The doctor hopes that all of the readers celebrating Thanksgiving (Dr. D’s favorite holiday) had a fabulous time with friends and family. While searching through the FDA’s Warning Letter Database, the doctor came upon a somewhat unusual warning letter issued to an establishment that manufactures tanning beds. Considering the growing number of skin cancers worldwide, it makes sense for FDA to provide regulatory oversight within the United States for devices that can potentially due great harm to skin cells. Dr. D realizes that the tanning fad and the use of tanning beds continues to grow at a rampant pace; and when used prudently, they provide a safer avenue for tanning than the great outdoors. However, the great outdoors is much more fun. For those unfortunate souls who develop skin-related carcinomas due to extended exposure to harmful UV rays, thank God for companies such as Sensus Healthcare and the state-of-the-art equipment (SRT-100’s) used for treating many types of skin cancers. However, regulation of the tanning bed industry is clearly one of the better options. Now, Dr. D has participated in far too many debates with clients and potential clients on what constitutes a medical device. Arguments such as it is only a tooth, dental tool, glove, stationary bike, treadmill, or the topic of this week’s guidance, a tanning bed will fall on deaf ears when dealing with our dear friends from the agency. If the FDA determines that a product is a medical device and assigns it an appropriate class, it is incumbent upon the owner of the regulatory filing (a.k.a. legal manufacturer) to comply with all applicable quality, regulatory and statutory requirements. Can you say establishing a quality management system (QMS)? No Chief Jailable Officer (CJO) wants to sit opposite of an investigator from the FDA and attempt to defend a deficient QMS or other offending practice. In fact, it is never fun to sit across from a pompous agency investigator bombinating (look-it-up) ceaselessly over potential Form 483 observations. Enjoy!

Warning Letter – October 25, 2017

The control of documents falls into Dr. D’s basic blocking and tackling category. Considering most device establishments understand the importance of document control, the doctor seldom sees document control compliance issues cited as a Form 483 observation. Additionally, when an establishment receives eight inspectional observations, bad things typically happen to the offending establishment. When one of the observations cited involves the violation of Part 806, bad things are definitely going to happen, unless the response to the observations scripted by the establishment rivals Rembrandt’s artistic ability.

Warning Letter Excerpt

Observation Three (3) “Failure to establish procedures for document control, as required by 21 CFR 820.40. For example,

A. Your firm has not implemented the requirements in your “DOCUMENT CONTROL PROCEDURE” (Q205-001, Rev 1, dated 03/10/2003) in that:

1. Your procedure requires maintenance of a Master Procedure and Form Log. You do not maintain this log.
2. There are different variations of your firm’s “Q.C. CHECK OFF LIST” for each tanning bed model/configuration and these documents are not identified with a “procedure number and revision level” as required by your procedure. Further, these documents include a “Revised on” date, which was identified as the date in which the document was printed and is not related to revision of the document.
3. A manufacturing procedure for your V3 160 Watt 230v tanning bed is an uncontrolled document.

B. Your firm has not implemented the requirements in your “DOCUMENT CHANGE REQUEST” procedure (Q305-003, Rev 0 dated 04/24/2000) in that:

1. Changes made to your “Q.C. CHECK OFF LIST” for the “Redacted Product Name” tanning bed on 07/27/2017 were not documented on a DCR record.
2. Changes made to your “Q.C. CHECK OFF LIST” for the “Redacted Product Name” on 10/26/2016 were not documented on a DCR record.

We have reviewed your firm’s response and we cannot determine the adequacy of your firm’s response because you have not provided your firm’s revised Document Control procedure Q205-001, Rev.2 for review. In addition, your firm has not identified complete and appropriate corrective actions to remedy the deficiencies identified during the inspection. This includes the disposition of uncontrolled procedures in use at your facility.”

21 CFR, Part 820.40 – Document Controls

“Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

(b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.”

Compliance for Dummies

The control of documents is the cornerstone of any QMS. Considering the plethora of document management systems such Master Control, CATSWeb, ETQ, Pilgrim, and a host of others, there should never be a good excuse for not having adequate tools in place to manage documents. Now granted, the software package selected needs to be appropriately validated for a device establishment’s application; and time needs to be invested in the scripting of a written procedure that complies with §820.40, and other applicable standards such as ISO 13485:2016, Clause 4.2.4.
From an agency perspective, the control of documents is really a simple process:

1. Documents must be reviewed and approved prior to their release (including date & signature)
2. Documents must be made available at their point of use (paper or electronic copies)
3. Obsolete documents need to be removed from use (ensure to retain obsolete documents as a record)
4. Changes to documents require a description of the change and formal review, approval, including signatures and dates (can you say DCO or ECO?)
5. State-of-the-art document management systems can effectively manage this entire process.

Remember, accuracy counts. It is imperative that only the latest and greatest documentation is released for use, at their point of use. As an establishment grows in size, the more problematic managing a paper-based system becomes, including the eventual migration to an electronic system. With an electronic system, everyone within the organization will have access to the same e-copy.

Finally, with an electronic system to manage documents, establishment team members that tend to procrastinate (you know who you are) will be bombarded with nasty grams until they complete their review of a document. Even better, their boss gets copied as well. A history of delinquent document approvals does not bode well when annual review time magically appears and the perennial procrastinator wants a raise. Ouch!

Takeaways

For this week’s guidance the doctor will leave the readers with just one takeaway. Regulations require that a device establishment exude a high level of control over their documents. It makes no difference if the system is paper or electronic; however, it is the doctor’s humble opinion, electronic systems should be considered as the preferred path. One final note, please do not forget to validate software used to manage the document control function. In closing, thank you again for joining Dr. D, and the doctor hopes you found value (and some humor) in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.

References

1. Code of Federal Regulation. (April 2017). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. (October 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. ProSun International, LLC. Accessed November 27, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm584155.htm