In the medical device industry, there are various audits that takes place. For example, customer audit, notified body audit from FDA or BSI, and internal audit. If you participated in an audit, briefly describe your experience, and is DHF usually reviewed? What does an auditor looks within the Device History File (DHF)?
Lastly, briefly describe the difference between Device History File (DHF) and Device History Record (DHR).
Just to clarify, the term audit is used when an internal company department performs evaluation of the company procedures, processes, facilities, etc. whereas inspection is when a regulatory agency visits a company to review the company documents, processes, procedures, facilities, etc. In my experience, regulatory agencies do not ask for the DHF (i.e. compilation of all documents), but they ask for specific documents from the DHF such as DDP, Verification and Validation matrix document, Human Factors evaluation, etc.
The DHF is a compilation of all documents generated during development that describe the history of a finished device. The DHR is a history/ traceability of each batch lot and unit produced pertaining to the production of the finished medical device.
Device history file - Each medical device has a document that displays the design history. This document is initiated as the design starts and moves on through development process. According to the FDA the design history should contain all the records necessary to demonstrate the design was developed in accordance with the designed plan and requirements of part 21CFR.
The device history record includes everything one needs to build and test the device contained in the record. It should include device specification, production process, quality assurance procedures and specs, packaging and labeling and installation. I have not been in an audit for medical device but I have been in an audit for a drug company and consumer products. The FDA checks to see if proper SOP guidelines and work instructions are used per their requirements and the companies guidelines.
In a DHF, all the documentation that went into preparing a product and designing it is contained. It contains all the neccessary documentation and proof that a product was made within spec of what was set out as well as within spec of regulating bodies. In essence, it is a history of how the product came to be what it currently is. In a DHR, all documentation and material relating to the manufacturing of the product is contained. This would include when the product was made, how many were made/sold, any device identifier (like GUDID), and more. In essence, it is a history of the production and life of the product at and after manufacturing.
Another important aspect of products to consider in the medical device development process is the Device Master Record (DMR). Contained within this is a record of every document and process relating to how to make and test the product in question. Things like product drawings, manufacturing processes for the product, quality procedures, packaging instructions. The DMR overlaps with the DHF greatly in what is referenced as much of it can also be produced and kept in the DHF as well.
Hello,
I have recently participated in a Medical Device Single Audit Program (MDSAP) audit and am currently preparing for the second part of the same audit within the end of this year. MDSAP is a single audit for medical devices that covers regulatory requirements for the US, Canada, Brazil, Australia, and Japan.
For more information: https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf
The first part of the audit was conducted at the location where the technical files are managed, so the DHFs of the products were not the primary focus. The DHFs will be the focus for the anticipated upcoming MDSAP audit at the R&D location where the DHFs are managed. From my experience in the past where we had two auditors for the mock-MDSAP audit, the DHF was the primary focus of one of the auditors while the other auditor focused primarily on open CAPAs. The targeted areas in the DHF that an auditor investigates is revolved around quality, risk management, and the key milestones (technical reviews, product development committee reviews, and key decisions made).
Lastly, I would like to help clarify your last question.
Design History File (DHF): design history file contains all documentation and records necessary to demonstrate the product’s design development (requirements, specifications, etc.), verification, and validation.
Device Master Record (DMR): device master record contains all documentation for manufacturing the product. This would include Bill of Materials (BOM), technical drawings, packaging/labeling specifications, manufacturing locations, production procedures/methods, quality assurance, etc.
Device History Record (DHR): device history record contains everything to make the device. This includes the quantities made, dates of being manufactured, distribution models, barcode labeling (UDI/UPC), etc.
I've participated in a couple of audits. US FDA, Korean FDA, Internal, and MDSAP. My participation was always limited to specifically my documents so I was questioned on some things but was able to adequately clarify everything.
Some of the classmates have already done a great job of explaining what DHR and DMR so I won't go in depth and instead try to summarize it best I can:
DHF - Simply, the history of the design of a specific product
DHR - Simply, the record of the device(s) - limited to a specific serial number or batch
It’s great to hear about everyone's audit experiences and insights on DHF, DMR, and DHR distinctions. I haven’t personally participated in an audit, but the breakdown of each document’s role in product lifecycle and compliance is helpful. The clarification on DHF covering design history and development, DMR on manufacturing details, and DHR on production records makes it clear how they each play a critical role in ensuring traceability and quality.
I’m curious, for those of you who have participated in MDSAP or FDA audits, did you find any particular approach useful for efficiently organizing or updating these documents? It seems like maintaining clarity and thoroughness across these files would be crucial in audits.
