Update: European Union (Energy Efficiency) Regulations 2014


  1. Does your organisation employ more than 250 people directly?
  2. Does your organisation have an annual turnover of more than €50 million per year and/or an annual balance sheet in excess of €43 million?
  3. Are you a public body with individual buildings having a total useful floor area of more than 500m2 or an annual energy spend of more than €35,000?

If you have answered ‘No’ to the above questions, this legislation is voluntary for your organisation.

However, if you have answered ‘Yes’ to any of the above questions, you must complete a high quality energy audit by the 5th December 2015, notify SEAI once complete, and repeat this every four years thereafter.  Alternatively, you can have a certified ISO 50001 Energy Management System in place, which requires you to conduct regular energy audits to maintain certification.

hand-holding-bulbThese are the rules established in the recently published (October 2014) European Union (Energy Efficiency) Regulations 2014, which transpose Article 8 of the Energy Efficiency Directive (2012/27/EU).

If your organisation meets the qualification criteria outlined, but is not fully covered by ISO 50001, you will need to conduct a high quality energy audit to comply with the Regulations.

These audits must include energy used by your buildings, industrial processes and transport to identify cost-effective energy saving measures.  The audits must sufficiently represent the overall energy performance of the organisation and the reliable identification of the most significant opportunities for improvement.

Audits are to be conducted with reference to the recently published ISO 50002:2014 or EN 16247 1-4.  Lead auditors conducting the audits must be members of the National Registration Scheme. For your audits, your organisation must:

  1. Calculate its total consumption
  2. Identify its areas of significant energy consumption
  3. Appoint a registered energy auditor
  4. Notify the SEAI
  5. Keep records

In order to comply with the Regulations, the audits must:

  1. Analyse the participant’s energy consumption and energy efficiency
  2. Use life-cycle cost analysis (LCCA) instead of Simple Payback Periods (SPP)
  3. Contain detailed and validated calculations for the proposed measures to determine potential savings
  4. Be based on up-to-date, measured, traceable operational data on energy consumption and (for electricity) load profiles

The organisation should be aware that if it does not meet its auditing obligations, for instance by failing to do the required audits or notify SEAI of compliance, it may be prosecuted by the SEAI and is liable on summary conviction to a class A fine.


Find out more about comprehensive lead auditor training necessary for you to conduct your own energy audits here.


Submitted by Ronan O’Sullivan, Antaris Consulting
To read more blogs from Antaris, click here


Fundraiser for The Blue Box

In 2013 SQT partnered with The Blue Box Creative Learning Center, a Limerick charity that uses arts therapy to support
Limerick city children and young adults to express themselves throughblue_box music, art and dance.

The Blue Box have a fundraiser event coming up on Thursday October 23rd in Limerick.

Brendan Markham artist in residence for the Blue Box and lead singer of Parliament Square will be performing in Cobblestone Joe’s on Thursday October the 23rd supported by The Fall, The Trip, The Tumble.

The event starts at 9pm in aid of the Blue Box,  Entry is free to the gig and there is a raffle which includes a pair of African Djembe drums. Donations can be made on the night or through the website at www.bluebox.ie. Also find them on Facebook.

Promises to be a good night!



Lean Six Sigma Certification

In order to evaluate and compare Lean Six Sigma course offerings it is important to understand the various certification options associated with them. Whilst course curriculums may appear similar, the requirements for certification can often vary dramatically.


There are three general classifications of programmes in terms of certification:

  1. Non-Certified Courses
  2. Academically Certified Courses
  3. Professionally Certified Courses


  1. Non-Certified Courses

Non-certified courses do not carry national recognition, however, there are advantages if gaining a qualification is not a key motivation for completing the training programme. For example:

  • The course can be tailored around a client’s specific training needs which may result in the removal of certain elements of a prescribed curriculum or body of knowledge (BOK) related to a specific belt
  • There is no assessment requirement. However, if a learner is motivated to complete additional self-study they could achieve professional certification by successfully completing relevant examination(s) from one of the professional accreditation bodies such as the ASQ (American Society for Quality) or IASSC (International Association for Six Sigma Certification).
  • Another advantage of non-certified training is that team based projects may be used as a means of assessment, this is generally not acceptable in academically or professionally certified training courses.



