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Protocol and Procedure for Installation Qualification of Programmable Logic Controller (PLC) connected with Manufacturing Equipment.

Installation Qualification of Programmable Logic Controller (PLC)

1.0   Objective :

• • The objective of this protocol to provide the written guidelines for execution of the installation qualification of Programmable Logic Controller (PLC) based HMI System for ________

• • Define the installation qualification requirements and acceptance criteria for the control system supporting automation of the machine.

• • Successful completion of these qualification requirements will provide assurance that the control system for the ________was installed as required in the processing environment.

2.0   Purpose :

• • The purpose of this protocol is to verify the Programmable Logic Controller (PLC) based HMI system for ____________ located in the ______ at ___________ is installed properly as per requirement.

• • The qualification document will provide documented evidence that the system meets its intended use based on recommendations and cGMP requirements.

3.0   Scope :

• • The IQ will be performed on Programmable Logic Controller (PLC) based HMI system for _____________ located in the _____ at _____.

4.0   References – Programmable Logic Controller (PLC) :

• • Operating Manual

• • Installation Qualification Document

5.0   Acronyms :

Acronym	Definition	Acronym	Definition
°C	Degree Centigrade	Ltd.	Limited
AC	Alternating Current	NA	Not Applicable
Mins.	Minutes	NABL	National Accreditation Board for Testing and Calibration Laboratories
CD	Compact Disk	WDS	Water distribution system
CFR	Code of Federal Regulations	No.	Number
cGMP	Current Good Manufacturing Practices	OQ	Operational Qualification
CM	Conductivity Meter	PG	Pressure Gauge
CSVMP	Computerized System Validation Master Plan	PLC	Programmable Logic Controller
CtQ	Critical to Quality	PMF	Planned Modification Form
DC	Direct Current	PRS	Pressure Reduction Station
DTI	Digital Temperature Indicator	PTFE	Poly Tetra Fluoro Ethylene
EPDM	Ethylene Propylene Diane Monomer	Pvt.	Private
ERES	Electronic Records and Electronic Signatures	QA	Quality Assurance
DQ	Design Qualification	QE	Quality Engineering
FM	Flow Meter	RH	Relative Humidity
GDP	Good Documents Practices	HMI	Human Machine Interface
GxP	Good Practices	SDS	System Design Specification
ID	Identification	SEN	Sensor
IOQ	Installation and Operational Qualification	SMPS	Switch Mode Power Supply
IPC	Industrial Personnel Computer	SOP	Standard Operating Procedure
IQ	Installation Qualification	HMI	Supervisory Control and data Acquisition System
KL	Kilo Liter	mA	Mili Ampere
LED	Light Emitting Diode	Secs.	Seconds

6.0  Responsibilities – Qualification of Programmable Logic Controller (PLC)

Role	Responsibility
Qualification Team	Preparation of qualification documents for execution. Execution of the issued protocol as per procedure mentioned in the tests. The recording and inspection of data generated during the execution of the protocol tests. Summarizing the results of the tests.
Engineering Department	Provide execution support. Review the test results obtained during executions and provide necessary support. Record the protocol deviations and corrective action by consulting concerned department. Review the final report.
User Department	Providing documentation required for validation including Specifications, Drawings, SOPs, Manuals, etc. To provide execution support. Support the protocol deviations root cause identification and provide corrective action. To review the final report.
Information Systems (IS)	To provide necessary documents required for Protocol preparation. Provide Information Systems related support and personnel to assist in the operation of the system during the execution of verification studies. To co-ordinate with Qualification Agency. during validation activities. To review the IQ Protocol.
Quality Assurance Department	Approving of the protocol. Approving any protocol modifications and/or deviations. Reviewing the protocol, test results and final approval of the documents.

