Involving the Shop Floor in the PQR Process: A Bottom-Up Approach

When we talk about the Product Quality Review (PQR) process in pharma, the focus is typically on Quality Assurance and Quality Control teams. But what if we told you that some of the most valuable insights are being missed simply because they never leave the shop floor? 

Operators, technicians, and line supervisors are often the first to notice subtle shifts in equipment behavior, raw material quality, or process inconsistencies. Yet, their voices are rarely factored into the formal PQR process. That’s a missed opportunity—both for compliance and continuous improvement. 

Why Operator Feedback Matters in the PQR Process 

Think of your PQR like a puzzle. You may have 95% of the pieces in place using data from batch records, deviation reports, and stability studies. But that missing 5%—real-world insights—can transform your analysis from good to great. 

Here’s how involving the shop floor brings that transformation: 

 Deeper Root Cause Understanding 

 Operator observations often provide the first signal of quality drifts, helping QA teams ask better questions during investigations. 

 Uncovering Hidden Trends 

 When floor-level feedback is collected systematically, it can reveal patterns that are otherwise invisible in formal data sets. 

 Creating a Culture of Quality 

 When operators are involved in the PQR process, they see themselves as stakeholders—not just executors. This increases SOP adherence and reduces the chance of non-compliance. 

How to Make It Work 

So how do you turn your operators into active contributors in your PQR process? 

 Feedback Forms That Make Sense 

 Avoid overcomplicating. A simple post-batch checklist or mobile prompt asking about material behavior, machine anomalies, or environmental conditions can work wonders. 

 Cross-Team PQR Review Panels 

 Instead of QA working in a silo, invite production supervisors and senior operators to join quarterly review discussions. 

 Digital QMS Integration 

 Modern QMS platforms allow direct input from shop floor devices, enabling real-time feedback and auto-tagging of relevant data to future PQRs. 

 Recognize Their Impact 

 Share examples where operator feedback prevented a deviation or helped improve a process. Make quality ownership a shared success. 

Beyond Compliance: A Smarter PQR Process 

Regulatory bodies love data. But what they appreciate even more is a pharma company that shows genuine process understanding and continuous improvement. 

By involving your shop floor team in the PQR process, you add a valuable, human-driven layer of intelligence. It’s not just about checking a box anymore—it’s about building a smarter, more resilient manufacturing operation.