Deviation Today, Recall Tomorrow: Lessons from QA

In any industry, small deviations can have big consequences if not handled correctly. Many product recalls don’t start with major failures they begin with minor, ignored deviations. 

What is Deviation? 

A deviation is any departure from approved SOPs, processes, or expected conditions during manufacturing, testing, storage, or distribution. Not all deviations affect product quality but every deviation matters. 

What is a Product Recall? 

A product recall is the removal of a product from the market due to quality, safety, or regulatory risks. Recalls are costly, invite regulatory scrutiny, damage brand reputation, and can put consumer or patient safety at risk. 

A deviation is the starting signal; a recall is the final consequence. 

Let’s Understand Types of Deviations & Their Impact 

Planned Deviations (Controlled) 

• Pre-approved and documented 

• Managed through change control  

• Enable validation, trials, and improvement 

For example: Alternate raw material, temporary process change, alternate test method 

Unplanned Deviations (Uncontrolled): 

• Unexpected and unintentional  

• Require immediate reporting and investigation  

• If ignored, directly impact quality and compliance 

For example: Equipment breakdown, power failure, contamination, human error 

Why Deviations Matter: Prevention Prevents Recalls 

• Minor deviations can escalate into major quality failures or recalls 

• Early reporting and investigation turn deviations into learning opportunities 

• Strong deviation management protects product quality, safety, and trust 

Every recall starts with a deviation that wasn’t managed correctly. 

Outcomes: Managed vs Ignored 

When Deviations Are Managed Properly (Right Action Today) 

• Product quality safety is protected 

• GMP and regulatory compliance is maintained  

• Root causes are identified and corrected  

• CAPA prevents recurrence  

• Trends drive continuous improvement 

• Transparency and quality culture are strengthened  

• Risk of batch rejection and recalls is minimized 

Small deviations today lead to stronger systems tomorrow. 

When Deviations Are Ignored (Recall Risk Tomorrow) 

• Minor issues escalate into major quality failures  

• Batch rejection and product loss  

• Regulatory observations, warning letters, or recalls 

• Repeated errors due to weak investigation  

• Damage to company reputation and credibility  

• Increased risk to Person safety  

• Poor audit outcomes and weak quality systems 

Deviation ignored today = Recall tomorrow 

Most recalls do not start with major failures they begin with small, unmanaged deviations and QA systems exist to break this chain early. 

QA’s Role: The Quality Gatekeeper 

Quality Assurance ensures that: 

• Deviations are properly assessed and justified  

• GMP and regulatory expectations are met  

• CAPA is effective before closure  

• No deviation is closed without evidence 

QA safeguards Clients, products, and the organization. 

Everyone’s Responsibility 

• Deviation management is not just QA’s job.  

• Report deviations immediately  

• Do not hide or self-correct errors  

• Follow SOPs strictly 

• Document facts clearly  

• Support investigation and CAPA 

A strong quality culture starts on the shopfloor. 

Final Takeaway 

Manage deviations today to prevent recalls tomorrow Quality improves when everyone reports, learns, and acts. 

Written by Zymist: Priyanka Gami & Edited by Zymist: Priyal Shah