This manuscript describes the tools and programs used by the Quality Assurance and Quality Control (QA&QC) department to monitor, control and evaluate activities carried out by the Directorate of Biomedical Engineering (DBE) at Jordanian Ministry of health (MOH) (30 hospital, 712 medical centers). The implemented QA&QC programs and procedures include measurement and monitoring of several performance indicators for services provided by DBE. The local designed Computerized Clinical Engineering Management System (CCEMS) is used to implement QA&QC procedures to monitor , analysis and evaluate different CE activates within DBE . The results of the implemented QA&QC tools and programs prove significant improvement of DBE activities for last three years.

1. N.A. Abu Osman, F. Ibrahim, W.A.B. Wan Abas, H.S. Abd Rahman, H.N. Ting (Eds.): Biomed 2008, Proceedings 21, pp. 746–750, 2008
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Quality Assurance and Control Of Clinical Engineering Activities
W.S. Trarawneh1
, A. Ghawanmeh1
, I. Malkawi1
and M.A. Ghannam1
1
Directorate of Biomedical Engineering, Ministry of Health, Amman, Jordan
Abstract — The improvement of clinical engineering activi-
ties has become an issue of increasing concern within the
health care services over recent years .This manuscript de-
scribes the tools and programs used by the Quality Assurance
and Quality Control (QA&QC) department to monitor, con-
trol and evaluate activities carried out by the Directorate of
Biomedical Engineering (DBE) at Jordanian Ministry of
health (MOH) (30 hospital, 712 medical centers). The imple-
mented QA&QC programs and procedures include meas-
urement and monitoring of several performance indicators
for services provided by DBE. The local designed Computer-
ized Clinical Engineering Management System (CCEMS) is
used to implement QA&QC procedures to monitor , analysis
and evaluate different CE activates within DBE . The results
of the implemented QA&QC tools and programs prove sig-
nificant improvement of DBE activities for last three years.
Keywords — Quality Assurance &Quality Control
(QA&QC), Directorate of Biomedical Engineering (DBE),
Computerized Clinical Engineering Management System
(CCEMS), Quality Assurance & Quality Control depart-
ment(QACD).
I. INTRODUCTION
The main DBE activities are : Corrective and Preventive
Maintenance, planning the needs of medical equipment,
preparing and updating technical specifications and pur-
chasing conditions, tenders evaluation, inspection
,acceptance and receiving of new equipment ,vendor fol-
low up during warranty period, contractor follow up, spare
parts purchasing and management ,training of users and
DBE staff , quality control of equipment and provided
services, evaluation of medical equipment conditions and
providing technical consultation to top healthcare adminis-
trative management.
For quality assurance purposes, DBE is required to
build a quality management system (QMS) based on inter-
national standards [1] (such as ISO 9001:2000), which
describe the DBE vision and mission, the scope of the
QMS including all details and justifications, provide a
documented working procedures and forms established for
the QMS processes, documented jobs description and
description of interactions between different processes. To
monitor, analyse, evaluate, control and improve the DBE
activities and QMS, a QACD were established within the
DBE. QACD is operated by the most experienced bio-
medical engineers in the country. The QACD has the au-
thority and power to monitor, inspect, and test and exam
all related DBE works and activities. The QACD reviews
in cooperation with DBE top management the QMS every
6 months to ensure its continuing suitability, adequacy and
effectiveness. The QACD conducts internal audits at
planned intervals to determine whether the QMS conforms
to the planned arrangements, related requirements of inter-
national standards, QMS requirements established by DBE
and if it is effectively implemented and maintained. The
QACD applies suitable methods to monitor, measure and
control of customer satisfactions, different QMS processes
and provided services. For this purpose different tools are
used such as: planned and unplanned inspections and tests,
data available within the CCEMS, measuring and test
equipment and the costumer complains.
II. MAIN RESPONSIBILITIES
The demands of providing high-quality care and lower-
ing its cost are reflected to DBE responsible for medical
equipment safety, services, and QA&QC. The primary
goal of QA&QC program is to provide safe and effective
medical equipment. The main elements to be controlled are
shown in Fig.1, where:
Safety: This covers patient, operator and technical per-
sonnel safety. The QA program ensures that all safety
measures are followed in all workshops of DBE during all
maintenance activities.
Fig. 1 Quality controlled elements

