Governance, Risk and Compliance Blog

Good Distribution Practice (GDP) – How enlisting a consultant can ensure compliance

Posted by Marc Gardner on Thu, Aug 17, 2017

EU guidelines revised in 2013 set out best-practice methods for how medicines and other pharmaceutical products should be stored, transported and handled. These Good Distribution Practice (GDP) guidelines have gained real traction, and the regulator, MHRA, is putting more and more pressure on businesses to ensure they're compliant.

Qualsys recently partnered with long-standing GDP consultants PJH Logistics Solutions. PJH have years of expertise in helping a wide range of businesses – from global pharmaceutical giants to regional transport firms – to understand and adapt to GDP.

We spoke to Pelleren Hodges, PJH's owner and director, about the benefits of enlisting a consultant, and why any company required to meet GDP should consider doing so.

Vast knowledge of what GDP involves

GDP is no different to many other quality standards and guidelines in that it's complex to interpret and often difficult to implement. It might be new to you, but a GDP consultant has been down that road many times before.

"Most of what we do revolves around GDP, particularly in relation to the pharmaceutical business," Pelleren says. "Part of it is sub-contracting for other consultancy firms, and the other part is direct work with our own clients. 

"It could be a project to get a company up and running in applying for a Wholesale Distribution Authorisation (WDA). It could be a pre-inspection audit or a customer inspection. We might act as Responsible Persons for WDA licences, or set up quality management systems. Our work is extensive."

Experience of implementing quality management systems (QMS)

Complying with GDP means taking a consistent, organised, systematic approach. There's no better way to do this than by implementing a QMS throughout your business. A GDP consultant will know how that implementation process should unfold, and consider questions like:

  • What kind of product do you provide?
  • Do you store the product yourself or do you outsource it to someone else?
  • Are your suppliers complying with what you want them to do?
  • What are your premises like? What equipment do you use?

"Gathering this kind of information means we can start to form the structure of what the QMS will look like," Pelleren says. "We can then draft the documentation, fine-tune it and get it approved by the necessary people within the company. Then we can provide general and more detailed procedural GDP training with all the staff who are going to be involved in GDP activity."

Understanding of how quality management software can help

Quality management can be made simpler and much more effective with the use of software. A GDP consultant will understand the part software can play in strengthening an organisation's QMS.

"Software is crucial, particularly when it comes to maintaining an audit trail, for example," says Pelleren. "It makes the task so difficult when you have bits of paper flying around, some of it's lost and it's impossible to track.

"We work with a lot of smaller companies, some of which don't employ a quality assurance person. They might assign that responsibility to two or three different people, which can cause difficulties in terms of who's doing what, when and how. So a software package such as EQMS gives us the tools to manage that."

Experience of dealing with all levels of staff and getting leadership buy-in

Complying with any sort of regulation or standard, implementing a quality management system – these can be initially disruptive to a business that's traditionally operated with a very fixed mindset. Changing a company culture can unsettle and attract resistance from employees at all levels. A GDP consultant will be familiar with this and have the skills to persuade people to buy in to the new ways of working.

"Some companies do see getting a WDA as a tick-box exercise, and once they have it, that's it," Pelleren says. "It could be that the senior managers have been told they have to do it, and even then it's only lip service. For us, it's about understanding that and tackling it.

"We'll look to provide the right metrics so that the very top manager in the business knows they're responsible for ensuring the managers below them hit their targets. They're the targets that MHRA will be looking for in their inspections.

"Other companies are more willing but pharmaceuticals might not be their core activity. So in those cases, we need to account for the staff not having that familiarity with GDP and getting that continual experience of handling it."

 

Are you a consultancy firm?

Michael Ord, New Business and Marketing Director, says: "Here at Qualsys we work to a set of core values centred around the idea of making other businesses fitter, faster and stronger. When we form partnerships we always look for organisations who share those values.

"It was clear right away that PJH Logistics Solutions believe in the same ideas, and then some, and we're delighted to partner with them to benefit both our customers and theirs."

If you're a consultancy firm, request more information about our partnership programme here:

 

Tags: Partnerships

Developing your Quality Management Software Strategy: Sodexo Shares Success Story at AIIM 2017

Posted by Emily Hill on Thu, Jun 29, 2017

The Association for Information and Image Management (AIIM) recently hosted a forum and invited Sodexo to present a talk on their experiences with implementing their enterprise quality management system, EQMS.  

Rob Gibson is IT Systems Manager at Sodexo. Watch the video below to learn more about his journey. The full transcript of Rob's presentation follows the video.

 

 

Transcript

About this presentation

This presentation is about driving engagement. It's a story about software I've been rolling out on numerous sites for lots of different customers over the past four years. 

I hope you can use some of my lessons learned and apply them to your own line of work or if you're implementing an electronic quality management system.

About Sodexo

Sodexo are a world leader in the provision of services that enhance the quality of life. We are the 19th biggest employer in the world. We manage other businesses' operations and services such as restaurants, hospitals, schools, prisons, offshore energy platforms, defence and leisure. Right now, we're serving fine dining and champagne at Royal Ascot.

