Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Jigou Jitoku.” For those of you moderately fluent in Japanese, the phrase is: “自業自得.” The literal translation is “One’s Act” or simply stated, “That’s what you get.” Typically used with negative connotations, if this phase is spoken by a member of PMDA, it is probably part of a longer conversation about removing medical devices from the Japanese market that fail to meet safety and efficacy standards. The good news is, the Chief Jailable officer will probably not be presented with a ceremonial sword to fall on, but that could change.

Folks – this week Dr. D is going to share some real earth-shattering news with you; and for those of you familiar with EN ISO 13485:2012, maybe not so earth-shattering but hopefully entertaining. The Japanese regulatory authorities actually expect device manufacturers to take the appropriate steps needed to continuously improve the effectiveness of the QMS. In fact, MO 169 (similar to 13485) requires CJOs to fall on swords if they fail to pursue improvement activities (just kidding – a pair of dull scissors will do).

Not wanting to over simplify Article 62 but obliged to do so, what part of “Improvement” (look-it-up) is not being understood? Seriously folks, if work is required around the house, you would work to improve your house. If your health is in question, you would see a physician and work to improve your health. If your son or daughter are constantly in trouble in school, you would slap the #$%^; just kidding, you would provide guidance to help them improve their behavior. So why is it so difficult for medical device companies to drive improvement activities? In this edition of DG, Dr. D will explore the requirements needed to drive QMS improvement.

 

Medical device manufacturers, in pursuit of complying with MO 169, are required to establish a quality policy, define quality objectives, perform internal audits, analyze the data collected, pursue CAPA, and hold management reviews, collectively to drive improvement of the QMS. For those readers following this series of DG from inception or are well-versed in ISO 13485, you are already aware that each of the elements the doctor mentioned in the previous sentence are not only salient requirements, they require established procedures. Guess what? Article 62 builds on the concept of having the need for established procedures. For example, medical device manufacturers are required to have established procedures for advisory notices, the handling of complaints, and the notification of the customer (end-user) when available information clearly points to device performance issues. Can you say RECALL (Dr. D’s favorite six-letter word)?

Some of the specific requirements associated with Article 62 are:

• Establishment of a procedure for the issuance of advisory notices or to ensure the requirement is placed into a suitable location, like complaint management procedure;
• Pursuit of an in-depth investigation for all complaints;
• Execution of extreme caution when the decision is made not to feed complaint information into CAPA (no one wants to blow-up their CAPA system with complaints; however, it is a daunting task attempting to defend why complaints did not result in CAPAs); and
• Collection and maintenance of impeccable complaint investigation records.

So folks, this is what Dr. D would do to ensure that a device organization always employs a path of improvement. For started, I would place a ceremonial sword (in a glass case) on the wall of the CJO. The sign above the sword would state; “Break glass and fall on sword in case of failure to improve the QMS!”

All kidding aside, make sure that the procedure scripted by your organization addresses all of the requirements associated with “Improvement” (Article 62). Since most medical device manufacturers, let me repeat “most device manufacturers,” get the complaint management piece right, let’s focus on what is often missed. For some reason, the issuance of advisory notices is often found missing from QMS procedures. Dr. D probably cites this as a non-conformance in one out of every four audits he performs. So guess what? If you guessed that you probably need to ensure the requirement to issue advisory notices needs to make it into a procedure, you would be correct.

Another issue the doctor often sees relates to having complaints feed into CAPA. Yes, it is possible to log complaints that may not require a formal CAPA; or CAPA is already being pursued on a similar complaint. Fine! You still need to document the reason (or maybe excuse) for not pursuing CAPA for a complaint. It might be as simple as providing a pointer to a CAPA that is already open, but you still need to do it! Finally, Dr. D would like to enforce the need for accurate and complete complaint records. You see, the good folks at MHLW have one very common belief that the Ministry shares with FDA. “If an event or action is not documented in writing, it never happened.” 

For those of you keeping up with the mapping of MO 169 to your QMS, Table 1.0 contains this week’s map. I have had a few folks that have asked the doctor if he will provide a complied map before the end of this series of articles. The good news is yes. The very last article in this series, a capstone article so-to-speak, will contain a compiled map of MO 169 to ISO 13485 and 21 CFR, Part 820.

Table 1.0 – Sample Requirements Matrix
Procedure	Procedure Name	Requirement	21 CFR, Part 820	EN ISO 13485:2003	MHLW MO 169
1271-1 Rev D	Improvement	Improvement	820.20	8.5	Article 62

 

For this edition of DG, the doctor will leave the readers with three takeaways. One – make sure detailed investigations and appropriate corrective actions are pursued for all complaints. If the decision is made not to pursue CAPA, the decision must be supported by written rationale. Two – do not forget to include the requirement for the issuance of advisory notices into a procedure. Three – make sure all complaint related investigations and activities are well-documented and the records of these activities retained.

Until the next edition of DG, when the doctor provides guidance on MO 169 – Chapter 2, Section 6 “Measurement, Analysis, and Improvement” (Article 63 – Corrective Action), 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