The main purpose of a Quality Assurance Manager (QA) in a Good Laboratory Practice (GLP) compliant facility is to provide independent assurance to management that facilities, systems and processes comply with the regulations and that study data submitted to government assessors is accurate, valid and of sound integrity. No pressure then! We caught up with XCellR8 QA Manager Jan Ball, to learn all about auditing and air guitars.
Tell us about a typical day in QA
My day always starts with a coffee whilst I check my mailbox for any new requests to audit study plans and reports or review new or updated standard operating procedures.
I then make final preparations for facility, process, study-based audits scheduled for that day. Today I’ve started preparing for the annual review of our computerised systems to assure the integrity of data collected/analysed and the monthly review of test item receipt, characterisation and storage to assure they are suitable for use on GLP studies. Dependent upon the number of concurrent studies, I can be in and out of the lab many times during a day. In our amazing home at Sci-Tech Daresbury, this involves transit between floors and despite being immensely proud of using the stairs, the anticipated effect on my waistline has yet to materialise!
In between lab visits I will be writing up audit reports, checking and filing responses to audits, auditing study plans and reports, monitoring trends in internal audit findings (to identify where re-training may be needed), considering how to continually improve quality in all that we do and planning how to roll out any improvements in a controlled manner (and drinking coffee). Today I have KeratinoSens study reports to review, staff are attending a QA-led session regarding data integrity (resulting from recent publication of an MHRA GXP guidance document) as part of a controlled change programme.
What are the most common issues around QA that you encounter?
‘Scary’ auditors can result in errors being hidden, and such errors may become impossible to resolve at a later date and lead to non-compliance. Having worked in a laboratory prior to taking the QA path I have experience of ‘being audited’, so try to be sensitive about the impact on the individual in order to achieve transparency. New staff often consider being audited quite an ‘ordeal’ (and stress can lead to errors), so I am always mindful of this – a friendly face, and calm approach works wonders. Continually auditing the same people provides opportunity to chat (and air guitar along to the radio) during gaps such as when samples are being spun.
Why did you choose a career as a QA Manager?
As a laboratory technician when GLP was introduced in the UK it has figured largely in my career progression to a laboratory manager, study director and quality manager. I moved into QA to take my experience ‘from the other side of the fence’ to champion a realistic approach to applying the regulations.
I enjoy learning about the cutting-edge assays we are developing, and helping scientists prepare them for GLP status. The most recent assay I’ve been involved in is the acute toxicity assay; I worked closely with the scientists to understand the testing process in order to advise what documentation was needed to verify compliance of study plans, reports, data collection and analysis with GLP requirements. I also enjoy the variation in my days: parts with my head buried in study plans and reports, other times in the lab with the study scientists observing the amazing science in practice.
What do you do at the end of the day to unwind?
I unwind by spending time with family, friends and my cats, watching the wildlife in my garden and satisfying my inner rock chick by going to see lots of bands.