Folks, if an event or activity is not documented in writing, it never happened in the eyes of our friends at FDA. When it comes to retaining accurate records reflecting manufacturing in accordance with the Device Master Record (DMR), having an accurate Device History Record (DHR) to reflect compliance is a salient requirement. In fact, similar to the DMR, the FDA feels so strongly about the DHR the Quality System Regulation (QSR) has a stand-alone requirement for DHR content. Simply stated, the DHR reflects compliance to the DMR, which is a requirement of the QSR, required by FDA. DMR, DHR, QSR, and FDA, enough acronyms for you? Remember, failure to comply with any part of the QSR and the Chief Jailable Officer (CJO) will be wishing for that magic elixir to achieve a “lenitive” (look-it-up) effect, as the FDA’s response to compliance issues will be harsh. Just to show the readers how serious FDA is about the DHR, Dr. D has taken the liberty of extracting one of the observations from a recently issued warning letter that reflects a violation of 820.184. In fact, it was the very first warning letter the doctor reviewed in support of this week’s guidance. Note: Dr. D purposely redacted the name of the violating manufacturer to protect the guilty.
FDA Warning Letter issued on June 12, 2013
Failure to maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of this part, as required by 21 CFR 820.184.
For example: Your firm does not have written procedures that govern which documents and information should be present in each DHR. Also, DHRs do not contain a final release signature of the person authorized to release each lot for distribution.
820.184 – Device History Record
Each manufacturer shall maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) Dates of manufacture;
(b) Quantity manufactured;
(c) Quantity released for distribution;
(d) Acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) Primary identification label and labeling used for each production unit; and
(f) Device identification(s) and control number(s) used.
Device History Record (DHR)
Let the doctor begin by stating device manufacturers cannot offload their quality and regulatory responsibilities to their suppliers. If a device manufacturer is employing a contract manufacturer in Kathmandu, they better be receiving, reviewing, and approving the DHR compiled by the contract manufacturer, including authorizing the release of finished medical devices. On another note, you just might want to visit your contract manufacturer from time-to-time (the topic of another recently-written DG weekly blog
Over the previous few weeks, the doctor has climbed to the top of his quality pulpit and pontificated on the importance of Identification, Traceability, and the DMR. This week it is time for Dr. D to pontificate over the DHR. One thing to keep in mind is that your friends from the agency will eventually stop by for that friendly cup of coffee and an inspection. During that inspection, they will ask to see DMRs and eventually review DHRs to verify finished medical devices are being properly manufactured, in accordance with the DMR.
Dr. D has seen all kinds of DHRs; and there is no secret sauce or magic recipe for creating a great DHR. In fact, the DHR can easily be tailored to a device manufacturer’s specific needs, providing all of the information required by §820.184 is included in the DHR. So what needs to be captured in the DHR? The DHR will contain:
- The lot/batch number (or serial number if applicable);
- A reference to each of the procedures used;
- A reference to each of the inspection and test procedures used;
- The names of individuals performing each of the process steps and the dates the process steps were performed;
- The quantity manufactured (pass/fail);
- The quantity released to distribution;
- The name of the individual (could be the CJO) responsible for releasing the lot/batch for distribution; and
- A label retain from the product/package labeling used.
Another important fact to keep in mind and a practice to instill in all employees is another favorite Dr. D acronym, GDP
! No one, including the FDA investigators, wants to spend hours stumbling through a DHR review because the GDP is horrendous. Dr. D recognizes that his penmanship is horrible so it was never a good idea for the doctor to make entries into the DHR. Thank God for whiteout correction fluid, just kidding. Make sure, everyone in the organization tasked with making entries in shop floor paperwork, a.k.a., production travelers, exhibits reasonable GDP.
For this week’s guidance, the doctor will leave the readers with three takeaways. One – make sure your organization scripts a stand-alone procedure for a DHR. Make sure the procedure includes all of the requirements delineated within §820.184. Two – during a friendly visit from the agency, the investigator will get around to reviewing your organization’s DHRs. Make sure the DHR reflects that devices were manufactured in accordance with the DMR. Three – neatness and accuracy count so make sure your organization loses the whiteout and trains all employees to GDP.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- FDA – U.S. Food and Drug Administration Website. (2013, June). Warning letters. Retrieved June 30, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/