Machine validation is an ongoing part of a medical device manufacturer’s quality assurance. It’s an essential method to ensure they’re delivering products that meet customers’ specifications.
While this process occurs in house, it’s important for customers to understand how machine validation influences the products that their manufacturing partner delivers – from reducing inspection time to ensuring each component is made accurately.
Benefit #1: A documented master validation plan reinforces regular validation processes.
As part of a quality assurance program, machine validation processes are often recorded in a master validation plan.
Each piece of equipment must be validated against installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols, according to FDA guidelines.
In addition to running IQ OQ PQ validation when a machine is first installed or after it’s moved, it’s important that PQ validation be an ongoing effort. Machine components can drift over time, and regular PQ validation ensures a machine repeatedly and predictably reproduces expected results.
When looking to work with a contract manufacturer, ask about its validation processes and if a master validation plan is in place. This plan will typically include IQ OQ PQ benchmarks and an outline of how frequently machines are validated.
Benefit #2: Validation ensures the manufacturer chooses the appropriate machine to create a component, which creates confidence that parts will be delivered to specification.
One of the biggest benefits of running routine validation is creating a high level of confidence that machines will repeatedly and predictably create parts to specification.
When a manufacturer like Lowell receives a CAD model from its customers, it surveys its equipment list to select the appropriate machines to create the components. Part of this decision is based on how well a machine can consistently manufacture a specific dimension, which is documented as part of process validation.
Machining cost is another factor. Equipment that’s capable of creating very tight tolerances to the submicron level is typically more expensive to run than machines with a wider capability range. By referencing validation documents, we can choose a machine that meets manufacturing requirements while also keeping an eye on the customer’s production cost.
Confidence can also reduce inspection time, which helps products ship more quickly. The example below shows how this can work, based on guidelines in AQL1.0.
If we create 2,500 parts, the number of parts recommended for inspection is 42. If we create 500 parts, the number recommended for inspection is 29. Running five 500-part jobs separately means 145 parts total should be inspected.
However, if we know a machine is validated to reliably create 2,500 parts to dimension, we can run the five batches together and reduce the inspection numbers from 145 to 42. This delivers immense time and cost savings for the customer.
Benefit #3: Validating processes via historical data streamlines pre-production time.
Each time a component is created, data is collected on the part and machine. Manufacturers can use this historical data to decrease the amount of pre-production time using a process called retrospective process validation.
In its Guide to Inspections for Medical Device Manufacturers, the FDA defines retrospective process validation as “validation of a process for a product already in distribution based upon accumulated production, testing and control data.”
This allows manufacturers to validate processes based on the data generated when similar parts were made – if the products have been shipped for distribution already – rather than create a brand-new validation process. Decreasing this pre-production time can help get a component into production sooner, improving overall time to market.
Process validation is a complex but essential part of any medical device manufacturer’s operations as they strive to deliver products in a timely and accurate manner. For more information about Lowell’s validation process and master validation plan, contact us at (763) 425-3355 or firstname.lastname@example.org.
 Guide to Inspections of Medical Device Manufacturers, U.S. Food and Drug Administration. https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114942.htm.
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