7.0  Training Record – Programmable Logic Controller (PLC)

Purpose	To be trained all personnel involved in the execution of this qualification protocol for following topics.
Topics	Purpose Procedure Acceptance criteria Documentation
Training given by Name			Sign & Date:			Training time			From: To :
Name of Participant		Area of operation			Signature/ Date		Remarks

8.0  Control System Description :

• • The main function of a Programmable Logic Controller (PLC) is to translate the instructions into the digital or analog codes needed to operate the device or machine.

• • The main function of this control system is to collect data from field instrumentation.

• • The instruments are connected to the system equipment and piping.

• • The collected data will be utilized by the Programmable Logic Controller (PLC) for process control.

• • The HMI system will assist the operator to supervise and control the process, based on the displayed information to the operator.

• • By means of user interface operator can provide commands to the Programmable Logic Controller (PLC).

• • The Programmable Logic Controller (PLC) then executes the operator instruction.

• • A PLC consists of a processor, an input/output (I/O) system, a memory unit, a programming language, and a power supply.

• • The processor consists of one or more standard or custom microprocessor and other integrated circuits that perform the computing and control functions of the control system.

• • The I/O system provides the physical connection between the process equipment and the processor.

• • The Programmable Logic Controller (PLC) uses many input circuit or modules, to sense and measure physical quantities of process, such as motion, temperature, level, current, voltage, position, and pressure.

• • Depending on  the status sensed the, processor controls various output module to energize or drive the field devices such as valves, motor starters and contactors that apply power circuit voltages to the control devices.

9.0  General Procedure – Programmable Logic Controller (PLC) :

• • Installation Qualification – Programmable Logic Controller (PLC)

• • The Installation Qualification of the Control System will be qualified by completing the tests provided in this protocol.

• • These tests will serve to document the installation qualification of the control system and its compliance with design and intended use.

• Completion of Qualification of Programmable Logic Controller will be governed by the following general procedures:

• • Each person who performs or reviews any section of the testing within this document must complete all information required on the “Signature / Initial Verification” .

• • Executor needs to make a comparison, calculation or an evaluation against the expected results.

• • During the execution of the protocol, if a deviation is identified, log that deviation and submit a Protocol Discrepancy / Deviation Report.

• • Engineering shall submit the Protocol Discrepancy / Deviation Report with identification of root cause through appropriate investigation as per established procedure available at site.

• • The protocol discrepancy/deviation number, test section and test page must be listed in the Protocol Discrepancy / Deviation Log

• • Protocol Discrepancy / Deviation Reports must be numbered sequentially throughout the execution of the protocol.

• • Based on the corrective action implemented or the conclusion of Impact Assessment, the Qualification Team determines which test steps must be repeated or revision of any document required.

• • If additional test to be performed to address corrective action, then Addendum protocol with its impacted/applicable tests shall be initiated and approved.

• • This determination, and its justification, will be documented in the Corrective Action section of the Protocol Discrepancy / Deviation Report.

• • After the stated corrective actions, have been performed, the test may be repeated and the results must be included with the Protocol Discrepancy / Deviation Report.

• • All protocol Discrepancy / Deviations must be closed and approved prior to the final approval of the executed protocol and summary report.

• • All test instruments utilized in the execution of this protocol must include calibration certification that must be traceable to NIST standards or NABL approved agency or equivalent.

• • Any comments regarding the test are to be recorded on the data sheets under the “Comments” section.

• • If there are no comments, the Comments section will be marked with NA.

• • The “Reviewed by” signature line will be signed by an independent reviewer who has read and agrees with the execution and conclusions.

10.0  Qualification Test Plan :

• • Qualification Procedure

• • Obtain approved of the required documents for Control System from Quality department.

• • Objective, procedure and acceptance criteria are described for each test and the results will be recorded on the corresponding tests.

• • The person who records the data and test results must sign with date on the respective tests wherever indicated and subsequently reviewed by second qualified personnel.

• • Any supporting documentation required during testing should be included as an attachment to the document with appropriate attachment number.

• • All the attachment shall be signed by the performer and cross verified by reviewer.

