Procurement Management and QCD Evaluation in Medical Devices

Procurement management plays an extremely important role in the design and manufacturing processes of medical devices. Under MDSAP, FDA QSR 820 Part D, ISO 13485, and Japan’s Pharmaceutical and Medical Device Agency (PMDA) guidance based on the Pharmaceutical Affairs Law, the procurement management process is subject to audit just like design management and manufacturing management. In particular, MDSAP emphasizes through what is called “process linkage” that the procurement management process is interconnected with other critical processes.

Preliminary Supplier Evaluation and Periodic Re-evaluation

Preliminary evaluation of suppliers and periodic re-evaluation (for example, at least once per year) are extremely important for ensuring the quality and safety of medical devices. For suppliers already making deliveries, supplier evaluation can be conducted based on the results of incoming inspections, the quality of delivered items, and the supplier’s performance (on-time delivery status, manufacturing quality, etc.). Conversely, for new suppliers, supplier evaluation must be conducted based on evaluation questionnaires, audits, and other assessment methods.

Many medical device companies are believed to evaluate suppliers using Q (Quality), C (Cost), D (Delivery), and other factors. However, the most critical point to note here is that the individual QCD components must not be summed to create a combined score.

Proper Evaluation Method for QCD

In medical device regulation, the highest priority must be given to quality. Therefore, acceptance criteria (passing threshold) must be established based solely on quality (Q) evaluation. If QCD items are summed, there is a risk that a supplier with poor quality could still be adopted if they offer low cost and short delivery times—a serious risk to the quality and safety of medical devices.

This principle can be illustrated by analogy with the interpretation of various laboratory values in clinical practice. For example, height, weight, and blood pressure are each distinct indicators with different clinical significance, and it would be meaningless from a medical standpoint to sum these measurements. Similarly, quality, cost, and delivery are independent evaluation dimensions that must be properly assessed against their respective standards. A supplier that fails to meet quality standards should not be adopted, regardless of how excellent their performance may be in other categories.

Risk-Based Supplier Evaluation and Management

On the other hand, corporate resources are finite, and it is not practically feasible to implement the same level of rigorous evaluation and audit for all suppliers. Therefore, phased management according to the degree of risk posed by the supplied product and the supplier becomes necessary. To ensure the effectiveness of supplier management, it is important to establish a risk-based classification system and define acceptance criteria (passing scores) corresponding to each class.

A typical classification example would be as follows:

Class	Description	Examples
Class A	Critical process outsourcing	Design outsourcing, major manufacturing process outsourcing, OEM supply, sterilization processing, etc.
Class B	Critical components/materials	Items that directly and significantly impact the safety and efficacy of the final product
Class C	Non-critical components/materials	Assembly components, general ancillary materials, temporary product storage services, etc.
Class D	Standard components/materials	Unit components, commercial off-the-shelf items, packaging materials, etc.
Class S	Services	Calibration services, analysis/testing services, transportation/packaging services, consulting services, etc.

Suppliers in Class A require the most stringent management. Specifically, supplier audits prior to contract finalization must be made mandatory, quality assurance and supplier communication protocols must be documented to enable rapid response when problems are identified, periodic supplier audits must be conducted at least annually as a rule, and supplier evaluations must be performed at least annually. These requirements must be clearly defined within the medical device company’s quality management system (QMS).

Additionally, the inspection method for supplied products must also be determined based on risk. Class A products may require 100% inspection in some cases, while products from well-established suppliers may be adequately controlled through sampling inspection. When sampling inspection is employed, it is important to set a statistically appropriate sample size, which is typically determined according to acceptance sampling standards such as ANSI/ASQ Z1.4.

The specific management requirements, acceptance criteria points, re-evaluation frequency, and inspection methods for each risk class must be documented in the company’s quality management system and communicated to all relevant personnel. This approach enables medical device companies to ensure quality and safety while efficiently allocating limited resources.