Governance, Risk and Compliance Blog

Using EQMS Audit Manager? We've made some really useful improvements... [Video]

Posted by Marc Gardner on Wed, Sep 20, 2017

Improvement is a huge part of everything we do at Qualsys. It's in our culture. We're constantly improving as a business and as people, and we're always aiming to provide products and services that meet the highest possible standards.

We never stop developing and refining the functionality of our EQMS software. Recently we've made a host of improvements to our Audit Manager module, and we've put together a short video to introduce them to you.

Watch this five-minute video, hosted by Declan Webster, one of our Service Implementation Managers, or read the full transcript that follows.

Transcript

Hello and welcome to the latest video on EQMS by Qualsys. I know you're all busy people so I’ll aim to keep the agenda nice and short. I’ll begin by talking about some of Audit Manager’s functions, and then I’ll take you through a few of the module’s practical uses. Then I’ll use the rest of the session to show you some of Audit Manager’s new features in more detail.

So to start off, what does Audit Manager allow you to do?

It allows you to schedule and plan your audits and inspections quickly and easily, and gives you a calendar view of your entire programme, filtered how you want. It can check an auditor’s availability before it assigns them responsibility for carrying out an audit, and it can notify those being audited that they have an audit looming. If you want to set milestone dates, or have audits that automatically recur after a set period of time, then the module can do all that for you as well.

Questions in Audit Manager are arranged into checklists. You can specify what type of response you need for each question. For example, it could be a date, a number, a selection from a drop-down list or simply a text field. You can make questions mandatory or optional, and you can determine which checklists apply to which type of audit.

It can automate corrective and preventive action by setting deadlines for tasks to be completed and triggering escalation to senior managers when issues are still to be resolved. It can assign as many actions as you need, to as many users as you need, so problems or potential problems are always identified and dealt with. And it can generate automated messages or emails to alert people when they need to take action.

It allows you to control security permissions for your audit records so responsibilities are clearly defined and records can’t be tampered with. You can restrict viewing to certain users or groups of users, or by audit type. You can enforce settings so auditors have read/write access to the appropriate records. And you can define your audit managers – in other words, those people who manage all audit activity for their area of responsibility – and set administrator privileges.

Like all our EQMS modules, we’ve built Audit Manager to be customisable and allow for a range of uses. Probably the most common use is the internal quality audit, where it helps avoid duplication of effort and allows much clearer and comprehensive data to be recorded.

A lot of clients also find it invaluable for their safety inspections, where it can be used to keep a full, detailed record of all safety activity.

But it’s not just handy for audits. Some of our clients use Audit Manager when new employees join the business, to keep track of paperwork, safety certificates, inductions and access to systems.

And those of our clients working in heavily regulated environments such as labs or medical device manufacturing facilities like to use the module to plan, schedule and carry out their cleaning reviews.

And now on to some of the latest features for Audit Manager.

First off, we have a new report, 494, which includes details of all questions, answers, comments, findings and more. The report adopts a similar style to many of the newer reports in the other EQMS modules, giving you the ability to rearrange, sort and filter the data to your requirements.

You can also save the filters and arrangement you apply to be able to retrieve a new report in the same format at a later date. Additionally, you can export to Microsoft Excel.

Another new feature is this small quality of life enhancement, deleting unrequired checklists. This can save a lot of time when making changes to new audits that use an existing template. Instead of having to remove each section separately, you can now remove the whole checklist in one action.

One of the biggest new features for Audit Manager is the .ICS Outlook integration. Email notifications sent out by the system regarding scheduling audits in EQMS now contain an attached .ics file. When the .ics file is opened in Microsoft Outlook it'll create an entry in your default Outlook calendar. When rescheduling, the notification email will also include an updated .ics file.

And the last new feature that I'd like to talk to you about today is the Auto-Start Audit. If enabled at an Audit Type level, required audits will automatically be updated from 'Planned' or 'Scheduled' to 'Ongoing' when the start date is reached. This ensures it's readily available for auditors to carry out the audit via the app or their web browser without the need for an administrator to update the status manually.

 

What you should do now

Our iEQMS Auditor app for iPad makes the entire audit process planning, producing reports and following up actions – far more efficient and effective. Click the image below to request a demonstration.

Auditing on the iPad


 

Tags: iEQMS Auditor, Audit Management Software

ISO/DIS 19011:2017 revision

Posted by Emily Hill on Fri, Jul 14, 2017

The ISO 19011 standard provides guidance on auditing management systems. It applies to all organisations that need to conduct internal or external management system (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 what you should do to prepare for them.