• • Draw a line through and mark “NA” any fields in the test sheet that are not used.

• • Wherever required screen shots or digital photographs of Human Machine Interface / MMI / HMI / HMI PC may be taken and print of the photograph may be presented as evidence from the acceptance criteria.

• • Execute all steps according to instructions / procedure provided in each test sheet.

• • Complete the “Performer /Reviewer Comments” section as appropriate Sign and date.

• • Enter a Pass/Fail determination, then sign and date in the Reviewed by section of this test sheet.

• • Print Screen Instructions / Attachment Instructions (Wherever Applicable):

• • A print screen is generated using MS Word application OR equivalent application. (If MS Word application is used follow the instructions below on steps 1, 2, 3 and 4 to capture the screen).

• • Ensure the data required to be captured is displayed on the screen.

• • Press the Print Screen (PrtSc) key. Open MS Word application. Paste the captured screen.

• • Document the following but not limited to each of the print screens:

• • • Test Number

• • • Test Title

• • • Page Number _X_ of _Y_ (X = Page Number, Y = Total number of printouts (i.e., print screens, print grids, any other attachments) for a given test script).

• • • Signature and Date on attachments.

• • • Print the document upon completion of each test.

• • Any attachments generated during execution or the data collected for validation shall be stored along with the validation package.

Note: If print screen using MS word is not available then photographs can be used.

• • INSTALLATION QUALIFICATION TEST     

VERIFICATION OF SYSTEM IDENTIFICATION

OBJECTIVE: To verify the details of equipment / system under validation.

TEST SETUP: NA

TEST PROCEDURE: 1.    Physically verify the system under test and records the observations in below table. 2.    Any discrepancy observed during verification shall be informed to concerned department and engineering department for necessary action.

REFERENCE DOCUMENT: NA.

ACCEPTANCE CRIETERIA: Actual Observation should be as Expected.

Step No.	Items	Expected	Actual Observation Meets as per expected result? (Yes/No)	Test Complies (Yes/No)	Performed By (Sign & Date)
1.	Equipment / System Name		YES/NO	YES/NO
2.	Equipment / System ID No.		YES/NO	YES/NO
3.	Location		YES/NO	YES/NO
4.	Manufacturer / Supplier		YES/NO	YES/NO

Comments	VERIFICATION OF SYSTEM IDENTIFICATION found satisfactory. YES / NO
Remarks
Test Result:	Pass		Pass with Deviation	Fail
Reviewed By (Sign & Date):

VERIFICATION OF SYSTEM DOCUMENTATION

OBJECTIVE: To verify the availability of system documentation.

TEST SETUP: NA

TEST PROCEDURE: 1.    Contact concerned department for availability of system documentation. 2.    Check each document listed below for their availability and its identification number 3.    System operation SOP shall be available in draft / effective. 4.    Any discrepancy observed during verification shall be informed to concerned department and engineering department for necessary action.

REFERENCE DOCUMENT: NA

ACCEPTANCE CRIETERIA: Below mentioned documents should be available.

 

Step No.	Item	Availability (Yes/No)	Identification\Attachment No.	Test Complies (Yes/No)	Performed By (Sign & Date)
1.	Wiring Diagram	YES/NO		YES/NO
2.	System Operational Manual	YES/NO		YES/NO
3.	System Operation SOP	YES/NO		YES/NO
4.	Preventive Maintenance SOP	YES/NO		YES/NO

Comments	VERIFICATION OF SYSTEM DOCUMENTATION found satisfactory. YES/ NO
Remarks
Test Result:	Pass		Pass with Deviation	Fail
Reviewed By (Sign & Date):

 

