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Laboratory Equipment Calibration Audit Checklist

A comprehensive checklist for auditing the calibration processes of laboratory equipment in pharmaceutical research facilities to ensure accuracy, reliability, and regulatory compliance.

Laboratory Equipment Calibration Audit Checklist

by: audit-now
4.1

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About This Checklist

Ensuring the accuracy and reliability of laboratory equipment is crucial in the pharmaceutical industry. This Laboratory Equipment Calibration Audit Checklist is an essential tool for maintaining compliance with regulatory standards and guaranteeing the quality of research and manufacturing processes. By systematically evaluating calibration procedures, documentation, and equipment performance, this checklist helps identify potential issues, minimize errors, and enhance overall laboratory efficiency. Implementing regular calibration audits using this comprehensive checklist can significantly improve data integrity, product quality, and regulatory compliance in pharmaceutical research laboratories.

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Industry

Healthcare

Standard

ISO/IEC 17025 - Testing Laboratory Competence

Workspaces

Research Facilities

Occupations

Quality Assurance Specialist
Metrologist
Laboratory Manager
Calibration Technician
Research Scientist
1
Is the laboratory equipment calibrated according to the established procedures?

Select the compliance status of the equipment calibration.

To ensure that all laboratory equipment meets the required calibration standards.
2
What is the accuracy percentage of the calibration?

Enter the accuracy percentage.

To verify that the calibration accuracy meets the regulatory standards.
Min: 90
Target: 95
Max: 100
3
Is there documentation available for the calibration procedures?

Provide details about the documentation.

To ensure proper documentation is maintained for traceability and compliance.
4
How often is the calibration performed on the equipment?

Select the calibration frequency.

To ensure that the calibration frequency aligns with regulatory standards and company policies.
5
What equipment was used for the calibration process?

Specify the equipment used for calibration.

To ensure that appropriate and validated calibration equipment is utilized.
6
When was the last calibration performed on the equipment?

Enter the date of the last calibration.

To track calibration history and ensure compliance with calibration intervals.
7
What calibration method was used?

Select the method used for calibration.

To validate that the calibration method is appropriate and compliant with standards.
8
What is the acceptable error margin in calibration (in %)?

Enter the acceptable error margin.

To ensure that the error margin is within acceptable limits as per regulatory standards.
Min: 0
Target: 2
Max: 5
9
Are calibration records readily available for review?

Select the availability status of calibration records.

To ensure that all necessary documentation is accessible for audits and compliance checks.
10
Please provide any comments or observations regarding the calibration process.

Write your comments here.

To capture qualitative feedback that may impact the calibration effectiveness.
11
How many deviations were noted during the last calibration?

Enter the number of deviations recorded.

To assess the number of issues that may indicate problems with the calibration process.
Min: 0
Target: 0
Max: 10
12
What is the next scheduled date for calibration?

Enter the next calibration due date.

To ensure that future calibration activities are planned and tracked appropriately.
13
Is the maintenance for the calibration equipment up to date?

Select the maintenance status of the calibration equipment.

To ensure that all calibration equipment is properly maintained to ensure accuracy.
14
What is the specified calibration interval in days?

Enter the calibration interval in days.

To ensure that the calibration is performed within the required time frame.
Min: 1
Target: 30
Max: 365
15
Who performed the last calibration?

Enter the name of the personnel who performed the calibration.

To ensure that qualified personnel conducted the calibration.
16
When was the last review of the calibration process conducted?

Enter the date of the last calibration review.

To track the frequency of reviews for continuous improvement.
17
Is the calibration process compliant with the Standard Operating Procedures (SOPs)?

Select the compliance status with SOPs.

To ensure that the calibration process follows the established SOPs for consistency and quality.
18
What is the identification number of the calibration equipment?

Enter the identification number of the equipment.

To ensure proper tracking and accountability of calibration equipment.
19
How long did the last calibration take (in hours)?

Enter the duration of the calibration in hours.

To assess whether the calibration process is efficient and within expected time frames.
Min: 0
Target: 2
Max: 24
20
Please describe any issues encountered during the calibration process.

Provide details about any issues encountered.

To identify potential problems that may need to be addressed for future calibrations.

FAQs

The frequency of calibration audits depends on the equipment type and usage, but generally, they should be conducted at least annually or as specified by regulatory requirements and manufacturer recommendations.

This checklist covers calibration procedures, documentation, equipment performance, traceability to national standards, personnel training, and calibration schedule adherence.

Typically, quality assurance personnel, metrology specialists, or designated laboratory managers are responsible for conducting calibration audits.

The checklist ensures that all aspects of equipment calibration meet regulatory standards, including documentation, traceability, and adherence to established procedures, which are crucial for compliance with GMP and other industry regulations.

If discrepancies are identified, they should be documented, investigated, and corrective actions should be implemented. This may include equipment recalibration, procedure updates, or additional staff training.

Benefits

Ensures compliance with regulatory standards and GMP requirements

Improves accuracy and reliability of laboratory equipment

Enhances data integrity and quality of research results

Reduces the risk of equipment-related errors and product recalls

Facilitates continuous improvement in laboratory processes