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Prosthetics and Orthotics International, 1995, 19, 31-36

British Standard (BS) 5750 - quality assurance?

Derbyshire Royal Infirmary, Derby, UK

Abstract bureaucratic and administrative burden on
BS5750 is the British Standard on "Quality companies, many of which are small, but the
Systems". Its equivalent in European Standards actual benefit of this certification as a means of
is EN29000 and in the International Standards ensuring quality is, at the very least,
Organisation ISO9000. This paper points out questionable. This is not to say that the process
that these standards lay down formalised gone through to attain BS5750 has not been of
procedures and require documentation but do value to some orthotic and prosthetic
not ipso facto lead to quality assurance. companies. Many of these are small and had
The author points to the Japanese post-war few formalised procedures; although this was
industrial success as being an example of Total found in larger companies as well. The process
Quality Management within the framework of formalising and documenting meant that the
provided by the philosophy of Dr. W. Edwards processes within the company were examined
Deming (1988 and 1993). This philosophy on and perhaps altered which gave some
the management of "systems" to provide high semblance of improved quality by tighter
quality products and services is briefly outlined. control of procedures (this should have been
The author argues that improvement in carried out regardless of the need for BS5750,
prosthetic and orthotic services will not be but was lacking generally in the orthotic and
reached through implementation of BS5750 but prosthetic industry). However, this article will
rather through radical rethinking and the detail where BS5750 fails in its objective of
adoption and application of the Deming guaranteeing high quality services or products
philosophy. and will outline the preferred process whereby
high quality is both assured and improved.
BS5750 has been promoted in the United The problem with BS5750
Kingdom in parallel with its European The main tenet of BS5750 is that by writing
(EN29000) and International (ISO9000) down, and adhering to, set procedures a high
counterparts as a means of ensuring quality of quality product or service will be produced.
products or services. The National Health This unfortunately does not ensure quality, only
Service, purchasing section has insisted that all repeatability and conformity to a standard.
orthotic and prosthetic companies trading in the What is more, the standard is set by the host
UK must satisfy BS5750 or its equivalent, The company or institution at a level of its choice.
standard has also found a place within the new Rarely will anybody set a target or level that is
European Medical Devices Directive unattainable as it would immediately invalidate
(93/42/EEC) as forming part of the conformity their certification, so they set ones which are
procedure. This has placed a considerable attainable. Having set these targets they are just
required to reach them to maintain their
All correspondence to be addressed to
certification which does not ensure anything
Dr. D. J. Pratt, Orthotics and Disability Research other than the company or institution has met an
Centre, Derbyshire Royal Infirmary N H S Trust, attainable target yet again. To prove to the
London Road, Derby D E 1 2 Q Y , UK. auditors that this level has been attained and

