. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers, is “Mayotte shimai mashita
” or if you speak and read Japanese “迷ってしまいました。
The literal translation: “I am lost.” You never want to use this phrase when speaking with members of MHLW or PMDA. Why? Because the response from MHLW or PMDA just might be “Mata atode aimashou
” or in Japanese, “またあとで会いましょう!
” The literal translation being, “See you later” and that could be a bad thing. Alright Dr. D’s knows, enough with the language lessons.
This week’s guidance is rooted in two basic concepts. One – Ministerial Ordinance 169 (MO 169) requires device manufactures wanting to play in the Japanese medical-device sandbox to monitor and analyze the effectiveness of tools employed to demonstrate product conformity and Quality Management System (QMS) conformity. Two – MO 169 requires device manufacturers to actively seek feedback (positive and negative) from their customers, including post-product performance of products. (Try repeating that phrase three-times-fast, “post-product performance of products.”)
One final thought before diving into this week’s guidance, the doctor strongly believes that device manufacturers failing to comply with all of the requirements imbedded in MO 169 will face a “lugubrious” (look-it-up) outlook when it comes to entering product into the Japanese market.
Ministerial Ordinance Number 169 (2004)
Chapter Two “Manufacturing Control and Quality Control in Manufacturing Sites of Medical Device Manufacturers, etc.”
Section Six – Measurement, Analysis, and Improvement
(Measurement, Analysis, and Improvement)
Article 54 The manufacturer, etc. shall establish a plan (including determination of the applicable testing procedure, such as the statistical techniques, and the extent of the application) and implement the monitoring, measurement, analysis and improvement processes needed for the following duties.
(1) To demonstrate the conformity of the products, and
(2) To ensure the conformity of the quality management system, and to maintain the effectiveness of the quality management system.
Article 55 As one of the measurements of the performance of the quality management system, the manufacturer, etc. shall monitor the information relating to whether the manufacturer, etc. have met the customer requirements.
2. The manufacturer, etc. shall ensure that the methods for obtaining and using the information specified in preceding Paragraph 1 are determined.
3. The manufacturer, etc. shall establish the documented procedure for the feedback system to provide early warning of the quality problems and for the input into the corrective and preventive action processes.
4. The manufacturer, etc. shall ensure that the review of the experience gained from the post-production phase forms part of the feedback system specified in preceding Paragraph 3.
What device manufacturers need to know
It is simply not enough for a medical device manufacturer to have an established QMS and to test, inspect, and eventually enter into commerce devices that they believe are conforming. Device manufacturers actually have to incorporate tools employed for measurement, analysis, and hopefully, improvement. MO 169 is very specific in regards to the development and implementation of tools for: (a) monitoring processes; (b) measuring processes; (c) analysis processes; and (d) improvement processes. Additionally, these tools must be versatile as they must support product conformity activities and QMS activities, including the sustained effectiveness of the QMS.
There’s more: Feedback is a salient input that can be used to gage QMS effectiveness and product performance. Can the readers guess where the feedback is originating from? If your response is; “Internal and external customers” you would be correct. In fact, MO 169 requires the establishment of a written procedure that delineates the components of the feedback system. The readers need to keep in mind that feedback in the medical device industry has many facets that need to be addressed. Feedback must have pointers to corrective and preventive action, customer complaints, post-market surveillance, and medical device reporting requirements in multiple regulatory environments. From an Article 55 perspective, the requirements are simple:
- Using feedback to ascertain if customer requirements are achieved;
- Using feedback as an early warning sign for potential quality problems; and
- Using feedback as an input into CAPA.
What device manufacturers need to do
Considering the amount of effort that goes into the development and implementation of a robust QMS, device manufacturers must also ensure adequate control mechanisms are in place for measuring, analysis, and improvement. Dr. D has seen far too many organizations spend a ridiculous amount of time collecting metrics only to do nothing with them. Here is a classic example (real-life Dr. D story) of how not to collect and use metrics. Once upon a time, the doctor was performing a due diligence audit for a client. The facility Dr. D visited was extremely proud of their ability to define and collect metrics. There had to be a metric for just about every quality-related process. The c-charts, p-charts, np-charts and a variety of other charts were as impressive as they were colorful. However, the data told a completely different story, For example, yields were decreasing, supplier yields were decreasing, delinquent SCARs increasing, overdue CAPAs increasing, internal audits late, etc. The reason the disturbing trends in overall QMS performance was being missed, management reviews had not been held in almost 2-years. Duh! The moral of the story is simple. If an organization is not going to bother using the metrics for some serious analysis and in turn use the data to drive continuous improvement, what is the point of collecting the data? Duh!
Getting back on topic, if a device manufacturer has a QMS that is compliant with EN ISO 13485:2012 and certificated by a recognized notified body, then Dr. D will climb out on that proverbial tree limb and assume compliance to MO 169 Articles 54 and 55 can be achieved with some minor tweaks. As the dedicated readers of DG already know, the doctor is a big proponent of creating a requirements matrix that maps regulatory requirements to a device manufacturer’s QMS (reference Table 1.0).
|| Procedure Name
||21 CFR, Part 820
|| EN ISO 13485: 2003
|| MHLW MO 169
| 1265-1 Rev B
|| Measurement, Analysis and Improvement
|| Measurement, Analysis and Improvement
|| Article 54
| 1266-1 Rev C
|| Customer Feedback
For this edition of DG, the doctor will leave the readers with two takeaways. One – ensure adequate tools (written procedures) are put into place that govern monitoring, measuring, analysis, and improvement activities needed to ensure product conformity and QMS conformity. Two – feedback, regardless of whether it is good or bad should be actively sought from customers (internal and external). Feedback should be used as valuable input to drive product and QMS performance improvements. If deemed appropriate, ensure CAPA activities are pursued when the feedback clearly points to a quality problem. One final comment from Dr. D; “Feedback is free, losing business because your organization failed to respond to feedback is expensive!”
Until the next edition of DG, when the doctor provides guidance on MO 169 – Chapter 2, Section 6 “Measurement, Analysis, and Improvement” (Article 56 Internal Audit), sayonara from Dr. D and best wishes for continued professional success.
- Code of Federal Regulation. (2011, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
- Linguanaut the Japanese phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm
- 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