Slide 62 of 200

The above is an example of where a company had a simple control system. Masters are kept on a protected drive. Each person responsible for a document ‘owns’ a directory which only s/he can write to. Control is, obviously, very decentralized.

Companies control documents in many was. Some use canned software. Some smaller companies have everything on paper. The position of the computer today makes paper systems very rare, but there are some that still exist.This is only to say that your system has to meet some basics but the variability makes it impossible to predict.

Important elements of your system should include:
Approval

Review - during initial construction, when changed and “…on a regular basis…” (which may be yearly).
Change control
Availability

Base System

Proposed

Document

Identify Document / Data Affecting Quality and Location(s) Requiring Access

Proposed - Revision

Identify Need for a Change to an Existing Document / Data Affecting Quality

Produce Document

In Personal Space

Using Appropriate

Template

From the Q Drive

Review

Approve

Revise Document

Upload Document to Appropriate

Q (Secure) Drive Directory

Communicate and Implement

Document ‘Owner’

Copy Old Document from the Q Drive to

Appropriate S Drive Directory or File Hard

Copy to Maintain History.

If Electronic, Copy to Personal Space From Q Drive

Any employee may recommend a new procedure or a revision to an existing procedure.

Yearly review in accordance with local procedure.

This is a COMPLIANCE CONTROL feature. It may be one or more people.

4.2.3 Control of Documents (4.5)

ISO 19011 - Quality and Environmental Management Systems Auditing Forum Discussions

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Discovering Change	Process Capability - Cp vs. Cpk	Histogram Animation	Process Loop Animation	Taguchi Loss Function
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