Think of computers, MGIT, autoclave, laminar flow, pipettes, timer clocks, etc. Include all equipment in an equipment register. The Strengthening Laboratory Management towards Accreditation (SLMTA) training provides also a template equipment inventory form.
In addition: the laboratory manager must investigate whether certain equipment is missing, causing problems in properly executing certain tests. If this is the case, budget needs to be reserved for ordering these pieces of equipment. The process of selection of suppliers and ordering of equipment will be standardized in phase 2.
Activities related to Phase 1 - Equipment
Determine if all equipment present in the laboratory is functioning properly and safely for the tests performed.
No tests should be hampered or negatively influenced due to defective/incorrectly functioning equipment. If this is the case, develop an action plan to eliminate this problem (repairing/purchasing new equipment) using SMART formulation.
When new equipment is purchased, it must be shown that the equipment is fit for use. This means that the equipment should give correct results based on controls; perform an examination with the piece of equipment on a negative and positive control and see if the results are correct.
As you’ve also already seen in the biosafety manual template chapters (which were in SOP format), the templates of SOPs we provide already have space allocated to including a version number, authorizers, verifiers, etc. These data are all parameters in the document control system which will be set up in phase 2. However, it may be good to already allocate space to these parameters and write all procedures in SOP format (rather than work bench protocols) to save double work in the second phase. Adapting SOPs to workbench protocols is less work then the other way around. To this end we already included the template Master SOP which explains how an SOP should be written, structured, and used. You don’t have to adapt this Master SOP to your local situation but just use this template for informational purpose.
Develop an SOP for each piece of equipment. In the Infosheet equipment SOPs the outline of equipment SOPs is given. Follow this outline for all equipment SOPs. The laboratory supervisor in conjunction with the quality project team should coordinate this process. It is possible (and maybe most optimal) to assign staff members working daily with a specific piece of equipment to write the SOP for that piece of equipment. Mind that this staff member should get a proper explanation on how to write an SOP.
The TB CAP Laboratory Toolbox provides several generic equipment SOPs. These SOPs were written for equipment used by most TB laboratories. These SOPs could be used as an example to be adapted to the laboratory’s own situation. IMPORTANT: when these SOPs are adapted to the local situation, be sure to follow the outline given in the Infosheet equipment SOP, so that the outline of all equipment SOPs within the laboratory is equal. Also take into account that the SOPs need to be adapted to the specific characteristics of the apparatus and the laboratory. If the apparatus needs specific operational steps to function properly these should be included in the SOP.
The TB CAP Laboratory Toolbox provides generic SOPs for the following equipment:
- Use and maintenance of class I and class II biological safety cabinets
- Use and maintenance of an autoclave
- Use and maintenance of an electromagnetic balance
- Use and maintenance of a centrifuge
- Use and maintenance of a freezer
- Use and maintenance of a refrigerator
- Use and maintenance of an incubator
- Use and maintenance of an inspissator
- Use and maintenance of a light microscope
- Maintenance of a fluorescence microscope
- Use and maintenance of a pH Meter
- Use and maintenance of a water distiller
Make sure that these SOPs are read by all relevant personnel members.