Managers who are now determined to compete on quality have been thrown back on the old questions: How much quality is enough? These are still hard questions today. One thing is certain: high quality means pleasing consumers, not just protecting them from annoyances. Even consumer complaints play a new role because they provide a valuable source of product information.
But managers have to take a more preliminary step—a crucial one, however obvious it may appear. They must first develop a clear vocabulary with which to discuss quality as strategy. They must break down the word quality into manageable parts. Only then can they define the quality niches in which to compete. I propose eight critical dimensions or categories of quality that can serve as a framework for strategic analysis: performance, features, reliability, conformance, durability, serviceability, aesthetics, and perceived quality. A product or service can rank high on one dimension of quality and low on another—indeed, an improvement in one may be achieved only at the expense of another.
It is precisely this interplay that makes strategic quality management possible; the challenge to managers is to compete on selected dimensions. For an automobile, performance would include traits like acceleration, handling, cruising speed, and comfort; for a television set, performance means sound and picture clarity, color, and the ability to receive distant stations. In service businesses—say, fast food and airlines—performance often means prompt service. Because this dimension of quality involves measurable attributes, brands can usually be ranked objectively on individual aspects of performance.
Overall performance rankings, however, are more difficult to develop, especially when they involve benefits that not every consumer needs. Suppose, however, that the two shovels possessed the identical capacity—60 cubic yards per hour—but achieved it differently: one with a 1-cubic-yard bucket operating at 60 cycles per hour, the other with a 2-cubic-yard bucket operating at 30 cycles per hour. The capacities of the shovels would then be the same, but the shovel with the larger bucket could handle massive boulders while the shovel with the smaller bucket could perform precision work.
A watt light bulb provides greater candlepower than a watt bulb, yet few customers would regard the difference as a measure of quality. The bulbs simply belong to different performance classes. So the question of whether performance differences are quality differences may depend on circumstantial preferences—but preferences based on functional requirements, not taste. Some performance standards are based on subjective preferences, but the preferences are so universal that they have the force of an objective standard.
Some people like a dimmer room, but who wants a noisy car? Similar thinking can be applied to features, a second dimension of quality that is often a secondary aspect of performance. Examples include free drinks on a plane, permanent-press cycles on a washing machine, and automatic tuners on a color television set. The line separating primary performance characteristics from secondary features is often difficult to draw. What is crucial, again, is that features involve objective and measurable attributes; objective individual needs, not prejudices, affect their translation into quality differences.
To many customers, of course, superior quality is less a reflection of the availability of particular features than of the total number of options available. Often, choice is quality: buyers may wish to customize or personalize their purchases. By offering their clients a wide range of funds covering such diverse fields as health care, technology, and energy—and by then encouraging clients to shift savings among these—they have virtually tailored investment portfolios.
Employing the latest in flexible manufacturing technology, Allen-Bradley customizes starter motors for its buyers without having to price its products prohibitively. Fine furniture stores offer their customers countless variations in fabric and color. Such strategies impose heavy demands on operating managers; they are an aspect of quality likely to grow in importance with the perfection of flexible manufacturing technology. This dimension reflects the probability of a product malfunctioning or failing within a specified time period.
Among the most common measures of reliability are the mean time to first failure, the mean time between failures, and the failure rate per unit time. Because these measures require a product to be in use for a specified period, they are more relevant to durable goods than to products and services that are consumed instantly. Reliability normally becomes more important to consumers as downtime and maintenance become more expensive. Farmers, for example, are especially sensitive to downtime during the short harvest season.
Reliable equipment can mean the difference between a good year and spoiled crops. But consumers in other markets are more attuned than ever to product reliability too. Computers and copying machines certainly compete on this basis. Nor is the government, our biggest single consumer, immune. This dimension owes the most to the traditional approaches to quality pioneered by experts like Juran. All products and services involve specifications of some sort. When new designs or models are developed, dimensions are set for parts and purity standards for materials.