  1. Academically Certified Training Courses

Many academic institutions such as technical colleges and universities provide certified Lean Six Sigma programmes within their post-graduate or life-long learning course offerings. The advantage of pursuing such programmes is that they have been validated against prescribed award standards and have undergone a significant element of peer review and oversight by the external awarding body.

The Bologna Process has ensured comparability in the standards and quality of higher education qualifications across European countries. For example, in Ireland, the National Framework of Qualifications (NFQ) has been designed for the development, recognition and award of qualifications based on standards of knowledge, skill and competence acquired by learners. The Framework consists of 10 levels, from basic learning (level 1) to Doctoral awards (level 10). SQT have agreed Quality Assurance Procedures with QQI, the national agency responsible for the external quality assurance of further and higher education and training and validates programmes and makes awards for certain providers in these sectors. SQT Offers QQI Certified Special Purpose Awards at Levels 6, 7 and 8 on the National Framework of Qualifications.

Another major advantage of perusing an academically certified programme (particularly those utilising real projects in the learner assessment) is that there is a deadline for project completion. Sponsoring companies can therefore expect significant benefits to be accrued by the learners in the short term during the course of the delivery and assessment period alone.

There are two main arguments against academic certifications. The first is that academic training providers may be far removed from industry and may tend to focus too much on theory rather than giving practical insight and guidance to learners. Against this argument there are some academically certified training courses which are delivered by private training organisations, such as SQT Training, which have trainers that are in fact current industry Lean Six Sigma experts. The other argument often used against academic certification is that the assessment is purely based on the learners’ knowledge of the theory rather than competency in its application.  In reality this argument doesn’t hold true in many cases as many QQI (formerly HETAC) accredited programmes use real project submissions in the assessment of the leaners. Project management, leadership and change management skills are also assessed. For example, the assessment of SQT’s QQI Certified Green Belt programme is based on the successful delivery of a real work project through all stages of the DMAIC methodology while correctly selecting and applying tools appropriate to the project. Therefore, while academically certified, the actual course delivery has a very practical focus.


A Word of Caution…..

If you are considering perusing academic certification be sure to do the following:

  1. Compare the training curriculum against the ASQ body of knowledge to ensure that no shortcuts have been taken
  2. Check to see what level of recent practical experience the tutor(s) have
  3. Establish if there is a project requirement as part of the assessment
  4. Understand what level the programme has been validated at and the number of credits allocated (Further information relating to levels and credits are available here)


  1. Professionally Certified Training Courses

Prior to 2010 there was only one accepted source of professional certification for Lean Six Sigma practitioners, namely ASQ (American Society for Quality). The ASQ has been at the forefront of professional certification for quality practitioners for over 65 years. It has worldwide recognition and charters all over the globe. Former chairs of the ASQ include some of the who’s who of quality gurus of the past century, including Armand Feigenbaum and Philip Crosby.  Since the emergence of Six Sigma as a global phenomenon in the late nineties, ASQ has been to the forefront in identifying a standardised body of knowledge (BOK) for Six Sigma belts.  In 2010 a new organisation, namely IASSC (International Association of Six Sigma Certification) emerged as an independent third-party certification body.  Both the ASQ and the IASSC rely on knowledge assessments (exams) to determine if learners demonstrate the capacity to be professionally certified.


The two main ASQ exams are the CSSGB (Green Belt) and the CSSBB (Black Belt) exams.  While project based assessment is not included in either of these certifications, the CSSBB does require that a project has been successfully completed, with an affidavit to that effect. It is widely held that the CSSBB is a very challenging exam due to the statistical requirements of Six Sigma. IASSC on the other hand do not require the submission of any project or affidavits, and while the exam format and BOK are almost identical to the ASQ, the IASSC exam is likely to have less statistical and more lean content.


