QA cannot report to a site manager so isn't this a similar situation?
RQA GLP Committee
The independence of QA should not be compromised by their reporting line, hence, if they were to audit a study and then report to the study director of that study this would be considered a compromise, as pressure could be applied to prevent them from reporting their findings.
Therefore, QA should report into the highest level where this is not an issue and if the Study Directors report in to TFM from one branch of the organisation and QA from another, then the SDs would not be able to influence QA reporting.