Engineers To Healthcare Industry®: Quality Assurance Protocol (QAP)

S INTERTECH TECHNOLOGIES PVT. LTD.
KG Engineers to Healthcare Industry®

PHARMA * FOOD * COSMETICS * CHEMICAL * PACKAGING
QUALITY ASSURANCE PROTOCOL
(QAP)
www.intertechglobal.com
PREFACE
This Standard details the level of documentation that INTERTECH TECHNOLOGIES PVT.LTD (ITPL) will provide during a
contract for fabricating tank(s) or portable equipment’s. 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:
 Brief scope of work / Project Description.
 Equipment schedule (including make, model, size, serial numbers)
 Tank & Equipment’s i.e. Reactor et . data sheets / specification.
 Process & Instrumentation Diagram (If applicable).
 Details of any departures from the design specifications at installation including materials of construction and
key equipment.
 Functionality Testing reports.
 Warranty on parts and workmanship.
QUALITY SYSTEM
The design and fabrication of portable and fixed hygienic tanks will comply with the following standards and
specifications:
 Design Specification
 Good Engineering Standards
 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.
CORPORATE OFFICE WORKS - 1 WORKS - 2

#4, 3rd Floor, B-7 Vasant Arcade, Dr. Nelson Building No. 1 & 2, “A” Wing, Unique Industrial Estate, Plot No. 5 and 6, Intertech Industrial Estate, Survey No. 62
Mandela Marg, Vasant Kunj. New Delhi - 110070 Survey No. 36, Hissa No. 10,Dhumal Nagar, Waliv, Hissa No. 2 and 3, Behind Verma Shell Petrol Pump, Waliv,
(India). Vasai (East), Distt. Palghar-401208, Tel: Vasai (East), Distt. Palghar, - 401208
Tel: +91-11-26899580/81/82 +91-9607940371-78
(QAP)
 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.
 Commonly Inspected Items Include:
 Raw material Inspection
 Individual component inspection i.e. Dish, cone, Shell after forming.
 Inspection of completed weld set up as per approved fabrication drawing
 Weld Quality inspection (NDT testing e.g. Radiography)
 Grinding and polishing of internal welds.
 Individual Nozzle inspection with end connection
 Nozzle set up verification on vessel
 Pre-polish inspection
 Agitator Assembly balancing verification
 Inspection of internal tank surfaces
 Pressure gauge calibration certificate (if applicable)
 Finishing verification
 Passivation
 Witnessing of pressure testing(e.g. Hydro testing )
 Final inspection of tank
 Application trial of vessel
 Tank documentation
 Pressure vessel certification
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 (WPS, PQR.)
 critical Fabrication set up
 Assembly stages as approved as per QAP
 Hydrostatic test;
 Roughness testing for surface finish
 Functional trial of equipment as approved in QAP

Tel: +91-11-26899580/81/82 +91-9607940371-78
(QAP)
 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.
 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:
 Vessel, Jacket & insulation
 Welding
 Equipment inspection & installation
 Cleaning of tanks & fittings
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.

Tel: +91-11-26899580/81/82 +91-9607940371-78
(QAP)
 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.
Incoming Materials Inspection Records

Upon delivery to ITPL work shop and Client site, all equipment & materials will be inspected to ensure that the item
is of appropriate quality and complies with purchase specification & has not been damaged during fabrication or
handling.
Materials Certificates / Letters of Conformity

Required to validate the authenticity of materials used during construction. Several companies may be approached to
test component materials and supply documentation to support the claim. These certificates ensure that the
construction material meets the same specifications and quality standards specified by Client.
Vessel: To verify the correct material composition, heat or mill certificates will be provided by the supplier.
Valves. Fittings & Piping: Material Certificates or Letters of Conformity shall be provided for all components in
contact with product. All pipeline valves and fittings in contact with product will be of stainless steel construction;
the tubing will comply with ASTM A270 grade 316L. Valve diaphragms, gaskets, o-rings etc will comply with
Codes of GMP ie. Teflon / EPDM.
File:
 Materials list referenced and indexed to drawings and certificates
 Material Safety Data Sheets for any insulation used
 Letters of Conformity / Material certificates / Certificate of Analysis
 Purchase orders, quotations, specifications and equipment changes.
WELDING
 Welding Quality System

To assure the welding quality the workman welder has to be qualified as per ASME code the procedures and
record includes following
• QW-482 Welding Procedure Specification(WPS) (Section IX, ASME )

