Quality Control? Forms? Filing??

by on 6th of December, 2010 in Career Development & Networking
About Vicki Ronaldson
Vicki studied chemistry at the University of Aberdeen (graduating in 2005), before moving to the University of Edinburgh to complete her PhD in synthetic organic chemistry. Following this, she spent one academic year as a transferable skills demonstrator at the University of Strathclyde, running tutorials and workshops covering topics such as scientific writing, presentation skills and team working. This was followed by a move into industry within a pharmaceutical CRO, where she was first a clinicial research scientist and laterly marketing manager. Vicki currently works in public policy within the science and technology field. Vicki is a Member of the Royal Society of Chemistry, the Institute of Clinical Research, the Academy of Pharmaceutical Scientists and the Controlled Release Society, as well as an Associate of the Higher Education Academy. In her spare time she enjoys horse riding and reading the Onion. (Separately, of course). Likes to blog at www.vickironaldson.com

Time to face your organisational fears if you’re planning to make the move into industry

Good Laboratory Practice. Common sense, surely? A requisite for the successful completion of a scientific degree, one would hope. We all exercise good laboratory practice, don’t we?

As a graduate student, I exercised the appropriate laboratory practice to get results, and therefore publications. This involved a mixture of determination, luck, creativity and resourcefulness—some ‘borrowed’ glassware here, a skip of the HPLC queue there—and this worked pretty well. I was accountable only to myself (ok, and my supervisor), I understood perfectly my own personal brand of record keeping and, in the every-student-for-themselves environment of the shared laboratory, I’d learned many tricks of the trade to fast track results. I had it down. Then I started a job in industry.

Suddenly my word wasn’t good enough. They wanted me to fill in forms, and logs, all the time, for everything! To prove that I was doing what I said I was doing, when I said I’d done it, that the instrument was calibrated to read what it was meant to be reading, and that I was trained to be operating the instrument in question and operating it according to the standard operating procedure, so that I could be sure of the validity of the readings. Phew. This, I discovered, is Good Laboratory Practice.

After completion of a science degree and three years of graduate school, the fact that what one would assume to be an inherent feature of bench science should be an actual topic in itself (with its own abbreviations no less) and can be a slightly baffling concept. It turns out Good Laboratory Practice is more than something you ‘just do’; it’s one of many quality assurance systems —the many variants of which has led to the term, ‘GxP’- likely to become a daily part of your working life post-academia.

This article isn’t intended to be an overview of the various types of quality systems (indeed I only have a few hundred words and a finite length of time), rather some words of guidance for those struggling with culture shock. If the ideas of completing a log of use and a cleaning record each time you use the centrifuge makes you feel slightly queasy, then read on for some tips that might help soften the blow, or at least prepare you for it:

The types of things that might bother you in the beginning

In the beginning there will be obstacles (as you will perceive them) at every corner, which prevent you from getting any actual work done and you will find this highly frustrating. For example: errors must be deleted using a single line, initialled and dated; undesirable data must be acknowledged  (the ‘pretend this result never happened’ philosophy is very much frowned upon); all data must be backed up multiple times and paperwork must be copied and filed, often in multiple locations. The PhD system of filing—a stack of paper in a corner or, as I have seen in some cases, the floor—won’t cut it unfortunately. Desks must be cleared away each night with lab books and data in fireproof safes and there will be some form of log of use for virtually every piece of equipment on the premises, bar the coffee machine perhaps. All of these things will upset you a little at first. You want to do great science, right? And you don’t need all these rules and restrictions getting in the way of your creativity and using your valuable time and brain space.

There’s no getting around it

Stage one in dealing with this mandatory change in your laboratory habits is acceptance. The key word here is mandatory.  Quality control is non-negotiable so, at the risk of sounding harsh, get used to it. This also sounds like fairly useless advice.  However, I found that simply acknowledging that this was the way things were, always would be, and that no amount of tutting at the preposterous notion of recording the batch number of distilled water was ever going to change that (yes, that did happen, the distilled water I mean), allowed me to get through the paperwork and get on with the science. It also helps to remember that every one of your colleagues has had to adapt to this new system at some point as well. Just because they adhere to quality control doesn’t mean they are crazed paperwork fanatics sent to make your life as difficult as possible – they’re just getting on with it.

