Krav til svejsedokumentation i farmaceutiske projekter
En praktisk vejledning for fremstillingsvirksomheder, der leverer udstyr til medicinalindustrien.
GLOSSARY
Welding documentation comes with its own language of standards, acronyms and regulatory terms. Here we explain the ones that matter, in plain terms, so you know exactly what is expected of your documentation and why.
The international standard for quality requirements in fusion welding of metallic materials. Unlike EN 1090, ISO 3834-2 is not a European standard alone, it is recognised globally and used alongside local codes such as AWS or ASME in the US. It sets requirements for how a company plans, executes and documents welding work, from welder certificates to WPS and material certificates. Many customers in offshore, pharma and process industries require ISO 3834-2 certification before they will even accept a bid.
The European standard for the execution of steel structures, covering welding requirements, CE marking and production control. Relevant for companies delivering load bearing steel structures into the EU, where documenting the welding process is a prerequisite for CE marking. EN 1090 is an EU product requirement, not a global standard, so projects outside Europe apply different but related codes, see AWS D1.1, CSA W47.1/W59 and AS/NZS 1554 below.
The international standard for qualifying welding procedures, most widely used in Europe. It ensures a welding procedure consistently produces joints with the required mechanical properties before that procedure is used in production. Its closest US counterpart is ASME Section IX, with one key practical difference: under ASME IX the manufacturer can self certify the procedure qualification record, while ISO 15614 requires an independent examiner to countersign it.
The international standard for qualifying welders, sister standard to ISO 15614. Where ISO 15614 qualifies the procedure, ISO 9606 qualifies the person, their practical skill within a defined range of materials, thicknesses and positions.
The American standard for qualifying welding procedures and welders for pressure retaining equipment, including piping, boilers and pressure vessels. ASME IX plays the same role in the US that ISO 15614 and ISO 9606 play in Europe, but allows manufacturer self certification rather than requiring an independent examiner. Relevant for SOCWeld customers in pipe welding and process industry supplying the US market.
The American standard specifically for bioprocessing equipment, covering the design, materials, and surface finish requirements used in pharmaceutical and biotech manufacturing systems. Where ISO 3834 and ASME IX cover welding quality in general, ASME BPE adds requirements specific to hygienic and sterile process equipment, directly relevant to pharma customers on the US market.
The EU Pressure Equipment Directive. It sets the essential safety requirements for pressure equipment sold within the EU, including a requirement that permanent joints, welding among them, are made using qualified procedures and qualified personnel. For higher risk equipment categories, a notified body must be involved in the conformity assessment.
The Norwegian standard for welding and inspection of piping, developed for the offshore oil and gas industry on the Norwegian continental shelf. It is stricter than many general welding codes in several areas and is commonly required by operators and EPC contractors working offshore in Norway, directly relevant to SOCWeld's maritime and offshore customers.
The European standard for industrial piping, covering design, manufacturing, testing and inspection, including the welding requirements that apply specifically to piping systems rather than structural steel or pressure vessels.
The American counterpart to EN 1090 for load bearing steel structures, published by the American Welding Society. AWS D1.1 combines welder qualification, WPS qualification and inspection acceptance criteria into a single code. Where EN 1090 is an EU legal requirement tied to CE marking, AWS D1.1 is a code called up directly in a contract, typically by a US owner, engineer or authority. A European supplier bidding on a US project will often need welders and procedures qualified to AWS D1.1 specifically, even where their domestic work runs to ISO 9606 and ISO 15614.
The Canadian counterpart to EN 1090 and AWS D1.1. CSA W59 sets the technical requirements for welding steel structures, while CSA W47.1 certifies that the fabricating company has the systems and qualified people in place to meet them, a similar split to EN 1090 (execution) and third party certification. W47.1/W59 is a legal requirement for steel structures in Canada, administered by the Canadian Welding Bureau (CWB). A European supplier with ISO 3834-2 certification typically has a head start, but still needs to qualify specifically to CSA standards for a Canadian project.
The joint Australian and New Zealand standard for welding steel structures, with several parts depending on application, for example AS/NZS 1554.1 for general steel structures and AS/NZS 1554.3 for wind turbine towers. Australia and New Zealand also use AS/NZS ISO 3834, the local adoption of the international ISO 3834 standard, often alongside AS/NZS 1554. Relevant for SOCWeld customers with projects or suppliers in the region, particularly in wind energy, one of SOCWeld's defined industries.
A document describing exactly how a given weld must be carried out, materials, current, preheat, welding position and more, so the weld meets the required standard. A WPS must be qualified, tested and approved, before it can be used in production.
The record produced when a WPS is qualified, documenting the actual test results, mechanical tests and inspection results, that prove the procedure meets the required standard. The WPQR is the evidence behind the WPS.
The ability to follow a material or a weld through its full history, from the original material certificate, through the welder who performed the work, to the final inspection. Full traceability means that for any given weld you can answer: which material, which welder, which procedure, which inspection.
A logged history of who did what, and when, within a documentation system. A proper audit trail shows not just the current status but the full path leading up to it, with nothing deleted or overwritten along the way. This is what an inspector or authority is actually testing for when they check whether your documentation holds up.
Inspection methods used to check a weld without destroying it, for example radiographic testing (RT), ultrasonic testing (UT), penetrant testing (PT) or magnetic particle testing (MT). The results of these inspections form a permanent part of a project's welding documentation.
A set of regulatory requirements, most commonly associated with the pharmaceutical and food industries, that governs quality management, traceability and documentation throughout production. For a welding supplier delivering into pharma, GMP means documentation must not only be correct, it must be provable as correct, with full traceability and a digitally signed approval chain.
The umbrella term for the various "Good [x] Practice" frameworks in pharma and life sciences, including GMP (manufacturing), GCP (clinical trials) and GLP (laboratories). When a pharma customer talks about GXP requirements, they typically mean the overarching expectation of documentation, traceability and data quality that runs across all of these frameworks.
A set of ten principles regulators use to judge whether data in a GXP regulated business can be trusted. The name is an acronym:
For a welding supplier in pharma, ALCOA+ means in practice that every single weld must be documented in a way that satisfies all ten principles, not just that the paperwork exists somewhere. See how your own documentation scores against these principles.
Start with the Free Assessment, 8 questions, 3 minutes, and get a personalised report on your documentation maturity level. From there, you can book a Flow Check for a deeper 60 minute review, and a Live Demo when it makes sense.
GRATIS VURDERINGLÆR MERE OM SOCWELD.
En praktisk vejledning for fremstillingsvirksomheder, der leverer udstyr til medicinalindustrien.
Se hvorfor Excel ikke er det rigtige værktøj til svejsedokumentation
Find ud af, hvorfor manuel svejsedokumentation bremser dit projekt, og hvordan du løser det.
Se hvordan vi passer på dine svejsedata
Sig farvel til papirarbejdet og manuelle svejselogs. Lær hvordan her.