Montajes & Assembleas
Asambleas están diseñados y fabricados para satisfacer sus necesidades específicas. Se fabrican en tres pasos :
1/ Especificación y Diseño
The design phase to develop a new Octopus assembly is operated under an ISO 9001:2008 quality system. This is a fully interactive process between you and Cellon. During this phase the assembly is designed,the materials selected and the in process testing requirements and post assembly processing requirements are determined. You are supplied with detailed dia-grams and bills of materials (CAD/BOMs) as prototype (PR) versions for project review/approval. All changes arerecorded and samples can be made available for testing. Follow-ing evaluation, the CAD can be further modified.Once the PR CAD is accepted /approved the PR CAD is converted to a "SG" (Specified graphic diagram) CAD issue 1.
Once the SG CAD is issued, the design is locked and future changes can only be made via our documented change control procedure. Changes documented through this process are recorded and indicated by an increase in the issue number of the CAD.
Manufacture of Octopus assem-blies, and final packaging, is carried out within an ISO 14644-1 Class 7 cleanroom facility operated under ISO 9001:2008 and ISO 13485:2003 quality systems.
Assembly process instructions (APIs) are produced from SG CAD specifications approved by you.
In addition to the API, an assembly batch record (ABR) is producedwhich details the specific test requirements for the assembly.The ABR is also used to record the batch details of all components used in the assembly and to record any test result data. All documents are controlled via a controlled documents procedure.Approved component parts are counted into the clean room in the number required and the assemblies are built according to the API.
Each assembly is visually checked by a second clean room technician and tested as defined in the API and ABR. Quality control personnel perform additional visual inspection on a specified number of assemblies before releasing the batch to final packaging. The completed ABR and all associated documents are then combined to form a "job pack" which is submitted to the quality department for review.Only after QC approval of the job pack is the product released.
3 / Procesamiento post-production.
You determine the level and type of post manufacture processing carried out on each specific assembly, based on the intended use of the assembly within your facility.
Cellon subcon-tracts post manufacture processing to approved independent service providers depending on what processing is required.
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