Medical device manufacturers must demonstrate adherence to strict installation, operational, and performance qualification protocols (IQ, OQ, and PQ, respectively) to ensure that the equipment used or installed will consistently manufacture products that meet quality requirements.
Each level depends on the other and unlocks distinct and critical pieces of the quality assurance puzzle, so tracking must be meticulous. And this poses a couple of challenges we’ll explore below, along with ways to fix them. First, we need to understand the qualifications.
Understanding The Qualifications
There are three stages in the equipment qualification and validation process, with the third stage broken into two parts.
The first stage, Installation Qualification (IQ), validates that newly installed or modified equipment and its sub-systems and ancillary systems can perform the expected requirements and produce the results defined in the Design Qualification document.
Success here hinges on the equipment’s configuration and how closely it meets the manufacturer’s specifications, be it hardware or software. There is typically an installation checklist.
The process needs to be documented in a Validation Master Plan (VMP) and then revalidated for every maintenance or modification. Recording calibration and validation dates of tools used for IQ is essential.
The real-world performance of the equipment is determined here. If the installation is off, performance will be as well. Errors at this stage will have a cumulative impact and can be catastrophic.
Next is Operational Qualification (OQ). This is where medical device manufacturers ensure equipment is performing optimally to meet specified operating ranges or limits for everything from startup and operation to maintenance, cleaning, and safety. Any equipment components or features that can impact final quality are inspected, thoroughly tested, and documented.
In this phase, there are specific tests for each component to confirm that every part operates as intended at pre-set thresholds.
Manufacturing equipment and corresponding processes are verified against worst-case conditions. The goal is two-fold:
- To ensure the manufacturing process is reproducible and results in conforming products.
- And to ensure it can withstand normal stressors and determine what conditions create failure.
The equipment must operate according to the requirements laid out.
And finally, Performance Qualification (PQ) and its partner, Process Performance Qualification (PPQ), which is phase two of this final stage. This is where the requirements defined earlier will be verified, documented, and then validated using a test plan that will need to be created—and this needs to happen for the equipment and then for each product as well.
And then the second part of the PQ stage calls for ongoing product quality documented through performance evaluations of processes over a period of time. This is the PPQ or process performance qualification phase.
The FDA states in its guidance that “CGMP-compliant procedures must be followed,” adding that “successful completion of Stage 2 is necessary before commercial distribution.” And it recommends tracking a number of important metrics, including:
- Manufacturing conditions such as equipment limits, operating parameters, and component inputs
- A thorough list of the data that should be recorded or analyzed during tests, calibration, and validation
- Tests to ensure consistent quality throughout production
- A sampling plan detailing the sampling methods used during and in between production batches
- Analysis methodology for making data, scientific and risk-oriented decisions based on statistical data
- Definitions for variability limits and contingency plans for handling non-conformance
- Approval of the PPQ protocol by relevant departments, namely the Quality Unit.
The complexities compound at each qualification and validation level and even tiny inconsistencies can snowball into serious issues—which brings us to our challenges.
Equipment Qualification & Validation Challenges Manufacturers Must Overcome
Medical device manufacturers need to have the proper qualification and validation protocols in place. This requires input from every impacted department and a process for tracking requirements and critical deadlines. Getting this process designed correctly up front will determine its overall success.
Unfortunately, deadlines and other business constraints can result in a rushed process where steps are skipped, and requirements are not properly validated. Planning ahead to prevent this is very important.
And as crucial as this whole process is, few manufacturers face a consistent equipment qualification and validation need, meaning it’s typically not a function that justifies a full-time hire. This creates dangerous disconnects around who owns a process or can create a disjointed process, particularly if testing requirements have not been meticulously documented and maintained and are easily accessible.
When in motion, the time and expertise required to successfully progress through each phase of these qualifications is extensive, but these instances happen sporadically, so sorting out how to best manage the process requires careful consideration.
Another hurdle is detailed by Devin Mack, Life Science Consultant, in a piece exploring IQ, OQ and PQ in FDA-Regulated Industries, “is a decades-long transition of influence from the engineering department over to the commercial team. The differing priorities between these functions can create tension that’s often uncomfortable to acknowledge, let alone confront.”
Devin explains there was a shift from extensive testing to writing justifications “to avoid the amount of testing that they would have done 30 years ago” and this transition has continued to evolve, landing somewhere in the middle—but the tension remains. His tips for resolving it include:
- Challenge any assumptions being made early in the product realization process—especially those that justify omitting certain activities from work plans.
- Devote ample time to, and be thoughtful about, laying out the full set of requirements for a given product with input from every impacted department.
- Acknowledge that few decisions can ever be responsibly made in a silo, especially early on. Don’t presume that a team need only be involved later on in the process.
So, how do we put it all together to consistently create successful equipment qualification and validation outcomes? It starts with digitalizing the process.
Equipment Qualification & Validation Success
Most medical device manufacturers have a constant need for equipment qualification and validation personnel, and software is no different.
Purpose-built processes and alerts can consistently track important indicators and prevent missed deadlines. It significantly impacts the entire performance protocol life cycle, making a difference right from the start, in the IQ stage, when recording calibration and validation dates of the tools used and generating alerts to maintain performance.
And as each level in this qualification and validation process depends on and builds upon its predecessor, this attention to detail and consistency positions the manufacturer for success. It also heads off the manual transmission of knowledge from one operator to the next or relearning occasional processes as cyclical or project-based needs dictate.
All the documentation, including requirements, upgrades, and maintenance logs are organized and accessible as a single source of truth in your CMMS, computerized maintenance management system, ready to ensure nothing is missed and everyone is immediately aware of changes. No more downtime spent sorting out where something went wrong and why, just precision-scheduled maintenance and upgrades.
We’re excited to show you how it looks in action, so be sure to reach out for a demo today!
