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)
(Monitoring and Measurement of Processes)Article 57 The manufacturer, etc. shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes.2. The manufacturer, etc. shall ensure that the methods specified in preceding Paragraph 1 demonstrate the ability of the processes to achieve the results defined in the plan specified in Paragraph 1 of Article 14.3. The manufacturer, etc. shall ensure that, when the planned results specified in Paragraph 1 of Article 14 are not achieved, the correction and corrective action shall be taken, as appropriate, to ensure the conformity of the products.(Monitoring and Measurement of Products)Article 58 The manufacturer, etc. shall monitor and measure the characteristics of the products to verify that the product requirements have been met.2. The manufacturer, etc. shall ensure that the monitoring and measurement specified in preceding Paragraph 1 should be carried out at appropriate stages of the product realization process in accordance with the planned arrangements and documented procedure specified in Item (2) of Paragraph 1 of Article 41.3. The manufacturer, etc. shall ensure that the evidence of the conformity with the acceptance criteria is maintained.4. The manufacturer, etc. shall ensure that the records indicate the personnel authorizing the release of the products.5. The manufacturer, etc. shall ensure that the product release and service delivery do not proceed until the arrangements defined in the product realization plan have been satisfactorily completed.(Monitoring and Measurement of Specially Designated Medical Devices)Article 59 The manufacturer, etc. shall record the identity of the personnel performing any inspection or testing specified in preceding Article of the products concerned with the specially designated medical devices.
- 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).
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.
| Table 1.0 – Sample Requirements Matrix
||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|
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.
- 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.