Are DMR (device master record) and DHR (device history record) inspected by FDA or audited by an NB

racglobal

Involved In Discussions
#1
Hello everyone,
DHRs are production records, but are they ever inspected by FDA or audited by a notified body? In the companies I've worked at, the DHR is a replica of the DMR except it the boxes for dating and initialing next to the manufacturing steps. So if the auditor reviews the production records (e.g. the DHR), doesn't that defeat the purpose of a DMR index because in reviewing the production records, they would see the entire manufacturing process anyway? The point of producing a DMR Index is so that you would not have to provide proprietary information during the audit. But if they have to looking at the manufacturing records, are we not also disclosing the manufacturing steps? I am looking for clarification. Any insight into this, I would appreciate it.

Thank you.
 
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chris1price

Trusted Information Resource
#2
To answer the first question, yes, in my last FDA inspection I was asked to produce 50 DHRs for review. The DHR is essentially the batch record. In the role of an auditor, I ask to see them as part of all manufacturing audits. There is nothing confidential about a DMR, irrespective of whether it is a index or the full file. auditors and FDA inspectors would expect to see it. The Index is just a short-cut to make it manageable, it has nothing to do with hiding proprietary information.

Essentially, the DMR is the recipe of what you are going to make (specifications, procedures, instructions, etc) and the DHR is the record to show that you did it.
 

somashekar

Staff member
Admin
#3
DHR inspection has been the major time spent in the last FDA inspection I was involved in. Essentially it tells FDA about the devices that have gone into the USofA and that is one of the most important part the FDA wants to inspect.
 

Al Rosen

Staff member
Super Moderator
#5
Hello everyone,
DHRs are production records, but are they ever inspected by FDA or audited by a notified body? In the companies I've worked at, the DHR is a replica of the DMR except it the boxes for dating and initialing next to the manufacturing steps. So if the auditor reviews the production records (e.g. the DHR), doesn't that defeat the purpose of a DMR index because in reviewing the production records, they would see the entire manufacturing process anyway? The point of producing a DMR Index is so that you would not have to provide proprietary information during the audit. But if they have to looking at the manufacturing records, are we not also disclosing the manufacturing steps? I am looking for clarification. Any insight into this, I would appreciate it.

Thank you.
The only records that the FDA is not entitled to see are Management Review, Internal audits and supplier audit reports. Look at 21CFR820.180
 
Last edited:

Ajit Basrur

Staff member
Admin
#6
Yes, the Agency’s policy prohibits FDA to review or copy reports and records that result from audits and inspections of the written quality assurance program, including audits conducted under 21 CFR 820.22 and written status reports required by 21 CFR 58.35(b)(4).. This is stated in CPG 7151.02 (CPG Manual subchapter 130.300). The intent of the policy is to encourage firms to conduct quality assurance program audits and inspections that are candid and meaningful.

CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
 

moounir

Involved In Discussions
#7
Yes, FDA and Notified Body look at both. See previous answers.

In Europe, DHR is the work order and DMR is not existing formally, but with the new ISO 13485, they created the term Medical Device File which is an equivalent.

So, when the auditors are selecting one or many products, then they ask to get an history list with all the orders manufactured for the last years. And they pick a sample of them. Then start the moment to print or to have that available on a thumbdrive.
I usually ask them to make the selection the previous day so we can have time to prepare all of them.

For the DMR, we are using an electronic version as this is a list of all documents needed to manufacture the product. So each time a document change, its reference is replaced automatically.

I hope this clarifies the question.
 

Tidge

Trusted Information Resource
#9
Does the FDA require in the DHR shipping documents in the contents?
I work at a manufacturing facility; we have never included a copy of the DHR with the shipped products. For specific products, it is possible that (for other sorts of devices) some DHR elements (such as specific test/calibration data at time of manufacture) could be shipped with the specific product, but even in that case I wouldn't expect anything like a full DHR to go with the product.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#10
FDA and NB will inspect them, although currently, FDA Remote Assessments are focused on complaints, investigations, nonconformances, MDR reporting, and design controls. For the record it's always CAPA plus one other system for the lowest grade of FDA Audit.

Our DHR Contains evidence of parts used by lot #, employees and training, tools and jigs used, pass-fail metrics, non confomrances, label verification, etc.

I want to remind everyone the FDA _Specifically_ asked us for the training records of employees who provide FINAL APPROVAL for devices prior to end packaging. They were very focused on that during the audit this summer.
 
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