As many of the doctor’s long-time readers already know, Dr. D is not a big fan of receiving inspection; he that prefers robust proves validation over mindless inspection activities. Considering the significant amount of money that device establishments shell out each year for raw materials and other services, the onus really needs to be placed onto the backs of the suppliers. Yes, the quality, regulatory and statutory responsibility resides with the device manufacturer. However, the expectation is that procured materials and services always meet expectations (documented, of course). “Prove it” is a very simple two-word statement that can quickly make the most indurated (look-it-up) Chief Jailable Officers (CJO) in a device establishment cringe. When the FDA shows up in a device establishment’s lobby for that friendly cup of coffee and an inspection, their expectation is eloquently simple. Investigators expect device establishments to comply will all applicable elements of 21 CFR Part 820, the quality system regulation (QSR). The only way device establishments can prove compliance is with documented evidence (i.e., put it in writing and keep it). This includes acceptance activities. Device establishments must clearly define the requirements employed for acceptance activities, including receiving inspection. If the reliance for data is going to be placed with the supplier, the requirements need to be defined (in writing). Otherwise, the CJO of an offending establishment, can expect an agency Form 483 Observation. Rack up enough Form 483 Observations during an inspection and a prized agency warning letter may be in the offending establishment’s future. Enjoy!
Warning Letter – April 25, 2017
An observation extracted from a warning letter issued in April appears to be quite innocuous (look-it-up) on the surface. The investigator noted that product was being accepted without the benefit of documented evidence to support acceptance. Now granted, the observation did not note where the acceptance lapse occurred and considering how diverse acceptance activities can be, the focus of this week’s guidance will be on receiving inspection, one of Dr. D’s favorite activities, or not so much.
Warning Letter Excerpt
Observation Six (6) – “Failure to establish and maintain procedures for acceptance activities that include inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). For example, a review of acceptance testing performed at your facility revealed the following inconsistencies:
Material inspection reports for three components were reviewed during the inspection: (b)(4). These reports did not include required functional/ mechanical fit, dimensional and visual inspection test results. These components were accepted despite the missing information.”
21 CFR, Part 820.80 – Receiving, In-Process, & 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.
Compliance for Dummies
The QSR is eloquently vague in what the FDA is willing to accept as documented evidence when it comes to complying with §820.80(b). However, sitting through numerous inspections during the past 20 years, the doctor will share his wisdom into what he believes the agency is looking for in regards to compliance.
As previously mentioned, receiving acceptance is not one of the doctor’s favorite activities. Call it what you wish: (a) receiving inspection (RI), incoming inspection (II), or incoming quality assurance (IQA); supporting an effective receiving acceptance program can be expensive. The costs associated with hiring trained inspectors, purchasing inspection and test equipment (e.g., vision systems), calibration of the necessary measuring and monitoring equipment, and developing the inspection instructions quickly add up and equate to on word: Expensive. However, RI often becomes a necessary evil. That being said, some of the elements to consider when implementing an effective receiving acceptance program include:
- Written inspection instructions with clearly defined acceptance criteria
- Use of a qualified statistical sampling plan (100% inspection is simply insane and is not an effective long-term tool)
- A metrology program that ensures measuring and monitoring equipment retains its accuracy
- A supplied data program that allows the suppliers to have input into the data collected and provided (remember they are the experts in regard to the commodities they supply)
- A robust supplier corrective action program that hold the suppliers accountable
- A quarantine cage or cabinet that has limited access (locked with only QA having the key)
- A First Article Inspection (FAI) program that provides value to engineering and the establishment as a whole
- The analysis of data collected as part of the receiving acceptance program to gauge the effectiveness of receiving inspection activities and supplier performance (including data for management review and supplier report cards)
- A robust record access and retention program (the CJO and FDA will appreciate the effort).
For this week’s guidance the doctor will leave the readers with three takeaways. One: Make sure your supplier base has skin in the game. They are the experts in their respective commodities and can identify which key features require inspection and monitoring. Two: Make sure you hold your suppliers accountable. A robust supplier corrective action program is a necessary evil. Three: Make sure the incoming acceptance program is supported by data. If an inspection activity is not documented in writing. In the eyes of the FDA, it never happened. In closing, thank you again for joining Dr. D, and I hope 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.
- Code of Federal Regulation. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (April 2016). Title 21 Part 807: Establishment registration and device listing for manufacturers and initial importers of devices. 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. (April 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Unetixs Vascular, Inc. Accessed May 13, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm555115.htm