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Personnel: The most valuable and critical element that
determines the quality standard. Therefore the QA program
was establish to monitor personnel in terms of different
indicators and parameters like, productivity, commitment,
behavior, motivation …etc.
Cost: The cost is very sensitive and vital factor in every
activity. Therefore the QA program includes inspection on
cost effectiveness of all activities within DBE. This in-
cludes spare parts prices control, man hours per mainte-
nance job, overtimes, transport costs…etc.
Time: The speed of service is very important factor in
health care. Therefore the QA program includes special
tools to monitor and measure time to deliver different
services related to medical equipment.
Quality: The QA program include tools and indicators
to measure the final results of each operation to determine
whether these operations comply to the predefined opera-
tion criteria’s, the stated objectives, the costumers needs,
and fulfill the requirements for quality .
The main responsibilities of the QACD in DBE are:
1. Carrying out control, inspection, audit, and assessment
of performance and achievement levels of all tasks and
duties. 2. Following up the levels of application of all
approved work mechanisms, regulations and instructions.
3. Detecting points of defects and following accountability,
and make necessary recommendations and mechanisms to
contain and remedy such defects. 4. Controlling the ser-
vices provided to medical equipment, including meeting
safety standards to the equipment and their users. 5. As-
sessing and controlling the directorate’s assets of equip-
ment, parts and different machines, and its purchases. 6.
Spreading and applying of new quality concepts in the
fields of biomedical engineering. 7. Controlling all
documents and records needed by DBE-QMS and ensuring
that processes needed for the QMS system are established,
implemented and maintained. 8. Reporting to top man-
agement the performance of the QMS the needs for its
improvement. 9. Ensuring the promotion of awareness of
customer (hospitals, med centers, companies... etc) re-
quirements throughout the DBE.
When a point of defect is detected as a result of moni-
toring, inspecting, testing, auditing and assessing, a quality
control remark is issued. Fig.2 shows the quality control
remarks flow chart protocol. Remarks are classified to
three levels: a. individual remarks (that concern certain
person), b. group remarks (that concern certain department
/ technical workshop or group), c. Administrative (remarks
that need to be reviewed by administrative top committee).
Each remark includes all the necessary documents required
to explain and prove the remarks. A certain period of time
is given for correcting & answering .Any remark not an-
swered or corrected within the given period of time, are
immediately transferred to higher level. The QACD keeps
a computerized record of all remarks, their last situation,
time to follow up, delay time for answering and correction,
corrective action taken .An analysis is carried out and
reported periodically to top management for all types of
non-conformity, their root causes and suggestion for cor-
rection and improvement.
III. PROCEDURES AND INDICATORS
The implemented procedures within the DBE allows the
QACD to monitor, measure and evaluate different indica-
tors in respect to these procedures and to assess different
DBE activities according to these indicators :
1. Corrective maintenance and repair. The main ele-
ments to be monitored and controlled are; speed and
quality of provided services, maintenance cost, equip-
ment availability (A%) & down time (DT%), engi-
neering DT [2] ,mean time between failures (MTBF),
mean time to repair (MTTR), pending working orders,
number of failures per location, model and equipment
type, type of failures (failure analysis- Fig.3), mainte-
nance load per engineer and engineering group, num-
ber and types of equipment recommended to be taken
out of service, and documentations of maintenance ac-
tivities .
2. Preventive maintenance (PM) and inspection. The
QACD monitor and control; PM compliance ,quality
of performed PM jobs, clinical engineers and techni-
cians commitment to the PM time plan, number and
types of equipment founded faulty during inspection &
PM and not reported , number and types of users train-
ing conducted during PM period, PM tagging, number
and type of equipment subject to PM program , num-
Fig. 2 Remarks flow chart protocol

3. 748 W.S. Trarawneh, A. Ghawanmeh, I. Malkawi and M.A. Ghannam
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ber of repaired equipment during PM, PM engineer-
ing load and engineering group load , PM fre-
quency and the needs for yearly changes, PM cost
(labor & parts), time
to perform PM & inspections activities and documen-
tation of PM & inspections activities. Also a control is
preformed for used test equipment and tools; number
of calibrated equipment according to the scheduled
plan, equipment not passing the calibration test, and
number of test equipment need to be replaced.
3. Equipment inventory, records and conditions. The
QACD continuously monitor the inventory data for the
existing within the MOH locations medical equipment
in addition to the new received and accepted equip-
ment. Main element to be controlled are ; numbers and
types of existing equipment , number of new equip-
ment delivered to these locations, equipment cost in
regard to their purchasing and resent cost ,equipment
age class, level of equipment utilization and load,
availability and DT, equipment environmental condi-
tion, assessments of equipment condition in respect to
A% ,maintenance cost ,age ,technology and utilization,
equipment disposal and number of equipment
scrapped pre location and reasons behind disposal of
medical equipment, recording, documentation, and
updating of equipment data.
4. Warranty and contract services. Indicators monitored
by the QACD are; speed and quality of services per-
formed by different service providers , equipment
availability, penalties issued to services providers
,times added to maintenance warranty period , level of
commitment to warranty and contract agreements,
number and type of training provided, level of in-
house engineering staff follow up, periodically evalua-
tion of service providers and equipment conditions,
documentation of activities carried out by vendors and
contractors, and action taken to correct non conformity
to the conditions of signed agreements.
5. Planning and Procurement of medical equipment.
DBE is the responsible body for all related to medical
equipment
issues in MOH. In the planning and procurement
phases the QACD monitor and control; recording
MOH locations needs, equipment life cycle cost
(LCC), equipment perfor-
mance and utilization, updating of equipment specifi-
cation and purchasing conditions according to needs,
number of specification updated and reasons for up-
dating, needs for changes on equipment purchasing
conditions, needs for changes on equipment selection
criteria, delay and time spent in studying equipment
offers, level of communication with hospital admini-
stration and others engineering specialties (architec-
ture, civil, electromechanical ), number, type and cost
of new purchased equipment in respect to actual
needs, and documentation of purchasing process.
6. Acceptance of equipment. The QA&QC dep’t monitor
and control; correct documentations of the acceptance
process activities and issuing of acceptance certificate,
adding of new accepted equipment to the inventory
log, correct distributions of equipment according to
planned needs, number of rejected new delivered
equipment, and action taken to correct non confor-
mity.
7. Spare parts purchasing and management. The main
elements to be monitored and controlled are; correct
coding of spare parts, speed and time of the purchasing
process, parts originality and compatibility, DT related
to delay in spare parts ordering and supply, level of the
minimum strategic parts stock, parts cost, documenta-
tions of parts received, discharged and available
stock, evaluation of parts venders, balance of non
stock parts ,number of parts purchasing orders, num-
ber of rejected parts, commitment to parts planning
criteria ( actually needed parts, budget available ,parts
balance and flow), deviations outside the predeter-
mined needed stock and budgeting, and number of
useful parts used from scraped equipment.
8. Training. The QA&QC dep’t monitor the following
indicators; number of conducted user training pro-
grams in respect to failure analysis (Fig.3), number of
user fault after training, number of in-house technical
training programs conducted mainly for DBE technical
staff working at pilot workshops and number of work-
ing orders performed by them after training, level of
commitment to the yearly training program, number of
Fig. 3 Failure analysis