the alternative illustrations of the success and use of Deming These do sound like rather grand claims but need to be presented followed by the fourteen all of these. a statistician by of documentation is produced which again does training. The train arriving late is now on time! and hospital. in part of TQM. Just after World for a policy or change. it was not mainly for his nothing to ensure a high quality product or statistical prowess that they employed him but service. the answer is. a vast amount Dr. Although some procedural lots of inspection. "process" and management time. But. have been proved to be basic rules of management set out by Deming. the question. of course. W. This management system more formalised inspection of products and is so designed that it involves everybody in the services which had a beneficial effect on the company or institution in working together quality of the product or service but the towards a high quality product or service. time spent correcting the procedures. lead to cessation of trading. and is devastated. hospitals. administration and management). may form process. "system" so that a high quality product or There was a need within the industry for service would result. There is a commonly held belief that to management works on the system to improve it have a high quality product or service requires continuously. This is systems and procedures forms one of TQM's not the case if a proper Quality Assurance (QA) key features and distinguishes it from more system is used. As they needed to get back into so commonplace that we can be unaware of its effective production quickly a method was use. A sound QA The success of the Deming approach is there system will lead to higher quality. However. as improved quality will lead to restricted approaches to quality management a reduction in waste of materials. Edwards Deming. Unfortunately. This aims to treat the whole of the found it easier to accept Deming's approach as company (or office or department) as one it was in line with their attitude to work and the system and manage its processes with one employer.32 D. workshop.) is viewed is adopted. J. etc. "what have the Japanese got that sales. This however slows down the systems. etc. true if this fundamental change in the way in which the whole system (company. This occurs in War II the Japanese industrial "machine" was Government. They (TQM). the background to a major international There are too many instances where numbers success story needs to be outlined as it sets the and statistics are manipulated to provide support scene for the rest of this article. which reduces the profits and could. lower unit for everybody to see. However. How can this be done? To answer this question some TQM. high quality that their products would be It is felt that rather than tackle the problem the purchased in preference to those from more statistics have revealed it is better to alter the established companies and countries. time spent on which concentrate on a rigorous adherence to re-doing jobs. nothing. ordering.for support rather than illumination. companies. Japan has made an costs and higher effective capacity (for all parts enviable reputation for itself and one has to ask of the system including manufacture. Statistics should be used only to help to sought that would provide this. This dependence of a quality assurance system on may sound naive but it works because people mass inspection as the main process will not work in the system and with their help work. In other others haven't?" Apart from a different work words proper Total Quality Management ethic. continual improvement in quality. many people and ways but to look for another system which organisations use statistics like a drunkard uses would ensure that their output would be of such a lampost . by applying the Deming common aim in mind. Pratt non-adherence has been rectified. It is just part of the audit trail required for his philosophy on the way to manage a as part of the certification process. and more. an emphasis on people rather than the extreme. such as parts of BS5750. customer satisfaction. In the way in which the statistics are collected or 1940's and 50's they employed the services of analysed to produce a false level of implied . By approach any company producing any product adopting this attitude the whole system can be or service will benefit by a marked and managed efficiently and with improving quality. with monitor and improve an aspect of manufacture great foresight they chose not to copy their old or policy. To explain other stories this.

By 1983. We are in a new with these mistakes. Defined in this way. Yet how that a visitor to Japan who asked the ticket many orthotic/prosthetic companies actually inspector to tell her when a certain station had involve their customers in their QA system? been reached. not just manufacturing. . with a plan to become that some trains will run late instead of all being competitive. the failure rate now represented one failed LED for every 200 Deming's fourteen points for management moving message displays. Constancy of purpose savings in replacement time and materials etc. Cease dependence on inspection approach of management needs to be changed Eliminate the need for mass inspection as a from the Directive or Results Management to way to achieve high quality by building what is called Process Management. that. early in Deming approach. quality level. ppm (1% many. Many of us accept that mistakes will be provide jobs.000 light emitting employ Deming's theories but more of an diodes (LEDs) about 150 would be defective. defective materials and expensive.000 ppm). using the example of the LEDS. What was. handling rework in all economic age. with the which is considered as the single most replacement LEDS being subject to the same important factor in actually improving quality. there has been a reluctance to accept improvement of products and service. with concomitant 1. The first step is to get over the belief defective workmanship. but also longer live with commonly accepted levels administration and other services is hugely of delays. after applying the principles of aspects are well accepted in existing Deming.quality assurance? 33 quality. in Japan the trains are so reliable fundamental to the whole process. mistakes. We can no activities. the principles of Deming in the western world allocating resources to provide for long- due to the inability to readily accept that there is range needs rather than short term anything wrong. Create constancy of purpose for continual However. the assurance of minutes of their timetable schedule to be on quality relies upon effective management of all time. quality into the product in the first place. This recounted the story that British Rail upon its ability to satisfy stated or implied had considered trains which arrived within 5 needs". and still is to been reduced to 50 parts per million. that what we are doing is right. To many of us it is inevitable profitability. This would usually mean a second It is necessary to state that not all of what process of replacement to make the final display Deming mentions is new as some of these work. to stay in business and to on time. One aspect of To correct this all of the failed LEDS had to be these which is very important is that of training unsoldered and replaced by hand. This cannot system look better but did nothing to solve the be achieved if the customer is not part of the underlying problem of late arrival of trains. The whole 3. just get off the train at sometimes ask selected customers for their 10.46"! opinion but this is not the kind of total inclusion More important than this trivial example is in the QA system which is envisaged by the that of Hewlett Packard in the UK who. An example of this was to be seen in A definition of quality is contained in the Daily Mail on 16th July 1987 in which BS4778 as "the totality of features and could be read "The train now arriving late is on characteristics of a product or service that bear time". but now this limit was to be extended to those affairs of an organisation which influence be within 10 minutes! This certainly made the the satisfaction of customer need. new is the totality of the approach. In QA system as customer satisfaction is comparison. Implement the new philosophy understand that developing systems for dealing Adopt the new philosophy. in each moving message This is not a comprehensive list of how to display of anything up to 15. the level of component failure had management theory. This meant that. as she could not read Japanese. made that have to be corrected and we do not 2. BS5750 . AQL = 10. introduction to his philosophy. the 1980's had a component quality level The fourteen fundamental ways (or (Acceptable Quality Level or AQL) of 1%. created in Japan. This does not mean that companies do not was told "Don't worry. This "Obligations") in which this is brought about was the worldwide industry norm and meant are listed below together with a brief outline. for example.

