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.