• QW-483 Procedure qualification record (PQR) (Section IX, ASME )
• QW-484A Welder Performance qualification (WPQ) (QW-301 ,Section IX, ASME )

Tel: +91-11-26899580/81/82 +91-9607940371-78
(QAP)
 A Welding Quality Record will include:
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 process;
 Welding machine;
 Grade of material used;
 Grade of Welding consumables: used gas, tungsten type and filler type;
 Tubing diameter & wall thickness
 Weld records (inc. Date, Job No., Drg. No., Operator etc)
 Weld Inspection reports
 Radiography report for all weld joints (As per approved QAP)
TESTING & VALIDATION

The Equipment’s will be tested as fully as possible prior to installation on site. Installation and Operational checks
(where applicable) shall be undertaken and full documentation provided. Where applicable, the following items shall
be tested and documented during the testing & installation phases. These tests and inspections may be conducted by
an independent third party as agreed to by Client.
 Mechanical
 Document and file evidence that the following items have been adequately function tested:
 Inlet / outlet valves
 drainage
 sample ports
 jacket services (inc. relief valves & non-return valves)
 stirrer / agitator
 spray balls
 load cells
 vent filters (inc. Integrity test reports of Letters of Conformity from manufacturer)
 Light glasses etc.
 Nozzle end connection fitment

Tel: +91-11-26899580/81/82 +91-9607940371-78
(QAP)
 Document and file evidence that the following items have been inspected and shown to meet Client
specifications:
 Bearings and seals
 Hinges
 Gaskets
 Insulation & cladding
 Baffles, if any
File test certificates for all above mentioned components
 Instrumentation & Calibration

All indicating, recording and controlling instruments need to be calibrated against certified instruments.
This includes:
 Test results for instrumentation used during hydrostatic pressure testing of tanks;
 Calibration of load cells
 Calibration of temperature/ pH/ conductivity probes Velocity ,transmitters , level sensors.
 Calibration of pressure gauges, vacuum gauge , differential pressure gauges.
File: a calibration report containing details of all findings, adjustments and tolerances, calibration
procedures & records.
 Passivation and Hydrostatic Test and surface finish

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.
 General assembly drawings
 Layout drawings
 Process & Instrumentation diagram (if applicable)
 Records of new & developing or modified drawings shall be maintained as part of this section.
A full drawing register must also be provided as part of this section.

Tel: +91-11-26899580/81/82 +91-9607940371-78
(QAP)
OPERATION AND MAINTENANCE
This section will contain a technical description of each component together with all associated maintenance
recommended by the manufacturer or supplier. The following information will be provided.
• Equipment technical data (including manufacturers' literature and suppliers' reference list) of all
components will be provided.
• Complete Operation overview
• If PLC operated system, complete system overview with operation sequencing. Alarm and safety interlock ,
I/O list details covered in Functional design specification(FDS) documents
• Any safety precautions necessary to protect personnel and equipment during maintenance.
• General Cleaning Procedure
• Repair, overhaul, disassembly and reassembly procedures, wear components spare parts, part numbers.
• Clear and specific maintenance instructions with illustrations to explain procedures and showing
replacement parts and quantities required.
• 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.
• A recommendation of all spare parts to be maintained at Client.

Tel: +91-11-26899580/81/82 +91-9607940371-78
(QAP)
QUALITY ASSURANCE PLAN

Sr. FORMAT Intertech
CHARACTERISTI ACCEPTANCE
NO ACTIVITIES TYPE OF CHECK OF Agency
C OF CHECK STD (AI)
. RECORD
Material
Identification: To ensure the quality (i) Dimensional and
(a) Plates. of the visual Inspection.
(b) Pipes For material specified. (ii) Co-relation between Material
1 Nozzles. Correlate the test certificate and ASME/ASTM test P H/W
(c ) Flanges properties specified marking on material. certificates
(d) Fittings with relevant code (ii) Finish of raw
(e) Rods specification. material.
(f) Flats
Material
Identificatio
Material
Material Identification Identification and testing n Report
Identification
2 with MTC and sample of material (Chemical & ASME/ASTM and P H/W
and sample
collection Mechanical Tests) Sample
collection
analysis
report
Details
Reputed make as per
Instruction manual Related product
3 All Brought item Technical P H/W
TC Review standards specificatio
Specification
n
Welding
4 Procedure Welding procedure Document ASME Sec IX Document P H/W
specification
Welding operator Approved
Welder Performance Visual, NDE/
5 performance ASME Sec IX WPQ & P H/W
Qualification Mechanical
qualification PQR
MAIN VESSEL
DP test
Dished end DP Test on knuckle Report &
1 ASTM-E-165 P H/W
formation Dimensional & DP portion of dished ends Dimension
al report
Weld setup of Approved
shell, dish ends, (i) Visual Inspection drawing
2 Visual Drawing P H/W
flanges and (ii) Dimensional check. and
nozzles reports.
To be
Welding of seam recorded in
3 joint, flanges and DP Test ASTM-E-165 DP Test Report stage wise P H/W
nozzles inspection
report.
100% Radiography
Welding quality
Film Test ASME SEC VIII
4 examination Film Report P H/W
(As per approved in Div1
(NDT)
contract )

