Devine Guidance

MHLW MO 169 – Chapter 3 – Training

By Dr. Christopher Joseph Devine
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Training is one of the areas that result in many non-conformances being issued during quality system audits.

Ohayou Gozaimasu. This week the term/phrase specific to Japan, the doctor would like to introduce to the readers is: “Byouin ni ikitai” For those of you moderately fluent in Japanese, the phrase is: “病院に行きたい。” The literal translation is “I need a doctor.” If this phrase is coming from your Chief Impalable Officer (CIO) after a particularly bad PMDA inspection, it is safe to assume, this individual has chosen to fall on the sword versus fixing the quality issues.
This week Dr. D is going to revisit the need for training as required by Ministerial Ordinance 169; and just about every other regulation known to man, as it pertains to medical device manufacturers. Let the doctor begin by stating, training is one of the areas that result in many non-conformances being issued by the doctor during quality system audits. You see, once all of the procedures have been written and forms created, medical device manufacturers must actually train to the procedures before applying them. Wow, who knew Dr. D?

Training should be considered a salient requirement and treated as a cornerstone for an effective QMS. Please note, Dr. D is not some ancient Roman “haruspex” (look-it-up) using dead-animal parts to predict the future, but just an author trying to provide some insight into an often boring topic, quality and regulatory compliance. That being said; enjoy this week’s guidance.

Ministerial Ordinance Number 169 (2004)
Chapter 3 Manufacturing Control and Quality Control in Manufacturing Sites of Labeling, etc. – Category Medical Device Manufacturers, etc.
(Training)
Article 71 The labeling, etc. – category medical device manufacturer, etc. shall have the person designated beforehand conduct the following duties in accordance with the documented procedure.
(1) To implement as planned the training concerned with the manufacturing ` control and quality control for the personnel,
(2) To report in writing the results of the training to the responsible engineering manager, and
(3) To establish and maintain records of the implementation of the training.
What device manufacturers need to know
Implementation of a compliant training program is a relatively easy task (Dr. D’s opinion) so how come far too many organizations fail to succeed? One of the pitfalls that the doctor frequently sees is the strong reliance on software to manage the training program when the software was actually designed for another task such as running MRP. If an organization wants software for training management, there are dedicated platforms available for that task. Heck, a simple database employing Microsoft™ tools such as Access™ will work just fine, if the controls are in place.
Article 71 pursues an extremely pragmatic approach to training with six basic steps employed.
  • Step 1 – Identify an individual, within the organization, to oversee employee training.
  • Step 2 – Generate an effective training procedure.
  • Step 3 – Perform training for manufacturing and quality personnel, although Dr. D will let you in on a little secret, “All employees, regardless of function, need training!”
  • Step 4 – Document and retain all records associated with training.
  • Step 5 – Report the result of the training and effectiveness to management.
  • Step 6 – Have swords available to fall on for all employees that fail training (just kidding about Step 6, a plastic spoon will do). Oops, there are really just five steps but hey, this is Dr. D’s column.
What device manufacturers need to do
What manufacturers need to be doing is so simple, Dr. D feels ridiculous bringing it up but obliged to do so. How about making sure employees are properly trained and their training documented. Pretty simple, hey? Seriously: (a) MO 169; (b) 21 CFR, Part 820; and (c) EN ISO 13485:2012 each have many common requirements, with training being one of them. So what is the problem with complying? For example, if an assembler is building a catheter, not only is the work instruction important but documented evidence the assembler has actually been trained to the work instruction is required. The same holds true for inspectors. If an inspector is inspecting a catheter, not only is the inspection instruction required but documented evidence the inspector has been trained to the inspection instruction, is a fundamental requirement.

The same holds true for device manufacturer employees performing internal audits or opening CAPAs. These individuals must have documented evidence that they have been trained to the procedures governing internal audits and CAPAs. If you can see the trend here – good!  If you cannot see the trend here, see your optometrist. If comprehension is the issue, see your CIO as this individual may have an extra sword or two.

Article 71 is nothing more than a reinforcement of Article 23. Training is a salient requirement and the regulatory folks in Japan expect device manufacturers to comply with the requirement through the training of employees. Table 1.0 captures an example of a requirements matrix with the training requirement, with multiple regulatory requirements being mapped to a single procedure.  

  Table 1.0 – Sample Requirements Matrix

Procedure(s) 

 Procedure Name(s) 

 Requirement 

 21 CFR, Part 820 

 EN ISO 13485:2012 

 MHLW MO 169 

 1247-1 Rev C 

 Competence, Awareness, and Training  

Training 

 820.25(b) 

6.2.2 

Article 23

Article 71 

Takeaways
For this edition of DG, the doctor will leave the readers with two takeaways. One – device manufacturers are required to establish a procedure that governs training. Two – device manufacturers must actually train their employees and the training documented. Remember, if the training is not documented in writing, in the eyes of the Japanese regulatory gods (MHLW and PMDA), the training never occurred.

Until the next edition of DG, when the doctor provides guidance on: MO 169 – Chapter 3 “Manufacturing Control and Quality Control in Manufacturing Sites of Labeling, etc. Category Medical Device Manufacturers, etc.” (Article 72 – Control of Documents & Records), 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
  5. Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International

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