We've provided both a video and a full transcript below: 

 

What does ISO 19011 cover? 

  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 and improving the programme.
  3. Conducting management system audits – initiating the audit to final reporting and follow-up.
  4. Evaluating the 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's not something an organisation can seek certification against. Despite this, it's 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 MS standards will be based on Annex SL, and existing MS standards will adopt Annex SL when they're next revised.

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

What are the 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'.

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's communicated at the closing meeting and what's ultimately contained in the audit report.

  • Structurally there have been some changes. The order of the sub-clauses under 6.4 'Conducting the audit activities' has been amended.
  • The role ICT now plays in audit, not just in terms of where evidence is stored but also in terms of how it's being employed to facilitate the audit process.
  • 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.
  • 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's very much a difference of opinion over this one.
  • 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 lifecycle, plus some significant changes to existing clauses (statistical sampling, guidance on visiting the auditee's location).
  • 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 light of Annex SL.
  • Audit team leaders are now expected to possess the competence to discuss strategic issues with top management.
  • 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'.
  • 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's unlikely they'll 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 forward, expect to see future auditing courses based on ISO 19001:2018, just as existing courses are based on ISO 19011:2011.

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

If you're 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'll affect you.

  1. Study the draft. It's not too early to start looking at the contents. Whilst this is still a work in progress the substantive content is unlikely to change that much. Take a look at what's 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're reviewed. You could just make the world of audit a better place!
  3. Be prepared to challenge your organisation – if you're 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's 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 their national standards body – in the UK, this is BSI.

The ballot closes in October. There's then a meeting of the AUS/1 committee (the ISO committee revising this standard) week commencing 6 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's still work to be done, it'll 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 that 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.

 

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Tags: Audit Management Software, ISO 19011

Paralysis by analysis: KPIs you should be focusing on – Global Quality Survey results (Part #3)

Posted by Jamie Rose on Wed, Apr 26, 2017

EQMS makes compiling reports much easier

 

Picture the scene.

Multiple spreadsheets open on your screen. Scribbled Post-Its – "non-conformity doubled", "increase in outdated documents" – stuck haphazardly around your desk. Piles of paper with last week's to-do lists. 

If this sounds familiar, you aren't alone! Over half of the quality professionals who responded to the Global Quality Survey 2017 said they spent at least a full week of every month compiling and producing reports.

While Big Data has created an explosion of opportunities for you to reinvent the role of quality, paralysis by analysis is slowly stealing your precious time and sanity. 

But it's difficult to avoid the overload. There's now so much data, it can be incredibly overwhelming. So where should you be focusing your efforts? 

Below, we have set out three essential key performance indicators and ways in which you can quickly get and measure this data. These metrics were recommended by 151 quality professionals in the Global Quality Survey 2017. You might also find the following articles useful:

3 tips for choosing KPIs

5 quality performance indicators you should be tracking

 


#1 – Customer complaints

It's more than 100 years since the catchphrase "The customer is always right" was popularised by retailers such as Harry Gordon Selfridge, but it's still an essential motto for every business, and the not-so-secret key to long-lasting success. 

Quality is driven by customer demand: a good and consistent product or service must be deemed a quality experience. That's why customer complaints come so high on the list of common KPIs: lots of complaints leads to a reduction in quality.

Customer complaints are a common KPI

Measuring customer complaints is complex and so is likely to be one of your most time-consuming tasks. Some factors you might encounter in your measurement include:

  • Number of complaints in a set time period
  • External factors to consider in the number of complaints (poor weather affecting delivery, for example)
  • Where the complaint originated (service, product, delivery, aftercare etc.) and the individuals linked to that complaint
  • How many complaints were solved immediately or had to be escalated
  • Time taken to resolve a complaint
  • Complaints dealt with outside internal SLA closing times
  • Type of action taken (refund, return, replacement, future discount etc.)
  • Result of corrective action (escalation, closure, customer NPS score).


#2 – Preparing for and reporting on audits

Audits are commonplace for any quality professional. But one problem they face all too often is the need to devote time to correcting potential non-conformities before their audits have even begun.

Those professionals who used systems such as EQMS Audit Manager spent considerably less time preparing for and reporting on audits. However, the principle remains the same: audits are crucial to ensuring continuous quality improvement.

