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Slide 193
Quality
Management System Implementation
Document Tiers & Classes
•It is uncommon to find
‘Pure’ documents. That is to say, it is not very often you find
a document which one can clearly define as ‘only’ Tier
I or Tier II or Tier III. In almost all cases there is some cross over. A good example is a Tier III
document which becomes a Tier IV document. In
this case we have a document which is a Tier III Procedure with some
places which which will eventually be filled
with data - which will then make it a Record (Tier IV).
•The idea of a defined
border and thus a pure document is fine, but is seldom actually seen. Normally the closest you will come is with the Quality
Systems Manual. A QSM will normally be the ‘purest’
document you will find within any given system.
•Purity is to some
degree a function of company size. A company with only 20 to 50 employees with simple processes will generally have
little need for ‘pure’ structure. The necessity of
structure in very large companies necessitates a more defined documentation structure in large part due to necessary overall
complexity.
•Also consider the idea of document classes. Classes may include production documents, engineering documents, Human
Resources documents, maintenance documents, etc. From this we should
understand there are
usually several classes of documents in any given tier.
•Document classes are related to document tiers. In most companies there
are multiple document ‘classes’. These
classes are always Tier II or lower.