BS5750

Meeting the international BS5750

standard IS0 9002/

J.A. Garrett and P.H. Smithson Medical Equipment Management Road, Bristol BS2 8ED, UK

Organisation,

Bristol

Radiotherapy

Centre,

Horfield

ABSTRACT In this paper we outline the ration& for applying British Standard BS5750 to a medical equipment management service and introduce some of th concept-sof the standard as thq, apply to thisfield. We see thb application as essential in today’s legal and commercial environment and indicate the ways in which this work ti being carriedforward by the Medical Equipment Management Organisation into total quality management systems. Keywords: Equipment

management,

quality assurance,

IS0 9002/BS5750

INTRODUCTION

Scope of quality assurance application

This paper outlines the application of the British Quality Assurance Standard BS 5750 (International Standard IS0 9002) to equipment management by the Medical Equipment Management Organisation (MEMO) of the Bristol and Weston Health Authority in the UK. Attention is focused on the provision of medical equipment maintenance in the context of the health sector and no distinction is made between the private and ublic domains. MEMO enjoys the distinction of g eing the first such medical equi ment service su plier to be awarded the Registere B Firm status un B er the British Standards Institute BS5750 registration scheme. We sketch the rationale for this approach, provide an overview of the principal re uirements of the standard and finally suggest how tx is work might be developed.

Technical. The first aim of a maintenance service is to provide a service which has the technical capability to maintain original equipment manufacturer (OEM) performance specification; maximize equipment reliability; deliver service competence. These form the minimum specification for organizational capability. They include training, spare part provision, adequate documentation and calibrated instrumentation.

RATIONALE Safety and effectiveness Medical equipment is costly. A substantial part of the cost is the string of maintenance charges which arise during the equipment’s useful lifetime. Maintenance is taken to include service, calibration and safety audit and, to meet legal re uirements, cannot be totally eliminated. This kin 8 of preventive maintenance must be dependable above all else. However, corrective maintenance can be kept to a minimum not only by good design but also by effective maintenance. There is a need for a systematic quality assurance (QA) approach to the provision of maintenance which is ‘fit for the purpose’, adequate safety margins within a minimum maintenance schedule and that maintenance attention is effective when needed (i.e. right first time very time!) This is a consideration of cost. Correspondence

and reprint requests to: Mr J. A. Garrett

Legal. The Health and Safety at Work Act and product liability legislation under the Consumer Protection Act in the UK make the following features of maintenance essential requirements: Safety (will not cause injury or damage to persons); Calibration (fit for intended m-pose); Modikation control (uncontrolled mo B ification negates manufacturers’ liability). Commercial forces. Medical equipment maintenance takes place in a market place, which is becoming increasingly competitive. Hence so-called third party maintenance organizations are appearing in a field traditionally left to the equipment manufacturer or the hospital in-house organization or some combination of these. It is widely reported in industrial manufacturing and service companies that waste or the results of poor quali amount to more than 20% of sales. It is likely that 3: is is also true of equipment maintenance. Considerable waste occurs in recalls because the problem was not resolved first time. Figure 7 illustrates how the traditional approach to quality has been to incur costs in so-called ‘corrective’ quality control b detection of goods and services which have faile J to meet the required standard. By comparison, BS5750 emphasizes the ‘preventive’ approach to quality, to which traditionally little money has been committed. The preventive approach should reduce the ‘corrective’ quality COSTS significantly and improve customer satisfaction.

@ 1990 Butterworths for BES 0141-5425/90/030253_07 J. Biomed. Eng. 1990, Vol. 12. May

253

MeetinginternationalstandardIS0 9OO.?/BS5750: J.A. Garrettand P.H. Smithson

Corrective

Ixternol failure

r.

\

Internal failure

Approisal

Preventive Preventive

Figure 1 Quality costs as a percentage of the total value

Thus the QA approach will have a payback in terms of: Cost (organizational service delivery cost); Equipment up-time (time available for use); and User satisfaction (confidence in the service).

