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ולידציה – SSO for Turbine Air Inlet Cooling

Posted on by אביב צברי

   Schedule of System Operation – SSO

Turbine Air Inlet Cooling

This article is an elaborated example of a schedule of system operaton – sso we did for one of our clients. Of course the actual documents contain all the operational and alarm parameters  

                Scope

This Schedule of System Operation (SSO) covers the required technical data and operation logic regarding the components of Turbine Air Inlet Cooling system, according to the Smartlogic's requirements and the client specifications

              System General Description

 :Turbine Air Inlet Cooling system contains two cold liquid circuits

Primary – 4 chillers and their respective primary pumps

Secondary – 2 pumps for each turbine inlet air cooling coil, 2 pumps for Cogen1, 2 pumps for Cogen2, and 2 pumps for the electric generator cooling (one operating and the other in standby

                Applicable Documents

User Requirements Specification (URS) for Monitoring and Alarm System

Parameters List

            Operational Parameters List

                          Alarm Parameters List

                              Operation Logic

            :Start Conditions of Chiller

COND_SYS_RDY Signal is on
Relevant pumps are waiting for our commands, including their corresponding valves

OIL_PUMP_OK Signal is on

READY Signal from MCC (C-025/RD) is on

READY Signal from Chiller (JM-025/RD) is on

ZS (Freeze protector) Signal is off, not indicating alarm

           : Running Logic for Chiller

Start corresponding Reg_valve (condenser regulate valve) on 100% and wait until valve feedback indicating >= 95%

Delay REG_VALVE_DLY_SP – 10 second

:If number of operating chillers <= 2

Send signal to  Start_cond_pump_1 – Start one Condense Pump

:If number of operating chillers > 2

Send signal to  Start_cond_pump2 – Start Two Condense Pumps

Verify from via communication that relevant cond_pump has

Delay 20 seconds

Perform PID on PDIT using Reg_valve according to relevant PDT-081-4_SP DeltaP SP
(in manual and/or auto mode)

Start CHW_Pump, chilled water pump

Delay 30 second

Verify relevant FS (flow) Signal is on for 20 seconds

Start Chiller

           : Stop operation for each Chiller

Delay 2 minutes , safety in case user changed the operation order of chillers from HMI

Stop Chiller

Wait for signal off from motor MCC feedback

Delay 60 Sec

If current chiller is 3rd , Send signal to stop Cond_pump_2

If current chiller is 1st , Send signal to stop Cond_pump_1

Close Reg_valve, condenser regulate valve

Delay 30 Sec

Stop CHW_Pump, chilled water pump
Interlock: in any case, CHW_Pump will continue operating as long as the corresponding chiller is operating

            Consumers Pump activation

User can always choose primary/secondary pump

If demand cooling for cogen1/2 via .DI 20 for cogen 1, DI 21 for cogen 2

For first activation: Check TT-087 (supply water) is below SP +1

:Perform PID control with relevant Cogen-TT
For Cogen-1 TE-315-022, for Cogen-2 TE-316-093
according to TT_315_022_SP / TT_316_093_SP using cogen-1/2 primary pump

If PID control loop reaches >= START_HZ_SP activate secondary pump and Continue PID control loop with both primary and secondary pumps

If both primary and secondary pumps at work and PID control loop reaches <= STOP_HZ_SP deactivate secondary pump and Continue PID control loop with primary pump only

If outlet air from cogen 1 or 2 below setpoint -2°C and the pump speed in minimum for 3 minute, stop the cogen pump

When the outlet air is above set point +1°C for 1 minute start the pump

*Generator equipment is not connected to the our PLC

           :Consumers Pumps activation for generator

If number of operating chillers <= 2 then activate first pump

If number of operating chillers > 2 then activate second pump

Stop pumps using reverse order

            :Temperature control for generator valves

Perform PID control with TT-090 according to SP using TV-088, If 316-J-21A operates

Perform PID control with TT-090 according to SP using TV-089, If 316-J-21B operate

           :Start Conditions of Chiller sequence

Demand Cooling at least from one of Cogen-1 / Cogen-2 / Generator. slot 4 DI-19-20-21

            :Chiller sequence run-up

Start first chiller according ‎6

The chilled water pump in the first chiller will start all the time even if we are not receive "chiller ready to start", we do need to receive "MCC ready" and do not receive "chiller shut down" . this function are necessary when the chiller stop in" low water temperature"

Delay Run-up Start_Chiller_DelaySP delay – 10 minutes

According to demand, start next chiller

:Perform sequence control using the maximum calculated value from
:{Flow measurement} calculation and {Temp measurement} calculation

