Checklist Equipment

Does the equipment register contain the following details for each piece of equipment? (tick off)

• Identity
• Label
• Serial number
• Manufacturer name
• Manufacturer’s contact person and contact details
• Service provider name
• Service provider’s contact person and contact details
• Date of purchase
• Date of putting into service
• Location
• Condition
• Frequency of maintenance
• Date of previous maintenance
• Date of next scheduled maintenance
• Remarks

Has the laboratory identified critical needs for specific pieces of equipment that must be present in order for the piece of equipment to function?

Does the laboratory have a standardized, documented procedure for acceptance or rejection of donated equipment?

Is the SOP for Procurement and Reception of Equipment demonstrably reviewed and verified by fellow staff members?

Are all technical and managerial staff members aware of the existence of the SOP and do they know when to use it?

Are all findings of validations (both validation of examination methods and validation of equipment) documented in validation reports?

Are Equipment SOPs written in accordance with the procedure described in the Master SOP?

Have staff members demonstrably read the SOPs that are relevant for them?

Do the equipment labels include the following data:

• Equipment code
• Date of last service/calibration
• Date of next service/calibration

Is there an standardized procedure in place assuring that the laboratory determines and corrects the negative influence of defective equipment on laboratory testing?

Has procedure for determining and correcting the negative influence of defective equipment routinely been performed in the past when equipment appeared to be defective?

Ask the interviewee to show an example.

Do staff members who are responsible for a piece of equipment know their responsibilities?

Take a sample by asking such a staff member.

Does the laboratory have a Maintenance Log Sheet for each piece of equipment that shows what maintenance has been performed at which moment to which piece of equipment?

Do staff members know how and when to fill out Usage Log Sheets/log books for each piece of equipment?

Are Maintenance Log Sheets of equipment stored orderly in the Equipment Archive?

Does the laboratory have a documented procedure that describes the following:

• Activities that need to be undertaken when new equipment is introduced in the laboratory
• The required measures for ensuring maintenance and calibration of the piece of equipment
• Ensuring presence of the SOP for maintenance and use of the piece of equipment

Are these Bench Aids in accordance with the SOPs for equipment?

Is the budget needed for the maintenance and calibration of equipment calculated and documented?

Have funds been identified for training of a staff member for internal maintenance and calibration of equipment?

Does the laboratory demonstrably adhere to this program?

Compare maintenance records for a piece of equipment from the equipment file with the dates this maintenance was planned in the Equipment Maintenance Schedule.

Does the laboratory have an SOP for Equipment Repair, including a clear procedure for disinfection and clear labeling the equipment as “defect”?