Today's medical device manufacturers must be self critical as they implement their quality systems, but being impartial about oneself can be difficult. For instance, many companies are aware of the fact that their quality systems should confirm to specific guidelines, but without an accurate outside perspective, they may have difficulties with the interpretation of laws, standards and guidelines.
The FDA's Quality Systems Inspection Technique, or QSIT, publication can cut through some of the confusion. Of course, even though this document serves as a valuable resource for firms that want to assess their quality systems management strategies and audit readiness internally, QSIT must be interpreted correctly to be effective.
Why Is QSIT Helpful?
As its full name implies, QSIT was originally published as a guideline designed to help inspectors perform comprehensive assessments of key quality system components with increased efficacy. Although it's not technically tailored towards medical device firms themselves, this reference can provide such organizations with a much better handle on the types of issues that the agency tends to target.
What Does QSIT Cover?
QSIT principles are divided into a number of sections that help FDA personnel conduct more organized inspections. Major groups include Management Controls, Design Controls, Corrective and Preventive Actions, Production and Process Controls, and Sampling Plans. In addition, the guidelines also address the procedures typically employed during pre-announced inspections and assessments of subsystems, and each subsection includes specific objectives and a decision-making flowchart.
You may have recognized some of these fields as critical components of your current quality systems. On the other hand, your custom quality system may include features that don't really seem to fit into the generic QSIT scheme.
Taking either situation for granted could lead to serious oversights in your pre-inspection preparations. It's just as bad to mistake your familiarity with a specific QSIT field for readiness as it is to fail to identify how a QSIT inspection might apply to your proprietary methods. Identifying how QSIT inspection methods apply to you is critical to coming through relatively unscathed.
Implementing QSIT Awareness
Remember that FDA inspectors rely heavily on guidelines to conduct assessments of your facilities, methodologies and quality systems. Inspections can take weeks, but preparation for these inspections can, and often do, take months. Adopting basic QSIT techniques, like top-down inspections, as you're attempting to judge the functionality of your quality systems, is a much easier way to view your own organization with the impartiality needed to make an accurate assessment.
Attaining success requires a thorough understanding of not just QSIT, but other guidelines such as 21 CFRs, GAMP 5, GPGs, SIGs, etc. Without a clear understanding and a carefully devised approach, compliance may prove difficult.
GxP-CC consultants have successfully trained numerous firms to improve their inspection readiness and identify improvements that might make their quality systems more effective. Contact them today to learn how you could be handling compliance more efficiently.