Tel: +91-11-26899580/81/82 +91-9607940371-78
(QAP)
FORMAT Intertech
Sr. CHARACTERISTIC ACCEPTANCE
ACTIVITIES TYPE OF CHECK OF Agency
NO. OF CHECK STD (AI)
RECORD
Mark Leg
orientation on
(i) Visual Inspection As Approved
cone/shell, Set- Markings of Leg
5 per Drawing Fabrication Report P H/W
up, Welding, locations
(ii) Dimensional check. Drawing
Visual
examination.
AGITATOR ASSEMBLY
i) Drawing approval of Approved
Dimension as per
agitator assembly Fabrication Report P H/W
technical specification
with support Drawing
1 Agitator ii) Drawing approval TC and approval of As per Approved
Report P H/W
of mechanical seal drawing Drawing
ii)Dynamic balancing ISO 1940 Grade Inspection
Balancing P H/W
of agitation shaft 6.3 Report
Alignment Visual
Final Approved Inspection
Final Dimensional Orientation Visual P H/W
Dwg. Report
verification as per Dimensions Measurement
As build drawing Integrity/ HT as per
2 ASME Sec VIII Test
(With All Nozzle Hydro-Testing ASME Sec VIII P H/W
Div 1 reports
Fitment) Div 1 procedure
Leak Testing Leak test as per ASME Soap Bubble Test
P H/W
Sec VIII Div 1 procedure Test reports
Inspection of
surface finish'
(Int./Ext.) before Approved Surface
testing ‘of Visual & Surface Drawing. finish
3 Surface finish P H/W
equipment. roughness meter (RA value inspection
Free from foreign Range) report
particle, rust dust
and grease.
(i)Operating panel
functions
verification
(i)Ensure Operations (ii)Interlock verification Approved
Functionality
4 and functions as per (iii) RPM verification Fabrication FAT report. P H/W
testing
specified requirement (iv)With Load drawing.
functioning trial
(v) Load cell calibration
Pipeline verification
AI Authorized Inspector (From Intertech Technologies Pvt. Ltd )
Agency Customer Authorized Third Party inspection Agency or Customer representative
H (HOLD): Stage of Inspection beyond which work shall not progress unless accepted by AI/Agency
Stage of Inspection for which AI /Agency shall be notified in advance, However work may
W (WITNESS)
proceed with AI's/Agency’s consent if AI is unable to undertake the inspection.
P(Perform) AI to perform the activity, document all results

Tel: +91-11-26899580/81/82 +91-9607940371-78

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S INTERTECH TECHNOLOGIES PVT. LTD.

KG Engineers to Healthcare Industry®

 Quality Assurance Representative

CORPORATE OFFICE WORKS - 1 WORKS - 2

 Inspection & Test Plans

CORPORATE OFFICE WORKS - 1 WORKS - 2

 At completion of final polishing prior to packing.

 Water Quality Report

 Commissioning & Testing

CORPORATE OFFICE WORKS - 1 WORKS - 2

Incoming Materials Inspection Records

Materials Certificates / Letters of Conformity

 Welding Quality System

• QW-482 Welding Procedure Specification(WPS) (Section IX, ASME )

CORPORATE OFFICE WORKS - 1 WORKS - 2

 A Welding Quality Record will include:

TESTING & VALIDATION

CORPORATE OFFICE WORKS - 1 WORKS - 2

 Instrumentation & Calibration

 Passivation and Hydrostatic Test and surface finish

CORPORATE OFFICE WORKS - 1 WORKS - 2

OPERATION AND MAINTENANCE

CORPORATE OFFICE WORKS - 1 WORKS - 2

QUALITY ASSURANCE PLAN

CORPORATE OFFICE WORKS - 1 WORKS - 2

CORPORATE OFFICE WORKS - 1 WORKS - 2

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