Dr. D has never been a big proponent of defensive receiving inspection, a.k.a. RI. In fact, Dr. D’s doctoral dissertation was premised on gaging the effectiveness of RI for medical device manufacturers. Now granted, just because Dr. D sees limited value in RI, FDA has made it a requirement as part of 21 CFR, Part 820. Therefore, device establishments are required to perform it; albeit how RI activities are performed is up to each device establishment to decide. The “vox populi” (look-it-up) on defensive receiving inspection performed in the device industry is that RI provides limited value, while being expensive. Enjoy!
Warning Letter – 04 February 2015
It seems to be just too-darn easy for the doctor to scan through the FDA’s warning letter database, on a weekly basis, and find candidates appropriate for Dr. D’s weekly column. Device establishments routinely receive Form 483 observations during their inspections. It is no big deal. Responsive establishments with experienced Chief Jailable Officers (CJO) can quickly respond to FDA (with an appropriate response) while pursuing mitigation activities needed to correct the Form 483 observations. However, some establishments just don’t get it! It is the doctor’s humble opinion; when a warning letter is issued and the body of the letter contains multiple “we have reviewed your response and have concluded that it is inadequate” responses; Houston we have a problem. As alluded to in the title of this week’s guidance, Dr. D will briefly explore RI for this week. It is not too-terribly often that Dr. D reads about RI being an issue with a device establishment. Performing RI essentially falls into the category of basic blocking and tackling. Most device establishments, at some level, just do it (thank you Nike)! Unfortunately, the object of this week’s Devine Guidance failed to just do it!
Warning Letter Excerpt
Observation Seven (7) “Failure to establish and maintain procedures for acceptance of incoming product. [21 CFR 820.80(b)] For example:
- There is no statistical rationale for measuring only one serum vial per lot at incoming inspection for serum vials (List #4050), for which the length of the thread overlap was determined to be significant in preventing oxygen contamination of bilirubin. Lot sizes received in 2012 through 2014 range from 791 to 6000 vials.
- Neither of your two written SOPs for raw material receiving or raw material packaging test parameters specifies the quantities to test at incoming inspection.
- If a vial fails any one of the five specifications for raw materials packaging test parameters, another vial is tested; the failed test is not documented.
We have reviewed your response and have concluded that it is inadequate. Please provide documentation to verify when the CAPAs have been completed. A follow up inspection will be required to assure that corrections are adequate.”
Subpart H – Acceptance Activities
Section 820.180 Receiving, In-process, and Finished Device Acceptance Note: Sections a and b only (sections c & d purposely omitted) (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
Make no mistake; facilitating a RI department can quickly become an expensive proposition. Adding a vision system, mechanical inspection tools, a reasonably-sized surface plate, and hiring/training competent mechanical inspectors is not cheap. However, device establishments can mitigate some of the costs associated with RI by implementing some pretty basic inspection concepts. Let Dr. D begin by stating; “Whatever happens in RI stays in RI” (just kidding). Regardless of how a device establishment scales the RI function, written procedures are the order of the day. It is not enough to have purchase orders and component specifications. Procedures are needed for the testing and inspection of components. Now granted, qualified mechanical inspectors are not going to need procedures on how to employ micrometers, calipers, gage blocks, dial indicators, etc. However, the inspection instructions should contain a reference to the measuring/inspection tool(s) to be used and the sample size(s) employed (hint: link sample size back to risk.
As previously stated, RI can quickly become expensive so Dr. D recommends that some of the following tools be considered.
- Always employ sampling plans that are realistic and qualified (including rational as to why the sampling plan is appropriate). Do not be afraid to reduce, or if deemed necessary, to increase the sample size premised on each supplier’s performance, for each individual component being inspected.
- The doctor is a big fan of supplied data coming from the supplier. Considering how much money device establishments spend on qualifying each supplier and the actual money spent on procuring components; it is a reasonable expectation that suppliers ship acceptable product. That being said; let the suppliers shoulder the inspection burden. Device establishments and their suppliers should be able to agree on what component characteristics are critical and what sample sizes are reasonable. Once this information has been determined, the supplier can inspect, collect, and provide this data with each shipment. The device establishment can quickly review the data provided and if the data is acceptable, place the received materials into stock.
- If a supplier has an outstanding history for quality; then skip-lot inspection may be considered. However, the device establishment needs to ensure rock-solid rational is placed into the RI file.
- Finally, one of the real values of RI that Dr. D recognizes is First Article Inspection (FAI). If more device establishments pursued an effective approach to FAI, the rejection rate at RI could be quickly reduced. The one question Dr. D likes to ask during audits is: “How can your establishment ensure you will be able to purchase qualified components from your supplier base if you have not performed a FAI on the component being procured?” Note: an FAI is not just one piece or one lot it is multiple lots. The doctor prefers at least three lots be included in the FAI process.
For this week’s guidance, Dr. D will leave the readers with three takeaways. One – yes, RI is an expensive proposition; however in accordance with §820.180(b) FDA has made it a requirement. Two – make sure adequate procedures have been scripted to support individual component inspections (e.g., inspection instructions). Three – consider employing tools that reduce the inspection burden: (a) qualified sampling plans; (b) supplied data; and (c) skip lot inspection.
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. (2014, April) 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’s enforcement page. (2015, February). FDA.gov Website. Retrieved March1, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433248.htm.