Articles of interest and curated content from the team at QCS International

Included in this edition we ask how has the climate change amendment impacted audits? 5 key points in ISO13485 Medical Device Management System for those new to the standard, accident investigation in health & safety management and ADHD awareness month.

Climate Change Amendment to Management System Standards

It is now six months since the changes in the harmonised structure for management systems required those seeking certification to consider if climate change was relevant to the system and its objectives.? The key text changes to the structure are within section 4, Context, as follows:

·?????? 4.1, the following was added –

o?? The organisation shall determine whether climate change is a relevant issue

·?????? A note was also added to the structure under 4.2, Interested Parties:

o?? NOTE: Relevant interested parties can have requirements related to climate change

As the new text is a requirement (a ‘shall’) this means that organisations must demonstrate that they have delivered this activity.? Simply, climate change must be considered in case it may have potential impact upon the effectiveness of the management system.?

Some examples of where climate change might be relevant for different standards include:

·?????? Quality Management: Changes to supplier chains should climate change disrupt or interfere with existing sources of goods or service.? Might it no longer be possible to receive specific food stuffs grown in certain parts of the world or may extreme weather patterns stop delivery.? This may then impact the organisation’s ability to meet customer requirements.

·?????? Cooling systems that support secure servers may have to be re-engineered should they be critical to information security in an ISO 27001 ISMS.

·?????? Will climate require organisations to reconsider hazards relevant to their workforce who may operate outside.? This would have to be reflected in an OHSMS certified to ISO 45001

As it is now a requirement, certification bodies may now raise nonconformance if they believe that there has not been any determination on the impacts of climate change.? However, evidence suggests that they continue to be taking a gentle approach to this update and there are very few, if any, examples of nonconformance known to us at present.?

In the UK, UKAS has been working with Certification bodies – ensuring that the change is interpreted and applied consistently.? Certification bodies have been training their auditors to ask the question – but agree that most auditors are unlikely to become climate change experts.? Like anything else within the clause 4.1 – the auditor wants to be satisfied that it has at least been reviewed and that climate change colours the controls within the management system where relevant.? Failure to consider the change or if an auditor clearly sees the impact of climate change not being considered may lead to nonconformance!

If you have certification, you may be concerned about the amendments, their implications and what you might have to do to remain in conformance (for any management system standard) then do get in touch with QCS, we can assist in interpretation and application of the updated requirements around climate change.?

Optimise the Value of Your Accident Investigation

?An in-depth guide (Part 1)

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We often don't realise how quickly our working environment can change. In just a matter of seconds, an accident can occur, and it comes as a shock to everyone. It's in these brief moments that we find ourselves questioning how such an incident could have happened and worrying about the potential

Organisations often promise to get to the root of the problem that caused it, but then complete an investigation that barely scrapes the surface.? When this occurs it’s a lost opportunity and the potential for recurrence exists.

Accident investigations can be seen as time-consuming, technical or invasive. So how can we get the best out of the limited time and resources available to ensure our accident investigation process provides value?? Here are some hints and tips to guide you.

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What is the purpose of an accident investigation?

In short, the main goal must always be to prevent recurrence.

When we hear the term "accident investigation," it often stirs up a sense of dread; we don’t have the time, there are other pressing priorities and people get defensive. Whilst an accident investigation can take time to complete (depending on the depth and complexity of an investigation) they are necessary in order to help us uncover the root cause of an issue. By investing this time, we prevent similar incidents from happening in the future.

There are likely to be some uncomfortable conversations when you start to ask questions about what happened. It's important to remember that the goal is NOT to point fingers or assign blame. Instead, it's about finding the problem. Accidents are unpredictable events that reveal weaknesses in your systems. The trick is to develop a culture that enables transparency and openness, this is a key feature of a good health & safety culture as this promotes positive behaviours.

So, rather than fearing an investigation, we should see it as a valuable tool for improvement and safety.

What accidents should we investigate?

Understanding the types of accidents and incidents to investigate is one of the first crucial steps. It is helpful to document your process for accident investigation and this should include guidance on what to investigate, how to investigate and the level of detail needed for different types of event.

?Each organisation has its own definition of accident, incident etc. The important thing is to focus on the actual or potential consequence and not to get bogged down in terminology.

Here are the two main categories we focus on:

Near Miss: These are unintentional occurrences that could result in damage, injury, or harm. They happen without prior planning and can vary in severity. Serious near miss events, i.e., those where the consequences would have been significant, are sometimes investigated, but are often ignored.? Remember that its often a case of good luck that a near miss occurred and not a serious accident so your accident investigation process should detail when near miss incidents are investigated further.

