Pathologist and QA
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I am curious to what your thoughts are on this.....
The pathologist at a subcontracted lab is married to the person in charge of QA. Since the QA person must audit the pathologist's work, do you find the relationship (being married to each other) a problem?
The Study Director is located at a different facility and I am not sure if the SD is aware of the relationship.
RQA GLP Committee
This is quite a common occurrence with specialists that work at home or in a small organisation, although not ideal, it is understandable given the way that they work. The regulators inspect these specialists as part of the compliance programme and do not routinely have issue with it, but it might be worth letting the study director know and potentially conducting an audit of their systems to ensure you are entirely satisfied with how things are running.
You will probably find that the Pathologist is also Test Site Management and the Archivist!
Thank you for your reply.
This pathology lab actually has 9 pathologists on the payroll, ALL of the GLP studies at this facility go through this one pathologist (that is married to the QA manager). The pathologist is not part of Test Site Management (the Test Site Management team is at a completely different facility unrelated to the pathology lab) or the Archivist. No other pathologists at the pathology lab are ever asked to participate on the GLP studies. So ALL GLP studies will always go through the same pathologist and QA manager. The owner/Manager of the pathology lab does not see the relationship as a problem. However my concern is that since ALL of the GLP studies will ALWAYS be performed by the same pathologist and QA person (reminder: husband and wife), this would appear to be a conflict. In other words, who has the final say, the pathologist or QA? I know the way the Owner/Manager of the pathology lab sees this is as long as any errors found during an inspection or audit is corrected, it does not need to be a concern to the Test Facility or Study Director.
RQA GLP Committee
The decision must lie with Management, Test Facility Management and the Study Director. There should not be a situation where ‘who has the final say, the pathologist or QA?’. QA can advise, point out errors or inconsistencies but the final decision will be down to the Study Director. If there were a conflict then the final decision lies with management.
In principle regulators may need you to demonstrate that there is no conflict of interest between pathologist and QA.