Equipment Management - sucls.sd · PDF fileFunction Checks Monitor instrument ... C- Shaft D- Handle E- Push button . 36 Micropipette Characterisation ... Control of Micropipettes

1

Equipment Management

MINISTRY OF HEALTH-KHARTOUM STATE

LABORATORIES ADMINISTRATION Mohamed Ahmed Eldow

2

Discussion of problem scenario

You have begun performing Spectrophotometer and the ELISAs reader fails. You don’t have a documented procedure for troubleshooting, the maintenance , log has not been updated for 2 years, and the manufacturer’s instructions are missing.

What should you do? Why?

3

Learning Objectives

At the end of this activity, you will be able to:

Explain the importance of a preventive maintenance program

List requirements for equipment preventive maintenance

Manage a preventive maintenance program for your laboratory equipment

4

Objectives

At the end of this session, participants:

will have seen the main principles needed for management and verification of an equipment stock;

will possess several useful tools for bettering equipment management;

will have observed examples:

5

Well-maintained Equipment is Vital for:

producing reliable test results

minimizing instrument breakdown

lowering repair costs

preventing delays in reporting test results

maintaining productivity

6

A good equipment program:

maintains a high level of performance

lengthens instrument life

reduces interruption of services due to breakdowns and failures

improves the technologist’s confidence and knowledge

produces greater customer satisfaction

7

Content Overview


1. Organization

2. Inventory

3. Selection and acquisition

4. Installation

5. Calibration / Validation (initial and ongoing)

6. Maintenance

7. Troubleshooting

8. Service and repair

9. Computer software

10. Retiring equipment / disposition

8

1-Organization

Assign responsibility for equipment management

A maintenance/equipment supervisor Preferably a biomedical technician

Or a motivated and “handyman” laboratory technician

Under the quality supervisor's coordination

In charge of Equipment management and verification

Associated documentation management

Calibration, metrology

Spare parts management

Writing choice criteria for new instruments

Writing procedures for maintenance

Communication with higher management

9

1-Organization

Equipment Management Oversight

Assign responsibilities for all activities

Ensure all personnel are trained on requirements and maintenance needs

Monitor equipment management activities by:

ensuring all procedures are followed

routinely reviewing all records

updating procedures as needed

10

2-Inventory

Equipment Inventory

Generally done room by room (reception, sampling, culture, parasitology, etc.)

Establish equipment inventory following a model grid

Note if equipment is functional, partially functional, non-functional

Determine if non-functional equipment is:

Reparable

Not reparable

Eliminate non-reparable equipment

Organise the work on reparable equipment

11

2-Inventory

Inventory Grid

Instrument type

Make and model, production number

Year and acquisition conditions (purchased new/used/reconditioned, loan, donation, etc.)

Attribute a laboratory specific number, generally in the style “YY-number” (04-001, 04-002, etc.)

Presence or absence of:

documentation

Spare parts

A maintenance contract

A local technician/business who’s familiar with this type of instrument

12

3- Selection and Acquisition

Selection Criteria

Use - match equipment with service to be provided

Performance characteristics

Facility requirements, including physical space

Cost

Supply of reagents

Ease of operation

Warranty, availability of service, service contracts

Safety

13


Determining Functional Characteristics

For each type of apparatus, establish:

The desired specifications

Those that entail the non-use of the apparatus

Those that do not entail the non-use of the apparatus

These specifications belong to you, YOU’RE the one who decides what you can accept or not

Within an accreditation context, the norm that you respect will establish the limits

14


Acquiring Equipment

Purchase, lease, or rent

Central acquisition

Bulk procurement

Donated equipment

Conditions of contract / acceptance

15


When negotiating acquisition, request:

wiring diagrams

computer software information

parts list

operators’ manual user training

installation by manufacturer

maintenance

trial period, to assure expected performance

16

4- Equipment Installation


Prior to installation:

verify physical requirements have been met (electrical, space, ventilation, water supply)

confirm responsibility for installation

establish checklist to assure performance specifications will be met

17


Equipment Installation

Upon receipt:

verify package contents

Backup software, if part of system

Do not attempt to use prior to proper installation.

When possible, have manufacturer install

18


Equipment Installation

After installation:

Establish inventory record

Define conditions of use and storage

Develop and implement protocols for calibration, verification, and operating procedures

Establish maintenance program

Provide training for all operators

19

5-Equipment Calibration

Equipment Calibration

Perform initial calibration

Calibrators or standards

Determine frequency of routine calibrations

Follow manufacturer’s instructions

20

Performance Validation and

Verification

Define Validation

Define Verification

Provide scenarios that illustrate differences between the two.

