Management of Equipment in an ISO/IEC 17025:2017 Accredited Laboratory
Part 2: Equipment Lifecycle Models
4.2 Equipment Selection
The selection of a laboratory instrument is a key phase in the lifecycle management of laboratory equipment. Clause 6.4.4 requires that equipment conforms to specified requirements. Without those requirements being clearly defined, it is impossible to determine if the equipment is suitable for its purpose. Errors in the selection process can result in an instrument that is deficient in some functionality which can present enormous technical, compliance and business issues. Therefore, it is critical to invest sufficient resources into the selection process and create a set of requirements that truly meet the laboratory’s needs.
The purpose of the selection phase is to:
1. Define the user, functional, and operational requirements of the instrument and ensure the instrument selected is of the correct type and will have the appropriate functionality
2. Document the decision process for the selection of the instrument and supplier
3. Ensure the selected supplier can meet company qualification and support criteria
Instrument specifications arebest developed by a multi-disciplinary team comprising several laboratory personnel and expertise, as applicable, from information technology, engineering, validation, and quality assurance. Outside consultants can also be involved, if needed to ensure that all required specifications are included. The outputs from the selection phase are:
1. User requirement specification (URS) – The purpose of the URS is to define what the user wants to do with the equipment; this should be written by typical users and should include:
i. A description of the intended use of the results of the tests carried out using the equipment or a description of the potential use of instruments calibrated by the equipment. This information can come from the laboratory’s scope of accreditation and other sources.
ii. A description of the use of the equipment – What types of samples, testing, or calibrations will be carried out with the equipment?
iii. A description of the operational environment – This should include a discussion of the regulatory or accreditation environment and the use environment; this should include any attributes required to conform with regulatory or accreditation requirements and the laboratory environment.
iv. A list of what the user requires – This should include the software that should be installed on the computer and computer security requirements, particularly if the equipment will be networked.
2. Functional requirement specification (FRS) defines the functionality the equipment must have to perform its assigned tasks, defined in the URS, and to comply with regulatory, accreditation, and laboratory requirements. The FRS will be created from the URS and the knowledge and experience of users. In addition, all the major manufactures publish detailed equipment function documents and performance specifications, which can be used as a guide. The author, however, does not advocate simply stating that the manufactures specifications shall be used as the official FRS. The functional requirements specification must consider the laboratory’s specific requirements. Simply using the manufacturer’s specification will not achieve this and may lead to much unnecessary work during the installation phase.
3. Operational requirements define what the equipment must be able to do and the limits it must be able to achieve, to fulfil its intended purpose. These will often define the accuracy and/or uncertainty that may be achieved by the equipment and maybe set by industry guidelines or national and international standards. These requirements will be used when installing, calibrating, and maintaining the equipment to determine that the equipment is suitable for its purpose. When considering such operational requirements, it is necessary to
i. Consider the customer’s requirements as the measurement obtained using the equipment will need to meet their requirements.
ii. Set the limits sufficiently broad so the equipment can routinely conform to them when being calibrated. However, limits set too stringently can result in regular calibration failures
iii. Not set the limit so broad as to be meaningless
4. Vendor Approval (VA) The selection and approval of the vendor will be controlled by the laboratory’s control of external providers procedures. However, when procuring new laboratory equipment, documented evidence needs to establish that the:
i. instrument was designed, developed, and manufactured under a documented quality management system
ii. Instrument was tested to a documented protocol that is traceable to design and requirement specifications
iii. Vendor can help with instrument installation, calibration, troubleshooting, maintenance and repair in a timely manner
iv. Vendor can provide satisfactory after-sales service
v. Vendor operates a customer feedback system
vi. Vendor operates a change control system
vii. Vendor will permit an audit if one is required
The extent of vendor qualification will vary depending on several factors, such as
1. The level of compliance risk associated with the instrument
2. The level of knowledge and experience the vendor has with the sector(s) the laboratory operates in
3. The vendor’s quality management system
4. The laboratory’s experience with the vendor
Depending on the situation, VA can range from obtaining documented evidence of an established quality management system to carrying out a full on-site audit. In practice, the extent of VA will lay somewhere between these two extremes. A major instrument supplier with significant experience in the sector(s) the laboratory operates in will unlikely require a full on-site audit unless performance issues are encountered.
The procedure discussing the selection of laboratory equipment needs to specify the format the URS, FRS Operational, and vendor requirements should be presented in. The level of detail needed for a specific instrument will depend on its use and complexity. The equipment classifications discussed in the previous paper2 in this series can be used to establish requirements for different categories.