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Accident: An accident is unexpected and unplanned. It typically results in damage to property or equipment, an injury, or even a fatality. The more serious the accident is (or potential), the deeper your investigation should be.

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Top Tips when Starting an Accident Investigation

We have highlighted some common errors we experience when supporting clients or reviewing their processes. These tips will help you to get added value from your accident investigation process.

Witness or Bystander?

Once the area where the accident occurred has been made safe and the injured person has received attention, immediately identify who was there. People are often in shock immediately after an accident and everyone responds differently.

People in the area often state that they saw what happened and it is not until you start to interview them that you realise, they did not actually see the accident. Rather, they heard the noise and turned around - i.e., they saw the result of the accident, and not what caused it.? These people are valuable when collating information for your accident investigation but are not witnesses – they are bystanders.? Therefore, you need to establish who saw the whole thing (i.e., a witness) and who turned around when they heard the accident occur (i.e., bystander).

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Interview your witnesses and bystanders as soon as possible.

This should ideally be within the first 24 hours, even if the initial conversation was a casual and informal chat to establish who saw what (see above). According to research as far back as Hermann Ebbinghaus in 1880 we forget or distort up to 80% of what we see, hear, and learn within a very short period, sometimes as little as 24 hours. Ebbinghaus called his research the forgetting curve. Other studies have been completed since, and the results are similar.? Therefore, time is critical and the longer an investigation is left, the more likely it is that key information will be partly or fully lost or distorted.

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Who should investigate?

Often, the wrong person is allocated to complete the investigation. Sometimes this is because the organisation has a blanket policy that specifies a particular role holder, e.g., line manager, as the person responsible. This role holder is often not provided with any training in accident investigation and report writing, does not have the expertise, competence, or time.

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Organisations who have their own health and safety specialist often allocate this role holder as their investigator This is a good starting point, but that person is likely to need additional expertise, e.g., in production, the process or the machinery. Therefore, an accident investigation process should have a key person to lead and to include other specialists, such as engineers, supervisors, and even external technical specialists.

Follow specialist guidance

The Health and Safety Executive has written practical and user-friendly guidance on how to complete a suitable and sufficient accident investigation.? This document is HSG245. It provides comprehensive guidance and can be downloaded free of charge from the HSE website.? Our own IOSH Approved training course “Accident Investigation and Report Writing” is based on the principles in this guidance.

Look out for further insight into accident investigation in our next newsletter when we explore some practical tips on how to undertake accident investigation. Meantime if you have an interest in health & safety including accident investigation join one of our expert tutors on our next ISO 45001:2018 training course or ask for details of our consultancy services.

?5 Key points in ISO 13485

Here at QCS we work with several core standards including ISO 13485. For those more familiar with other standards such as ISO 9001 Quality Management, ISO 14001 Environmental and ISO 45001 Health & Safety Management, the medical device standard can appear to be a bit of a mystery. So, what is ISO 13485 and who is it for?

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specifically for the medical device industry. Here are the key points:

1.????? Quality Management System (QMS): Organisations must implement and maintain a QMS that meets the standard’s requirements, ensuring consistent quality in their processes and products.

2.????? Management Responsibility: Top management must demonstrate commitment to the QMS, including establishing a quality policy, setting quality objectives, and conducting management reviews.

3.????? Resource Management: Adequate resources, including trained personnel and infrastructure, must be provided to ensure the effective implementation and maintenance of the QMS. This section includes contamination control.

4.????? Product Realisation: This covers the entire lifecycle of a medical device, from design and development to production, installation, and servicing.?It ensures that products meet customer and regulatory requirements.

5.????? Measurement, Analysis, and Improvement: Organizations must monitor and measure the performance of their QMS, analyse data, and implement improvements to enhance the effectiveness of their processes and products.

6.????? ISO 13485 helps organizations ensure the safety and effectiveness of medical devices, building trust with regulators, stakeholders, and customers.

ISO 13485 is likely to be applied in organisations manufacturing a product subject to MHRA regulation and for use in a healthcare environment. Patient safety is central to the standard which is itself based on ISO9001 in that it promotes the process approach in management systems used in the manufacture of medical devices.

If there a specific aspect of ISO 13485 you are particularly interested in then do get in touch. We are sure to be able to offer guidance or at the very least our expert opinion on quality management in the medical device sector. QCS International is a leading provider of medical device quality management systems training including CQI IRCA registered ISO 13485 Lead Auditor training.

?ADHD ?Awareness

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?October is ADHD Awareness month. How aware are you about the signs, traits, behaviours, challenges, and opportunities of a colleague who is neuro-divergent?? ADHD is one of many conditions that come within the broad spectrum of neurodiversity, this term including other conditions such as Tourette's, Dyslexia, Asperger’s Syndrome, and Autism Spectrum Disorder. Here are 6 simple tips to help anyone who is neurodivergent at work that won’t single them out as being “different” and will help to make their time at work easier to manage.