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training programs conducted for university students
and fresh graduate biomedical engineers.
IV. APPLICATIN OF CCEMS IN QC PROGRAM
The CCEMS is used by all DBE departments (6
dep’t) and workshops (23 pilot workshops all over the
country) to collect, store and analyze data on all related
to medical equipment (more than 27000 medical equip-
ment) fields and works; equipment inventory, spare parts
purchasing management, maintenance management,
equipment planning, selecting, receiving and distribut-
ing, warranty & contract management, tenders and ven-
dors follow up, QA&QC, training…etc [3]. All system
components are designed and developed by the DBE
staff according to needs and reflect the working proce-
dures. The implemented CCEMS provide powerful tool
to control, monitor, measure, assess and analysis of the
different performance indicators related to DBE activi-
ties such as;
Equipment availability (A), down time (DT): A & DT
are not used only for assessment of equipment condition,
but also as performance indicators of engineering activi-
ties by measuring the engineering DT (DTe) [2].
CCEMS generate different reports with respect to these
indicators (Fig.4), where also the MTTR and MTBF are
also measured as performance indicators of engineering
activities.
Preventive maintenance compliance (C): The system
allows detecting of not preformed or not completed PM
jobs within the PM schedule, measuring the engineering
compliance, re-evaluating the PM frequency, time spent
on PM jobs and others indicators related to PM works.
Pending working orders: The QC officers control via
a special screen all pending jobs. Any job out score the
predetermined times shall be colored alerted (Fig.5).
The CCEMS allows also monitoring engineering per-
formances in respect to training process, purchasing
process for medical equipment and spare parts, vendors
follow up and many others DBE activities.
V. RESULTS AND CONCLUSIONS
The implemented QA&QC program within DBE (59
biomed engineers and 86 biomed technicians) plays a vital
role in the improvement of DBE activities. In results of
this program and CCEMS a noticeable improvements have
been achieved. Table 1 shows the changes in some of the
measured performance indicators for the last three years
(2005-2007). The QACD continuously develop and
improve the used QA&QC program for the aims to im-
prove healthcare services, safety, quality of services pro-
Fig. 4 Measurement of engineering Down Time
Fig. 5 Pending jobs monitoring screen
Table 1 measured performance indicators
Indicator 2005 2006 2007
Availability (yearly) 83.7% 89.1% 92.3%
PM compliance (yearly) 85% 90.4% 93.5%
Pending working orders
(quarterly)
107 66 39
Utilization of working time
(8 h/day)
5.2 h 6.1 h 6.8 h
Number of users training
( half yearly)
8 13 19
Speed of parts purchasing
(average)
24 day 14 days 9 days
Customer satisfactions
( average - good )
72% 78% 84%

5. 750 W.S. Trarawneh, A. Ghawanmeh, I. Malkawi and M.A. Ghannam
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vided to medical equipment and customers and to improve
the clinical engineering activities.
REFERENCES
1. AMMI Medical devices—Quality management systems—Guidance
on the application of ISO 13485:2003.ANSI/AAMI/ISO
TIR14969:2004
2. Walid Tarawneh, Iyad Mobarek (2006) Fully automatic calculation
of medical equipment down time phases, IFMBE Proc.vol.14 World
Congress on Med. Phys & Biomed Eng., Seoul, Korea 2006, pp
3636-3640
3. I Mobarak, W Tarawneh, F Langevin, M Ibbini, Fully Automated
Clinical Engineering Technical Management System, Journal of
Clinical Engineering. 31(1):46-60, January/March 2006.
Address of the corresponding author:
Author: Walid Salameh Tarawneh
Organization: Ministry of Health
Department: Directorate of Biomedical Engineering
City: Amman
Country: Jordan
Email: wal-tarawneh@accenet.org