"70% of those who responded to the survey agreed that 'being ready for external audits' is important or extremely important to their role and organisation."


Internal audits were found to be a key metric, whether carried out as standard for continuous quality, or before planned external audits to prevent non-conformities from being raised.

Quality professionals who used audit tools such as EQMS Audit Manager reported less stress on their workload overall, highlighting technology as essential to success in an integrated quality culture. Automated reports and on-the-go audit options reduced the time spent collating information and findings, and allowed internal auditors to carry out audits on-site without the need to duplicate any effort.


#3 – Reviewing, uploading and changing documents

Quality professionals who are, or want to become, ISO 9001:2015 certified highlighted the importance of reporting on document-related issues within their organisation.

Problems such as outstanding feedback and outdated documents affect quality at a broader level. Reporting on these problems helps you to find the sticking points in the feedback process, identify areas in which you can further streamline automated workflows, and highlight usage metrics the quality management system provides.

KPI dashboard


Organisations that are ISO 9001:2015 certified have found that, despite having a quality management system in place, the number of employees actually using that system can remain low (for example, managers with administrator capabilities leaving out-of-date documents on the site). 
This can lead to further problems (such as incorrect customer instructions being followed), resulting in a flawed product which does not meet requirements. The costs involved in rectifying such flaws are limitless, so by using documentation review as a KPI you will be able to stay ahead of potential problems.



What you should do now

For more information about the Global Quality Survey, download the report here. 

Or, for more information about using EQMS to bring together all your quality performance indicators, request a free demonstration here.

Request your EQMS Software demonstration

 

 Photo credit: Alamy

Tags: Quality Management Software, Audit Management Software, GRC Dashboard

12 different ways to use EQMS Audit and Inspection Manager as your single source of truth

Posted by Chris Owen on Thu, Mar 23, 2017

EQMS is a very flexible solution which can be configured to meet your business processes. But how could you use it to make the most of your audit and inspection processes?

At the EQMS Spring User Group 2017, Chris Owen shared 12 ways EQMS Audit and Inspection Manager is being used by Qualsys and our customers to deliver control, business efficiency, and a single source of truth. 

Here are some of the examples: 

 

1. Employee Onboarding / Offboarding

When new employees start, it is a critical time to ensure all the information they need and that all boxes are checked. 

  • Do you have their certificates? 
  • Has all necessary paperwork been completed?
  • Has their induction process been completed? 
  • Do they have access to all the systems they need? 
  • When is their probation review due? 

EQMS Audit and Inspection Manager controls employee onboarding and offboarding processes. When a new employee starts at the company, a new record is created and the employee onboarding process begins. 

More information here

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2. Appraisals

For employee retention and performance monitoring, EQMS Audit and Inspection Manager can be used to plan, manage, and record employee appraisals. 

EQMS Audit and Inspection Manager can be used to check all appropriate appraisals actions have been completed by the line manager and the employee. 

The module also integrates with EQMS Training Records Manager so that any associated training records can be attached to the appraisal. 

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3. Housekeeping Reviews

When we get busy, it can be difficult to remember everything that needs to be done. The smallest step forgotten could have serious implications later. EQMS Audit and Inspection Manager can be used for housekeeping checklists to ensure all important small steps have been taken, and no stone left unturned. 

 

4. Internal Quality Audits

Probably one of the most common uses for EQMS is internal quality audits. Lee Clack, W. E. Rawson Ltd, said "Since implementing EQMS, we've been able to do more audits in the past few months than in the past 3 - 4 years." So EQMS software can make it a lot quicker to conduct a large volume of audits and gain greater visibility of the performance of the organisation. 

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5. Process Audits

As well as quality audits, it is also important to audit processes. You need to make sure processes are working throughout the organisation, rather than just one procedure. 

In 'Next Generation Auditing', Colin Partington, Quality Management Consultant and ISO 9001 expert says: 

“Process based auditing is more about following through a trail by taking a job from start to finish and reporting what is seen as it passes through the various departments. By taking this approach, a number of clauses can be covered in one audit.”

These audits involve looking at the processes, even those for the audit itself, and asking whether it is actually working. 

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6. Safety Inspections

Safety Inspection audits check that your policies, procedures, and practices of employees and visitors remain relevant to your operation and are known to all staff. EQMS Audit and Inspection Manager makes it easy to take photos of issues, make voice recordings, attach documentation, and record video clips so you can keep a full record of safety performance across your organisation. The advantage to iEQMS Audit App is that this information can immediately be recorded in-situ, without the need for vague notes trying to explain a safety hazard or non-conformity.

