Domains Definition

In recent times, domains definition has become increasingly relevant in various contexts. Software Unit definition - The Elsmar Cove Quality Forum. I would first assess at a conceptual level the individual packages and their functional domains and the relation to their classes. Your name tells me you are QA responsible, don't you have a software architect that did the design? Another key aspect involves, or do you need to do a retrospective architecture / design? Rework - FAA Definitions. This defacto definition introduces the concept of a REPAIR possibly including the complete REPLACEMENT of a discrepant / non-conforming part.

From another angle, rEPAIR - USA FAA ADVISORIES AND OTHER GUIDANCE INFORMATION If the regulations are vague, legalistic, contradictory and a bit messy in places, then the advisories are more of the same. ISO 13485 Complaints (what is a complaint). The QE then reclassifies the record in the system so it is no longer a complaint but is instead called something else.

To me, even if the product meets specification, it is still a complaint based on the ISO definition which only requires an allegation of deficiency and we shouldn't be reclassifying complaints into a new category. When does the FDA consider a component a medical device?. Thank you in advance. I assume you are referring to a surgical staple.

If this is the case, the staple is considered a medical device because it can be argued to be intended for one of the purposes listed in the Medical Device definition on its own (after "implantation"). IATF Definitions - Reworked product (8.7.1.4) vs Repaired product (8.7.1.5). Equally important, i don't know why there are 2 similar but separate clauses for rework and repair.

What is the difference between rework and repair? Definitions in ISO 9001:2005: Rework - action on a nonconforming product to make it conform to the requirements. In relation to this, repair - action on a nonconforming product to...

What to include in SOP Definitions section. Hi there, Have been writing/editing SOPs for years but am interested in others opinions about what should be included in a Definitions section. Personally I think it is only terms that require interpretation within the context of the SOP. Terms that are commonly understood by the organization...

Reprocess - Definitions - Pharmaceuticals. Re: What is meant by "rework" and "reprocess"? Pharmaceuticals Scott is right on the definitions. Just to cite an official definition from the (broken link removed) Reprocessing is the treatment of a batch or sub-batch of materials of unacceptable quality by repeating the same process steps from a defined stage of production so that its quality may be made acceptable. NOTE: The occasional ...

Difference between Non-Conformance, Variance and Deviation. Could someone please explain the difference between deviation and variance?