Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Youkoso irasshai mashita” or for those of you with some degree of literacy in Japanese; “ようこそいらっしゃいました.” The literal translation is “welcome.”

If the individual greeting you is not smiling and offers a plate of Fugu, while insisting that it is okay to consume it raw (all parts), you may want to politely bow and then run quickly in the opposite direction.

Similar to EN ISO 13485:2012, Ministerial Ordinance 169 (MO 169) requires device manufacturers to actually monitor and measure the effectiveness of the QMS. Similar controls are required for products and specially designated medical devices (unique to PAL). If you take some time and digest the concept of monitoring and measuring, the reasons driving these regulatory requirements are eloquently simple but immensely important in the manufacture of medical devices that are safe and effective.

That being said, Dr. D will spell out the concept. It is not enough for device manufacturers to simply clone a QMS or develop procedures employed for device manufacturing. Device manufacturers must be able to gauge the effectiveness of the policies, procedures, and processes employed and provide objective evidence that their approach to quality and the manufacturing of devices is effective. This is where the monitoring and measuring comes into play.

For example, if production yields are being adversely influenced by poor supplier performance; not only are the yield metrics important, so are metrics reflecting the supplier’s performance. These metrics may be viewed as supplier yields, on-time-delivery, or even the response to supplier corrective action requests (SCARs). The beauty of it all is that it is your system so you can define the approach to monitoring and measuring that fits your organization’s QMS and overall approach to device manufacturing. Some of the readers may find this hard to believe, but the doctor has spent a great deal of his life “peripatetic” (look-it-up). However, this constant being in motion has allowed Dr. D to absorb much knowledge and be in a position to share his wisdom and smart-ass comments with others.

Ministerial Ordinance Number 169 (2004)

 

Dr. D will keep it simple for the readers this week, or as they say in da hood, keep it real. As stated in the introduction, it is not sufficient for device manufacturers to write great procedures in support of establishing a QMS. In fact, attempting to clone the biggest, bestest (yes – bestest but the doctor isn’t playing scrabble here) and most effective QMS might be a noble endeavor. However, device manufacturers must still devise ways to effectively monitor and measure the effectiveness of the QMS. Guess what? If the QMS is not operating effectively or meeting the planned outcomes, the QMS will need to be tweaked (yes-another highly-technical term from the doctor). In this context, the term tweaked equates to the device manufacturer’s need to pursue Corrective Action and Preventive Action (CAPA), as appropriate. 

For you scholars of Quality Management 101, the monitoring and measuring concept implies the use of metrics to gauge the overall effectiveness of the QMS, well at least in Dr. D’s world it does. So what metrics should an organization consider doctor? Some of the time-tested favorites that Dr. D recommends are:

• Timeliness of internal audits;
• Non-conformances identified during internal audits;
• CAPAs with a focus on timely completions and verification of effectiveness;
• Supplier performance;
• Timeliness of management reviews;
• Customer feedback and complaints; and one of the doctor’s favorites,
• Product recalls (recall that nasty six-letter word).

The beauty of MO 169, just like ISO 13485, it is up to the device manufacturer to decide what to monitor and measure. However, if your organization’s voicemail system is being blown up due to customer complaints; or product recalls are marching through the doors like Napoléon’s return to France, their just might be a problem with the monitoring and measuring of the QMS. Can you say CAPA? Better yet, can you say PMDA or MHLW? Why? Because if medical device manufacturers are having quality problems with devices entering into Japan, it is not a question of if PMDA will come calling, it is a question of when.

In an effort to continue with the keeping it real concept, dudes – it is not enough for medical devices to actually just work. Like wow dude, you mean we just can’t throw stuff together and call it a medical device? Alright the doctor will stop. Seriously, it is a salient requirement for medical devices to be safe and effective in their intended use. However, that is not enough. Medical devices must be manufactured in an appropriate environment that employs recognized standards, documented procedures, and processes. Hopefully, those processes have been properly validated.

Not only do medical devices designed, developed, manufactured, and approved for the Japanese market need to be safe and effective, there must be documented evidence of conformity to the product specification, standards employed for testing, MO 169; and any all requirements (statutory and regulatory), as required. Records of conformity, including the individual(s) authorizing the release of medical devices, must be meticulous.

Getting back to MO 169, the monitoring and measuring of processes applicable to the product, similar to the monitoring and measuring of the QMS, must be effective. It is incumbent upon the device manufacturer to identify metrics relevant to the manufacturing processes used to build their products. For example, if a tip-tensile test is required to ensure the tip of an electrophysiological catheter does not separate from the catheter shaft, then this critical process should probably monitored. From a generic perspective, critical processes, inspection toll-gates, and product yields are excellent areas to collect metrics relevant to evaluating products. Unfortunately, so are customer complaints, if non-conforming products make their way into the hands of the healthcare providers.

The monitoring and measurement of specially designated medical devices is a requirement specific to Japan (reference PAL). MO 169 requires that the identity of the individual or individuals performing any inspection or testing on specially designated medical devices be recorded. The primary reason for this requirement is that if medical devices entering into the Japanese market seriously injure a patient or result in a patient death, PMDA needs to know which individuals within your organization receive a ceremonial sword to fall on (just kidding).

From Dr. D’s perspective, regardless of whether the monitoring and measuring applies to processes or products, the approach needs to be effective. The metrics selected must be meaningful and the data collected actually analyzed to ensure the QMS or the manufacturing environment is firing on all cylinders. A problem the doctor sees far too often, while auditing organizations, is the collection of marvelous metrics, with all kind of charts (p-charts, n-charts, etc.); however, the data is months old and management is doing nothing with the data being collected. What in the heck is the point of monitoring and measuring just for the sake of monitoring and measuring, if an organization is not going to use the data to drive continuous improvement? Trust the doctor when I say, it will be just a matter of time until bad things happen to a medical device manufacturer that fails to monitor and measure all aspects of their organization (processes and products). Before Dr. D forgets, and for those of you still interested, the doctor continues to be big on mapping regulations and requirements to the QMS. With that in mind, Table 1.0 contains an example of a mapping matrix relevant to the articles discussed.

Table 1.0 – Sample Requirements Matrix
Procedure	Procedure Name	Requirement	21 CFR, Part 820	EN ISO 13485:2003	MHLW MO 169
1267-1 Rev A	Monitoring and Measuring of Processes and Products	Monitoring and Measuring of Processes	820.70	8.2.3	Article 57
1267-1 Rev A	Monitoring and Measuring of Processes and Products	Monitoring and Measuring of Products	820.70	8.2.4	Article 58
1268-1 Rev A	Monitoring and Measuring of Specially Controlled Medical Devices	Monitoring and Measuring of Specially Controlled Medical Devices	N/A	N/A	Article 59

 

For this edition of DG, the doctor will leave the readers with just two takeaways. One – It is incumbent upon device manufacturers to monitor and measure processes and products employing robust metrics that actually have some intrinsic value. When the results of monitoring and measuring point to the need for CAPA; “Get er Done!” (comment courtesy of Larry the Cable Guy).  Two – If the folks tasked with inspecting and testing specially designated medical devices remain focused and ensure only medical device that are safe and effective make their way into Japan, they will never need to worry about someone shipping them a ceremonial sword.

Until the next edition of DG, when the doctor provides guidance on MO 169 – Chapter 2, Section 6 “Measurement, Analysis, and Improvement” (Article 60 Control of Nonconforming Product), 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.