How do you align your equipment qualification process with the quality management system (QMS)?

1 Define your EQ scope and objectives

The first step to align your EQ process with your QMS is to define your EQ scope and objectives clearly. This means identifying the equipment types, functions, and parameters that need to be qualified, as well as the acceptance criteria and documentation requirements. You should also establish the roles and responsibilities of the EQ team and the stakeholders involved in the process. By defining your EQ scope and objectives, you can ensure that your EQ process is consistent, traceable, and aligned with your QMS goals and policies.

2 Follow the EQ lifecycle approach

The second step to align your EQ process with your QMS is to follow the EQ lifecycle approach, which consists of four phases: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Each phase has its own purpose, activities, and deliverables, and they should be performed in a sequential and documented manner. The EQ lifecycle approach helps you to verify and validate that your equipment is designed, installed, operated, and maintained according to your QMS standards and specifications.

3 Integrate EQ with risk management

The third step to align your EQ process with your QMS is to integrate EQ with risk management. This means identifying, assessing, and mitigating the potential risks associated with your equipment throughout its lifecycle. You should also monitor and review the performance and reliability of your equipment and implement corrective and preventive actions (CAPA) when needed. By integrating EQ with risk management, you can enhance your QMS effectiveness and efficiency, as well as prevent or reduce the occurrence of non-conformities, deviations, or failures.

4 Coordinate EQ with calibration and maintenance

The fourth step to align your EQ process with your QMS is to coordinate EQ with calibration and maintenance. This means ensuring that your equipment is calibrated and maintained according to the manufacturer's instructions and your QMS procedures. You should also keep records of the calibration and maintenance activities and results, and update your EQ documentation accordingly. By coordinating EQ with calibration and maintenance, you can ensure that your equipment remains in a qualified state and operates within the specified limits.

5 Train and educate your EQ personnel

The fifth step to align your EQ process with your QMS is to train and educate your EQ personnel. This means providing them with the necessary knowledge, skills, and competencies to perform their EQ tasks effectively and efficiently. You should also ensure that they are aware of the QMS requirements and expectations, and that they follow the EQ policies and procedures. By training and educating your EQ personnel, you can improve their performance and competence, as well as foster a culture of quality and continuous improvement.

6 Review and improve your EQ process

The sixth and final step to align your EQ process with your QMS is to review and improve your EQ process. This means conducting regular audits, inspections, and assessments of your EQ process and its outcomes, and identifying the strengths, weaknesses, opportunities, and threats. You should also collect and analyze feedback from your EQ personnel, stakeholders, customers, and regulators, and use it to improve your EQ process. By reviewing and improving your EQ process, you can ensure that it meets the QMS requirements and standards, and that it delivers the expected results.

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?