Surprise – Device Establishments are Required to Pursue Acceptance Activities –Who Knew?
Folks Dr. D knows he is preaching to the proverbial choir when he climbs onto the pulpit and begin to pontificate about the importance of acceptance activities and inspection in the device industry. Now although the doctor is an old quality guy growing long in the tooth, Dr. D does not believe in mindless inspection. A common sense approach to acceptance activities, supported by documented evidence, is a Chief Jailable Officer’s (CJO) best friend during a friendly visit from FDA. However, Dr. D often wonders about how the “esurient” (look-it-up) tendencies of some device establishments prevent these organizations from doing the right thing, like establishing a cohesive Quality Management System (QMS) that complies with the FDA’s Quality System Regulation. In this week’s guidance, the doctor will dive into the tepid waters associated with acceptance activities (or lack of). Enjoy.
Warning letter – 27 August 2014
This week’s device establishment earning the FDA’s coveted warning letter award, failed to recognize the importance of actually recording the results of inspection activities. Seriously, everyone in industry knows that if an activity or event is not documented in writing, in the eyes of the agency, it never happened. Besides, as Hilary Clinton likes to say, “What difference does it make!” People, the difference between not documenting and documenting acceptance activities is that not documenting acceptance activities will result in an FDA warning letter and documenting acceptance activities will not. The doctor thinks that this is a significant difference. To make matters worse, fail to provide FDA with an adequate Form 483 response and you might as well just go out and find a bear and poke it in the eye with a sharp stick. Simply stated, this warning letter recipient is about to feel a new level of regulatory pain.
Warning Letter Excerpt – Observation 6
“Failure to document and maintain acceptance activities as part of the device history record [21 CFR 820.80(e)]. Your firm failed to document all inspections, tests, or other verification activities associated with receiving, in-process, and final acceptance for the dental operative units and chairs you manufacture. We have reviewed your response and have concluded it is inadequate because no information was provided for review. No procedure or records were provided to verify required data is actually determined and established.”
21 CFR, Part 820 – Receiving, In-Process, and Finished Device Acceptance
(a) General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.
(b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.
(c) In-process acceptance activities. Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.
(d) Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:
- The activities required in the DMR are completed;
- The associated data and documentation is reviewed;
- The release is authorized by the signature of a designated individual(s); and
- The authorization is dated.
(e) Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:
- The acceptance activities performed;
- The date(s) acceptance activities are performed;
- The results;
- The signature of the individual(s) conducting the acceptance activities; and
- Where appropriate the equipment used. These records shall be part of the DHR.
Compliance for Dummies
In §820.80, the phrase “shall establish” is depicted four (4) times and the phrase “shall document’ is depicted once. So the doctor struggles with device establishments failing to understand a specific requirement in the QSR, especially when the requirement is well-documented. For those of you that do not know the meaning of “establish” in FDA speak; in accordance with §820.3(k) it means to define, document (in writing or electronically), and implement. This definition is pretty clear to Dr. D. That being said, there are multiple approached to scripting an acceptance activities procedure. One – individual procedures can be scripted for receiving, in-process, and final inspection, with subsidiary procedures for the actual performance of acceptance activities, i.e., incoming inspection procedures, in-process inspection procedures built into:
- Manufacturing Process Instructions (MPIs);
- Assembly Instructions (AIs);
- Work Instructions (WIs);
- Inspection Instructions (IIs); and documented using
- Production Travelers.
The beauty of all of this is the approach to inspection is left entirely up to the device establishment; however, the approach better be: (a) documented by procedure, (b) supported by inspection records; and (c) most important—defendable to the FDA during an inspection. Make sure you link risk to the inspection process, e.g., risk-based inspection). Two – device establishments can script one high level acceptance activities SOP that captures receiving, in-process and final inspection activities from 50,000 feet and still support the approach with subsidiary procedures. As long as a robust procedure exists, covering all elements of the QSR, and documented evidence collected, proving compliance will be a simple task with FDA arrives at your doorstep for a cup of coffee and an inspection.
Finally, do not forget about the Device History Record (DHR). The DHR will contain all of the results of inspection/acceptance activities and will be need to support compliance that the device was manufactured in accordance with the Device Master Record (DMR). Note: this week’s warning letter recipient also failed to maintain DHRs in accordance with §820.184 and failed to establish DMRs in accordance with §820. 181. How in the heck can a device establishment determine if the manufactured to correct device, if the DMR is incomplete, contains errors, or has never been created? Considering the issues with the DMR, I am surprised the agency did not cite design controls (§820.30) as a Form 483 observation, but the doctor digresses.
Takeaways
For this week’s guidance, there are so many issues associated with the failure to establish procedures for acceptance activities, the failure to collect documented evidence of acceptance activities, DHR issues, and DMR issues, the doctor could leave a page full of takeaways. However, the doctor will leave just one. Establish, establish, establish, and establish. The doctor strongly recommends repeating the word establish; continuously, until the full weight of this word’s meaning is clearly understood. Every requirement in the QSR that states “shall establish” requires a written procedure, PERIOD! This is not rocket science folks. Every requirement in the QSR that states “shall document” requires the collection and retaining of objective evidence to support compliance, PERIOD! 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.
References:
- Code of Federal Regulation. (2013, 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.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA’s enforcement page. (2014, September). FDA.gov Website. Retrieved September 20, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/.
Related Articles
-
The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance,…
-
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
-
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap."
-
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers…