Both the ASQ and IASSC offer certification options to suitable training providers on a fee basis. The ASQ do so in a partnership model to ensure the training is consistent across providers (there are a small number of ASQ partners).  IASSC remain an independent certification body and therefore do not provide training.  Both the ASQ and IASSC exams are open to any applicant regardless of the source of training.


In Summary…

When evaluating a Lean Six Sigma Programme it is wise to remember the following:


  1. Academically certified programmes have undergone a significant level of independent review and oversight by an external awarding body, however, there is still much variance in courses offered. It is vitally important to examine the curriculum, understand the level of the qualification and associated credits, establish the practical experience held by the tutor(s), and finally whether the practical work (in most cases a project) actually forms part of the assessment.
  2. There may be valid reasons to opt for an uncertified programme, this is particularly the case where team based projects and significant customisation is required by the company seeking the training. Large corporations such as Honeywell and GE self-certify according to their own requirements.
  3. Professional bodies such as the ASQ provide the best source for what a ‘belt’ should know (body of knowledge), the exams are open to all learners but a successful result will not verify if the learner has the ability to be a good Green or Black Belt, as no practical work is examined. The professional body IASSC is relatively new and is therefore a little too early to compare with ASQ. Certification for both bodies is exam based only.


Having delivered all three types of programmes described here it is SQT’s experience that the best option both for personal development and company delivery is to choose an academic certification which assesses learner capability via project delivery. This will ensure a win/win for the learner and his/her organisation.


Quality Conference in October

We are happy to draw your attention to the upcoming Quality in Ireland Conference taking place in the Radisson Blu Hotel in Galway on Tues 21st Oct hosted by NSAI and IT Sligo.

This is an excellent event with many great speakers so worth noting in diaries.

See http://www.nsai.ie/NSAI-Quality-in-Ireland-2014.aspx for more details.



How to transition from Project to Program Management

The world of project management is becoming all too familiar. Yes, there are still challenges and learning to be had but when project management is discussed it is known on how to develop and mature. As a project manager, the biggest driver is being able to deliver under the pressures of time, cost and scope constraints and can be considered to be a balance of project management skills, leadership skills and process management skills.

One of the items that gains continual attention now … is how to transition from project to program. If you are in a PMO, you may have heard the following question, which of the project managers is ready to take on the program of work? This is now the easiest question to answer because first we ask ourselves, what is exactly Program Management and what do we mean by it.
In projects, we talk about planning, team development and process management. Whereas in programs we talk about business delivery, team dependencies and strategic management. They are two different sets of skills and to assume that a project manager can develop these without guidance / structure is a lot to ask. The first step in transitioning from project to program manager is to develop the mind-set for program management. For example, moving from the world of project / timeline delivery to program strategic execution.
My 10-steps or factors that are essential is developing professionals from a project manager’s role into a program management role are: -
  1. Think Business instead of Delivery
  2. Think Dependencies instead of Schedule
  3. Think Escalation instead of Reporting
  4. Think Strategy instead of Scope
  5.  Think conflict instead of Crisis
  6.  Think Governance instead of Teams
  7. Think Transition instead of Transfer
  8. Think Challenge instead of Salary
  9. Think Relaxation instead of Stress
  10. Think Program Triple Constraints (Benefit, Customer, cost)
Why are these different from project management? To answer this question, they are all business related and not one of them are focused on the task mindset that is often evident in project management. This is the subject matter of the paper I will be presenting at PMI® Global Congress 2014—North America on the 27th October in Phoenix, AZ
Liam DillonSubmitted by Liam Dillon, Turlon, SQT Project Management tutor

Don’t Set Threshold RPN’s for Actions to be Taken in FMEA

It is common practice in organizations where Failure Mode Effect Analysis (FMEA) is used as a quality improvement tool, to set thresholds on the Risk Priority Numbers (RPN’s), above which actions should be taken to reduce the RPN. I don’t believe that setting such thresholds is good practice. I propose instead that responsibility should be placed on the team to decide whether action is appropriate. In the event that the team decides that it is not necessary to take action on a particular identified cause of the failure mode, then the team leader should sign off on this decision on behalf of the team; i.e. the team will take responsibility for proposing no corrective action be taken, should that be the decision.

