Control of purchasing and supplier management activities continue to be the Achilles heel for many medical device companies. The problem is rooted in effective supplier management. You see, there is simple seven-letter word “control” that is often misinterpreted by device manufacturers. In the eyes of regulatory bodies, or in this case the Japanese regulatory bodies (MHLW and PMDA) control of suppliers means device manufacturers must actually evaluate and select their supplier base premised on the supplier’s ability to meet requirements. However, Dr. D would like to add a four letter word of his own @#!$ (just kidding) the word is “risk.” Device manufacturers need to be pursuing a risk-based approach to supplier selection, evaluation, qualification, and sustaining activities. Now the doctor is not one to want to vilipend (look-it-up) the Japanese regulatory bodies, as that would equate to poking a bear in the eye with a sharp stick. So the message that needs to be sent, in the case of this week’s guidance, is to just comply baby. That being said, Dr. D hopes you enjoy this week’s guidance.
(Purchasing Process)Article 37 The manufacturer, etc. shall establish the documented procedure to ensure that the purchased products conform to the requirements that they specify for the purchased products (hereinafter referred to as “purchased product requirements”).2. The manufacturer, etc. shall ensure that the type and extent of the control applied to the supplier and the purchased products are dependent upon the effect of the purchased products on subsequent product realization or the final products.3. The manufacturer, etc. shall evaluate and select the suppliers based on their ability to supply the products in accordance with the purchased product requirements.4. The manufacturer, etc. shall ensure that the criteria for the selection, evaluation and re-evaluation are established.5. The manufacturer, etc. shall ensure that the records of the results of the evaluations specified in preceding Paragraph 3 and any necessary actions arising from the evaluation are maintained.(Purchasing Information)Article 38 The manufacturer, etc. shall ensure that the information on the purchased products (hereinafter referred to as “purchasing information”) describes the products to be purchased, including the following items where appropriate.(1) The requirements for the approval of the purchased products, procedures, processes and equipment,(2) The requirements for the qualification of the personnel,(3) The quality management system requirements, and(4) Other information necessary for the purchased products.2. The manufacturer, etc. shall ensure the adequacy of the purchased product requirements prior to their communication to the supplier.3. The manufacturer, etc. shall maintain, to the extent required for the traceability given in the documented procedure in accordance with the provision of Paragraph 2 of Article 48, relevant purchasing information, i.e. documents and records.(Verification of Purchased Products)Article 39 The manufacturer, etc. shall establish and implement the inspection or other activities necessary for ensuring that the purchased products meet the specified purchase requirements.2. Where the manufacturer, etc. or their customer intends to perform the verification at the supplier’s premises, the manufacturer, etc. shall state the intended verification arrangements and method of the product release in the purchasing information specified in preceding Article.3. The manufacturer, etc. shall maintain the records of the verification specified in preceding Paragraph 2.
Eventually, a device manufacturer will end up disqualifying a bad supplier. Furthermore, records of supplier evaluations are required. Can you say documented evidence of compliance? Dr. D knew you could.
- Define the actual requirements (i.e., material specs, purchase orders, etc.);
- Define special requirements in regards to personnel qualifications for a supplier (if deemed appropriate);
- Define QMS requirements (e.g., ISO 9001:2008); and
- Any additional information that may be considered relevant to the procurement process.
- Make sure the Purchasing SOP defines all aspects of the procurement process.
- Make sure the Purchasing SOP references the Supplier Management SOP.
- Make sure the Purchasing SOP references the Purchase Order Form.
- Make sure the Purchasing SOP references the use of an Approved Supplier’s List (ASL).
- Make sure the Purchasing SOP states that purchase orders (including change orders) are always sent to the supplier.
- Make sure the Purchasing SOP states that a component specification, purchase specification, or other supporting documentation accompanies each purchase order.
- Make sure the Purchasing SOP delineates the type of purchasing record(s) to be retained and where the records are retained.
- Make sure the Purchasing SOP delineates the use of a Supplier No-Change Agreement.
- The requirements for supplier selection;
- The requirements for supplier evaluation (including audit checklists and questionnaires);
- The requirements for supplier re-evaluation; and
- The requirements for supplier disqualification.
- The establishment of a supplier statistical data program (supplied data) in lieu of defensive-receiving inspection;
- The establishment of a skip-lot inspection program and similar programs to reduce the burden of defensive-receiving inspection;
- The use of supplier report cards;
- The supplier corrective action process;
- Target acceptance rates at incoming inspection; and
- A supplier quality agreement that delineates the roles and responsibilities for the device manufacturer and the supplier.
- Inspection sample sizes;
- Material acceptance requirements;
- Acceptance labeling;
- References to types of inspection (First Article, Receiving, Skip-Lot, or Supplier Statistical Data; a.k.a., supplied data);
- The collection of inspection metrics;
- A pointer to the non-conforming material process; and
- A pointer to the supplier corrective action process.
|Table 1.0: Sample Supplier Categories
|Annual On-Site Assessment Mandatory – Due to Risk||Contract Manufacturers|
|Category 2||On-Site Assessment Mandatory – Once Every 2 years (Premised on Schedule & Risk)||
Components Identified as Critical Premised on the Device FMEA
|Category 3||On-Site Assessment as Necessary (Premised on Risk)
Mail-in Survey Required Once Every 3 Years
Non-Critical Custom Material, Process, and/ or Component
Current EN ISO 9000 or EN ISO 13485 Quality Certificate is acceptable in lieu of survey
Distributors of Catalog Components
|Table 2.0: Sample Requirement Matrix|
|| 21 CFR, Part 820
|| EN ISO 13485:2003
||MHLW MO 169|
1251-1 Rev B
|Purchasing||Purchasing Process||820.50||7.4.1||Article 37|
|1251-1 Rev B||Purchasing||Purchasing Information||820.50(b)||7.4.2||Article 38|
|1252-1 Rev A||Supplier Management||Purchasing Process||820.50||7.4.1||Article 37|
1253 – 1 Rev C
|Receiving Inspection||Verification of Purchased Product||820.80(b)||
- Write separate procedures for Purchasing, Supplier Management, and Defensive-Receiving Inspection.
- Make sure a supplier no-change agreement is signed and on file.
- If possible, implement a supplied data program.
- When deemed appropriate, always issue a supplier a corrective action request for non-conformances.
- The doctor strongly recommends writing supplier quality agreements for key suppliers.
- Make sure the supplier selection and evaluation process is linked to risk.
- 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