Governance, Risk and Compliance Blog

Michael Ord

Recent Posts

ISO 31000: Understanding the context of the organisation

Posted by Michael Ord on Wed, Apr 05, 2017

As part of ISO 31000, leadership need to demonstrate an understanding of the organisation and its context in regards to internal and external influences.

Being able to demonstrate the context of the organisation helps a business to properly align its risk management strategy with its overall risk appetite and risk tolerance in order to gain a competitive edge without compromising business continuity.

 

 

Considering PESTLE – Your External Contributors To Risk

Common factors to consider when understanding your organisation’s context in relation to external factors can be assessed using the PESTLE acronym:

  • Political
  • Economic
  • Social
  • Technological
  • Legal
  • Environmental

There are, of course, further factors which will influence the risk elements of an organisation, but it is these which are key to understand for any business.

With each element of the PESTLE acronym, it is important to consider: trends, external stakeholder relationships or impact, drivers affecting the organisation’s objectives, and contractual relationships and agreements.

 EQMS_Risk_Manager.png

 

Assessment Of Internal Context

Understanding the internal context could include the mission, vision, values and the alignment of strategic goals and objectives; standards or regulations adopted by the organisation (which are not required by legislation – that falls under external); and impact of resource.

Internal context can also cover:

  • Complexity of networks
  • Knowledge resource, sharing, and management
  • Contractual agreements and internal dependencies, and
  • Information systems including technological resource or reliance

 

 
 
 
 
 
28:39
 
 
 
28:39
 
 
 
 
 
 
 
 
 
 
 
Wistia video thumbnail - EQMS Risk Manager
24:50
 

Thanks for reporting a problem. We'll attach technical data about this session to help us figure out the issue. Which of these best describes the problem?

Any other details or context?

Cancel
message
 
 
 
 
 
 
 

The Role Of Leadership In Understanding The Context

When leaders have recognised the influence of external and internal factors which may impact on risk, it is up to them to use this information – the context of the organisation – to assess the severity and likelihood of risks posed within these parameters.

As part of the risk management strategy, once the context is defined it is helpful to the progress of an organisation adhering to an ISO 31000 framework to communicate definitions and understanding to key stakeholders.

Next in the series: Clauses 5.4, 5.5, and 5.6 – Implementation, Evaluation, and Improvement

ISO 31000 Risk Management Toolkit

Tags: ISO 31000

Global Quality Trends Report

Posted by Michael Ord on Thu, Mar 23, 2017

In March 2017, Qualsys Ltd distributed the annual benchmarking Quality survey, asking quality professionals about their challenges, key responsibilities and resources.

Global Quality survey 27017 - cover.png

Download the Report FREE here: 

The 34 questions in the survey were grouped into four broad categories: the role of the quality professional; main challenges; technology and systems; and the responsibilities and activities within the quality operations.

Over 150 quality professionals took the survey, raising £151 for Sheffield Children's Hospital Charity. 

The 151 responses we received—from around the world, across more than a dozen industries, and from organisations large and small—took the temperature of the industry to understand how the role of the quality professional is changing.

In the Global Quality Trends Report, we have collated the key information from the Global Quality Survey.  

Download your FREE copy of the report to: 

  • Access a 15 Page (7 minute read) Report
  • See how you compare and benchmark against your peers
  • Insights from industry experts 

 Get the report by filling out the form below >>> 

 

 

 

 

Tags: Quality Culture

ISO 31000: Risk management principles

Posted by Michael Ord on Wed, Mar 22, 2017

ISO 31000 relies on the application of some core risk management principles. These are designed to illustrate the importance of risk within the context of the organisation, and will help you to understand why risk management is vital to business success.

 

Core Risk Management Principles

Core risk management principles PNG.png

Assessing risk enables you to create and protect value within your organisation. Identifying risks allows you to illustrate areas for improvement, align business goals with a more refined scope, and protect your assets (physical and intellectual).

 

How Risk Management Creates And Protects Value

Risk is often approached in a haphazard manner, when frameworks such as ISO 31000:2009 are not yet in place. This leads to higher costs associated with failures, which reduces the overall value of the organisation. Failures caused by poorly managed risks can also damage the reputation of an organisation, with the impact spreading much further than the initial risk failure.

