“Key Strategies for Enhancing GMP Compliance”- 12 Top Tips for Leaders and Qualified Persons
Article By Philip Rose, Independent Consultant for EPiC
Whether you work for a gold-standard site or one that needs to improve its GMP compliance, at some point, you will need to influence people to move compliance in the right direction. You may have joined a new company that is not where you would like it to be, identified risk areas with your site, or had adverse inspection findings.
I’ve been to several hundred sites around the World and have seen those QPs and leaders who stand out and inspire; they are commonly at sites that have good compliance or are moving in the right direction, which isn’t a coincidence. So, what makes those leaders so influential?
Here are my top tips for influencing compliance at your site:
1. Lead by example
This is by your actions, your behaviours and your attitude. Model the behaviour you want to see in others by doing it yourself. As a QP, don’t be the QP who approves everything because it’s easier. If you want to see good standards at your site, demonstrate them and maintain them personally.
When I’ve seen leaders I’ve looked up to and aspired to be like, this is the trait I’ve respected the most. It sets the standards but is also highly motivating for a workforce. Particularly for sites that have had issues. If they see a leader who is doing the right thing, upholding the standards of the site, and buying into the site, this will bring others with them.
With this trait, make sure the promises you make you follow through with, even the small ones. If you don’t, it is a lot quicker to lose respect than to get it back.
2. Be seen
You can’t hope to influence people and compliance if you aren’t there. Traditional QPs and leaders were chained to their desks and thought by the companies to be batch releasers. Modern QPs aren’t like this, and modern companies know how much more value a QP can bring if they aren’t just at their desks.
Leave your desk, or better still, move your desk to the factory. Be known in the factory, QC laboratories, warehouses and engineering departments.
This is visible leadership and demonstrates that you are present, engaged and actively involved with your teams and the site. It also shows you are interested and available.
If people know you, and that you are there, there’s a lot more chance that you can influence things which are going on.
With remote ways of working, this is more difficult, but it is critical if you want to be a great QP or leader.
3. Keep up to date
There have been more changes to legislation and guidance over the last few years than I can previously remember, particularly as we exited the EU with things like the Windsor Framework and with updates such as the revision to Eudralex, Volume 4, Annex 1. It makes sense that if you want to know your and your site’s responsibilities that you need to keep up to date with these updates. Use the resources available to you, such as conferences, forums and notifications services. Use your peers, network and join interest groups.
4. Know your processes
Make sure that you know your systems: your quality systems, production systems and your products. Know your dosage forms and your product portfolio. Importantly, know the risk points for these. Know where these risks exist for your products and processes.
Along with this, know your licenses and importantly that, what you are doing is operating within them.
Also, and importantly, know what is going on at your site and within your company. Know what is going well and what isn’t working so well. Know where you are understaffed or where there is inexperience in the team and link that back to the risk points.
With this knowledge you will be in a safer place. You will know your risks and be able to start tackling them. You will also be valued and be able to mentor your team and influence your company to where the risks exist.
5. Be curious
As QPs or leaders we often think we are meant to know everything. Don’t ever assume this is the case and keep that curiosity going. Those people that do think they know everything rarely do and are often quite dangerous as a result.
Ask lots of questions and keep learning. I know that I am constantly learning every time I go to a site. In order to influence compliance, we need to keep this curiosity and learning going, it’s how we find new ways of doing things. Those new ways may be different but also may be easier and potentially more compliant than the ways we may have today.
6. Listen
Listen to your team, your peers and your management team. You are doing this to understand their concerns and also their motivations. When doing this, put yourself in their shoes, even if what they are telling you doesn’t seem important to you, it is important to them, so make time to listen. By doing this, you will gain their respect, and that will allow you more opportunity to influence.
Importantly, it will also allow you to understand more and more of what is going on with the company. It allows you to understand more of the risks and challenges that you might not have identified otherwise.
Make sure you make time to listen to your team and that you do actually listen. Be present; leave your computer and phone behind.
7. Mentor, develop and encourage your team
As a QP or leader, you have a lot of knowledge and experience. If you can impart some of this to your team, they will grow and benefit. Not only will they grow and look up to you, but they will also be able to help you by taking some of the burden but also by influencing the wider company.