 

7. Checklists for Your External Provisions 

EQMS Audit and Inspection Manager can be used to onboard and manage performance of your external providers.

Find more information about the new ISO 9001:2015 requirements and customer case studies: 

 

 
 
 
 
 
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8. Cleaning / Catering Reviews

In heavily regulated environments, such as laboratories and medical device manufacturing facilities, it is essential that the correct cleaning and maintenance checks have been completed and that there is a record that can be easily accessed without risk of the data being tampered with during an investigation.

Many of Qualsys' customers use EQMS to plan, schedule, and conduct cleaning and catering reviews. 

Find out how Sodexo uses EQMS for cleaning and catering reviews here

 

9. Risk Controls

The incorporation of Annex SL into the ISO 9001:2015 revision is a key driver towards the ‘risk based approach’. Incorporating what was previously titled ‘Preventive Action’, the risk based approach requires an organisation to determine the risks and opportunities, plan actions to address these risk and opportunities, implement the actions into its quality management system processes, and evaluate the effectiveness of these actions.

EQMS Audit and Inspection Manager integrates with EQMS Risk Manager, so actions can be determined, planned and addressed in the system.  

Read more on Risk Based thinking

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10. Claim Call Monitoring

Customer service employees can use EQMS Audit and Inspection Manager for claim call monitoring. This can ensure the correct process has been followed each time, without having to wait a long time for a response. 

 

11. Internal Compliance Audits

Probably one of the most common uses for EQMS is compliance audits. As you can associate the requirements for the standard with each audit, it makes it easier to gain an insight into the performance of the organisation. 

Thomas Miller also use EQMS for external compliance audits. They give external auditors access to EQMS a few days before an audit so they can see all the information is there. Read more about how Thomas Miller use EQMS here. 

 

12. VDA 6.3 

VDA 6.3 defines a process based audit standard for evaluating and improving controls in a manufacturing organisation’s processes. Qualsys has some templates which can be used for your own VDA 6.3 audit. Ask one of our team for more information or download the IATF 16949 toolkit. 

 

What you should do now: 

Got a process which needs to be audited, but not sure how EQMS could manage it? Talk to one of our experts. 

Alternatively, if you would like more information about EQMS Audit and Inspection Manager, request a demonstration here. 

 

Auditing on the iPad

 

Tags: iEQMS Auditor, Audit Management Software

5 undeniable advantages of using software for auditing

Posted by Annie Grace on Mon, Feb 27, 2017

Audits are a necessary part of any business, especially those that operate to tight regulations and standards. Whether conducted in-house or by visiting auditors, audits take up considerable amounts of time and require a lot of paperwork. At least, that’s how it used to be: software changes everything.

Enterprise quality management software is proven to slash the time it takes to do an audit. It also provides a comprehensive data trail with a few clicks of a button, eliminating the need for paper records. Instead of taking weeks, an audit can take hours. When you know the auditor's coming in, it's easy to have everything in one place in preparation – without the need to go through large piles of paperwork.

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These four Qualsys customers currently use EQMS Audit Manager. We talked to each of them to find out what drove them to implement the software throughout their businesses – and there were five clear points that came up time and again. 

 

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1)  Reduce the duplication of effort

Every auditor has experienced the frustration of carrying out an audit on site, filling out reams of paperwork, then having to return to the office to type up their notes. It's an unnecessary duplication of effort, and adds no value to the audit process.

Audits involve a lot of preparation. It means finding the right paperwork, and making checks beforehand to reduce the risk of non-conformances arising.

It wastes so much time!

Using audit software means you can have information ready at the click of a button. Customisable reports make it easy to display data visually, if you need to. There's no more paperwork – and preparing for an audit is much quicker as non-conformances are quickly highlighted and can be addressed in good time.

With EQMS Audit Manager, you can gather evidence and answer questionnaires on the spot. The iEQMS Auditor app allows you to download the audit, work offline during the audit – attaching relevant data as you gather it, then uploading it as a completed audit once you have a wi-fi connection. There's no duplication of effort, saving you hours or even days for every audit you carry out.

Using the iEQMS Auditor application, I estimated that I saved around 60% of
my time on auditing.
- Carl Stanbridge, Group VP of Quality and Compliance at Sodexo

Watch our interview with Sodexo's Carl Stanbridge here

2)  Improve the accuracy of data captured during an audit

 

Paper audits are not only time-consuming but restrict you to writing notes or completing a checklist without being able to provide accompanying evidence. And there's significant scope for human error and bias, as a description of a non-conformance can be as detailed (or as vague) as you choose.

