Programmable Logic Controller (PLC) Qualification - Pharma Beginners (2023)

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 :

6.0 Responsibilities – Qualification of Programmable Logic Controller (PLC)

7.0 Training Record – Programmable Logic Controller (PLC)

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.

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• • 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

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:

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

• Refer following table to determine overall risk level:

Tags: HDMI, PLC Calibration, PLC Validation