Governance, Risk and Compliance Blog

Emily Hill

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Pharmaceutical Development Company Nanopharm Opt for EQMS by Qualsys

Posted by Emily Hill on Thu, Aug 03, 2017

Qualsys are delighted to welcome pharmaceutical development company Nanopharm as a new EQMS customer. Nanopharm will be implementing a full suite of EQMS modules to support scalable quality and compliance management systems. 

Nanopharm are the leading provider of tailored analytical and product development of orally inhaled and nasal drug products (OINDPS). They'll be using EQMS to manage all their documentation, audits, corrective and preventive actions.

Susanne Durie, Head of Quality at Nanopharm, said the team are excited to see how the system will grow within their organisation. "We’re looking forward to exploring the software and finding out how we can make the most of it." 

EQMS by Qualsys is the preferred solution for many pharmaceutical development companies, as the software helps connect data, processes, business systems, assets and people in a central, unified solution. The system helps organisations to meet standards such as ISO 17025, ISO 13485 and ISO 14971, and robust controls required for MHRA and FDA.

Welcome cake sent to Nanopharm


Alex Swan, New Business Manager at Qualsys, has seen many lifescience and medical device manufacturers discover more hidden value in EQMS during the implementation process.

"The Qualsys implementation team take a best-practice approach to implementing EQMS," Alex said. "This is the best opportunity most quality professionals get to take a deep look at their processes and, with our help, make them more streamlined, efficient and compliant.

"After the implementation process, not only do our customers see considerable cost savings, they find their organisations are more agile and faster to adapt to change. We help other businesses to become fitter, faster and stronger.

EQMS KPI Dashboard

For more information about using EQMS for pharmaceutical, medical device and lifescience quality management systems, download our customer case studies here. 

Download EQMS Case Study Booklet

Tags: FDA, ISO 13485, ISO 17025, MHRA

Synexus Launch Enterprise Document Management System

Posted by Emily Hill on Wed, Aug 02, 2017

Qualsys are delighted to announce that Synexus, the world's leading site management organisation, have recently launched EQMS Document Manager across their entire company. 

Synexus engage, recruit and manage patients for clinical trial research. The company have grown significantly both in the UK and abroad, and have been recognised by The Sunday Times HSBC International Track 200 as one of Britain's private companies with the fastest-growing international sales.  

As the company continued to grow, Synexus sought a solution which would enable all their employees to access controlled information. After a competitive tendering process, they opted for EQMS by Qualsys

"Synexus have grown 400% in the past few years. Currently, all employees have a very high understanding of compliance and quality requirements. However, as we continue to grow to 5,000 employees by 2020, we needed a system which would give managers better visibility into issues and challenges."

EQMS workflows

Robert Oakley, Commercial Director at Qualsys and account manager for Synexus, said: "We're really excited about our partnership with Synexus. Our Customer Success Team have been working closely with Synexus to train, implement and engage their employees with EQMS. So far, it's been a huge success with almost all employees logging into the system over the past few weeks."

To drive engagement with EQMS, Synexus asked their employees to choose a name for EQMS.
EQMS has been rebranded to eQual.

 

Is your organisation growing? 

For more information about implementing EQMS in your company, arrange a discovery call with one of our experts. They'll ask you a series of exploratory questions to see if EQMS might be a good fit for you. 
 
Request your EQMS Software demonstration
 
 

Tags: Document Manager, New Customers

Global Compliance Management System: How BT Global Services use EQMS

Posted by Emily Hill on Fri, Jul 21, 2017

BT Global Services, who have used EQMS since 2001, considers Qualsys one of their strategic partners. 

Robert Oakley, Commercial Director at Qualsys, has managed the BT Global Services account for the past 17 years. "BT came to us with the requirement to share documentation with their customers in a controlled way," Robert says. "Key to this was making sure customers and internal employees only saw information they had permission to see."

The first system was implemented in 2001. That quickly grew to eight systems, then 16. Within a year there were 64 different EQMS systems within BT. Each EQMS had a separate database, which meant BT could segregate each of the contracts to prevent any from being shared incorrectly.

