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 :
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- 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 ________
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- Define the installation qualification requirements and acceptance criteria for the control system supporting automation of the machine.
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- 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 :
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- 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.
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- The qualification document will provide documented evidence that the system meets its intended use based on recommendations and cGMP requirements.
3.0 Scope :
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- 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) :
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- Operating Manual
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- 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 |
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Engineering Department |
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User Department |
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Information Systems (IS) |
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Quality Assurance Department |
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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 |
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Training given by Name | Sign & Date: | Training time | From:
To : |
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Name of Participant | Area of operation | Signature/ Date | Remarks | ||||||
8.0 Control System Description :
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- 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.
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- The main function of this control system is to collect data from field instrumentation.
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- The instruments are connected to the system equipment and piping.
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- The collected data will be utilized by the Programmable Logic Controller (PLC) for process control.
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- The HMI system will assist the operator to supervise and control the process, based on the displayed information to the operator.
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- By means of user interface operator can provide commands to the Programmable Logic Controller (PLC).
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- The Programmable Logic Controller (PLC) then executes the operator instruction.
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- A PLC consists of a processor, an input/output (I/O) system, a memory unit, a programming language, and a power supply.
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- 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.
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- The I/O system provides the physical connection between the process equipment and the processor.
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- 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.
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- 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) :
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Installation Qualification – Programmable Logic Controller (PLC)
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- The Installation Qualification of the Control System will be qualified by completing the tests provided in this protocol.
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- These tests will serve to document the installation qualification of the control system and its compliance with design and intended use.
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Completion of Qualification of Programmable Logic Controller will be governed by the following general procedures:
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- Each person who performs or reviews any section of the testing within this document must complete all information required on the “Signature / Initial Verification” .
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- Executor needs to make a comparison, calculation or an evaluation against the expected results.
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- During the execution of the protocol, if a deviation is identified, log that deviation and submit a Protocol Discrepancy / Deviation Report.
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- Engineering shall submit the Protocol Discrepancy / Deviation Report with identification of root cause through appropriate investigation as per established procedure available at site.
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- The protocol discrepancy/deviation number, test section and test page must be listed in the Protocol Discrepancy / Deviation Log
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- Protocol Discrepancy / Deviation Reports must be numbered sequentially throughout the execution of the protocol.
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- 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.
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- 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.
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- 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.
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- All protocol Discrepancy / Deviations must be closed and approved prior to the final approval of the executed protocol and summary report.
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- 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.
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- Any comments regarding the test are to be recorded on the data sheets under the “Comments” section.
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- If there are no comments, the Comments section will be marked with NA.
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- 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 :
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Qualification Procedure
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- Obtain approved of the required documents for Control System from Quality department.
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- Objective, procedure and acceptance criteria are described for each test and the results will be recorded on the corresponding tests.
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- 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.
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- Any supporting documentation required during testing should be included as an attachment to the document with appropriate attachment number.
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- All the attachment shall be signed by the performer and cross verified by reviewer.
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- Draw a line through and mark “NA” any fields in the test sheet that are not used.
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- 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.
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- Execute all steps according to instructions / procedure provided in each test sheet.
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- Complete the “Performer /Reviewer Comments” section as appropriate Sign and date.
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- Enter a Pass/Fail determination, then sign and date in the Reviewed by section of this test sheet.
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Print Screen Instructions / Attachment Instructions (Wherever Applicable):
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- 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).
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- Ensure the data required to be captured is displayed on the screen.
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- Press the Print Screen (PrtSc) key. Open MS Word application. Paste the captured screen.
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- Document the following but not limited to each of the print screens:
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- Test Number
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- Test Title
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- 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).
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- Signature and Date on attachments.
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- Print the document upon completion of each test.
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- 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.
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INSTALLATION QUALIFICATION TEST
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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 |
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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 |
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Remarks | ||||
Test Result: | Pass | Pass with Deviation | Fail | |
Reviewed By (Sign & Date): | ||||
VERIFICATION OF HARDWARE INSTALLATION AND CONFIGURATION |
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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. |
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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 |
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Remarks | ||||
Test Result: | Pass | Pass with Deviation | Fail | |
Reviewed By
(Sign & Date): |
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VERIFICATION OF ENVIRONMENTAL CONDITIONS |
OBJECTIVE: To verify the environment condition of area in which control system is installed/operated. |
TEST SETUP:
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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) |
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Temperature °C | 0°C to 60 °C | YES/NO | ||||||
2. |
Relative humidity % | 10% to 90 % RH | YES/NO | ||||||
HMI | |||||||||
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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 |
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Remarks | |||||||||
Test Result: | Pass | Pass with Deviation | Fail | ||||||
Reviewed By (Sign & Date): | |||||||||
VERIFICATION OF POWER SUPPLY |
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OBJECTIVE: To verify and document the power supply installations provided to the control system. | |||||
TEST SETUP: Calibrated Digital Multi-meter. | |||||
TEST PROCEDURE:
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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) |
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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) |
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Earthing | Earthing should be below to 2.0 VAC | YES/NO |
Comments | VERIFICATION OF POWER SUPPLY found satisfactory.
YES/ NO |
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Remarks | ||||
Test Result: | Pass | Pass with Deviation | Fail | |
Reviewed By (Sign & Date): | ||||
VERIFICATION OF SOFTWARE INSTALLATION |
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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.
or
or
or
or
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REFERENCE DOCUMENT: NA. |
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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 | ||||||
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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 |
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Remarks | ||||||||
Test Result: | Pass | Pass with Deviation | Fail | |||||
Reviewed By (Sign & Date): | ||||||||
VERIFICATION OF FIELD INSTRUMENTS CALIBRATION |
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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. |
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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) |
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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 |
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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 |
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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:
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- All tests as mentioned in protocol have been executed.
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- All required signatures on the tests have been obtained.
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- These signatures include the performer and the reviewer.
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- Any deviations / discrepancies have been satisfactorily resolved (when appropriate, this criterion may exclude deviations and discrepancies that are low risk and not critical).
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- All data generated by the execution of this protocol shall be summarized in a summary report and has to be reviewed.
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- This report will serve to highlight specific issues and resolutions that have been encountered.
12.0 Handling of Changes – Programmable Logic Controller (PLC)
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- Any changes made to the system will be handled using Change Control SOP “Change Control Management”.
13.0 Handling of Discrepancies
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REPORTING
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- During the qualification if any test result does not meet the acceptance criteria then Discrepancy / Deviation shall be initiated.
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- Discrepancy / Deviation report number shall be assigned in the Discrepancy / Deviation log of this document.
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- Discrepancy / Deviation report number shall be assigned as DR-NN, DR represents discrepancy report and NN is the serial number of discrepancies.
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- 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.
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- Reference of the discrepancy report number shall be mentioned in the respective test sheet.
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- Discrepancy shall be entered in the Discrepancy / Deviation Form by updating the reporting section of the Discrepancy / Deviation Form.
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- As required controlled copies of the Discrepancy / Deviation Form shall be obtained from Quality Engineering / Quality Assurance department as per respective procedure.
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- Attachment for deviation/discrepancy shall be used if provided space in worksheet is insufficient.
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ASSESSMENT
- Assess the Severity, Probability and Detectability of the discrepancy as per the following table:
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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.
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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 |
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