Production Runs

This is where you’ll identify any gaps that compromise quality, efficiency, and scalability. Your initial pilot production runs will help you validate process reliability, assess yield performance, verify quality control effectiveness, and confirm your operator’s competence. Inadequate pilot production will allow unproven processes to enter full production, where problems can grow, create costly delays, and potentially compromise on patient safety. The difference between achieving a smooth production launch and struggling with chronic quality issues reflects whether you’ve been rigorous with validation exercises, gathered systematic feedback, and resolved the problems you’ve found before commercial production.

Validate process reliability and assess yield performance

Production runs need to demonstrate how your manufacturing processes produce devices that conform reliably across multiple production cycles. So, plan pilot production runs that span multiple days or weeks to capture problem variations. Execute runs with different operators, material lots, and equipment to assess process robustness (Processes that only succeed under ideal conditions and expert supervision will fail during routine commercial production).

Document process parameters achieved during pilot runs. Compare actual parameters against specified ranges to verify process capability. Statistical process control during pilot runs will help to establish baseline performance data that enables ongoing process monitoring. Check that your process validation processes accurately reflect actual manufacturing conditions. Aim to use production equipment, typical operators, and representative materials during validation.

Assess process stability throughout your pilot run duration. Monitor this for process drift, equipment degradation, and material variation that affects output quality. Execute worst-case scenario testing that challenges process limits. Deliberately use materials at specification extremes or operate equipment at parameter boundaries. Worst-case scenario testing will reveal process margins and identify the conditions that require enhanced controls.

Process validation represents the foundation upon which commercial manufacturing rests. Pilot production runs provide the opportunity to discover and correct process weaknesses before the product reaches the patient.

_{Professor Emeritus Nigel Slater. Former Director of Medical Materials. Cambridge University.}

Next. Track the actual yield achieved during pilot runs, including first-pass yields, rework rates, and your scrap percentages. Compare these achieved yields against business case assumptions to verify commercial viability, analyse the losses to identify dominant failure modes, and categorise defects by type, frequency, and process stage. Pareto analysis will reveal which defect types contribute most significantly to yield losses.

Evaluate rework feasibility and economics for common defects. Excessive reworks indicate process problems that require correction rather than post-production sorting. If you monitor your cycle times and throughput rates and compare actual production rates against capacity assumptions, you can identify challenges that limit overall production.

Making sure to find problems

Production runs are there to ensure that your quality control procedures detect failures and prevent defective products from reaching customers. Make sure to execute each and every planned inspection and testing procedure throughout your pilot runs. Determine whether inspection methods reliably detect defects, assess inspection efficiency and practicality, and inspect every part of the pilot run output to compare against the sampling plan performance.

Evaluate measurement system capability for critical characteristics. Conduct gauge repeatability and reproducibility studies using pilot run products, review that measurement variation remains small compared to specification tolerances, and validate automated inspection systems using pilot run products spanning acceptable and non-conforming conditions.

Now assess your operator’s competency with careful observation during pilot runs. Check that they understand the procedures, execute steps correctly, and recognise abnormal conditions. Try to identify procedure sections that cause confusion, hesitation, and errors. Gather their feedback on procedure clarity, completeness, and practicality. It’s something that can prove vital in your success story.

Evaluate training effectiveness based on operator performance. Operators who struggle despite training indicate inadequate training programmes requiring enhancement. Assess whether additional hands-on practice, clearer written procedures, or visual aids will improve competency. Refine your training programmes based on pilot run observations.

Manufacturing procedures that seem clear to procedure writers often prove confusing to production operators. Pilot production runs with systematic operator feedback reveal ambiguities and unclear acceptance criteria that development teams overlook.

_{Professor Ken Catchpole. Surgery and Perioperative Science. Cedars-Sinai Medical Centre}

Following instructions

Production runs validate material traceability systems that enable recall execution and root cause investigation. Verify that material lot numbers, quantities, and usage dates are accurately recorded in batch records. Trace finished devices back through production to the source materials to confirm traceability system functionality.

Check your material handling procedures to prevent mix-ups and contamination. Examine whether materials are properly identified, stored in designated locations, and used in correct sequences. Evaluate the material consumption tracking accuracy. Compare any recorded material usage against actual consumption, as discrepancies will indicate errors in documentation or material handling problems. Implement feedback collection from manufacturing teams during your pilot runs, and conduct structured debriefs after each production run. Ask your team to identify procedure ambiguities, missing information, process difficulties, quality concerns, and improvement suggestions. Document all of their feedback with specific procedure references.

Prioritise feedback collation based on impact on quality, safety, and efficiency. Address critical quality or safety concerns immediately. Communicate your feedback resolution to manufacturing teams, demonstrating that their input creates tangible improvements (responsive feedback incorporation only improves a quality culture).

Finally, revise procedures, work instructions, training materials, and quality plans based upon your pilot run learning. Update any documents before commercial production begins. Verify that changes address identified issues through these confirmation runs. Treat pilot production as a learning process. Multiple pilot run cycles create robust, reliable processes, ready for commercial production.

Quality Workshop

Production runs determine whether manufacturing processes achieve reliable commercial production. We can help you set up reliable processes to create consistency through multiple production cycles under realistic conditions. This way, you can assess yield performance and identify efficiency opportunities, check quality control effectiveness, and operator competency through comprehensive validation and observation. By confirming material control and traceability system functionality, we’ll help you gather systematic feedback from manufacturing teams on procedure clarity and practical improvements.

Waypoint checklist

Focus on these considerations with your production runs:

• Check if the making process works reliably every time.
• See how many good devices are made and if there are delays.
• Make sure quality checks actually find problems.
• See if workers understand and follow the instructions correctly.
• Confirm that materials are tracked and controlled properly.
• Treat your pilot run not just as a test of the process, but as a critical learning phase.
• Actively gather feedback from your manufacturing team on the clarity of procedures.