BT_logo.svg.png


By 2005, BT Global Services's procurement team were envisaging a future in which the system would expand much more widely across the business. They approached Qualsys for a strategic solution, and Qualsys put together a contract to enable BT to procure batches of 25 systems at a time. Now, in 2017, BT has over 500 systems.

EQMS at BT Global Services 

  • Over 16,000 users 
  • 6 audit management systems 
  • Microsoft Word, Excel and Powerpoint integrations 
  • 125 document management systems on BT Global Services Portal 
  • 6 training records systems 

Robert Oakley adds: "We see BT, like many of our customers, as a partner. We've shared ideas about how we provide solutions within BT, and the system has been propelled by BT over the years. They've had a big influence in driving EQMS forward over the years, and invested a lot to get EQMS to the high standard it's reached today."

"And that value has been passed on to our other customers. It's a true partnership, and our relationship goes from strength to strength. As we speak, a new EQMS system has been launched for a major European bank, and BT Contracting are managing the relationship there."

During the EQMS User Group, Carl Butler, Key Controls Manager at BT Global Services, spoke of how BT are using EQMS for compliance and how the system adds value to their business. Below, you can read the transcript of Carl's presentation. 

The 'cloud of clouds'

We made a strategic decision to silo our business into different divisions. BT Global Services looks after global customers.

My team of subject matter experts looks after heavily regulated pharmaceutical companies in North America. At the moment, the team is based in Canada and we look after both their document management and their training management.

One of our key drivers at the moment is the 'cloud of clouds'. While everyone knows what the cloud is, few organisations have the technology, human and financial resources to manage cloud-based information well. BT are great at this.

EQMS User group 2.jpg

[EQMS User Group]

EQMS has become embedded in BT Global Services 

Security is critical for us. We have the overarching administration system, EQMS, which determines who can administer and see certain documents. EQMS has become embedded in BT Global Services.

EQMS helps us to make sure our relationship with the customer is transparent and that we're sharing the right information at the right time. The customer always has access to their service level agreement, billing information and manuals.

There's always a record of activity, which is essential when managing heavily regulated contracts, such as global pharmaceuticals which are regulated by the FDA. As we're essentially an outsourced business service, the compliance burden falls on us, so EQMS helps demonstrate these compliance requirements.

[EQMS for document and policy control]

The EQMS team

BT Global Services have document control distribution. This is a subject matter expert who manages document control for many critical accounts. This subject matter expert is accountable for all document management. The subject matter expert controls who sees what, and whether a document should be seen by the customer or kept for internal use only. It's an incredibly important role.

We have a number of subject matter experts for whom this is their sole responsibility. We're now in the phase where we're developing the team, whereby the back office are the subject matter experts for the whole team.

My team are being retrained to be more consultancy-based. This means they'll spend more time with the customer, capturing client information and ensuring we deploy EQMS to the best of our ability. If our sales team need any consultancy, the subject matter expert will be able to provide value to the customer.

Great for careers

We're upskilling our team. This is great for their careers because if you've been doing document management or training management for several years using EQMS, the organisation can use your knowledge as a value-added service.

[EQMS Training Matrix]

The value of EQMS at BT

One of the things we've been discussing with Qualsys is what is the value of EQMS?

If you look at all of the industry sectors – banking, aerospace, gas, pharmaceuticals the unit I work for goes right across the organisation. We're growing rapidly and that means we have lots of new recruits. It's critical that behind all of that is EQMS. Without the automation of EQMS, we couldn't cope.

Before EQMS, it would have been spreadsheets. For BT, managing training records on a spreadsheet when there are hundreds and thousands of employees is impossible. To be a 'qualified person' such as a project manager, technician or Cisco computer expert in a heavily regulated organisation, you have to have a valid training course to work on the contract. With EQMS Training Records Manager, it makes it much faster to manage, retrieve and update training records. 

Everything is documented. So when we're audited by the FDA, or another regulator, we can quickly answer questions such as "What kind of network do you have?" and "Who looks after it?". EQMS gives our customers confidence that we're compliant.

Business case for EQMS Tool

Going forward

In the future, EQMS is only going to grow within BT Global Services. For example, we have a customer who wants to share the risk of the system. There is a lot of trust involved in that.