Because this approach to conformance equates good quality with operating inside a tolerance band, there is little interest in whether specifications have been met exactly. For the most part, dispersion within specification limits is ignored. Should one part fall at a lower limit of its specification, and a matching part at its upper limit, a tight fit is unlikely.
Even if the parts are rated acceptable initially, the link between them is likely to wear more quickly than one made from parts whose dimensions have been centered more exactly. To address this problem, a more imaginative approach to conformance has emerged. It is closely associated with Japanese manufacturers and the work of Genichi Taguchi, a prizewinning Japanese statistician. These losses include warranty costs, nonrepeating customers, and other problems resulting from performance failure. Taguchi then compares such losses to two alternative approaches to quality: on the one hand, simple conformance to specifications, and on the other, a measure of the degree to which parts or products diverge from the ideal target or center.
Traditional approaches favor production process 2. The challenge for quality managers is obvious. Exhibit Two approaches to conformance Source: L. Incidentally, the two most common measures of failure in conformance—for Taguchi and everyone else—are defect rates in the factory and, once a product is in the hands of the customer, the incidence of service calls.
But these measures neglect other deviations from standard, like misspelled labels or shoddy construction, that do not lead to service or repair. In service businesses, measures of conformance normally focus on accuracy and timeliness and include counts of processing errors, unanticipated delays, and other frequent mistakes.
A measure of product life, durability has both economic and technical dimensions. Technically, durability can be defined as the amount of use one gets from a product before it deteriorates. After so many hours of use, the filament of a light bulb burns up and the bulb must be replaced. Repair is impossible.
In other cases, consumers must weigh the expected cost, in both dollars and personal inconvenience, of future repairs against the investment and operating expenses of a newer, more reliable model. Durability, then, may be defined as the amount of use one gets from a product before it breaks down and replacement is preferable to continued repair. This approach to durability has two important implications.
First, it suggests that durability and reliability are closely linked. A product that often fails is likely to be scrapped earlier than one that is more reliable; repair costs will be correspondingly higher and the purchase of a competitive brand will look that much more desirable. Because of this linkage, companies sometimes try to reassure customers by offering lifetime guarantees on their products, as 3M has done with its videocassettes.
Second, this approach implies that durability figures should be interpreted with care.
We better get it right. Richard Kravitz. Each has a different purpose and these different outcomes are not dependent on each other — though they may be correlated to a greater or lesser extent [ 53 ]. Research into HRQL is more extensive than that into the other outcomes but it is questionable whether it has reached a particularly high quality in most cases. Further research is required to improve the assessment of HRQL and into assessment of the other outcomes. There is no reason why, for example, development work on the assessment of QoL should be sacrificed to increase efforts to assess patient satisfaction.
However, it seems likely that market forces will govern where research efforts are directed. As the different types of outcome are based on different measurement models and have dissimilar aims, one type of outcome cannot and should not be seen as a surrogate for another. The science of patient-reported outcome measurement has been hindered by the practice of taking measures of one type of outcome and implying that they assess a different outcome.
Instruments such as the Sickness Impact Profile [ 54 ], Nottingham Health Profile [ 55 ] and SF [ 56 ] were developed as health status instruments for use in population surveys as indicated by their authors. Over the years they have become commonly referred to as 'QoL' measures, as the need arose to assess this construct in clinical trials. As a consequence of their widespread use in this context, relatively few 'true' QoL instruments are now available, limiting our ability to determine the true overall impact of disease and its treatment on the patient.
Care must also be taken in using the terms 'health needs' and 'needs' interchangeably. HRQL restricts consideration to issues that are capable of influence by health services [ 57 ] and, consequently, misses many important aspects of a patient's QoL which may benefit from an improvement in health status. As defined in the editorial, 'health needs' are also restricted to ways in which 'health services can improve overall health'. This could lead to the conclusion that health needs have been satisfied while neglecting the fact that this has been at the cost of other needs.
For example; economic needs may be increased as a result of paying for treatment, emotional needs may be adversely affected by certain pharmaceutical treatments or appearance needs may deteriorate following radical surgery. Proponents of the needs-based approach postulate that life gains its quality from the ability and capacity of the individual to satisfy their needs either inborn or learned during socialisation processes [ 58 ].
