Focus on Training

Tutor-led Virtual Classroom - update your training plan for 2025

Some of our courses are now available via a virtual classroom format.? These courses are delivered live by one of our highly qualified and experienced tutors and offer delegates the opportunity? to receive our training from a location of their choice.?

The courses are not simply our classroom courses online – they contain different exercises, case studies and interactive activities that allows students to continue to meet all the curriculum requirements of these CQI & IRCA approved courses.? As with our other training, these will be delivered by IRCA-registered auditors from our offices in Scotland in the UK.

To find out more get in touch with our training team who will guide you as to how you can update your training plan and CPD for 2025 or simply book a course now, directly from our website.

What are Audit trails and why are they useful?

You could summarise the term audit trails by simply saying ‘areas of investigation’ but there is a little more to it than that. An actual definition can be difficult to find in ISO management system supporting documentation such as ISO 9000 Terms and Vocabulary and yet audit trails are essential in management system process audits.

We could look further at the individual definitions of audit and trail and arrive at something like

‘A systematic approach to collecting evidence based on specific samples, that the output of a series of inter-related processes meets expected outcomes.’

But what does this mean in practice? Although applied by some auditors, the use of an audit trail is by no means universally accepted. It is the failure to ensure all audits employ process audits following an audit trail that undermines their credibility. Auditors should understand the path of the process that they are auditing and perform the audit, accordingly, ensuring that the requirements of the process are being met. For example, as a matter of course auditors will visit the shop floor. This enables the auditor to see what is taking place and to identify the specific order numbers of jobs that are going through at that time. From this information it is easy to identify in the sales department the agreed specification for that product or service and select relevant samples to be chosen. This means the process can be checked to ensure that what takes place is controlled and will meet the required specification. From here, the audit trail is picked up and followed through. Using the audit of a purchasing activity as an example, you need to identify what material or equipment has been purchased for your sample order. It is always important to understand what drives the process. In this case, it is normally the requisition, which defines what is wanted. If the auditor does not understand the specification, then he or she cannot check if the process being followed meets the requirements of the requisition. Some checklist questions might include:

????????? What does the requisition require – does this comply with the agreed specification?

????????? How is the decision to purchase made?

????????? How is the specification decided?

????????? Is it adequate?

????????? Who decides what is required and do they have the authority?

????????? Who chooses the supplier and by what criteria?

????????? What is the process for bid evaluation?

????????? How is the specification advised to the supplier?

????????? Are national or international standards used?

????????? What controls the process?

????????? Are there any special packing delivery requirements?

Sampling

The starting point for the audit is to use the chosen samples and identify the process path and the controls that were applied. It is vital that the samples are linked and come from the same trail. Too frequently, audit samples are taken at different stages of the process and are not related or linked to the initial sample chosen, which means that an auditor is unable to verify that the process is working. He will only be able to check if that a document is filled in correctly. Procedures and forms, other documents or data, all ensure that a process is managed and controlled effectively. It is essential that auditors take the time to understand what is required from the process they are auditing. It is impossible for a second- or third-party auditor to carry out an audit of an organisation if the auditor does not take the time to understand the specification of its product or service, including statutory and regulatory requirements. It is this professional approach to auditing that allows the auditor to identify any weaknesses in the process and decide if an organization is capable of meeting the specified requirements. The audit trail approach applies to any audit be it an internal, second- or third-party audit.

To discuss audit trails or discover other elements of auditing management systems there are a number of routes available. It may be that you’re a certified organisation looking to refresh your audit practices or perhaps you’re an aspiring auditor looking to join one of our CQI IRCA approved training courses. Whatever the reason the best place to start is simply checking out our website or making contact with our team to find out which route is right for you.

Face Fit Testing – Understanding the Requirements.

