Back in the saddle
Apologies all for the extended absence from posting here. Time for a more personal than usual update.
To make excuses the last couple of months have been very hectic and the site had to take a back seat.
Unexpectedly I picked up a liver infection last year and had to have my gall bladder removed in a hurry earlier this year. Expect a post on the excellence of QA and double checks within the NHS at some point. I have been very fortunate.
I have recently moved jobs. I am taking up a new position as Head of Quality and QP in a different business next week. I am really excited to get stuck in an develop my experience in a new area. More details to follow
The most significant life update is that I have had the life changing arrival of our son into the house and well, its hard to think of scenarios when you have chronic sleep loss. I focussed on the day job for a bit! This is something I do exclusively apart from my day job and I didn’t have as much time in the evenings.
Finally, with the move to my new role I am linking the site to my personal LinkedIn account. While I am not, and nver had hid from anything I write on the page I have always wanted the content to “stand alone” (like every good GMP document) and not have its value tied to my personal experience but ultimately to gradually improve the content and links the site can use this is for the best.
I have a couple of scenario questions and training notes to share over the next few weeks and will hopefully be settling down to a more consistent posting pace.
Thanks for your continued support
Mark
QA - A Doctrine?
If there is one thing the pharmaceutical industry is not short of it is paper. Literal mountains of guidance exist covering thousands of topics with millions of words. But do we need more? Despite the guidance available non compliance is a persistent issue.
I have been reflecting on how people I admire in the industry do have a set of core values they embody on a daily basis. And it extends to a level of understanding that is both more in depth and more applied than core QRM principle where the management of risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient. At the same time it could be more succinctly expressed than all the regulations and all the guidance already published. Ask anyone to read the orange guide cover to cover to see the definition of a chore.
Do we need a further compass? A succinct guiding philosophy and set of principles of Quality Assurance (QA) that exists not as a mandatory regulatory compliance activity but as an ethical obligation and a strategic imperative.
I occasionally get left contemplating that something could exist at an intermediate level. A shared way of working that is both easily accessible for everyone engaged in pharmaceutical manufacture and a useful set of guiding principles. Something that would defining and emphasizing the purpose of QA and how it shapes everything we do and must do to operate in this space.
Working from Trainee to Qualified Person
One reader, early in their trainee QP journey, reached out to ask what activities they could do to help build out their application.
I would respectfully suggest this is the wrong question. The goal of your period as a trainee is to make you a QP at the end – the process of gaining QP status is in effect a secondary outcome. You need to be able to be the QP from the moment you finish that application – because that is you saying, “I’m ready.”
If you get involved in the right activities- you will gain the experience you need - then you need to write it down.
So how do you start to do things that turn you into the QP you want to be? Here are a few potential things to get stuck into to try and flesh out your experience. All of these should be discussed with your sponsor and/or your line manager.
1) Go where the system needs fixing.
I have yet to find any company or person that says their operation is without flaw. Every single site with a manufacturing licence will have issues that need fixed. Potential work will be generated either by change imposed from outside (See the recent Annex 1 revision for a work generation activity) or by a desire for continuous improvement. Rarely does the QMS and the processes it supports sit still.
So, find where change needs to be done and do it yourself. I don’t mean review and approve changes alone but get hands on with changing your QMS or even a production or QC process itself.
It’s far more educational to try and change the system than merely watch it change and nod along.
As an example – how would you implement a change to increase a batch lot by 100%? How would you make one of your production processes continuous? How would you improve your raw material receipt system? It will take work but its invaluable learning.
2) Build an expertise in part of your business.
You should understand that you need to stand out and be known as a source of reference for at least one area – be it stability review, HPLC analysis, environmental monitoring or production of a particular API etc.
If you're just another heifer in the herd of quality people, nobody's going to notice you and, more importantly no one will come to you with problems. QPs get hit with problems/issues/please help fix this constantly, so you need to get familiar with the feeling. It will also involve you in cross functional problems or projects that will build out your documentable experience.
3) Review and Propose
It takes a village of people to run a manufacturing site, big or small. No one can run a site with an MIA single handed. This leads to very well-trodden roles within the industry and a standard pattern of work. One of these you will be familiar with is QA approval of everything. Trend reports, process performance reports, maintenance reports, OOS/OOT and validation documentation. Please read, nod and sign here….
Its important to not just review and correct, take the review process and use it to understand the system and then propose how things could be improved. A major soft skill you will need is influencing people to make positive change and using review processes to help you start these conversations is a good way to gain some momentum.
4) Dry run a certification.
Take a batch that your sponsor QP has certified and (with giving them a heads up beforehand) see if you could comply with all the legal duties within Annex 16 without delegating these to anyone else such as a batch review team – could you lay your hand on every piece of information you need to satisfy yourself the batch is compliant to the requirements. DO it for a product you know and move on to products unfamiliar to you.
Each of these suggestions has the added benefit of helping you build up strong connections with the network of people who operate at your site. It also has the benefit of making you familiar with parts of the business you may not have been exposed to before and build some of the soft skills you will rely on.
These are only a couple of things to try. Make use of your sponsor when proposing what to get stuck into.
Change vs Consistency
The tension between maintaining consistency and enabling change within Quality Assurance (QA) is a complex interplay and is the essence of what a Pharmaceutical Quality System should manage.
