Ensuring Consistency in Critical Manufacturing Processes
In manufacturing, certain “special processes” produce outcomes that cannot be fully verified by inspection alone. Examples include heat treatment, coating, welding, plating, sterilization, and NDT. These processes require validation to demonstrate, with objective evidence, that they consistently deliver the desired results.
Special Process Validation ensures that your processes, equipment, and personnel meet required standards and are capable of producing reliable and repeatable results. This is especially crucial in regulated industries such as aerospace (Nadcap), automotive (CQI), and medical devices (ISO 13485).
BQCIS provides independent audits and validation services to verify process capability, control, and documentation integrity. Our assessments confirm your compliance with sector-specific standards and boost customer confidence in your manufacturing quality system.
Key Validation Activities
Process Qualification Review (PQR)
Reviewing validation evidence such as test data, calibration records, and performance trials to verify the process achieves its intended results under controlled parameters.
Equipment & Personnel Qualification Audit
Ensuring that process equipment is calibrated, maintained, and capable, and that operating personnel are trained and qualified according to documented standards.
Key Benefits of Special Process Validation
Ensure Process Consistency
Provides assurance that the process performs reliably and repeatedly within validated parameters, minimizing deviations.
Meet Stringent Industry Standards
Supports compliance with Nadcap, CQI, and medical validation requirements across global supply chains.
Reduce Final Product Testing
Validated processes reduce dependence on destructive or repetitive product testing by ensuring built-in quality.
Improve Product Reliability
Enhances confidence that critical processes affecting product performance are consistently controlled and monitored.
Success Story
Heat Treatment Process Validation Achieves Nadcap Accreditation
An aerospace component supplier needed Nadcap accreditation for its heat treatment operations, requiring full validation of furnaces, thermocouples, and process controls.
BQCIS conducted pre-assessment audits based on Nadcap checklists, verified TUS and SAT data, and confirmed calibration traceability for all critical instruments.
Following BQCIS guidance and corrective actions, the supplier successfully passed the Nadcap audit, ensuring compliance and continued approval for aerospace supply contracts.