Setting up your document control system to be simple, sustainable and effective is critical to the success of your quality management system. Some of our suggestions are included below:

Build effective documents.

• Make them clear, concise, and user-friendly.
• Use short sentence starting with a command verb.
• Use present tense (e.g.: is, are). Make it clear who is performing the task.
• Format your documents to make them easy to read: use headings and white space.

Have the right amount of documentation.

• Too much
  • Overlap and repetition - including a process in more than one work instruction
  • Work instructions written for virtually everything

• Too little
  • The goal is consistency for your processes. If two trained employees were to perform this task, would they do it the same way? If the answer is "maybe not," a work instruction is appropriate.

• Just right
  • You have SOPs and work instructions to cover key processes.

Outline your document control system.

• Clarify your terminology.
  • Procedure: describes the process
  • Work instructions: tells how to perform the process
  • Attachment: information attached to the procedure for clarification

• Determine what to control.
  • Procedures
  • Work instructions
  • Forms
  • Attachments
  • External documentation
  • Prints
  • Drawings
  • Routers/travelers

Determine where to keep your documents.

• Planning your infrastructure
  • ISO gives you the specifications.
  • You prepare your own blueprint.
  • You choose your document control system.
    • A simple word processing program
    • An existing database program
    • A packaged document control software
• What will be best for your company?
  • Consider the following when choosing a system for your company.
    • Company size
    • Computer setup and availability
    • Number of different processes performed
    • Rate of change for your processes or documents
• Your company may need more than one system.
  • If documents are different enough, it may be best to have two distinct systems. For example,: one for quality system documents, and one for engineering documents

Hardcopy/Paper Document Control Systems
Online Document Control Systems
Engineering Prints
Documents of External Origin
ISO Software Packages