Equipment Qualification

Deborah L. Griffin, BALaboratory Supervisor, HSCLab

Hillman Cancer CenterUniversity of Pittsburgh Cancer InstituteUniversity of Pittsburgh Medical Center

Equipment QualificationHSCLab rules (SOP)

Laboratory equipment that is to be used for assay validation must be qualified according to a pre-approved protocol prior to the start of method validation.

A document of the instrument qualification is to accompany any resulting method validation report.

Receipt of Equipment

Documentation of: Date of receipt and initials of accepting

tech entered into ordering log book or other inventory system

Inspection of packagingAny evidence of visible physical damage

Unpacking equipment

Assistance of factory vendor representative, if major equipment

Documentation of: Correct equipment shippedAll accessories presentInspection of equipmentAny evidence of visible physical damage

Internal Asset Control

Notify Clinical Engineering Perform electrical and safety testing Asset management

Computerized equipment inventoryPreventive maintenance schedule

Control tag placed on instrument indicating it has passed inspection

Documentation

Type of Equipment:

Equipment Manufacturer Model number Vendor

Date ordered Tech: *Attach copy of Purchase Req.

Receipt

Date of Receipt: Time of Receipt: Carrier:

Inspection of Packaging Acceptable Unacceptable (see F42) Tech:

Entered into Inventory Log Book Tech:

Installation

Unpacking performed by:

Factory Vendor/Service Rep present: No Yes, Name

Inspection of Equipment Acceptable Unacceptable (see F42) Tech:

Inspection of Accessories Acceptable Unacceptable (see F42) Tech:

Clinical Engineering

Clinical Engineering contacted: Date: Time: Tech:

Electrical and Safety Assessment Acceptable Unacceptable (see F42) Tech:

Asset Management Inventory Number PM Due

Signature of Tech Completing Form: Date:

Director Analysis: Initial Installation Acceptable Unacceptable (see F42)

Director Comments:

Laboratory or Medical Director Signature: Date:

Installation of EquipmentPosition in logical areaPlug into dedicated circuits or

emergency power if necessaryInstall according to manufacturer's

instructions Assure proper start up and general

operation

Priority of EquipmentDetermine

priority levelCritical piece

of equipmentor

One of many

Priority EquipmentA CytometerA Hematology AnalyzerA Scientific BalanceA Biological Safety Cabinets A Floor model CentrifugeA Cell washerA LN2 Transport ContainerA LN2 Vial VesselA Cryogenic Control Management & Fill SystemA LN2 Vessels (1 -> 5)A Cell SeparatorA Control Rate Freezers A Heat SealerA Active Blood Bank RefrigeratorA Sterile Connecting DeviceA Transplant Water BathsA Particle MonitorA Centrifuge inserts for CBUsB SerofugeB Dry ShipperB Fluorescent MicroscopeB Brightfield MicroscopeB PipettorsB Quarantine Blood Bank RefrigeratorB Vial CoolersC CO2 IncubatorC -70 FreezerC Clean Room FridgeC Clean Room FreezerC Stopwatches and TimersC Thermometers

Qualification PlanThe Qualification Plan must be documented

prior to performing any tests. PrincipleGoalReagents and Supplies Procedure

Manufacturers TestsInternal Tests

Target Values/Acceptance standardsResult ReportingQuality ControlReferences and Appendices

Manufacturers TestsDetermine manufacturers tests prior to instrument releaseExamples:

Electrical testing CalibrationReproducibilityCarryover

Internal TestsDetermine required tests prior to lab instrumentrelease, document in Qualification Plan, prepared specifically for each new piece of equipment, depending on critical nature ofequipmentExamples:

Linearity Accuracy and PrecisionStabilityCross-validation

Qualification TestingQualification:

Testing performed according to specifications.Record test results in a spreadsheet or

database, as appropriate. When critical equipment:

Run in parallel on other qualified machinery in lab (if replacement or an additional unit).Run in parallel with other certified

laboratories (when a new piece of equipment).

Documentation Review

Review of Qualification Plan and specified parametersCompilation of test resultsStatistical analysis of test resultsSummary of test resultsReport prepared by technologist detailing the results of the qualification

Laboratory Director reviews all documents and signs off on Qualification, specifying an implementation date. The Equipment Qualification Report is placed into the appropriate Equipment Binder.

Equipment BinderEach Binder contains five sections and is specific to equipment type. (e.g. Centrifuges, Microscopes, Refrigerators)

QC ProceduresQC ResultsPM DocumentationDeviation Management (failures, malfunctions, accidents, servicecalls)Validations (qualifications, method validations and manufacturers manuals)

At this point we meet as a group to discuss Method Validation and required QC Procedures with the Laboratory Director. These documents will also be filed in the Equipment binder once complete and approved.