The doctor would like start this week’s Devine Guidance with a couple of questions. Can the readers point to Dr. D where the use of a Supplier Corrective Action Report (SCAR) is required within 21 CFR, Part 820 (the FDA’s Quality System Regulation)? How about within ISO 13485:2003? The doctor will provide the answers for the readers just in case some of you might have to look. The answer is “NO” to both questions; and “NO” Dr. D is not being “persnickety
Getting back to SCAR, device manufacturers really do need a vehicle for communicating and documenting supplier problems. Yes, the doctor said documenting. Why? Because if an action is not documented in writing, in the eyes of FDA (not one of the doctors favorite acronyms), the action never occurred; kind of like Bill Clinton smoking a joint but never inhaling. That being said, Dr. D hopes you enjoy this week’s guidance.
The doctor is just full of questions this week so here goes another one: Do all supplier non-conformances require a SCAR? The answer is a resounding ‘NO!” For example, if a supplier sends a Certificate of Conformance (C of C) containing a typographical error or an incorrect quantity, it is acceptable to call the supplier and ask that this issue be remedied ASAP (another great acronym). This is called effective communication. However, if the supplier makes the same error again, the correct path would be to SCAR (God the doctor loves this acronym) the supplier. Let’s talk about the SCAR process. Dr. D believes in having two categories of SCARs: (a) Information Only – no response required; and (b) Response Required. The doctor used to have a third category “Terminate Supplier with Extreme Prejudice.” However, after several months there were no suppliers remaining on the Approved Suppliers List (ASL – another good acronym); just kidding about the category folks. Seriously, if the problem is really benign, and more than a phone call is required, Dr. D recommends issuing an “Information Only Scar.” If the problem is more severe such as component dimensional issues, test failures, process steps missing (e.g., missing anodize), etc. then a “Response Required” SCAR is probably the correct path to pursue.
The next question coming from the inquisitive Dr. D is: “What is the appropriate time period for a supplier to respond to a SCAR?” The answer is it depends and not the adult diaper version. Typically, 30-days has always been an acceptable standard. However, if the supplier issue has resulted in Medical Device Reports (MDR’s – another valuable acronym) or even worse a product RECALL, Dr. D’s favorite six-letter word, then 5-working days is not an unreasonable request. The doctor’s best advice is to premise the required response time on the appropriate level of risk.
The next logical question pertains to evaluating a suppliers SCAR response. How should device manufacturers evaluate a suppliers SCAR response? For starters, if a supplier has failed to respond, the problem needs to be quickly elevated to the supplier’s management. If a supplier refuses to respond, then find a new supplier. There are too many good suppliers in this world to suffer through having a non-responsive or arrogant one. When evaluating a SCAR response the doctor looks for three things.
- What action has the supplier taken in regards to immediate containment?
- What action has the supplier taken rectify the problem and ensure acceptable product is manufactured and shipped?
- What action has the supplier taken to prevent future recurrences?
If the supplier has provided a reasonable response it all boils down to verification of effectiveness (VOE – another acronym for the readers). If the supplier issue is not an Earth-shattering problem, then accepting the suppliers VOE should suffice. Since Dr. D strongly believes in phrase made famous by Deming; “In God we trust all others bring data,” it is strongly recommended that a review of all SCAR VOEs be assessed during supplier audits. On another note, if a supplier is racking up SCARs, regardless of their responsiveness, it just might be time to qualify a new supplier. Finally, SCAR information should be included in supplier report cards.
For this edition of Devine Guidance
, the doctor will leave the readers with a few pearls of wisdom. It is imperative that medical device manufacturers have a tool for communicating supplier issues back to their suppliers. Yes, a phone call is probably alright for a minor issue; however, it is always better to have documentation. Why? You just don’t know when the Agency might show up on your doorstep for a cup of coffee and an inspection. The issuance of an “Information Only” versus a “Response Required” SCAR is really driven by risk. If a response is required from the supplier, make sure the supplier actually responds and the response is adequate.
In closing, the doctor hopes you have found some value in this week’s guidance. 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.