Dr. D would like to start this week’s guidance wishing all my readers a prosperous New Year. As this series on Japan winds down, the doctor is looking for suggestions for his next series of articles. If you have a topic you would like to see Dr. D explore, please let me know.

Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Gomenasai.” For those of you moderately fluent in Japanese, the phrase is: “ごめんなさい。” The literal translation is “sorry” or simply stated when hanging in the hood, “my bad!” If a member of PMDA politely states, sorry, followed by the phrase; “Your organization’s Seihin Hyojun Sho is completely unacceptable” and offers the Chief Impalable Officer (CIO) a sword to fall on; well Houston, I think we have a problem.

The doctor knows that many of the readers may suffer from some form of “Seasonal Affective Disorder” (look-it-up) also known as SAD, during the winter months. No, Dr. D is not making this stuff up. One cure for this affliction is creating a diversion to occupy one’s thoughts. Reading Devine Guidance (DG) and coming away with some knowledge and a chuckle can always be used to treat SAD. That being said, Dr. D is prescribing the need to read this week’s DG. Enjoy.  

What device manufacturers need to know

The doctor was on the phone the other day talking to a friend of mine at MHLW. Because of the continued concerns over quality management system (QMS) compliance, in 2013, a new division of MHLW is going to be rolled out to better drive compliance. The Samurai Division of PMDA will become a reality (just kidding). On a serious note, the regulatory gods in Japan, similar to FDA and the Competent Authorities in Europe, have promised an increased oversight of device manufacturers in the coming year. There are just way too many incidents surrounding regulatory compliance leading to device safety and efficacy issues. In a perfect world, device manufacturers should be policing themselves through established policies and procedures designed specifically for sustaining compliance to various regulatory requirements and standards. However, when the desire to obtain yen, dollars, or euros out-paces the need to design and manufacture medical device that are safe and effective, then compliance problems begin to raise their ugly little heads.

The labeling, etc. – category medical device manufacturer, etc. are required to establish a procedure for and actively pursue corrective action. Please keep in mind, Article 69 does nothing more than reinforce the requirements delineated within Article 63 (Corrective Actions). Basically, Article 69 is where the proverbial rubber meets the road in regards to complying with the MO 169 requirements for corrective action. Fundamentally, complying with the corrective action requirements delineated within Article 69 can be broken down into five-sound bites:

1. Establishment of a “written” procedure (reference Article 63);
2. Identification and evaluation of all nonconformities;
3. Identification and pursuit appropriate action(s) to preclude a recurrence of nonconformities;
4. Follow-up of all actions pursued to verify their effectiveness; and
5. Preparation to fall on a sword if the actions taken did not prevent a recurrence of nonconformities.

Additionally, make sure meticulous records are taken in regards to the corrective action process. Why? Because, in Japan just like in the good ole U.S. of A., if the investigation and subsequent corrective action(s) taken are not recorded, then in the eyes of MHLW, PMDA, and the newly formed Samurai Division, the events never happened. If corrective action has not been pursued or has not been documented, now would be the time to remove the sword from its sheath and hand it to the CIO. Heck why stop there, when the CIO is finished hand the sword to the CEO as well (just kidding).

There is no way to sugar this requirement because corrective action is not only a salient requirement for all regulatory environments; it is considered a cornerstone for an effective QMS. Considering the importance of corrective action, the doctor believes that maximum effort must be exuded when developing the corrective action procedure and the form that accompanies the procedure. As Dr. D stated a few weeks ago, fell free to combine corrective action’s (CA) best friend, preventive action (PA) into the same procedure. Just like Jack Daniel’s and Ice, CA and PA belong together, henceforth the term CAPA.

Another term that pops into the good doctor’s regulatory deranged mind is “urgency.” If the need for CAPA is being driven by product safety and efficacy issues, there is no time like the present to act with URGENCY! If you think it is tough to regain market share after a product recall (Dr. D’s favorite 6-letter word), just wait until you have a product withdraw from Japan. Quite literally, the regulatory samurai’s in Japan are sending swords to the entire management team to fall on, including the MAH in Japan. That sure is a lot stainless steel flying around baby. Seriously, it is inevitable that recalls will happen; however, the corrective action taken to preclude a recurrence of device safety and efficacy issues, will determine, in part, the fate of the offending device manufacturer. That being said, CAPA is a powerful tool that organizations need to employ to correct and hopefully prevent bad things from happening.

The nice thing about corrective action is that regardless of regulatory environment, it maps nicely to the QMS (reference Table 1.1). Finally, just a Dr. D watch out, the Verification of Effectiveness (VOE) is an area where device manufacturers need to be spending a little more time and  effort. Not performing an adequate VOE is an area where the doctor issues numerous non-conformances throughout the year. Remember, the pursuit of corrective action should not be considered a bad thing or a paperwork exercise but a valuable tool needed by device manufacturers to drive change.    

Table 1.0 – Sample Requirements Matrix
Procedure(s)	Procedure Name (s)	Requirement	21 CFR, Part 820	EN ISO 13485:2003	MHLW MO 169
1272-1 Rev A	Corrective & Preventive Action	Corrective Action	820.100	8.5.2	Article 63  Article 69

Takeaways

For this edition of DG, the doctor will leave the readers with just one takeaway. Corrective action should never be considered a bad thing. In fact, a fully functional approach to CAPA can result in a viable tool for driving organizational change. One area for device manufacturer’s to focus on, when pursuing corrective action, is the need for VOE. VOE is an integral part of the corrective action process and as a result, shortcuts should never be considered or taken to accelerate the pace of the corrective action process.

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 70 – Internal Audit), sayonara from Dr. D and best wishes for continued professional success.

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.