Safety Column
Testing and continually updating the procedure helps to validate that the procedures in place are adequate for the inspection of the device and that all information is being collected and recorded properly for future review. Technical competence is asking if the inspector is trained to handle the equipment or test the device in the field. What does your organization or program have in place to ensure that the employee in the field has the appropriate training? These can be hours of on-the-job training with an experienced employee or supervisor, tests regarding relevant material, reading materials or official manuals, and online or in-person courses. The list can be endless, but you want to document all training to ensure you can verify the inspector can perform the inspection correctly and repeatedly. Finally, measurement assurance. Most of us have spreadsheets, applications, or LIMS to help us with our everyday inspections and testing. How do we ensure those systems are operating and calculating properly? New formulas and tolerances are periodically updated so we want to ensure our systems are updated as well. These checks can be done by comparing hand calculations to the results the application gives, comparing one system to another with the same inputs, or comparing your application to another company or state using the same software. You will want to check these systems on set intervals determined by your program or regulations. Maintaining these checks will help keep the system accurate over time. This continuous oversight proves your measurements were reliable on the exact date your inspector evaluated a device. This, of course, is not a complete list of everything we can do to prevent lawsuits. There is always the possibility of a lawsuit in today’s world so the best we can do is mitigate that possibility by following these 7 elements.
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