Audit management software means you can capture evidence in real time and attach any type of common file, including videos, photos and sound recordings.

The advantage of being able to attach evidence is that non-conformances can be viewed the same way by everyone there's no need for interpretation. This process also eliminates the need to make lengthy notes to describe an issue, once more saving considerable amounts of time.

With EQMS Audit Manager, the quality engineer has to look at his iPad and physically see a question. This means that before he leaves, he can instantly see if something hasn't been addressed.
- Nigel Mangnall, Head of Quality and Compliance at Carillion Direct Sourcing

Read our interview with Carillion's Nigel Mangnall here

 

3)  Gather more information during every audit

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The wasteful way

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The EQMS way

Chances are you've faced an audit and found yourself pushed for time, as you work to make sure your business is compliant and gather together the relevant paperwork. Because of this rushing around, you're more likely to make mistakes and have your attention diverted away from your core duties. A missed file or unclear paper trail takes up more of the auditor's time and risks them having to hurry the rest of their audit.

The time limits imposed upon an auditor mean information can be missed or incomplete, especially if a problem occurs to delay access to vital details. This means non-conformances may be missed, which in turn could turn into larger and more costly business risks.

We give our auditors access to EQMS a few days before an audit, and all the information is already there. It saves our auditors hours!
- Sarah Oliver, Quality Manager at Thomas Miller

Because EQMS Audit Manager removes the need to do audits on paper, auditors have more time to analyse the organisation in detail and deliver a much broader and comprehensive review of operations. Instead of rifling through paper checklists and writing up notes, they can take photos, record voice notes and video clips, and take the time to get into those granular details that are often overlooked.

4)  Eliminate ambiguity in audit reports

What one person says is a major non-conformance, another may describe as minor – and it's difficult to prove when the only evidence that exists is a few pages of the auditor's hand-written notes.

Audit management software takes away the confusion and ambiguity by making sure evidence is gathered and attached to an audit on site, there and then.

And reports are no longer affected by bias  it's all there in black and white (and colour, if multimedia evidence is attached!) when you come to review the audit.
 

5)  Demonstrate compliance throughout the audit trail

Working from paper trails makes compliance difficult to prove  one missing file and you risk non-conformances or failing the audit completely. When your business must comply to regulations and standards, downtime to correct issues can be very costly.

EQMS Audit Manager allows you to easily plan and schedule regular internal audits, with automated workflows triggered when a finding is raised. This makes it very easy for you to demonstrate your commitment to regulations and other quality standards, and delivers a full and comprehensive audit trail for anyone investigating your compliance.

Watch EQMS Audit Manager Demonstration here

 

What you should do now

If your organisation performs regular audits, you're guaranteed to experience significant time savings with audit management software.

To learn how EQMS Audit Manager can save you time, money and headaches, schedule a 30-minute free demonstration here.

Auditing on the iPad

Tags: Audit Management Software

3 reasons to audit your suppliers (Hint: It saves you more than cash!)

Posted by Annie Grace on Fri, Feb 03, 2017

Many organisations handle so many suppliers that conducting regular audits seems inconceivable. You might carry out a suitability check when onboarding a new supplier, but after that how do you know you can continue to trust your suppliers?

Why is supplier quality critical?

When a supplier fails you, you pay the cost. It's not just about money, either: your reputation can hang in the balance, and if you handle an incident poorly you even risk losing your talented staff. They might choose to go elsewhere; you might suffer such a financial loss that you're forced to make job cuts; or your staff might have to take the fall for what was actually the fault of your supplier.

Disruption to your supply chain is similarly costly. Not only do you have to manage production downtime, you'll also need to assure your customers and re-jig other production schedules to continue maximising profit for your facility.

In fact, one in three businesses last year experienced cumulative losses via supplier failures to the tune of a cool €1m. That study doesn't take into account the long-term impact on reputation or the ability to retain talent, either.

If that's not enough for you to think about regularly auditing your suppliers, here are three more reasons to consider:


#1 – It will save you money

The first and most obvious benefit of regularly auditing your suppliers is that it significantly mitigates risk. You can:

  • track how your suppliers are performing against service level agreements
  • identify repeated problems, and
  • highlight potential future issues before they happen, and create contingency plans

No more €1m annual losses from supplier failures!


