Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Saru mo ki kara ochiru.” For those of you moderately fluent in Japanese, the phrase is: “猿も木から落ちる” The literal translation is “Even monkeys fall from trees” or simply stated, “No one is perfect.” Or as they say in the hood, “my bad!”

If a device manufacturer is having a conversation with PMDA about product entering into the Japanese market that is not safe and effective, 猿も木から落ちる is not a valid excuse. After product has been withdrawn from the Japanese market, the Chief Jailable Officer (CJO) can withdraw the ceremonial sword from its sheath and fall on it. Sayonara!

Before I dive into this week’s guidance, I wanted to thank the readers that visit and read Devine Guidance week-after-week. I do thank you from the bottom of my heart. I know most of you enjoy reading what I write. It is you (the readers) that give me the drive and inspiration to write every week. Trust me, writing every week isn’t easy. Some of you (and you know who you are) hate what I write, but I am still glad you have taken the time to at least attempt to read my weekly tirades. I will convert you to my quality and regulatory beliefs eventually. Some of you who are new to the device industry or have no opinion, please keep reading and I promise I will make you a believer of Dr. D’s path toward quality and regulatory compliance. 

In recent years, I have had a few folks claim that Dr. D was absolutely blind when it comes to a realistic approach to quality and regulatory compliance. Guess what, there may be some truth to the being blind part. However, the blind piece is from a physiological standpoint and not a philosophical standpoint (my opinion). Dr. D has put off, long-enough, necessary cataract surgery and will going under the knife at the end of this week to restore my vision. That being said, there will be no DG next week (Thanksgiving Week). For those of you living in the states, I hope you and your families have a safe and enjoyable Thanksgiving. For my readers residing outside of U.S. enjoy life. I will be back in a couple of weeks. Remember, one should never feel “compunctious” (look-it-up) about realizing their dreams, work hard and good things will happen. 

Ministerial Ordinance Number 169 (2004)

Preventive action is one of the areas where Dr. D sees mixed levels of compliance. The doctor believes that this is due in part because of the fine line between corrective action (CA) and preventive action (PA) and knowing what the differences are between the two. For example, if a device manufacturer is already experiencing product failures in the field; and customer complaints are lighting up the phone lines, the time for PA has passed. The time for PA is when a customer casually mentions a product performance issue (still a complaint mind you) but the potential issue has yet to go ballistic. Better yet, process improvements are identified and made preventing a performance issue from ever occurring.

From an Article 64 of MO 169 perspective, similar to CA, there are very specific requirements that need to be included in the established procedure. For those of you that have not had the chance to read last week’s edition of DG; now would be a good time. Why? Last week Dr. D covered CA; and the doctor strongly believes that CA and PA should be combined into one procedure (CAPA), not unlike peanut butter and chocolate found in a Reese’s Peanut Butter Cup or Jack Daniel’s and ice found in Dr. D’s favorite beverage. The salient requirements device manufacturers need to address, as part of a PA, procedure are:

• The identification of non-conformances before they happen (the RA & QA folks need to be clairvoyant);
• The Evaluation and determination of the need for action;
• The implementation of appropriate action to prevent a non-conformance from occurring;
• The recording and maintaining of records of all PA pursued; and
• The execution of the VOE for the PA pursued.

Dr. D frequently is asked “How does an organization determine the VOE for PA?” Once again, the doctor’s answer is “it depends.” For example, if a sales rep was sitting in on an electrophysiological procedure (being performed in Tokyo) employed to treat an arrhythmia; and the EP doc complained (in Japanese of course) that the catheter steering was more difficult than usual (still a complaint); immediate action taken to remedy the problem could be categorized as PA. If no “formal complaints are received,” after the PA has been implemented, the VOE could be deemed effective. If the same doc hints that a different color handle would be beneficial in the catheter lab (day-glow green let’s say) and a preventive action request (PAR) is opened to change the handle color. Once the new handles have been implemented and the EP doc is happy, then the VOE would be deemed acceptable. Dr. D is sure most of you could probably come up with better examples of PA on your own, but hey, this is my weekly blog.

What device manufacturers need to do

As Dr. D has already stated, instead of generating a stand-alone procedure for PA, combine it with PA’s bestest (not a word, the doctor knows) friend CA and form a CAPA procedure. Another little secret the doctor will let the readers in on; medical device manufacturers may actually want to initiate some PA activity. PA is a fundamental requirement in Japan; and the PA requirement can be found in just about every medical device regulation and standard known to man. Failure to pursue PA and a device manufacture threatens to annoy the regulatory deities, in Japan, tasked with enforcing these regulatory requirements.

For those of you continuing to build your requirements matrix, Dr. D has added the PA requirement. As you can see, the doctor has taken the liberty of combining CA and PA to form CAPA. What a novel thought, but not Dr. D’s idea. Maybe Deming?

Table 1.0 – Sample Requirements Matrix
Procedure	Procedure Name	Requirement	21 CFR, Part 820	EN ISO 13485:2003	MHLW MO 169
1272-1 Rev A	Corrective & Preventive Action (CAPA)	Preventive Action	820.100	8.5.3	Article 64

Takeaways

For this edition of DG, the doctor will leave the readers with two takeaways. One – be proactive and create just one procedure for corrective action and preventive action (CAPA). Two – medical device manufacturers must actually pursue PA and have documented evidence of their efforts. After all, if PA is not documented in writing, it never happened. Failing to have documented evidence during a PMDA inspection, may result in the CJO being asked to fall on that proverbial ceremonial sword.

Until the next edition of DG (two weeks on 11/28), 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 65 – Responsible Engineering Manager), 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. EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
3. Linguanaut the Japanese phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm
4. 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