IQ/OQ/PQ
IQ/OQ/PQ stands for Installation Qualification, Operational Qualification, and Performance Qualification. It's a three-step checking system used in medical device manufacturing to make sure equipment and processes are working correctly and safely. Think of it like a thorough inspection process: first making sure equipment is installed correctly (IQ), then confirming it works as intended (OQ), and finally verifying it consistently produces good results (PQ). This process is important because medical devices must meet strict safety standards. Similar terms you might see are "equipment validation" or "process validation."
Examples in Resumes
Led IQ/OQ/PQ validation programs for new manufacturing equipment
Developed and executed IQ OQ PQ protocols for sterilization processes
Managed Installation Qualification/Operational Qualification/Performance Qualification documentation for FDA compliance
Typical job title: "Validation Engineers"
Also try searching for:
Where to Find Validation Engineers
Professional Organizations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you handle a situation where IQ/OQ/PQ results don't meet acceptance criteria?
Expected Answer: A senior candidate should explain the importance of investigating root causes, documenting deviations, implementing corrective actions, and possibly revalidating the process. They should mention involving key stakeholders and maintaining compliance with regulations.
Q: How do you determine sample sizes for PQ validation?
Expected Answer: They should discuss statistical methods, risk assessment, product complexity, and regulatory requirements. Should mention the importance of justifying sample sizes in validation documentation.
Mid Level Questions
Q: What documentation is required for IQ/OQ/PQ?
Expected Answer: Should mention protocols, test procedures, data collection forms, deviation reports, and final reports. Should understand the importance of proper review and approval processes.
Q: Explain the difference between IQ, OQ, and PQ phases.
Expected Answer: Should clearly explain that IQ verifies proper installation, OQ confirms operation meets specifications, and PQ ensures consistent performance under actual conditions.
Junior Level Questions
Q: What is the purpose of IQ/OQ/PQ?
Expected Answer: Should explain that it's a systematic process to ensure equipment and processes are properly installed, operating correctly, and consistently producing quality results.
Q: What basic documentation do you need before starting IQ?
Expected Answer: Should mention equipment specifications, manufacturer documentation, installation requirements, and calibration certificates.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of validation protocols
- Ability to follow established procedures
- Documentation management
- Basic knowledge of FDA requirements
Mid (2-5 years)
- Protocol writing and review
- Execution of validation programs
- Risk assessment participation
- Understanding of regulatory requirements
Senior (5+ years)
- Validation program management
- Risk assessment leadership
- Regulatory compliance expertise
- Team leadership and training
Red Flags to Watch For
- No knowledge of FDA or regulatory requirements
- Unable to explain basic validation concepts
- Lack of documentation experience
- No understanding of Good Manufacturing Practices (GMP)
- Poor attention to detail in previous validation work
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