Not wanting to over simplify Article 62 but obliged to do so, what part of “Improvement” (look-it-up) is not being understood? Seriously folks, if work is required around the house, you would work to improve your house. If your health is in question, you would see a physician and work to improve your health. If your son or daughter are constantly in trouble in school, you would slap the #$%^; just kidding, you would provide guidance to help them improve their behavior. So why is it so difficult for medical device companies to drive improvement activities? In this edition of DG, Dr. D will explore the requirements needed to drive QMS improvement.
(Improvement)Article 62 The manufacturer, etc. shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of the data, corrective and preventive actions and management review.2. The manufacturer, etc. shall establish the documented procedure for the issue and implementation of the advisory notices, and shall ensure that such a procedure is capable of being implemented at any time, with the proviso that this provision shall not apply in case where the customer issues and implements the advisory notices, and the manufacturer, etc. shall provide the customer with the information necessary for issuing the advisory notices).3. The manufacturer, etc. shall ensure that the records of all the customer compliant investigations are maintained.4. If the investigation specified in preceding Paragraph 3 determines that the activities outside the manufacturer, etc. contributed to the customer compliant, the manufacturer, etc. shall ensure that the relevant information is exchanged between the organizations involved.5. The manufacturer, etc. shall ensure, if any customer compliant is not followed by the corrective and/or preventive action, that the reason is authorized and recorded.6. The manufacturer, etc. shall, in case where they become aware of the information on the products specified in Paragraph 2 of Article 253 of Enforcement Regulations, establish the documented procedure to notify such information to the customers.
- Establishment of a procedure for the issuance of advisory notices or to ensure the requirement is placed into a suitable location, like complaint management procedure;
- Pursuit of an in-depth investigation for all complaints;
- Execution of extreme caution when the decision is made not to feed complaint information into CAPA (no one wants to blow-up their CAPA system with complaints; however, it is a daunting task attempting to defend why complaints did not result in CAPAs); and
- Collection and maintenance of impeccable complaint investigation records.
All kidding aside, make sure that the procedure scripted by your organization addresses all of the requirements associated with “Improvement” (Article 62). Since most medical device manufacturers, let me repeat “most device manufacturers,” get the complaint management piece right, let’s focus on what is often missed. For some reason, the issuance of advisory notices is often found missing from QMS procedures. Dr. D probably cites this as a non-conformance in one out of every four audits he performs. So guess what? If you guessed that you probably need to ensure the requirement to issue advisory notices needs to make it into a procedure, you would be correct.
Another issue the doctor often sees relates to having complaints feed into CAPA. Yes, it is possible to log complaints that may not require a formal CAPA; or CAPA is already being pursued on a similar complaint. Fine! You still need to document the reason (or maybe excuse) for not pursuing CAPA for a complaint. It might be as simple as providing a pointer to a CAPA that is already open, but you still need to do it! Finally, Dr. D would like to enforce the need for accurate and complete complaint records. You see, the good folks at MHLW have one very common belief that the Ministry shares with FDA. “If an event or action is not documented in writing, it never happened.”
|Table 1.0 – Sample Requirements Matrix|
||Procedure Name||Requirement||21 CFR, Part 820||EN ISO 13485:2003||MHLW MO 169|
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Until the next edition of DG, when the doctor provides guidance on MO 169 – Chapter 2, Section 6 “Measurement, Analysis, and Improvement” (Article 63 – Corrective Action), 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