The reality is that the choice of the values (Severity, Occurrence, and Detection ratings) which go to make up the RPN is very much based on the judgement of the team members, and there is wide scope for variability in the values that will be chosen. It is a virtual certainty that if two teams with identical backgrounds are given the same failure mode to analyse, even if the causes are agreed among them, they will come up with different RPN’s. That is the nature of FMEA. In these circumstances, I don’t believe it makes sense to have fixed RPN thresholds for action on causes. One of the teams may well have RPN’s below the threshold whereas the other team working on the same failure mode may not.

I think there tends to be too much emphasis and reliance on the RPN values in FMEA in making decisions on whether or not corrective actions should be implemented. I believe the real benefit of the FMEA is the intense discussion that takes place between the team members. I believe that by the time the team has reached the stage of calculating the RPN, the discussion that has taken place up to that point should be sufficient to inform the team’s decision on whether or not corrective action is to be taken, and the responsibility for the decision, should rest with the team.

Learn more about FMEA techniques by attending our Failure Mode Effect Analysis training course.


EN 14971: 2012 Content Deviation #5: Risk Control Options

During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices Directives (MDDs), namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these discrepancies are described in EN 14971: 2012 as “Content Deviations”. This newsletter deals with Content Deviation No. 5: Risk Control Options.

Content Deviation #5: Risk Control Options
ISO 14971: 2007 requires the manufacturer to “use one or more of the following risk control options in the priority order listed:
(a)  inherent safety by design;
(b)  protective measures in the medical device itself or in the  manufacturing process;
(c)  information for safety”
but does not require that all three options be used; instead ISO 14971: 2007 implies that once the risk has been reduced As Low As Reasonably Practicable then further risk control measures need not be taken.
In contrast, Annex I of the Medical Device Directive 93/42/EEC requires the manufacturer “to select the most appropriate solutions” by applying cumulatively what has been called “control options” in ISO 14971. The MDDs do not regard these control mechanisms as options or alternatives but as three separate control mechanisms that must be applied in consort to reduce the associated risk as far as possible.

It must also be remembered (as outlined in our previous newsletters) that the manufacturer must not stop reducing a risk when it has reached an acceptable level, but that the risk must be reduced as low as possible irrespective of the risk magnitude. When complying with the Medical Devices Directives the only justifications for not implementing a control are that either the control in question will not reduce the risk any further or that it may give rise to a new risk which is less desirable than the risk which it is intended to control.
It can therefore be concluded that risk acceptability has no impact upon whether or not risk controls are necessary. Traditional FMEA-based methods of risk analysis have included an evaluation of the risk – both before and  after the implementation of risk controls measures. Under ISO 14971: 2012 and the MDDs there is no need to perform a risk evaluation prior to the implementation of risk control measures. However, manufacturers may still want to show in the FMEA the effect of risk control measures on the RPN in order to support their claim that the risk has been reduced as far as possible. Therefore it may be a good idea to leave the before and after RPN calculations in the FMEA document but to omit any reference to the acceptability or otherwise of the risk in question prior to the application of control measures. Many risk management procedures that are based on the 2007 version of the standard contain a flowchart describing the risk management process; the preliminary risk evaluation step should be removed from the flowchart in addition to removing it from the risk management procedures and the FMEA, templates and records.

