Risk Assessment Philips Lumea IPL Intense Pulsed Light Hair Removal System SC2001/00 student name: Tom Fejér s-number: s101866 OUC31 - Risk Society Offline 2011 May word count: 2 118

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Introduction 3

Methodology 5

Risk Assessment 6

Risk Evaluation 12

Response Strategy 13

Annex 15

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Introduction The main goal of the risk assessment increasing product value while reducing cost by understanding the user, the environment, technology and discovering latent failures to predict and reduce possible failures and injuries. My chosen product is the Philips Lumea IPL Hair Removal System which is a relatively new product on the market (2010) using a completely new technology developed by Philips Research in more than 5 years.1 The product includes obvious risks by its nature (using intense light pulse, direct contact with the skin) and requires to learn how you can use it in an appropriate and safe way. This knowledge is communicated in numerous ways in a special interactive website (http://www.lumea.philips.com/) / tutorial videos on the Internet / DVD / product manual. In my assessment I will look through the possible failures of the different parts of the product. By that, and also by analyzing the complex steps of usage I will define and prioritize risks for giving response strategies what would make the product more safe and higher quality .

1Philips Product Manual SC2001 - 4203.000.6357.2

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Technology - IPL hair removal system The Intense Pulse Light (IPL) works by heating up the hair and the root beneath the skin using gentle pulses of light absorbed by hairs melanin. An internal optical filter ensures no UV light reaches the skin.1

Product introduction This appliance has been designed and developed for use by women only and is intended for removing body hair on areas of underarms, bikini area and legs.1

1Philips Product Manual SC2001 - 4203.000.6357.2

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Methodology DFSS - Design For Six Sigma The Design for Six Sigma is an emerging business-process management methodology2. steps of the 'design for six sigma' Proactive DEFINE - IDENTIFY - DESIGN - OPTIMIZE - VERIFY Reactive MEASURE - ANALYZE - IMPROVE - CONTROL - MONITOR FMEA - Failure Mode and Effects Analysis FMEA is a risk analyzing technique which helps you to investigate what could go wrong and define actions to reduce these risks. It is a brainstorming and thinking process based on a these steps: FUNCTIONS - FAILURE MODE - EFFECT - CAUSE MECHANISM - CONTROLS PREVENTION - CONTROLS DETECTION After the pre-work when I will have more detailed knowledge about the product, the circumstances of the usage (the process, steps, possible side effects and skin reactions) which is necessary to do the risk assessment. In this part also interesting to see what kind of safety measures had been taken by the design of the product and in the communication design. RPN - Risk Priority Number3 In my assessment I'll define three factors of the risks: severity (severity of the effect to the user) (1-10) occurrence (expected frequency of the failure) (1-10) detection (likelihood of the detection of the failure before the it affects) (1-10) severity x occurrence x detection = risk priority number These numbers will help to prioritize and categorize the risks. The advantage of this method is it is fast and gives prioritized results. On the other hand for a complete assessment necessary full understanding the mechanism and technology and when it is a brand new technique than it is a specially hard task.

2"Design for Six Sigma - From Wikipedia" Accessed 21 May 2011. <http://en.wikipedia.org/wiki/Design_for_Six_Sigma> 3 "Failure Mode and Effects Analysis - From Wikipedia" Accessed 21 May 2011. <http://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis>

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Risk Assessment Pre-work - General description1

A - Light exit window with filter glass B - Removable window C - Metallic surface inside the removable window D - Safety system (safety ring with contact switches) E - Flash button F - Intensity lights (1-5) G - Intensity increase button H - Intensity decrease button I - Charging light and battery low indication J - On/off button K - ‘Ready to flash’ light L - Appliance socket M - Adapter N - Small plug O - Air vents

Technical specifications4 Battery type: Lithium Ion Frequency: 50-60 Hz Power: 7.5 W Voltage: 100-240 V Light energy level: 2 - 6.5 J/cm² (depending on chosen setting) Light spectrum: >570 nm Estimated lamp lifetime:50,000 flashes Logistic data4 Product size: 120 x 100 x 119.5 mm Product weight (excl. packaging): 790 g Product weight (incl. packaging): 1.3 kg Country of origin: Hungary

1Philips Product Manual SC2001 - 4203.000.6357.2 4"Philips Lumea IPL hair removal system - Product Specifications" Accessed 21 May 2011. < http://www.philips.com.au/c/hair-removal/lumea-sc2001_00/prd/;jsessionid=4E80ED8513D04CFD77014903196C6AD2.app101-drp1?t=specifications>

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Exploded view - to get an overall picture about the structure of the product

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Using the appliance5 preparation5 - fully charged battery in 90 min. - charging light lights up green continuously than it’s charged - shave before treatments (for the first 4-5 times) - ensure the “window” is clear and free of dirt and hair - select light intensity - according to your skin and body-hair color (1-5)

usage5 (first time users should start with the skin-test) - switch on Lumea - find the level that suits you - place the window on your skin at 90° - contact all the switches of the window pushed on to your skin - the ‘ready to flash’ light turns on - press and release the flash button - you will see a flash repeat this action make sure you overlap areas (without flashing the exactly same place twice) ensure to leave the device from your skin between flashes repeat treatment every 2 weeks5 cleaning5 - clean after every treatment - before clean it turn it off and let it cool down - store it in the

5"Tutorial video - audio source" Accessed 21 May 2011. <http://www.philips.com.au/c/lumea-shaving/273487/cat/#/intro>

