Some regulations may not be relevant to you, for example, Class I devices do not require design controls. It is up to your company to determine what is applicable to you, perhaps with the assistance of a regulatory consultant. Inspectors are required by law to show their credentials upon conduction of an inspection. Your records are your proof. They should demonstrate that you are following your written procedures, supported by all ongoing activities. To interview key personnel within your organization.
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Software Validation Software validation is required for any software used in your company for managing aspects of your business impacting quality. This can include QMS software , manufacturing inspection software, etc. Calibration Calibration relates to any gauges and equipment used to take measurements of product during manufacturing processes.
The gauges shall be certified to recognized standards and updated periodically to ensure gauges continue to measure accurately and precisely. Preventive maintenance applies to routine actions required to keep gauges and equipment operating as expected. This can include temperature and humidity requirements. Your product may also require installation at point of use. If so, this needs to be defined. Servicing Servicing relates to any activities required to keep your product functioning and operational.
This generally applies to reusable products and not usually for single-use devices. All servicing activities shall be document and records included with the original product DHR. Complaint Handling Any time a customer provides any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution fits the official FDA definition of a complaint.
You need to establish complaint handling procedures, including how you will investigate and address complaints. More than that, this fits the criteria of an adverse event and may need to be reported to FDA and other regulatory bodies. Your procedures need to address adverse event reporting. Customer Feedback A complaint is a type of customer feedback.
Complaints are generally reactive: you learn about the issue after it has occurred. ISO expects that you establish customer feedback processes where you solicit feedback on the use of your products in a proactive fashion.
Analysis of data is one means to measure your QMS performance. Note that any data you analyze shall be done so with proven statistical techniques. A quality manual briefly describes your company quality policy and brief descriptions of all the required quality system elements. You set the schedule and frequency for internal audits. It is important to make sure that personnel conducting internal audits have been appropriately trained to conduct audits.
Often times, internal audits are outsourced. Internal auditing is a very important function. This is a way to monitor whether your company is following established procedures. Internal audits should be used as means for continuous improvements. When establishing your internal audit program, I recommend structuring this in a way that mimics a system approach, as well as conducting individual process audits too.
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The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection
There are simply too many medical device manufacturers for FDA to inspect annually, so FDA prioritizes its limited inspection staff according to the risk posed by manufacturers and their devices. Some companies get more attention than others. The risk-based approach means companies with new or existing Class III devices are the highest priority, especially those making implantable and life-supporting devices. Class II manufacturers the bulk of the volume are next in line, along with any companies that have recently introduced a device via the k process. Companies that have had their hand slapped in the past tend to get frequent repeat visits, which are often unannounced. Foreign companies typically get more advance notice so that travel and translator arrangements can be made. Before the inspection, FDA may request that you send them a copy of your quality system manual and management review procedures to facilitate the inspection.
QSIT: Quality System Inspection Technique
Fall within these bounds, and you can anticipate an FDA inspection at your facility. For the scope of this article, though, we will focus specifically on the inspection of medical device manufacturers. Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different. Pre-Approval Inspections are conducted after a company submits an application to FDA to market a new product. These inspections focus on verifying data included in the application, and confirming that the facility is capable of manufacturing said product. The outcome of a pre-approval inspection is that inspectors will recommend for or against FDA approval. A compliance follow-up is conducted to verify the adequate correction of previous violations, to document continuing violations, or to support future regulatory action.