In Episode 5 of the Better Batch Podcast, hosts Alex Koves and Peter Suddard sit down with Nate Call, CEO of Qualitas, to uncover what’s really going wrong in batch manufacturing quality systems. From audits and failed batches to bloated teams and fire drills, Nate explains why manufacturers often struggle with compliance and how to build quality systems that actually work.
With stories from hundreds of facilities and insights into how world-class manufacturers operate, Nate breaks down how you can improve performance, reduce costs, and create a culture of quality that empowers—not frustrates—your team.
Batch failures usually stem from poor documentation, not operator mistakes. Most teams follow instructions—but if the instructions are wrong, failure is inevitable.
More people won’t fix broken systems—better processes will. A bloated quality team often signals inefficiency, not excellence.
You can’t rush audit readiness in 60 days. Auditors want to see months of data, so prep needs to start long before deadlines loom.
Even with great tech, culture still determines quality success. Operators must be trained to respect error messages, not bypass them for speed.
Good systems don’t have to be expensive. With proper controls and stage gates, even Google Sheets can support compliant manufacturing.
Quality and ops need alignment, not antagonism. The CEO must set the tone so both teams work toward shared goals.
Cost of quality and cost of poor quality are must-track metrics. They reveal hidden losses and help justify better investments in systems and training.
Not every complaint is worth a full investigation. Use trends and risk levels to decide what needs urgent action.
Great quality teams are small, focused, and results-driven. They eliminate fluff and get things done without endless meetings.
Training is the most important investment—and the most delayed. Without it, manufacturers stay stuck in fire drills and avoidable errors.
Quality isn’t just about compliance—it’s a lever for profit. When done right, it cuts waste, reduces risk, and unlocks operational value.
Audit your SOPs monthly to ensure what’s written aligns with what’s actually done on the floor.
Map out your quality team structure and eliminate unnecessary layers or duplicated responsibilities.
Set your next audit prep timeline today, allowing at least 6–9 months to build historical data.
Train operators to understand and act on system warnings, not bypass them under pressure.
If you’re not ready for ERP or MES, implement manual stage-gates with clear approvals and double checks.
Host a quarterly alignment meeting between quality, ops, and leadership to reinforce shared goals.
Start tracking cost of quality (CoQ) and cost of poor quality (CoPQ) with simple metrics tied to batch reworks, labor hours, and waste.
Create a complaints triage protocol to identify which ones require investigation vs. documentation only.
Focus your quality team on high-value activities like root cause analysis, internal audits, and process improvement—not just paperwork.
Dedicate time for formal training every quarter, even if it means slowing down temporarily.
Reposition quality as a value enabler by tying your improvements directly to ROI, fewer reworks, and better client outcomes.
Nate Call is the CEO of Qualitas, a quality and compliance firm working with CPG brands and manufacturers across food, beverage, supplements, and beauty. With over 15 years of experience and 800+ manufacturing facilities under his belt, Nate brings deep expertise in quality systems, GMP audits, and regulatory strategy. Through Qualitas, he helps manufacturers of all sizes transform their quality programs, avoid catastrophic losses, and build systems that scale.
Nate is known for his no-BS style, rapid implementation model, and ability to save clients hundreds of thousands of dollars by fixing root issues. He’s a frequent speaker and educator in the CPG and manufacturing quality space.
🔗 LinkedIn: Connect with Nate
Alex Koves: As the President and CEO of Mar-Kov, Alex leads the charge in delivering purpose-built software tools that simplify complex manufacturing challenges. His background in operations management fuels his passion for helping businesses optimize their processes. Connect with Alex on LinkedIn.
Peter Suddard: Peter has worked with batch process manufacturers for years, helping them scale and improve their business. He has extensive experience ensuring customer success and driving product enhancements, making him an invaluable resource for manufacturers seeking to scale. Connect with Peter on LinkedIn.