One of the frequent lapses Dr. D sees when assessing quality management systems (QMS) is either a failure of an establishment to actively pursue corrective action with their suppliers or a failure to follow-up with suppliers when supplier corrective action requests (SCAR) are issued to suppliers. Coincidentally, the doctor loves the acronym SCAR and the connotations around the pain induced by the issuance of SCARs. As is the case of this week’s guidance, the agency agrees. In fact, they introduced some scarring of their own when they visited a device establishment last June in New York. This particular visit resulted in several Form 483 observations and the eventual issuance of a prized agency warning letter. One of the observations noted in the warning letter was an ineffective SCAR process. In the age of outsourcing, the agency expects establishments to provide substantial supplier oversight. The ability to manage an establishment’s supplier base, while ensuring corrective action performed by suppliers is robust and effective must be considered a mission-critical activity. After all, a device establishment cannot outsource their quality, regulatory and statutory responsibilities. If an establishment’s name is on the label and they own the regulatory filing, they own the responsibility. Simply stated, if it walks like a duck and quacks like a duck, it’s a duck: Quack, quack, quack. Unfortunately for the Chief Jailable Officer (CJO) of this week’s offending establishment, blessed with the opportunity to sit across from the FDA investigator during a visit for a cup of coffee and an inspection, things did not go well. Hopefully, the CJO was not too somnolent (look-it-up) during the inspection, as FDA investigators have ways of quickly garnering one’s undivided attention. It’s called a wake-up call. Additionally, when the establishment’s responses to Form 483 observations were deemed to be “not adequate”, bad things happen quickly. Can you say warning letter? Enjoy!

Warning Letter –February 26, 2016

One of the driving forces behind the issuance of an agency warning letter, unless an establishment is totally screwed up, is the inability to respond to Form 483 observations. Dr. D believes that most warning letters can be prevented with a robust response to inspectional observations noted during an inspection. The key is to formulate a response that is clear, concise, and addresses the following elements: (a) containment, (b) corrective action plan (including root-cause investigation process), (c) proposed mitigation activities to preclude a recurrence of the violative behavior, and (d) verification of effectiveness (VOE). Please note, the best practice is to load each inspection observation into a stand-alone CAPA. Anything less and the CJO might as well find a cave and poke a sleeping bear in the eye with a sharp stick. In either case—ticking of the FDA or making a bear angry—things are going to end badly.

Warning Letter Excerpt

Observation Five  – “Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Supplier Corrective Action Report (SCAR) #2014-003, dated 9/22/2014, documented your supplier of PE bags (b)(4) was supplying packaging with wrinkles in the seal. The root cause was determined to be improper pressure for the rewind belt and the operator using excessive tension settings and the SCAR was closed based on employee retraining on 9/30/2014. However, review of your Material Disposition Log for your High-Flo 4-needle set, 26 gauge 9 mm length needles (b)(4), documented continued problems with seal quality, to include wrinkles in the seal, for additional seals provided by this supplier on 12/2/2014. Your SCAR did not adequately verify or validate the corrective action made by the supplier to ensure the action was effective and did not adversely affect the finished device. The SCAR was closed without requiring or ensuring the root cause of the seal wrinkles was corrected and effective. When continuing issues were identified with package seals from this supplier on 12/2/2014, you did not re-evaluate or re-investigate the SCAR.” 

“We reviewed your firm’s response and concluded that it is not adequate. You indicate you revised the corrective action process, SOP 8034 Revision G. Revised written CAPA procedures, however, have not been provided to date. Your response does not indicate any further corrective action activities will take place with respect to the package issues with your supplier.” 

21 CFR, Part 820.100 – Corrective and Preventive Action

“(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;

(2) Investigating the cause of nonconformities relating to product, processes, and the quality system;

(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;

(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;

(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;

(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and

(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.”

Compliance for Dummies

Managing supplier corrective action is not rocket science. However the SCAR process should always be driven by risk. Years ago, W. Edwards Deming emphatically stated a famous quote: “In God we trust, all others bring data.” The “trust but verify” mantra is a critical piece of the SCAR process. For example, an establishment might have a minor issue with a supplier that fails to place a certificate of conformance into a shipping carton with the product. This minor nuisance can typically be resolved with a quick phone call (documented, of course). If the nonconformance occurs a second time, maybe an information-only SCAR will suffice. However, if the problem continues to recur, formal corrective action is probably going to be warranted. Unfortunately, for device establishments that fail to effectively employ SCARs, corrective action will not be forthcoming from the supplier. In fact, history will continue to repeat itself.

Conversely, if the supplier is shipping bad product or a supplier’s nonconforming product has found its way into an establishment’s supply chain, causing a recall (Dr. D’s favorite 6-letter word), formal corrective action should always be required. Issue the darn SCAR people! Additionally, make sure an appropriate level of VOE is pursued. It is ok for suppliers to take ownership of the SCAR, but it is always going to be the device establishment’s responsibility to perform VOE or at least to ensure the VOE pursued by the supplier is adequate. Trust but verify!

Furthermore, ensure the suppliers actually respond to a SCAR in a timely manner. In fact, ensure suppliers respond, period! Far too many times Dr. D has seen an establishment issue a SCAR, and then it fails to actually follow-up when a SCAR response has not been received from an offending supplier. Remember, it is not enough to just issue the SCAR.

Finally, suppliers do not like surprises either. No supplier wants to be on the receiving end of a call that starts with: “We are pulling the plug on your organization due to quality issues.” This is particularly true when the device establishment has failed to provide any indication of quality-related issues. No calls, no SCARs, nada!

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway. The SCAR is an extremely important tool needed to manage supplier performance issues. If an establishment fails to notify suppliers when non-conformances occur ,then supplier-related problems are not going to be corrected. History is destined to repeat. Remember, FDA does not like surprises, device establishments do not like surprises, and suppliers do not like surprises. Develop a robust approach to SCAR management and use it! 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. (April 2015). 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. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Repro-Med Systems, Inc. Accessed March 08, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488301.htm