Process Control System - Installation Qualification
What is Installation Qualification?
If you are perusing this article, it is likely that you are already acquainted with Installation Qualification, known as IQ or CIQ (Computer Installation Qualification). This phrase is frequently employed during the Validation phase, but it can also be encountered under the term "Integration Phase" during the Project Phase.
REFRESH:
Installation Qualification is documented verification that a Process Control System is installed according to written and approved specifications. (GAMP5)
What is the purpose of the Installation Qualification?
"IQ" stands for "Installation Qualification" which is documented proof that the system design and configuration are correct as intended. It also ensures that the equipment has adequate accuracy, precision, and range for the intended use. Additionally, it verifies that there are appropriate system manuals, as-built drawings, instrument calibration reports, and SOPs (Standard Operating Procedures) that explain how to operate the system correctly.
Do we need to perform the Installation Qualification only on Category 4, and Category 5 Process Control System?
Process Control System classification is not considered in Installation Qualification, therefore for all categories Installation Qualification shall be performed.
Where I shall write the scope of the Installation Qualification?
The scope of the Installation Qualification (IQ) should be explicitly defined in the Validation Plan for the Process Control System. The scope should encompass all IQ activities associated with the high-level topic. For more comprehensive information regarding Qualification, the Validation Plan can refer to the Installation Qualification Protocol.
Do I need to include the Installation Qualification Tests in the RTM?
The Requirements Traceability Matrix (RTM) is a crucial document that contains all information relating to the requirements and their respective testing during the qualification phase, thereby ensuring traceability. As such, the RTM serves as a vital tool in the management of requirements, facilitating streamlined and efficient processes. In essence, the RTM enables project stakeholders to track requirements from inception to implementation, thereby ensuring that all requirements have been adequately addressed. Furthermore, the RTM is an indispensable document in the context of regulatory compliance, as it provides a clear and concise record of the qualification process. Therefore, the RTM must be developed and maintained with the utmost care and attention to detail.
Who shall sign the Installation Qualification Protocol / Report?
Having too many signatures can cause delays in the qualification processes and activities. Therefore, the essential signatures required are:
- (Supplier) Project Manager (Originator/Approver),
- (Client) System Owner (Approver),
- (Client) Operational Quality (Approver).
A) Against what shall be Installation Qualification performed?
Documented verification that a Process Control System is installed according to written and approved specifications.
As stated above, the Installation Qualification shall be performed against approved design specifications and manufacturers' installation specifications. What does it mean?
The Process Control System shall be qualified against the Hardware / Software Design Specification, which was issued by the supplier's Design Department.
The Installation Qualification (IQ) therefore shall verify the following, but not limited to:
Control System components shall be inspected for the proper installation location, component type, and other critical information specified for each component (i.e., humidity, power requirements)
- Power Supply Modules,
- CPUs,
- I/O Modules,
- Interface Modules and communication modules,
- Interfaces with the Process Control System, and other systems/equipment,
- Printers, Vision Systems, Scales, Barcode Readers, Checkers, Servo Drives, VFDs, etc.,
- All critical field instrumentation identified by the supplier.
The task at hand involves verifying the configuration of DIP switches, jumpers, and other hardware settings, in accordance with the supplier's specifications for the intended application or use. The settings must be correctly configured to ensure optimal performance and avoid any potential issues that may arise due to incorrect configuration. Therefore, a thorough examination of the hardware settings is necessary to ensure that they are set up as per the supplier's guidelines.
An inspection of the installed power supplies and circuit protection devices to the Process Control System shall be performed to ensure that they are installed and sized as defined in the manufacturer manuals. This shall include, but is not limited to:
- Rack Power Supplies,
- I/O Module power fuses,
- Circuit breakers,
- Non-Interruptible Power Supplies (UPS)
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Prior to commencing the Installation Qualification process, it is necessary to perform backups of the Process Control System Programs (Source Code), field configurations, and data. These backups should be provided to the client as either hard copies or electronic copies for archiving purposes. It is worth noting that some regulated companies may require a virus scan report to be attached to the Installation Qualification Report to ensure that no viruses are detected.
- Programmable Equipment, (SIMATIC S7 1200, PLC1)
- Program Manufacturer, (Supplier 1)
- Program Name, (Program_ProcessMonitoring)
- Program Version / Release / Level, (Revision_1)
- Used Firmware. (FW 4.1)
Operating System verification consists of the following, but is limited to:
- Operating System Equipment, (Vision Sys_PC)
- Operating System Manufacturer, (Microsoft)
- Operating System Version, (Windows 10 IoT Enterprise, 22H2, 19045.3930)
- Necessary applications, drivers ( SIMATIC WinCC/Audit Viewer 2008 SP2)
The process of verifying software settings and parameters entails comparing them against the specified software settings and parameters outlined in the Software Design Specification. This is an essential step in ensuring that the software operates as intended and meets the requirements of the end-users. Therefore, it is imperative to conduct a thorough verification process to identify any discrepancies between the specified and actual software settings and parameters.
Process Control System shall be configured with multiple access groups, which have different user access rights. The most common user groups are Operator / Technician / Engineer / Administrator.
A general inspection of the installed Process Control System shall be performed. The equipment to be inspected will be listed in the Installation Qualification Protocol and shall include, but not be limited to:
- Verification of validation Plan, Quality Plan, and Change Control Records,
- Verification of Design Review Reports,
- Verification of architecture diagram,
- Verification of approved design specifications,
- Verification of approved wiring diagrams, pneumatic diagrams,
- Verification of cleanliness of Process Control System Cabinets,
- Verification of wiring/pneumatic labeling, marking,
- Verification, that no broken or damaged equipment is present,
Regulatory findings
Attempts are often made to "RUSH IN" to start the Installation Qualification with the consequential problem of failure of tests/inspections. In that case, it can raise a question during the audit, that the Process Control System was not implemented by a quality-aware organization.
(FDA 483)
There are currently no approved requirement specifications for XXXX software prior to execution of the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts. (2004)
The IQ protocol stipulated that all required software be installed, but the protocol did not state what software was required (2002)
Headquarters has failed, despite deviations and problem reports, to establish adequate control of software configuration settings, IQ, and Validation (2002)
Bottom line:
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