For example, a manufacturer that does not check the quality of materials from a supplier could unknowingly create a sub-standard product. The far-reaching cost of this poorly managed risk extends to recall processes, replacements, refunds, machine downtime, delay in re-supply, and ongoing costs to reputation which could result in less new business and lost existing customers.

When risks are identified, action can be put in place to mitigate the damage should the risk occur. Risks can be more easily managed, and risk treatment plans will reduce the long-term cost of a risk occurrence.

 

 

 

More Efficiency, Greater Profit

Risk management creates value by helping an organisation to identify not only potential hazards to the business, but also possible opportunities.

A more efficient risk management process will impact on business operation: workplace risks can be removed to create a safe environment, or data controls put in place to simplify document access and reduce risk to stolen or corrupted data.

Creating a more efficient environment will naturally increase the profit margin of a smooth-running business. However, opportunities identified during risk management can also be implemented to further create value in an organisation.

For example, the understanding that sharing knowledge via a document hub is less risky than relying on one person to hold the knowledge for a process will lead to a more collaborative working environment. This knowledge share could open further innovative discussion for future profit opportunities, and will at the very least enable the organisation to maintain business continuity.

 

Next In The Series: Clause 5.2 – Leadership and Commitment: 11 Essential Steps

ISO 31000 Risk Management Toolkit

Tags: ISO 31000

EQMS ROI Calculator – First Release, Feedback Requested

Posted by Michael Ord on Wed, Apr 01, 2015

People buy EQMS solutions for a variety of reasons: to upgrade from paper, spreadsheets and / or legacy systems, to improve access to KPI data and reports and to increase decision-making velocity.

Quantifying the 'business benefits' is relatively straightforward. But for many of our customers, there is a CFO or Procurement Department who require a Business Case Report which examines 'economic benefits' such as savings or increased efficiency.

EQMS Business Case

 

Qualsys have years of experience supporting organisations through their procurement process. We know that Quality professionals are busy people, so we have developed a range of tools to help ensure a 'painless' procurement process.

Building on the success of the recently released EQMS Buying Toolkit (which includes editable templates, technical information, case studies, etc.), Qualsys have developed and formalised the Return on Investment Calculators that are typically provided in spreadsheet format.

Business Case: Process Mapping and Efficiencies

Qualsys' Process Mapping experts have supported complex businesses all over the world. Over time, we have produced best-practice models for various quality processes, such as:

  • Completing a document version change
  • Change requests and CAPA management
  • Conducting a supplier audit
  • Conducting an internal audit
  • Managing training records

Customers often ask us to produce 4 Year Return on Investment reports which map an existing process against how the process would perform with an electronic quality management system (EQMS). The difference in time-savings for completion of each process can be multiplied by volume to identify a percentage saving and an economic justification.

See the example Version Change Process below:

Process Flow Chart

 

EQMS ROI Calculator –  4 Year Business Case Report

The EQMS ROI Calculator has recently been released, and enables prospective customers to create a 12 page Business Case Report in just four simple steps.

ROI Document Manager

Initially focussing on EQMS Document Manager, simply complete the four steps to see an instant preview of how and where your organisation would see process efficiencies.

Every organisation is different, so the ROI Calculator allows you to edit the values / times or simply use the default data. You can aslo choose to recieve a fully customised PDF report which can be shared internally.

How to use the EQMS ROI Calculator

ROI Calculator Flow Chart

 

Your feedback please

We have additional EQMS modules such as Audit & Inspection Manager, Risk Manager, CAPA Manager and Training Records Manager ready to go. However, as this is a new approach we'd really value your feedback about the usability and content of the EQMS ROI Calculator.

We will take any feedback on board as we refine this tool to provide maximum value for your procurement process.

Simply email me at michael.ord@qualsys.co.uk or call +44 114 282 3338 with your comments and suggestions.

Thanks in advance, 

 

Michael Ord

Michael Ord

Qualsys

T: +44 114 282 3338

E: michael.ord@qualsys.co.uk

 

Useful Resources

ISO 9001 Software CTA

 

 

IRCA Webinar: "ISO 9001 - The Story so Far" - Qualsys Sponsor

Posted by Michael Ord on Fri, Jun 13, 2014

IRCA Logo


Qualsys are pleased to announce our partnership with IRCA (International Register of Certificated Auditors), the world's original and largest international certification body for auditors of management systems.

