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Management of Equipment in an ISO/IEC 17025:2017 Accredited Laboratory

Part 2: Equipment Lifecycle Models

8 Periodic Review

The purpose of carrying out periodic reviews is to:

1. Create evidence that provides a high degree of assurance that the equipment continues to function according to appropriate, predetermined criteria.

2. Ensure the instrument conforms to current requirements and expectations, which may have changed since the installation of the equipment

3. Detect any trends in performance.

4. Detect any deterioration in performance.

5. Implement any necessary remedial action

Periodic reviews need to also consider new requirements, expectations, and guidelines that are currently being developed and any trends in nonconformities reported by the accreditation bodies and, where appropriate regulatory authorities. For example, the warning letters on relevant topics issued by the United States Food and Drug Administration and published on the FDA.gov website can be expected to be incorporated into new accreditation body expectations.

The laboratory will need to identify what records should be included in the review; this will usually include, as appropriate:

1. Maintenance, qualification, and calibration records

2. Malfunction and repair records

3. Records for routine replacement of parts, such as lamps and pump pistons

4. Deviation reports

5. Training records

6. Change control and configuration management

7. Backup and archive records

The laboratory will also need to determine how to record each review in some kind of report. The following is a suggested content:

1. Identification of the equipment being reviewed

2. Responsibilities: Define who is responsible for doing what

3. Identification of personnel involved

4. Detailed instructions on how to perform the review

5. Review findings

6. Conclusions and recommendations

7. Instructions on how to handle non-conformances and deviations

9 Decommissioning

When it is time to remove the equipment from service, careful consideration needs to be given to the decommissioning process; several issues need to be addressed. The most important of these, from the compliance perspective, is the need to demonstrate that the instrument was still calibrated and suitable for its purpose from the time of its last calibration up to the time it was last used. Other aspects that need to be addressed are:

1. Ensuring that all instrument records are accounted for and archived

2. Ensuring that all service contracts are cancelled

3. Ensuring that the instrument scheduling is cancelled in the validation master plan

4. The instrument is thoroughly cleaned, and any contamination removed

The calibration status of the equipment can be confirmed by performing a final as is calibration on the instrument; if the equipment passes this, it can be concluded that the instrument was still performing to its established specification up to the time of that final calibration. If the instrument fails, or it is not possible to calibrate the equipment due to non-repairable damage, the event needs to be treated as a nonconformity and an investigation initiated to determine the impact on any measurements made using that instrument.

The procedure for decommissioning equipment needs to provide instructions for recording the decommissioning activities, which will be in a report. The following is a suggested content:

1. Purpose Define the purpose of the report:

2. Responsibilities: Define who is responsible for doing what

3. Copy of calibration protocol or calibration instructions

4. Summary of test results, together with acceptance criteria and a statement of outcome

5. Confirmation that all records associated with the equipment have been accounted for and archived.

6. Confirmation that all service contracts have been cancelled

7. Confirmation that the equipment scheduling is cancelled in the quality plan.

8. Confirmation that the equipment has been thoroughly cleaned and all contamination removed.

9. Instructions on how to handle non-conformances and deviation

10 References

1. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. International Organisation for Standardisation, Geneva, 2017

2. D. Trew, Management of Equipment in an ISO/IEC 17025:2017, Accredited Laboratory Part 1. Classifications of Laboratory Equipment.

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