Qap
Qap
Qap
(QAP)
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
PREFACE
This Standard details the level of documentation that INTERTECH EQUIPTECHNOLOGIES PVT.LTD (IET) will
provide during a contract for fabricating tank(s) or portable equipments. Extensive documentation is required for this
system to assist in the validation of critical services to comply with FDA / EU regulatory authorities. This documentation
will be compiled in the form of a Quality Assurance manual, the format of which is outlined in this specification. It will
contain all necessary information regarding design, construction, installation and validation undertaken by IET.
INTRODUCTION
Document and file:
Details of any departures from the design specifications at installation including materials of construction
and key equipment.
QUALITY SYSTEM
The design and fabrication of portable and fixed hygienic tanks will comply with the following standards and
specifications:
Design Specification
Quality Records
The direct contractor shall operate to a quality system for all works in this contract, inc. Materials and
workmanship. The quality system will comply with cGMP norms or equivalent.
Full details of the Quality System will be submitted to client prior to the commencement of
manufacture. A final and signed copy will be included with the final documentation submission.
Throughout the project, IET will maintain records to verify that quality procedures and standards have
been adhered to. Variations or modifications must be documented and approved by client prior to
implementation.
Quality Assurance Representative
After the contract is let and a minimum of 14 days before the work is to commence, IET shall nominate
the person responsible for insuring that the quality assurance requirements are implemented and
maintained.
Inspection & Test Plans
Full details of the quality system, including inspection and test plans will be submitted to client for
approval prior to the commencement of manufacture. Inspection, test and hold points shall be prepared
and presented to client for approval prior to commencement of manufacture. A copy of this will be
provided in the QA manual.
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
Pre-polish inspection
Passivation
Tank documentation
Independent tank inspection reports will also be incorporated into the Quality Assurance manual.
Hold Points
The following designated production hold points shall be incorporated into the Inspection and Test
Plan.
The IET shall give client a minimum of 72 hours prior to reaching any hold point inspection stage:
qualification of weld procedures/operators;
assembly of jacket spirals to inner shell; (for jacketed vessels only)
welding of stay to inner shell and dished heads;
initial assembly of jacket shell to heads; (for jacketed vessels only)
at completion of welding of pressure retaining components;
hydrostatic test;
Roughness testing for surface finish; and
at completion of final polishing prior to packing.
Will Client waive the right to the nominated inspection IET shall carry out internal checks and
document the same for future verification by the client
Drawing Approvals
Records of new or modified drawings will be maintained as part of the quality assurance manual. All
new drawings and modifications will be approved by Client prior to distribution or implementation.
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
Equipment s Construction
Surface Finish
The internal surface of the vessel is to be mechanically polished to a surface finish as per
Client specifications. The surface will be free of surface defects, tarnishing, scuff marks or
burrs. Provision of surface roughness measurements will be at the discretion of the Project
engineer pending the nature of the vessel application.
Test Samples
The Client can request to submit a surface finish sample. The sample shall consist of two
pieces of the vessel material (approx. 6 x 6), double butt welded and polished on one side to
the surface finish specified.
Water Quality Report
Required to determine the quality of water used during any stage of fabrication, final cleaning
and hydrostatic testing. High concentrations of certain chemicals, such as chlorides, may
adversely affect the surface of the vessel and result in long term problems.
Site Installation
Any standard procedures followed in order to meet industry / Client standards must be referred to. If
appropriate, Quality Procedures will be incorporated into the quality assurance documentation. Quality
procedures will apply to the following aspects:
Welding
The installation work is to be performed to the best industry standards. Inspections are to be carried out
during installation to ensure that IET is working in accordance with specifications and is performing
work to the best industry practices. Any reports generated from such inspections must be included.
Commissioning & Testing
Commissioning and testing procedures will comply with industry & Client standards. Details of
procedures, testing methods & final test results will be included in the QA manual.
Completion
After delivery on site, documented proof shall be provided to verify that the vessel meets industry &
Client standards. Other documents such as non-conformance report, rectification Lists and Handover
Inspection reports will also be incorporated into an appropriate section of the Quality Assurance
manual.
MATERIALS OF CONSTRUCTION
Materials of construction will be shown to comply with Client specifications. Evidence in the form of check
sheets, material certificates or letters of conformity, shall be provided for 'critical' materials. i.e. those that
impact on the quality of the final product.
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
WELDING
Welding Quality System
The method of welding used to fabricate the tank and associated piping will be clearly stated. Details of
Company Welding Quality systems will also be given. A Welding Quality system will identify the
following areas:
Welding procedure
Weld approval
Welding process;
Welding machine;
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
Grade of Welding consumables: used gas, tungsten type and filler type;
Weld records (inc. Date, Job No., Drg. No., Operator etc)
Certification of welders
Welders shall meet, as a minimum, the qualification requirements of ASME Evidence in the form of
copies of Welders Certification will be provided to verify this qualification.
drainage
sample ports
stirrer / agitator
spray balls
load cells
vent filters (inc. Integrity test reports of Letters of Conformity from manufacturer)
Document and file evidence that the following items have been inspected and shown to meet Client
specifications:
Hinges
Gaskets
Baffles, if any
File test certificates for rupture discs and/or pressure relief valves.
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
certified
This includes:
test results for instrumentation used during hydrostatic pressure testing of tanks;
File: a calibration report containing details of all findings, adjustments and tolerances, calibration
procedures & records.
Passivation and Hydrostatic Test
Following polishing, the tank will be passivated and hydrostatically tested to an agreed documented
procedure.
File: Test results / reports.
AS-BUILT DRAWINGS
The following 'As-built' drawings must be provided in hard copy and as soft copy (AutoCAD version 2000
format).
Fabrication drawings
Records of new & developing or modified drawings shall be maintained as part of this section.
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
Repair, overhaul, disassembly and reassembly procedures, wear components spare parts, part numbers
and,
Any special tool requirements necessary tolerance fits, alignments, tensions, adjustments, and testing
procedures if correct settings are not made.
The expected service life of normal wear items or replacement frequency of services items in operating
hours.
Any safety precautions necessary to protect personnel and equipment during maintenance.
Equipment technical data (including manufacturers' literature and suppliers' reference list) of all
components will be provided.
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
2. Quality System
Introduction to Quality System
Quality records
Inspection and Test Plans
Subcontractor/ Quality Records
Drawing Approvals
General inspection reports & audits
Pressure vessel testing & registration
Site Installation: (Welding records, pipework, Equipment Inspection.)
Commissioning / Testing Procedures & standards
Completion
Non-conformance reports Rectification Lists
Handover Inspection reports
3. Materials of Construction
Materials list
Incoming materials inspection reports
Materials of construction check sheet
Materials certificates / Letters of Conformity
4. Welding
Welding Quality Procedures
Welders Certifications
Welding records
5. Testing and Validation
Equipment check sheets (valves, agitators, etc)
Commissioning & testing reports
6. As Built Drawings
Fabrication Drawings
Process & Instrumentation Diagram (If applicable)
7. Operation and Maintenance
Detailed maintenance
Spare Parts
Manufacturer's literature
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374
INTERTECH
EQUIPTECHNOLOGIES
PVT.LTD.
www.intertechequip.com
DELHI OFFICE
#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Mandela Road, Vasant Kunj, New Delhi 110070 (INDIA)
TEL. : +91-11-47697777 FAX. : +91-11-26897238
WORKS
UNIT NO. 5,6,7 & 8, NIKISHA INDUSTRIAL ESTATE, MIRA ROAD (E), DISTT : THANE (INDIA)
TEL.. : +91-22-28453372, 28453374