The procedure addressing the selection and installation of equipment will also need to provide instructions on how to document instructions for performing an equipment installation and how to record the installation. The following outline is for a combined set of installation instructions and records
1. Purpose: Record the purpose of the document
2. Scope: Define what is covered and what is not covered by the document.
3. Responsibilities: Define who is responsible for doing what
4. Identification of Personnel Involved: Table the following information:
Signatures and initials.
5. Documentation of the Site of Installation Record thefollowing information:
Room No. / Bench No.
Required Bench/Floor Area
Available Bench/Floor Area
Record the required number of power sockets and total current requirement
Record available circuit numbers, number of available sockets, circuit rating, current load, and available current
Record the required number of network sockets
Record the reference numbers of the available sockets and socket(s) record
6. Reconciliation of Deliveries
Record and check the part number(s) of each item match the part number on the Purchase Order and on supplier’s Delivery Note
Record and check the serial number(s) on each item agree with the serial number on supplier’s Delivery Note
Inspect each item for damage and record condition
Inspect any tilt indicators, confirm they are all present and intact, and do not show the package has been tilted
7. Reconciliation of software, documentation, cables, manuals, spare parts, and consumables. Compile a list of all items together with respective part numbers and document presence and are undamaged.
8. Documentation of the Equipment Record the following information:
Actual part number
Laboratory asset number of the hardware components
9. Documentation of computer hardware
Record the following information relating to the computer and monitor:
laboratory instrument No.
Actual processor type and speed
RAM type and size
Graphics adaptor type
Hard disk size and partitions
LAN Interface model identity
Optical drive type
Determine that the components conform to specification established in the design qualification
10. Installation, configuration, and documentation of software This section is used to record the configuration of the software. This can include:
Electronic signatures (format)
Passwords (password expiry and complexity requirements)
11. A list of all installed software Record the following information about each software package installed: -
12. Clock Configuration Provide instructions on how to configure the computer clock and record the following information.
Daylight saving (Yes/No)
Time server address
13. Installation Testing Provide instructions on how to test the equipment has been correctly installed. Including testing of:
Key equipment functions
Audit trail features
14. Equipment Logbook
Confirm an equipment Logbook has been Issued and record logbook number and date of issue.
15. QMS Procedures
Record QMS Procedures numbers and Titles
16. Routine Preventative Maintenance (PM) and Calibration
Record Calibration and Preventative Maintenance (PM) has been scheduled and any contracts have been established.
Record all training necessary to use the new equipment
18. Change Control (CC)
Describe change control procedures
Manufacturer’s hardware installation instructions
Manufacturer’s software installation, configuration, and verification instructions
Supplier’s delivery note, or waybill
Laboratory instrument number request form(s)
Copies of installation engineer’s training certificates
Copies of calibration certificates
Conformance certificates (e.g. CE marking)
Supporting documentation created during installation
Management of Equipment in an ISO/IEC 17025:2017 Accredited Laboratory