Laboratory Equipment related issues: include problems in:
– Calibration – The process of checking or adjusting the accuracy of a measuring instrument by comparison with a standard is known as calibration.
– Preventative Maintenance – Preventive maintenance means providing care and servicing to maintain laboratory equipments and facilities in a satisfactory functioning condition. Purpose of this preventive action is to prevent the equipments used in the laboratory or the facility from failure in inspection through repeated detection and correction. Maintenance on the other hand, includes experiment, measurements, modification, and substitution, and is done to thwart faults before they take place.
– Laboratory Validation – It is a process that ensures that laboratory test data and results are reliable, correct and to-the-point. Faulty validation report can lead to non-compliance of laboratory regulations.
Standard Operating Procedures – SOP’s: SOPs are written procedures for a laboratories program. They define how to carry out protocol-specified activities. They are written to explain how the lab procedures are supposed to work. Though there are no stipulated methods for developing SOPs, but SOPs are most of the time written in a chronological listing of action steps and include few mandatory information such as scope of the SOP, hazard assessment, assessment of exposure control, description of protective equipments. Absence of these information and others may result into failure in compliance. Following are the necessary components to ensure effective SOPs
– Laboratory Records – Failure to keep records with right dates and reports can lead to non-compliance of laboratory regulations.
– Data Sheets – Maintaining data sheet with accurate data and assessment of data help the facility to avoid non-compliance.
Out of Specification (OOS): Trough OOS investigations, following problems can be found:
– Laboratory Errors – These errors suggest problems in inadequate training, poorly maintained equipment, and improperly calibrated equipment.
Investigations – OOS investigation should be done scientifically and should be free from any bias. Target of the investigation is to inspect the containers, data and SOP.
– Documentation – Documenting of every step of OOS investigation is important as failure to documentation may lead to non-compliance.
Training: Insufficient training can raise problems in areas such as documented program, analytical method validation and reagents, solutions and reference standards.
