Document Control: How to Avoid Common Mistakes

Updated 4 May 2012 A. Ochs

An effective document control system is the backbone of an effective quality system. We offer you some tips so you can avoid common document control problems.

Common Problems to Avoid

  • Employees writing documents do not understand the difference between a Procedure and a Work Instruction.
  • Terminology has not been defined, and is not used in a consistent manner.
  • Revisions take too long so documents are not kept current.
  • There is no process for tracking changes or training on changes.
  • Inconsistent use of other documents such as
    • Forms
    • Attachments
    • Drawings
    • Documents of external origin
  • Too many documents are distributed making it difficult to maintain the system.
  • Lack of control of documents of External Origin
  • Some database systems may lead to circles. Allows comments but not changes. This may require a new draft version to allow for changes.
  • Not keeping distribution current.

How to Avoid These Problems

Plan Ahead

The basics of a good document control system include: Having good documentation

  • Clear
  • Concise
  • User friendly

Have the right amount of documentation

  • To determine if a work instruction is needed, ask “If 2 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.

Outline Your Document Control System

  • Quality Manual: explains how you will meet the standard
  • Procedures: describe the process
  • Work Instructions: tell how to perform the process

Determine where to keep the documents

  • Hardcopy system
  • Online system
  • ISO software system

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