REQBS FOR A SYSTFMATIC QUALITY APPROACH The foregoing

is basically non-controversial. However, to be effective in practice, the technical, legal and commercial requirements must be substantiated by documentary evidence. Three tests have to be satisfied if this is to be the case across the spectrum of activities which form an organization capable of delivering a quality service. These include: traceability from source to end user of all materials, documentation, calibrations, training, etc.; conformity to specified contractual requirements agreed between the service provider and service consumer; validation objective assessment that requirements are met and continue to be met in practice, These tests applied across all the activities which make up the equipment management service are the essence of the systematic approach to QA specified by BS5750. In its simplest form it can be represented as an analytical matrix as shown in Table 7.

BS5750 The British Standard on Quality Systems (BS5750) Table 1

Quality matrix

Requirements

Traceability

Conformity to requirements

Technical

? ? ?

? ? ?

Legal Commercial

254

J. Biomed. Eng. 1990, Vol. 12, May

now also an International Standard, known as the IS09000 series. The Standard has been accepted in Europe and beyond, including the Peo les Republic of China. In the UK, the British Stan B ards Institute (BSI) has assessed and registered 5000 companies for their quality management systems. The increase is of the order of 1800 per annum BS5750 is divided into a number of parts. The one most frequently used for assessment is Part 2 Specification for production and installation*. It is a model for a quality management system in these areas. The product or service is immaterial. The standard has been developed over the years to incorporate the vital QA practices. These are necessary to maintain quality in any process. Part 2 is itself divided into 18 sections (see llizble 2). Sections 1 and 2 deal with management responsibility and are about and quality systems, respective1 getting the organization right in x e first place. The desire and will to improve quality must come from the very top management. This must be proved by the appointment of a senior person whose prime responsibility is QA of the product or service. Then the quality system itself must exist in a carefully maintained quality manual. The manual will document the key processes that need control. Many of the other sections are self-explanatory. However, some particular ones will be dealt with in more detail later. BS5750 itself is a very general standard, so at some point the organization needs to recess it is going to do well. declare what particular ecide to provide a medical For example, it may dp equipment maintenance service, or produce and supply specialist nerve stimulators. BSI then offers two choices to the organization. It can either be assessed as an individual firm (making specialist items) or they can be assessed against one or more quality assurance schedules ((LASS).

Validation ? ? 7

is

QUALITY ASSURANCE SCHEDULES QASs are developed as an industry group standard. A typical standard is the ‘call routing apparatus installation’ used by British Telecom and its subcontractors. MEMO was assessed against QAS 34160 ‘The repair of specialist electric and electronic equipment’. These QASs have requirements in addition to Table 2

BS5750: Part 2 sections

1. Management responsibility 2. Quality system 3. Contract review 4. Document control 5. Purchasing 6. Purchaser supplied product 7. Product identification and traceability 8. Process control 9. Inspection and testing IO. Inspection measuring and test equipment 11. Inspection and test status 12. Control of non-conforming product 13. Corrective action 14. Handling, storage, packaging and delivery 15. Quality records 16. Internal quality audits 17. Training 18. Statistical techniques

Meeting internationalstandard

BS5750 to ensure a better service. AS 34/60, for example, requires all service calls to46 e logged and traceable at all times. If many medical physics groups and estate departments are to be involved with BS5750, there is great scope for QASs within the UK National Health Service (NHS). Why are there no national standards on acceptance testing infusion pum s or defibrillators, for instance? This would be a goo B opportunity to develop manufacturers’ trust and understanding. PARTICULAR

REQUIREMENTS

When hospitals first try to meet the standards, they will have to make a number of than es to their way of working; for example, to their goo B s inwards inspection (GII), segregation shelves, status labels, call logs and complaints/audit review handling. GII comes under Section 9 of BS5750. The organization must ensure that goods are not used or processed unless they conform to specified requirements. There has to be an area where someone can check goods and spares coming in, to ensure they are what was ordered and are not damaged. There cannot be a ‘free-for-all’ when the postman arrives. GII is very useful and saves time later. Segregation shelves (Section 11 BS5750) are used to prevent faul items becoming mixed up with repaired ones. IX ey are used in conjunction with the status label. We have labelled our shelves as in Table 3. Some departments have more or fewer of these depending on workload. The status label shown in Figure 2 is attached to each item of equipment coming into MEMO. The appropriate box is initialled and, at the same time, the job is entered onto the call log. As the job progresses, more boxes are initialled. If anyone is away, the supervisor can see at a glance the status of the job. All maintenance sections in MEMO have found that the status label is a very useful innovation. Call logging is more difficult. One can either have a log book next to the telephone or use a computer s stem, as we do. Figure 3 shows the call entry screen. d ther screens allow supervisors to track the progress of each call in any section. The drawback is the time taken to enter each call and to update it. The benefit is that calls are not forgotten. Handling complaints from clients can be an area of neglect. Therefore BS5750 requires a proper system to review and improve this activity. Sections 12 and 13 cover this. We have a formal complaints procedure with weekly progress checks. BSI and the quality manager always check the complaints file on an audit. Action to prevent the cause recurring must be discussed and minuted in the bimonthly management review meeting. Putting a new quality system into effect in an organization is not easy. BSI is rigorous in its Table 3

