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How can you maintain equipment after qualification?

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Equipment qualification is a critical process in manufacturing to ensure that your machines and systems meet the specifications and performance standards for your products. However, qualification is not a one-time event. You need to maintain your equipment after qualification to prevent failures, defects, and non-compliance issues. In this article, you will learn how to do that by following these steps:

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1 Review your qualification documents

The first step is to review your qualification documents, such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols and reports. These documents contain the acceptance criteria, test methods, and results of your equipment qualification. They also provide the baseline for your maintenance activities. You should check if there are any deviations, corrective actions, or recommendations that need to be addressed or implemented. You should also update your documents if there are any changes in your equipment, processes, or regulations.

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Eisenhower Rockefeller

CEO at Eisen Precision | Director at Pinator Energy
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its done by establishing a robust maintenance schedule, conduct regular inspections, prioritize preventive maintenance, train personnel on equipment care, and leverage data analytics for predictive maintenance, ensuring sustained performance post-qualification.

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2 Perform routine inspections and calibrations

The second step is to perform routine inspections and calibrations of your equipment according to the manufacturer's instructions and your quality standards. Inspections and calibrations are essential to verify that your equipment is functioning properly and accurately. They can also help you detect any signs of wear and tear, damage, or malfunction before they affect your product quality or safety. You should record and document your inspection and calibration activities and results, and compare them with your qualification data.

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3 Conduct preventive maintenance and repairs

The third step is to conduct preventive maintenance and repairs of your equipment based on the manufacturer's recommendations and your risk assessment. Preventive maintenance and repairs are necessary to prevent breakdowns, extend the lifespan, and improve the reliability of your equipment. They can also help you avoid costly rework, recalls, or regulatory actions. You should schedule and perform your preventive maintenance and repairs according to a defined plan, and document your actions and outcomes.

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Caelyn Audrain

Medical Device Regulatory Affairs and Quality Assurance
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I would argue this is the most necessary step of all listed. An ounce of prevention is truly worth a pound of cure, and if you keep up to date with all preventative maintenance, then you can avoid visible issues that could cost you valuable production or time, as well as prevent safety risks.

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4 Monitor your equipment performance and output

The fourth step is to monitor your equipment performance and output using appropriate indicators and metrics. Monitoring your equipment performance and output can help you evaluate the effectiveness and efficiency of your equipment and processes. It can also help you identify any trends, patterns, or anomalies that may indicate potential problems or opportunities for improvement. You should collect and analyze your data using statistical tools and methods, and report your findings and conclusions.

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5 Implement continuous improvement actions

The fifth step is to implement continuous improvement actions based on your monitoring and analysis results. Continuous improvement actions are aimed at enhancing your equipment performance and output, reducing your costs and risks, and increasing your customer satisfaction and loyalty. They can include modifying your equipment, processes, or procedures, adopting new technologies or methods, or providing training or feedback to your staff. You should document your improvement actions and their impact, and verify their effectiveness.

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6 Requalify your equipment when necessary

The sixth and final step is to requalify your equipment when necessary according to your quality system and regulatory requirements. Requalification is required when there are significant changes in your equipment, processes, or products that may affect their quality or safety. Requalification is also required when there are major repairs, modifications, or replacements of your equipment that may alter its functionality or performance. Requalification involves repeating some or all of the qualification steps to confirm that your equipment still meets the specifications and standards.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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David Martinez-Kennedy

Trusted Quality Assurance Leader | QMS Implementation ? People Management ? Project Management ? Regulatory Compliance ? Engineering Mentorship | 2x Promoted at Fitbit | Data Analytics Boot Camp Certification
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Consider implementing a system, preferably a data analytics tool, to track trends of how your equipment has been performing and how the equipment may be deviating from the validated nominal parameters. For example, have you noticed any trends in rising frequency of servicing or deviations due to high usage? And how would you define high-usage? Is the equipment still providing the same output (without having to adjust to the higher range of the process capabilities) from 1, 2 or 5 years ago?

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How can you maintain equipment after qualification?

1

2

3

4

5

6

7

1 Review your qualification documents

2 Perform routine inspections and calibrations

3 Conduct preventive maintenance and repairs

4 Monitor your equipment performance and output

5 Implement continuous improvement actions

6 Requalify your equipment when necessary

7 Here’s what else to consider

Manufacturing

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How can you maintain equipment after qualification?

1

2

3

4

5

6

7

1 Review your qualification documents

2 Perform routine inspections and calibrations

3 Conduct preventive maintenance and repairs

4 Monitor your equipment performance and output

5 Implement continuous improvement actions

6 Requalify your equipment when necessary

7 Here’s what else to consider

Manufacturing

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