21

Performance Validation

Compare new method with old method – two test comparison

Potential needs to further validate method

Literature search

Testing known samples in sufficient quantity to satisfy performance parameters

22


Performance Verification

Verify the performance of new equipment prior to use; for example:

Test known samples, analyze data for reproducibility

Verify that printouts/output is accurate, information is not changed

Establish stability and uniformity for temperature controlled equipment

Test pipettes

Check centrifuge RPMs

23


Functional Characteristics

Example: Micropipette specifications

Leaks: measure on H2Od

100 % = perfect

<100 % = rejected

Accuracy: on 10 measurements

> 99 % = perfect

> 97 % = to be re-verified

< 96 % = rejected

Precision: on 10 measurements

CV < 0.5 % = perfect

CV < 2 % = to be re-verified

CV > 3 % = rejected

Fictional numbers

24


Functional Characteristics

Once the functional characteristics are established:

Establish the time period for which the characteristics are considered constant, for example:

Fixed-volume pipette: 6 months of normal use

Variable-volume pipette: 3 months of normal use

Establish the necessary maintenance, preventive and verification tasks, their frequency and eventually the desired results

Create the logbook for the equipment

25

6-Maintenance

Equipment Maintenance

WHAT?

Systematic and routine cleaning, adjustment, and replacement of parts

WHEN? Performed periodically, daily, weekly, monthly

Examples: Cleaning optical lenses

Baseline or zero adjustments

26

6-Maintenance

Function Checks Monitor instrument parameters to verify that

equipment is working according to the manufacturer’s specifications

Performed periodically, daily, weekly, monthly

Performed after major instrument repair

Examples:

Daily monitoring of temperatures

Checking wavelength calibration

Checking autoclave indicator paper

27

6-Maintenance

Equipment: Spare Parts Establish and maintain an inventory of most

frequently used spare parts, to include: Spare parts for each piece of equipment Part number Average use Minimum number to be stored Cost, when to order Dates of entry and issuance from inventory Balance of items remaining in inventory

28

6-Maintenance

Equipment: Documents

Develop written procedures for all equipment Step-by-step instructions for maintenance and

function checks Guide for troubleshooting

Establish maintenance records to track: Function checks Routine maintenance Calibration Manufacturer’s service

29

6-Maintenance

Equipment: Documentation

Develop a problem log record Date problem occurred, equipment

removed from service

Reason for breakdown or failure

Corrective action taken

Date returned to use

Change in maintenance or in function checks

30

6-Maintenance

Records Needed for


Written maintenance procedures

Charts

Logs

Checklists

Graphs

Service Reports

31

6-Maintenance

Logbook

32

6-Maintenance

Logbook

33

6-Maintenance

Logbook and Follow-up

34

6-Maintenance

Once the logbook has been created

For each type of instrument, define then write:

Description and diagram

Norms (if needed or existing)

Use

Verification

Maintenance

EXAMPLE

35

Micropipette Description

A- Tip ejector

B- Tip

C- Shaft

D- Handle

E- Push button

36

Micropipette Characterisation

Volume

Fixed / variable

Accuracy

Precision (repeatability)

Accuracy and precision are generally determined by the manufacturer and tied to apparatus class

37

Recommendations of the ‘Movement Français pour la Qualité’ (MFQ)

Pipette type Frequency Accuracy Repeat. Bias

38

Pipette use 1. Setting volume

2. Tip-mounting

Tip quality

3. Aspiration

Pre-rinse the tip

Press the button to the first positive stop

Hold the pipette vertically

Place the tip’s end in the solution (2 to 4 mm for a blue tip)

Release the button slowly and smoothly

Wait one second

Withdraw the tip and wipe off the sides, without touching the extremity

4. Dispensation

Angle of 10 to 40° between tube wall and tip extremity

Press to the first stop

Wait one second

Press all the way

Withdraw the pipette while sliding it along the wall

Eject the tip

39

Pipette Use

40

41

Control of Micropipettes

Two controls are needed:

1. Leak test

2. Accuracy and precision

Equipment needed:

A laboratory balance with milligram precision and its accessories

A stopwatch (or a watch with a seconds hand)

Distilled water

42

Leak Test

Draw the quantity of water that corresponds to the pipette’s MAXIMUM

Wait one minute while holding the pipette vertically

No drops should form

43

Accuracy and Precision

44

Pipette logbook

45

An example of documentation (Gilson) on maximum permissible errors

Differences between ISO norms and Gilson norms

Reality?

Marketing?

