Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Baka wa shinanakya naoranai.” For those of you moderately fluent in Japanese, the phrase is: “馬鹿は死ななきゃ治らない。” The literal translation is “Unless an idiot dies, he won’t be cured” or simply stated, “You can’t fix stupid.” If this phrase is coming from a medical device manufacturer’s Japanese customer base, or even worse, the regulatory authorities in Japan, then Houston, I think you have a problem.
Similar to EN ISO 13485:2012, the Japanese regulators expect the manufacturers of medical devices to monitor processes used to gauge the effectiveness of the Quality Management System (QMS), analyze the data collected, and actually use the analysis of data to drive QMS improvements. Collecting and analyzing data to drive improvements. What a novel concept? Who knew?
Seriously folks; one of the doctor’s pet peeves is driving organizations to perform the collection of useful data that can be analyzed and employed for driving continuous improvement. If device manufacturers are just going through the proverbial motions and collecting data just for the sake of collecting data, well – what is the point? The data collected needs to be relevant. Let Dr. D repeat, “The data collected needs to be relevant!” The doctor is a “fecund” (look-it-up) reader and uses the material obtained through reading to drive the weekly diatribes presented in Devine Guidance. That being said, the doctor hopes you enjoy this week’s guidance.
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
(Analysis of Data)
Article 61 The manufacturer, etc. shall establish the documented procedure to determine, collect and analyze appropriate data (including the data generated as the result of the monitoring and measurement and from other relevant sources) to demonstrate the suitability and effectiveness of the quality management system and to evaluate if improvement of the effectiveness of the quality management system can be made.
2. The manufacturer, etc. shall ensure that the analysis of the data specified in preceding Paragraph 1 provides the information relating to the following items.
- The feedback collected in accordance with the documented procedure specified in Paragraph 3 of Article 55,
- The conformity to the product requirements,
- The characteristics and trends of the processes and products including the opportunities for the preventive actions, and
- The suppliers.
3. The manufacturer, etc. shall ensure that the records of the results of the analysis of the data specified in preceding two Paragraphs 1 and 2 are maintained.
What device manufacturers need to know
Start scripting the procedure folks. Why? Article 61 requires that medical device manufacturers establish a procedure that delineates their organization’s approach to the collection and analysis of data. So where does one find this so called data required by MO 169? Not too long ago, Dr. D discussed the monitoring and measuring of processes and products. This just might be an area to commence with the hunt for meaningful data. Article 61 requires that the data be relevant. It also points the reader to look at feedback (e.g., post-market surveillance data), product-related data, process-related data, and supplier-related data. Results of the data collected and subsequent data analysis should be retained as a permanent record. So let’s see if the doctor can make a simple idea such as data collection and analysis even easier to comprehend.
Dr. D will use a true story to drive home the point of data collection and analysis employed to drive continuous improvement, including business decisions. Several years ago, the doctor was working with a plastic-injection molding facility. This facility was manufacturing handles (two-halves) for an electrophysiological catheter. Over time, there was a gradual shift in handle color from white to light green. The change was subtle at first but eventually one half of the catheter handle was white and the other half was light green. When the molder stated that light green was an acceptable variation on the color white, we backed up the turnip truck and picked up the molds. The moral of the story is we were late in being able to tie the color trend to a vendor problem. The problem did not become obvious until two handles were actually welded together and the color difference became obvious. The time and costs associate with moving the molds and the revalidation of a new supplier were eye-openers.
Trends, regardless of the data being product related, supplier related, or related to the performance of QMS, warrant attention. If customers are blowing up your complaint hotline and MDRs are piling up faster than a wreck on the last lap of a NASCAR race, your organization just might have a problem. If the correct data is being collected and a sincere effort is being pursued in regards to real-time data analysis, then surprises should be few and far between.
What device manufacturers need to do
A weakness Dr. D often sees in regards to an organization’s QMS is the lack of a procedure defining the analysis of data. If an organization has crafted a procedure for the analysis of data, it often lacks the necessary granularity to be effective. People, you need to ensure the procedure is very specific about the types of data being collected, the type of analysis being performed, and the use of the trend information to drive continuous improvement. For example, if on-time delivery and product quality coming from suppliers is important; and trust Dr. D when I say this data should be important, your organization needs to quantify how this data is collected, analyzed, reported, and employed to drive improvement. Otherwise, the procurement of ½ green and ½ white catheter handles might be in your organizations future. Remember, the procedure needs to contain at least four element “congruent” (look-it-up) with Article 61:
- Feedback, e.g., post-market surveillance data;
- Product conformance to stated requirements;
- Product and process performance trends; and
- Suppliers of green catheter handles (just kidding – suppliers will do).
For those of you that are continuing to build your requirements matrix, Table 1.0 contains this week’s map. If you haven’t already noticed, Article 61 significantly mimics the ISO 13485 requirement.
|| 21 CFR, Part 820
| EN ISO 13485:2003
| MHLW MO 169
| 1270-1 Rev D
|| Analysis of Data
|| Analysis of Data
For this edition of DG, the doctor will leave the readers with just one takeaway. Please do not be that organization that gets stuck buying green catheter handles, when the requirement is for white. Article 61 does not tell device manufacturers what data needs to be collected and analyzed. It is completely up to each organization to decide. Remember, your organization, your data. You decide what data is important.
Until the next edition of DG, when the doctor provides guidance on MO 169 – Chapter 2, Section 6 “Measurement, Analysis, and Improvement” (Article 62 – Improvement), 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.