Segregationshelves

Awaiting acceptance/repair Awaiting spares/information Repaired, awaiting final test Tested, awaiting delivery Quarantine

IS0 9002/BS5750:JA.

Garrett and P.H. Smithson

B.8tW.H.A. MEDICAL

MEMO JOB

EOUIPMENT

MANAGEMENT

ORGANISATION

No. No.

EQUIPMENT

STATUS INITIALS

AWAITING

ACCEPTANCE/P.P.M.

AWAITING

REPAIR/MANUFACTURE

AWAITING

SPARES/INFO

COMPLETED INSP/TEST

WAITING

FOR

QUARANTINED Reason

~

PASSED

FINAL

INSPECTION/TEST

Date Other: Call Log reg. no. Label Removed

by

(User) ILEScm4 1 89

FORM L112A

Figure 2

Statuslabel

requirements. It will take a minimum of 6 months and possibly up to 2 years to meet the requirements of BS5750. Table 4 shows the timescales relating to MEMO’s application. A QA consultant was engaged for a few days to give guidance on assessment techniques. Good training of staff is necessary in the early stages. There is free information available4, which includes booklets and videos for loan. These are useful to show the benefits of introducing a quality system. There are also large databases on quality assurance techniques available from The National Qrality Information Centre, The Institute of Quality Assurance, 10 Grosvenor Gardens, London SW1 W ODQ, UK. Once the system is approved, BSI carries out a surveillance audit every 6 months. This independent ‘look over the shoulder’ goes a long way to keeping the organization at its best. REQUREMENTS INFORMATION

FOR A MANAGEMENT SYSTEM

Many organizations now have a management information system (MIS). If proper1 developed and controlled, items such as ‘ob call rogging, are facilitated. For instance, the ca I’1 log will keep a job on file until a completed job report is received. Then the log is cleared automatically and the job information put into the history file. For a large hospital department, such as MEMO, the MIS combines the advanta es of having devolved sections with central data faci f ities. There are work-

J. Biomed. Eng. 1990, Vol. 12, May

255

Meeting intcmationul stuna’ard IS0 9002/BS575O:J.A. Garrett and P.H. Smithon _ _ _. - _ ___--__--_---

__--_----__----w--w-

1:

Heg *

Model Manf Inv.Loc 3: Location Contact Name 5: 7: Urqency 8: Job Request 9: Req ’ Date 11: Call Date 13: Job For Grp/Sect 14: Call Entered By 15: 16: 17: 18:

__---_-~---__~~-~~_~--~~~-----~-~~~-

2:

Number

Job kssgd To Job Status Remarks Hos. Tran.(Y/N)

________ ________

I=============================

} Enter N to obtain the NEXT REG.NO 1 Enter REG.NO to Update I Enter \ to clear the REG.NO 1 (return) to END the session

~~-~--~~~~~~~~-~---~~~~~~~~~~~~~~~~~~~ _____-___c__________-

Start August 1987 Initial assessment by QA Consultant - 1 day Write quality policy document (volume 1) - 4 weeks Apply to BSI for assessment Write procedure manual (volume 2) - IO weeks Start implementing quality control methods Start calibrating test gear Produce work instructions and forms (volume 3) - IO weeks Send volumes 1 and 2 to BSI for assessment Pre-assessment audit by consultant (March 1988) Assessment by BSI - 1 day

Approval as Registered Firm on 21st April, 1988.

shops in five hospitals in the Bristol and Weston district. Each workshop has one or more terminals. Each terminal has an online printer to print a job sheet instantly from the call log. Every workshop also has access to statistical data, company records, etc. Cross-charging our clients for jobs done is also carried out centrally. Table 5 gives brief details of the MIS system. A smaller system was used originally. A need to increase access speed and the number of terminals produced an agreement with the Works department. They were also interested in call logging, so now a faster system (as shown here) has been purchased jointly. PROGRAM

Table 6 1. 2. 3. 4. 5. 6. 7.

