PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS
PURPOSE :To describe the procedure for equipment / facility qualification: prepare qualification protocols, to initiate, conduct, and document equipment / facility qualification studies.
SCOPE : This SOP shall be applicable to all new and upgraded process related equipment /facility.
REFERENCE(S) :ISPE, Volume 5, Commission & Qualification.
DEFINITION
Qualification: is defined as an action of providing that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
User Requirement Specification (URS): is a list of all requirements of buyer regarding the equipment/Instrument to be purchased. URS is prepared by the equipment/Instrument user department.
Risk assessment (RA): is a systematic process of identifying hazards and evaluating any associated risks within a workplace and Equipment/Instrument and Facility, then implementing reasonable control measures to remove or reduce them.
Design Qualification (DQ): is the review made to verify that the owner/user requirement which include establishment of critical operating or operational parameter or specifications before the final design is agreed, have been met.
Enhance design Review (EDR): The EDR is review made to verify that the FDS/DQ of vendor and the design equipment meet the establish specification of FDS (Functional Design specification) with final design. It is performed to review the vendor FDS/DQ with actual design available on site.
Installation Qualification (IQ): States that the facilities, system and equipment are installed according to design document, purchase specification and manufacturer literature.
Verification installation Qualification (VIQ) States that the verification of established document of equipment/instrument which is installed in facilities or system from the Vendor.
Operational Qualification (OQ): States that the equipment/instrument, facility and system operate as intended throughout all specific or requirement range.
Verification Operational Qualification (VOQ): States that the verification of operational parameter of equipment/instrument which is installed in facilities or system from the Vendor as per specification or requirement range.
Performance Qualification (PQ): Defines that an integrated system or processing operation is capable of performing consistency to give an outcome that meets predetermined specification.
Performance Re-Qualification (PRQ): Ensuring that the equipment/Instrument, facility and system is still in the qualified state after a change and periodical assessment of equipment/Instrument, facility and system within defined time intervals.
ABBREVATIONS
URS : User Requirement Specification
RA : Risk Assessment
DQ : Design Qualification
EDR : Enhance Design Review
IQ : Installation Qualification
VIQ : Verification Installation Qualification
OQ : Operational Qualification
VOQ : Verification Operational Qualification
PQ : Performance Qualification
PRQ : Performance re-qualification
RESPONSIBILITY
User & engineering department shall responsible for
Engineering, Projects, User department shall be responsible for equipment qualification.
QA Head shall be responsible for
Head QA shall be responsible for approval of protocol, review of result and evaluation quality attributes.
Plant Head shall be responsible for
Plant Head shall be responsible for approval of protocol.
PROCEDURE
SAFETY/PRECAUTION/EHS
All Qualification Protocol/Report/Documents Shall be prepare as per this SOP.
Only Approved copies of documents/protocol shall be made available at the time of Qualification activity.
Previous Qualification activity shall be documented & completed while performing next activity of qualification.
Design Review/Design Qualification/EDR
The user department shall provide URS/specification /parameters of the required equipment/ facility
Engineering/Project shall develop detailed requirement with description, proposed specification and drawing along with User department and QA. The proposed specification and drawing shall be documented in Design Qualification (DQ) protocol.
Quotation shall be taken with specification and drawing, from different vendors. Engineering/ Project department shall narrow down to a few desired vendors. The details should be filled in the Design Qualification protocol or should be attached with the protocol.
The Engineering, Projects, user department and QA shall carry out detailed evaluation of the Design specifications and drawing. All developmental details shall be noted in the DQ protocol.
Final design specification and drawing shall be provided by the vendor and documented in Design Qualification protocol .Design specification shall be finalized and purchase order shall be raised from user Department.
After the facility / equipment is built, where appropriate, to support qualification the installation or operation checks should be conducted and documented as factory acceptance test at supplier site.
The project / Engineering should provide or make available all documents i.e. purchase order with specification, installation drawing, operating & maintenance manual and test reports which are required for the qualification (IQ, OQ, PQ) effort.
Based on the design specification, validation designee shall prepare IQ, OQ, PQ protocol. The protocols shall be circulated for pre-approval.
