For those readers that frequently visit Dr. D’s column, you already know that for an old quality guy, the doctor has a fond dislike for mindless inspection, especially receiving inspection. My dear readers, your establishments pay damn good money for the materials and services that are procured in support of manufacturing finished devices that are safe and effective in their intended use. The expectation is that when materials reach the receiving dock, they are fit for use. Unfortunately, that level of QA utopia (quality nirvana) has yet to be reached, so sometimes, receiving inspection becomes a necessary defense. Many, many moons ago, the doctor spent a year reading through piles of inspection data in support of attempting to determine the effectiveness of defensive receiving inspection as a viable tool for the device industry. In fact, a significant portion of Dr. D’s doctoral dissertation explored the effectiveness of receiving inspection and in many cases the lack thereof. However, regardless of the doctor’s strong opinion on the topic of receiving inspection, our dear friends from the agency expect device establishments to develop appropriate tools for performing receiving acceptance activities. Failure to do so is Form 483 observation worthy. It is a very uncomfortable position indeed for any Chief Jailable Officer (CJO) to sit across from an investigator from the FDA and attempt to defend not having a robust procedure or set of inspection instructions to ensure procured materials and services meet specifications and/or contract requirements. In fact, receiving several Form 483 observations at the end of an inspection is clearly not going to have a “salubrious” (look-it-up) effect on the CJO suddenly tasked with mitigating the observations. Enjoy!
Warning Letter – 21 August 2017
For those readers that perused through Dr. D’s column in last week’s edition of MedTech Intelligence, there was sufficient material in the warning letter used in last week’s Devine Guidance (DG) to recycle it and use it again. Unlike Dr. D, our dear friends from FDA actually enjoy dabbling in an establishment’s inspection records. Heck, that’s what they get paid to do. For starters, what is the purpose of performing Receiving Inspection (RI) if the procedures are not going to be followed? If the RI instructions are not accurate, they need to be revised to accurately reflect current practices. That does not mean opening up a specification so far that everything passes. Seriously, if an establishment is going to rely on RI, then the procedures and tools employed need to adequately reflect the inspection process. Simply stated, the inspection needs to add some value; otherwise, what’s the point? If an establishment is relying on RI and the establishment fails to perform RI in accordance with established procedures, rest assured a Form 483 observation will be issued during an inspection. Receive a significant number of inspectional observations and a warning letter is in an offending establishment’s future. The CJO does not need to be clairvoyant to see the can of regulatory whoop-ass the agency is about to unleash.
Warning Letter Excerpt
Observation Four (4) “Failure to adequately establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example:
A. “Quality Assurance Procedure for Receiving and Handling of Chemicals Used in Manufacturing – Chemical Constituent Test Limits” (PS410) is not followed in that the analysis required and/or test limits are not met for multiple chemicals. The “Raw Material Number Procedure” (SP1038) and associated form that describes the requirements to be met often differs from the PS410 procedural requirement. This form is utilized by personnel receiving and accepting materials. See below for examples of the discrepancies described above and noted during the inspection.
B. Procedure PS410 lacks specifications for the water for injection used to manufacture “Redacted Name” and “Redacted Name” organ transplant preservation solutions.”
“We reviewed your firm’s response and find it inadequate”
21 CFR, Part 820. 80 – 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
RI can be a rather expensive proposition, depending on the type of inspection being performed. If the RI process is mechanical inspection laden, then a competent mechanical inspector is needed; and good ones are very hard to find. Additionally, building a state-of-the-art mechanical inspection tool set (including the calibration program) can get expensive quickly. The price begins to sky-rocket once smart scopes and coordinate measurement machines (CMM) come into the picture. Furthermore, the entire inspection process has to be documented by written procedures.
So what does the agency expect to see during one of their friendly visits for a cup of coffee and an inspection? As the doctor has already touched on in this article, procedures are always going to be a consistent theme. Written procedures, inspection instructions, data collection forms are clearly necessary. Additional requirements for an effective RI program to be considered include:
- Test method validation (TMV) – the inspection modalities applied are expected to be validated;
- First Article Inspection (FAI) – when performed correctly, is a valuable tool for the engineers and suppliers (inspection correlation);
- A robust approach to sampling (it’s not enough to just state C=0 is used, options for increased sampling or reduced sampling should be stated in a procedure);
- Gage R & R Studies (repeatable and reproducible results are mission critical for an RI program);
- Reduced inspection programs such as skip-lot inspection can be employed for low risk components;
- Supplier Corrective Action Requests (SCARs) are a necessary evil to ensure the supplier base corrects issues that result in nonconforming product;
- Supplied Data Programs that rely on the supplier providing statistical data to support claims of compliance with specifications;
- Ship-to-Stock programs for low-risk products being supplied by qualified suppliers; and last but definitely not least
- Accurate data (being close only counts when tossing a hand-grenade).
Furthermore, supplier partnerships are mission-critical relationships that really do need to be nurtured, not unlike a marriage. A marriage to a bad supplier can quickly elevate the costs associated with an RI program as the costs, due to massive amounts of inspection, begin to escalate. If an establishment is spending more time generating nonconforming material reports and SCARs versus performing RI activities, it’s time to reach out to new suppliers and change things up a bit. Sometimes one just has to stop cutting bait and realize it’s time to go fishing.
Finally, and as mentioned in the last bullet point, accuracy counts. If the procedures and inspection instructions being used in RI are not being adhered to, then Houston, we have a problem. Dr. D guarantees that if FDA dives into RI and the process is broken, they are going to quickly identify the issues and reward the offending establishment with a Form 483 Observation. It is nothing personal, it is just business.
For this week’s DG, the doctor will leave the readers with three takeaways. One – accuracy counts! If an establishment is going to pursue an effective RI program, do it right the first time. A half-ass approach will always result in a half-ass outcome or in this industry a potential compliance disaster. Two – accuracy counts (yes, Dr. D is repeating himself)! Please ensure the written procedures, written inspection instructions, and inspection tools employed are actually capable of obtaining an acceptable inspection result. Three – accuracy counts! Use all of the tools at your disposal such as FAI, supplied data, SCARs, etc. to drive an effective RI program. In closing, thank you again for joining Dr. D; and the doctor hopes 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. (2017, 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. (2017, September). FDA.gov Website. Retrieved October 06, 2017,