Operating on client premises, Sodexo often employ staff who used to work for the client. They outsource the contract to us and this means that employees often transfer in from the client's organisation. 

This often means there are different ways of working. There's a blend of how the Sodexo mothership wants things to be done and how the client expects things to be done. There are often inconsistencies which need to be accommodated.

How Qualsys fits in at Sodexo

Qualsys provide software called EQMS which we procured a few years ago now. Qualsys was established over 20 years ago and has its headquarters in Sheffield. Qualsys provide a mature, integrated electronic quality management system with lots of rich functionality for managing documents, training records, audits.

EQMS helps us to automate a lot of the processes we have challenges with out in the business – for example, audits and inspection checklists where you need to go and check that a room or laboratory has been maintained to the correct specification. We also have to keep things recorded and provide evidence. The modules that EQMS provides help us to evidence compliance.

How Sodexo uses EQMS

Sodexo has many pharmaceutical clients. Some are blue-chip, household brands who produce the medicines we're all familiar with. As you'd expect, these organisations need to work to rigorous international standards. If you're making medicines and vaccines, you have to hold records in case there are any product recalls or evidence of contamination. As our customers need to do this, we do this as well. We have to keep records, training records, follow procedures, demonstrate standard operating procedures and our methods. There are all sorts of documents we need to have and we need to make sure they're in a safe place. This creates quite a records challenge.

EQMS reduces the cost of compliance and makes the records challenge manageable. 

The challenges with implementing enterprise software 

I've deployed a number of systems over the years. There have been different contexts, different customers. And I've come across different challenges to make the software 'sticky' – to make the software part of the daily activity. You want to software to be useful, established and efficient. 

Here are the four main challenges I've come across: 

1.  Not invented here syndrome

If someone from headquarters comes in and says "I know your job and this is how you're going to do it," there'll be a lot of resistance because they don't know their job and they don't do it in that way. So, we have to listen to our customers and employees and make sure we articulate what it is they need and how we can help them. 

2.  Time pressures

Everyone's under time pressures. Rolling out this scale of system takes time because it has to be a transition. If you say they need to take an afternoon to do training or attend a workshop, the answer is probably going to be no.

3.  Ownership of the current solution 

You've probably all come across this – someone has created a colour-coded spreadsheet with hundreds of formulas, and they're really proud of it because it does exactly what they need, they know how to use it and it works for them. You have to go in and introduce a better and more efficient way of working. 

4.  Deployment project ends 

The project management lifecycle lets us down from time to time. This is when you get a really good system, which has been really well deployed but then the project draws to a close and the person managing it disappears. What happens then is that there is data 'ROT': redundant, outdated and trivial data, which is put into the system. You end up with outdated information and the system becomes polluted.

Enterprise software needs to be fed and maintained.

Is this important? Will it impact your business? 

There are many opportunities with systems such as EQMS. If we can get systems into the organisations that are really going to help users and team members do their job better and provide a better service for our customers, they'll feel happier and more engaged. If we can get the company culture right, we can get systems into the business that will drive engagement. It's worth getting it right. 

However, 57% of IT projects deliver less value than forecast. Harvard Business Review research puts it down to processes being incorrect, costs difficult to quantify and the benefits not accurately articulated. 

When implementing a new system, you need to consider the risks and the opportunities. For example, there's a risk that if you put bad data into the system, you're in a bad place before you have even started. You need to put good data into the system. 

The quality and compliance challenge at Sodexo

Sodexo needs to comply with lots of international standards and regulations. The international bodies, such as the MHRA and the FDA, come into these organisations and check that the product has been made to specification. The challenge for us is balancing our processes with our clients expectations to satisfy regulators.

We have our operating processes, and we have a library of documents such as:

  • Core processes
  • Guidelines 
  • Local and contractual requirements
  • Opportunities for their own 

Our end-users and our customers need to feel like this system belongs to them. It's not being imposed on them. The framework for implementing software requires organisations to get their key personnel and superusers involved from the beginning. It's a very difficult balance to maintain and there are always different things to do. One of the best ways to get people involved and sharing information is to look at what works really well. Then replicating this in other areas of the business. 

Advice for a successful journey

1.  Demonstrate value for users

EQMS fits all of our compliance information management requirements. It helps to manage processes and documents, ensures people have a safe place to keep all their records, and helps us complete all of our audits. 

We use iPads with iEQMS to complete audits and inspections. They're much more efficient as we can enter the data, take photos, and notify relevant people instantly if there's a health and safety incident. 

If someone's saying that it doesn't work or it isn't doing what they want it to, you need to work with them to take a step back and demonstrate the overall bigger picture. 

One thing I'd highly recommend is having a formal health check. This involves talking to people, surveys and analytics of the system. Our software vendor, Qualsys, came in and did this for us as they were able to be agnostic. There was a lot of useful feedback from the health check; it helped us establish objectives and recognise opportunities. We'd like to get Qualsys to do the health check again in a year. 