What is required is the targetted use of arbitrary numerical quotas for the SPC to aid the Deming philosophy. more than just money. meaningful way in Japan. Institute training on the job Encourage education and self-improvement Institute modern methods of training. to avoid problems. Improvement of quality will obligation to implement all of these principles. This Encourage effective two-way com­ is wrong as many companies outside Japan have munication and other means to drive out now found to their great benefit. posters and exhortations for the workforce demanding zero defects and new levels of productivity. production and service. etc. solely on the basis of price tag. something to society. End lowest-tender contracts leadership in order to achieve continual End the practice of awarding business improvement of quality and productivity. must be changed from sheer numbers to to improve quality and productivity and quality. and staff areas. to make better use of every ever-broadening opportunities to add employee. thus constantly decrease cost. J. price has no meaning their right to pride of workmanship. People in different areas such as Research. This is not a fear throughout the organisation so that Japanese system but a system devised by an everybody may work effectively and more American and first implemented in a productively for the company. 13. Top management's commitment helping people to do a better job. responsibility of managers. Encourage education 6. Administration. ranking (or performance appraisal) and of 5. including careers.34 D. Permit pride of workmanship require meaningful measures of quality Remove the barriers that rob workers of along with the price. in their retraining. It can and does work 9. The Improve constantly the system of planning. Eliminate arbitrary numerical targets of statistics has already been shown to be Eliminate work standards that prescribe useless. Constantly improve the system Management by Objective. Instead 12. Institute leadership otherwise. etc. Eliminate exhortations Eliminate the use of slogans. Many of these points may read initially as 8. the blind use 11. Break down barriers and is encapsulated in Deming's "Chain Break down barriers between departments Reaction" (Fig. The Clearly define top management's responsibility of managers and supervisors permanent commitment to ever-improving must be changed from sheer numbers to quality and productivity and their quality. they need management. Sales. supervisors. Substitute aids and helpful combined value of Deming and Shewart is well . the bulk of the causes of low quality and low productivity belong to the To make the best use of the Deming points system. Deming's "Chain Reaction" relationships. Pratt 4. without providing methods. and thus lie beyond the power of for management the use of Statistical Process the workforce. Shewart workforce and numerical goals for people (1986) was the first to recognise this and the in management. 1). This without a measure of the quality being implies the removal of the annual merit purchased. on the job for all. 1. However. materially and 7. Drive out fear idealistic and incapable of implementation. Adopt and institute leadership aimed at 14. must: work in teams to tackle and prevent problems that may be encountered with products or service. and in everyone. People require. 10. automatically improve productivity. Control (SPC) is vital. Such exhortations only create adversarial Fig.