VERIFICATION OF HARDWARE INSTALLATION AND CONFIGURATION
OBJECTIVE: To verify and document the proper installation of specified system hardware components, hardware is verified with the manufacturer specifications.
TEST SETUP: NA
TEST PROCEDURE: 1.      Perform a visual inspection of the major hardware components listed on the following test data sheets. 2.      Record each component make / model no. and quantity in test data table. 3.      Record the configuration details of applicable hardware components. 4.      Any discrepancy observed during verification shall be informed to concerned department and engineering department for necessary action.
REFERENCE DOCUMENT:  NA
ACCEPTANCE CRIETERIA: Actual result should match with specification.
Step No.	Description	Specification	Actual Observation Meets as per Specified result? (Yes/No)	Test Complies (Yes/No)	Performed By (Sign & Date)
Programmable Logic Controller (PLC)
1.	Make		YES/NO	YES/NO
2.	Model		YES/NO	YES/NO
3.	Digital I/P Module		YES/NO	YES/NO
4.	Digital O/P Module		YES/NO	YES/NO

 

Step No.

Description

Specification

Actual Observation Meets as per Specified result (Yes/No)

Test Complies (Yes/No)

Performed By (Sign & Date)

 

1.	Analog I/P Module		YES/NO	YES/NO
2.	Analog O/P Module		YES/NO	YES/NO
3.	No.of Digital Inputs		YES/NO	YES/NO
4.	No.of Digital Outputs		YES/NO	YES/NO
5.	No. of Analog Input		YES/NO	YES/NO
6.	No. of Analog Output		YES/NO	YES/NO

 

HMI
1.	Make		YES/NO	YES/NO
2.	Model		YES/NO	YES/NO
UPS Supply
3.	UPS Supply	Programmable Logic Controller (PLC)/HMI should be connected to UPS supply	YES/NO	YES/NO

 

Comments	VERIFICATION OF HARDWARE INSTALLATION AND CONFIGURATION found satisfactory. YES   / NO
Remarks
Test Result:	Pass		Pass with Deviation	Fail
Reviewed By (Sign & Date):

 

VERIFICATION OF ENVIRONMENTAL CONDITIONS

OBJECTIVE: To verify the environment condition of area in which control system is installed/operated.

TEST SETUP: Calibrated Thermometer/Hygrometer or suitable monitoring device

TEST PROCEDURE: 1.      Place thermo hygrometer at a nearby control panel, Programmable Logic Controller (PLC) and HMI system and wait for stable reading. 2.      Record the displayed Temperature and Relative humidity from thermo hygrometer in below table. 3.      Any discrepancy observed during verification shall be informed to concerned department and engineering department for necessary action.

REFERENCE DOCUMENT: NA.

ACCEPTANCE CRITERIA: Actual observation should be within specified limit.

 

Step No.	Test parameter			Specified Limit		Actual Observation		Test Complies (Yes/No)	Performed By (Sign & Date)
Programmable Logic Controller (PLC)
	Temperature °C			0°C to 60 °C				YES/NO
2.	Relative humidity %			10% to 90 % RH				YES/NO
HMI
	Temperature °C			0°C to 60 °C				YES/ NO
2.	Relative humidity %			10% to 90 % RH				YES/NO
Comments		VERIFICATION OF ENVIRONMENTAL CONDITIONS found satisfactory. YES / NO
Remarks
Test Result:		Pass			Pass with Deviation		Fail
Reviewed By (Sign & Date):

 

VERIFICATION OF POWER SUPPLY
OBJECTIVE: To verify and document the power supply installations provided to the control system.
TEST SETUP: Calibrated Digital Multi-meter.
TEST PROCEDURE: Power on the Programmable Logic Controller (PLC) system and set the multi meter in DC voltage measurement range and measure the voltage at Programmable Logic Controller (PLC) System terminal end. Note down the voltage reading in the test data sheet. Power on the HMI system and set the multi meter in DC voltage measurement range and measure the voltage at HMI System terminal end. Note down the voltage reading in the test data sheet. Any discrepancy observed during verification shall be informed to concerned department and engineering department for necessary action.
REFERENCE DOCUMENT: Wiring Diagram/Control System Component Data Sheet.
ACCEPTANCE CRITERIA: Observed power supply reading should match with the specified limit.
Step No.	Test parameter	Specified	Actual Observation	Test Complies (Yes/No)	Performed By (Sign & Date)
	Programmable Logic Controller (PLC)	24 ± 10% VDC		YES/NO
2.	HMI	24 ± 10% VDC		YES/NO

