EquipmentManagement

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The Quality System

Process Control

(Quality Control & Specimen

Management)

Purchasing & Inventory

AssessmentOccurrence

Management

Information Management

Process Improvement

Customer Service

Facilities & Safety

Organization Personnel Equipment

Documents & Records

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Discussion of problem scenario

You have begun performing ELISAs and the 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?

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Well-maintained Equipment is Vital for: producing reliable test results minimizing instrument breakdown lowering repair costs preventing delays in reporting test results maintaining productivity

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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

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Content Overview Equipment Management

1. Organization2. Inventory3. Selection and acquisition4. Installation5. Calibration / Validation (initial and ongoing)6. Maintenance7. Troubleshooting8. Service and repair9. Computer software10. Retiring equipment / disposition

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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

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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

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Commissioningcommissioning includes:

the selection, installation and validation of equipment

all stages of commissioning must be documented

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Selection of equipment define your needs, for example

- space/services- robustness/ruggedness- reproducibility- range- capacity- precision/accuracy- sensitivity/specificity- technical expertise- training- delivery time- cost vs. budget

compare with manufacturer's specifications

select "best fit"

“Selection is based on suitability for purpose”

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Installation prepare to receive equipment

- prepare space and services- define acceptance criteria

check items match order specification check normal operation of controls obtain or give training / write instructions for

use document who is authorised to use the

equipment prepare equipment record

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Validationdocumentation of the method used and the

results obtained which show that the equipment meets the defined needs consistently, under routine and "worst case" conditions

may be repeated at intervals to show continuing satisfactory performance

can be prospective, that is pre-planned, concurrent or retrospective

make sure services are validated before equipment

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Qualification (1) Design qualification (DQ)

new equipment and procedures may need a design qualification, that is documented verification that the design of the equipment and its components is adequate for your requirements

Installation qualification (IQ) documented verification that, at the time of installation, equipment and equipment-related systems comply with the recommendations of the manufacturer, as well as with design specifications, system specifications and appropriate codes

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Qualification (2) Operational qualification (OQ)

documented verification that equipment performs in accordance with manufacturers' specifications and testing requirements and that the appropriate quality systems (e.g. training, calibration, maintenance.....) are in place

Performance qualification (PQ)documented evidence that an analytical method performs as intended and that it produces a test result that consistently meets appropriate specifications and the requirements defined in the protocol

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6-Maintenance

Equipment MaintenanceWHAT?

Systematic and routine cleaning, adjustment, and replacement of parts

WHEN? Performed periodically, daily, weekly, monthly

Examples: Cleaning optical lenses Baseline or zero adjustments

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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

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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

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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

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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

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6-Maintenance Records Needed for

Equipment Management Written maintenance procedures Charts Logs Checklists Graphs Service Reports

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Logbook

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6-Maintenance Logbook

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6-Maintenance Logbook and Follow-up

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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

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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

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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

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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

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Tools for Management Equip program

Notes – Add info on Commercial software

Maintenance scheduler See additional slides

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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

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Discussion of problem scenario

You have begun performing ELISAs and the 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?