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.”[1]
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 requestinfo@lowellinc.com.
[1] 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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