 

Step No.	Test parameter	Specified	Actual Observation	Test Complies (Yes/No)	Performed By (Sign & Date)
	Earthing	Earthing should be below to 2.0 VAC		YES/NO

 

Comments	VERIFICATION OF POWER SUPPLY found satisfactory. YES/ NO
Remarks
Test Result:	Pass		Pass with Deviation	Fail
Reviewed By (Sign & Date):

 

VERIFICATION OF SOFTWARE INSTALLATION
OBJECTIVE: The objective of this test is to verify and document the proper installation of system software. This test shall also verify the specified software versions installed for HMI are verified with the specification.
TEST SETUP: NA
TEST PROCEDURE: Verify system software and record all data on table below. Programmable Logic Controller (PLC) Software Name and Version verification procedure Verify Programmable Logic Controller (PLC) Software Name and Version from vendor documents. (I.e. Declaration letter, DQ, User Manual etc.) or Verify Programmable Logic Controller (PLC) Software Name and Version from world wide web (internet support). HMI Software Name and Version verification procedure Verify from HMI system screen. or Verify HMI Software Name and Version from vendor documents. (I.e. Declaration letter, DQ, User Manual etc.) or Verify HMI Software Name and Version from world wide web (internet support). HMI system Software Name and Version verification procedure Verify HMI software Name and Version from vendor documents. (I.e. Declaration letter, DQ, User Manual etc.) or Verify HMI software Name and Version from world wide web (internet support). Verify and attach the supporting documents The system software configuration and record the observation in below table. Verify and record the application software name and version. Any discrepancy observed during verification shall be informed to concerned department and engineering department for necessary action.
REFERENCE DOCUMENT: NA.
ACCEPTANCE CRITERIA: Software detail should match as per specified
Step No.	Software detail	Specification	Actual Observation Meets as per Specified (Yes/No)	Test Complies (Yes/No)	Performed By (Sign & Date)
Programming Software for Programmable Logic Controller (PLC) system
	Name of Software		YES/NO	YES/NO
2.	Version		YES/NO	YES/NO
Application Software for HMI system
3.	Name of Application Software		YES/NO	YES/NO
4.	Version		YES/NO	YES/NO

 

Comments		VERIFICATION OF SOFTWARE INSTALLATION found satisfactory. YES/ NO
Remarks
Test Result:		Pass		Pass with Deviation	Fail
Reviewed By (Sign & Date):
VERIFICATION OF FIELD INSTRUMENTS CALIBRATION
OBJECTIVE: To verify the validity of calibration status of measuring instruments associated to Programmable Logic Controller (PLC) control system.
TEST SETUP: Calibration certificates.
TEST PROCEDURE: 1.    Collect all instruments calibration certificate from concerned department. 2.    Verify and record the calibration date and calibration due date. 3.    Any discrepancy observed during verification shall be informed to concerned department and engineering department for necessary action.
REFERENCE DOCUMENT: Calibration Certificate.
ACCEPTANCE CRITERIA: All instruments calibration certificate should be available with valid calibration date.
Step No.	Instrument Name					Test Complies (Yes/No)	Verified By  (Sign & Date)
	All instruments associated to Programmable Logic Controller (PLC) should be calibrated and instruments calibration certificate should be Available in concerned department.
2.	The calibration certificate should be included with calibration date and calibration due date with their Calibration Frequency.

 

Comments	VERIFICATION OF FIELD INSTRUMENTS found satisfactory. YES/NO
Remarks
Test Result:	Pass		Pass with Deviation	Fail
Reviewed By (Sign & Date):

 

VERIFICATION OF TRAINING DOCUMENTATION

OBJECTIVE: To verify the availability training documentation of system users.