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Understanding the Requirements for Face Fit Testing PPE

When it comes to protecting workers from hazardous substances, the importance of correctly fitting personal protective equipment (PPE) cannot be overstated. One critical aspect of PPE when dealing with airborne contaminants, is respiratory protective equipment (RPE). To ensure RPE provides the intended level of protection, face fit testing is a required under the Approved Codes of Practice (ACOPs) supporting a number of regulations, including COSHH. This article will guide you through some of the key requirements and considerations for face fit testing RPE.

Why is Face Fit Testing Important?

Face fit testing is essential because it ensures that the required and selected RPE fits the wearer’s face properly. A poorly fitting mask can allow airborne contaminants to leak into the breathing zone, negating the protective benefits of the RPE. This is especially crucial in environments where workers are exposed to hazardous substances such as dust, fumes, or chemical vapours. Effective fit ensures that the mask forms a proper seal against the skin, preventing dangerous substances from being inhaled.

Legal Requirements for Face Fit Testing

In the UK, the use of RPE is governed by the?Control of Substances Hazardous to Health (COSHH) Regulations 2002, along with several other regulations such as the?Control of Lead at Work Regulations 2002?and the?Control of Asbestos Regulations 2012. These regulations mandate that where RPE is used as a control measure, it must be suitable for the wearer. To achieve this, face fit testing is required under the Approved Codes of Practice (ACOPs) to confirm the adequacy of the fit.

The Health and Safety Executive (HSE) provides clear guidance on face fit testing, specifying that:

• Face fit testing must be conducted by a competent person: This could be someone who has undergone appropriate training or possesses the relevant experience to perform the tests correctly. Competence can be demonstrated by accreditation under the?Fit2Fit RPE Fit Test Providers Accreditation Scheme.
• Testing is required for all tight-fitting facepieces: This includes disposable masks, half masks, and full-face masks. Loose-fitting devices like hoods or helmets do not require fit testing but must still be suitable for the specific use case.
• Face fit testing must be repeated in certain situations: If the RPE changes. This could include type, model, size, etc… If the wearer undergoes any significant changes to their face shape, such as weight fluctuations or dental work, that could affect the fit. As a part of the periodic review to ensure ongoing suitability of the RPE.
• Records of the face fit test must be maintained: These records should include, but not restricted to, persons details, the date of the test, the RPE tested, the method used, and the results. Records should be kept for as long as the employee uses the specific type of RPE.
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Types of Face Fit Testing

There are two main methods of face fit testing:

• Qualitative Fit Testing: This method is typically used for disposable and half-mask respirators. It involves the wearer tasting or smelling a test agent (like a bitter or sweet solution) while wearing the mask. If the wearer can detect the agent, the fit is inadequate. This method is more subjective but is commonly used for simpler types of RPE.

• Quantitative Fit Testing: This is a more advanced method that uses a machine to measure the actual leakage into the respirator. It provides a numerical result called a fit factor, which quantifies the effectiveness of the mask. This method is generally required for full-face masks and provides more accurate results.

Practical Considerations for Employers

Employers have a duty to ensure that their workers are adequately protected through proper face fit testing. To comply with the regulations:

• RPE fit testing is carried out by a competent person.
• Determine the appropriate method of fit testing: Depending on the type of RPE used, choose between qualitative and quantitative methods.
• Plan and schedule regular fit testing: Ensure that new employees are tested before they start work in hazardous environments and where there is reason to suspect the test is no longer valid, change in RPE model etc… and that periodic retesting is conducted.
• Ensure proper training: Users of RPE should be trained on how to correctly put on and remove and check the fit of their RPE. ?Known as fit checking, this is in addition to the face fit test carried out at selection and issue.
• Maintain accurate records: Keep detailed records of all face fit tests conducted, including any follow-up actions required.

Face Fit Testing and Facial Hair

Many masks require a secure seal against the face to ensure that when you inhale, the air is drawn through the filter material. If there are gaps around the edges of the mask, unfiltered air can bypass the filter and enter your respiratory system. It is crucial the mask is worn correctly and checked for a correct fit each time.

