The equipment supervisor coordinates the inventory, procurement, installation, maintenance, calibration, repair and (later on) validation of equipment. This person is responsible for the timely and proper execution of the actions in this implementation guide related to equipment.
Make sure that the equipment supervisor is trained and is as such capable of technical maintenance of the equipment present in the laboratory.
Activities related to Phase 2 - Equipment
All equipment in the laboratory should be labelled to be related to information in documents such as the inventory list and maintenance records. This was done in phase 1. As quality management is about writing what you do an doing what you write, you have to write an SOP for identification of equipment.
The generic SOP on identification of equipment can be adapted to describe this process of identifying and labelling equipment.
Make sure that this SOP is read by all relevant personnel members.
Label all equipment in accordance with the codes in the inventory list made in phase 1 under Equipment.
Label all equipment with unique codes so that the equipment register and maintenance records/contracts can be traced back to each piece of equipment. The label should be resistant against fluids, chemicals, light, and wearing.
The labels should indicate the date the equipment was last calibrated and when next calibration is due in case of equipment needing regular calibration (e.g. micro pipettes) or maintenance.
Make sure the labels are durable (e.g. cleaning proof).
Determine which organizational positions are authorized and responsible for use of each piece of equipment.
Add this, in the form of a table, to the SOPs for operation of equipment as developed in phase 1.
Read through all equipment SOPs to see if changes and corrections are necessary.
Completing this activity is the responsibility of the quality officer since this position has the responsibility over the correctness and updating documentation of the quality management system. The quality officer must assign the author of each SOPs to review and, if necessary, revise SOPs. After this the verifiers indicated in each SOP should verify the corrections and the general correctness of each SOP. Authorizers perform a last check and authorize the use of the SOP in practice. Then the quality officer must print the SOPs and replace the old versions for the new version. He/she should archive the retrieved versions. He/she should also notify the personnel members of the existence of new/changes SOPs and make sure that these are read by all personnel members.
These bench aids should be simple and concise and placed in a visible place nearby the machine (e.g. on the wall). In essence the bench aids are only the step by step procedures copied from the SOPs. An example bench aid is provided.
This activity could be completed by the equipment officer but also the authors of SOPs of different pieces of equipment could be assigned.
Important is to also include a list of measures that should be taken in case contamination has occured.
The way in which you organize maintenance (internal and external) for the laboratory’s equipment will depend on the size of the equipment stock, the frequency of use and the complexity of the equipment.
Especially consider equipment that could have an effect on biosafety or results. Some equipment may need calibration (this should also be documented).
Some elements that should be considered in developing the maintenance programme:
- The frequency of maintenance of equipment for each piece of equipment separately.
- The frequency of calibration of the equipment.
- Examination of electrical safety (assess risk to short-circuit, no uncovered cables).
- Assessment of emergency stop devices if appropriate.
This activity is the responsibility of the equipment officer in conjunction with the laboratory supervisor.
The equipment supervisor is responsible for proper adherence to this schedule.
In addition, a programme should be established to monitor the need for calibration of certain pieces of equipment (where appropriate). This programme regularly monitors and demonstrates proper calibration and function of instruments by including internal quality controls during measurements.
The generic equipment SOP on identification of equipment can be adapted.
Make clear in the SOP that equipment recalibration dates need to be taken into account when developing an equipment maintenance schedule.
The use of equipment needing maintenance based on hours of use (e.g. flow cabinets, centrifuges, etc.) has to be recorded on log forms.
The generic log form was already provided in appendix 1 of the generic SOP on identification of equipment. This form, after adaption to the local situation, has to be filled out for relevant pieces of equipment.
The equipment officer has to monitor the use of these pieces of equipment and arrange timely maintenance.
Maintain log files for the entire life-span of each equipment piece.
The TB CAP Laboratory Toolbox contains many logsheets and maintenance forms for various pieces of equipment generally used in TB laboratories. These can be adapted to the local situation. The forms were adapted from the forms included as annex to the equipment SOP templates provided in phase 1.
Note that calibration data should also continuously be recorded in these records as the laboratory needs to be able to show correct functioning of equipment.
When equipment is defective a clearly visible sign shall be placed on the equipment with the notification that use of this specific piece of equipment is not allowed. Disinfection shall be carried out if appropriate according to the SOP of the specific piece of equipment to protect maintenance personnel from infection.
When placed into service again, the functioning of this equipment according to expectations and examination requirements shall be shown before routine work is initiated. This test is comparable to the test as described in phase 1 that is done when new equipment is taken into service (check correct functioning of equipment with samples/controls with known values). The nature of these tests varies per piece of equipment. Analysis equipment can be tested by employing positive and negative control samples. Data from these tests shall be included in the Equipment File pertaining to that specific piece of equipment.
Ensure that equipment is appropriately protected when it is transported (e.g. in case it is defective and transported to the manufacturer).
Write a procedure for packing instruments for transport so that it is protected from shocks and vibrations. Include this procedure in the equipment maintenance SOP.