The impact of Content Deviation # 5 is to require the manufacturer to implement multiple control measure whereas in the past, one control measure may have been considered sufficient. For example; a manufacturer of a device which incorporates a heating element may have previously considered that the design of the device was sufficient to minimise the possibility of the device overheating and therefore the risk to the patient had been reduced to an acceptable level. Such a manufacturer is required under the MDD to explore means of protecting the patient from overheating in the (unlikely) event that it occurs and to consider including a warning in the IFU detailing the risk of possible device overheating, and the precautions to be taken. In many cases the manufacturer will already have done both of the above, but a review of a company’s risk analysis documents such as FMEAs will almost inevitably reveal risks for which the application of all three types of control measures has not been considered. Additionally, the manufacturer must explore if there are any further design controls necessary to reduce the risk as far as possible (and not just to an acceptable level).

The outcome of actions taken to deal with Content Deviation # 5 will mean additional design controls, increased protective measures and alarms, and longer, more detailed IFUs. However, additional measures must only be taken if they will actually reduce risk and will not give rise to additional or alternative risks that are equally or more undesirable.
In order to comply with Content Deviation # 5, manufacturers must do the following;

  • Revise risk management procedures to require that all three types of risk control are utilised. Remove the risk management process step of risk evaluation prior to the application of risk control measures.
  • Review and update risk management documentation to ensure that all three types of risk control measures have been applied and that risks have been reduced as far as possible.
  • Review the information given to the user and in particular the IFU to ensure that all information that is necessary for reducing risk as far as possible, has been given to the user in a manner that is easily understood and can be easily acted upon.

In this newsletter we looked at the implications of Content Deviation # 5 and the requirement of the MDDs to implement all three types of control measures; design controls, protection measures and the giving of information to the user.

Abbreviations used in this newsletter:
FMEA: Failure Modes and Effects Analysis
IFU: Instructions for Use
MDD: Medical Devices Directive
RPN: Risk Priority Number


Household Energy Saving Tips

Save Energy – Save Money – Help the Environment



Light, Electrical Appliances & Energy Tips:

  • Turn lights on only when you need them and turn off when you leave the room.
  • Keep your lamps and lamp shades dust free – more light in less time.
  • If you want lighten your lighting bill, replace incandescent bulbs with energy efficient compact fluorescents and LED lighting.
  • On outdoor security lighting use timers or motion sensors. They run only when required.
  • In general, the most energy efficient HD televisions are LED followed by LCD and then Plasma.
  • Switch off and save up. When you leave the TV on standby it can use up to half the electricity in standby as when switched on.
  • Be smart with your computer, use energy saving mode and turn it off when not in use.
  • If you want save up to 20% on your electricity bill try using a home energy monitoring device. It can help you to manage your energy consumption.
  • When replacing a home appliance always chose an appliance with the highest energy efficiency rating. It is a good choice for your wallet and for the environment.
  • Plug out mobile phone chargers when not in use

Kitchen & Laundry Tips:

  • energy_sqtUse lids on your saucepans. The food will be tastier and it will reduce the cooking time.
  • Cook several items of food at one time. Use pans that can divide into sections or use the different temperatures of the space in oven (hotter on top, cooler below).
  • When you use the oven resist the temptation to check every minute! 20% of the heat escapes each time you open the door!
  • Slow cookers and pressure cookers save energy.
  • When using the kettle boil only the quantity of water you need. It is better for the bill, for the environment and for your health. Over-boiled water has a high concentration of limestone.
  • Stop the dishwasher before the drying cycle and open the door to let the dishes air-dry.
  • If you put hot food into fridge or freezer, they will have to work extra hard to cool it. You can let the food cool first and then put it in the fridge or freezer.
  • Defrost your freezer at least every 6 months and check your fridge and freezers door seals.
  • Put a full load in the washing machine if you can and use the lowest water temperature required. In this way you can save the money and save the fibres – your clothes remain new longer.
  • Iron smart – you should do the low temperature clothes first and the high temperature clothes last.
  • Weather permitting dry your clothes outside on the line.  In Ireland, the weather doesn’t always permit this (though we’ve had a good run!!).  If using a tumble dryer, dry heavy and light articles separately and turn the dryer off as soon as the clothes are dry.

