Dr. D has never been a big fan of receiving inspection. After all, device establishments pay a nice sum of money to their suppliers for procured product that meets specification. There are viable programs, such as “supplied data,” in which suppliers provide documented evidence through inspection, statistical, test, and/or product performance data to support product acceptance. Such activities reduce the inspection burden for device manufacturers; however, someone still has to sift through the data and reports to ensure procured product meets specification. Additionally, the higher the risk (product, patient, regulatory, statutory and/or business), the greater the emphasis needed to be placed on receiving acceptance activities. The doctor would really hate to be in the shoes of the Chief Jailable Officer (CJO) who is tasked with supporting the device establishment mentioned in this week’s guidance, after the ignominious (look-it-up) awarding of a prized agency warning letter—especially one that cites issues with receiving inspection. Enjoy!
Warning Letter – December 22, 2015
Now before you decide you want to tar and feather old Dr. D, the doctor is not completely against defensive receiving inspection, especially when a device establishment has no defense to prevent the potential introduction of non-conforming product into the supply chain. Unfortunately, if the receiving inspection methodology, including supplier specifications does not support design output requirements, “Houston, we have a problem!” If a device establishment feels the need to inspect, measure, test, pull, tear, or peel product during receiving inspection, the requirements darn-well better align with product requirements. What is the value of the product specification if a device establishment is going to ignore the intrinsic value of the document when creating a viable approach to inspection activities? In fact, if receiving inspection activities are suspect, are there potential issues with the supplier’s approach to inspection? If it is a finished device, does the contract manufacturer have a Device Master Record? Do the contract manufacturer’s material specifications align with the legal manufacturer’s product spec? These are great questions that need to be considered and hopefully answered before the first finished medical device is ever entered into commerce.
Warning Letter Excerpt
Observation Four: “Failure to adequately establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, the specifications contained in the supplier agreements for polypropylene and PTFE mesh components do not match design output requirements for characteristics that are critical for surgical meshes: mesh thickness, mesh weave characteristics, pore size, mesh density, tensile strength, device stiffness, suture pull-out strength, burst strength, and tear resistance.”
21 CFR, Part 820.80(b) – Receiving, In-process, and Finished Device Acceptance
(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.”
Compliance for Dummies
If you believe the FDA has a really burdensome approach to receiving acceptance activities, you would be mistaken or misinformed. In fact, it is Dr. D’s opinion that it is quite the opposite. All the FDA asks of device establishments is to develop a realistic approach to receiving inspection and document the results: Pass or fail. If the receiving inspection process is effective, the data will support the claims of effectiveness. As mentioned earlier in this week’s guidance, Dr. D is not a big fan of mindless inspection. However, sometimes it is a necessary evil. If a device establishment is inclined to implement receiving inspection, then some common sense, including some documentation and qualified personnel will be required.
Some of the documents and tools that FDA is going to expect to see during an inspection are:
- A high-level procedure that defines the receiving acceptance (inspection) process
- Inspection instructions for each inspection
- Validated test methods
- Inspection records documenting the results of each inspection (pass/fail)
- Calibrated measuring and monitoring equipment
- Adequate material controls to ensure product is not released into stock until inspection is completed
- Acceptance (or rejection) labeling to maintain inspection status
Not wanting to state the obvious but obliged to do so, device establishments will also need trained and qualified inspectors to support receiving inspection. Simply stated, the entire receiving inspection function can become expensive quickly, so it is imperative that device establishments plan wisely.
For this week’s guidance, the doctor will leave the readers with just one takeaway. If an establishment is hades-bent on pursuing receiving inspection, please do not make the same mistake as this week’s warning letter recipient. Take the time and ensure the inspection parameters employed in receiving inspection and materials procured by your contract manufacturer align with the design output requirements. If you have to ask why, well you just might be in the wrong industry. 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. (April 2015). 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. (December 22, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. ARB Medical, LLC. Accessed January 12, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480523.htm
I find the classification of this Warning Letter under receiving acceptance activities to be strange. The stared problem is that the design output is not correctly translated into the specifications in the supplier agreement. In other words, the firm is not purchasing the material the design team specified.
The linkage to receiving acceptance is not clear.
It would be interesting to know how the firm derived the receiving acceptance procedures, i.e., are they checking against the design output specs, the supplier agreement specs, or some other set of specs.
Dan, Great comments and thanks for reading DG. Be Well, Dr. D