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1.???? ??Provide a framework and timings – many neurodivergent people need routine and structure rather than being left to get on with a project without any timelines.

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2.???? ?Write clear notes when sending meeting / calendar invites.? Uncertainty causes anxiety to many people, including those who are neuro divergent.? Instead of writing “meeting with … “write something like update meeting regarding “name of project or topic”

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3.???? ?Provide flexible working patterns. Some neuro-divergent people find the background noise of a workplace to be stressful and distracting, particularly when they are in hyper-focus mode.? This can be a real super-power if they can harness this high period of concentration and they can produce high quality work in a short timeframe. If they must be in the workplace, give them a quiet room or area, or allow them to work somewhere else of their own choosing.

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4.???? ?Break larger projects into smaller bite-size chunks, each with an output/ targets and objective. This helps to reduce the feeling of being overwhelmed and out of control.

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5.???? ?Workers with ADHD can be very impulsive and get distracted easily. Giving the person a clear framework, explaining the relevance, and showing them why their work and input is so relevant may help. Get their involvement and input to help them with their focus.

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6.???? ?A common feature of neuro-divergence is “time blindness”.? Support the worker to set up time reminders on tasks they are allocated (e.g., via their calendar or even on their phone or watch) and provide a little extra time for the worker to complete a task so they can enter their hyper-focus mode and achieve high quality work without anxiety about failure.?

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These will work for many workers, both neuro-divergent and neuro-typical. The fascinating thing about neuro-divergence is that it affects everyone in different ways so a “one rule to fit all” approach will not work. ?An assessment should be completed so that the traits of the individual can be considered in relation to their work and working environment, so that the adjustments that are needed are tailored to the individual.? Therefore, flexible working practices are needed, along with some specialist guidance and input on health and safety workplace assessment of those with neuro-divergent conditions.

Whether?ISO 45001:2018 Health & Safety, ISO 9001:2015 Quality or other management system disciplines - which ever area of the organisation we consider, people are at its core. To discuss further or to seek specialist advice contact our advisors today.

Asbestos risk in buildings – how ISO 45001:2018 can help identify risk.

Asbestos remains in millions of homes and buildings today and it can become dangerous when disturbed or damaged.

The latest HSE campaign to highlight the risk of asbestos to tradespeople working in buildings is a timely reminder of what dangerous materials may have been used in the fabric of our buildings. Whilst auditing at a large facility last week our paths crossed numerous times with a contractor undertaking an asbestos survey. From offices to production area the surveyors examined floor and ceiling tiles, materials used in roofing and cavities and generally visually inspected materials then sampling those that appeared likely to contain asbestos before submitting for analysis and confirmation either way. Like us they would have sampled areas where risk may exist, like us they would submit a report and hopefully contribute to improvements in worker safety.

Every tradesperson is likely to undertake work in a building that contains asbestos at some point. Those carrying out repairs or refurbishment work are at a higher risk of disturbing asbestos, especially when working in houses built before the year 2000.

An ISO 45001 Health & Safety Management audit may not be seen to directly contribute to identification of asbestos and any likely hazardous material but it absolutely does require that organisations develop systems and frameworks to enable those inspections to take place.

Organisations have a legal duty to manage asbestos in buildings. In terms of ISO 45001 we may first consider clause 6.1.3 where the standard asks that we maintain a process to identify legal and other requirements. Has asbestos legislation been identified and included in our planning? Or perhaps we leap to 9.1.2 where we can consider evaluation of compliance, in other words what are we doing to ensure that we meet and comply with those legal requirements? We haven’t even got to 6.1.2.1 Hazard Identification and already we can see the numerous ways in which ISO 45001 can contribute to the investigation of how an organisation supports the management of asbestos risk.

Finally, a note on Health and Safety Executive guidance. The HSE website is a fantastic resource and includes asbestos specific guidance on:

• what the legal duty is, and the steps required to comply with the law?
• who the duty holder is, depending on the type of building etc, and what they must do
• new templates of an asbestos management plan and an asbestos register with a site plan

In addition to examples of how asbestos can be managed across different industries.?

For more information on ISO 45001 or to reserve your place on our next health & safety management system training course go to our website www.qcsl.co.uk or contact the training team directly through the web site.

QCS international are a leading provider of management system training and consultancy to companies and individuals across a range of sectors. Supporting learning and continuing professional development, QCS International have a broad reach, offering training courses in ISO standards and audit from our dedicated training centre, online virtual classroom and on site within your organisation.

'quality in a safe environment' October 2024