#2 – You'll ensure suppliers are complying to your standards

If you don't regularly audit your suppliers, how do you know you're on the same page? You have high standards to comply to, but are they meeting the same? How do you know they practise what they promise?

Standards are changing and adapting all the time, so it’s essential that you regularly audit your suppliers in line with the relevant changes. For example, upcoming changes to ISO 80000 reveal the differences in measurements between suppliers. If your supplier prices by the kilogramme, for example, how do you know you are getting a fair price – is it the kilogramme measurement YOU use, or another version?

Back in 1999 there was a worldwide omnishambles when NASA lost the Mars Climate Orbit satellite. It burned up, all $125m of it. All because the international teams had used two different measurements: the English had used imperial measurements, and the US team metric. Interpreting measurements incorrectly led to the loss of an extremely expensive piece of kit.


#3 – You’ll ensure continuous quality improvement

Without ongoing audits of your suppliers, it's difficult to know whether you're receiving consistent products, on time, to the right standard, without defects. That makes your own commitment to continuous quality improvement nigh on impossible. You need a full and comprehensive overview of your suppliers' performance in order to set in place best-practice touch points for continued quality improvement.

By regularly auditing your suppliers, you're also strengthening your relationship with them. If you let your suppliers "just get on with it" then you're missing out on opportunities for further partnerships, better prices, and opportunities to share knowledge.  

Integrated supplier managementRegular audits of your suppliers are possible and even easy with software tools such as EQMS Audit and Inspection Manager. Audits can be conducted on site without needing wireless internet access, so your auditors can visit sites and complete their audits without having to return to complete paperwork.


 

What you should do now

Download our ISO 9001:2015 Supplier Management Toolkit.

Supplier management

 

Tags: Audit Management Software, Supplier management

How to assess your suppliers with EQMS

Posted by Annie Grace on Mon, Jan 30, 2017

Under clause 8.4 of ISO 9001:2015, "Control of externally provided processes, products and services", your organisation must:

  • establish criteria to evaluate external providers' performance
  • document the results of the evaluation or re-evaluation, and
  • document any necessary action. 

If you are currently using spreadsheets or paper forms to manage your suppliers, you're going to run into difficulty. 

Supplier Management Pre-Webinar Survey 2016

Successfully assessing your suppliers is essential if you're to be serious about delivering a high-quality service while mitigating the huge risks involved in any part of a supply chain. If a key supplier can't deliver on time, how will that affect your business? What costs will delays have for your budgets – and your reputation?

An effective quality management system will enable you to conduct comprehensive assessments of your suppliers at every stage of the lifecycle, from pilot and trial, to onboarding, to continuous improvement. A supplier who isn't delivering on agreements will cost you time and money, and could impose further risks on your supply chain too.

EQMS Audit and Inspection Manager is designed to make assessing your suppliers easy. You can even take the app, iEQMS Auditor, to your supplier's site and conduct an audit offline without having to duplicate any work later on.

A full audit of your supplier at the trial and onboarding stage of the process allows you to anticipate and mitigate potential pitfalls that supplier might bring. From there, regular audits and performance reviews ensure your business is receiving the very best service at the best price, at all times.

EQMS Audit and Inspection Manager provides you with real-time reporting at any time, presenting information in visual graphs on a need-to-know basis, so you can tailor data to your audience. Keep track of your suppliers' performance, maintain positive relationships, and ensure best practice by implementing a comprehensive audit and review system.


 

What you should do now

Download our ISO 9001:2015 Supplier Management Toolkit to learn how Carillion Direct Sourcing uses EQMS to conduct thousands of audits.

 

Carillion EQMS Audit for Suppliers

 

Tags: Audit Management Software, Supply Chain Management

Internal auditing challenges: Emerging trends from ISO 9001:2015

Posted by Emily Hill on Fri, Nov 18, 2016

Back in July 2014, Richard Green, CQI's former Head of Technical Services, said he believed the upcoming changes to ISO 9001 meant the auditor's role would transition from 'auditor' to 'assessor'. Auditors would increasingly need to deal with "shades of grey" and "new evidence sources would need to be examined".

Now many organisations have made the transition to ISO 9001:2015, how have internal auditors coped with the new changes? Have the changes been logical? Are there brand-new challenges, problems and issues? 

In the following short videos, Richard Green shares five main challenges internal auditors may now have to face. 

