As promised, Dr. D is going reload the cannons with additional fodder for this week’s guidance by revisiting the warning letter issued in late October to a device establishment that just didn’t understand the basic concept of complying with FDA’s Quality System Regulation (QSR).

As mentioned in the previous edition of Devine Guidance, the establishment received eight Form 483 Observations pertaining to their inept approach to quality. In fact, the agency threw much of their quality management system (QMS) under the big bus. It is the doctor’s opinion that a “recusant” (look-it-up) attitude when dealing with a regulatory body is always going to end badly for a device manufacturer. However, with FDA the regulatory pain is just beginning.

As many of you know, Dr. D is not a big fan of mindless receiving inspection. Device establishments pay significant dollars to their supplier base in exchange for components, materials, and services, needed to manufacture finished medical devices that are safe and effective in their intended use. The expectation is that all procured materials and/or finished devices, if an establishment is using a contract manufacturer, meet all purchase order requirements and applicable specifications. However, the medical device industry is not a perfect world. If it were truly a Utopian industry, there would be no need for regulations and of course, FDA. Enjoy!

Warning Letter – 28 October 2014

Folks, as the doctor mentioned in the introduction to this week’s guidance, there is so much cannon fodder surrounding this week’s offending establishment, a second visit to their warning letter was warranted. Dr. D is completely floored as to how a device manufacturer can have no, none, zero, zilch, nada, etc. records of receiving inspection activities. Seriously, the agency does not require device establishments to perform 100 percent inspection on everything procured; however, the QSR requires some level of inspection to occur to ensure acceptable materials are received and used in the manufacture of finished medical devices.

Warning Letter Excerpt

Observation Six: “Failure to establish procedures for acceptance or rejection of incoming products, and failure to maintain documentation of acceptance or rejection of incoming materials, as required by 21 CFR 820.80(b). For example, your firm receives components such as PCBs, cable assembly/power unit, and custom pads. 21 CFR 820.80(b) requires incoming product to be inspected, tested, or otherwise verified as conforming to specified requirements; however, your firm had no documentation of any inspections, tests, or other verification to demonstrate that all component shipments met their specified requirements.

Subpart H – Acceptance Activities

Section 820.80 – (a) General & (b) Receiving Acceptance Activities

“(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.”

Compliance for Dummies

For those of you that are not familiar with Dr. D’s bio, the doctor spent a few years in his doctoral program, with two years spent working on his dissertation (Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study). As previously mentioned, the doctor is not a big fan of mindless inspection, especially receiving inspection (RI). However, Dr. D is big on compliance. When it comes to defining an approach to receiving inspection, FDA does not require an overly burdensome approach. In fact, FDA only requires written procedures and inspection records needed to support documented evidence of compliance. If your organization’s approach to RI is material identification and damage, a.k.a., “ID & Damage” and the collection of certification; as long as the methodology for RI is defined in a procedure and the process is effective for the organization, then it is probably going to be acceptable with our friends at the agency. However, no established procedure, no evidence of inspection, and no inspection records; guess what happens? If your answer is an angry investigator and a subsequent warning letter, your answer would be correct.

The best advice Dr. D can offer when it comes to RI is make the approach risk-based. For example, there should be a direct correlation between product and user risk back to critical components. People; remember not every component is going to be critical. You decide. For example, the tip of an electrophysiological ablation catheter is critical for the transfer of energy needed for cardiac ablation. That means some level of inspection is probably going to be warranted, i.e., critical dimensions, material certs, etc. You just might want to treat the tip as a critical component and be done with it. Now just because it is now a critical component; that does not mean 100 percent inspection of every component in every single lot is required. That is why sampling plans are used. Can you say C=0 sampling plan (ANSI/ASQ Z1.4)? Conversely, if your organization is procuring commercial-of-the-shelf (COTS) material from a distributor, simple ID & Damage is probably going to be acceptable. For example, machine screws, discrete components such as resistors, etc., are not going to require a whole lot of inspection. The good news is, you decide!

Not wanting to over simplify the RI process, the doctor is going to provide you with a list of some other inspection goodies, you may want to make sure that:

• All of the drawings and specifications placed in use in RI are released and/or controlled;
• Inspection instructions are created for the material being inspected. It is an acceptable approach to place similar material, with similar requirements into the same inspection instruction;
• An inspection instruction record is created for all material lots being inspected. This is your documented evidence of compliance; and your Chief Jailable Officer (CJO) will thank you;
• All material passing into and out of RI is appropriately identified, e.g., green acceptance labels, receiving travelers, and when necessary non-conforming material labels (hopefully bright red);
• All material identified as nonconforming in RI is quickly identified as such and placed into a secure quarantine location;
• All inspection personnel have been properly trained and the training documented;
• Adequate inspection equipment and tools are available in RI and the inspection equipment and tools are calibrated as appropriate;
• RI takes an active role in the performing of First Article Inspections (FAIs). A well-executed FAI is of immense value to R & D during the design and development phase for new products or when the qualification of new suppliers is warranted;
• All of the data collected as part of the RI function is collected and used to track supplier performance. In fact, issuing supplier report cards (at least quarterly) is always a nice touch; and
• When in doubt, contact Dr. D for some Devine Guidance.

Takeaways

For this week’s guidance, the doctor will leave the readers with just two takeaways:

1. Unfortunately establishing a procedure for RI and actually performing inspection on procured materials is not optional. This includes collecting the results of inspections as documented evidence of compliance.
2. FDA has given device establishments a gift in regard to the vagueness of the RI requirement. It is up to each device establishment to decide how much RI is required. However, at the end of the day the approach for RI must be defendable during an agency inspection. Remember, when in doubt, the approach to RI should be risk-based.

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:

1. Code of Federal Regulation. (2014, April) 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’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm.