At VistaTek, quality is not just a final check... it’s a fundamental philosophy that runs throughout our entire manufacturing process. From prototype to production, our dedicated Quality Department ensures every part meets or exceeds expectations through a structured and data-driven validation process.

Whether you're an OEM, medical device company, or a partner in the consumer goods space, understanding our process gives you confidence in the consistency, compliance, and precision of the parts we deliver.

Our Quality Department: Purpose-Driven and Detail-Focused

Our Quality Department serves as the gatekeeper for product integrity. With advanced inspection tools, precise measurement techniques, and robust traceability, our team is deeply involved at every step of the production lifecycle.

Key in-house capabilities include:

•  Incoming and in-process inspections
• Gage R&R (repeatability & reproducibility)
• Optical Comparator & Micro-Vu CMM technology
• Root cause analysis
• Statistical Process Control (SPC)
• Documentation & traceability aligned to ISO 9001 : 2015

The Validation Journey: From Development to Production

Our validation process is a systematic approach to confirming that every product and process meets its defined requirements before, during, and after production. This is especially critical for industries with tight tolerances and strict regulatory requirements.

Step 1: Installation Qualification (IQ)

IQ ensures that equipment, tools, and gauges used in production are installed correctly and according to the manufacturer’s specifications. This step includes:

• Verification of utilities and equipment setup
• Tooling readiness checks
• Initial calibration of measurement devices

Step 2: Operational Qualification (OQ)

OQ tests the equipment and processes to ensure they operate consistently within the defined limits. This includes:

•  Identifying and challenging process parameters
• Running test parts to evaluate repeatability
• Gage capability studies (Gage R&R)
• Machine process capability (Cp, Cpk)

Step 3: Performance Qualification (PQ)

PQ validates the ability of the full process to consistently produce parts that meet specification under real-world production conditions. This is where the process is stress-tested under normal variations. Key components:

• Full production run under standard conditions
• Use of statistically significant sample sizes
• Part measurements and dimensional studies
• Short-term and long-term data analysis

Step 4: Production Part Approval Process (PPAP)

For many industries, particularly automotive and medical, we complete a formal PPAP to submit to the customer. This includes:

• Dimensional results (typically 1st Article Inspection)
• Process capability data
• Material certifications
• Control plan and Process Flow Diagram (PFD)
• Design FMEAs and Process FMEAs
• Appearance approval report (if applicable)

Final Inspections & Continuous Monitoring

Even after validation, our work continues. Every production run undergoes:

• First Article Inspection (FAI) to reconfirm part dimensions
• In-process inspections at defined intervals
• Final inspection with traceable documentation
• Customer-specific checklists and criteria

Traceability and Documentation

All validation and quality records are stored securely, ensuring:

• Full traceability from raw material to final part
• Easy access for audits and regulatory reviews
• Peace of mind for customers with critical applications

Why It Matters

In industries where failures can have serious consequences, validation isn’t optional... it’s essential. At VistaTek, our validation process ensures:

• Risk reduction
• Regulatory compliance
• Increased production reliability
• Customer confidence and satisfaction

Ready to Collaborate?

If you're looking for a manufacturing partner who takes quality and validation as seriously as you do, VistaTek is ready. Reach out to our team to learn more about how we can build trust through precision.