Being clean-shaven while wearing tight-fitting masks, which depend on a good seal, helps prevent contaminated air from leaking around the mask edges. Facial hair, such as stubble and beards, can prevent a tight seal between the mask and the face.

If there are good reasons for having a beard (e.g., for religious reasons), alternative forms of RPE, that do not rely on a tight fit to the face, are available.

Conclusion

Face fit testing is an essential part of workplace safety, particularly for environments where workers are exposed to hazardous airborne substances. By understanding and adhering to the legal requirements, ACOPs and guidance, employers can work to ensure that the workforce is adequately protected and reduce the risk of occupational illnesses. Initial and regular fit testing programme, competent persons and suitable training along with diligent record-keeping are key components of a successful RPE programme.

Staying compliant not only safeguards employees but also helps companies avoid potential legal repercussions. Always consult the latest HSE guidelines and consider professional advice when implementing or updating your face fit testing procedures and systems.

If you have any questions or queries following on from this article, then please contact QCS International and enquire about our?ISO 45001:2018 Health and Safety Management System training or consultancy services?and how we can help you.

Our thanks to Leigh Simmonds, Managing Director of our sister company QLM for sharing his knowledge and expertise in this article.

Medical Device Regulations and Device Classification

Let’s start with a definition, Medical device’ means ‘any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.’ Examples of medical devices may include dental or surgical instruments, bandages or even hospital beds.

IVDR (In Vitro Diagnostic Medical Device) has a different meaning and hence definition but we’ll leave that for another day and another discussion.

ISO 13485 specifies the requirements for a Medical Device Quality Management System – Requirements for Regulatory Purposes, so from the off, that reference to regulation is embedded within the standard. Most of us know that in this area of operation the regulator is the MHRA (Medicines and Healthcare Products Regulatory Agency) and that key legislation includes the MDR or Medical Device Regulations 2002. The MDR legislation is of course derived from the original EU Medical Device Regulations and post Brexit there are a number of nuances that may apply when placing a device on the Great Britain market (Northern Ireland Regs are slightly different) and organisations selling or distributing medical devices in the UK must have a UK based UKRP. QCS International have a well-established UKRP (United Kingdom Responsible Person) service for those organisations requiring guidance and support in this area. The key responsibilities of a UKRP include ensuring regulatory compliance of medical devices, keeping technical documentation accessible to the MHRA for inspection, facilitating communication between the MHRA and the manufacturer and reporting complaints or feedback from healthcare professionals, patients and users to the manufacturer.

So, back to routes to market, how do we begin marketing and selling our medical device in Great Britain? One of the first tasks is to determine the risk associated with the device which will identify the medical device class and in turn determine whether assessment is required by a notified body. For medical devices there are four risk classification groups:

·???????? Class III – includes pacemakers and heart valves (highest risk)

·???????? Class IIb – includes lung ventilators and bone fixation plates

·???????? Class IIa – includes dental fillings and surgical clamps

·???????? Class I – includes wheelchairs, stethoscopes and spectacles (lowest risk)

For further information on our UKRP service and how we support medical device manufacturers placing devices on the UK market or ISO 13485 Medical Device QMS Auditor training reach out to our friendly team of advisors who will welcome your enquiry and be pleased to offer assistance.

Training in 2025

Last but definitely not least, we’d like to highlight the superb training opportunities available for those individuals or organisations looking to develop auditor skills in 2025.

Not purely in terms of demonstrating competence but also consider too the continuing professional development aspects of participating in some career defining CQI IRCA Approved auditor training.

QCS International hold regular face to face and online training events both in classroom (physical or virtual) or in house on site at your organisation’s locations. From foundation level to lead auditor, from ISO 9001, ISO 14001 to ISO 45001 to ISO 13485 and more. QCS International are a globally recognised training provider reaching out from our UK based training location. Further information and course dates are available at www.qcsl.co.uk or contact our Training Team for assistance including sign posting the right training path for you.

Have a wonderful holiday season and our very best wishes for a happy 2025.

Merry Christmas

QCS International