FDA QR Internal Audit Checklist

Our FDA Quality System Review internal audit checklist is an effective way of documenting internal quality assurance audits. It features a tabular listing of ISO 13485 requirements which should be assessed during an internal audit.

Process Definitions is the first subject area covered by this table, covering audit questions related to what a process entails and its inputs, with Process Execution as its next focus area.

Procedures
An FDA inspection checklist helps medical device companies prepare for on-site evaluations by serving as an aid during inspection itself. Its structure represents what an inspector typically looks for in each department – this could include quality planning, sampling from production lines, analyzing test reports and charts, searching for training manuals or verifying qualifications.

The process audit section of a checklist features a table with audit questions and scoring options such as non-conformance, corrective action, preventive action and opportunities for improvement (OFI). This is similar to what can be found in supplier audit checklists but features different questions.

Evaluation of existing clinical practices and documentation (such as protocols, logs, disclosure forms, site SOPs, and correspondences ) should be completed by the person conducting the audit in order to give a more in-depth view of any changes required for improving overall performance of your company. This evaluation process can give a good indication as to which improvements might need to be implemented in order to increase performance levels.

Documentation
An FDA audit, particularly ISO/FDA 13485 inspections, requires many documents that need to be documented in order to be successful. These include those related to CAPAs, complaint handling processes, acceptance activity controls and purchasing controls as well as purchasing controls and acceptance activity monitoring systems. Finally, auditors will look closely at your quality processes in this section in order to evaluate if they are functioning as intended.

An audit report template should also be created. This template will serve as the foundation of all internal audit reports you send to auditors to make informed decisions on whether your company is following industry standards.

At the conclusion of your checklist will come purchasing procedures. This critical element demonstrates whether or not your company has established an efficient purchasing system for materials and services.

Training
To achieve compliance with FDA Quality System Regulation (QSR) and ISO 13485: 2016, manufacturers, specification developers, contract manufactures, re-labelers/re-processors and distributors must implement effective medical device validation, regulatory and management processes. In order to verify if these are being carried out appropriately it is vital that regular internal audits take place.

An audit checklist for Quality Service Register must include all aspects of its Quality Management System, from documentation and training through monitoring. Specifically, verification that there exists a system for training needs assessment as well as certification history/records of qualification records as well as suitable methods for verifying job skills are important parts of an effective QSR audit.

As part of your preparations for an FDA inspection, train employees on how to respond to an EIR or Form 483. If auditors identify problems in your medical device production, they will issue an EIR document detailing those issues and any steps needed to address them. If adequate action are not taken by you within an acceptable timelineframe, enforcement action could ensue against your company by the FDA.

Follow-Up
Medical device industry impacts numerous lives globally, which is why adhering to stringent manufacturing and quality assurance standards is imperative. Unfortunately, however, with so many regulations it can sometimes be challenging.

Internal audits can help ensure compliance by conducting comprehensive assessments that cover everything from process improvement activities (PDCA) to documentation requirements and more. Unfortunately, however, these audits can also be time consuming and challenging to manage.

To make sure your internal audits are effective, it’s essential that you properly prepare. That means defining its scope and criteria. Doing this will allow you to easily identify any gaps or weaknesses in your processes that might require attention.

An important element of internal audits is conducting them on an ongoing basis. This ensures that any issues don’t go unaddressed, which could otherwise lead to failed inspections. If needed, plan your audit schedule so you can reschedule an audit quickly if vacation or external training require postponing it – rescheduling could save a great deal of time in terms of wasted efforts and lost productivity.