Now don’t laugh, but seriously, as an old quality guy Dr. D really does not see much upside in the value of RI. In fact, considering device manufacturers are spending good money for their raw materials, the expectation should be that suppliers produce good products all of the time. Unfortunately, that type of quality utopia still does not exist, as Mr. Murphy is alive and well and living at a supplier near you. Before the doctor jumps into this week’s guidance, the Dr. D recalls fondly a comment made by Kim Trautman, the FDA’s foremost Quality System Regulation expert. According to Trautman; “Suppliers providing defective products are directly related to an increase in medical device recalls (The Sheet – Medical Device Quality Control – May 2007). The burgeoning (look-it-up) costs associated with playing in the medical device sandbox, continues to escalate. As a result, RI is becoming a less and less attractive alternative; however, if the quality of a supplier is less than stellar, RI becomes a necessary evil. Enjoy this week’s guidance.
Failure to inspect, test, or otherwise verify that incoming product conforms to specified requirements, as required by 21 CFR 820.80(b). Specifically, incoming lots of latex tips were not properly inspected, tested, or verified to ensure that they conformed to specified requirements. For example;
a. Latex tip lot 25071 was accepted for use in production on August 22, 2011 despite having more defects than the documented reject level size. The “Latex Tips: Acceptance Testing Worksheet” for lot 25071 documents a total of nine defects and your reject level size was identified as (b)(4).
b. Test results for incoming acceptance of latex tips are not routinely documented. Test results for (b)(4) observed to be missing for lots PJL12/25343 and 25377/POC12.
We reviewed your firm’s response and conclude that it is not adequate. Specific test results need to be recorded. Placing an “x” mark only if the test is not within limits is not acceptable. Proper disposition of material not meeting pre-determined specifications cannot be determined at this time and will need to be verified during a subsequent inspection.
Sampling and Reduced InspectionFirst off, if you must inspect your organization’s purchased product, the doctor suggests at least employing a sampling plan (recommend C=0) to reduce the inspection burden. Additionally, Dr. D recommends identifying all of the dimensions/features on the specification as:
- <C> – Critical, e.g., AQL 0.40;
- <M> Major, e.g., AQL 1.0;
- <m> Minor, e.g., AQL 4.0; and
- <A> Audit, e.g., one piece.If the quality being received from your supplier is good, the sampling plan can be loosened. If the quality from you supplier is not so good, you can tighten the sampling, while you begin the search for a new supplier. If the quality is excellent, you may want to consider skip-lot-inspection.Supplied Data ProgramAn even better approach to RI is to have your suppliers perform the inspection and provide the statistical data for your review. A program that many organizations call supplied data is premised on a signed agreement between the procuring organization and their supplier. The agreement identifies the features to be inspected, the sampling plan, and the acceptable CpK. For example, the OD for a hypo-tube may be specified at 0.50” +/- 0.01; with a sample size of n=30; and a minimum CpK of 1.33. Statistical data associated with this dimension would be provided with the shipment. Upon receipt, RI personnel will quickly verify the data and move the parts into stock. However, it is strongly recommended that lots be stopped once or twice a year just to keep the suppliers honest, remember Mr. Murphy is alive and well. Since the suppliers are the product experts, they can help you identify the features that require monitoring to ensure compliance with your specification. Typically, two or three dimensions are all that will be required.First Article InspectionOne of the values Dr. D does see in RI is First Article Inspection (FAI). Performing FAI provides significant value especially in support of product development. An effective approach to FAI can assist the R & D engineers in developing and qualifying components and materials, that when they are assembled into a finished medical device, will be safe and effective in their intended use. Dr. D strongly recommends that all suppliers of custom components and product be required to pass an FAI before shipping production parts. In fact, FAI should be performed prior to placing a supplier into a supplied data program.Source InspectionFinally, if your organization is struggling with the quality of product coming from critical suppliers, source inspection may be an option, although a rather expensive one. If a high-dollar-value product is continuing to be inspected, rejected and returned to the supplier, then source inspection can be used to break the cycle, while sending a strong message to the supplier that they inhale greatly (a.k.a., they suck).
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.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.