On the one hand, consistency is foundational to pharmaceutical clinical development and commercial delivery.
Your drug is safe and will work because it is fundamentally the same drug as what passed through a clinical trials program. Consistency ensures that products or services reliably meet clinical and patient expectations. Therefore, unwavering consistency is fundamental to trust among consumers or end-users, as they know what to expect every time. A mentor introduced GMP to me as "Say what you are going to do, write it down, and do it again, and again and again".
On the contrary, change allows for adopting better technologies, processes, or methodologies. It's the path to innovation and continuous improvement and organisations must change to remain competitive. More importantly from an assurance perspective change will be forced upon us. Both well-intentioned and quality "enhancing" change such as new regulations, and technologies, along with unwanted change from deviations, defective inputs, and bankrupt suppliers. Machine parts will wear and brain cells will forget instructions.
To navigate the change / consitency tension, there are only a few principles that I have found any consistency in always helping:
Simplify:
The fewer moving parts in any system, the fewer things that can change and the fewer things that will interact with the change, causing a propagation of further change, wanted or not. Relentlessly pairing down on system bloat is a necessary obsession.
Phased Implementation: Introducing changes in phases, allowing for gradual adaptation and feedback loops to form before you commit fully.
Stakeholder Engagement: Involving all stakeholders in the change process, addressing their concerns, using their experience for a smoother transition and understanding where and how the "rubber meets the road".
These will never be included as regulatory advice but remain essential principles to navigate what we do in Quality Assurance.
Choosing curiosity
Your approach as a trainee QP will always be shaped by the business structure you sit within. Which will dictate how far you sit from the front lines.
Personally I think as a trainee you need to find and jump headlong into the “thick of it” where QA meets the operational realities of a business, to learn what will work and what won’t.
This in turn is based on a personal belief that the greatest source of learning you have access to is using your own lived experience of your processes, problems and quality systems to learn the broader underlying foundation and additional knowledge you need to have.
This both gives you a structure to hang your learning on but also encourages you to prepare to certify your site by learning the business “top to bottom”.
It sets a bar that is often daunting - but you need to know the processes you quality assure as well as the majority of people executing them on the front line.
While that sounds almost ridiculous when taken as an isolated statement - the truth is if you want to be known as a QP you are trying be a person that is both legally and institutionally viewed as someone who understands both the foundations and the intricacies of this pharmaceutical lark better than most.
If you don’t understand the operational reality of the processes you are taking responsibility for you don’t understand how easy or hard they are to comply with and you will not understand the potential for non compliance that will undermine your quality system.
Approaching with curiosity, daily, and being open to discovering issues within pharmaceutical quality assurance allows us, as QA professionals, to uncover the underlying issues individuals are addressing, encouraging transparent communication to quality rather than defensiveness.
Consistently employing this approach enables you to cultivate a reputation as a problem solver within the quality assurance unit as opposed to a compliance dictator. While it will at times cause you to ask “why me?” a queue of individuals seeking advice at your door will be a sign of development as your expertise becomes sought after.
This positions you advantageously. Team members actively seek your input to prevent risky process adaptations (proactive risk management). Simultaneously, you maintain a broader perspective on change management in practice, even those beyond your immediate influence.
Therefore at the point you qualify and have to rely on the PQS and the people within it - the organisational relationships exist to let you certify.
It will also shape your reactive risk management. Your disposition decisions and deviation risk assessments will be driven by the risks identified on the operational front lines and the potential worst-case outcomes if these risks were realised.
It’s not an approach that I am always able to follow. It’s hard to constantly be open minded to every issue that’s thrown your way but it is an approach that helped me learn the ropes.
So the core of this blog post is, read less blogs, fix more problems.
Approach and Comments
So thanks to everyone for the support in the first week. It’s stunning to see how many views and likes some of the posts have received. A few people have been nice enough to reach out and offer thanks which is very humbling.
I want to highlight a few caveats I need to make clear.
The posts are not very academically rigorous. I have written papers in the past and its a really great way to stop any urge to write at all.
Partly they exist for me to improve my own practise, you will learn more by trying to teach the essence of a topic than reading it yourself, in my own experience.
They are not intended to be the last word (or even a middle word) on a topic, but I feel I have a pragmatic approach that is logic based and quality risk minded.
They reflect how I approach a problem. There are several ways to tackle any problem. They key is you find one that is functional for you.
If anyone really has an issue with the content they are free to highlight it. I present my words in good faith.
I want to make clear that I don’t really have a grand goal in mind. Daily I even question why put this content out. It’s just a will to try and make something more enduring than the next QMS record. I am not currently planning to do any discussion sessions with trainees or groups - I am trying to divert my limited non-work time into fleshing out the content on the site.
If anyone really has an issue with the content they are free to highlight it. I present my words in good faith.
I have learned how to turn comments on - but only for the blog posts yet.
Step out in the unknown
While this isn’t my first website, its the first that relates to my profession. I wrestled with the idea of the website for quite some time. A lot of the content will have some reflection on my own risk appetite, areas of interest and my own approach to the role of QP. So take it all, as with all information, with a pinch of salt.
I’m giving it a year. If you come alone for the ride I am trying to give you two to three posts a week with the intention of helping people train for their QP viva in the UK.