BAB I - Effective product safety management is really all about preventing errors. - It is impossible to eliminate all hazards from any product. Hazard - A hazard is defined as a potential source of harm. - Hazard can range from the relatively minor to the very severe - Hazards can also range from relatively low exposure “inaccessible” to a relatively high exposure 100% accessible Risk - Risk is used to express the combination of hazard severity and exposure (probability of harm) - Risk is the most appropriate measure of product safety because it includes both exposure and severity factors Safety - Safety is defined as freedom from unacceptable risk - Safety is defined as freedom from unreasonable risk Unreasonable risk - Product must be designed for reasonably foreseeable use and misuse by the user - Manufacturer may need to consider human factors and perform surveys and human test trials to obtain information on reasonably foreseeable use and misuse - Considerations that could establish whether the risk is reasonable/acceptable: 1. Kegunaan dan keberadaan product berpengaruh terhadap ekonomi dan social benefits dan biaya 2. Bahayanya udah jelas 3. Tidak adanya opsi produk lain 4. The avoidability of injury by reasonable care in the use of the product 5. Common knowledge and normal public expectation of the danger - Bahaya baru dapat muncul seiring perkembangan teknologi State of the art - State of the art means the level of technical knowledge and standards that exist at the time of product creation - Excellence is both possible and expected → achieved by maintaining a state of the art product safety process Invest in Prevention - The only way to achieve excellence in product safety is to prevent defects from occurring in the first place - Pencegahan lebih mudah daripada mengeliminasi setelah defect terjadi - The earlier the easier and less cost Design defects and recalls - Majority recalls and injuries in the past decade were a result of design defects - Design defect berpengaruh 100% ke produk Voluntary and regulatory requirement and recalls - Achieving product safety excellence is much more than just meeting generic safety standards - Product design assessment must also include hazard identification checklists, reviewing general injury information, understanding human factors, and evaluating foreseeable product use and misuse Comprehension VS Commitment - Achieving product safety excellence is not about getting more worker commitment - Achieving product safety excellence is about comprehension → understanding what to do and how to do it. It is about educating the organization to understand and apply the right tools and processes The seven vital elements - The key to achieving product safety excellence can be reduced to just seven necessary elements - With all seven elements in place, a business can achieve excellence in product safety 1. Technical collaboration - using knowledge resources 2. Concept evaluation - achieving inherently safe designs 3. Design qualification - confirming safety, reliability, and manufacturability 4. Supplier qualification - verifying capabilities, capacities, controls, and commitment 5. Product qualification - documenting design and process and testing conformance 6. Supplier quality process - verifying process performance 7. Strategic auditing - monitoring, confirming, and improving effectiveness of prevention systems - Even on of the elements is missing or inadequate, success is jeopardized, and defects, waste, and product liability become significant problems BAB II - Lack of knowledge is a major root cause of product safety errors Technical collaboration the communication and information exchange with the outside network of knowledge resources is necessary when dealing with new and unusual product concepts Discovering needed knowledge - The things we dont know about are the areas of concern - The things that we know we dont know about arent usually a problem area → expert assistance - Things we dont know we dont know about are the big troublemakers - Trying to maintain all of this diverse expertise within the company’s organization would be inefficient and cost prohibitive - More cost effective to augment the company organization with outside technical and product safety resources that are available when needed Neiss Information - The information provided by NEISS can be very valuable when considering expanding your product line into new product - Prevent similar injury with new products CPSC recall history - When evaluating and assessing potential new product categories, a review of product recall information for similar products can be very beneficial and can help prevent from making similar mistakes - A comprehensive product safety process uses product recall information as one part of a complete review of new product concepts Trade Associations - An organization of business that operate in a specific industry - Main focus: collaboration between member companies for industry standardization, especially product safety standards. - Technical collaboration with trade associations can provide important safety knowledge on safety standards - Provide critical information on standard rationales and emerging hazards Medical expertise and academia - Butuh medical specialists atau akademisi apalagi untuk produk baru yang menggunakan new material formulations that could present concerns relating to toxicity dll Laboratories and consulting firms - Resources can provide useful interpretations and explanations of safety requirements and test procedures Partner supplier input - Strategic partnership is a commitment by both the supplier and the customer (company) to a long term relationship involving joint business planning and a sharing of strategies, cost, and technology - Compatible values and a strong ethical foundation are essential criteria for selecting a partner supplier - Early collaboration with partner suppliers will help you to be more knowledgeable and circumspect in the quest for product safety excellence Benchmarking and competition - Beneficial to routinely meet with best inc alss companies to search for new ideas, processes, methods, and best practices - Sharing information would be beneficial for both companies and most importantly consumer - Benchmarking helps a company keep current with SOTA product safety technology, processes, and standards - Beneficial to routinely test and evaluate the product