IRCA are the sister organisation to the Chartered Quality Institute (CQI) and represent the voice of over 10,000 Auditors worldwide.

simon wells resized 183

Simon Wells, Training Manager at Qualsys:

"Education is crucial to creating a culture of compliance. At Qualsys, we are constantly learning from our customers and from organisations like IRCA and CQI.  

We feed this knowledge into our EQMS Governance, Risk and Compliance solutions  such as iEQMS Auditor for iPad  with a view to giving our customers crucial tools to help make compliance excellence a competitive advantage.

Our partnership with IRCA is a natural extension of this approach.

We have augmented our Implementation and Training courses even further and will be announcing a range of inititives alongside IRCA  including CPD Points for Training, co-hosted webinars, Auditing and ISO 9001:2015 Resources and more."

IRCA Webinar - sponsored by EQMS Auditor for iPad

As part of our ongoing commitment to Quality Management excellence, we extended our coverage of the changes to ISO 9001:2015 by sponsoring IRCA's webinar, 'ISO 9001 - The Story So Far'. 

Richard Green, IRCA

IRCA’s Technical Manager Richard Green (above), said: "It’s an exclusive opportunity to find out the latest on the proposed ISO 9001 changes, in light of the DIS (Draft International Standard), released in May 2014."

The webinar covers:

• the revision timeline and most significant changes to date
• the drivers for change – why move away from the 2008 version? 
• the importance of Annex SL 
• how it will affect auditors and quality professionals

IRCA on the importance of Audit

Richard Green (IRCA) said:

"‘The adoption of Annex SL as the basis for all future ISO management system standards will drive a transition from ‘Auditor’ to ‘Assessor’.

"Increasingly audit personnel will need to deal with ‘shades of grey’. Yes, Standard requirements will still need to be met but there will be new evidence sources to be examined and interpreted and the need for increased use of judgement to assess the capability of the system to fulfil current and future requirements and outcomes.

"New competencies will need to be acquired and existing ones refined if present auditors are to successfully move on up to the next level."

View the Webinar Now

Simply click here and quickly register your details to watch the webinar instantly.

Alternatively, you can download the webinar slides for free.


IRCA Website

 

Learn more about EQMS Auditor for iPad

EQMS Auditor for iPad

More ISO 9001:20915 Resources:

ISO 9001:2015

Tags: ISO 9001:2015

Happy New Year! EQMS Special Offers from Qualsys

Posted by Michael Ord on Tue, Jan 14, 2014

The New Year is a time for reflection and optimism.

Since we returned from the winter break, the Qualsys Account Management team have been conducting telephone interviews with EQMS Customers and Partners from around the world.

Quality Managers, Compliance Officers and Audit Managers from companies such as BT, Diageo and Sodexo, as well as a whole host of small and medium-sized Enterprises have been sharing their thoughts and expectations on the year ahead;

  • What have we learnt from 2013? 
  • What challenges did we overcome? 
  • How is quality management changing? 
  • How can we drive even more business improvement? 
  • What are your new year's resolutions?

The initial feeling is that despite the differences between sectors, the issues facing Quaility Managers from around the world are remarkedly consistent;

External

  • Speed of change (regulatory/competitive/customer demand/ technology) 

Internal

  • Communication
  • Business case (delivering visible value)
  • Technology as an enabler
  • Multi-jurasdiction/regulation compliance

Over the next few weeks we'll be compiling the responses into a series of free whitepapers and articles. We'll share the expert insights and reflections and would welcome your thoughts and ideas too.

It's a uniquely dynamic and exciting time; we wish you a happy and prosperous 2014.

New Year Special Offers

In the meantime, here are two special new year incentives which are available to new and existing EQMS customers.
 

Special Offer #1

2 days of Design Time for FREE*: Worth £1,380

Branding image

 

What?

  • Any EQMS Software or Training Purchase Order (PO) recieved before February 28th 2014 qualifies for Free Custom Branding of your EQMS system.
     
