Part one of this series discussed the importance of increasing visibility into adverse events to assess their criticality and apply corrective action if necessary. In this installment we will look into another essential element of the quality management system (QMS): document control... or lack thereof.

Document control

Company documents include, among other things, information regarding processes and procedures for employee training, training statuses, job descriptions, work instructions, and more. It’s critical that this information be properly maintained and up to date across the entire enterprise.

Without standardized, accessible, and up-to-date documents, risk factors include:
• Unsecured, outdated documents (particularly if they are used on the shop floor)
• Training and status information that is inconsistent from site to site
• Slow approval cycles
• Noncompliance issues
• Lag time in changes to documents existing in multiple locations
• Difficulty of verification

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