The major differences between commercial and academic research

As ludicrous as some of the enforcements of quality control may seem at first (again, batch number of distilled water), when you consider the differences between academic and industrial research you can see why such measures are necessary. When you submit manuscripts for publication, you’re trying to disseminate your best results to your peers. The reviewers will not demand to see evidence of an audit trail for every piece of data. In the commercial world, a great deal of money is at stake.   Clients don’t pay for ‘fairly accurate’ or ‘relatively good quality’. In drug development and clinical research, the health of trial patients and the wider public is the most important consideration, so stringent regulatory requirements is, of course, a no-brainer.

Consider the consequences of non-compliance

In the event that quality is less than satisfactory, there must be an audit trail to allow identification of the point of error, enabling assessment of the likely impact and implementation of appropriate steps to reduce the risk. If a marketed drug is recalled, you’d better have your data in good order because it will all need to be dragged back out and gone through with a fine tooth comb. What if a patent is disputed? Your lab book and any associated raw data may be all you have to get the company out of hot water in court – so you’d better hope it’s impeccable! I remember as an undergraduate being told to bear in mind that if I were to come to an unexpected and untimely death, a scientist of similar education and background should be able to pick up from where I left off in my lab book. Morbid I know, but its advice that’s stuck with me.

The Upside

The leap from the creative chaos of the university lab to the well-oiled machine of the industrial lab is not without its advantages. There is generally a lot more money available, so begging neighbouring labs for left over reagents is a thing of the past. There is no fighting over glassware (cleaning is non-negotiable in the industrial lab, relinquishing the need to pilfer from your lab mates – hoorah) and, in the unlikely event that equipment should be left in less than pristine condition, there will be a perfect paper trail leading you to the culprit, so no need for the traditional passive aggressive post-it or ‘whodunit’ circular email (we’ve all been there).

Don’t worry if you don’t know it all – but have an awareness of the importance of quality control

No one expects you to go into your first industry job with working knowledge of all quality systems. Following my PhD, I started work in a GMP (Good Manufacturing Practice – we’ll save that for another day) laboratory. I was aware of the concept of quality systems but had never worked in a regulated environment (hence my horror at many of the aforementioned conventions of QC).  The good news is, although the degree of paperwork makes it all seem rather convoluted, quality assurance, in all its guises, is common sense. In fact, we all exercise our own quality control during our graduate days without even realising it. The big difference is that we don’t consciously document every act of quality control during our PhD studies, because we’re never likely to have to justify or prove it to anyone other than ourselves, and maybe the external thesis examiner… In industry, ‘traceability’ is key.  Remember the mantra: ‘if it isn’t documented, it didn’t happen.’

At some point in your industrial career, you will make an error, big or small (but hopefully small…). But—you’ll spot it early and be able to exercise appropriate damage limitation because of your adherence to quality control, and you’ll be glad of the hours you spent on paperwork. Honestly.

4 thoughts on “Quality Control? Forms? Filing??”

  1. Avatar of tvrulezall tvrulezall says:

    Thanks for the insight to working in the industry for quality control. Personally, I am one year into my PhD and i am thinking that PhD doesn't really suit me. Therefore, may i ask what who would hire an undergrad with a degree in Life Sciences to work in their QC? As in what kind of various industries are we talking about?

    1. Hi there,

      What is your degree in? I can tell you that I work with people who are hired as formulation scientist but whose degree was originally in biology, so it's not uncommon to make quite a shift from your degree subject – the real learning starts when you start work anyway! I suppose I had pharmaceuticals in mind when I wrote this article, as that's the industry I'm in. Any large pharmaceutical company will have graduate analyst positions – GSK, AstraZeneca, Pfizer. The drug development process goes from synthesis and screening of potential drig candidates, through formulation (deciding how the drug will be delivered to the appropriate part of the body, e.g. as a controlled release tablet or a subcutaneous injection, for example) to clinical trials and eventually market launch. There are life scientists working at every stage of this process. As well as the pharma industry there's the growing biotechnology sector and many contract testing organisations. Whatever your job title, if it's lab based, you will definitely be implementing QC and possibly working to GMP standards. Hope this helps! I'd check out the big organisations' careers sections for an overview of the types of positions available.

  2. Avatar of tvrulezall tvrulezall says:

    Hi Vicki,

    Mine is a degree in Biological Sciences. We studied subjects like molecular biology, cell biology, biochemistry and genetics etc. I would say that this degree prepares graduates more for a career in research and therefore, without any knowledge in the quality assurance and control field, i thought that chances of entering the field might be slim. But i guess you are correct that the real learning only starts when i start work. And i have never thought that biology graduates can become formulation scientists! Thanks for the information once again!

    1. A very late reply… but just to let you know that an ex-colleague of mine working as a formulation scientist had a microbiology degree!

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