Before we start with an Operational Qualification (OQ), we want to make sure we are well prepared. Make sure you think about the following before starting with an OQ:

- Process Parameter and Limits
- Calibration that covers entire range
- Work Instruction
- Trained people on that work instruction
- IQ for equipment
- Materials that fulfill specifications
- Valid Test Method

You'll find more comprehensive information about Operational Qualification (OQ) in medical device manufacturing in our blog post:

[ Ссылка ]

In this article, you'll learn the following:

- Why you should perform an Operational Qualification (OQ)
- What is an OQ?
- How to establish a process window
- Running at worst-case settings
- What is meant by worst-case

If you have any further questions about OQ, please comment below!

Don't forget to subscribe to our SIFo Medical YouTube channel to receive more informative videos about Quality- and Supplier Management in Medical Device Manufacturing.

#OperationalQualification #medtech #medicaldevices #medizintechnik #samplesize #regulatoryaffairs #medicaldevicemanufacturing #qualitycontrol #iq #oq #pq #processvalidation

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At SIFo Medical, we are passionate about empowering MedTech companies in Quality- and Supplier Management. From our base in the Austrian Alps, we provide MedTech manufacturers with our expertise in Quality Management, especially with:

- Compliant Technical Documentation
- Internal & External Audits
- Test Method Validation
- Product Development
- Process Optimization
- Packaging Validation
- Process Validation
- Risk Management
- Design Control
- Statistics

On YouTube, our experts provide short, informative, and easy-to-digest videos about medical device Quality- and Supplier Management to support MedTech manufacturers to produce safe medical devices and comply with necessary regulations and standards (like ISO 13485, MDR 2017/745 or FDA requirements).

Expand your knowledge in MedTech and profit from countless hours of practical expertise in the medical device industry.

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Related Topics:
Medical Device Consulting
Quality Management
Supplier Management
Process Validation
Process Validation in MedTech
Process Validation in Manufacturing
Requirements of Process Validation
Stages of Process Validation
MedTech Process Validation
Operational Qualification Sample Size
Operational Qualification Requirements
IQ OQ PQ
Operational Qualification Definition

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