:By flow measurement

Chiller #2 operates when total flow is > CH2_FLOW_SP + CH_FLOW_OFFSET_ SP

Chiller #3 operates when total flow is > CH3_FLOW_SP + CH_FLOW_OFFSET_ SP

Chiller #4 operates when total flow is > CH4_FLOW_SP + CH_FLOW_OFFSET_ SP

Chiller #2 stops when total flow is <= CH2_FLOW_SP – CH_FLOW_OFFSET_ SP

Chiller #3 stops when total flow is <= CH3_FLOW_SP – CH_FLOW_OFFSET_ SP

Chiller #4 stops when total flow is <= CH4_FLOW_SP – CH_FLOW_OFFSET_ SP

Total flow = FM1 + FM2 + GenFM

Here are some examples of the PLCs used by Smartlogic: 6XV1830-0EH10, 6ES7131-4BF00*0AA0, 6ES7193-4CA40-0AA0, 6ES7134-4GD00-0AB0, 6ES7193-4CA40-0AA0, 6ES7138-4CA01-0AA0, 6ES7193-4CC20-0AA0, 6ES7590-1AB60-0AA0, 6ES7511-1AK00-0AB0, 6ES7954-8LP01-0AA0, 6ES7155-6AU00-0BN0, 1746-NO4V, 1769-L16ER-BB1B

 

ולידציה – 3 Validation case study – part

Posted on by אביב צברי

ולידציה – 3 Validation case study – part

 This article was written by Iian Shaya, validation,automation and control expert

אילן שעיה Ilan Shaya
Ilan Shaya CEO , control and automation specialist and designer

Documentation for IQ and OQ – to be checked at PDI/FAT

Welding reports

Surfaces finishing test reports

PDI and FAT results

As-built drawings, 3 sets in nominated project language, plus 1 set in English

As-installed versions of all documentation submitted for design review

Back-up software on diskette/CD-ROM, as appropriate, ready for re-installment

Machine configuration/start up, set-up and commissioning data, including tabulation of all change parts and identifications

Full machine parts list

Complete documentation (protocols and method statements) required for equipment DQ, calibration, IQ and OQ specified for manual and automatic operations

Calibration certificates for all required instruments to NIST

Specification for all parts manufactured by sub-contractors

Full identification of all parts according to the P&ID, including valves, regulators, instruments, pipes, media and flow direction arrows

Tags for electrical and pneumatic wiring

Documentation to ensure qualification in compliance with FDA and EMEA, as outlined above

DQ Protocols Including PC/PLC

Approval

Statement of purpose

System description

Traceability matrix

IQ Protocols Including PC/PLC

Approval

Statement of purpose

System description

Specifications

Materials in product contact

Engineering drawings

Subsystem inspection

Components

Piping

Valves

Instrumentation and calibrations

PC/PLC requirement definition

Software development documentation

Manual / technical literature

Test equipment data sheet

Component data sheets

Utility requirements

Exceptional conditions, if required

Summary

OQ Protocols Including PC/PLC

Statement of purpose

System description

Manual and automatic control over all modules through HMI

PC/PLC validation protocols

Step-by-step checking of schedule of system operation – SSO

Alarm and message reaction

HMI synoptic screen vs. P&ID

System operation tests

Operation tests for HMI to ensure compliance with 21 CFR part 11

Application software certification

HW documentation

SW code

SW components data sheets

HW components data sheets

PLC configuration

Graph printout

Synoptic screen list and printout

Operation screen list and printout

Parameters list screen

Messages and alarms list, and printout

HW inspections

SW inspections and application

Approved schematic description

Ladder diagram validation

PLC capabilities

PLC accuracy

SW development documentation

List of control devices

Exceptional conditions

Reports – verification of authorization inspection

PQ Protocols Including PC/PLC

Statement of purpose

Analysis procedures

Staff instruction

Plan for sampling

Criteria for acceptance

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – FRS – Regulatory & HMI Requirements

Posted on by אביב צברי

ולידציה – FRS – Regulatory & HMI Requirements

 This article was written by Iian Shaya, validation,automation and control expert

Regulatory Requirements

These requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands

Method to provide a computerized system that complies with 21 CFR Part 11 definitions, such as the system access control by the user's managing personnel, who shall be responsible for the content of the electronic records (ERs) contained in the system

Method to restrict logical access to the system according to specified authorization levels

Method to restrict logical access to the system only to specific user ID and password

Method to provide system capability to record the values, alarms, user changes and any other events, and provide readable forms and reports of ER data

Method to allow storage of historical events, current alarms and historical alarms data records on the computerized system database

Capability of data display to the user in "view only" mode, so the user cannot alter or delete data/records

Provision of user's capability to backup data daily, weekly and monthly, according to his procedures, to ensure protection of the records and to enable their accurate and ready retrieval throughout the records retention period

Provision by the supplier of a project plan and quality assurance (QA) processes during development and the testing stages as part of his QA systems

Provision by the supplier of the following documents

Functional Requirements Specification – FRS

Functional Design Specification- FDS

IO List

Schedule of System Operation – SSO

Installation Qualification (IQ) protocol

Operation Qualification (OQ) protocol

Performance Qualification (PQ) protocol

HMI Requirements

These requirements are intended to provide the URS demands from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer's contract with the supplier. The HMI screens provided usually are of the following types

Main Screen

Synoptic screens for displaying online values and status

Parameters screens for displaying temperature, humidity and pressure parameters values

Data logging and storage of historical trends, alarms and events

Tabular screens for displaying alarms

Graphical screens for displaying trends

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – URS – Regulatory & HMI Requirements

Posted on by אביב צברי

ולידציה – URS – Regulatory & HMI Requirements

 This article was written by Iian Shaya, validation,automation and control expert

Regulatory Requirements

These requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands

Computerized system compliance with 21 CFR Part 11 definitions, such as the system access control by the user's managing personnel, who shall be responsible for the content of the electronic records (ERs) contained in the system

System capability of restricting logical access to the system according to specified authorization levels.

