One final point Dr. D would like to make before diving into this week’s guidance is the evils associated with taking short-cuts. When installing a QMS, please do it right the first time. Make sure input is obtained from all members of your organization; and if necessary, hire an experienced consultant (like Dr. D) to assist with the QMS development and implementation.
- To implement the quality management system and to maintain its effectiveness, and
- To meet the regulatory and customer requirements.
- The appropriate training, and
- The appropriate skills and experience.
- To determine the necessary competence for the personnel performing the work affecting the product quality,
- To establish the documented procedure for identifying the training needs,
- To provide training or take other actions to satisfy the needs determined by the documented procedure specified in preceding Item (2),
- To evaluate the effectiveness of the actions specified in preceding Item (3),
- To ensure that the personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
- To maintain appropriate records of the training, skills and experience.
- The buildings, workspace and associated utilities,
- The process equipment (both hardware and software), and
- The supporting services (such as transport or communication).
- The manufacturer, etc. shall provide and maintain the following infrastructure in case where they manufacture the following products.
(1) For the products which need the control of dust, humidity, insects and rodents, the buildings or facilities for controlling dust, humidity, insects and rodents,(2) For the products of which manufacturing process the poisonous gases are handled, the facilities necessary for disposing of such poisonous gases,(3) For the products in a form of liquid, sol, gel or powder (excluding those concerned with the sterilized medical devices), the work rooms that meet the following requirements,
a. Being the buildings which do not allow passage of the personnel other than those conducting operations in such work rooms, with the proviso that this provision shall not apply in case where the products, etc. could not be contaminated by the personnel other than those conducting operations in such work rooms,b. Not being provided with the entrances directly leading to the outside (except those for emergency), with the proviso that this provision shall not apply in case where the work rooms are provided with the buildings and facilities necessary for preventing contamination due to the outside,c. Being provided with the entrances and windows that can be closed,d. Being provided with the buildings and facilities necessary for preventing contamination by dust or microorganisms according to the type and manufacturing process of the products, with the proviso that this provision shall not apply in case where the manufacturing facilities, etc. provide equivalent functions,e. Being provided the effluent facilities, in case where they are provided in the work rooms, with the buildings necessary for preventing contamination of the work rooms, andf. Being provided with the facilities for supplying water of the quality and quantity necessary for the manufacturing, according to the type and the manufacturing process of the products.
- The manufacturer, etc. shall establish the documented requirements for the maintenance activities, including their frequency, when such activities or lack thereof can affect the product quality.
- The manufacturer, etc. shall ensure that the records of such maintenance are maintained.
- The manufacturer, etc. shall establish the documented requirements for health, cleanliness and clothing of the personnel if contact between such personnel and the products, etc. or work environment could adversely affect the quality of the products, with the proviso that this provision shall not apply to the process in case where the products are cleaned in the subsequent process in accordance with the provision of Item (1) or (2) of Paragraph 1 of Article 41.
- If the work environment conditions can have an adverse effect on the product quality, the manufacturer, etc. shall establish the documented requirements for the work environment conditions and the documented procedure or work instructions to monitor and control these work environment conditions, with the proviso that this provision shall not apply to the process in case where the products are cleaned in the subsequent process in accordance with the provision of Item (1) or (2) of Paragraph 1 of Article 41.
- The manufacturer, etc. shall ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained as specified in Item (3) of Article 23, with the proviso that this provision shall not apply in case where the personnel are supervised by a trained person.
- The manufacturer, etc. shall ensure, if appropriate, that the special arrangements are established and documented for the control (including identification specified in Paragraph 3 of Article 47) of the contaminated or potentially contaminated products in order to prevent the contamination of other products, the work environment or personnel.
- Determining necessary levels of employee competence;
- The providing of actual training for employees;
- The evaluation of training effectiveness;
- Linking the day-to-day activities of employees and the influence these activities have on the achievement of an organization’s stated quality objectives; and
- The documenting and retaining of training records.
Remember, regulatory responsibility cannot be outsourced. That being said, whether an organization manufactures devices “in-house” or “outsources” manufacturing, MO 169 requires:
- a suitable facility;
- manufacturing equipment (hardware and software);
- utilities to power the facility;
- support functions, e.g., and IT;
- a written facilities- control procedure to address temperature, relative humidity, pest control, etc.;
- disposal of poisonous gases if used in the manufacture of medical devices, e.g., ethylene oxide employed in device sterilization;
- controlled work environments;
- a written procedures for maintenance activities, including frequency of maintenance activities; and finally,
- written records (please do not forget to keep meticulous records).
- Have restricted access (no employee pass-through permitted);
- Entrances not opening directly to outside areas (need a controlled entrance, e.g., pre-entrance room, gowning room, and pass-through door);
- HEPA filtration system to prevent particulate contamination; and
- When required, clean water and other supplies needed to support manufacturing operations.
- Establish written procedure(s) defining health, hygiene, and clothing requirements for employees;
- Establish written procedure(s) for the actual work environment (note: extremely important for manufacturing in cleanrooms and controlled environments);
- Train employees that are tasked with working within special environmental conditions; and
- Establish written procedure(s) for the identification, control, segregation, removal, and disposition of contaminated products, from the work environment.
Table 1.0 – Sample Matrix
|| 21 CFR, Part 820
|| EN ISO 13485:2003
||MHLW MO 169|
1246-1 Rev A
|1246-1 Rev A||Personnel||820.25||6.1|| Article 22
|1247-1 Rev C||Competence, Awareness, and Training||820.25(b)||6.2.2|| Article 23
|1248-1 Rev D||Infrastructure||820.70||6.3|| Article 24
|1248-1 Rev D||Work Environment||820.70||6.4||Article 25|
Until the next edition of DG, when the doctor begins providing guidance on MO 169 – Chapter 2, Section 5 (note: Section 5 will be broken down over several weeks) “Product Realization” (Articles 26 through 29), 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 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
- 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.