Value-added services

In all large organisations, stakeholder management is a minefield. With Qualsys, we're currently getting results by articulating the value of the system very well.

To give you an idea of the scale of the operation, Heinz, Mars, Barclays, Deutsche Bank, Microsoft and BMW are all using EQMS. Each of those systems is shared with BT. We can provide further value to our customers by encouraging them to use the system internally and up their supply chains. 

 

What you should do now 

If you need a business management system, EQMS is a proven solution not just for large global organisations, but for hundreds of medium-sized organisations. Start by requesting a call back below. One of our team will call you to learn a bit more about your objectives. We have a "fail-fast promise" – so if EQMS is not a good fit for you, we won't continue to contact you. 

Request a call back here:

 

Tags: Case Studies

ISO/DIS 19011:2017 Revision

Posted by Emily Hill on Fri, Jul 14, 2017

ISO 19011 is an International Standard which provides guidance on auditing management systems. It is applicable to all organisations that need to conduct internal or external MS audits or manage audit programmes.

In this webinar, Richard Green, Managing Director of quality, audit and risk consultancy Kingsford Consultancy Services Ltd, discusses the changes to ISO 19011. Richard is an established expert in all quality and auditing matters.

Richard is on the International Committee for ISO 19011, so he’s able to provide more insight than most into what the changes are and how to prepare for them.

Please find the video below or read the transcript: 

 

ISO 19011 covers: 

  1. the principles of auditing – ‘moral values which underpin the profession’ - integrity, fair presentation, due professional care, confidentiality, independence, evidence based approach.
  2. managing an audit programme – designing, implementing, monitoring and reviewing & improving the programme
  3. the conducting of management system audits (initiating the audit to final reporting and follow up)
  4. the evaluation of competence of individuals involved in the audit process, including the person managing the audit programme, auditor team leaders and individual auditors.

As a guidance standard it is not something an organisation can seek certification against. Despite this, it has been universally embraced as the definitive blueprint for MS assessment. 

 

Why review the standard? 

ISO 19011 was first introduced in 2002 as guidelines for quality and/or environmental systems auditing - at that time these were the only ISO management system standards available.

By 2011 we were starting to see an expansion beyond quality and environment, so there was consequently a need to make the standard more generic.

Since then we’ve seen the introduction of a new breed of management system standards based on annex SL. This means they share a common high level structure, identical core text and common terms and core definitions. Going forwards all new ISO MSS will be annex SL based, and existing MSS will become annex SL based when they are next revised.

ISO 19011 therefore needed to be updated to reflect both the structure and contents of these new MS standards.

 

Key anticipated changes to ISO 19011?

Most significantly, we see the introduction of a seventh audit principle. ‘Risk-based approach: an audit approach that considers risks and opportunities’.

old vs new requirements.png

This risk-based approach should substantively influence the planning, conducting and reporting of audits in order to ensure that audits are focused on matters that are significant for the auditee and for achieving the audit programme objectives. Indeed, the need to consider risks (and opportunities) is prevalent in all sections of the document, from design of the programme to determining who should be on the audit team, from conducting the audit itself through to drawing audit conclusions, through considering what is communicated at the closing meeting and what is ultimately contained in the audit report.

  1. Structurally there have been some changes. The order of the sub-clauses under 6.4 ‘conducting the audit activities’ has been amended. 
  2. The role ICT now plays in audit, not just in terms of where evidence is stored but also in terms of how it is being employed to facilitate the audit process. 
  3. An interesting addition in clause 6.4.7 is text recognising that in the new annex SL world (based on documented information and not documents and records) not all information can be verified 100%. This introduces the concept of Professional Judgement which an auditor now needs to employ to determine the extent to which they can rely on such information.
  4. The old annex A has been deleted. This contained sector specific examples of the knowledge and skills required to audit particular types of industry. This may be reintroduced however there is very much a difference of opinion over this one.
  5. The old annex B now becomes annex A. This has been substantively reworked. This provides specific guidance for auditors in key topics. The range of topics has now been expanded to include; methods of auditing, professional judgement, performance outcomes, verifying information, auditing risks and opportunities and life cycle plus some significant changes to existing clauses (statistical sampling, guidance on visiting the auditee’s location).
  6. In addition, auditors must understand the application of management system standards in the post annex SL world and the relationships and interactions between the components of a management system in the light of annex SL.
  7. Audit team leaders are now expected to possess the competence to discuss strategic issues with top management.
  8. Throughout, terminology has been revised to reflect that latest definitions (audit criteria, audit team, technical expert, audit scope, risk, management system have all be revised). Also, suppliers has been replaced with external providers, documents and records by documented information.
  9. There remains an ongoing discussion as to whether ‘audit plan’ should become audit planning output and ‘audit report’, audit reporting output but as the former are such commonly used terms it is unlikely they will be changed.