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worksheet1 - based on the diagram

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worksheet2 - based on the diagram

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Risk Evaluation color codes for the table I. green - no action required at the moment (0-120) II. yellow - low priority (120-190) III. orange - high priority (190-250) IV. red - highest priority (>250) The first part of the evaluation (with the color codes) helped ranking the risk scenarios and possible failure modes. This worksheet can be helpful for the further development of the product by preventing possible errors and by increasing quality to reach a better user experience. We should also characterize the risks qualitatively. How can this product effects on the user and which failure modes means real danger for the user? In this case quantitative data is not available because the product was only introduced last year. This new technology works completely differently than the typical permanent laser hair removal treatments on the market which are always controlled by a trained beauty specialist. Anyway, we can assume (based on the function and the price of the product) most of the user are grown up females and they use the product as an additional beauty tool so they were voluntarily chose to use the product. This means a consumer behavior which is willing to learn about the safety and effective usage of the product. As I familiarized myself with the product I experienced that Philips tried to overprotect the product and teach the users for the safe usage in multiple ways (by booklets, website, dvd). I would like to highlight the 'ready to flash' feature built in to the product which is prevent unwanted / dangerous flashing when you don't push the product to your skin properly. The most controversial aspect of handling risks refers to the process of dealing and justifying a judgment about the tolerability or acceptability of a given risk (HSE,2001). The traffic light model represents an oversimplification, but still a helpful tool to categorize risks. With this we can label the risks to three different categories: acceptable, tolerable, intolerable. In my color codes the color green matches for the acceptable risks (where no additional action required for risk reduction), and the rest of the colors refers to the tolerable risks(some actions required ). I couldn't find any failure mode or horrible possible effect where I could categorize the risk as intolerable.

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Risk Analysis Conclusion The FMEA analysis is a really useful effective tool in product design and development. Investigate about what can possibly goes wrong, how does it effect on the user and what can a designer, engineer or marketing communication person do to prevent these failures / injuries. Another practical advantage of this method is the prioritized failure modes and actions which also helps focusing on the bigger issues during the development. The elements of the analysis such as the block diagram and the worksheet are helpful tools to look through a complex system. The results of the assessment are not complete and based on my personal impression because of the lack of information I could get access. Also because as it was described it is a very new product and technology on the market which means there are still not much feedback and information available about the accidents, injuries or long term effects. Meanwhile these kind of assessments helps to develop the product and prevent bigger or smaller failures and injuries.

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Response Strategy - concepts Ready to flash light reposition With repositioning the 'ready to flash light' or make it visible on other parts of the machine would make this feedback visible in those positions when the back part is not visible.

Indicator lights Visible feedback - not only on the small UI in the front - from the light intensity

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Safety strap This would prevent the accidents when the cause is the appliance was dropped down.

Hard plastic case To avoid the dust / mechanical damage.

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Annex students feedback With my fellow students we took two round of exchanging our reports - first when these were still in draft form and second time when we finalized the documents based on the feedbacks we get. "The report has a professional look and feel, and contains lots of information about the product. Having access to this detailed information about the product helped to create a solid risk assessment. The FMEA analysis has a clear structure and it is easy to see which are the important and less important failure modes thanks to the color coding. The response strategy is like the rest of the report, also visually appealing and clear. I would like to have seen some more details, just like in the pre-analysis and FMEA analysis. For example, some predictions about which of the factors (occurrence, detection or rpn) is influenced by the proposed improvement. "

Pepijn Fens, 30-05-2011 "In your initial statement in the introduction, you claim that your goal is to ‘increase product value while reducing cost by predicting possible failures and injuries’. I think this is an important idea to address in your conclusion and response strategy. At first all I saw in your Response Strategy were additional UI elements, an extra case and a strap, which while solving the problems, would increase the cost of the product. I think you need to communicate to stake-holders that these are necessary costs that are justified by the need to avoid harm to the user which could result in a negative image of the company and potential law-suits. Your methodology is described clearly and scientifically, but what I would have liked to know in addition, is why you chose this method for you assessment, and how your paper links in with the concepts described in the literature to this course (Ortwin Renn – Risk Governance). I accept your premise that the RPN is a very useful indicator, and while you have described how it is calculated I am not sure where the information for the severity, occurrence and detection indexes came from, and how it is translated into a 1-10 rating. I would also suggest that you rename Risk Analysis Conclusion to something like Reflection on Method, and that in the conclusion you briefly describe the nature of the risks you have discovered as described in the literature (i.e. traffic-light system). You have given clear priorities to the risks that exist, but haven’t described which risks are acceptable and which require redesign. Don’t forget that risk perception is also a major influence and that objective handling of risk does not solve all your issues. What I mean is that a risk with 0.0001% probability of occurrence and 100% severity is still a huge problem while it will be ranked low in the FMEA priorities. Because of your methodology you have focused a lot on the functionality of the product and the interaction with it, but as a general suggestion I would urge you to be careful that this doesn’t over-power the work you have done in the assessment."

Erik Kogler, 31-05-2011

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source of the pictures cover - promo picture from the philips website + photoshop pg3 - promo pictures from the website pg4 - screen shot from the tutorial video / sketch by me pg6 - illustration from the manual pg7 - sketch by me pg8 - screen shots from the tutorial video pg9 - block diagram by me (used illustrations from the manual) pg13-14 sketches by me