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