This week’s Devine Guidance on 21 CFR, Part 820 – Subpart O (Statistical Techniques) is the proverbial “Final Act” in regards to the QSR. There is a plethora of data, standards, and websites that can provide useful information needed to create robust procedure(s) for establishing effective statistical control and sampling plans. Establishing robust statistical procedures will mitigate the potential receipt of a Form 483.
Servicing is a functional requirement, mandated by the Quality System Regulation, and often overlooked by device manufacturers. Though 21 CFR, Part 820.200 is often associated with capital equipment, manufacturers of disposable medical devices still must consider the requirement. It really is a mission critical assignment to provide adequate servicing for equipment deployed in healthcare facilities, while ensuring all of the relevant servicing activities are recorded, tracked trended, analyzed, etc.
Not unlike the inevitability of death and taxes, device manufacturers can expect to receive a complaint or two, or two thousand. The sooner device manufacturers face this reality, the sooner they can develop and deploy effective complaint-management systems that comply with the Quality System Regulation.
Complaints, complaints, and more complaints, extracted from the opening sentence from the previous edition of Devine Guidance, is also an appropriate introduction for this edition DG and Dr. D’s continued diatribe on complaint management covering Subsections ‘d’ and ‘e.’ There is really only one takeaway from this edition of DG, complaints “shall be promptly reviewed, evaluated, and investigated.
Whether major or minor, complaints require a significant organizational commitment to ensure a fastidious and consistent approach to complaint management. This week’s Devine Guidance will begin analyzing and providing insight and guidance needed for maintaining an effective compliant management system–mainly complying with 820.198, subsections a, b, and c.
In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.186 (Quality System Record). The Quality System Record, not to be confused with the Quality System Regulation, can be a document/procedure that points to where all documentation, procedures, and other records, required by the regulation are located, within the context of a device manufacturer’s quality system. The key for compiling a QSR and ongoing compliance with the QSR (y…
In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.184 (Device History Record). The Device History Record (DHR) is a collection of activities such as production routers, as-built configurations, test and inspection results, copies of labeling, etc., retained for a specific device or batch of devices. Device manufacturers can take it to the proverbial bank: DHRs will be scrutinized during a routine inspection.
In this edition of Devine Guidance , Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.181 (Device Master Record). Ensuring the DMR is the receptacle for the appropriate type of records and the ongoing sustaining of the DMR are the basic salient requirements associated with 820.181. Remember, the DMR will never remain in a steady state.
In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.180 (General Requirements). General requirements are boring; however, just like basic blocking and tackling drills in football, device manufacturers must get the basics correct.
Distribution and installation are extremely important processes that ensure approved, safe, and effective medical devices make it into the hands of healthcare practitioners. In this edition of Devine Guidance (DG), Dr. D continues with his guidance for 21 CFR, Part 820, Subpart – L (Handling, Storage, Distribution, and Installation), specifically 820.160 (Distribution) and 820.170 (Installation).