 

Any advice for internal auditors?

I don’t expect to see training providers offering any form of ISO 19011 transition training and I’m not expecting any of the professional bodies for auditing to be mandating this for their members either. That said, these changes are significant and I’d expect organisations operating in the MS audit arena to be providing details on these to their clients.

IRCA are currently considering whether some form of mandatory CPD is required for IRCA certified auditors, perhaps in the form of required reading, and also whether revisions are necessary to their auditor training course criteria. Going forwards expect to see future auditing courses based on ISO 19001:2018, just as existing courses are based on ISO 1901:2011.

I’d expect there to be a lot of reading material out there for those who are genuinely interested in this area.

If you are serious about your role as an internal auditor (or indeed an external auditor) then you’ll want to know about these changes and how they will affect you.

  1. Study the draft. It’s not too early to start looking at the contents. Whilst this is still work in progress the substantive content is unlikely to change that much. Take a look at what is being proposed, then take an objective look at yourself and ask ‘is there any self- development required?’ For most of us the answer will be ‘yes’.
  2. Comment on the draft. If you think the changes go too far or don’t go far enough then have your say – everyone’s comment carries equal weight when they are reviewed. You could just make the world of audit a better place!
  3. Be prepared to challenge your organisation – if your unhappy with the way your organisation currently manages and conducts its audit programme this revision will provide an opportunity to effect change. There are real cost and efficiency benefits to be enjoyed from the deployment of an appropriately structure audit programme. Use this document to persuade top management that this is the case.

 

What is next? 

All international standards go through a well-established process on their journey from concept though to finished article. We are currently at the Draft International Standard (or DIS stage).

This is the point where the ‘ordinary person on the street’ for want of a better expression is able to comment on the proposed content via there national standards body – in the UK, this is BSI.

The ballot closes in October.  There is then a meeting of the AUS/1 committee (the ISO committee revising this standard) w/c 6th November in Mexico City. This meeting will consider the comments received and will amend the draft if deemed necessary.

Depending on the extent and nature of the comments received the committee will then either move to publish the new standard or, if there is still work to be done, it will create a final draft international standard (FDIS) as an interim step before full publication.

We will know for sure after the Mexico City meeting however ISO are currently quoting ‘mid 2018’. I think this is a fair representation.

 

 

Managing Audits using EQMS

Qualsys provide a range of auditing solutions which make it easy for auditors and management teams to identify trends in information and to see when something goes wrong.

In this article, we’ve listed 5 benefits of using our Audit Manager software.

 

advantages of using eQMS 2.png

 

Tags: Audit Management Software, ISO 19011

10 Reasons You Should Enter the CQI's International Quality Awards

Posted by Emily Hill on Tue, Jul 11, 2017

The CQI's International Quality Awards is now accepting applications for awards in the following categories: 

Quality Professional of the Year 

Emerging Talent Award 

Leadership Award 

Quality Team of the Year 

Quality Professional in a New Project

If you're not sure whether to enter, here are 10 reasons why you definitely should. 

Quality Awards.png

1) Why shouldn't you win?  

Many people feel they have to wait to be recognised: to be promoted, to be hired, to be selected for an award. 

The most successful people look for ways to accelerate their career. Make the most of the opportunity the International Quality Awards presents. It's a chance for you to talk about what you do best. After all, why shouldn't you win?

2) Promote yourself or your team


We know you do some truly transformational work. We see it every day. It's about time you got recognised for all your hard work. 