46

Micropipette Maintenance

Three tasks:

Clean the pipette with a water or alcohol moistened tissue

Clean and lubricate (if needed) the piston

Caution: use only the lubricant furnished by the manufacturer

Clean or change the seal/o-ring

Refer to the manufacturer’s instructions

47

7-Troubleshooting

Equipment: Troubleshooting Determine source of problem:

Sample problem Reagent problem Equipment problem Check electrical supply Check water supply

Check manufacturer’s instructions Make one change at a time

48

7-Troubleshooting

When In-house efforts fail: Options for testing:

Refer to nearby laboratory

Obtain back-up instrument from central stores

Do NOT use equipment that does not function properly

Seek help from manufacturer or other technical expert

Ensure that all staff know instrument is not working; put notice on instrument

49

8-Service and Repair

Service and repair provided by:

Manufacturers

Laboratory must schedule service that must be periodically performed

Warranty may require repair handled by manufacturer

In-house biomedical service technicians

50

9-Retiring Equipment / Disposition

When? When experts indicate not

repairable

Outmoded, will replace with new equipment

Why? Prevent errors

Uses valuable space

Hazardous

How? Salvage any useable parts

Consider biohazard, follow safety disposal procedures

51

Tools for Management Equip

program Notes – Add info on

Commercial software

Maintenance scheduler

See additional slides

52

Key Messages: Benefits of an

equipment management program

Safety

Fewer interruptions of work

Lower repair costs

Elimination of premature replacement

Less standby equipment

Identification of high maintenance cost

Reduction of variation in test results

Greater confidence in the reliability of results

53

Spectrophotometer (Biosystem)

log book

54

1. Unit identification:

Name of the Unit ………………………………….. Manufacturer ………………………………………. Serial No………………………………………….. Model No…………………………………………. Code No………………………………………………

Hosp. /Lab Name............................................................

Location……………………………………………. 2. Warranty information:

Date of Purchase………………………………………. Date. Received………………………………….. Manufacturer’s Warranty #

Covers a) ……..………... From ……………. To …….…….. b) ….…….…….. From …………… To…………….. c) ) ………..…….. From …………… To…………….. For Service, call …………………………………………

Address………………………Telephone #....................... Other Warranties

Name ……………………………………………………

Address ……………………………………………….. Telephone #.....................................................................

Covers a) ………………From ………..….. To ……..…….. b) …………….. From …………… To…………….. c) ) …………….. From …………… To……………..

55

Date Check

lamp Check base line

stability Check short

circuits Cleaning

cuvette

flow

Duration

Time Sig.

1 2 3 4 5 6 7

Daily Maintenance (Month…………year….. )

56

Date Calibration

pump accuracy

and

linearity

Stray

Light temperature

sensor Cleaning

lens Sig.

Every – Month maintenance (year….. )

57

Date Defected part Spare part uses Engineer name Sig.

Maintenance Description

58

linearity of instrument:

deviation of an instrument’s performance from the ideal straight line relationship between the instrument’s output and the measured variable

By solid glass filter

By cobalt ammonium sulphate(2-4-6-8-10-12-14-16-18-20)(0.25-0.50-0.75-1.0-1.25 -1.50 -1.75 -2.0 – 2.25- 2.50 nm)

59

60

61

62

63

64

Stray light

It is a radiation that reaches the detector at wavelengths that from source other than light passing through the sample.

Detected by either filters or solutions (acetone, sodium bromide,NiSo4)

65

base line stability

Stability is the ability of a measurement system to produce the same values over time when measuring the same sample.

Detected by absorbance reading s of a substance are made by one minute internal the difference in reading must be less than 2%.

Is usually cause by a failing light source.

66

Autoclave log book

67

date water level

During Sterilization Sterilization status Sig

Temp C Pressure Pass Fall

1

2

3

4

5

6

7

Daily check (Month…………year….. )

68

68

Sterilization indicators

69

date Changing water door safety Air leakage Sig

Weekly check (Month…………year….. )

70

Incubator

log book

71

Month JAN FEB

Sig minimum maximum minimum maximum

1

2

3

4

5

6

Record Temperature maximum and minimum daily

72

Month JAN FEB

Sig minimum maximum minimum maximum

1

2

3

4

5

6

Record Temperature maximum and minimum daily

73

Sysmex KX21N

log book

74

Date Execute Shutdown

Check trap

chamber level

and drain Clean Duration

time Sig.

1

2

3

4

5

Daily maintenance (Month……year….. )

75

Date Auto rinse Clean rinse

cup

Clean .WBC\

RBC transducer

aperture

Replace

waste tank Sig.

As- Needed Maintenance

76

Date Clean sample rotor waive(SRV ) Sig.

Every 3 month (year………… )

77

Date Automatic Manual Sig.

CALIBRATION CHECKS Each Month (year…… )

78

79

80

81