of your major competition - Primary focus on the consumer Summary - Those resource tools can help ensure thorough and comprehensive evaluations that will keep your products and processes SOTA with respect to product safety BAB III - Concept evaluation the earliest stage of product design and development occurs when the product is only and idea or a general concept Early safety influence - Over time the organization becomes more and more attached to a product and any efforts to make late changes may be met with objections because of lead time, delivery, cost, and emotional product attachment issues - This can lead to compromises - Downside dari investasi di concept stage, tidak jarang konsep produk tidak jadi dikeluarkan karena tidak layak. Kerugian ini termasuk kecil dibandingkan benefit yang didapat dari investasi early safety influence. Kalau produk layak jadi bagus - Product safety resources must be invested in every new product concept, regardless of its eventual fate Hazard identifications checklists - Identification and evaluation of potential hazards - Ensure design concept is thoroughly evaluated for potential hazards - Harus selalu diupgrade ketika ada informasi baru dan new product experience occur - Information from mandatory and industry safety standards and their rationales should also be factored into the HIC - Include information from technical collaboration activities - HIC is living and evolving tool that serves to ensure that thorough evaluations occur for all potential hazards Energy hazard relationship - It can generally be stated that all products become hazardous upon the transfer of energy in excessive amounts - Kinetic energy and potential energy Foreseeable use and misuse - The product must also remain safe when it is subjected to reasonably foreseeable use and misuse - New product concept evaluation must include an assessment of reasonable use and misuse Intended use and product labeling - Evaluating any consumer product for intended use, several factors must be considered: 1. Manufacturers stated intent: label on the product or on the packaging. Only one factor 2. Product’s advertising, promotion, and marketing: communicate a clear and specific message about appropriate and reasonable use: label 8 tahun tapi modelnya 3 tahun jadi bisa dianggep bisa buat 3 tahun 3. Commonly recognized use of the product: Teddy bear Consumer assembly - Assembly harus mudah dilakukan, sisanya ada instruksi dll (specified tools harus disediakan produk) Product operation - Proper operation of the product by the consumer must be intuitive and fool proof Product packaging - Packaging should be minimized - Convenient and safe fo the consumer to remove Claim substantiation - Claim is any representation whether stated or implied concerning a product or service attribute - Never exaggerate or fail to substantiate any claim directed to the consumer - Avoid general terms Different use environments - The product concept evaluation must consider that the product will be use in various environmental conditions Expected product life - Product reliability - A product safety rule of thumb is to test and qualify products for three times the normal lifetime of the product Alternative consumer uses - Important when establishing requirements for children’s products Human factors - Anthropometry, strengths, capabilities - HF information is necessary when performing comprehensive safety assessments during new product concept evaluations - Fishhook effects Technical collaboration input - HIC, foreseeable use and misuse eval, and HFA → ensure product concept evaluation is thorough and circumspect Warning Label Problems Avoiding hazard elimination - First problem, warnings is that they are sometimes used in lieu of addressing the actual product hazard Failing to influence user behavior - Second problem associated with warnings is that they are often ineffective - In order for a warning label to be effective it must trigger five consumer responses 1. It must be noticed. Does it attract the consumer’s attention? 2. It must be read. Is the consumer likely to read it? 3. It must be understood. Does the consumer comprehend it? 4. It must be remembered. Will the consumer recall it? 5. It must be compiled with. Will it influence consumer behaviour - Warning label effectiveness depends on several conditions: 1. Consumer must be able to read 2. Must be alert, sober, and not overloaded with other information 3. Label must be convenient and noticeable, large enough with sufficient contrast 4. Label must be brief, legible, easily understood 5. label must make consumer believe there is significant hazard 6. Consumer must not accept the risk or consider the cost of compliance to be greater than cost of ignoring the label Inappropriate for children - Young children will not read and heed them - Warning is not an option - Warning intended for parent or caregiver Summary - Primary objective: make products inherently safe so that warnings are not needed - When hazard cannot be eliminated, the objective is to provide a guard or some other means of reducing the danger to an acceptable level. Warning should be always last resort Concept risk assessment - Risk analysis and the risk evaluation of that concept - Risk analysis: identification of hazards and the estimation of associated risks - Risk evaluation: judgment of risk acceptability - - - Risk assessment: identification of all potential hazard, the estimation of the association hazard risks, and judgment of whether the risks that cannot be reasonably eliminated are acceptable Identified potential hazards → foreseeable use and misuse have been assessed → HF considered → technical collaboration has occurred → the risks can be assessed→ concept can be evaluated. Two analytical tools can be helpful when evaluating new product concepts 1. FMEA (failure modes and effects analysis) Determining the effects a component failure would have on the entire product.The data provide the bases for determining how and where component changes can be made to improve the probability that the product will function successfully. Bottom up methodology. The main purpose FMEA evaluate the frequency and consequences of critical component failures. Engineering judgement is usually used to identify the critical components 2. FTA - Reverse of FMEA. supposing that the product has failed and considers the possible causes that could have led to failure