Heating Tips:

  • When going away, turn off your central heating and set the timer to warm the house up for your return. Switch off heating before you go to bad. The radiators will continue to heat your home for some time.
  • Use time clocks to ensure the heating system works only when you need. With central heating systems use zone controls where necessary and fit thermostatic radiator valves to all radiators.
  • Turn heating thermostat down by 1°C can save you up to 10% on your annual heating costs. Room thermostats should be set on 18°C for the bedroom, and on 20°C for the living room.
  • Your boiler is heart of an efficient heating system. You should have it serviced annually to ensure it is working as efficiently as possible.
  • Ensure your house is well insulated. Double glazing and loft & external wall insulation are fundamental for saving money and for keeping your house warm. Improving your insulation is one of the best investments you can make in your home.
  • Carpets or rugs are good to insulate floors.
  • In cooler weather, keep the windows and doors closed – save the heat!
  • Curtains – close at night and open during the day. This little trick will help you to improve your house temperature management.
  • If you have a chimney but you don’t use or use occasionally you can fit a removable chimney cover to cut down the air infiltration.
  • Before you turn on your central heating…put on a jumper!
  • Radiators: to deflect heat back into a room place a shelf or longer window ledge over the radiator. For the same reason fit reflective foil-backed insulation behind it if it is on the external wall.

Water Heating Tips:

  • If your boiler is more than 10 years old, to plan to replace it. The modern ones are significantly more energy efficient. Older boilers operate at lower efficiency levels; on average 60% – 70% which means you are wasting heat and money.
  • To avoid overheating water put a thermostat to your hot water cylinder.
  • Lag your hot water pipes where you can and fit an insulating jacket on your hot water cylinder. For best results replace your existing hot water cylinder with a cylinder with factory applied insulation.
  • Take a shower rather than a bath. Usually an electric shower uses only one fifth of the energy of a full bath.
  • To save water and energy you should use a low flow shower head.
  • Use radiant heat lamps to heat the bathroom area rather than fan heaters.
  • If you use spray taps, you can reduce the amount of hot water you use.

You can also save Energy at work.  If you are interested in training in this area, view our range of Energy Management training courses – many of which are accredited.

Sources of Energy Saving Tips & Tools:






Don’t Expect to Find a Single Root Cause when Solving Problems

I think that because of the emphasis in the literature on “Root Cause” analysis some teams working on problem solving tend to believe that they are expected to identify a single root cause of the problem. I don’t believe that they should expect that outcome. Over the years I have trained and consulted with more than 100 teams undertaking root cause analysis, and it is a rare occasion in my experience in which a team will be able to identify a single cause of a problem. Indeed, if a team tells me they have managed to isolate a single root cause, I will question whether they have considered all of the possible causes in sufficient depth.

It is much more usual that the team will identify a number of possible causes of the problem. These causes may well have complex interactions, which will be difficult to disentangle, without substantial data gathering and mathematical analysis, most likely beyond many teams undertaking root cause analysis.

I believe that the best that can be expected is that the team will undertake a thorough analysis of all possible causes and identify a short list of causes, on which corrective actions can be taken. I don’t think that there is merit in teams at the point of identifying a short list, devoting time to try and find the single root cause of the problem, which I see teams attempting to do. If the team is successful in identifying the potential short list of causes, and corrective action is implemented on this short list, and is effective, then the problem will be eliminated. It is a key responsibility of the team to identify the causes on which action is to be taken.

Learn more about the techniques of problem solving by attending our Root Cause Analysis Control training course.


ISO 14971: 2007 – Content Deviation #4

During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices Directives (MDDs), namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these discrepancies are described in EN 14971 as “Content Deviations”. This newsletter deals with Content Deviation No. 4 - Risk/Benefit Analysis

Risk Benefit Analysis involves weighing the clinical benefits derived from the device against the risks inherent in using the device, known as the residual risks (i.e. those risks that have not been designed out).  Clauses 6.5 and 7 of ISO 14971 suggest that a Risk/Benefit Analysis is only required for risks that would otherwise be deemed unacceptable. Annex D.6.1 of ISO 14971 gives guidance that Risk/Benefit Analysis is not required for every risk. However, Essential Requirements 1 and 2 contained in Annex 1 of the MDDs require that a Risk/Benefit Analysis be performed for each risk and for the overall residual risk. In addition, Essential Requirement 6a of the MDDs also requires a Risk/Benefit Analysis as part of the conclusion in the clinical evaluation report (see MEDDEV 2.7.1 rev 3 http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf for guidance on the format and content of a clinical evaluation report).