  • New & Existing Customers making additional purchases will qualify.
     
Free Custom Branding (Worth £1,380)


Special Offer #2

2 days for 1*: EQMS Spring Clean (Save £790+VAT)

EQMS offer

Make the most of your EQMS, start the new year with a clean, organised and up-to-date navigation, permissions, workflows and document control set up.


Qualsys experts will review your navigation and document structure and provide detailed feedback and best practice guidance.

I want the 2 for 1 Special Offer!


Tags: Quality Management Software, EQMS

Outsourcing by Government set to net £11.5 billion savings p.a.

Posted by Michael Ord on Mon, Oct 28, 2013

Osborne 2600702b

As George Osborne looks to make £11.5 billion savings in government spending and cut government borrowing by £49 billion, the public sector is facing its stiffest challenge for decades. 

Local Government, the Civil Service and the Police are all in the throes of cost-cutting which is leading to an ever-increasing focus on front line services and the questioning of any non-core activity.

Outsourcing organisations are being approached to take-on non-core activity and are being challenged to drive down costs. The value of these opportunities may be lower than previous contract values but their volume is set to rise dramatically.

A typical example of this was announced earlier this month with Dorset Police’s four-month trial of out-sourcing the guarding of major crime scenes to private company Securitas.

police dorset

Police and Crime Commissioner Martyn Underhill recently highlighted Dorset as the fourth lowest spending force in England and Wales – an indication that a creative approach to managing cost can pay dividends.

Trend to lower value Outsourcing Contracts 

The ISG Outsourcing Index for the Europe, the Middle East and Africa (EMEA) shows activity in the UK public sector worth €2.0bn in the first half of this year. Last year the annual market was worth €4.6bn, significantly more than double this year's first-half amount. 

However, these figures track outsourcing contracts with an annual value of €4 million or more. Smaller contract values are ignored but will inevitably begin to form a much greater proportion of outsourcing business.

The shortfall in high value contracts may well prove to be a blip as full-year UK figures for 2013 will still exceed their five-year average. And the UK continues to dominate public sector outsourcing activity in the EMEA region. In the first half of this year, the two billion euros worth of public sector outsourcing activity that took place in the UK represented an astonishing five-sixths of all public sector outsourcing activity in EMEA by value.

Only outsourcing operations that employ systems to truly standardise services across multiple contracts irrespective of contract size will make commercial sense of these opportunities.

Technology platforms such as ECMS Change Management for Outsourced Service Providers from Qualsys provide the controls to deliver standardised, compliant services across multiple contracts and manage change control to optimise flexibility and maximise profitability.
ECMS image


Armed with tools like this, niche players are set to benefit as are the most nimble of the larger players. The growth opportunities for those outsourcing organisations that can demonstrate this agility will be huge.

Learn more about ECMS >

 

Tags: Quality Management Software, ECMS, Compliance Outsourcing

‘Obamacare’ shifts global power balance of Pharmaceutical Industry

Posted by Michael Ord on Fri, Oct 18, 2013

As the gridlock in Washington subsides for the time-being, the effects of the Patient Protection and Affordable Care Act; so-called ‘Obamacare’ are set to extend to all corners of the globe.

washington 


Obamacare looks set to trigger a shift in the balance of power in the global pharmaceutical industry. We review the news to identify the key issues for Quality and Compliance Teams within Pharma-chem companies.

$350b Bonanza for Indian and Chinese Pharma

pharma image

The introduction of the new legislation will inevitably lead American purchasers to source generic drugs at a reduced cost. Indian and Chinese generic manufacturers are gearing up for a bonanza that will see them try to prise away market share in the $350 billion US market.

The major challenge for the Indian and Chinese manufacturers will be compliance with exacting FDA regulations and the introduction of compliant manufacturing processes and record keeping essential to deliver the product quality expected by the American market.

FDA Sanctions in 2013

Already this year, according to agency data, as many as 19 manufacturing facilities in India have been barred by the FDA from supplying products to the US, more than any other country. Problems faced by Ranbaxy Laboratories, Wockhardt, RPG Life Sciences and Dabur India have been widely publicised and here. Chinese Pharmaceutical facilities have received the next highest number of sanctions at seven.