Access to the system allowed only by user ID and a specific password

System capability to record the values, alarms, user changes and any other events, and provide readable forms and reports of ER data

Storage of historical events, current alarms and historical alarms data records on the computerized system database

Data display to the user in "view only" mode, so the user cannot alter or delete data/records

Provision of user's capability to backup data daily, weekly and monthly, according to his procedures, to ensure protection of the records and to enable their accurate and ready retrieval throughout the records retention period.

Provision by the supplier of a project plan and quality assurance (QA) processes during development and the testing stages as part of his QA systems

Provision by the supplier of the following documents

Functional Requirements Specification –FRS.

Functional Design Specification – FDS

IO List

Schedule of System Operation – SSO

Installation Qualification (IQ) protocol.

Operation Qualification (OQ) protocol

Performance Qualification (PQ) protoco

HMI Requirements

These requirements cover the provisions demanded from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer's contract with the supplier

:Note

The final contents of the URS and FRS are tailored according to the type and size of the system under validation. Since the URS and FRS regarded herein are generic, they include requirements that may not be necessary in small or simple systems

 This article was written by Iian Shaya, validation,automation and control expert

ולידציה – Operation Qualification – OQ- part 2

Posted on by אביב צברי

ולידציה – Operation Qualification – OQ- part 2

Protocol Preparation Overview

This article provide overviews of the main test procedures and verification, and their purposes. This OQ procedure is generic, and relevance of the test procedures and verifications provided below depends on the composition of the system under validation

:Note

As mentioned in the previous artcle on OQ Protocol Contents, the final contents of the OQ protocol are tailored according to the type and size of the system under validation. Since this document is generic, it covers test procedures that may not be necessary in small or simple systems

:Where relevant, the OQ procedure may consists of five main test procedures

HMI Screen Test Procedure – intended to verify that the HMI screens provide the graphic design and functionality required for properly monitoring and controlling the environmental conditions in the user's

Parameters Lists Verification – intended to verify that the system parameters lists comply with the values specified in the SSO

: Two types of parameters are checked

Process parameters

Alarm parameters

System Operation Test Procedure – intended to verify that system monitoring and control components are capable of maintaining the user's facility within specified temperature, humidity and pressure levels

System Alarms Test Procedure – intended to verify that when the specified temperature, humidity and pressure levels exceed its specified limits, an alarm message is displayed, and an SMS or e-mail notification is sent to relevant personnel

Test of HMI Compliance with 21 CFR Part 11 – This test is intended to verify that the HMI meets Valtech Cardio's URS regarding 21 CFR Part 11. These : requirements are divided into 5 categories for the sake of clarity

Security

Electronic Records

Audit Trail

Archive

Backup

 HMI Screen Test Procedure

This section includes specific test procedures for all the relevant HMI screens, where each test procedure serves to verify that the specific HMI screen provides the graphic design and functionality required for its intended purpose within the monitoring and controlling functions

Parameters Lists Verification

:This procedure covers the verifications of two types of parameters

Process parameters

Alarm parameters

Process Parameters List Verification

This procedure is intended to verify that:

The system enables to set the default values of the process set-points of each monitored environmental parameter.

The system provides automatically the corresponding low and high limits of these default values. These limit values are listed in  below

The system rejects all the SP values that exceed their allowed ranges, as specified in the SSO

Alarm Parameters List Verification

:This procedure is intended to verify that

The system enables to set the default values of the alarm set-points of each monitored environmental parameter

The system provides automatically the corresponding low and high limits of these default values

The system rejects all the SP values that exceed their allowed ranges, as specified in the SSO

 System Operation Test Procedure

This procedure is intended to verify that system monitoring and control components are capable of maintaining the user's facility within specified temperature, humidity and pressure levels. For this purpose, it is necessary to temporarily change set-points, in order to activate the control devices

System Alarms Test Procedures

This procedure is intended to verify that, when an environmental parameter value exceeds the specified normal range, the system reacts as specified in the SSO, by providing a specified alarm indication, a relevant e-mail alarm message, and relevant records in the Current Alarms and Historical Alarms screens

Test of HMI Compliance with 21 CFR Part 11

This test is intended to verify that the HMI meets the user's URS regarding 21 CFR Part 11. These requirements are divided into 5 categories for the sake of :clarity

Security

Electronic Records

Audit Trail

Archive

Backup