Functions such as employment, hobbies and socialising are important only insofar as they provide the means by which these needs can be fulfilled. In this approach it is taken as axiomatic that QoL is high when most human needs not just health needs are fulfilled and low when few needs are being satisfied. Again, focusing only on those needs that can be influenced by health services will give an incomplete picture of their value to patients.
In order to evaluate the benefits of any service it is essential to have high quality instruments with good psychometric properties. For most diseases such instruments are lacking for all types of outcomes listed above. Extensive instrument development work is required in each of these outcome areas.
Consequently, it is too soon to talk of achieving a 'balance' or reducing efforts into any one particular type of patient-reported outcome. Stephen P. Each of the three broad areas addresses a potentially different and important field. Many measures of quality-of-life reflect the views and judgements of the experts. The respondent is asked to indicate whether or not they can perform or feel in a certain way. Dependent upon the answer a judgement is made usually on statistical basis that they have what do not have a high quality of life.
In Needs analysis the respondent is often asked for their judgement about whether or not they have a need in a particular area. This allows the respondent themselves to determine priorities and perceptions of what assistance they require. It is this area of research which currently requires more effort on development of both the theoretical and pragmatic aspects of measurement.
More than balancing current research in the evaluation of health status, needs, satisfaction and quality of life, the integration of these scientific researches in the assistance process is, in my opinion, the most important challenge that is currently set to the health agents. Luis Prieto. Since the mids there seems to have been an increase in research focusing on health status, satisfaction, and quality of life as independent concepts. Very little seems to have focused on needs. Even fewer if any efforts have attempted to study the inter-relationships between health status, needs, satisfaction, and quality of life.
Chris Haffer. Rather than reducing either, we should continue to strive for combining them in meaningful ways that each "side" understands and values. Why these two alternatives? I would like to see more of both, but especially more on discriminating between the characteristics of the main Health Related QoL measures, their empirical significance, and their usefulness to organisations such as NICE. Any sensible answer to this question has to begin by asking 'what the research is for? I have read the editorial with interest but also with some confusion.
After some thinking I find my confusion might arise from the fact that in orthopaedics we deal with diseases that you do not die from at least not primarily. This applies to your open question 2, research on QOL or survival. That is not applicable to my area, if we do not take prosthesis survival into account. This is how orthopaedic surgeons have assessed the success of total joint replacement for years. Generally, assessing QOL in musculoskeletal disease seem the most appropriate in clinical studies since the correlation between the patients perspective and impairments such as radiographic status is poor.
Ewa Roos. Which area should "pay" for an increase in the number of studies on needs and satisfaction assessment? In my opinion, we have too many disease targeted QOL measures. Although these measures are sometimes sensitive to clinical change in specific populations, they do not clearly guide us toward overall better outcomes. The degree of focus on health status or Health Related Quality of Life HRQL measures compared to more traditional clinical outcomes depends on a number of factors.
Typically, if the disease state and the outcomes of treatment can best be reported by the patient e. A second consideration is whether achieving a particular clinical endpoint is the primary objective of a medical treatment. In palliative care, for example, patient comfort and well-being may be favored over aggressive chemotherapies that might provide a limited extension of life.
PROs may also be given equal weight in situations where the costs of treatment are considered against the degree to which such treatments provide some larger societal benefit. In Europe, for example, QALYs are a routine part of formulary decisions and patient access to competing treatments. In contrast, the market access in the USA is less centrally determined and to some degree diverse market forces determine medication availability.
Thus a variety of cultural and clinical factors need to be considered when addressing this question and advances in outcomes research are not by any means uniform. Mark J. Perhaps the question would be: in which contexts type, stage of disease, treatment side effects , should health status and QoL studies be expanded? Both can be measured. Where more thought and research is required is how to combine results from different types of endpoint.
