A special process is one where conformity of the resulting output cannot be readily or economically verified by subsequent monitoring or measurement.
ISO 9000 describes these processes as activities where confidence in the result must be established through validation of the process itself. Destructive testing may sometimes be required to prove the output, which means routine product inspection alone is insufficient.
Conventional process
The completed output can usually be measured directly using calibrated inspection equipment.
Special process
The output may contain hidden characteristics that cannot be fully confirmed without damaging or destroying the product.
The practical test is whether the organisation can fully verify the important output characteristics after processing. Where it cannot, the organisation must demonstrate that the process conditions, equipment, people, materials and methods are capable of consistently producing the planned result.
- The critical result cannot be completely checked afterwards.
- Verification would be destructive, impractical or uneconomic.
- Process variables directly influence product integrity.
- Validation and ongoing control are therefore essential.
If you cannot confidently verify the finished result without destroying the product, you must prove that the process itself is capable, controlled and repeatedly effective.
ISO 9001
Clause 8.5.1 f requires validation and periodic revalidation where resulting outputs cannot be verified by subsequent monitoring or measurement.
AS9100
Clause 8.5.1.2 adds explicit controls for aviation, space and defence special processes.
- Define criteria for review and approval.
- Determine the conditions needed to maintain approval.
- Approve facilities and equipment.
- Qualify personnel.
- Use specified methods and procedures.
- Retain appropriate documented information.
Special-process assurance focuses on demonstrating that the complete processing system can repeatedly achieve the intended outcome.
Periodic testing verifies that the process remains capable after initial approval. The exact method and frequency should come from the applicable specification, customer requirement, approval scheme or internally validated control plan.
Some processes depend heavily on operator judgement, technique or interpretation. Formal qualification and periodic requalification may therefore be required.
Monitoring confirms that the equipment and process system continue to operate within the conditions established during validation.
| Category | Processes |
|---|---|
| Welding | Rotational friction and inertia welding, torch and induction brazing, flash welding, laser welding, electron beam welding, resistance welding, fusion welding and evaluation of welds. |
| Surface Engineering & Chemical Processing | Electroplating, electroforming, electroless plating, anodising, chemical conversion coatings, passivation, painting, dry-film coatings, surface enhancement, etching and chemical cleaning. |
| Electronics | Printed circuit board manufacture, PCB assembly and soldering, cable and harness assemblies, conformal coating, battery-cell manufacture and array assemblies. |
| Composites | Prepreg, adhesive bonding, resin film infusion, metal bonding, core processing, liquid resin processing and compression moulding. |
| Elastomer Seals | Plate seals, fabric or textile reinforced seals, O-rings and moulded shapes. |
| Heat Treatment | Brazing, pyrometry, heat treating, carburising, nitriding, hot isostatic pressing, induction hardening and sintering. |
| Materials Testing & Inspection | Chemical analysis, mechanical testing, metallography, micro-indentation hardness, corrosion, fastener, physical and thermal testing, and coordinate measuring machines. |
| Nonconventional Machining | Electrochemical machining, electrochemical grinding, electrical discharge machining, laser beam machining, laser part marking and spark-erosion grinding. |
| Non-Destructive Testing | Penetrant, anodise flaw detection, magnetic particle, ultrasonic, radiographic and eddy-current inspection. |
| Directed Energy Deposition | Laser Engineered Net Shaping, electron beam additive manufacturing and wire arc additive manufacturing. |
| Powder Bed Fusion | Selective laser sintering, selective laser melting, direct metal laser sintering, electron beam melting, selective heat sintering and high-speed sintering. |
| Sheet Lamination | Laminated object manufacturing, selective lamination composite object manufacturing, plastic sheet lamination and selective deposition lamination. |
| Material Extrusion | Fused deposition modelling and fused filament fabrication. |
| Material and Binder Jetting | PolyJet, nanoparticle jetting and drop-on-demand processes. |
| Vat Photopolymerisation | Stereolithography, digital light processing and continuous digital light processing. |