1)  Internal auditing is still seen as a box-ticking exercise

Colin Partington, quality management consultant, says in 'Next Generation Auditing', Qualsys's whitepaper, that the changes in ISO 9001:2015 require internal auditors to move from procedure-based auditing to process-based auditing. He said this will drive a cultural shift from procedure auditing where "findings are discovered, corrective actions and made, and ultimately, boxes are ticked, to a more analytical approach which focuses on process auditing".

So, is there still a perception that ISO 9001 is a box-ticking exercise? Richard shares his thoughts: 

 

 
 
 
 
 
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KEY POINTS

  • ISO 9001 makes top management responsible and accountable for carrying out a certain number of activities themselves.
  • Clause 5.1.1 lists some activities top management need to be involved in. Some they can delegate, others they can't.
  • This is all designed to bring people at the highest levels into the quality management system. It can no longer be centred around the quality management representative.
  • Leadership must promote quality management as a process and need to understand how all processes fit together.
  • There are also requirements around risk.
  • Leadership now need to make decisions around whether the system is effective, and rectify any issues.
  • It has come as quite a shock for some organisations but the changes are logical.
 


2)  Moving from procedure-based to process-based auditing

Clauses 4.4 and 6.6 of ISO 9001 say auditors must monitor, measure and evaluate their organisation's processes to make sure they are helping to achieve the outcomes the organisation wants. This requires process-based auditing.

As Colin Partington says: "Process-based auditing is more about following through a trail by taking a job from start to finish and reporting what is seen as it passes through the various departments. By taking this approach, a number of clauses can be covered in one audit."

So how are auditors coping with the new challenges? Richard explains: 

 

 
 
 
 
 
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KEY POINTS

  • Things are now less clear cut than they used to be.
  • Context is amorphous – your perception of context is different from the auditor's.
  • The challenge for auditors, especially checklist auditors, is that it used to be black and white, but there are now a lot of grey areas. That's where the assessor comes in.
  • There now needs to be judgment calls based on objective evidence that the auditors see.
 


3)  Leadership commitment to enforcing audit controls

Under ISO 9001:2015, senior management must be accountable for the effectiveness of their quality management system, and ensure that it delivers real improvements to their business.

But are internal auditors seeing the level of commitment they need from top management? And are top management listening to their internal auditors as much as they should be? Richard explains:

 

 
 
 
 
 
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KEY POINTS

  • Internal auditors are the most valuable auditors out there.
  • Internal auditors understand the business and the standard processes; they know where your weaknesses are.
  • Internal auditing is too often seen as a secondary part of the role.
  • The organisation and top management need to recognise the real worth of their internal auditors, nurture and develop those people, and make use of their insight.
  • These are the people who are completely familiar with the business management system and can significantly impact the bottom line, if you listen to what they're saying.
 


4)  Speaking the language of the board

In 'Next Generation Auditing', Richard Green says: "Going forward, assessors are going to need to be able to speak the language of the boardroom. They will need to engage with top management regarding strategy and context, not minor operational matters. They will need to feel comfortable challenging individuals at this level." 

But are auditors comfortable challenging top management? What about when they have to deliver bad news? Richard shares his thoughts:

 

 
 
 
 
 
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KEY POINTS

  • Auditors have always had to deliver bad news.
  • It's more challenging when bad news isn't directed at quality managers but at those people at the helm of the business.
  • In certain parts of the world, the very notion of challenging what top management do is completely alien to their business culture.
  • It'll be difficult and take a while for auditors to find their feet.
  • The skills set out in ISO 9011, in terms of the approach of auditing, diplomacy and tact, are all coming to the forefront now.
 


5)  Training to meet new requirements 

"Many auditors come to me overwhelmed with increasing commercial pressures and time constraints," Colin Partington says in 'Next Generation Auditing'. "Such issues can result in constrained or irrelevant information being delivered to senior management.

To rectify this, as stated in ISO 9001:2015 4.1, Understanding the Organisation and its Context, the auditor must understand what the organisation does and what influences there are upon the organisation. How the auditor will establish these factors needs to be considered, almost certainly needing the top management to be interviewed to discover these." 

This requires a whole new skillset. So are auditors getting the training they need to meet the new requirements? Richard offers his response: 

 

 
 
 
 
 
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KEY POINTS

  • When we saw the new version of ISO 9001:2015, the requirements were significantly different for auditors in terms of their skillset.
  • CQI's transition courses now actually last two days.
  • 85% of the transition course focuses on skills and behaviours.
  • Because auditors must be able to interpret all the diverse sources of evidence, they'll need to learn new skills.
 