After the protocols have been approved and equipment/ system installed, designee from Validation, Engineering and user shall conduct the necessary qualification test functions as outlined in the approved protocols. The observations and test reports should be documented in the protocol. User department also done RA (Risk assessment) for safety purpose.
Deviations/exceptional conditions shall be identified and corrective actions taken shall be documented. The impact of the deviations/corrective action shall be evaluated and if necessary, the qualification work shall be stopped, until deficiency is corrected; otherwise the qualification testing shall continue.
A summary and the conclusion drawn shall be written in the report and post-approvals shall be taken.
A typical Installation Qualification should address following points and shall have specifications to verify as approved in the design.
Protocol approval: Shall include the signatures of the author and approval from the Head of User department, Engineering / Project head, Formulation & development head and Quality Assurance In-charge. Protocol shall be authorized by QA Head and Plant Head.
Introduction: Brief Introduction to indicate the purpose /usage and location.
Purpose: Should describe the purpose of Installation Qualification.
Responsibilities: Responsibility to prepare the protocol and carry out protocol execution. Also carries the Qualification execution sign- in.
System description: Blank space to write the system description. May include the major component, location, tag no. and overall description of system functionality.
Document checklist: To review certificates & drawings (schematic, P & ID, wiring diagram) supplied by the manufacturer and to verify availability of material of construction certificates, purchase order details & the Installation/ operation/maintenance manual.
Installation checklist: To include a checklist to verify the installation visually.
Identification of major components: Identify major component as per the design.
Major component installation checklist: Detailed checklist of instruments, features & smaller operational components within the major components.
Material of construction : To verify the material of construction of contact and non-contact part as per the design by reviewing the material of construction certificate or appropriate test like molybdenum test for SS 316 parts.
Supporting utilities: Verify proper connection of utilities as per the recommendations of the vendor or the design specifications.
Identification of critical instruments to be calibrated. Critical instrument as defined in the calibration policy should be identified for calibration.
Identification of Standard Operating procedure: Standard operating procedures required for the correct operation, maintenance & cleaning of the equipment and its supporting systems, if any, should be identified. Draft SOP should be ready before operation qualification. List of spare parts: Availability of spare parts/ change parts to be verified. List of lubricants: Availability of recommended lubricants & lubrication schedule to be verified. Deviation and corrective action: Any deviations/ exceptional conditions and corrective action taken should be noted and approval should be taken for the same. Final report: A brief summary and conclusion drawn should be written and approval should be taken from the persons who had approved and authorized the protocol. Attachment: Relevant documents, drawings, test certificates and details of test instruments, if any shall be attached / referred to with the installation qualification protocol.
A typical Operational Qualification should address the following points & shall have specifications to verify as approved in the design. Appropriate operational tests are determined based on the operational & safety features.
Protocol approval: Shall include the signatures of the author and approval from the Head of User department, Engineering / Project head, Formulation & Development head & Quality Assurance In-charge. Protocol authorization shall be done by QA Head and Plant Head.
Introduction: Brief Introduction to indicate the purpose /usage & location.
Purpose: Should describe the purpose of operation qualification.
Responsibilities: Responsibility to prepare the protocol & carry out protocol execution. Also carries the Qualification execution sign- in.
System description: Blank space to write the system description. May include description of equipment and process, and of system critical components. Include a statement of how the identified unit should normally operate. Also include a statement describing any limiting parameters of the equipment. Standard operating procedure verification: Verify that the instructions as given in the cleaning, operation & preventive maintenance SOP are adequate & personnel are able to follow the SOP. The SOP gives adequate direction to ensure consistent machine operation. Document the name of trainee & trainer & the date. Corrections if any should be done and SOP finalized. Alternately, equipment should be operated during qualification following the operating.
Manual & a statement indicating the same should be included in the protocol.
Instrument calibration review: Review of calibration status of the instrument Identified during IQ as critical instruments. Operational tests should be carried out only if calibration has been done.
Equipment functionality: Each functionality should be verified. Should include operations of switches, controls, valves & control panel. Alarms, interlock & safety features should be checked. The expected results for each of the specified test should be described. This should include enough detailed evaluation so an evaluation of pass or fail can be conducted.
