Folks you simply cannot make this stuff up. While Dr. D was performing his weekly ritual of reading through recently issued agency warning letters, the doctor found an interesting one delineating a compliance issue associated with a product label referencing an outdated ANSI/AAMI, but wait there’s more! Not only did the agency take issue with the label, they rewarded “Simply Clean Air and Water” (great name by the way) with a warning letter that cited a failure to inspect purchased components upon receipt. In short, there was no Receiving Inspection (RI) being performed, not even basic identification and damage.
According to the warning letter, the procured components were placed directly into stock. Now granted, although Dr. D is an old quality guy, the doctor has no love for mindless RI. Yes, at times RI is a necessary evil; however, the doctor would never have thought clean air and water were dependent upon RI. Besides, living in California, the air is always bad, but I digress. Unfortunately for this device establishment, FDA disagreed with the doctor. There is no doubt this establishment is now faced with an “operose” (look-it-up) task of putting into place some inspection instructions and tools to support RI; however, a risk-based approach may ease the burden of compliance. Enjoy!
FDA Warning Letter – 18 August 2014
The warning letter in question essentially cited four Form 483 observations, with all of the observations linked by a common thread, inspection, or in the case of this offending organization, a lack of RI. The doctor has taken the liberty of extracting the warning letter citation specific to RI.i Please note, this establishment does not have inspection, test, or acceptance criteria for materials used in the manufacture of medical devices. Seriously, this type of performance will always result in bad things happening when the agency shows up for a cup of coffee and an inspection. Simply stated, Dr. D would not want to be in this Chief Jailable Officer’s (CJO) shoes when he or she has to sit across from the investigator and explain their organization’s approach to compliance with §820.80.
“2. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example, your firm does not have any inspection, test or acceptance criteria for materials used in the manufacture of your medical devices. We observed that incoming components are placed directly into inventory upon receipt.”
21 CFR, Part 820 §820.80 – Receiving, In-process, and 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
Although at times RI is often perceived as an expensive proposition and frequently viewed with disdain by the folks in operations, FDA thinks there is value in the inspection of procured materials for use in finished medical devices. However, there are ways for device establishments to lessen the burden. For example:
(a) employing ANSI sampling plans;
(c) supplied data (having your suppliers inspect and provide the measurement data); and
(d) aligning inspections premised on risk can significantly reduce the cost associated with RI, while improving the overall quality of a finished medical device.
Remember garbage in will equate to garbage out. Garbage out in the device industry will equate to a finished device’s failure to be safe and effective in its intended use and that is a bad thing. Can you say recall (Dr. D’s favorite 6-letter word)? If your organization has a RI group or is contemplating on adding RI capability, remember that the foundation of RI begins with:
- Quality mechanical inspectors that are properly trained;
- Adequate support from the engineers;
- A strong working relationship with the procurement folks;
- Suitable measuring and monitoring equipment;
- Well written procedures, including one for dispositioning nonconforming material; and
- Quality suppliers (if your suppliers are shipping garbage the doctor thinks it is time to find new ones).
Additionally, it is imperative to keep meticulous inspection records, including proper lot traceability. If an organization fails to keep proper traceability, it becomes a daunting task in deed to ascertain how many medical devices need to be recalled if a specific component results in medical device failures. Trust Dr. D when he says device recalls are expensive.
Furthermore, performing basic ID and damage is actually a viable approach for low-risk components. ID and damage is quite suitable for material procured as Commercial-off-the-Shelf (COTS) from distributors. Expendable floor stock items such as razor blades, Q-tips, wipes, etc. do not typically require any inspection and are suitable candidates for immediate placement into stock. Moreover, there is no requirement to perform 100 percent inspection on everything a device establishment procures. Please use some common sense and apply a risk-based approach. For example, if the material composition for a catheter marker band is deemed critical, it is prudent to ask your suppliers for chemical and physical analysis reports. If a machined component or an injection-molded part has critical features, you are going to want to ensure these features are verified through inspection, either by your RI group or by your supplier (with documented evidence of inspection to your requirements).
Finally, it really is about the documentation. For example, it is imperative that device establishments give their suppliers written purchase orders, released specifications (including inspection and test), and all of the relevant information necessary for the supplier to successfully manufacture materials to be used in your finished medical devices. Dr. D strongly suggests that a supplier quality agreement be part of the supplier contracting process.
Folks, FDA views inspection, test, and acceptance testing as extremely salient requirements for device establishments to comply. That being said, the doctor will leave the readers with just one takeaway from this week’s guidance. The QSR does not dictate how to execute a RI program. It only stipulates that purchased materials must be assessed for their suitability to be used in the manufacture of medical devices that are safe and effective in their intended use. It is up to the establishment to define their approach to RI; however, the program better be constructed in a manner in which the CJO can defend it during an inspection, without laughing hysterically. After all, warning letters are no joke!
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. (2013, 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. (2014, August). FDA.gov Website. Retrieved August 26, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410467.htm