TEST SETUP: Training Record

TEST PROCEDURE: 1.    Review the training attendance sheet or equivalent record for appropriate training completion for the system users. 2.    Any discrepancy observed during verification shall be informed to concerned department and engineering department for necessary action.

REFERENCE DOCUMENT: NA

ACCEPTANCE CRITERIA: System users should have appropriate training for the operation of the system.

 

Step No.	Verification	Is there Document Available? (Yes/No)	Test Complies (Yes/No)	Performed By (Sign & Date)
1.	Training documentation for the system users on the operation of the system exists?	YES/NO	YES/NO
2.	System users have received training on operation of the system as per applicable training SOP’s	YES/NO	YES/NO

 

Comments	VERIFICATION OF TRAINING DOCUMENTATION found satisfactory. YES/ NO
Remarks
Test Result:	Pass		Pass with Deviation	Fail
Reviewed By (Sign & Date):

11.0   Acceptance Criteria :

• This Protocol will be deemed successful if it meets the following criteria:

• • All tests as mentioned in protocol have been executed.

• • All required signatures on the tests have been obtained.

• • These signatures include the performer and the reviewer.

• • Any deviations / discrepancies have been satisfactorily resolved (when appropriate, this criterion may exclude deviations and discrepancies that are low risk and not critical).

• • All data generated by the execution of this protocol shall be summarized in a summary report and has to be reviewed.

• • This report will serve to highlight specific issues and resolutions that have been encountered.

12.0   Handling of Changes – Programmable Logic Controller (PLC)

• • Any changes made to the system will be handled using Change Control SOP “Change Control Management”.

13.0   Handling of Discrepancies 

• • REPORTING

• • During the qualification if any test result does not meet the acceptance criteria then Discrepancy / Deviation shall be initiated.

• • Discrepancy / Deviation report number shall be assigned in the Discrepancy / Deviation log of this document.

• • Discrepancy / Deviation report number shall be assigned as DR-NN, DR represents discrepancy report and NN is the serial number of discrepancies.

• • Serial number should start with 01. At the time of closure corrective action report number shall be assigned as CR-NN, CR represents corrective report and NN is the serial number of corrective action for this document.

• • Reference of the discrepancy report number shall be mentioned in the respective test sheet.

• • Discrepancy shall be entered in the Discrepancy / Deviation Form by updating the reporting section of the Discrepancy / Deviation Form.

• • As required controlled copies of the Discrepancy / Deviation Form shall be obtained from Quality Engineering / Quality Assurance department as per respective procedure.

• • Attachment for deviation/discrepancy shall be used if provided space in worksheet is insufficient.

• • ASSESSMENT

  • Assess the Severity, Probability and Detectability of the discrepancy as per the following table:

Value	(P) Probability estimation (Likelihood of event occurring)
3	High (H):  Often
2	Medium (M):  Periodic
1	Low (L):  Seldom

 

Value	(D) Level of detectability
1	High (H):  The risk can be detected without fail through control measure/system and the detection system is automated.
2	Medium (M):  The risk may be detected through control measure/system and the detection is through manual method
3	Low (L):  The risk cannot be detected through deployed control measure/system the detection is possible after longer period/interval.

 

Value	(S) Severity of event (Consequence)
3	High (H): Direct and significant impact on data security/integrity/GxP requirements.
2	Medium (M): Indirect and insignificant impact on data security/integrity/GxP requirements.
1	Low (L):  No effect/Impact. on data security/integrity/GxP requirements.

• Calculate risk score by multiplying severity, probability and detectability.

• Refer following table to determine overall risk level: 

Risk Score	Risk Level	Action to be taken
9 to 27	High	Resolution for the discrepancy has to be ensured before release of the system to next stage.
6 to 8	Medium	Resolution for the discrepancy has to be ensured before release of the system to next stage.
1 to 4	Low	Discrepancy may be acceptable with appropriate justification