Operation tests: Test runs analyzing unit operational functions (e.g. temperature, pressure, and speed, direction of rotation, flow, volume, and timing) should be checked.
Deviation and corrective action: Any deviations/ exceptional conditions and corrective action taken should be noted and approval should be taken for the same.
Final report: A brief summary and conclusion drawn should be written and approval should be taken from the persons who had approved and authorized the protocol.
Performance Qualification (wherever required) protocol should address following points & shall have specifications (user requirements) to verify as approved in the design.
Protocol approval: Shall include the signatures of the author and approval from the Head of User department, Engineering/Project head, Formulation & development head & Quality Assurance In-charge. Protocol authorization shall be done by QA Head and Unit Head.
Introduction: Brief Introduction to indicate the purpose /usage & location.
Purpose: Should describe the purpose of Performance qualification.
Responsibilities: Responsibility to prepare the protocol & carry out protocol execution. Also carries the Qualification execution sign- in.
System description: Blank space to write the system description. May include description of equipment and process, and of the system critical components. Include a statement of how the identified unit should normally operate. Also include a statement describing any limiting parameters of the equipment and safety of equipment/operator.
Qualification tests: Test plan should describe the specific testing to be conducted, the rationale for testing and specific acceptance criteria. Challenge test (if any) appropriate to the function should be written with acceptance criteria. Reporting formats should be provided where appropriate.
Deviation /exceptional condition: Any deviations/ exceptional conditions and corrective action taken to be noted and approval to be taken for the same.
Final report: A brief summary and conclusion drawn should be written and approval should be taken from the persons who had approved and authorized the protocol.
Verification Qualification (VQ) & Re-qualification (RQ) protocol for (VIQ, VOQ & PRQ) shall have following sub-headings. Verification qualification is aimed to qualify in-use equipment, when it is not possible to undertake the details of installation nor operational qualification is possible. It should also address, review of preventive maintenance history, breakdown history, change controls of the equipment. Verification of DQ is done for reviewing the design for conformance to operational and regulatory expectation.
Protocol approval: Shall include the signatures of the author and approval from the Head of User department, Engineering/ Project head, Formulation & development head & Quality Assurance In-charge. Protocol authorization shall be done by QA Head and Unit Head.
Introduction: Brief Introduction to indicate the purpose /usage & location.
Purpose: Objective to writes this protocol stated in brief.
Responsibilities: Responsibility to prepare the protocol & carry out protocol execution. Also carries the Qualification execution sign- in.
System description: Blank space to write the system description as it is observed before execution.
Major component installation checklist: Detailed checklist of instruments, features & smaller operational components under the major components. In case re-qualification is for change in a major component, installation of the component only needs to be verified.
Supporting utilities: Verify proper connection of utilities as per the recommendations of the vendor or the design specifications or requirement of the equipment.
Instrument calibration review: Review of calibration status of the instrument identified during IQ as critical instruments to be calibrated.
Verification: Verify the instructions as given in the SOP are adequate & operating persons are able to follow the SOP. The SOP gives adequate direction to ensure consistent Machine operation.
Equipment functionality: Key functionality to be verified. To include operations of switches, controls, valves & control panel. Alarms, interlock & safety features should be checked. The expected results for each of the specified test should be described. This should include enough detailed evaluation so an evaluation of pass or fail can be conducted
Operational tests: Test runs analyzing unit operational functions (e.g. temperature, pressure, speed, rotation, flow, volume, and timing) should be checked. Review of Preventive maintenance history, breakdown history, and change controls of the equipment: Review the documents and check if any modification, which can impact the performance, has been verified subsequently
Deviation and corrective action: Any deviations/ exceptional conditions and corrective action taken to be noted and approval to be taken for the same.
Final report: A brief summary and conclusion drawn should be written for review of Design qualification (EDR), for Verification of Installation qualification, for Verification of Operational qualification and for performance
Re-qualification and then approval should be taken from the persons who had approved and authorized the protocol.
NOTE: Attached all datasheets / all working sheets footer part contain document number of approved protocol.
REVISION HISTORY:
New SOP Prepared
