LIFE SCIENCES
PHARMACEUTICALS & BIOLOGICS
Our inspection and verification services eliminate materials of construction deviations, installation errors, and TOP punch lists when it counts the most…..at turnover. Meet your construction and IQ validation schedule with QAM’s third party experience, fully electronic and searchable TOP, and proprietary PreVal System. Also see our ISO 8573 Compressed Air Testing services.
PHARMACEUTICALS & BIOLOGICS
Our inspection and verification services eliminate materials of construction deviations, installation errors, and TOP punch lists when it counts the most…..at turnover. Meet your construction and IQ validation schedule with QAM’s third party experience, fully electronic and searchable TOP, and proprietary PreVal System. Also see our ISO 8573 Compressed Air Testing services.
Project Organization
Project Quality Plan
We take a systematic approach to each project which starts with front end validated process system planning that aligns the fabricator’s processes, QAM services, and your validation team’s expectations to the project specifications ensuring the installation and TOP/IQ documentation will meet project requirements before the first weld is made.
Project Training
The project team will develop project specific training courses which includes the GDP protocol, weld documentation, welding and installation requirements, and acceptance criteria. This course is given to all fabrication and QAM personnel that work on validated process systems.
RESOURCES
STAFF
Equipment
Inspection and material testing equipment is maintained by our equipment department ensuring equipment is operating to the OEM specifications and is calibrated in accordance with our Quality System. Equipment is functionally tested before shipment to the project. Calibration documents are provided for all calibrated inspection equipment.
MATERIALS OF CONSTRUCTION
Validated Material Inspection
PVDF and PFA Systems
Material traceability and material documentation for PVDF or PFA systems are drastically different than stainless steel systems. These systems require detailed planning regarding purchase specifications, material documentation requirements, and validation requirements. QAM has the experience to plan for these challenges before construction begins.
WELDING VERIFICATION
WELDING PROCEDURE SPECIFICATION
Auto-GTAW process WPS/PQR is evaluated for conformance to ASME Section IX and/or BPE and approved by project engineering.
WELDING OPERATOR PERFORMANCE QUALIFICATION
Auto-GTAW process WOPQ is evaluated for conformance to ASME Section IX and/or BPE and approved by VT Level 2 inspectors.
WELDING BACKING / SHIELDING GAS
FABRICATION AND INSTALLATION SURVEILLANCE
Production welding and welding operators are verified for conformance to the approved WPS / WOPQ. Weld sample coupons are made in accordance with project requirements. Fabrication and installation is verified for overall compliance with approved SOPs and the engineering design.
WELD INSPECTION, WELD AUDIT & MOC VERIFICATION
WELD INSPECTION (SS, PVDF, PFA)
Production welds are inspected by direct visual or use of video or fiber-optic borescopes based on the project inspection plan and evaluated to the project weld acceptance criteria. Weld, welding operator, MOC, welding machine, and welding gas data is entered into the Electronic Documentation System for processing.
WELD DOCUMENTATION AUDITS
ISO drawings and weld logs are audited at the point of inspection and prior to turnover. Weld data entered into the Electronic Documentation System is auto verified by our proprietary PreVal system where materials of construction, welding operator qualification, and gas certification documentation is verified.
AUTO TOP VERIFICATION
PreVal performs hourly auto-verification cycles which pre-validate ISO drawing data to inspection and verification reports. The system notifies inspectors and document control personnel of all deviations.
WELDING STATISTICS
XRF/PMI TESTING
Alloy verification testing can be performed during incoming material inspection and / or performed after fabrication to confirm materials of construction. XRF testing is most beneficial when there are more than one grade of material being installed such as 316L, AL-6XN®, or HASTELLOY® C-22. C22 consumable inserts can also be tested on a random basis.
INSTALLATION VERIFICATION (IV)
FINAL INSPECTION
Some IV processes are performed to extend possible during construction, however final IV is performed at mechanical completion of the system to verify conformance to the ISO drawings and engineering design.
HANGERS / SUPPORTS
Hangers and supports are verified to the ISO drawing and hanger detail requirements including specification conformance for installation, welding, materials, and surface finish.
SLOPE
Slope is verified in accordance with P&ID / ISO drawings once the hangers and supports are accepted. Slope direction and degree are measured for conformance to the engineering design including dead leg evaluation and valve drain angle verification.
AS-BUILT
The overall installation is verified to the ISO drawings. Red lines are made on the ISO drawings to provide an accurate representation of the system for future P&ID verification. PreVal provides another value add for tagged item verification during this process.
FINAL WELD AUDIT
Weld audits are performed during weld inspection, however this cannot be the only weld audit. A final audit is always required before final turnover so any changes will be evaluated.
PUNCH / TASK LIST
IV deviations are recorded per ISO drawing. The deviations are tracked and re-inspected or re-verified until corrected. QAM IV Stamps are a typical method for documenting final ISO drawing acceptance.
TESTING & CLEANING VERIFICATION
PRESSURE TEST
The pressure test is verified for conformance to the engineering design and / or piping code. The pressure test package is verified for conformance to project specific requirements.
CLEANING, FLUSHING, OR BLOWDOWN
System conditioning required by the engineering design is verified for circuit, boundary, criteria and documentation requirements.
PASSIVATION
System passivation is verified for circuit, boundary, and other parameters determined by the owner.
TURNOVER PACKAGE
ORIGINAL PAPER TOP
The original paper TOP is provided in the tradition manner. The paper TOP is organized to mirror the electronic TOP, and each document is traceable to the electronic TOP.
ELECTRONIC TOP
Each TOP document is in a completely text searchable PDF format allowing tag numbers, etc. to be searched among thousands of files and found in seconds. Real time access to the TOP can be provided to the customer, transmitted to local drives, or uploaded into any file sharing platform.
OUR CUSTOMERS
QAM’s PreVal system will eliminate construction deviations before the validation process begins.