3 Defining and Documenting the Equipment Management Lifecycle Model
The lifecycle model can be defined by describing each key point; this is usually presented in the laboratory’s quality manual. The details of each key event should be explained in the respective procedure. It is recommended the following procedures are implemented.
1. Selection and Installation of Laboratory Equipment
2. Calibration and Preventative Maintenance
3. Periodic Review of Laboratory Equipment
4. Decommissioning of Laboratory Equipment
It may be possible to combine all these individual procedures into a single procedure. However, this will usually result in an exceedingly long procedure. As users will seldom need to use all these processes simultaneously, the author does not advocate this approach unless the laboratory has no computer-controlled equipment.
4 Selection and Installation of Laboratory Equipment
As the selection and installation of laboratory equipment usually occur together, these two key events can be conveniently combined into a single procedure.
4.1 Selection and Installation Planning
A project to select and install more complicated laboratory instruments should usually start with a project plan. The purpose of the project plan to
1. Decide on the strategy for qualification
2. Identify the activities that will be carried to qualify the instrument
3. Assign roles and responsibilities
4. Determine a timeline for the activities
5. Determine the resources required to deliver the project
6. Identify what records need to be created to evidence the instrument conforms to appropriate specifications
7. Define how to handle deviations from the plan in the event of unforeseen events
8. Develop contingency plans in the event the instrument does not deliver as expected
The benefits of creating a project plan are:
1. Everyone involved in the project understands what is expected
2. Management can approve and buy into the plan
3. Management knows what resources are required and can assign those resources as required
4. Management knows how long it will take to deliver the projects and can plan laboratory operations accordingly
5. Management can see that there is a contingency plan available
6. The accreditation body or regulatory authorities can readily see adequate planning and thought has been invested into the selection, installation and demonstrating the instrument meets appropriate specifications and is suitable for its purpose
A project plan may not be required for some categories of equipment. For example, analytical equipment assigned to category 1 and measuring equipment assigned to categories 1 and 2 would probably not require a detailed project plan. However, as the complexity of the equipment increases, a project plan becomes more important and is expected by the regulatory authorities and accreditation bodies.
4.1.1 Documenting the Plan
The records created during the planning phase will communicate requirements to management and all those concerned. In addition, the records created will serve as a record of the management approval. It is suggested the records should be in the form of a single document containing the following information:
4.1.1.1 Introduction
This should contain a description of what is to be qualified and the purpose of the document,
4.1.1.2 Scope
This should define the plan’s scope, what is included and what is not included, together with justification.
4.1.1.3 Users
Identify the individuals that will be using the instrument and list the names of the users together with any access privileges.
4.1.1.4 Regulations, Policies, Standards and Procedures
Compile a complete list of regulations, policies, standards, and procedures to which the instrument must conform; this will serve as a reference point during the selection and installation of the equipment.
4.1.1.5 Strategy
Discuss the overall strategy that will be followed during selection and installation, including reference to any laboratory policies and SOPs and industry practices.
4.1.1.6 Roles and Responsibilities
Define the responsibilities of users, owners, the vendor, and other departments (IT, Validation, Quality Assurance etc.)
4.1.1.7 Equipment Categories
Document the assigned categories with appropriate justification.
4.1.1.8 Deliverables
This should include the
1. Records that need to be created.
2. Procedures that may be impacted by the new instrument and need to be reviewed and amended if required.
3. Procedures requiring creation, review, or amendment
This also needs to include responsibilities for preparing, reviewing, and approving these documents.
4.1.1.9 Timeline
A timetable of events should be established; this can be presented either in tabular form or using a Gant Chart.
4.1.1.10 System Security
Discuss the steps to be taken to ensure the security of the system.
4.1.1.11 Contingency Plan
The contingency plan is what are you going to do if the equipment fails to meet the specifications. With a new instrument from a major supplier, this happens extremely rarely. Such an event should be carefully investigated to identify the root cause and determine an appropriate course of action.
4.1.1.12 Deviation Handling
The handling of deviations should be described in laboratory policies and procedures. It has been the author’s practice to provide detailed instructions in the documents associated with the installation, calibration, review and decommission of the equipment (since that is when the deviations will occur). In the planning document, the author has limited this section to defining what a deviation is for the purposes of the project, commenting that instructions for handling deviations will be provided in the respective document and making a reference to the respective document
4.1.1.13 Glossary
A list of terms used together with definitions should be included.