To inspire you to get started, here are some examples of projects we've witnessed: 

3) Demonstrate your leadership potential

CQI Competency Framework

The CQI's Competency Framework has leadership as one of its core competencies. Part of a leader's role is to communicate the importance of quality and the value it can bring. ISO 9001:2015, for example, requires leadership to:

  • Inform stakeholders of the importance of the quality management system
  • Tell stakeholders why they should participate in its effective implementation
  • Promote risk-based thinking in respect of their organisation’s quality management system

There probably isn't a better opportunity to tell, inform and promote quality in your organisation than entering an award with the CQI. 

4) Plan, do, check, act

Just by entering the awards, you're taking the opportunity to reflect on your achievements and plan how you can improve. Set aside a couple of hours or a "Lunch and Learn" session to think about what you and your team have done really well and use the awards application form as a framework. By the end of the session, you'll have a completed application form you can send off to the CQI. 

Furthermore, by getting involved with the International Quality Awards, you'll be able to reflect and learn from hundreds of other quality professionals. You'll then be able to apply their war stories to your own organisation. 

5) Meet the Qualsys team

Qualsys are sponsoring the awards! That means you'll get to meet our team at the awards ceremony in November.

The Qualsys team

Don't worry, we're much better at developing quality management solutions than forming a 'Q' shape... 

6) Look at the venue!

Yes, the application will take some effort. But while you're writing it, why not have half an eye on the drinks reception for the event! You and your colleagues could be here in November (thanks to you!):

Merchant Taylors courtyardMerchant Taylors Hall

This is Merchant Taylors Hall – Sponsored by Qualsys 

7) Define the profession 

It's an exciting time to be in quality. Unlike many other professions, there isn't a clearly defined career path. By showing your support and entering the awards (for free), you'll be helping to share knowledge across the industry. 

8) Your marketing and sales team will love you

Quality World magazine

By entering the awards, you'll be sending a clear message to your organisation, supplier and customers that your organisation is good at quality. The winners of the awards will have an article featuring their achievements in Quality World magazine, which is sent every month to over 20,000 quality professionals. That's certainly one way to get the attention of your marketing and sales team!

9) Engage your team with quality 

Qualsys talks to hundreds of quality professionals every week. One common theme that arises is they struggle to engage others in what they are doing. Usually the feedback is: "No-one seems to be interested in what I'm saying." 

The honest response is: You're right!

Growing companies can be chaotic. Keeping up can feel impossible for a management team. It's not uncommon for everyone to remain in their own bubble and not set aside time for anything or anyone else. Promoting an achievement such as entering an award galvanises others to bring their ideas out into the open and ensure future efforts can learn from it.

10) Boost your career

 The opportunity to connect with others, learn and even possibly win an award will help accelerate your career. 

 

What you should do now 

Applications close on 31 July 2017 – so hurry!

 

 CQI Quality Awards

Tags: CQI

Could you tweet your quality strategy?

Posted by Emily Hill on Mon, Jul 10, 2017

We've talked a lot recently about engaging employees with quality and the quality management system, so we're always looking for innovative ways to get the message out there. 

John Oakland, founder of the Oakland Institute and author of several books on quality management, urges quality professionals to apply their quality knowledge to drive the strategy. During the Qualsys User Group, John said: "We [quality professionals] don't come to this game with a very good reputation. So you need to start thinking, 'If I did get the 60 seconds in the lift with my top management team, what would I say?'

"Quality professionals can help organisations as a statistician, if you apply your thinking, your tools and techniques in the right way and in the right areas. If you start talking about distribution, it's going to be a big turn-off. And that's a challenge we all face in this space of quality, helping as professionals in the area.

Time-poor teams 

In the same vein, Richard Chambers, Global CEO of The Institute of Internal Auditors, recently asked his Twitter followers whether internal auditors could condense their audit findings to a single tweet:

 He received a mixed response. Some followers agreed responses should be succinct, others believed there's more value provided in the detail. 

Gemma Baldan, Key Account Manager at Qualsys Ltd, says many quality teams can communicate short 'tweet-like' broadcasts using EQMS

"It's important that we don't throw the book at teams," Gemma says. "It's much easier to get the message across if it's short and succinct. 

