The document hierarchy is also very important

Typically, the way the document system is structured is as follows:

First of all, the Quality Manual is the overarching top level document.

Then we have policies. Policies should not be more than a few pages long, and provide operational framework for departmental functions.

Standard Operating Procedures (SOPs)

Next we have standard operating procedures (or SOP’s).

Procedures provide the process for which to implement the policies. A policy can be thought of as “what” the function provides operationally, whereas the SOP can be thought of “how” it is to be carried out.

Work Instructions

There are also Work instructions (WIs) that provide detailed instructions for specific tasks.

And finally we there are specifications, forms and records.

Example: Materials Management Policy

As a simple example we can look at there being a materials management policy.

The materials management policy would tell us what type of materials need to be controlled and that temperature controlled storage units must be qualified.

Then below that there may be a specific SOP on the how to qualify a controlled temperature storage unit.

There might be a work instruction on the maintenance of the cold storage unit which would require the completion of a form.

The form, once complete then becomes a record, and we’ve gone from the top level quality manual down through the document pyramid to a completed record.