If the team and the company understand the “why” they will often be more compliant. This is always a much more effective approach than just telling them how to do something without any understanding behind it.
If you develop, mentor and build your team they will listen, respect you and help you with compliance along the way. You will almost certainly learn things from them along the way too.
8. Ensure your pharmaceutical quality system (PQS) is functional (and being used)
If the PQS isn’t being used then you can’t be compliant. As Michelle Yeomans has detailed in a previous “Top Tip” session, the MHRA commonly have given significant observations around failing quality systems and sometimes at the “critical” category.
So how can we do this?
Performing internal audits or self-inspections of the systems to review them and how compliant they are, is a good starting point. This is a regulatory requirement so should already be part of your processes.
Also, walk the areas (or better as mentioned above, you’ve already moved your desk to production). With these walks look at: are the systems being used and does this reflect what you are seeing? Are there deviations that aren’t being raised? Have changes occurred that you can see which haven’t gone through the change control system?
Another approach is to review the metrics you have. What do the figures look like and does it show that the systems are working, adequately resourced and when they aren’t, are they given the priority they need? With metrics it is often necessary to go one step further. How are the metrics designed and are they capable of showing us when things aren’t working, or are they themselves actually influencing the compliance – in the wrong way? This isn’t a new concept, the idea of metrics driving culture and compliance has been around since before I started in the industry, but at a lot of sites we haven’t moved very far with the concept. There are sites where they still have targets on the maximum number of deviations raised per month. What usually happens in this case is that, that number will be raised and no more. The other issues still may be happening but just aren’t put through the system. I much prefer trends being used as metrics rather than absolute figures. This way we can see which direction things are going in. Feel free to reach out to us if you would like a more in-depth review of your metrics.
Review your metrics and change them if you need to. You want a system which shows you how well your facility is operating in a useful way so that you can do something with it.
9. Get Involved
You are not going to be able to influence compliance unless you become part of the management team. Make sure you are part of the management review meetings and not just on a distribution list. Make sure that you have a voice in the forums within the company and that you are heard.
As an attendee at the meetings, you can make sure the meetings are useful and relevant. You can make sure that the focus is on those things which are important and where influence for compliance is needed.
10. Know when to ask for help
We all need help sometimes and knowing when you can’t do it on your own is vital. Sometimes the task is too big to do it on your own or you just need a second opinion. Sometimes you might even be completely stuck so rather than just leaving it, reach out and ask for help.
I have been contacted by people I’ve worked with at sites where they have significant issues, we can usually find a way to solve the problems or at least start to tackle them.
I often have to ask for help or second opinions on things. I will often reach out to other members of the EPiC team to ask for a second opinion or if I don’t know the answer to something. It goes back to the part about constantly learning. None of us knows everything and so knowing when we don’t know is very important.
Understand your strengths and weaknesses and don’t be worried about saying “I don’t know”.
Have a support network. This is very important and particularly when we are remote or travelling a lot. Have people both inside work and outside work who you can bounce things off. Nobody knows everything or can do all jobs on their own, and we all need support sometimes.
11. Be prepared to say “no”
Although saying yes to everything is easy and largely stops conflict or challenge, it’s definitely not always in the interest of the patient – or the company. Sometimes as both QPs and leaders we need to be prepared to say no or stop.
To influence compliance sometimes we need to make those difficult decisions and saying no, can be part of that. However, it is often a last resort and shouldn’t be the only way we look to influence.
12. Finally – do the right thing
The final advice I would give to anyone in a leadership position is to do the right thing. Sometimes it can seem very lonely when we do this and I personally have had some sleepless nights as a result, questioning, “am I actually right?” and “why am I the only person thinking this?” Down the line though, you will remember why you did it and will know it was the right thing to do.
Additionally, you will also be influencing people, both those more senior and those more junior than yourself. People will look up to you and respect you when you show courage and make difficult decisions.
Remember, wrong is wrong, even if everyone else is doing it.
To summarise, being a QP or leader is a great role and a privilege to be given those opportunities in companies involved with pharmaceuticals. But both come with a lot of responsibility, both legally to the patients, as well as to the company and those people looking to you for leadership.
It can often be difficult and lonely, but if done correctly, with passion and the right attitude, it has a real opportunity to influence people and the company’s compliance.
Get in touch if you need further support with GMP compliance.
Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com