The Medical Devices Directives require that a Risk/Benefit Analysis be performed for each individual risk and the totality of all residual risks—not just the risks that have been identified as unacceptable and irrespective of the magnitude of those risks. Performing Risk/ Benefit Analysis on risks that were hitherto described as acceptable or negligible risks may seem like an unnecessary and purely academic exercise; however this is required in order to conform to the Directives.

In order to comply with the Essential Requirements of the European Directives relating to Risk/Benefit Analysis  (i.e. the fourth content deviation between the ISO 14971 Standard and the Essential Requirements of the European Directives), a change is required to a manufacturer’s risk management process and procedures. To comply with EN ISO 14971:2012, it must be ensured that it is clear in the procedures that Risk/ Benefit Analysis is required for every risk regardless of magnitude. In the case of risks that cannot be justified by Risk/Benefit Analysis those risks cannot be considered acceptable and the product cannot be placed on the market unless those risks are eliminated or reduced to the point where they are outweighed by the clinical benefits of using the device. Risk/Benefit Analysis must take into account the risks of using the device given the current state of the art and alternative therapies that are available. This may mean that where new technologies become available, risks that were previously acceptable may no longer be justifiable.

In a previous blog, we determined that all risks must be reduced as far as possible, meaning an end to the concept of ALARP for devices sold in Europe. Combined with the requirement to perform Risk/Benefit Analysis, this effectively leaves only two classes of risk; those that have been reduced as far as possible and can be justified by Risk/ Benefit Analysis and those that cannot be justified by Risk/Benefit Analysis.

Clinical input is an essential component of Risk/Benefit Analysis. For companies that are currently involved in developing new products, access to clinical input should present no difficulty, but for companies that have older product lines, or are producing ’me-too’ devices or low risk devices, access to clinical input may require developing new relationships with clinicians where these do not already exist. Another possible difficulty could be reluctance by clinicians who have not been involved in the development stages of the product to sign off on Risk/ Benefit Analysis especially considering the litigious environment in which clinicians operate today.

However, clinical input need not always be direct clinical input. All devices placed on the market in Europe require a clinical evaluation.  In some cases this is achieved by a review of published clinical literature and post-market surveillance data so some form of clinical input will be available for every device already on the market. It is recommended that Risk/Benefit Analysis be included in the clinical evaluation process using the device’s residual risks as inputs to the clinical evaluation. The clinical evaluation report should include a statement as to whether these risks are outweighed by the clinical benefits of using the device.  The risk management report and the clinical evaluation should be cross-referenced. Both documents should provide traceability to each risk identified in the risk analysis, and decisions on risk acceptability should be based on the conclusions of the clinical evaluation. Risk Management Reports should state clearly that Risk/ Benefit Analysis has been preformed for the individual risks and for the totality of risk and that these risks are outweighed by the clinical benefits of using the device.

The clinical evaluation and Risk/Benefit analysis will need to be updated periodically following modifications to the device, in the event of adverse incidents and on foot of other post-market surveillance information. The need to do this should be included in the company’s Risk Management procedure as part of the system for period review of risk and in the company’ procedures on clinical evaluation and post market surveillance.

Compliance with Content Deviation Number Four will require updates to a number of procedures and to the format of Clinical Evaluation reports and Risk Management Reports. From the procedures and reports it should be clear that the total and individual risks associated with using the device are clearly out weighed by the clinical benefits.

My next blog will deal with Content Deviation #5 Risk Control for CE Marking Medical Devices

Submitted by John Lafferty, SQT Healthcare tutor

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