Internal Audits To Ensure FDA Compliance
Medical devices must meet strict criteria that are outlined through the FDA. Auditing equipment on a routine basis is standard protocol and will aid manufacturing employees or technicians with avoiding issues that could cause a failure during an FDA inspection. An audit encompasses the safety, craftsmanship, and operational efficiency of a medical device that will eventually be marketed.
The Checklist
A checklist may seem like a fairly standard way to audit equipment, but the simplicity of this auditing process and the manner in which it provides detailed information that is readily available makes this auditing tool invaluable. Prepare a checklist for each medical device that is currently being prepared for marketing purposes.
If a prototype of each product is used during various tests, filling out a checklist can be conducted during a routine testing session. Leave space on each checklist, allowing your auditing team to record notes that pertain to each item that is assessed during the auditing process.
Since checklists are inexpensive to prepare and each one can be mass-produced, make copies of the original forms and keep them inside of a filing cabinet or folders. Require your auditing team to perform routine audits and to go over their findings with the development team, to aid with resolving any issues.
The Software
Medical device auditing services include software that is designed to permanently record information about each inspection. A software program can be used in conjunction with checklists and will provide a user-friendly way for past data to be retrieved.
After each visual audit, all of the checklists that have been filled out can be handed over to the person who will be responsible for keying in information about each medical device that was assessed. Information about whether a device is compliant or any technological or manufacturing issues that were identified can be input.
These details will be presented to the individual who accesses a particular file during a subsequent audit and they can also be retrieved if an issue arises later on and a development team member would like to determine if the same problem occurred at a prior date.
External Help
For a busy work environment that does not support your employees handling the majority of the internal auditing steps, hiring an outside source may be necessary. Hire an auditor who is familiar with the medical devices that are being designed and request that targeted information is recorded. This information will help you and your employees hone in on any issues that need to be remedied, prior to an FDA inspection.
For more information, contact a local medical device quality system auditing service.
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