For example, what if in a clinical trial one group experiences improved survival, but worse quality of life? What if an intervention affects a clinical outcome, such as a pain score, but does not appear to have an important effect on quality of life? This question begs a Solomonic response: both "subjective" measures such as health status and quality of life and "objective" measures such as morbidity and mortality are critically informative, but in different ways.
Creating a parsimonious set of generic health measures absent a larger set of disease-specific measures is extremely seductive but ultimately misguided. The reason is that medical care can extend lives and improve function but cannot, ultimately, make people happy. It is difficult to make a judgement about this issue without having a clearer idea about the clinical topic which is being addressed.
For example in the area of cancer control that has not been a clinically significant improvement in mortality for some types of cancer. Here the research focus should continue to be on health status, perceived need, and quality-of-life until the interventions exist which will substantively increase the length of life. When this occurs there will be a need to balance the length of life with the quality of that experience.
The challenge, again, is in the integration of these two ways of health assessment. Despite the quality-adjusted life year QALY continue to represent the paradigm of the integration of the biomedical and the psychosocial models, this indicator has been criticised on technical and ethical grounds. A salient problem relies on the numerical nature of its constituent parts. The appropriateness of the QALY arithmetical operation is compromised by the essence of the utility scale: while life-years are expressed in a ratio scale with a true zero, the utility is an interval scale where 0 is an arbitrary value for death.
In order to be able to obtain coherent results, both scales would have to be expressed in the same units of measurement.server.geod.in/harry-potter-madrid-2020.php
Competing on the Eight Dimensions of Quality
The different nature of these two factors jeopardises the current meaning and interpretation of QALYs. Further steps in the integration of different health dimensions, like quality of life and survival, are thus necessary. Rather than viewing these research foci as being in competition, I believe it is more beneficial to view each as complimentary. Both bring unique value to and are essential in providing effective patient care. In other words, they both measure different components of the same phenomenon and both are necessary to maximize positive patient outcomes.
James T. Although there has been an increase in health related quality of life studies over the last decade, there remain major gaps in the literature. Decisions about areas of priorities and the balance of studies must be driven by the research questions to be answered. There continue to be too many isolated studies, with small samples; rather than multi-site investigations combining samples using standardized measures with established protocols. We also need additional studies related to methods, such as determining the best times to measure quality of life in relation to the critical events we are trying to capture.
Evidence related to ethnically diverse populations is just beginning to emerge and as our world becomes smaller with the use of increased technology, these studies will only enrich our interventions. As our knowledge base grows, clarity will evolve about how HRQL relates to other variables. It's important we design studies that help to clarify the mechanisms to effect predictors and outcomes. Clinically, standardized HRQL measures can enhance screening patients for clinical problems and monitoring them for changes; but overall this process will not take the place of asking patients what they want and what helps to improve their health.
With the increased opportunities to do collaborative research across continents, it is a time to increase our efforts to do HRQL research not to reduce them. However, our studies must be theory driven, well designed, multi-site, and build on our previous work. Ruth McCorkle. Neither should be reduced. Instead incentives should be provided which would encourage researchers to undertake studies on the undeserved topics mentioned above.
Incentives could be: financial providing money to support the work , educational encouraging students to undertake dissertations and theses in the areas , or professional thematic journal issues dedicated only to publishing research on particular topics. Yes, this kind of risk always emerges when one tries to use a related concept to estimate another. I would say, not at all to the former and only to the extent that it correlated with a conceptually correct version might the answer to the second be affirmative.
In orthopedics, measures of satisfaction have been used to determine the outcome of total joint replacement. I am however concerned about the single question that has been used. From unpublished data I know that patients reporting to be satisfied with a total knee replacement may have revision surgery within a year. This is bothering when considering validity of the satisfaction question. I do not think that QOL measures can serve as surrogates for satisfaction and needs. In fact, it is important to maintain independence. For example, it would be valuable to demonstrate that satisfaction goes up when outcomes improve.
However, evidence is necessary to demonstrate this relationship. Important conceptual and practical distinctions exist between HRQL and treatment satisfaction and more broadly, patient satisfaction. As the term suggests, Quality of Life is typically considered a quality or characteristic of one's life and HRQL is an independently definable quality or state of one's life or health.
