SQT Blog

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:

• Use 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:

http://www.airtricity.com/ie/home/smarter-energy/

http://www.bordgaisenergy.ie/energy-efficiency/home/

https://www.electricireland.ie/ei/residential-energy-services/home/index.jsp

http://www.energia.ie/Energy-Services/Energy-Efficiency

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.

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