Turning Mistakes into Improvements: GMP Deviations and Effective CAPA Systems

What Counts as a Deviation?

A deviation occurs when an operation strays from an approved process or documented standard. Some are planned — and some aren’t. Common examples include:

• Skipping a required step in a standard operating procedure (SOP)
• Operating outside temperature or humidity specifications
• Using an unapproved material or component
• Delaying a scheduled maintenance, even with approval 
• Discovering an uncalibrated piece of equipment during production

Document every deviation immediately, no matter the severity. Timely reporting helps teams contain issues faster and investigate them more accurately.

How to Investigate Deviations

A thorough investigation gets to the heart of why something happened. Teams should use root cause analysis GMP tools, like:

• Fishbone diagrams (Ishikawa) to break down contributing factors
• The 5 Why's to drill deeper into the root cause
• Interviews with operators and review of batch records to uncover gaps

Want to sharpen your deviation investigation skills? CfPIE’s Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy course walks through real case studies and RCA frameworks that can improve how your team tackles root cause analysis.

Taking Corrective and Preventive Actions

Corrective actions (CA) resolve the immediate issue. That may mean rejecting a batch, reprocessing materials, or updating a document. Traceability matters — what did you do, when, and who approved it?

Before closing out the CA, teams must verify that it worked. Too often, companies skip this final check, and problems reappear later.

Preventive actions (PA) take things a step further. These are proactive adjustments that stop similar issues from happening again. Some examples include:

• Revising SOPs or adding clarification to reduce ambiguity
• Updating training programs to address knowledge gaps
• Modifying a piece of equipment or process to reduce variation

Tracking patterns in deviation reports is a key strategy. For example, if one site is experiencing recurring documentation errors, that’s a signal to investigate process design, not an individual’s performance.

Encouraging employees to suggest PAs makes this strategy even more effective. Operators are often the first to notice recurring friction points, and a simple adjustment could prevent headaches later.

How to Document CAPA Properly

Track every CAPA in manufacturing environments from start to finish and integrate it into your broader quality system. A good CAPA log includes:

• Description of the deviation
• Assigned owner for each action
• Due dates and closure verification
• Status updates and notes from periodic reviews

Need help building consistent and reliable documentation? Check out CfPIE’s Effective Document Management for Pharma, Biotech & Medical Device, covering strategies, workflows, and audit-ready record systems

Common Pitfalls and Best Practices

Some of the most common pitfalls in GMP deviation handling include:

• Shallow root cause analysis that blames “human error” without digging deeper
• Failing to involve the right people across departments
• Letting documentation pile up without timely follow-up

Instead, follow these best practices:

• Involve QA, production, supply chain, and training staff in your CAPA reviews
• Standardize how you classify and investigate deviations
• Reinforce expectations through ongoing training, not just one-time SOP sign-offs

Make CAPA Part of Your Culture

Corrective and preventive actions clean up mistakes and build innovative systems that keep issues from happening in the first place. 

If you're ready to improve how your organization responds to deviations or to build a CAPA system from the ground up, check out CfPIE’s full selection of compliance training.

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