A solid equipment control program is an integral component of any laboratory quality management system. The goal of the equipment control program is to ensure that your equipment is under established controls at all times. Equipment control is an area too lengthy to comprehensively define in a short article, so I’ve included some key points to keep in mind.
The equipment control program must be defined and documented, which is usually accomplished in a standard operating procedure (or however named).
The equipment control procedure must describe how equipment is uniquely identified (e.g. asset numbers, calibration ID numbers, etc.) and tracked.
A calibration list or register is typically created to capture all the relevant information about each piece of equipment. List items should include, but are not limited to the following information:
- Unique ID number
- Description/ Name of the Equipment
- Manufacturer of the Equipment
- Model Number
- Serial Number
- Equipment Location
- Calibration Frequency
- Last Calibration Date
- Calibration Due Date
- A reference to the relevant SOPs
Newly purchased equipment should undergo a documented and detailed qualification process (i.e. DQ/IQ/OQ/PQ). Qualification should then continue on a routine and scheduled basis. This is a key area that must be well-defined with little room for interpretation. Equipment qualification requirements will be described in an upcoming article.
Equipment control programs must include a requirement for laboratory logbooks (or equivalent) to be assigned in order to record activities such as use, qualification, calibration, repair, training, etc. In addition, all equipment should be tagged with a calibration ID and with calibration status indicated.
A key area that needs to be thoroughly defined and detailed is how instrument failures are handled and documented. At some point, all instruments will fail, so you will need to have a course of action prepared. Some organizations create a separate system for handling equipment failures, while others capture it in the corrective action program. Regardless of where it is recorded, if an instrument fails or gives suspect results; it must be unambiguously tagged ‘out of service’ to preclude against further use. An impact on quality investigation must be immediately launched to determine if any results have been released to customers that may be suspect. The impact on quality investigation will require a review of all data generated between the last passing instrument check (e.g. calibration check, performance verification, system suitability check, etc.) and the failure. If your laboratory requires infrequent instrument checks, then such an investigation can be quite time-consuming and lengthy, with more work in question.
And finally, supplemental to the overall equipment control SOP, all individual equipment must have procedures for general use and control that describe at least the following:
- General operating instructions
- Environmental condition requirements
- Specific calibration and qualification requirements, frequency, and acceptance criteria
- System suitability, performance verification (or however named) requirements, frequency, and acceptance criteria
- Preventive/ routine maintenance
- Safety considerations/ PPE requirements
In summary, equipment control is vital for generating sound and reliable data, as it is the backbone of any laboratory. It is essential to have equipment controls documented in a procedure that details how control is maintained during routine operation and when failures occur. Furthermore, procedures need to be established for all individual equipment in order to provide details on use and control. The equipment control system needs to be systematically tracked and easily auditable, as it is an area that you can be sure will be heavily scrutinized during an audit.