MIS options

Order records Stock inventory MEMO contracts Equipment management system Call logging and tracking Non-medical inventory Contract management

options. The great benefit of the larger suite of programs is the interaction that starts to occur. Figure 4 can be used to illustrate this. When the system was first set up at MEMO, a medical equipment inventory was required (1) for the whole District. When a job call is logged, only the inventory number is needed (2). The system fills in the details, such as equipment type, location, age and owner. At any time the technicians can consult a contracts file (3) to check the response time required, or if spares are to be charged se arately. Once the job is completed, the job report Q4) is entered into the system. Spares details and prices can come from the stock inventory (5). 1

I

Call

lag

LJ (2)

Job report

INTERACTION

MEMO MIS system

Computer type: Fujitsu system 2400 32-bit 68020 processor 20 MHz Memory facilities: 2 Mbyte RAM 139 Mbyte Winchester Total number of terminals (MEMO): 23 Back-up facilities: 60 Mbyte data cartridge Operating system: PICK multi-user Uninterruptible power supply

256

f I

21: Print Job Report

Table 6 showssome of the options available. Smaller departmentsmaywantscaled down versions ofthese Table 5

I

Call log entry screen

Table 4 Timescales for implementing BS5750 Part 2 within MEMO (Electronics groups)

1. 2. 3. 4. 5. 6. 7. 8. 9. IO.

No

10: Reg. Time 12: Call Time

19: Job Number 20: Camp. Date Figure 3

Memo

Contract Ref. Repair Warr. Manu. War-r. 4: Req No.. 6: Tel/Ext No.

J. Biomed. Eng. 1990, Vol. 12, May

X- chorginq (internal and external)

Figure 4

MIS program interaction

,

I

Inventory (21

Meeting internationalstandard IS0 9002/BS5750:JA.

The computer program cleverly puts the job report information into a number of files which detail crosscharging information for the Treasury and equipment history for reliability. Job report information is also added to the contracts file to see how much the contract has cost so far. The program now allows internal costs to be displayed. Technicians now are surprised to find how much their ‘special little bracket’ has cost to produce. Now they know how our customers feel! The MIS suite of programs is written using pseudoEnglish commands in the PICK operating system. PICK is used by many local councils and other organizations because it is a relational database with very good re ort-generating facilities. To ask for a printout of al P ultrasound machines in the age range 2-5 years is relatively simple. There is now also a version which will run on IBM PCs. Table 7 shows some reports from the database which are particularly useful. There are many more. Figure 5 gives an example of the history printout. The header gives running totals of jobs, down time, costs and so on. Each report is divided into 1 year lengths (AprilApril). BENEFITS SYSTEM

OF A MANAGEMENT

INFORMATION

We think that the benefits of a developed MIS system are obvious. If a department can keep track of its own costs and cross-charges, the District Treasury figures can be double checked. Quality managers are very interested in reducing unnecessary costs and wastage. Table 7

Example report headings

l Spares orders overdue for delivery l Spares stock by equipment supplier l Inventory by budget and location

@ History report for inventory item

Garrett and P.H. Smithson

They are also of use in tracing equipment histories. These are kept more accurately on the computer file than in the human brain. Engineers instantly can access an item’s previous faults to give a better response to the customer. REALIZATION

OF BENEFITS

MEMO has been running a BSI registered scheme since April 1988 and during this time has received three external BSI audits. Costs of running the scheme fall under two headings. First, the system costs money to implement. These costs comprise consultancy fees, the cost of writing a quality manual, registration fees with BSI and an consequential reorganization costs which arise. d is represented about X6000 at today’s prices. Second, there are additional internal costs which have to be met in order that the procedures and activities of MEMO can continue to conform to the BS5750 requirements. These costs include the cost of QA administration in the form of the QA manager function, some additional paperwork and costs associated with calibration of test equipment and stora e. Once again, for MEMO, at today’s prices ta is represents about X5000 per annum. It is, however, true that these costs have been recovered by the new level of activity which has resulted. In any event, these costs are unavoidable if we are to ensure that grounds are not given for the equi ment manufacturer to pass on liability to MEM 6 and meet the competitive challenge on service quality (response, competence, effectiveness, cost). Benefits of BS5750 continue to emerge as we begin to learn more about our own operation. A system of work which is written down in the form of procedures over which tight control is exercized is good. Those systems which use the mechanisms of document control, internal and external audit and are subject to regular management review are better still.