"We've increasingly found that EQMS administrators are making the most of the broadcasts feature. These broadcasts are, by default, less than 100 characters and can be shared instantly with all employees. Our customers use the broadcasts to report issues and findings but also to shout about their successes. By keeping it short, those who want to read more can investigate further." 

What about you? Could you get your audit findings, quality plans or quality strategy under 140 characters? Comment below or tweet @QualsysEQMS. 

 

Tags: Quality Culture

The International Quality Awards: Interview with Vince Desmond, CEO at CQI

Posted by Emily Hill on Mon, Jul 10, 2017

Marc Gardner and Emily Hill from Qualsys Ltd recently interviewed Vince Desmond, acting CEO at the Chartered Quality Institute (CQI), to learn more about the CQI's goals and vision, how the quality profession is changing, and the new CQI Quality Awards. 

In this blog, Vince talks about what the CQI Quality Awards aim to achieve. Alternatively watch more of the interviews here. 

Vince Desmond, CQI's Acting CEO

Raising quality's profile

We need to work on the image of quality, that image that suggests "we're going to check your homework".

We really need to reposition quality as a business partner who's going to help you to make the business better. This message is much more attractive for the business and it's much more effective to achieve the purpose of the profession.

We've identified that one of the key weaknesses of the profession, and the CQI, is marketing. We need to celebrate the profession's amazing achievements. 

This is the first International Quality Awards, which we're delighted Qualsys is supporting. We need to know what projects quality managers are working on and celebrate their successes.

The International Quality Awards can only be good for careers, businesses and for the CQI.

CQI Quality Awards

Get recognised. Build your organisation's reputation. Define the profession. 

The International Quality Awards are an interesting thing.

The first thing is that the quality profession can shine a light on what it does. This will help raise the profile of quality. The awards are going to help other parts of the organisation understand what we do, and encourage and recognise success. Helping quality professionals to get recognition is important. 

It's important as well because organisations can demonstrate to their suppliers, customers and partners that they're good at quality and they're a good organisation to work with.

From the partner's perspective, we're all swimming in the same pond. CQI and Qualsys share an aspiration that organisations benefit from really exemplary quality management.

We have great organisations standing shoulder to shoulder. We have employers, recruiters and technology companies. We're all trying to solve a complex puzzle on how we improve the quality profession. With our partners, this message is more powerful that the International Quality Awards is not just the CQI. It's a message from the entire community that this is really important.

Start now – Applications close 31 July 2017

There are five category awards: 

  • Quality Professional of the Year
  • Emerging Talent
  • Leadership 
  • Quality Team
  • New Project 

You don't have to be a member of the CQI to enter the awards.

 

CQI Quality Awards

 

Tags: CQI

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

ISO 19011 Revision: Your Questions Answered [Webinar]

Posted by Emily Hill on Tue, Jun 27, 2017

Are you an internal auditor? Does your organisation follow ISO 19011? Or are you considering introducing ISO 19011 into your organisation? 

If you answered 'Yes' to any of the above, clear your diary on Thursday 13 July, 2pm–2.30pm.

iso19011.jpg

ISO 19011, the international standard that sets forth guidelines for the auditing of management systems, is currently being revised.

Richard Green, owner of Kingsford Consultancy Services and former Head of Technical Services at IRCA, is on the international committee that advises changes to the standard.

Richard says: "The new ISO 19011 will raise the bar for internal auditors. The committee recently went to Milan to discuss the changes. We entered with a pussycat and came out with a tiger. I'm really excited about the changes."

He continues: "The new standard is fit for the 21st century. The next international meeting is in Mexico City in November, where we'll discuss the draft international standard comments. We're looking to publish the full ISO 19011 in March 2018." 

How will the changes to ISO 19011 impact your role?

Qualsys are delighted to announce that Richard Green will be taking part in a live 'Question and Answer webinar' on Thursday 13 July, from 2pm to 2.30pm. He'll share his insights and answer your questions on what to expect from the new standard. 

[Richard Green at the Qualsys User Group]

Submit your questions / Sign up for the webinar below

 

Sign up for FREE: Thursday 13 July 2017: Live Q&A Webinar

 

 

Tags: ISO 19011