 

What you should do now

Want more information about ISO 9001:2015? Download our toolkit.

ISO 9001:2015 Toolkit

Tags: Audit Management Software, ISO 9001:2015, Quality Culture

Yazaki Europe Ltd opts for EQMS

Posted by Emily Hill on Mon, Oct 24, 2016

International automotive parts manufacturer, Yazaki Europe Ltd, is in the process of implementing a range of EQMS modules to improve overall business efficiency. EQMS will assist the manufacturer to optimise processes by providing rapid response to business issues and automating time-heavy administrative activities.

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Yazaki was founded in 1929 by Sadami Yazaki and now employs almost 300,000 people worldwide in 45 countries across over 400 locations. The world's largest producer of wiring harnesses also supplies terminals, connectors and other electronic components for automotive vehicles.

In a move to continuously improve all processes, Yazaki Europe Ltd recognised an opportunity to implement a new electronic quality management system which could manage their complex audit requirements. After a competitive tendering process, Yazaki Europe Ltd selected Qualsys Ltd.

A full suite of EQMS modules are now being configured to meet Yazaki Europe Ltd's unique quality requirements. The solution will be used to cut out time-heavy administrative activities and ensure internal and supplier audits are managed in a closed-loop.

 

About EQMS 

Robust Audit Scheduling   

EQMS Audit and Inspection Manager provides end-to-end functionality for managing the complete audit lifecycle. Authorised users are able to:

  • Plan and schedule audits. 
  • Develop standard audit plans and checklists. 
  • Control data field collection and built-in remediation workflows. 

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360-Degree Visibility into Performance

iEQMS, a permission controlled mobile auditing application, provides critical functionality for a multi-location workforce. Within the application, auditors are able to: 

  • Raise findings and actions.
  • Attach sound, video or documentation as evidence.
  • Work offline, as the application automatically re-synchronises once WiFi connectivity is restored.

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100% Accountable

Any issues, completed and overdue actions can then be viewed through the EQMS Dashboard. The dashboard has a 1-click drill down functionality, enabling rapid response to business issues. Actions can even be directed at Supplier staff without giving them access to other records in the system. EQMS features: 

  • Built-in remediation workflows.
  • Time tracking.
  • Email based notifications and alerts.

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Want end-to-end functionality for managing your complete audit lifecycle with easy status tracking?

Request a demonstration: 

EQMS demonstration

 

 

Tags: Audit Management Software, New Customers, ISO/TS 16949

Audits at breaking point: How to improve audit efficiency, effectiveness and agility

Posted by Emily Hill on Fri, May 27, 2016

Audit departments are required to be the 'eyes and ears' of senior management. They must evaluate compliance, identify and eliminate problems, and advise the organisation on opportunities for improvement.

But with ever-increasing regulatory demands, more complex business challenges and greater responsibilities, do quality professionals feel the audit process is efficient, effective and agile? 

Our results suggest that only a very small minority of quality professionals feel their audits are truly effective. Only two  percent said their audit process is systematic and efficient. So, why do quality professionals feel their current audit processes lack results? And what can be done?

We explore the key reason why many audits are failing and some more resources for optimising audits below.  

 

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Results from the survey during EQMS Audit and Inspection Manager Workshop

During the EQMS Audit and Inspection Manager workshop, a thirty minute webinar held by Michael Ord, New Business and Marketing Director at Qualsys, the audience were asked what they felt their main auditing challenge was. 

A significant majority said that following up recommendations and actions was their greatest challenge. 

 


Results from the survey during EQMS Audit and Inspection Manager Workshop

A key contributing factor, says Gemma Baldan, Key Account Manager at Qualsys who works closely with quality and compliance professionals on aa daily basis, is that auditors do not have the time and the resources to follow up recommendations and actions. She adds:

"Many organisations operate in complex and technical industries where there are new compliance obligations which continue to come out of the wood work on a daily basis.

The follow up recommendations require a number of specialists, and managing and coordinating even a small follow-up recommendation or action can be really difficult without robust systems in place to control any changes."

To find out more about how you can improve your follow-up recommendations and auditing processes, watch the EQMS Audit and Inspection Manager Workshop with Michael Ord to see how you can use the system to track any issues through to resolution.

Watch the workshop in full here.   

Tags: Audit Management Software