2.  Sharing success stories

We had a milestone a few weeks ago where one of the sites was celebrating their 10,000th training record uploaded onto EQMS. That's 20,000 pieces of paper not printed off, not filed, and not in a silo somewhere. That made their onsite newsletter and their noticeboard. 

3.  Keeping the good news flowing 

One of our team has to go out on site and do lots of very detailed audits using the iEQMS Auditor application. Then he has to write a formal report about the findings. It used to take three days. Now it's automatically produced the same day. That's a really powerful story. 

4.  Competitions between teams

Comparing the performance of teams has been really useful. I once worked for a car manufacturer and we got the night shift team to compete against the day shift to encourage some competition.

5.  Training 

If you don't get training right, it can be a killer. Sometimes, just five minutes' awareness training can help, sometimes it needs an hour. Getting to the why. 

6.  Use the vendor

We couldn't have got to where we are today without the support from Qualsys. Qualsys has other customers who've been through the same situation and they've held our hand all the way. We have regular meetings with Qualsys. 

7.  Having management support 

Leadership is more important than ever. You need to demonstrate that leadership are on board. 

 

8.  Not a one-size-fits-all approach

Another issue is ignoring project warning signs. Do you have a team of people and a process for enabling your people to say if there's something wrong? I don't need to remind you of the Challenger space shuttle explosion. 

When you find someone who's nervous about the battlefield, go and talk to him or her and find out why, as it's not a "one-size-fits-all" approach. 

We've had some fast wins, slow wins and failures. 

Fast wins

Document control was the low-hanging fruit for us. EQMS Document Manager provides us with a safe place to control and manage documentation. It has customisable permissions, finds out when it needs to be reviewed and see who needs to approve the document in the workflow. 

Training records was a hidden requirement. It wasn't critical to start off with, but as we went through we realised how many spreadsheets were being used and the amount of time it was taking to update the spreadsheets; it became a much bigger project. EQMS enabled us to kill all of these redundant spreadsheets. 

Slow wins

The iEQMS Auditor application took us several attempts to get it right. We needed some additional training to ensure we were doing everything in the most efficient way and staying compliant. For some sites, internal auditing was a completely new process. They knew it was something that would be useful, but they hadn't done it before. Through EQMS, we can introduce regular internal audits. 

Failures

We did find there was sometimes local resistance, and this meant that we haven't succeeded yet. Sometimes, there are business restructures or employees leave.

Looking ahead 

EQMS is a proven solution in Sodexo. We're now looking for ways to expand our operations globally, optimise existing system, and roll out more EQMS modules such as EQMS Risk Manager. 

 

ISO 9001:2015 Toolkit

 

Tags: Implementing EQMS, Partnerships

Blackmores Discusses New Partnership with Qualsys

Posted by Emily Hill on Wed, Jun 28, 2017

Qualsys Ltd is delighted to partner with quality, sustainability and risk management consultancy service provider Blackmores. 

Blackmores

Melanie Blackmore, Founder and Managing Director of Blackmores, shared what the partnership means for the two companies and how their customers will benefit.

Can you tell me a bit about Blackmores?

I founded Blackmores UK in 2006 after recognising a requirement for a quality, environment and risk management consultancy which had expertise in industry-specific standards, as well as the well-known ISO 9001 and ISO 14001. 

We now have 10 consultants in the UK and 13 consultants based in EMEA who have expertise in a range of industries, from aerospace to public sector, data centres to construction.

We have a large portfolio of customers across the globe, including the NHS, Morgan Sindall and Lloyds, providing both specialist project consultancy and ongoing support. 

 

Blackmores' client portfolio

[Blackmores' client portfolio] 

Why did you partner with Qualsys? 

We've looked at other business management software vendors in the past, but none were ever fit for purpose. We recently came across EQMS by Qualsys and we're confident that it has the functionality and easy-to-use interface that will add value for our customers. 

EQMS KPI Dashboard

[EQMS KPI Dashboard]

How will your customers benefit?

When we're working with our customers, if we recognise a requirement for a centralised management software system we may recommend EQMS by Qualsys.

Blackmores will also provide Qualsys with insights into product development to meet regulatory and quality requirements. For example, with the European Union's new General Data Protection Regulation, we can provide Qualsys with insights into how to make EQMS compliant to meet the Private Impact Assessment requirements. 

 EU GDPR

 

How does Blackmores keep in touch with changing quality demands? 

Blackmores are heavily involved with the Chartered Quality Institute, the CQI. This week, we're running an event from the Chiltern branch on how quality professionals should embrace social customers. You can sign up for the event here: https://www.eventbrite.com/e/embracing-your-social-customers-tickets-35368899330?aff=WebsiteCommunityEventListing.

 

Are you a consultancy firm?

Michael Ord, New Business and Marketing Director at Qualsys, says: "EQMS is proven to make organisations more resilient, efficient and profitable. We partner with organisations who have the same values – to make businesses fitter, faster and stronger. We're delighted to partner with Blackmores to provide value-added services for our customers and theirs." 

If you're a consultancy firm, request more information about our partnership programme here:

 

Request more information about EQMS Partnership programmes:

 

Tags: Partnerships