Although such perceptions are subjectively influenced by disease processes, they are thought to exist somewhat universally and independently of particular life events and circumstances. Indeed, both HRQL and satisfaction constructs are both strongly influenced by the effects of illness and moderated by the effects of available treatments. Nevertheless, these classes of PROs differ in some profound ways. A closer inspection reveals that satisfaction measures are actually composed of questions asking patients to make judgments or appraisals about a specific set of treatment-related events and experiences.
HRQL and Health Status, on the other hand, are appraisals of a quality or status of one's health, and thought to exist somewhat independently of specific situational events. Such a distinction between the two types of measures is more clearly appreciated when one realizes that HRQL measures may be used prior to starting a treatment at baseline but that the same cannot be said for treatment satisfaction. Prior to the occurrence of a treatment event, one cannot assess treatment satisfaction only the expectations or anticipations towards future treatment events.
Moreover, such expectations have been shown to be relatively weak predictors of patients' later satisfaction with treatment [ 59 ]. Thus treatment satisfaction can be thought of as an experiential appraisal of the degree to which a current treatment has been able to moderate the impact of illness without being causing bothersome side effects or be a great inconvenience. Such a distinction may explain why measures of treatment satisfaction do not seem to be as strongly associated with patients' emotional states as HRQL measures [ 60 ].
Any decision to use one as a proxy for another would be based on a fair number of assumptions that are not yet well understood. A parallel can be drawn between 'patient need' as defined by the authors of this author, namely, a state of discrepancy from a condition that most healthy persons would be expected to possess. Patients who experienced an important improvement in quality of life are likely to be more satisfied that those who do not; however, a patient who responds dramatically to a treatment my have poor satisfaction if, for example, the clinician was rude, treatment overly expensive or waiting times too long.
Quality of life, satisfaction and needs are distinct concepts that should largely be measured separately; that said, it is not always important to measure all three. This question cannot be addressed without a clear conceptual model linking medical care to physiological and psychological health to quality of life and satisfaction [ 61 ]. Quality of life is not a proxy for satisfaction unless measured using scales that incorporate patients' own utilities. I really appreciate the discussion you approached in this paper. Several years ago, physicians tried to treat a disease, supposing that a reduction in the tumoural mass could improve patients' health status.
In this context, complete or partial responses by the tumour were classified as "response rate", and the response rate was considered as the main outcome of a treatment.
Unfortunately, it was easy to demonstrate that response rate and overall survival were not always correlated; response rate was classified as an index of activity and overall survival as an index of efficacy of a treatment, using response rate as a surrogate index of efficacy in clinical practice. Likewise, after the first enthusiastic results of chemotherapy against metastatic tumours, a plateau in the outcomes was rapidly reached, and all oncologists met a sort of stalemate in the results of their approaches, regardless the introductions of new molecules or new schedules.
It was the time when the oncologists became aware of the side effects of chemotherapy, and beyond side effects, the way to overcome the resistance to chemotherapy and to outcome improvement were considered. Unfortunately, neither the CSF, nor the other cytoprotectans favoured a significant improve in the outcomes of treatment of the most part of solid tumours, although it was evident that chemotherapy could be better tolerated with the use of appropriate supportive approaches.
When it became evident that an improve in overall survival could not be so easy to obtain with standard chemotherapy in a large part of solid tumours, the oncologists reconsidered the problem of the symptoms burden, hypothesising both a possible role of chemotherapy in the treatment of cancer-related symptoms, and a direct relationship between response rate and symptoms improve. Two approaches were followed:.
The identification of arbitrary indices to define and assess the clinical benefit in cancer-related symptoms with chemotherapy;. The identification of a new field for clinical research, in which quality of life or better "health-related quality of life" was defined as an outcome for a medical approach. Did health-related quality of life represent an outcome both in patient's and physician's points of view? In this context this paper about patients' needs, satisfaction and quality of life intervenes approaching some controversial aspects of the problem:.