Without the proper use of intervention of adjustment to the final Control Charts there is no way that the two diameters. counter those effects which can be controlled There will be small variations in all of these and not to waste time trying to correct common which are essentially uncontrollable by the cause variations. cutting speeds. and because any process contains sources of vice versa. The monitoring of this variation was generally a common cause variation . exact system to be adjusted. Fundamental to the use of SPC is they installed an automatic compensation for the understanding of variation. They reasoned that if companies. No shaft is outside the limits but scope of this paper but are fundamental to there is a random spread of diameters between effective TQM. money and personnel on diameters with the automatic compensator trying to "control" common cause variation can switched off .due and its time history with Control Charts will to aspects such as ambient temperature provide the necessary information to allow the variations. The shaft diameters with the automatic compensator actual specifics of this are well outside the in operation. Figure 2(b) shows the shaft the waste of time. Figure 2(a) shows the variation in causes of variation can be differentiated. The source of the variability is either more uniform shaft diameters and hence common cause or special cause. The former of improve their quality. However. On the face of it this was these is generally outside the specific control of a logical approach but it totally failed to the system but special cause variations are recognise that the variation in shaft diameter controllable. BS5750 . 2. No two products the turning machine.quality assurance? 35 illustrated by the experience of many transmission input shafts. a useful example of these limits. etc. The answer is that the production process The following is adapted from Scherkenbach was already in statistical control. to material properties of the stock metal. when a shaft came out too or service elements will be exactly alike wide the next one would be made smaller. when appropriate. . Shaft diameters (a) Automatic compensation turned on. This they hoped would produce variability.resulting in reduced variation. Without the (1986) and relates to the effort Ford put in to compensation device the process was already trying to control the turned diameter of exhibiting its lowest variability as only common Fig. (b) Automatic compensation turned off. be illustrated by the experience of the Ford How could this be? Motor Company. humidity.

company executives. . Advanced Engineering Study. .Knoxville. . that what we do is right.Luxembourg: Office for Official Publications way is via the Deming philosophy. i. Continuing Engr Educ. steadier cutting speeds.Quality systems. Out of the crisis.Quality vocabulary. . compensation device. . Center for is of value." NEAVE HR (1990). we too have a flat earth mentality.London: BSI. of the Earth. The first step is to get over the belief stable temperatures. Reduction of that produce some percentage level of scrap and variability could only be produced by rework and that some devices will not be ready improvements in the process itself. . What this is saying is that. The use of Control Charts and related SPC would have shown the lack of need for the BS4778: . The attitude of the European Communities. The Deming route to orthotic/prosthetic products and services in this quality and productivity: roadmaps and road blocks. the oceans and the continents was not ignorance but the illusion of knowledge. MA: Massachusetts Institute of Technology.e. Dept. The practice of Management. 1987. Pratt causes were present. with respect to our SCHERKENBACH WW (1986). Editor's note: In July 1994 BS5750 was formally renumbered as BS EN ISO 9000. Statistical method from the that our orthotic/prosthetic workshops will viewpoint of quality control. The compensation device was not an improvement in the process but is an example of what Deming calls "tampering" with a stable REFERENCES process. For us. - country. it seems inevitable SHEWHART WA (1986). J. 1987. etc. Cambridge. . In reply to that kind of statement the following DEMING WE (1993). quote from Daniel Boorstin in The Discoverers government. "The greatest obstacle to discovering the shape DRUCKER P (1968). TE: SPC Press. - Oxford: Heinemann. is that "we do not need to Cambridge University Press.we are doing this right already". of most managers. cannot let go of the things that we believe to be correct. The Deming dimension. DC: George Washington Univ. DEMING WE (1988). education. to quality improvement via BS5750 is COUNCIL DIRECTIVE 93/42/EEC Ref LI69 Volume 36 fundamentally wrong and how a more proven 1993. about this approach. We Washington. . The new economics for industry.New York: Macmillan.36 D. etc. This is a brief paper to outline why the path BS5750: .London: BSI. therefore. change . more on time.Cambridge.