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FREQUENTLY ASKED QUESTIONS

How does validation add value to my business?

Validation adds value by demonstrating that a system will perform as expected and continues to meet predetermined requirements. Validation also offsets the costly risk of regulatory non-compliance.

When do I have to validate a process?

If the output of a process cannot be verified, then it must be validated.

Where do I find the regulations for validating medical device manufacturing processes and equipment?

The Quality System Regulation is located in FDA 21 CFR 820.75

How do you know when to verify and when to validate?

The decision to validate or verify a process is dependent on the process output. If the output is verifiable then the consideration should be made as to whether or not verification alone is sufficient to eliminate unacceptable risk or impact to product safety and effectiveness and is a cost effective solution. If the verification method is reliable and cost-effective, then the output should be verified and process should be controlled.
If the output of the process is NOT verifiable then a decision to redesign the product, redesign the process, or validate the process shall be made. The product or process may be redesigned so that the output is fully verifiable. If the product or process cannot be redesigned so that the process can be fully verified, then the process shall be validated and controlled.
Also, a change in a manufacturing process may result in the need for the process to be re-validated even though the process formerly only required verification.
Process outputs that are measured through destructive testing shall be validated. The following are examples of processes that must be validated:
• Sterilization processes
• Clean room ambient conditions
• Sterile packaging sealing processes
• Heat treating processes
• Plating processes
• Plastic injection molding processes
• Welding processes
• Sealing processes

The following processes may be verified:
• Manual assembly processes
• Manual cutting processes
• Visual inspection of printed circuit boards
• Visual inspection of labels
• Manufacturing and testing of wiring harnesses

What is a Test Method Validation?

A Test method validation is providing objective evidence that a test method can consistently differentiate conforming from non-conforming products. There are two types of test methods, attribute and variable.

Attribute test methods may evaluate products for cuts, scratches, nicks, scuffs, bubbles, foreign matter, etc.

Variable test methods may be classified as destructive or non-destructive. An example of a non-destructive test could be opening/closing force, torque, and dimensional measurements for length, diameter, width etc. An example of a destructive test method could be of any test to failure such as a pull test, or burst test for seal strength.

Many companies require a Measurement System Analysis/Gauge R&R using software to evaluate the test method using an acceptance criteria of 15 - 30%SV (Study Variation) The acceptance criteria, sample size, confidence, and reliability is defined through a risk-based approach.

What is a Design Control?

Design Control Requirements are established in FDA 21 CFR 820.30. Design controls require the establishment of intended use and design inputs, a design plan, periodic design reviews throughout the design process which are captured in meeting minutes with key stakeholders, and confirmation that design outputs meet the design inputs through Design Verification (Did we design the device right?) and Design Validation (Did we design the right device?) and translation of the design into specifications that can be consistently met by manufacturing. The whole design process and resulting deliverables are captured in the Design History File (DHF)