Can you say, “If an activity or event is not documented, in the eyes of the FDA it never happened?” Chief Jailable Officers (CJOs) from around the globe unanimously agree that documented evidence of compliance is their best friend during an agency inspection. Considering the documenting of inspection activities is usually a given in the medical device industry, failure to comply with §820.80 is a relatively rare event. However, occasionally investigators have the opportunity to bring this compliance issue to the forefront when they visit an establishment for a cup of coffee and an inspection. Dr. D strongly recommends that when a CJO finds him or herself sitting opposite of FDA at a conference room table and the CJO does not have the necessary documented evidence, be contrite and fall on the proverbial sword. It is better to acknowledge the compliance transgression and fix it versus becoming an iconoclast (look-it-up) and alienating the investigator. Enjoy!

Warning Letter – June 2, 2016

During the doctor’s weekly trip through recent warning letters, he was able to find one with 12 Form 483 observations, including an observation associated with the failure to maintain acceptance records. Considering acceptance activities are one of the fundamental elements associated with a quality management system (QMS), not having documented evidence of compliance with §820.80 is always going to end with a Form 483 observation. However, 12 Form 483 observations are almost always going to end with an eventual warning letter. Now granted, there is no magic number for what constitutes the agency’s threshold for warning letter issuance, double-digit Form 483 observations usually result in the issuance of the prized agency warning letter. Suitable for framing, the doctor would like to add.

Warning Letter Excerpt

Observation Eight (8) “Failure to adequately establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example, your firm did not maintain records to demonstrate that receiving, in-process or final acceptance activities were conducted on any of your devices manufactured through the inspection in October 2015 prior to their being released for distribution, including documentation that the device passed final testing.

We reviewed your response dated November 17, 2015 and cannot evaluate this aspect of the response because you did not provide supporting documentation. You stated you plan to initiate a corrective action to address this deficiency, and that you hired an outside consultant to assist you in developing appropriate acceptance activities, procedures and work instructions, but provided no further evidence of implementation of these corrective actions.”

21 CFR, Part 820.80 – 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.

Compliance for Dummies

For this week’s guidance, the compliance piece is simple. Since establishing procedures is a salient requirement, you can either script one high-level SOP for §820.80 compliance or you can script stand-alone SOPs for: (a) receiving acceptance, (b) in-process acceptance, and (c) final acceptance activities. Additionally, receiving inspection activities should encompass the collection of certification and applicable inspection and test data provided by the supplier. In fact, Dr. D strongly recommends that a stand-alone First Article Inspection (FAI) SOP be scripted. FAI is a valuable tool for assisting the R&D folks in product development and at the same time ensuring suppliers have the ability to manufacture your establishment’s products (components, subassemblies, materials, etc.).

Furthermore, in-process and final inspection activities should be well-documented in lot travelers (Shop Floor Paperwork or SFPW for you SAP fans). Manufacturing Process Instructions (MPIs) and Inspection Instructions (IIs) can be used to augment the performing and subsequent documentation of acceptance activities.

Finally, someone within the establishment has to own the product release responsibility as part of final acceptance. Hopefully, this individual is a member of the quality organization. The final acceptance activities must be clearly documented, and the name, date, and signature of the individual accepting the product for release shall be captured in the device history record (DHR). The final acceptance should include the review of the DHR, including product labeling. If product is being shipped to sterilization, the review of the sterility data (e.g., LAL testing) shall occur prior to product release.

Takeaways

For this week’s guidance, the doctor will provide just one takeaway. Documented evidence is always going to be your CJO’s best friend during an agency inspection. Please do not be that organization that throws your CJO under the proverbial bus because documented evidence of compliance does not exist. Remember, if an activity or event is not documented, in the eyes of the FDA it never happened. In closing, thank you again for joining Dr. D, and the doctor hopes you found value 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 2015). 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. (June 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. General Medical Company. Accessed July 11, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm508251.htm