Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Kaeru no ko wa kaeru.” For those of you moderately fluent in Japanese, the phrase is: “蛙の子は蛙.” The literal translation is “child of a frog is a frog” or simply stated, “Like father, like son.”

Depending on the competency of a device manufacturer’s Chief Jailable Officer (CJO) and the CJO’s direct reports, this Japanese saying could be a good thing or a bad thing. If the Japanese regulatory gods, and specifically the good folks at PMDA believe that a device manufacturer’s attempts to comply with Ministerial Ordinance 169 (MO 169) are futile; then 蛙の子は蛙 is a bad thing. In fact, if a device manufacturer’s QA and RA staff is clueless, that would be a very bad thing indeed. But cheer-up, Dr. D believes strongly that most QA and RA folks want to do the right thing and comply with MO 169. 

 
Now the doctor is quite sure each and every one of the readers has a “tutelary” (look-it-up) quality or regulatory guru that they rely on for direction. It is very important to query these experts whenever you have questions about country-specific requirements in regards to quality and regulatory. Otherwise, failing to comply with a minor detail can result in a device manufacturer’s products being locked out of a viable market. In short, ask! If you do not know, feel free to ask Dr. D. The doctor has several tutelary gurus that he can go to when he has questions. These sessions are called Dr. D’s “drink’n and think’n sessions.”  

Ministerial Ordinance Number 169 (2004)

What device manufacturers need to know

A couple of months ago, Dr. D discussed MO 169, Article 60 and the similarities of Article 60 to EN ISO 13485:2012 (clause 8.3) & 21 CFR, Part 820.90 requirements. Article 68 just reinforces the need for the labeling, etc. – category medical device manufacturers to actually implement the necessary policies and procedures to control nonconforming product. As the doctor’s followers already know, the Dr. D is big on written procedures. When it comes to identifying and controlling nonconforming product, the doctor places a significant emphasis on the need for a robust system, premised on well-written procedures for controlling nonconforming product. Remember, it is always a bad thing for nonconforming product to find its way into the supply chain. How would you like to be on the receiving end of a medical device that fails to be safe and effective in its intended use, because the device or some of its components are nonconforming? The doctor’s answer is pretty simple – NO, NO, NO, NO, NO!

What device manufacturers need to do

The basic principles associated with the control of nonconforming product, according to Dr. D (Dr. D’s Nine Principles for the Control of Nonconforming Product) are:

• Generate a well-written procedure that delineates the entire control of nonconforming product, including the links to CAPA System and the Complaint Management System.
• Make sure there is a tag or label (Bright Red) that can immediately be affixed to nonconforming product.
• If the nonconforming product is no longer under the control of the device manufacturer, it needs to be recovered ASAP! Can you say recall (Dr. D’s favorite six-letter word)?
• Immediately segregate the nonconforming product. The best place to put nonconforming product is in a locked room, cage, or cabinet with the key placed into the hands of quality only. Make sure the cage has a top on it or has razor wire near the top (sorry Fernando).
• Make sure the nonconforming material form is correctly designed to support basic material identification data, with dedicated fields for: (a) initial review; (b) final disposition; (c) Corrective Action Request (CAR) number (if applicable); (d) Supplier Corrective Action Request (SCAR) number (if applicable; (e) approval signatures; and other relevant information deemed appropriate for a device manufacturer.
• Once final disposition has been made, e.g., Scrap, make sure the nonconforming product is quickly scrapped. If it is a finished device, make sure the device is rendered unusable. Use a fork lift to destroy the product (place the product on the ground and run it over). Trust the doctor when I say; “Fork lifts work great.”
• Hold regularly scheduled Material Review Board (MRB) Meetings to ensure nonconforming product is quickly reviewed and assigned a disposition. If your organization has folks with meeting attendance issues, send a love note to the offending individual’s manager. If that doesn’t work use the fork lift to stage an industrial accident (just kidding, please do not run the offending party over with a fork lift). Since this series of article is about MO 169 and Japan, give the offending individual a sword to fall on.
• If the nonconforming product is supplier related, hold the supplier accountable. Issue a SCAR and demand a reasonable response and attempt at corrective action. If the supplier is non-responsive, find another supplier that wants the business.
• If the nonconforming product is due to a complaint, make sure a thorough complaint investigation is held, including the need to report potential adverse events. 

At the end of the day, device manufacturers must pursue any action necessary to ensure nonconforming product never finds its way into the supply chain. All kidding aside, Article 134 – sub-clause 104(z) of MO 169, requires the Chief Impalable Office to fall on a sword if nonconforming medical devices find their way into the Japanese market. Just kidding, jumping into a volcano will do. Can you say Mt. Fuji? 

For those of you still building the traceability matrix, Article 68 maps directly to ISO 13485 and 21 CFR, Part 820 (reference Table 1.0). Can you guess why the mapping for the control nonconforming product requirement is so easy? It is easy because the control of nonconforming product is a priority in all regulatory environments, regardless of country. 

Table 1.0 – Sample Requirements Matrix
Procedure(s)	Procedure Name	Requirement	21 CFR, Part 820	EN ISO 13485:2003	MHLW MO 169
1269-1 Rev A	Control of Nonconforming Products	Control of Nonconforming Products	820.90	8.3	Article 68

For this edition of DG, the doctor will make the takeaway so simple, even a caveman could do it (thank you GEICO). Once identified, nonconforming product must be: (a) tagged/labeled; (b) segregated and preferably placed under lock and key; (c) documented on a nonconforming material report; (d) evaluated; (e) assigned a final disposition; (f) have the disposition approved – hopefully by quality; and (g) the disposition executed. It sounds pretty simple right? Trust Dr. D when I say; “Mr. Murphy is alive and well and no matter how hard a device manufacturer tries to be perfect, stuff happens.”

Until the next edition of DG, when the doctor provides guidance on: MO 169 – Chapter 3 “Manufacturing Control and Quality Control in Manufacturing Sites of Labeling, etc. Category Medical Device Manufacturers, etc.” (Article 69 – Corrective Actions), sayonara from Dr. D and best wishes for continued professional success.

References: 

1. Code of Federal Regulation. (2011, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
2. Device master file. (2012). Emergo Group Website. Retrieved November 29, 2012, from http://www.emergogroup.com/services/japan/device-master-file-japan
3. EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
4. Linguanaut the Japanese phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm
5. Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf
6. Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf.