The reason the doctor is writing about “failure to define” is that Dr. D came across an interesting warning letter this week.  One of the Form 483 Observations noted in a warning letter date 03 July 2013 stated:

Now as many of the readers already know, Dr. D loves to pontificate about regulatory compliance and the need to have documented evidence to support claims of compliance. In fact, Dr. D’s rants on compliance have often been equated to an “irascible” (look-it-up) old guy. But hey, the doctor is just attempting to keep the readers out of FDA Purgatory. Enjoy.

If you decide to pick-up a copy of the QSR or access a copy through www.fda.gov, you just might stumble across the frequent use of the phrase “shall establish.” Shall establish means you had better start pecking away on your computer key board as written procedures are required. If the requirement is not defined in a written procedure, then the device manufacturer can expect to receive a Form 483 observation that commences with the phrase “failure to define.”

Now if you want to complicate the issue of compliance, do not bother to collect records (a.k.a. documented evidence) to support claims of compliance. One of Dr. D’s favorite quotes is; “If an event or activity is not documented in writing, in the eyes of FDA, it never happened.” As you can quickly ascertain from the warning letter excerpt in the previous section, this device manufacture not only failed to define but failed to have quality data records. The real travesty is that supplier quality should be one of the easier QSR requirements to achieve compliance. The doctor has taken the liberty to cut and paste the requirement. So why does Dr. D think this requirement is a proverbial cakewalk? Simply stated, create a reasonably coherent procedure, execute to the procedure’s content, and keep records to support claims of compliance. Remember, nowhere in §820.50 does it state device manufacturers must spend mega bucks performing on-site audits of suppliers. Establish a system and procedure that is effective for your organization and collect records that reflect compliance. You never want to be the firm that “fails to define or fails to have quality data records.”

Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

1. Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
2. Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
3. Establish and maintain records of acceptable suppliers, contractors, and consultants.

For this edition of Devine Guidance, the doctor will leave the readers with two takeaways. One – if the QSR states “Shall Establish” that means FDA is expecting a written procedure. Two – without quality records, there is no chance in Hades of convincing an FDA inspector of compliance during a friendly FDA 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.

References: 

1. Code of Federal Regulation. (2013, 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. FDA – U.S. Food and Drug Administration Website. (2013, June). Warning letters. Retrieved July 27, 2013, from           http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/