Indian and Chinese companies will need to accept intense scrutiny if they want to make the most of the opportunity. India is one of the first countries, apart from China, in which the FDA has opened offices, and the country recently allowed the regulator to increase its number of inspectors in the country by seven to 19.

Conclusions

The US and European pharmaceutical giants will no doubt look to protect their position but this is likely to lead to cost-cutting and pressure on the ability to deliver quality at the right price.

This dilemma of a squeeze in resources and a demand for greater efficiency will force Quality Managers and Compliance Teams to review their processes, adopt new technological approaches all under the burden of greater over-sight.

Ultimately, the consumer is set to benefit provided the FDA and other regulators retain the power and sanctions needed to assure their protection.

Robert Oakley, Qualsys Director said:

"At Qualsys, we are already seeing a greater demand for iEQMS Auditor for mobile auditing, ECMS Change Management software and EQMS Risk Manager - all tools with powerful workflows that can easily demonstrate business efficiencies and ROI. 
 

iEQMS Auditor for iPad

EQMS interest from Pharmaceutical Manufacturers in China, the Middle East and the US, shows us that everyone sees the same opportunity and feels the same pressures.

It will be interesting to see how Obamacare plays out."


 

Attend Free Webinar


Image credit: here and here

Tags: EQMS, FDA, Pharmaceutical Regulation

New Release: iEQMS Auditor for iPad

Posted by Michael Ord on Wed, Oct 09, 2013

iEQMS Auditor for iPad will be released to the Appstore over the next week. Completely integrated with EQMS for on/offline work and real-time synchronisation, it is set to revolutionise the way distributed Audit Teams function.

AppStore

Robert Needham, Qualsys Technical Director said: 

"iEQMS Auditor for iPad allows your auditor or team of auditors to record the results of any audit or inspection using their iPad.  The simple-to-use iEQMS Auditor App works in tandem with your EQMS Audit & Inspection Manager solution and allows each auditor to check out their allocated audits or inspections locally to their iPad for completion before synchronisation back into the system. 

iEQMS Auditor for iPad gives you access to your EQMS system and assure accurate question completion and evidence collection, even on the move.  Your team respond to questionnaires that comprise simple, recognisable checklists of questions that you devise, providing responses in the format that you require and instantly attaching any mandatory evidence such as photos, videos or sound recordings. 

Audit and inspections are completed quickly, easily and accurately without the rekeying of information typified by most offline auditing processes. The streamlined iEQMS Auditor audit process means any non-conformances are identified immediately and EQMS workflow automates immediate corrective action.

I'd like to thank Ashley, Paul and the Qualsys Development Team for their sterling work leading up-to our winter release"

Here is a sneak-peak of some of the v0.5 screenshots:
 

iEQMS Auditor

iEQMS Auditor App

iEQMS Auditor App

Register to attend the upcoming EQMS Webinar:

Attend Free Webinar

 

 


Tags: iEQMS Auditor, Audit Management Software

EQMS New User Interface (UI) - coming very soon

Posted by Michael Ord on Mon, Sep 30, 2013

Giving you another reason to upgrade your EQMS, we are pleased to release these preview images of the new EQMS user interface (UI).

Mike Pound, MD of Qualsys said:

"EQMS has always been about making life easier for the user - whether that be higher level users who need the ultimate flexibility or read only 'end users' who want the simplicity to get on with their job without distraction.

When releasing our iEQMS Document Management mobile app and our Microsoft Office 'Add ins' this brought us closer to our vision of bringing quality and compliance to the user - allowing you to access crucial funcitonality from directly within your preferred business tools.

With around 900,000 users of EQMS we have to evolve carefully.

The new EQMS release brings next generation look and feel, without requiring additional training for your existing users. They benefit from a refreshed experience (in any browser) which improves usability, business efficiencies and buy-in"

The screenshots below are from the EQMS CAPA Manager and EQMS KPI Dashboard modules.

Speak to your Account Manager about scheduling your upgrades to benefit all the new features.


EQMS New UI CAPA

New UI CAPA 3

 

REQUEST DEMO

Tags: CAPA Software, EQMS, Document Management