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CHAMD

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Figure 5

History log entry screen

J. Biomed. Eng. 1990, Vol. 12, May

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MeetinginternationalstandardIS0 9002/BS5750:JA.

Garrett and P.H. Smithson

will also go a long way towards satisfying a court of law that every reasonable care is taken in the repair of medical equipment. It is not for us to claim the benefits perceived by our clients, but it is not unreasonable to assume that some of the benefits experienced by MEMO have a ‘knock-on’ effect. Among the significant benefits to emerge are: identification of defects in performance; reduced variability in service quality; more robust organization under stress of staff changes; reduced waste in recalls and better identification; accurate knowledge of operational costs; reduced risk of legal liability; higher personnel morale.

They

LIMITATIONS

OF BS5750

Limitations of the British Standard are to be found in the fact that its focus is the contractual standard with the third party to whom the product or service is offered. By itself, the standard has no built-in standards of organizational performance and does not address the subject of quality improvement. It fimctions as an essential baseline. FUTURE

In

control

-f!!l&

(special causes eliminated)

7

Out of control (special causes present)

Size -+

Figure 6

Example of processes with normal distribution

WORK

Conformity to such a rigorous standard has been possible only as a result of considerable attitudinal change in the organization, articularl in the acceptante of being consumer-&ven ani of individual responsibilities for corporate success. The attitudinal change required for continuous quality improvement will be et another quantum leap. It calls for personal owners h ip of improved quality, not only with the external customer, but also in dependent relationships within the organization where the final service is the sum of many individual efforts. It requires self monitoring of performance weaknesses and consequential roposals for improvement. To m s e these developments possible we are now improvement programme. embarking on a quali This entails the use o9 two tools tested widely in industry. improvement The first is the company-wide quali (CWQI) scheme. This involves the Zevelopment of customer-supplier relationships within the organization. Within an organization the success of each person’s work relies upon the satisfactory performance of another’s work. The concept of an organization as an internal chain of linked supplier-customer relationshi s is fundamental. In principle, this set of internal re Pationships is subject to the same considerations as those of the external customer relationships. The second is the use of statistical process control (SPC) techniques. This involves the use of individual charting of certain performance criteria subject to random change before a crisis arises, in an attempt to detect processes which may be drifting out of control. The aim is that all organizational performances can be quantified in an active way. Figure 6 illustrates how erformance, for a given parameter of organizational example, repair turnaround time, w Kich is subject to random variation, can be represented as a value in a normal distribution. In a system where control is uncertain it is unclear to which population the performance figure belongs. The introduction of a

258

causes

J. Biomed. Eng. 1990, Vol. 12, May

External

failure

Appraisal

II I

Figure 7

Prevention

D

i

I

I

2

I

3 Development

I

phase

4

Reducing costs by improving quality

BS5750 quality system is aimed at introducing the s stem control illustrated by the middle set of B istributions, where the performance figure belongs always to a similar distribution. Quality im rovement results from determining the position of J: e peak of the distribution (most common value) and reduction in the variation or baseline of the curve. Such an analytical approach has been developed into a simple analytical approach that can be used for self monitoring3. In these ways, the chart in Figure 7 illustrates how, by paying more attention to preventive-type QA (D), we have begun to reduce the cost of detective-type QA(A + B + C) by the potential reduction of overall quality costs and increase in customer satisfaction. REFERENCES Ware J. A head start in Europe. BSI News 1989; August: 3. BSI. BS5750: Part 2: 1987 Qua&y Systems: Specifcation for Production and htallution. London: British Standards Institution. Owen M. SPC and Continuous Improvement. Bedford: IFS Publications, 1989: 102. UK Department of Trade and Industry. Getting to Grips with @al& available c/o IBIS, FREEPOST, London Colney, St Albans, Herts AL2 lYY, UK.