Are the researches in quality of life, patients' needs or satisfaction adequately approached in clinical setting? In my opinion the response is no, as we are still creating in our mind a surrogate index of the needs of patients that is still too much "physician-related" but too-little "patient-related".
Can improvement in health-related quality of life be assumed as an index of satisfaction of the patient? In my opinion the response is no, because it only represents the "health-related" dimension of quality of life, that could be strictly related to, but shall not be considered the same of patient satisfaction. Are we sure that we have all the instruments to assess the needs and satisfaction of our patients? I do not know, but I fear for two potential risks that we will be contented with the easiest solution of some surrogate composite indices of satisfaction as occurred with clinical benefit and quality of life in clinical oncology avoiding to define better instruments to assess needs and satisfaction, or, worse, that the needs and satisfaction assessment or their surrogate indices will be used as an instrument for a political or administrative consent, that is so far from- but unfortunately even so near to- the real dimension of patients.
Davide Tassinari. The use of the word proxy is in my opinion inappropriate: Quality of life, Qol Health Care Needs HCN and Satisfaction Sat are all distinct concepts and Qol cannot be assessed "in the place of" the other two. An attempt to prove this replaceability was made by measuring the correlation between them [ 3 ] the absence of such correlation would be surprising!! A sound proof would have been to demonstrate that the contents of the three concepts are equivalent, but, unfortunately, this is not true also when speaking of different instruments for quality of life evaluation and is very likely to be false for the three concepts in examination.
Identifying quality of life score cut-offs able to detect high levels of HCNs or low levels of Sat at an appreciable degree of sensitivity and specificity would be useful but would not solve the problem to have valid and reliable instruments for HCNs and Sat assessment. Cinzia Brunelli. Views will vary. However if we assume the needs of patients represent their judgement about whether or not they wish to receive assistance with a particular area, reflected an item on questionnaire, then quality-of-life should not be used as a proxy.
For example patients suffering from chronic condition may experience a substantive pain, not be able to take care of themselves and lack of mobility. For most quality-of-life scales this would be reflected in a low score. A poor quality-of-life.
This maybe an accurate representation of the respondents experience. However, perceived needs may reflect what the respondent may wish to have improved. That is, they may indicate while that they are experiencing considerable pain is not that that they wish assistance with but how to deal more effectively with the medical system or get help for their partner. Given this scenario it is clear that quality-of-life should not be used as a surrogate measure for perceived needs. This is a question that must be responded with empirical evidence. In my opinion, there is a likely relationship between the concepts, but the direction and strength of this association must be ascertained in practice.
The strongest sites in our analysis tended to have a higher number of products with CQAs: 71 percent for high performers versus 40 percent for poor performers. However, unless sites linked these CQAs directly to their shop-floor processes, the impact was limited. At sites with the best quality performance, 70 percent of products had CQAs defined and linked to CCPs, while sites with the highest share of low-quality products had only 33 percent of their products formally characterized this way Exhibit 2. Operational maturity: people. Device manufacturers can reduce deviation levels and recurrence by addressing operational structural factors, such as better employee-retention activities and shared quality targets.
Our analysis found that sites with higher product quality have lower employee turnover. At the high performers, average employee turnover is 3.
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We also found that a high share of employees with quality targets correlates with better quality outcomes. The strongest sites include contribution to quality as part of their evaluation criteria for all or most employees. These sites report that they do this with specific, quantitative individual targets. In contrast, poorer-performing sites may agree that quality is generally important but usually do not enforce specific measures to improve it. Operational maturity: production assets. The proper maintenance and renewal of manufacturing assets is necessary for sustainable production and quality performance.
Sites that have a sufficient focus on preventive maintenance have fewer issues with equipment and facilities. In the long term, companies also need to invest sufficiently in the renewal of their production assets to avoid serious issues with both quality and compliance. We found that the sites that spent less than 1 percent of their annual cost of goods sold COGS on preventive maintenance generally suffered from a higher occurrence of deviations related to equipment. On average, sites spending more than 1.
