“Failure to define the type and extent of control to be exercised over suppliers, as required by 21 CFR 820.50(a)(2). Specifically, Your Purchasing Process and Supplier Evaluation Process Map (7.4.1) is ambiguous on how you will monitor your suppliers. Your process map lists the “input” for monitoring trends of performance as identifying performance parameters for suppliers. These parameters are not defined. Additionally, your firm has no quality data records to show that suppliers are being monitored.”
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.”
(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
- 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.
- Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
- Establish and maintain records of acceptable suppliers, contractors, and consultants.
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.
- FDA – U.S. Food and Drug Administration Website. (2013, June). Warning letters. Retrieved July 27, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/