We consider 1. By setting a formal preventive-maintenance plan and ensuring its appropriate funding, companies can shift focus from remediating deviations to preventing equipment-related issues. Sufficient reinvestment in maintaining capital assets is also crucial to prevent facilities and equipment from aging and eventually failing.
To reach appropriate levels of asset renewal, average annual capital investment in replacements should be 1. Quality system maturity. Aspects of quality system maturity, such as supplier quality and fast but thorough investigations, drive better quality performance and reduce quality cost. Strong-performing sites share their internal quality processes with their suppliers.
In our research, 56 percent of the highest-performing sites shared their own CQAs with suppliers and had them translated into supplier process CCPs. By contrast, only 10 percent of the poorest-performing sites did the same Exhibit 4, left side. Proper investigations are a fundamental part of any high-performing quality system. The challenge for device makers, however, lies in ensuring that they are sufficiently thorough in their investigations without getting bogged down in activities that take too long or cost too much.
We found that investigations that are too fast or too long each promote a high recurrence of nonconformances. High-performing sites generally conduct thorough investigations that span, on average, 40 to 55 days Exhibit 4, right side. Working at this speed seems to provide sufficiently rapid information to correct deviations while also allowing enough time to get to the true root cause of a problem. The best companies monitor deviation investigations to ensure the timely handling of emerging issues, but they also use performance metrics, such as CAPA effectiveness and deviation-recurrence rate, to drive investigation robustness.
Conversely, setting investigation-closure time as a performance metric often leads to short, cursory reviews, ineffective CAPAs, and recurring problems. Quality culture maturity. Aspects of culture maturity, such as involving operations personnel in quality activities, also help to achieve better quality outcomes.
High-performing sites do not leave quality to the quality function alone; instead, they embed quality-related activities into the roles of staff across the organization. Manufacturing and engineering personnel are involved in a range of activities, from prevention validation and equipment maintenance to remediation investigations and root-cause problem solving.
By involving nonquality employees in such activities, these organizations help to ensure that they have technical expertise to continually improve operation robustness and fix issues at their root cause. At the strongest sites we analyzed, the equivalent of 10 percent of site full-time equivalents FTEs or more are nonquality personnel involved in quality work.
Numerous examples illustrate how device manufacturers have applied these best practices to recover the cost of quality. Automating data collection. A manufacturer used a paper-based system for maintaining device history records DHRs , with individual DHRs containing hundreds of pieces of paper and thousands of quality data points. Based on the amount of quality data manually collected throughout the process, there were nearly opportunities for documentation errors every day.
The manufacturer replaced this paper-based system with a closed-loop manufacturing-execution system. This system enabled faster detection and prevention of problems and improved investigations through greater speed and visibility in finding and correcting root causes. The system likewise improved data consistency across plants and the supply chain and deployed dashboards for key metrics, enabling continuous improvement.
The manufacturer achieved a productivity improvement of 6 to 10 percent and captured significant reductions in key performance indicators KPIs : production noncompliance reports 41 percent decrease , overall complaints 58 percent decrease , workmanship complaints 65 percent decrease , and documentation errors percent decrease.
Launching a holistic quality improvement program. After receiving a corporate warning letter, a manufacturer launched a holistic quality improvement program that encompassed its management philosophy, business processes, systems, and culture. Its vision was to make quality a source of competitive advantage and continuously improve to drive higher performance. To comply with global regulations and standards, the manufacturer developed a standardized quality management system based on ISO It also implemented single global electronic systems for key quality system processes like CAPA to ensure a consistent approach and behavior and promote a culture of compliance.
The manufacturer appointed stewards for each of the key quality system processes that are responsible to engage and empower talent from across the organization to drive rates of improvement across the quality system. As a result of such initiatives, field actions are now one-third of what they were in , and CAPA cycle time has fallen by 50 percent, during which time the business has grown in size and complexity.
Because there are fewer service issues, inventory has been reduced by 25 days, resulting in millions of dollars in savings. Quality spending decreased by 8 percent from to , compared with an average increase of 7 percent industry-wide during that period. Improving yield.
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